This paper showcases a project involved in the international Genetically Engineered Machines (iGEM) competition – a competition dedicated to the advancement of synthetic biology – executed at Delft University of Technology, the Netherlands. Through this case, we illustrate how Value Sensitive Design (VSD) and Safe by Design (SbD) are embedded in education associated with iGEM to arrive at a safe and responsible project design by integrating values and, particularly, the value of safety. As particularly SbD is still quite generally described in literature, we aim to make SbD more tangible to peers, and to inspire other iGEM teams and educators. In addition, we reflect on VSD and SbD in the context of Responsible Research and Innovation and provide guidelines for other iGEM projects to implement VSD and SbD approaches in their designs. To conclude, we explore if, and how SbD and iGEM projects could function as anticipatory governance tools for synthetic biology.@en

Promoting inclusive development through public policies is a complex task that presents different challenges and even controversies. The National Program for Biodiesel Production and Use (PNPB) in Brazil is one example of an effort to promote sustainable development within an inclusive strategy with good intentions but many challenges. One of the PNPB goals is to diversify feedstocks for biodiesel production, and oils from the Acrocomia spp. palm genus have the potential to meet this goal. As acrocomia's value chain is under development in Brazil, particularly with a focus on the macaúba palm (Acrocomia aculeata), and in different regions of Latin America, we state that it is possible to develop it with the inclusion of smallholder farmers. In this sense, this paper focuses on analyzing the challenges and opportunities for smallholder productive inclusion in the value chain. Our main question is: How can the participation of smallholders in the cultivation of macaw palm be promoted? The answer to this question is based on literature and field research carried out by the authors. Our study finds opportunities for inclusion, but also four main challenges to be considered with caution: i) the shift from agroextractivism to commercial plantations, ii) the limited acreage available to some small farmers, iii) the slow pace in generating economic results, and iv) negative past experiences with other crops. We emphasize the importance of development strategies that offer incentives, mitigate risks, and guarantee greater security in decision-making for those involved. The available literature about the acrocomia value chain focuses mainly on technical and agronomic aspects, with few outputs on inclusion. In this sense, this paper calls attention to the development of the novel biobased value chains from the acrocomia palm without leaving social responsibility behind.

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Science would not be possible without trust among experts, trust of the public in experts, and reliance on scientific instruments and methods. The rapid adoption of scientific foundation models and their use in AI agents is changing scientific practices and thereby impacting this epistemic fabric which hinges on trust and reliance. Foundation models are machine learning models that are trained on large bodies of data and can be applied to a multitude of tasks. Their application in science raises the question of whether scientific foundation models can be relied upon as a research tool and to what extent, or even be trusted as if they were research partners.

Conceptual clarification of the notions of trust and reliance in science is pivotal in the face of foundation models. Trust and reliance form the glue for the increasingly distributed epistemic labour within contemporary technoscientific systems. We build on two concepts of trust in science, namely trust in science as shared values, and trust in science based on commitments to processes that provide objective claims. We analyse whether scientific foundation models are research tools to which the concept of reliance applies, or research partners that can be trustworthy or not. We consider these foundation models within their socio-technical contexts.

Allocation of trust should be reserved for human agents and the organizations they operate in. Reliance applies to foundation models and artificial intelligence agents. This distinction is important to unambiguously allocate responsibility, which is crucial in maintaining the fabric of trust that underpins science.@en

Bio-based value chains (BBVCs) have often been criticized for their detrimental social and environmental effects. Existing methods such as social impact assessment do not sufficiently address these negative effects because of their limited focus and lack of attention to social justice. This paper explores the contribution of Capability Sensitive Design (CSD) to designing BBVCs for social justice. CSD is a combination of Value Sensitive Design (VSD), an approach to account for human values in a design process, and the Capability Approach (CA), a normative framework that incorporates multiple dimensions of human well-being. Three case studies demonstrate how CSD can be used to make design choices in the early stages of developing new BBVCs from waste biomass. The cases explore olive oil residues in Spain, coffee and cocoa residues in Colombia, and encroacher bush in Namibia. CSD is a relatively new approach and its contribution to social justice in BBVCs remained unexplored. We show that CSD can contribute to distributive, recognition, and procedural justice by allowing the identification of local vulnerable stakeholders and providing tools to connect their needs, knowledge, and capabilities to concrete design choices.

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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.

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Novel plant technologies present increased opportunities for rational plant management, promising more sustainable and efficient agricultural practices. However, questions about their desirability also arise. Many novel plant technologies emanate from a mechanistic, reductionist perspective on living organisms, whereas from a holistic perspective, other solutions to sustainable food production may be more desirable. These diverging perspectives lead to debates on how to assess the safety of novel plant technologies, achieve global economic justice against the backdrop of the increased mechanisation of plant breeding, and how to achieve sustainable agriculture. This latter debate evolves in the context of the clash between agroecological practices and rational, digitalized agriculture. These debates and the most prominent arguments will be discussed in this chapter. As such the chapter provides an agenda of issues that need to be addressed to arrive at a societally robust evaluation of novel plant technologies.@en

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.

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Terwijl de natuur in rap tempo verloren gaat, ontstaat tegelijkertijd een wildgroei aan data afkomstig uit de natuur. Die data worden als gemeengoed gezien waarvan iedereen, waaronder natuurbeschermers, profiteert. Er ontstaan echter nieuwe vormen van digitale uitsluiting door ongelijkheden in onderzoekscapaciteiten, databeheer en datanormen met negatieve gevolgen voor internationale wetenschappelijke samenwerking en natuurbehoud. Producenten en gebruikers van data moeten daarom veel meer doen om de digitalisering van de natuur in juiste banen te leiden.@en

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.

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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, wemust 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.@en

The increasing societal demand for safer, biobased products, and processes
creates opportunities for industrial biotechnology and chemistry. To succeed,
controlled learning about new emerging risks is crucial but both fields endure
difficulty in doing so by their respective regulation and risk management culture.@en

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.@en

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.

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More pluralised understandings of incumbencies are often overlooked in transitions research, which may lead to underestimating the enabling roles of incumbents in niche projects. This study explores these roles by applying a power framework to five struggles revolving around a path-breaking decentralised wastewater treatment project in the city of Ghent (Belgium). Remarkably, incumbents from multiple regimes use power to enable the niche project. The study identifies and discusses four patterns in the enabling role of incumbents in niche projects. These patterns are clarified by focussing on incumbents from multiple regimes, belonging to local authorities, neighbouring and more distant regimes, as well as on the power of structural trends related to the urgency of sustainability challenges. As such, the study contributes to the understanding of multiple incumbencies and the conditions under which these may reinforce niche projects. For practitioners, the study underscores the role of power dynamics in the water/wastewater sector.

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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.@en

Environmental problems are usually not tackled with path-departing policies but rather with incrementally adjusted or unchanged policies. One way to address incremental change is the policy feedback approach, which initially focussed on self-reinforcing feedback and path-dependency. Today, self-undermining feedback is also increasingly being studied, centring on agency and change. However, it is unclear precisely how actors use power in policy feedback processes. Therefore, this study applied a power perspective and the policy arrangement approach to a case study of the reorientation towards a circular economy in Dutch wastewater policy between 2008 and 2018, which resulted in incremental instead of fundamental policy change. Here it was observed that self-undermining feedback was generated from 2008 onwards but the balance quickly shifted back to self-reinforcing feedback, indicating that the analysed power struggles led to incremental change. These dynamics resemble a shift from the so-called paths and forks (i.e. fork in the road) towards the boomerang pattern (i.e. returning to its original position) of policy change. The patterns are explained by focussing on powerful actors that resist change through the use of incremental reforms, the ongoing struggles of these actors in facilitating self-reinforcing feedback and the role of interpretation in using feedback as a resource. Overall, this study provides a nuanced understanding of incremental change by directing attention to the power struggles of actors in policy feedback processes. For practitioners, the study emphasises the importance of power struggles in enabling a circular economy.

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New technological developments such as CRISPR-Cas, advanced genetic sequencing and the digitalization of agriculture offer promising prospects to realize the potential of a sustainable bioeconomy. At the same time, enormous challenges abound such as the pressure on biodiversity and the associated risk of pandemics, climate change and the ever-increasing global economic inequality. The bioeconomy can play a beneficial role in this; however, this will only be possible if the bioeconomy is developed on the basis of inclusion. In this chapter I will explain the relevance of inclusion for the bioeconomy and describe some of the sociotechnical developments where inclusion should be realized in order to build a resilient and sustainable bioeconomy. These developments include biosphere capacity, global biobased value chains, digital genetic resources and the digitalization of agriculture. I will conclude with the question of who bears responsibility for an inclusive bioeconomy.@en

The term "responsibility" embodies many meanings, also in the context of corporate research and innovation (R&I). The approach of Responsible Research and Innovation (RRI) has emerged as a promoter for responsible conduct of innovation but so far lacks a systematic framework for describing, inventorying, and eventually managing different responsibilities that R&I units hold in companies and further in society. In this paper we take forward the idea of developing RRI into a "meta-responsibility" approach, for orchestrating responsibilities in corporate R&I. First, we introduce a frame for defining responsibility, which is inclusive of four elements (care, liability, accountability, and responsiveness), and is attentive to the intrinsic uncertainty of the R&I setting. Drawing on empirical data from interviews, we then examine how these responsibility elements become operationalised in an actual R&I project. As a result, we develop a meta-responsibility map for corporate R&I, bringing various and sometimes contradicting principles, expectations and obligations under the common terminology of responsibility. We suggest that such integrative outlook on responsibilities increases theoretical solidity and practical applicability of RRI as an innovation management approach. Regarding R&I practices, we conclude that the meta-responsibility map can support R&I units in exploring their co-existing and sometimes conflicting responsibilities, and in managing those responsibilities in the highly uncertain R&I setting. In particular, meta-responsibility shows applicability in (i) balancing risk and precaution, (ii) exposing and addressing concerns about the goals and impacts of innovation, and (iii) accelerating sectoral transition whilst securing one's own competitive advantage in it.

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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.@en