Exploring the Impact of Tensions in Stakeholder Norms on Designing for Value Change: The Case of Biosafety in Industrial Biotechnology.

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.

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.

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.

The Food Warden: An Exploration of Issues in Distributing Responsibilities for Safe-by-Design Synthetic Biology Applications.

The Safe-by-Design approach in synthetic biology holds the promise of designing the building blocks of life in an organism guided by the value of safety. This paves a new way for using biotechnologies safely. However, the Safe-by-Design approach moves the bulk of the responsibility for safety to the actors in the research and development phase. Also, it assumes that safety can be defined and understood by all stakeholders in the same way. These assumptions are problematic and might actually undermine safety. This research explores these assumptions through the use of a Group Decision Room. In this set up, anonymous and non-anonymous deliberation methods are used for different stakeholders to exchange views. During the session, a potential synthetic biology application is used as a case for investigation: the Food Warden, a biosensor contained in meat packaging for indicating the freshness of meat. Participants discuss what potential issues might arise, how responsibilities should be distributed in a forward-looking way, who is to blame if something would go wrong. They are also asked what safety and responsibility mean at different phases, and for different stakeholders. The results of the session are not generalizable, but provide valuable insights. Issues of safety cannot all be taken care of in the R&D phase. Also, when things go wrong, there are proximal and distal causes to consider. In addition, capacities of actors play an important role in defining their responsibilities. Last but not least, this research provides a new perspective on the role of instruction manuals in achieving safety.

Safe-by-Design: from Safety to Responsibility.

Safe-by-design (SbD) aims at addressing safety issues already during the R&D and design phases of new technologies. SbD has increasingly become popular in the last few years for addressing the risks of emerging technologies like nanotechnology and synthetic biology. We ask to what extent SbD approaches can deal with uncertainty, in particular with indeterminacy, i.e., the fact that the actual safety of a technology depends on the behavior of actors in the value chain like users and operators. We argue that while indeterminacy may be approached by designing out users as much as possible in attaining safety, this is often not a good strategy. It will not only make it more difficult to deal with unexpected risks; it also misses out on the resources that users (and others) can bring for achieving safety, and it is undemocratic. We argue that rather than directly designing for safety, it is better to design for the responsibility for safety, i.e., designers should think where the responsibility for safety is best situated and design technologies accordingly. We propose some heuristics that can be used in deciding how to share and distribute responsibility for safety through design.

Gone with the Wind: Conceiving of Moral Responsibility in the Case of GMO Contamination.

Genetically modified organisms are a technology now used with increasing frequency in agriculture. Genetically modified seeds have the special characteristic of being living artefacts that can reproduce and spread; thus it is difficult to control where they end up. In addition, genetically modified seeds may also bring about uncertainties for environmental and human health. Where they will go and what effect they will have is therefore very hard to predict: this creates a puzzle for regulators. In this paper, I use the problem of contamination to complicate my ascription of forward-looking moral responsibility to owners of genetically modified organisms. Indeed, how can owners act responsibly if they cannot know that contamination has occurred? Also, because contamination creates new and unintended ownership, it challenges the ascription of forward-looking moral responsibility based on ownership. From a broader perspective, the question this paper aims to answer is as follows: how can we ascribe forward-looking moral responsibility when the effects of the technologies in question are difficult to know or unknown? To solve this problem, I look at the epistemic conditions for moral responsibility and connect them to the normative notion of the social experiment. Indeed, examining conditions for morally responsible experimentation helps to define a range of actions and to establish the related epistemic virtues that owners should develop in order to act responsibly where genetically modified organisms are concerned.