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.
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.
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.
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.The planetary boundary for production and release of new chemicals and plastics 1 , rising CO 2 levels, depletion of fossil-based raw materials, and geopolitical dependencies present an urgent call for an industrial transition toward a biobased economy. Industrial biotechnology (and the associated field of green chemistry) aim to find more sustainable alternatives to conventional chemical manufacturing routes. Particularly the development of CO 2 -negative approaches (e.g., CO 2 conversion into chemicals and fuels 2 ) and biobased alternatives to fossil resources-derived chemicals, polymers, and plastics 3,4 show great potential to fight today's problems and for countries or regions to become less dependent on others. However, biotechnology is struggling to compete with conventional chemical methodologies 5,6 . This can be explained by the history, size 7,8 , and influence (e.g., having a strong lobby in terms of policy measures 9,10 ) of the chemical industry, and the simple fact that these industries are already established and matured compared to the biobased industries. However, it also appears that the respective risk management cultures in each industry differ greatly, which hinders the development of biotechnology and the biobased industry in becoming technically and economically feasible.The risk management culture in biotechnology emphasizes uncertain risks and is subject to a strong precautionary regime, particularly in Europe, leaving little room for development when uncertain risks are involved. In contrast, for chemistry, the focus is on known risks which has resulted in a culture of passive learning (i.e., through accidents) and many examples of regrettable substitution 11,12 . The two risk management regimes seem to be at odds with each other even though both types of risk emerge in each field. If we want to tackle the global challenges of today, we need to develop new, safer products and processes that may require new types of chemistry in which biotechnology could play a pivotal part. This requires a middle way between the risk management regimes of chemistry and biotechnology: one that stimulates awareness of uncertain risks and also creates room to gain new knowledge of these risks. Therefore, we need to put designated procedures and institutions in place solely for the aim of learning about uncertain risks, i.e., active, or controlled learning, so new products and processes can be developed safely. Safe by Design (SbD) approaches could provide a framework to achieve such controlled learning, as has already been demonstrated in biotechnology 13 and
In September 2015, the United Nations General Assembly established the 2030 Agenda for Sustainable Development, which includes 17 Sustainable Development Goals (SDGs) [...]
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