Advanced gene editing techniques such as 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. 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 more 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 in industrial biotechnology in the Netherlands. Our empirical research reveals three main themes: (1) diverging expectations with regard to safety and risks, and to establishing 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.

Date Submitted: 2020-02-18