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Safe‐by‐Design: Stakeholders’ Perceptions and Expectations of How to Deal with Uncertain Risks of Emerging Biotechnologies in the Netherlands
Author(s) -
Bouchaut Britte,
Asveld Lotte
Publication year - 2020
Publication title -
risk analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.972
H-Index - 130
eISSN - 1539-6924
pISSN - 0272-4332
DOI - 10.1111/risa.13501
Subject(s) - pace , risk analysis (engineering) , process (computing) , risk governance , corporate governance , anticipation (artificial intelligence) , process safety , inherent safety , engineering , process management , business , management science , computer science , work in process , operations management , geodesy , finance , artificial intelligence , nuclear engineering , geography , operating system
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.