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Safe‐by‐Design: Stakeholders’ Perceptions and Expectations of How to Deal with Uncertain Risks of Emerging Biotechnologies in the Netherlands

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  • Britte Bouchaut
  • Lotte Asveld

Abstract

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.

Suggested Citation

  • Britte Bouchaut & Lotte Asveld, 2020. "Safe‐by‐Design: Stakeholders’ Perceptions and Expectations of How to Deal with Uncertain Risks of Emerging Biotechnologies in the Netherlands," Risk Analysis, John Wiley & Sons, vol. 40(8), pages 1632-1644, August.
  • Handle: RePEc:wly:riskan:v:40:y:2020:i:8:p:1632-1644
    DOI: 10.1111/risa.13501
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    References listed on IDEAS

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    1. Ewen Callaway, 2018. "CRISPR plants now subject to tough GM laws in European Union," Nature, Nature, vol. 560(7716), pages 16-16, August.
    2. Igor Linkov & Benjamin D. Trump & Elke Anklam & David Berube & Patrick Boisseasu & Christopher Cummings & Scott Ferson & Marie-Valentine Florin & Bernard Goldstein & Danail Hristozov & Keld Alstrup Je, 2018. "Comparative, collaborative, and integrative risk governance for emerging technologies," Environment Systems and Decisions, Springer, vol. 38(2), pages 170-176, June.
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    Cited by:

    1. Svana Helen Björnsdóttir & Pall Jensson & Saemundur E. Thorsteinsson & Ioannis M. Dokas & Helgi Thor Ingason, 2023. "Aligning Stakeholders and Actors: A New Safety and Security-Based Design Approach for Major National Infrastructures," Sustainability, MDPI, vol. 16(1), pages 1-44, December.
    2. Pieter van Gelder & Pim Klaassen & Behnam Taebi & Bart Walhout & Ruud van Ommen & Ibo van de Poel & Zoe Robaey & Lotte Asveld & Ruud Balkenende & Frank Hollmann & Erik Jan van Kampen & Nima Khakzad & , 2021. "Safe-by-Design in Engineering: An Overview and Comparative Analysis of Engineering Disciplines," IJERPH, MDPI, vol. 18(12), pages 1-28, June.

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