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SAMKUL-Samfunnsutviklingens kulturell

Non-safety assessments of genome-edited animals: ethical and regulatory challenges and solutions

Alternative title: Samfunnsmessig forsvarlig genredigering av dyr: Etiske og regulatoriske utfordringer og løsninger

Awarded: NOK 11.4 mill.

Genome editing is a promising form of biotechnology, enabeling targeted changes in animals, making them more suitable for human purposes and better adapted to climate change. However, the debate on regulation of this technology has mainly concerned risk assessments, largely neglecting so-called non-safety issues: whether the products are sustainable over time, how they will affect society for good and bad, and whether they are ethically sound. The public debate on biotechnology has, furthermore, mainly focused on plants. But there are separate social and ethical potentials and challenges of genome edited animals that should be discussed before they are approved for production. The aim of this project is to set out the conditions for a sustainable, ethically and socially acceptable use of genome editing on animals. The research group includes people from biotechnology, philosophy, sociology and law. They will work together to create a framework for assessment of genome editing of animals that integrates these different perspectives. First, they will map the main trends in research on genome editing of animals and the main arguments in discussions on how to regulate the technology. Then, they will discuss genome editing of animals in interviews and focus groups, using examples from animals in research laboratories, in food production and in the wild (for conservation). This will be input to two in-depth studies that will include relevant academic research. First, an analysis of the sustainability of different kinds of genome editing in animals. Second, an analysis based in a virtue-ethical approach developed as part of the project. These studies will be combined in a structured analysis that will be useful in assessments of which cases of genome editing of animals that can be beneficial and justified in legal practice. This will contribute to the public debate on the use of this technology and for non-safety assessments of genome editing.

Disruptive genome editing technologies such as the CRISPR system have potential to revolutionize food production. However, this technology poses regulatory challenges on at least two accounts: First, the regulatory debate has mainly been centered around risk and safety assessment, while the potential ethical and social impact of this technology justifies a widening of the scope to include non-safety assessments. Second, the academic and political debate on the promises and challenges of genome editing in agriculture, with a few exceptions, focus on plants. Hence, they might not be fit to address the questions of genome-edited animals, which have separate social and ethical potentials and challenges. The CRISPRWEL project seeks to determine the conditions for a sustainable, ethically and socially acceptable use of genome editing on animals to inform non-safety assessments in regulatory practice. The interdisciplinary research group draws on resources from biotechnology, philosophy, sociology and law in order to build an integrated, transdisciplinary evaluation framework. The basis for this framework is first a mapping of the existing regulatory and technological landscape for genome editing in animals to identify the main trends in technological research and regulatory discussions. This is followed by a qualitative exploration of citizen and stakeholder views on the sustainability and moral acceptability of different forms of genome editing of animals – in the lab, the farm and the wild – using interviews and focus group studies. These findings will be analyzed within an empirical virtue ethics-framework. These studies are combined in an evaluative framework that will inform assessments of the conditions under which genome editing of animals can be beneficial and justified in legal practice.

Funding scheme:

SAMKUL-Samfunnsutviklingens kulturell