Non-safety Assessments of Genome-Edited Organisms: Should They be Included in Regulation?
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Non‑safety Assessments of Genome‑Edited Organisms: Should They be Included in Regulation? Bjørn Kåre Myskja1 · Anne Ingeborg Myhr2 Received: 19 March 2019 / Accepted: 4 May 2020 / Published online: 18 May 2020 © The Author(s) 2020
Abstract This article presents and evaluates arguments supporting that an approval procedure for genome-edited organisms for food or feed should include a broad assessment of societal, ethical and environmental concerns; so-called non-safety assessment. The core of analysis is the requirement of the Norwegian Gene Technology Act that the sustainability, ethical and societal impacts of a genetically modified organism should be assessed prior to regulatory approval of the novel products. The article gives an overview how this requirement has been implemented in the regulatory practice, demonstrating that such assessment is feasible and justified. Even in situations where genome-edited organisms are considered comparable to non-modified organisms in terms of risk, the technology may have—in addition to social benefits—negative impacts that warrant assessments of the kind required in the Act. The main reason is the disruptive character of the genome editing technologies due to their potential for novel, ground-breaking solutions in agriculture and aquaculture combined with the economic framework shaped by the patent system. Food is fundamental for a good life, biologically and culturally, which warrants stricter assessment procedures than what is required for other industries, at least in countries like Norway with a strong tradition for national control over agricultural markets and breeding programs. Keywords Sustainability · Social utility · GMO · Ethical impacts · CRISPR · Norwegian Gene Technology Act
* Bjørn Kåre Myskja [email protected] Anne Ingeborg Myhr [email protected] 1
Department of Philosophy and Religious Studies, Faculty of Humanities, NTNU, 7491 Trondheim, Norway
2
GenØk-Centre for Biosafety, SIVA Innovation Centre, PB 6418, 9294 Tromsø, Norway
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B. K. Myskja, A. I. Myhr
Introduction Regulation of genetically modified organisms (GMOs) has mainly been concerned with safety for human health and the environment, expressed in strict assessment procedures. However, in some jurisdictions these procedures are supplemented with assessments of a broader nature, including societal issues. The paradigmatic example is Norway, where the Gene Technology Act (GTA) demands that sustainability, societal utility and ethical aspects are included in assessments of any GMO. However, recent technical developments within gene technology have challenged the regulatory frames for risk assessment, and may also pose problems for non-safety assessments. These new techniques have opened possibilities for editing genetic information and expression in organisms in a faster and more targeted way than previous methods. One of them is the genome editing technique clustered regularly interspaced short palindromic repeats (CRISPR), which has been rapidly adopted by aca
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