THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Need for Broad Assessment in the Regulation of Genome-Edited Products
Broad assessment of societal, ethical and environmental concerns is required for GMOs in some countries, in addition to the risk assessment. When genome-edited organisms are regulated as GMOs, should they also be subject to such broad or so-called ‘non-safety’ assessments as is required for GMOs?
A recent article analyses, using actual cases, the requirement of the Norwegian Gene Technology Act that the sustainability, ethical and societal impacts of a GMO should be assessed prior to regulatory approval of the novel products. The regulatory practice in Norway shows that such assessments of GMOs or genome-edited organisms are feasible without being unreasonably costly or time-consuming. The main arguments for including broad assessment in the regulation of genome-edited products are:
- The ownership issue remains the same as with GMOs: this is a patentable technology although it is yet not clear how that right is affected if the resulting organism also could have been produced by non-patentable methods.
- Genome-editing technologies have, independent of whether there is or is no addition of foreign material, the potential for altering characteristics with significant impact on sustainability, societal issues and ethics.
The authors conclude that these assessments are also morally and politically justified in other countries, whether or not they have comparable values to Norway regarding agriculture and food, as genome editing is a disruptive technology with great potential for societal and environmental impact, and food has a special status in human lives regardless of culture.
With best wishes,
Third World Network
131 Jalan Macalister
10400 Penang
Malaysia
Email: twn@twnetwork.org
Websites: http://www.twn.my/and http://www.biosafety-info.net/
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NON-SAFETY ASSESSMENTS OF GENOME-EDITED ORGANISMS: SHOULD THEY BE INCLUDED IN REGULATION?
Myskja, B.K., Myhr, A.I.
Science and Engineering Ethics
18 May 2020
https://doi.org/10.1007
https://link.springer.com/article/10.1007%2Fs11948-020-00222-4
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.