Gene-edited organisms should be assessed for sustainability, ethics and societal impacts

A number of new animal and plant breeding techniques (NBTs) has been developed, such as the genome editing technique CRISPR/Cas9. Internationally it is debated if gene-edited organisms should be subjected to the same risk assessment requirements as GMOs. Sweden has decided that gene-edited plants with no foreign genetic element should not count as GMOs, arguing that they are similar to plants altered through conventional breeding or plant mutagenesis. This regulatory discussion is not decided yet in the EU, but we will here argue that even if gene-edited plants and animals are exempt from GMO risk assessment, an approval procedure should include a broad assessment of such plants and animals. We take our point of departure from the Norwegian Gene Technology Act (GTA) which states that risk assessment of GMOs should be supplemented by an assessment of the sustainability, ethical and societal impact prior to regulatory approval of the novel products. Even if gene-edited organisms are considered comparable to non-GMOs in terms of risks, the technology has impacts that calls for an assessment of the kind required in the GTA. With NBTs it may possible to develop plants that have increased drought and saline tolerance relevant for the developing world. Such gene-edited plants can have positive, stable long-term effects on environment, economic and social conditions, and hence be argued to contribute to sustainability. Conversely, the same plants may also have adverse long-term environmental effects. Social benefits are such that are good, or at least not harmful, for small scale producers and consumers, not merely for patent holders and industrial farming. Possible examples are blight resistant potatoes and virus resistant pigs. The assessment of ethical impact becomes increasingly important when dealing with powerful technologies such as genome editing. One example is the potential for developing virus free pigs to be used growing human organs or other alterations that increase the usefulness of animals for industrial production. Questions related to welfare and protection of integrity needs to be evaluated. A wide assessment as required by the GTA will ensure that the NBTs will be beneficial for society in general.