Comparative regulatory approaches for groups of new plant breeding techniques

This manuscript provides insights into ongoing debates on the regulatory issues surrounding groups of biotechnology-driven ‘New Plant Breeding Techniques’ (NPBTs). It presents the outcomes of preliminary discussions and in some cases the initial decisions taken by regulators in the following countries: Argentina, Australia, Canada, EU, Japan, South Africa and USA. In the light of these discussions we suggest in this manuscript a structured approach to make the evaluation more consistent and efficient. The issue appears to be complex as these groups of new technologies vary widely in both the technologies deployed and their impact on heritable changes in the plant genome. An added complication is that the legislation, definitions and regulatory approaches for biotechnology-derived crops differ significantly between these countries. There are therefore concerns that this situation will lead to non-harmonised regulatory approaches and asynchronous development and marketing of such crops resulting in trade disruptions.

► Some ‘New Plant Breeding Techniques (NPBTs)’ provide regulatory challenges.
► Countries differ in defining NPBTs crops as GMOs/non-GMOs.
► Thus, asynchronous marketing of such crops may cause trade disruptions.
► An approach is suggested to assist harmonised evaluation of NPBT-delivered crops.