Trends in the global regulation of new breeding techniques and perspective

Abstract

‘New Breeding Techniques (NBTs)’ have been one of hot issues, since their future will be affected profoundly by national as well as international regulatory landscapes. In this review, we compare characteristics of NBTs with conventional and genetic modification, and analyze genetically modified organism (GMO) regulatory systems in the context of possible regulation of NBTs. NBTs are very heterogeneous in terms of principles, methodologies, and final products. As Living Modified Organisms (LMO) is defined in the Cartagena Protocol on Biosafety (CPB) as an organism containing novel combination of genetic materials obtained by the use of modern biotechnology, CPB as well as other national legislations locate itself somewhere in the middle between product-based and process-based regulations. It is also noted that jurisdictions with regulatory systems more oriented to product-based one tend to be more productive and decide or may decide to exempt site-directed nucleases-1 from GMO regulation. In this context, Korean legislations are reviewed to clarify the commons and differences in GMO definitions. Act on Transboundary Movement of LMO Act, Food Sanitation Act and Agricultural and Fishery Products Quality Control Act are three major acts to regulate GMOs. It is noted that there are differences in the definition of LMO or GM food/products especially between the LMO Act and the Food Sanitation Act. Such differences may cause conflicts between Acts when policydecision regarding the regulation of NBTs is made. Therefore, it is necessary to reorganize legislations before policies regarding the regulation of any techniques from biotechnology are made.