Global status of the regulation of genome editing technologies.

Abstract

Abstract Innovations affect societies in various ways. For example, the latest innovations in cell phones and electronics are readily adopted without hesitation. However, many innovations regarding the breeding of plants, the production of food crops and the processing of food products, can be met with fear and trepidation by some societies. Europe, the foundation of the Industrial Revolution, has developed strong adversity to agricultural innovations that involve innovative genome editing methods in general and to genetically modified (GM) crops in particular. While much of the industrial world models their regulatory frameworks for plant agriculture on the science-based risk assessment framework developed through the efforts of the Organisation for Economic Cooperation and Development, the European Union's regulatory framework for GM crops is based on the precautionary principle, approving but a single GM crop variety for production in the twenty-first century. As any field of science and technology advances, so has the breeding of GM crops. GM crop varieties were developed through the insertion of a gene or genes from a different species, such as the insertion of the trait for insect resistance in plants that originally came from a soil bacterium. Crop varieties are now being developed through a group of targeted, site-directed mutation technologies, known as genome editing, where some of this group of technologies results in no foreign genes being transferred into new varieties. While technologically viewed as a significant advancement in the development of new plant varieties, some jurisdictions have chosen to regulate genome editing as equivalent to GM crops, thereby establishing a de facto ban on the application of the technology. Yet other jurisdictions have chosen to embrace the technology, announcing that some applications of genome editing will face no regulatory oversight. This paper provides a global overview of the various regulatory frameworks for genome editing.