Regulation of animal and plant agricultural biotechnology.

Abstract

Fifty years ago, scientists developed a regulatory framework for the safe use of recombinant DNA that focused on potential biosafety risks associated with the products of genetic engineering (GE). This morphed into an expensive and lengthy premarket risk assessment requirement for GE agricultural biotechnology products triggered solely by the fact that modern molecular technologies were involved in the development of those products. This has limited the commercialization of GE crop products primarily to multinational enterprises and precluded the development of GE animals at scale. Gene editing offers an opportunity to rethink the regulation of agricultural biotechnologies, and several countries have determined that gene-edited products lacking any 'foreign' DNA will be treated in the same way as products of conventional breeding.