Chapter 20 - Challenges and prospects in the regulation of CRISPR-edited crops

Abstract

New breeding technologies (NBTs) such as genome editing have the potential to revolutionize the landscape of agricultural biotechnology. With their precision, cost, and time efficiency, NBTs can help tackle issues including food security and climate change. As is the case with other frontier technologies, the successful adoption of NBTs is directly linked to the global regulatory architecture. Presently, the fate of NBTs is mired in regulatory uncertainty, perpetuated by a trans-Atlantic divide, with some countries reviewing their existing biosafety frameworks. The debate is centered on the basic definitions of biotechnology products, the kinds of triggers used, and the possibility of excluding some variants of NBTs. The regulatory divide has also created nontrade barriers affecting the ability of developing countries to benefit from NBTs adequately. There are related contentious issues such as the role of socioeconomic factors in regulations and achieving a science-based risk assessment regime. The fragmented international regulatory regime, notably the Cartagena Protocol on Biosafety, has posed many impediments to harmonization and has been unable to generate consensus among states. While many countries, including Australia, Argentina, and Brazil, have opted to review existing legislation, the European Union has taken a highly conservative approach toward NBTs, declaring them similar to genetically modified organisms (GMOs). This outcome is unfavorable not only for building toward harmonization but has also reduced member states’ ability to develop and benefit from NBTs. Distinguishing NBTs from previous methods of plant breeding is not only scientifically accurate but also crucial for their democratized commercialization. Developing countries that are dependent on agricultural trade will suffer if existing regulatory regimes are not changed. Furthermore, social acceptance of NBTs is also a significant determinant of their success.