Regulatory and Policy Considerations Around Genome Editing in Agriculture.

Abstract

The increasingly widespread use of genome editing brought with it a fierce debate about the most adequate regulation of this latest innovation in modern biotechnology and the products resulting from it. In almost all cases, this debate has become a repetition or continuation of the deliberations concerning genetically modified organisms (GMOs) of the 1990s and early 2000s.This chapter aims to untangle the historically influenced and often biased arguments of the debates by addressing the complex question of the correct interpretation of relevant underlying law and its applicability. In doing so, the chapter considers 25 countries and regions that have published results or ongoing investigations and discussions pertaining to the governance of genome editing in their jurisdictions: 16 have published policies or signed statements that exempt gene edited plants from GMO-regulations, as long as no foreign DNA or transgene remained in the final product. Such exemptions are based on the widely supported acceptance that the products of the underlying genome editing processes resemble those of "conventional breeding" techniques. These policies and statements often refer to the important role that modern precision biotechnologies, of which genome editing is one, play in addressing some of the world's overarching challenges, such as the loss of biodiversity, pest and disease control, and climate change; they are furthermore shown to exhibit an adherence to the four universal principles of good regulation: (a) proportionality, (b) non-discrimination, (c) predictability, and (d) enforceability. And while it is the right of jurisdictions to develop their own regulations independent from that of their neighbors, it is specifically the principle of "enforceability" that may become the ultimate litmus test of those regulations that do not grant exemptions from GMO-regulations.