Assessing agricultural gene editing regulation in Latin America: an analysis of how policy windows and policy entrepreneurs shape agricultural gene editing regulatory regimes.

This article explores the new developments and challenges of agricultural Gene Editing (GED) regulation in primarily nine countries of Latin America and the Caribbean (LAC) Region: Argentina, Bolivia, Brazil, Colombia, Guatemala, Honduras, Mexico, Paraguay and Peru. As Gene Editing technology develops, Latin America and the Caribbean regulatory regimes struggle to keep pace. Developers and regulators face challenges such as consumer perceptions, intellectual property, R&D funding (private and public), training, environmental and social impact, and access to domestic and international markets. Some Latin America and the Caribbean countries (e.g., Argentina) interpret existing legislation to promulgate regulations for biotechnology and Genetically Modified Organisms (GMOs), while others (e.g., Brazil and Honduras) have specific legislation for Genetically Modified Organisms. In both those cases, often a case-by-case approach is chosen to determine whether a Gene Editing organism is subject to Genetically Modified Organisms regulations or not. Other countries such as Peru have opted to ban the technology due to its perceived resemblance to transgenic Genetically Modified Organisms. After presenting the regulatory landscape for agricultural Gene Editing in Latin America and the Caribbean, this article addresses some of the differences and similarities across the region. Some countries have had more foresight and have dedicated resources to increase capacity and develop regulations (e.g., Brazil, Argentina, Colombia, Guatemala, Honduras, Mexico before 2018) while others struggle with bureaucratic limitations and partisanship of policymaking (e.g., Paraguay, Bolivia, Peru, Mexico after 2018). We propose that the differences and similarities between these regulatory regimes have emerged in part as a result of policy entrepreneurs (influential individuals actively involved in policy making) taking advantage of policy windows (opportunities for shaping policy and regulation). The third and remaining sections of this study discuss our main findings. Based on 41 semi structured interviews with regulators, scientists, product developers, NGOs and activists, we arrived at three main findings. First, there seems to be a consensus among most regulators interviewed that having harmonized regimes is a positive step to facilitate product development and deployment, leading to commercialization. Second, reducing bureaucracy (e.g., paper work) and increasing flexibility in regulation go hand in hand to expedite the acquisition of key lab materials required by developers in countries with less robust regimes such as Peru and Bolivia. Finally, developing public and private partnerships, fostering transparency, and increasing the involvement of marginalized groups may increase the legitimacy of Gene Editing regulation.