Regulatory Challenges and Global Trade Implications of Genome Editing in Agriculture

Danilo Fernández Ríos^1,2*Silverio Andrés Quintana¹Pilar Gómez Paniagua¹Andrea Arrúa^1,3Gustavo René Brozón⁴Moises Santiago Bertoni Hicar⁵Andrés Castro Alegría²María Florencia Goberna^6*

• ¹Facultad de Ciencias Exactas y Naturales, Universidad Nacional de Asunción, San Lorenzo, Paraguay
• ²San Carlos University, Asuncion, Asuncion, Paraguay
• ³Grupo de Investigación Mycology Investigation and Safety Team, Centro Multidisciplinario de Investigaciones Tecnológicas, Universidad Nacional de Asunción, San Lorenzo, Paraguay
• ⁴Centro Multidisciplinario de Investigaciones Tecnológicas, Universidad Nacional de Asunción, San Lorenzo, Paraguay
• ⁵Unión de Gremios de la Producción, Asunción, Paraguay
• ⁶Coordination of Innovation and Biotechnology, National Bioeconomy Directorate, Sub-secretariat of Agricultural Production and Forestry, Secretariat of Agriculture, Livestock and Fisheries, Buenos Aires, Buenos Aires, Argentina

In this article, we analyse the impact of regulatory divergence on the development and commercialization of genome-edited crops, focusing on how process-based versus product-based approaches affect innovation and trade. Using examples from the European Union, Africa, Asia, and Latin America, we examine how classification criteria, risk assessment triggers, and approval procedures shape the cost and feasibility of bringing genome-edited products to the market. Our analysis highlights how small developers and public sector initiatives are particularly disadvantaged by inconsistent definitions and regulatory uncertainty. We evaluate ongoing efforts toward regulatory alignment and assess their potential to support harmonized, science-based oversight. This contribution supports the development of adaptive biosafety frameworks that promote equitable access to agricultural innovation.