Regulatory challenges and global trade implications of genome editing in agriculture

National University of Asuncion Faculty of Exact and Natural Sciences Department of Biotechnology 10º Seed Congress of the Americas - Seed Association of the Americas  GE Regulatory Landscape  October 01 2025, Foz do Iguaçu, Brazil Danilo Fernández Ríos [email protected] Regulatory challenges and global trade implications of genome editing in agriculture -Bachelor of Science (Biology). -Postgraduate degree in Plant Molecular Genetics. -PhD in Agricultural Sciences. -Graduate on risk analysis for the agri-food sector at the Graduate School “Agronomist Alberto Soriano” (FAUBA). -Adjunct Professor (Biology and Biotechnology) (FACEN-UNA). -Research Professor (FACEN-UNA). -Member of the Mycology Investigation and Safety Team (MISTpy). -PRONII Level 2 Researcher (CONACYT). -Member of the National Commission of Agricultural and Forestry Biosafety (CONBIO) of the Ministry of Agriculture and Livestock (MAG). Who am I? -Innovation in plant breeding plays a critical role in advancing the SDGs, particularly in areas like zero hunger, good health and well-being, and climate action. -Gene editing has become a key tool for improving crop productivity, disease resistance, and adaptation to adverse climatic conditions. -Its adoption faces regulatory challenges owing to divergent policies between regions. high costs, delays in commercialization Analyze the main regulatory challenges and their impact on global trade and propose strategies for harmonization Introduction Triggers Characteristic Process-Based Product-Based Basis for Regulation rDNA, "modern biotechnology" Final product's traits and whether they are novel or unfamiliar Scientific Foundation Risk is not necessarily inherent to the process Aligned with international scientific consensus Primary Question New combination? New traits or characteristics that could pose a risk? Efficiency Can regulate low-risk products and under-regulate high-risk products? Risk proportionate Adaptability to Technology Definitions can be challenging More adaptable? https://doi.org/10.3389/fbioe.2025.1600610, https://doi.org/10.1080/21645698.2016.1228516 -Lack of Early Clarity (Pre-market) -Uncertainty about the regulatory path during early R&D -Disproportionate Data Requirements (Pre-market) -Requiring GM-like data for products indistinguishable from conventionally bred plants -Redundancy for Similar Products (Pre-market) -Requiring individual regulatory evaluations for every new variety with the same functional change -Post-market requirements -Labeling, traceability, segregation, etc. -“Patchwork” of Global Policies (Trade) -The same product may be considered conventional in one country but GM in another Challenges https://worldseed.org/document/a-call-for-policy-actions-to-foster-plant-breeding-innovation/ Global overview https://doi.org/10.3389/fbioe.2025.1609110 Current trends https://doi.org/10.3389/fbioe.2025.1609110 - Adaptive frameworks - Case-by-Case - Risk proportionality - More flexible frameworks - China reduced approval times - India exempted SDN1 and SDN2 products without foreign DNA - Prior Consultation - Conventional Classification - Regional Cooperation - Classification as GM - Undefined Preand Post-Market requirements - Potential for future changes Opportunities and examples of cooperation Food Standards Australia New Zealand FSANZ ●Joint food system with unified safety criteria New Partnership for Africa’s Development NEPAD ●Strengthening regulatory capacities and harmonizing biosafety policies These models demonstrate that regional cooperation improves efficiency, security, and competitiveness ABRE-BIO ●Promote regulatory synchronization ●Reduce regulatory costs and times ●Foster regional development through innovation and technological cooperation ●Strengthen inter-agency collaboration Agências de Biossegurança em Rede para Biotecnologia https://doi.org/10.3389/fbioe.2025.1609110