국내 유전자교정 식물의 사후 안전관리 제도 적용 가능성에 관한 규제 시나리오 분석
Regulatory scenario analysis on the applicability of post-market safety measures for genome-edited plants in South Korea
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초록
The commercialization of genome-edited organisms (GEOs), particularly those developed using site-directed nuclease type 1 (SDN-1) technology, is emerging as a central issue in the global bioindustry. Countries worldwide are refining regulations to boost GEO-based product commercialization, while South Korea is concentrating on enhancing its current legal and policy framework for stricter governance of GEOs. Accordingly, a study is necessary to examine global and domestic trends in the development, commercialization, and regulation of GEOs, focusing on postmarket safety management. To date, countries have adopted various regulatory approaches for GEOs, each with varying requirements for product labeling, traceability, and postmarket environmental monitoring (PMEM). Categorizing potential regulatory scenarios for SDN-1 generated GEOs may support informed policy development in South Korea. Three regulatory models are considered: (1) full regulation aligned with existing GMO frameworks, (2) a relaxed regulatory approach, and (3) exemption from regulation. Each case examines the applicability and feasibility of labeling, traceability, and PMEM. These findings suggest a need for a tailored regulatory framework that balances technical detectability, administrative practicality, economic efficiency, and market flexibility. A revised policy approach is recommended to ensure public safety without imposing excessive regulations. Finally, this review offers foundational insights for designing post-market management systems and guiding future policy directions for GEO governance in South Korea.
Abstract
The commercialization of genome-edited organisms (GEOs), particularly those developed using site-directed nuclease type 1 (SDN-1) technology, is emerging as a central issue in the global bioindustry. Countries worldwide are refining regulations to boost GEO-based product commercialization, while South Korea is concentrating on enhancing its current legal and policy framework for stricter governance of GEOs. Accordingly, a study is necessary to examine global and domestic trends in the development, commercialization, and regulation of GEOs, focusing on postmarket safety management. To date, countries have adopted various regulatory approaches for GEOs, each with varying requirements for product labeling, traceability, and postmarket environmental monitoring (PMEM). Categorizing potential regulatory scenarios for SDN-1 generated GEOs may support informed policy development in South Korea. Three regulatory models are considered: (1) full regulation aligned with existing GMO frameworks, (2) a relaxed regulatory approach, and (3) exemption from regulation. Each case examines the applicability and feasibility of labeling, traceability, and PMEM. These findings suggest a need for a tailored regulatory framework that balances technical detectability, administrative practicality, economic efficiency, and market flexibility. A revised policy approach is recommended to ensure public safety without imposing excessive regulations. Finally, this review offers foundational insights for designing post-market management systems and guiding future policy directions for GEO governance in South Korea.