국내 유전자교정 식물의 사후 안전관리 제도 적용 가능성에 관한 규제 시나리오 분석

• 영문명: Regulatory scenario analysis on the applicability of post-market safety measures for genome-edited plants in South Korea
• 발행기관: (사)한국식물생명공학회
• 저자명: 이범규 민홍
• 간행물 정보: 『Journal of Plant Biotechnology』52권 2호, 174~183쪽, 전체 10쪽
• 주제분류: 농수해양 > 기타농수해양
• 파일형태: PDF
• 발행일자: 2025.06.30

국문 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.

목차

서 론

국내외 GE 식물 연구개발 및 상용화 현황

국내외 GEO 관련 법･제도 및 규제 동향

국내외 GEO의 사후 안전관리 사례 분석

국내 GE 식물의 상업화 이후 사후 안전관리 제도 적용 가능성에 대한 분석

GE 식물의 사후 안전관리 체계에 대한 국제 규제 옵션 분석과 국내 정책 방향

국내 SDN-1 방식 GE 식물에 대한 규제 시나리오별 사후 안전관리 제도 적용 가능성 분석

적 요

References

키워드

Genome-edited organisms Post-market safety management Regulatory frameworks Labeling and traceability Post-market environmental monitoring