Notification and permission for the installation and operation of facilities using the LMO production process
According to Article 22-3 of the Act on Transboundary Movements, etc. of Living Modified Organisms, a production facility using living modified organisms (LMOs) is referred to as a facility utilizing the production process. When operating a production facility using LMOs for healthcare purposes, a risk assessment of the healthcare LMOs must be conducted before determining the appropriate safety management level.
- Level 1
Production process utilization facilities that use living modified organisms confirmed, through a risk assessment under Article 7-2 of the Act, not to cause disease in healthy humans or harm to the environment
Report - Level 2
A production facility using living modified organisms that have been confirmed through a risk assessment under Article 7-2 of the Act to cause disease in humans but for which effective treatment and preventive measures are available, and where the risk of spread is low, such that even if released into the environment, the harm is deemed minimal.
Report - Level 3
A production facility using living modified organisms that have been confirmed through a risk assessment under Article 7-2 of the Act to cause a fatal disease in humans that is difficult to treat and highly infectious, with significant harm expected if released into the environment, and for which healing is challenging
Permit - Level 4
A production facility using living modified organisms that have been confirmed through a risk assessment under Article 7-2 of the Act to cause a fatal disease in humans that is difficult to treat and highly infectious, with significant harm expected if released into the environment, and for which healing is challenging
Permit
LMO 생산공정이용시설의 안전관리등급의 분류 및 허가 또는 신고 대상
Laws related to the production facilities using LMOs
- Transboundary Movement, Etc. of Living Modified Organisms Act
- Enforcement Decree of the Transboundary Movement, Etc. of Living Modified Organisms Act
- Enforcement Rules of the Transboundary Movement, Etc. of Living Modified Organisms Act
- Consolidated Notice on the Transboundary Movement, Etc. of Living Modified Organisms Act