Living Modified Organism
- A living modified organism is a living organism whose genes have been artificially recombined (added, deleted, or relocated).
- Under the Act on Transboundary Movements, etc. of Living Modified Organisms (“LMO Act”), it is defined as an organism that contains newly combined genetic material through the use of modern biotechnology.
- (Modern biotechnology) This is technology that artificially recombines genes or directly injects nucleic acids that constitute genes into cells or organelles, classified as cell fusion technology that transcends the boundaries of taxonomic families.
- (Organism) Any biological entity that can transmit or replicate genetic material (including non-reproductive organisms, viruses, and viroids).
South Korea’s safety management system for living modified organisms
The Korea Disease Control and Prevention Agency is responsible for the overall safety management of living modified organisms (LMOs) that require national management for public health under the Act on Transboundary Movements, etc. of Living Modified Organisms
Biosafety Committee
(Chairperson: Minister of Trade, Industry and Energy)
(Chairperson: Minister of Trade, Industry and Energy)
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National Responsible Authority (Ministry of Trade, Industry and Energy)
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National Focal Point (Ministry of Foreign Affairs)
- Ministry of Science and ICT
Tasks related to the export and import of LMOs for testing and research purposes
- Ministry of Agriculture, Food and Rural Affairs
Tasks related to the export and import of LMOs for agriculture, forestry, or agricultural and livestock purposes
- Ministry of Trade, Industry and Energy
Tasks related to the export and import of industrial LMOs
- Ministry of Health and Welfare
Tasks related to the export and import of LMOs for healthcare
- Ministry of Environment
Tasks related to the export and import of LMOs for environmental remediation
- Ministry of Oceans and Fisheries
Tasks related to the export and import of LMOs for marine and fisheries purposes
- Ministry of Food and Drug Safety
Tasks related to the export and import of LMOs for food and medical device purposes
Korea Disease Control and Prevention Agency LMO safety management
- Safety management related to the export and import of living modified organisms for healthcare and testing/research purposes
- Assessment and consultation on human health risks of non-food living modified organisms
- Approval for the import, development, and experimentation of living modified organisms for testing and research purposes
- Permission for the installation and operation of research facilities (human health risk levels 3 and 4) for living modified organisms used in testing and research
[Safety management system for living modified organisms]
Safety management of living modified organisms under the jurisdiction of the Korea Disease Control and Prevention Agency
| Subject of control | Key tasks | |
|---|---|---|
| Healthcare-related LMO Safety Control | Living modified organisms used for the purpose of protecting and promoting public health (excluding those for food and medical devices) *Living modified organisms used for the production of raw materials or finished products for cosmetics, quasi-drugs, and hygiene products |
Risk assessment of new LMOs Approval of import, production, and use; notification and permission for production process utilization facilities |
| National approval subjects Safety management of living modified organisms for testing and research purposes | Living modified organisms for testing and research purposes with high potential for human health risks* * LMOs using nationally controlled pathogenic microorganisms, producing protein toxins, containing drug-resistance genes, or using unidentified organisms |
National approval for LMOs (import, development, experimentation), export notification Management of living modified organisms for testing and research purposes |
| National management of biosafety research laboratories (BSL) | BSL-3 and BSL-4 facilities handling LMOs of Risk Levels 3 and 4 with high human health risks, and BSL-1 and BSL-2 facilities under the Ministry of Health and Welfare handling LMOs of Risk Levels 1 and 2. * Classified into risk levels 1 to 4 based on the “Guidelines for Recombinant DNA Experiments. |
Approval for new research facilities, Reconfirmation every 3 years Implementation of system Regular on-site inspections (annual) |
| Consultative review of human health risks of living modified organisms managed by other ministries | Non-food living modified organisms used in fields such as agriculture, industry, and marine fisheries * Living modified corn used for feed and agricultural processing, and living modified microorganisms used for biodegradable plastics in industry, etc. |
Consultative review of human health risks of living modified organisms managed by other ministries |
Laws related to living modified organisms
- 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