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Public Health Weekly Report
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Ensuring safety management, and installation and operation for living modified organisms production facilities for health and medical applications
- Date2018-03-22 20:39
- Update2018-03-22 20:39
- DivisionDivision of Strategic Planning for Emerging Infectious Diseases
- Tel043-719-7271
Ensuring safety management, and installation and operation for living modified organisms production facilities for health and medical applications
Baek SeungWoo, Yun Haesun, Sim Kyungjong, Lim Seungho, Kang Yeonho
Division of Biosafety Evaluation and Control, KNIH, KCDC
BS Support Co., Ltd.
Background: Safety management along with installation and operation guidelines should be established for living modified organisms (LMO) production facilities used in health and medical applications to prevent risks to public health and support the conservation and sustainable use of biological diversity. Such guidelines should be established through the application of administrative and engineering controls in accordance with relevant laws and regulations.
Current status: To prevent environmental release, defined as the intentional exposure of an LMO to the natural environment without contained measures taken within a facility, installation, or physical structure, necessary standard and procedure for closure should be followed according to the Transboundary Movement of Living Modified Organisms Act act, and similar regulations. These standards should be followed concerning the scope of production facilities using an LMO for health and medical applications at each biosafety level, including standards and procedures for the establishment and operation of an LMO production facility. A person who intends to establish and operate a facility in which will be used for any LMO for health and medical applications in the production process shall manage it safely to prevent a risk to public health and the environment, and will obtain permission from the head of the Korea Centers for Disease Control and Prevention (KCDC) or file a report to the head of KCDC according to the relevant biosafety level.
Future perspective: Preparation of a guide-book for the safety management, installation, and operation of production facilities of LMOs for health and medical applications will be helpful to individuals intending to establish and operate a facility in which any LMO might be used in the production process according to the biosafety level.
Keywords: Safety management, Living Modified Organisms, Public health, Biological diversity, Biosafety
Baek SeungWoo, Yun Haesun, Sim Kyungjong, Lim Seungho, Kang Yeonho
Division of Biosafety Evaluation and Control, KNIH, KCDC
BS Support Co., Ltd.
Background: Safety management along with installation and operation guidelines should be established for living modified organisms (LMO) production facilities used in health and medical applications to prevent risks to public health and support the conservation and sustainable use of biological diversity. Such guidelines should be established through the application of administrative and engineering controls in accordance with relevant laws and regulations.
Current status: To prevent environmental release, defined as the intentional exposure of an LMO to the natural environment without contained measures taken within a facility, installation, or physical structure, necessary standard and procedure for closure should be followed according to the Transboundary Movement of Living Modified Organisms Act act, and similar regulations. These standards should be followed concerning the scope of production facilities using an LMO for health and medical applications at each biosafety level, including standards and procedures for the establishment and operation of an LMO production facility. A person who intends to establish and operate a facility in which will be used for any LMO for health and medical applications in the production process shall manage it safely to prevent a risk to public health and the environment, and will obtain permission from the head of the Korea Centers for Disease Control and Prevention (KCDC) or file a report to the head of KCDC according to the relevant biosafety level.
Future perspective: Preparation of a guide-book for the safety management, installation, and operation of production facilities of LMOs for health and medical applications will be helpful to individuals intending to establish and operate a facility in which any LMO might be used in the production process according to the biosafety level.
Keywords: Safety management, Living Modified Organisms, Public health, Biological diversity, Biosafety
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