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A national biorisk management is designated to prevent diseases among personnel and to protect the community from harm by preventing the release of infectious pathogens. The Division of Biosafety Evaluation and Control (DBEC) performs an effective biorisk management based on the “Infectious Diseases Control and Prevention Act (No. 14316)” and reinforces biosafety awareness. For these purposes, the DBEC increases the regulatory compliance through a combination of training, inspections, evaluations, review, and clear communication. We provide the guidelines of the biosafety and biosecurity, and technology for the construction and operation of containment laboratories. We also develop programs related to biosafety and biosecurity with the purpose of enhancing capacities and carrying out policies and regulations established by the Ministry of Health and Welfare.
Management of High-Risk Pathogens(HRPs)
According to the ‘Infectious Disease Control and Prevention Act’, the 36 pathogens were designated as HRPs which have potential to pose a serious threat to public health and might be used as bioterrorism agent. MERS-CoV was added to HRPs list on 28 July 2015. There are requirements for isolation, possession, use, and transfer of HRPs in order to protect public health and safety under the Act. To provide information on biosafety and biosecurity and training opportunities, the DBEC held the 6th Conference for the Biosafety and Biosecurity Management. In addition, the DBEC published “Guideline for handling requirement and possession of HRP” for the safe practices and security in the handling of HRPs. To boost the morale of individuals and institutions who possess and handle HRPs and run containment facilities in the appropriate manner, the Ministry of Health and Welfare rewarded superior institutes and biosafety managers.
Management of Living Modified Organisms(LMOs)
Living Modified Organisms(LMOs) refers to the artificially recombined(inserted, subtracted, or changed) living organisms. Since 2008, a national approval system has been initiated to monitor the import and research related to LMOs as following cases: (a) the genes of pathogens with unknown risks to humans, (b) genes with the ability to express toxins, (c) genes resistant to antibiotics, and (d) genes of pathogens designated to be under government control. To control developed LMOs under the national approval system, the DBEC is responsible for the LMOs safety management throughout the entire period from the development of the LMOs to the disposal after use.
Management of Containment Laboratories
As biotechnology has improved recently, known and novel pathogens are emerging and reemerging more frequently. As a result, the biosafety practices in bio-medical facilities have become more important. In order to maintain the biosafety capacity of containment facilities in Korea, the national approval and management system for these facilities, such as Biosafety Level 3 (BL3) and Biosafety Level (BL4) facilities, has been developed based on the “Act on Transboundary Movements etc. of LMOs”. After the enactment of Act in 2008, to respond to national bio accident in health sector KCDC set up BL3 facility at first and since then Health Environment Institute and Livestock Experimental Hygiene Station has built and has operated BL3 facilities.
Based upon the recent version of the “Act on Transboundary Movements etc. of LMOs”, we revised the biocontainment facility construction and operation guidelines etc. (ABL3 and BL1, 2 lab.), which includes laboratory accreditation, remodeling, and shutdown procedures. These guidelines are expected to provide lab managers with valuable tools to acquire essential information on design features for biocontainment facilities, the test methodology for validation, and operation procedures.
The safety transport management of infectious substances
Recently, the number of collected and transported infectious substances is rising for various reasons including disease investigations, clinical trials, surveillance studies, and routine analysis. As the chances of exposure to infectious substances is increasing, we have revised the “Guideline for Safe Transport of Infectious Substances (2018)”. This guideline includes how to pack and transport the infectious substances safely. Through the establishment of the national safe transportation system of infectious substances, we could prevent the diffusion of infectious diseases. Furthermore, we are going to promote the safe transport of infectious substances and legalize related guidelines for the safe transport of infectious substances.