The National Oversight of Bioscience Researches in Korea : Biosafety & Biosecurity WK Seong, CK Yoo, JK Lee, JB Ahn, and TJ Son Division of Biosafety Evaluation and Control, Korea Centers for Disease Control and Prevention, Seoul, , Korea Brief History Introduction No. of items Lab general Lab general6 Design and physical requirement Design and physical requirement17 Supporting system Supporting system9 HVAC system HVAC system15 Waste treatment system Waste treatment system7 Lab equipments Lab equipmentsBSC13 Autoclave6 Work-Flow for the National Certification of BL3 Facility 80 Items for BL3 Facility Validation The Following Experiments Involving Recombinant DNA Tech. Require KCDC Approval in Advance Virus Cercopithecine herpesvirus 1, HERPes B virus Crimean-Congo haemorrhagic fever virus Eastern Equine Encephalitis virus Ebola virus Hendra viruses Lassa virus Marburg virus Monkeypox virus Nipah virus Rift Valley fever virus South American Haemorrhagic Fever viruses Tick-borne encephalitis complex (flavi) viruses Variola virus Variola minor virus, Alastrim Venezuelan Equine Encephalitis virus SARS-Cov Avian influenza virus affecting humans Bovine spongiform encephalopathy agent Bacteria, Rickettsia and Fungus Clostridium botulinum and toxin Vibrio cholerae O1 ․ O139 Yersinia pestis Bacillus anthracis Brucella melitensis Brucella suis Burkholderia mallei Coxiella burnetii Escherichia coli O157 Francisella tularensis Rickettsia prowazekii Rickettsia rickettsii Coccidioides immitis For the capacity building of researchers for laboratory biosafety & biosecurity, KCDC have been trying to promotes the education & training programs and risk communication activities. National Approval of Specific experiments Education and Risk Communication Summary 2005 Revising The Prevention of Contagious Disease Act to include the definition and the lists of highly dangerous pathogens 2005 Revising The Prevention of Contagious Disease Act to include the definition and the lists of highly dangerous pathogens 2001 Legislating The Act on the Transnational Transportation of Living Modified 2001 Legislating The Act on the Transnational Transportation of Living Modified Organisms to implement the Cartagena Protocol on Biosafety in Korea Organisms to implement the Cartagena Protocol on Biosafety in Korea 1997 Notifying The Guideline on Recombinant DNA Experiments 1997 Notifying The Guideline on Recombinant DNA Experiments 2005 Establishing The Division of Biosafety Evaluation & Control at KCDC 2005 Establishing The Division of Biosafety Evaluation & Control at KCDC 2006 Legislating The Act on the Prohibition of Biological or Chemical Weapon and the Control 2006 Legislating The Act on the Prohibition of Biological or Chemical Weapon and the Control of the Production, Export, and Import of Specific Chemical and Biological agents (CBWPA) of the Production, Export, and Import of Specific Chemical and Biological agents (CBWPA) 2006 Notifying The National Guideline for Laboratory Biosafety 2006 Notifying The National Guideline for Laboratory Biosafety 2007 Revising The Guideline on Recombinant DNA Experiments 2007 Revising The Guideline on Recombinant DNA Experiments 2008 Coming into effect The Act on Transnational Transportation of Living Modified Organisms 2008 Coming into effect The Act on Transnational Transportation of Living Modified Organisms 2007 Coming into effect the CBWPA 2007 Coming into effect the CBWPA There has been a rapid development of bioscience in Korea. The emerging outbreaks of highly pathogenic avian influenza and the international concern on the use of infectious agents in bioterrorism and dual–use of modern biotechnology have proposed the necessity of a national and international regulatory framework for biosafety & biosecurity. The public expects laboratory personnel to act responsibly and not to expose the community to the biorisks, to follow safe working practices associated with practices that will help keep their work and materials safe and secure, and to follow codes of conduct including Biosafety, Biosecurity and Bioethics. For the health security relating to biorisk, five priority areas are as follows: Raising awareness, preparedness for intentional release, developing risk assessment methodologies, Developing guidelines for research oversight, and capacity-building for risk management. According to the Cartagena Protocol on Biosafety, "The Act on the Transnational Transportation of Living Modified Organisms" was legislated in 2001, and finally came into effect in According to this Act, the provisions related to the national certification of the specific facilities such as biosafety level 3 in compliance with the specific requirement and the review of the specific experiments requiring national approvals were included. We emphasized the importance of risk assessment by an investigator himself to decide on the appropriate measures for containment, also the education program enhancing practical knowledge and skills. It is also accepted that research supervision and other measures to address concerns about the misuse of life sciences research should be pursued in conjunction with efforts to promote beneficial applications of such works. Institutional Training Public’s Awareness-raising On-line Information Center PublicationsPublications The experiments involving the cloning of genes from the microorganisms that are new and unknown relating to human health effect Highly Dangerous Pathogens Annual training program for related persons Workshops for Biosafety & Biosecutiry The International Symposium for Biosafety Biosafety education for new employees Biosafety education for new employees KCDC’s Biosafety officer training KCDC’s Biosafety officer training BL3 work practices & principles education BL3 work practices & principles education As the Biosafety Information Center for the public ( For the Risk management of Related Experts through Web The experiments involving the cloning of toxin molecules with LD 50 of less than 100 ng/kg body weight The experiments of deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally The experiments of involving the cloning of gene from highly dangerous pathogens that were notified by the Act on the Prevention of Contagious Disease Guidances and Manuals for Biosafety & Biosecurity Practice Biosafety Newsletter and Related Materials Biosafety Newsletter and Related Materials Notification Applying for the National Certification Checking the submitted Documents Reviewed by The Inspection Committee On-site inspection, if necessary Decision on Approval 60days Requirements for the Submitted Document Blue Print for the Facility Blue Print for the Facility Primary and Secondary Barrier Waste treatment system etc Documents for the Facility Validation Documents for the Facility Validation Institutional Biosafety Manuals and SOPs Institutional Biosafety Manuals and SOPs