Ratification of BWC BWC Expert Group, Republic of Korea Compendium of National Activities in Korea: Measures to Improve Biosafety and Biosecurity Hei Chan Lee* and Baik Lin Seong** BWC Expert Group *Institute of Biomoleculae Reconstruction & Department of Pharmaceutical Engineering, Sun Moon University, Asan, , Korea **Department of Biotechnology, College of Engineering and Bioproducts Research Center, Yonsei University, Seoul , Korea Since the Republic of Korea ratified the 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological and Toxin Weapons and on their Destruction (the “BWC”), it has attached ever greater importance to enhancing biosafety and biosecurity by enacting effective legislation and establishing a comprehensive national regulatory regime to ensure the measures for prohibition and prevention required by the BWC. Legislative and administrative measures are summarized. Legislative MeasuresAdministrative Measures A B C D E f 1.CBWPA effective from January The Combined Notification – revised in April The Prevention of Contagious Diseases Act – amended in July The Guideline on Recombinant DNA Experiment – notified in 1997; revised in 2007 under the Biotechnology Promotion Law 5.The Notification on the Designation of Goods Subject to Customs Verification of Clearance Requirements and Verification Methods Pursuant of the Provisions of Article 226 of the Customs - applied to all biological agents: June The Act on the Transnational Transportation of Living Modified Organisms (LMO) – legislated in 2001, effective January The Laboratory Biosafety Guidelines - The Korea Center for Disease Control and Prevention (KCDC) 1.The export/import of biological agents and toxins - Foreign Trade Act and Combined Notification/CBWPA 2.National declaration and authorization system for biological agents and toxins 3.The system for the categorization of export control items for the sake of compatibility of Export Control Numbers in trade with the EU, Australia and the USA 4.A tracking system to monitor highly dangerous pathogens 5.A training programs on biosafety – KCDC 6.The International Symposium on Biosafety and Biosecurity 7.Examine the situation of storage and facilities for infectious agents, the safety management of research facilities, and education on the National Regulations - NVRQS Legislative MeasuresAdministrative Measures L1. CBWPA: the Act on the Prohibition of Chemical and Biological Weapons and the Control of the Production, Export, and Import of Specific Chemicals and Biological Agents - The revised version of the Chemical Weapons (Prohibition) Act, effective from January 2007 A central pivot for all legislative mechanisms for the implementation of the BWC Provisions for scheduled and occasional inspections, strong punishment for violations The use of 67 types of biological agents and toxins is strictly prohibited Exception: peaceful purposes (the prevention and treatment of illness) L2. The Foreign Trade Act and The Combined Notification The Foreign Trade Act and the Combined Notification of the Import and Export of Strategic Materials and Technology (the Combined Notification – Revised in April 2007 Regulate biological agents and toxins (Common Control List of the Australia Group) Requires the declaration and notification of the production/import, permission for their export L3. The Prevention of Contagious Diseases Act Amended in July 2007 Include the definition and the lists of highly dangerous pathogens and related requirements for enforcing biorisk management. A system for safety management for the safekeeping, separation, transportation and exposal of pathogens - established in January 2006 through the Amendment to the Enforcement Ordinance and Enforcement Regulation of this act L4. The Guideline on Recombinant DNA Experiments Notified in 1997 under the Biotechnology Promotion Law - Revised in 2007 Prevent any mishap or fallout in advance as the rapid development of biotechnology in Korea lead to increased concerns over adverse effects and the possibility of misuse L5. To All Biological Agents The Notification on the Designation of Goods Subject to Customs Verification of Clearance Requirements and Verification Methods Pursuant of the Provisions of Article 226 of the Customs – applied to all biological agents as of June 2007 Build the credibility and strengthen domestic biological safety standards L6. The Act on the Transnational Transportation of LMO Legislated in 2001 & effective from January 2008 Implement the Cartagena Protocol on Biosafety and prevent any potential risks National authorization of specific experiments and the specific facilities such as Biosafety Level 3 (BSL-3) L7. Laboratory Biosafety Guidelines(KCDC) Provide information on the safe handling of pathogens, risk assessment procedures, the operation of the Institutional Biosafety Committee A1. The export and import of biological agents and toxins The export requires a license issued by MKE as stipulated under the Foreign Trade Act and the Combined Notification. Imports are regulated under the CBWPA except for cases authorized by the Act on the Prevention of Contagious Animal Diseases and the Plant Quarantine Act. A2. National declaration and authorization system for biological agents and toxins To enhance biosafety by MKE Conducted inspections of facilities producing and possessing biological agents and toxins regulated by the CBWPA Producers and possessors submit declaration reports on production and possession Standards on installation and management of such facilities Certified or declare themselves in accordance with the risk level of pathogens Safety rules at each level in appropriate research facilities A3. System for the categorization of export control items Export Control Numbers compatibility in trade with the EU, Australia and the USA With the revision of the Foreign Trade Act and the Combined Notification: in December 2007, MKE A4. A Tracking System to Monitor Highly Dangerous Pathogens Safe management of specific pathogens - KCDC Unique tracking numbers: to the specific traits/ the date of isolation or importation/ the related institution/ other relevant information/ the use, transportation, and conservation of the pathogens are then monitored A5. Training programs on biosafety - two major programs-KCDC Biological Safety Management Course: researchers in non-governmental institutes Laboratory Biological Safety Course: researchers in government agencies. The Biosafety Newsletter Provides consultation services - installation and management of the research facilities A6. International Symposium on Biosafety and Biosecurity – July 2008 Strengthen awareness Raise and review the domestic management system KCDC, the Bioindustry Association of Korea (BAK) and Korea University Biosafety and biosecurity experts from the USA, Canada, and Japan A7. NVRQS: The National Veterinary Research and Quarantine Service Its own strict regulations Inspections to assess the management of livestock infectious disease agents National Regulations of Livestock Infectious Agents Examine the situation of storage and facilities for infectious agents, the safety management of research facilities, and education on the National Regulations Abbreviated Terms BWC the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological and Toxin Weapons and on their Destruction CBWPA the Act on the Prohibition of Chemical and Biological Weapons and the Control of the Production, Export, and Import of Specific Chemicals and Biological Agents KCDC The Korea Center for Disease Control and Prevention LMO Living Modified Organisms MKE the Ministry of Knowledge Economy NVRQS The National Veterinary Research and Quarantine Service Abbreviated Terms BWC the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological and Toxin Weapons and on their Destruction CBWPA the Act on the Prohibition of Chemical and Biological Weapons and the Control of the Production, Export, and Import of Specific Chemicals and Biological Agents KCDC The Korea Center for Disease Control and Prevention LMO Living Modified Organisms MKE the Ministry of Knowledge Economy NVRQS The National Veterinary Research and Quarantine Service