High Containment Laboratories in Ukraine - Local Resources and Regulations Olena Kysil *National Taras Shevchenko University of Kyiv **Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine Istanbul, July 11-13, 2011

Population: 46,2 mln Territory: 603,700 sq.km Europe geographic center is on its territory Administrative system - a unitary state: Crimean AR, 24 oblasts, 2 cities – Kyiv and Sevastopol with separate status Crossroad and Transit – connecting West Europe with Trans-Caucasia & Central Asia: 7 land neighboring countries and 3 across Black Sea

4058 registered microbiological laboratories 1. What high containment biological (high BSL) laboratories exist in your country? What are the facilities’ main goals and priorities? 2 ones work with microorganisms of the I pathogenic group 402 ones work with microorganisms of the II pathogenic group 3654 ones work with microorganisms of the III-IV pathogenic groups 1, 2 – two labs of SI “Ukrainian I. I. Mechnikov Anti-Plague Research Institute” of the Ministry of Health of Ukraine (Odessa). One of them is of BSL3 level 3 – one lab of Central Sanitary Epidemiological Station of the Ministry of Health of Ukraine is of BSL3 level 2 – scientific and practical investigations 1,2 12 – scientific and practical investigations 390 – epidemiological and diagnostic investigations 3 ! the classification is inverted towards international

- the Central Regime Commission, which works together with regional Regime Commissions of the State Sanitary Epidemiological Service of Ukraine and regional chief state sanitary doctors of Ukraine (State Sanitary Rules and ) 2. What government organizations are responsible for the safety and security of high BSL laboratories? - to our knowledge there are no established criteria for such a decision. 3. If there are high BSL laboratories in your country, are there some established criteria for deciding?

1. The State Sanitary Rules "The safety of work with microorganisms of the I-II pathogenic groups” (1999) 2. The State Sanitary Rules "The rules of the organization and the safety of work at microbiological laboratories (departments, units)" (2002) 3. The State Sanitary Rules "The organization of laboratories’ work in the case of investigation of materials containing the biological pathogenic agents by molecular-genetic methods" (2008) 4. The Order of Ministry of Health of Ukraine N183 from "On regime of work with pathogenic microorganisms" 5. The Order of Ministry of Health of Ukraine N452 from "On strengthening of anti-epidemical regime of work at microbiological laboratories" The project of the Regulation of Cabinet of Ministers of Ukraine, proposed by the Ministry of Health of Ukraine "The question of permit issue for work with the microorganisms of the I-IV pathogenic groups for microbiological laboratories and the functioning of regime commissions on biosafety" (2008) is currently undergoing public discussion. 4. What standards exist for high BSL laboratories for: a. Engineering and construction? b. Licensing? c. Safety and security? d. Regular oversight and re-certification?

According to the information received from the Central Regime Commission during the last twenty years, there were no registered accidents at high containment laboratories in Ukraine. 5. Have there been any accidents at high BSL labs in your country? - equipping and reconstruction of laboratories (State Programs, International Cooperation with WHO, EU, the USA Department of Defense, Global Partnership Program), - updating of the regulations, - special projects on training of personnel of laboratories, - some projects of individual laboratories: Implementation of the Laboratory Biorisk Management Standard CWA 15793:2008 in the EDI laboratory of the CSES, Development of Best practices guidance by the Anti-Plague Research Institute 6. Have any steps been taken to minimize high BSL laboratory accidents? 7. Have any steps been taken to increase security at high BSL facilities? If so, by whom (i.e., regulation, voluntary measures, individual laboratory practices)?

Thank you for your attention! Olena Kysil, Istanbul, July 11-13, 2011