E7

HIGH-CONTAINMENT LABORATORIES IN UKRAINE: LOCAL RESOURCES AND REGULATIONS

Olena Kysil1,2, Serhiy Komisarenko1
1Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine and
2National Taras Shevchenko University of Kyiv, Ukraine
bs.conf@gmail.com

What high-containment biological (high BSL) laboratories exist in your country? What are the facilities’ main goals and priorities?

There are over 4,000 registered microbiological laboratories in Ukraine, but only 2 of them have a permit to work with microorganisms of the first pathogenic group, 402 laboratories have a permit to work with the microorganisms of the second pathogenic group, and all others are allowed to work only with microorganisms of the third and forth pathogenic groups. Here it is necessary to note that the classification of pathogenic organisms and therefore classification of the laboratories in Ukraine differs from the international one. It is inverted (i.e., in Ukraine “one” is the highest risk and “four” is the lowest risk) and also has some additional differences. That is why when speaking about high-containment laboratories according to Ukraine’s official classification we need to consider the laboratories that have a permit to work with the microorganisms of the first and the second pathogenic groups. At the same time it is not possible to say that a laboratory that has a permit to work with microorganisms of the first pathogenic group in Ukraine is equivalent to an international BSL-4 lab or that one working with microorganisms of the second pathogenic group is equivalent to a BSL-3 lab.

According to the available data, there are no laboratories in Ukraine that fulfill BSL-4 requirements. One of the laboratories that has a permit to work with the microorganisms of the first pathogenic group did, however, recently undergo an international audit as a BSL-3 laboratory and received a preliminary positive evaluation. This is one of the laboratories of the SI (State Institution) “Ukrainian I. I. Mechnikov Anti-Plague Research Institute” of the Ministry of Health of Ukraine (Odessa), which is responsible for the identification of especially dangerous biological pathogens. This laboratory was reconstructed and technically updated up to the BSL-3 level through a cooperative agreement between the United States Department of Defense and the Ministry of Health of Ukraine that started in 2005. The collaboration focuses on preventing the spread of technologies, pathogens, and knowledge that can be used in the development of biological weapons. The updated laboratory serves as Interim Central Reference Laboratory with a depozitarium (pathogen collection). According to Ukrainian regulations, it has a permit to work with both bacteria and viruses of the first and second pathogenic groups. A second laboratory of the SI “Ukrainian I. I. Mechnikov Anti-Plague Research Institute” of the Ministry of Health of Ukraine also has a permit to work with microorganisms of the first pathogenic group, but it is not updated to the BSL-3 level. This laboratory works only with the especially dangerous infections of bacterial etiology. The third laboratory upgraded to the BSL-3 level belongs to the Central Sanitary Epidemiological Station of the Ministry of Health of Ukraine. This laboratory was updated within the State program and the above-mentioned cooperative agreement between Ukraine and the United States. It has a permit to work with microorganisms of the second pathogenic group and is intended for work with especially dangerous infections.

According to the information received from the Central Regime Commission, the main authority that is responsible for the registration of microbiological laboratories in Ukraine, among the 402 laboratories that have permits to work with microorganisms of the second pathogenic group, 37 are subordinate to the Ministry of Health of Ukraine. Out of these 37 laboratories, 6 laboratories belong to research institutions, and therefore their main goals are scientific and practical investigations, while 31 laboratories belong to the Sanitary Epidemiological Service of Ukraine. These 31 laboratories are responsible for epidemiological and diagnostic investigations. Three hundred sixty two laboratories that have a permit to work with microorganisms of the second pathogenic group are subordinate to the Ministry of Agrarian Policy and Food of Ukraine. Out of them, 358 laboratories are responsible for diagnostic investigations,



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E7 HIGH-CONTAINMENT LABORATORIES IN UKRAINE: LOCAL RESOURCES AND REGULATIONS Olena Kysil1,2, Serhiy Komisarenko1 1 Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine and 2 National Taras Shevchenko University of Kyiv, Ukraine bs.conf@gmail.com What high-containment biological (high BSL) laboratories exist in your country? What are the facilities’ main goals and priorities? There are over 4,000 registered microbiological laboratories in Ukraine, but only 2 of them have a permit to work with microorganisms of the first pathogenic group, 402 laboratories have a permit to work with the microorganisms of the second pathogenic group, and all others are allowed to work only with microorganisms of the third and forth pathogenic groups. Here it is necessary to note that the classification of pathogenic organisms and therefore classification of the laboratories in Ukraine differs from the international one. It is inverted (i.e., in Ukraine “one” is the highest risk and “four” is the lowest risk) and also has some additional differences. That is why when speaking about high-containment laboratories according to Ukraine’s official classification we need to consider the laboratories that have a permit to work with the microorganisms of the first and the second pathogenic groups. At the same time it is not possible to say that a laboratory that has a permit to work with microorganisms of the first pathogenic group in Ukraine is equivalent to an international BSL-4 lab or that one working with microorganisms of the second pathogenic group is equivalent to a BSL-3 lab. According to the available data, there are no laboratories in Ukraine that fulfill BSL-4 requirements. One of the laboratories that has a permit to work with the microorganisms of the first pathogenic group did, however, recently undergo an international audit as a BSL-3 laboratory and received a preliminary positive evaluation. This is one of the laboratories of the SI (State Institution) “Ukrainian I. I. Mechnikov Anti-Plague Research Institute” of the Ministry of Health of Ukraine (Odessa), which is responsible for the identification of especially dangerous biological pathogens. This laboratory was reconstructed and technically updated up to the BSL-3 level through a cooperative agreement between the United States Department of Defense and the Ministry of Health of Ukraine that started in 2005. The collaboration focuses on preventing the spread of technologies, pathogens, and knowledge that can be used in the development of biological weapons. The updated laboratory serves as Interim Central Reference Laboratory with a depozitarium (pathogen collection). According to Ukrainian regulations, it has a permit to work with both bacteria and viruses of the first and second pathogenic groups. A second laboratory of the SI “Ukrainian I. I. Mechnikov Anti-Plague Research Institute” of the Ministry of Health of Ukraine also has a permit to work with microorganisms of the first pathogenic group, but it is not updated to the BSL-3 level. This laboratory works only with the especially dangerous infections of bacterial etiology. The third laboratory upgraded to the BSL-3 level belongs to the Central Sanitary Epidemiological Station of the Ministry of Health of Ukraine. This laboratory was updated within the State program and the above- mentioned cooperative agreement between Ukraine and the United States. It has a permit to work with microorganisms of the second pathogenic group and is intended for work with especially dangerous infections. According to the information received from the Central Regime Commission, the main authority that is responsible for the registration of microbiological laboratories in Ukraine, among the 402 laboratories that have permits to work with microorganisms of the second pathogenic group, 37 are subordinate to the Ministry of Health of Ukraine. Out of these 37 laboratories, 6 laboratories belong to research institutions, and therefore their main goals are scientific and practical investigations, while 31 laboratories belong to the Sanitary Epidemiological Service of Ukraine. These 31 laboratories are responsible for epidemiological and diagnostic investigations. Three hundred sixty two laboratories that have a permit to work with microorganisms of the second pathogenic group are subordinate to the Ministry of Agrarian Policy and Food of Ukraine. Out of them, 358 laboratories are responsible for diagnostic investigations, 171

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172 Biosecurity Challenges while 4 belong to research institutions and perform scientific and practical investigations. The four laboratories of the National Academy of Agrarian Sciences of Ukraine, which have a permit to work with microorganisms of the second pathogenic group, are research oriented. The one laboratory of the Ministry of Defense of Ukraine that has a permit to work with microorganisms of the second pathogenic group performs diagnostic investigations. What government organizations are responsible for the safety and security of high BSL laboratories? According to the existing regulations, the main authority that is responsible for the registration of microbiological laboratories and their biosafety and biosecurity is 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 (according to the State Sanitary Rules 9.9.5.035-99 and 9.9.5-153-2008). If there are high BSL laboratories in your country, are there established criteria for deciding: a. Whether or not to establish such facilities? b. Where to place such facilities? c. What research will be done in such facilities? d. What scientific, technical, and management advice is available to governments when making their decisions? In the case of state subordination of a new laboratory, the decision to establish it or not needs to be taken by the State based on recommendations of a Ministry or a state institution. Then, for example, the decision to establish a new laboratory needs to be included into a state program. To our knowledge there are no established criteria for such a decision. What standards exist for high BSL laboratories for: a. Engineering and construction? b. Licensing? c. Safety and security? d. Regular oversight and re-certification? These are the main regulations that set the high BSL laboratory standards: 1. The State Sanitary Rules 9.9.5.035-99 "The safety of work with microorganisms of the I-II pathogenic groups” (1999) 2. The State Sanitary Rules 9.9.5.-080-02 "The rules of the organization and the safety of work at microbiological laboratories (departments, units)" (2002) 3. The State Sanitary Rules 9.9.5-153-2008 "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 14.12.1992 "On regime of work with pathogenic microorganisms" 5. The Order of Ministry of Health of Ukraine N452 from 06.11.2001 "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. Have there been any accidents at high BSL labs in your country? 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. Have any steps been taken to minimize high BSL laboratory accidents? A few virology laboratories of the State Sanitary Epidemiological Service of Ukraine were updated with equipment to fulfill international biosafety requirements for working with poliomyelitis, measles, and influenza as part of a World Health Organization (WHO) Program. The laboratories of the Central Sanitary

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173 Appendix E: Country and Region Overviews Epidemiological Station of the Ministry of Health of Ukraine and the SI “Ukrainian I. I. Mechnikov Anti- Plague Research Institute” of the Ministry of Health of Ukraine were also reconstructed and equipped as part of an agreement with the United States. Over the next years, a few of the regional Sanitary Epidemiological Stations of the Ministry of Health of Ukraine and laboratories of the National Academy of Agrarian Sciences of Ukraine are also scheduled to be updated as part of the same agreement with the United States. It is also important to mention activities connected with training of laboratory personnel. For example, intensive training programs are running as part of an agreement with the United States. There is also a new Training Centre on Biosafety in Odessa functioning as part of SI “Ukrainian I. I. Mechnikov Anti- Plague Research Institute.” Its creation was supported by Canada’s Global Partnership Program through the Science and Technology Center in Ukraine (STCU) to ensure modern biosafety and biosecurity training programs. There are also some projects to increase the biosafety and biosecurity, which are being run by individual laboratories. For example, the Central Sanitary Epidemiological Station of the Ministry of Health of Ukraine laboratory that works with especially dangerous infections is implementing the Laboratory Biorisk Management Standard CWA 15793:2008 with support from Canada through STCU. All these steps aim to minimize the risk of accidents and to increase laboratory security. Have any steps been taken to increase security at high BSL facilities? If so, by whom (i.e., regulation, voluntary measures, individual laboratory practices)? Besides the above-mentioned activities, which are intended to both minimize accidents and increase of security at high BSL facilities, there is also a project to strengthen the education of life scientists on biosafety, biosecurity, and dual-use issues. The project is run by the Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine in close collaboration with the University of Bradford with support of Canada through STCU. The aim of the project is to strengthen support for the prohibition of the misuse of the modern life sciences by pioneering the formulation and implementation of a national system of biosafety, biosecurity, and dual-use issues education.

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