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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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