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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