Report of the World Health Organization (WHO) biosafety inspection team of the variola virus maximum containment laboratories, Koltsovo, Novosibirsk Region, Russian Federation 8–13 December 2014
Overview
The inspection was carried out at one of the two WHO-authorized variola virus (smallpox) repositories, the State Research Centre of Virology and Biotechnology (“VECTOR”) in the Russian Federation, in December 2014 by the WHO team of international experts, in accordance with World Health Assembly resolution WHA60.1 (2007), as agreed by all relevant parties in a preparatory meeting before the visit.
The activities of the WHO team included inspection of the physical high-containment facilities designated for research use of variola virus, the supporting engineering systems and the long-term, secure specimen storage arrangement. The team also heard presentations from and had interactive discussions with VECTOR staff and reviewed records, regulatory instruments, instruction manuals, meeting minutes, floor plans and other documents that they requested.
The VECTOR management and staff described in detail their institutional commitment to biosafety and biosecurity and their facility systems and operations throughout the inspection. The observations and findings were presented and discussed with VECTOR on the last day of the inspection. VECTOR has also completed a new self-assessment form to identify updates and modifications since the previous inspection, to provide continuity between inspections.
Improvements have been made since the previous inspection, in 2012, with many findings addressed and closed. During the 2014 WHO inspection, no finding that required immediate corrective action (Priority 3) was identified, although further work was requested on some issues. In conclusion, the VECTOR repository was found to meet international levels of biosafety and biosecurity for variola virus research and storage. VECTOR remains, however, responsible for the continued safe, secure storage of and conduct of work with live variola virus; this inspection report places no responsibility on WHO. VECTOR is requested to present to WHO an action plan to address the issues raised for further improvement within 30 days of receipt of this report.