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E4
OVERVIEW OF HIGH-CONTAINMENT BIOLOGICAL LABORATORIES IN RUSSIA
Michael V. Ugrumov1 and Sergey V. Netesov2
1
Councilor of the President of RAS on Foreign Affairs and Biology, Moscow, Russia
2
Vice Rector, Research, Novosibirsk State University, Novosibirsk, Russia
Russia’s extensive experience in working with dangerous pathogens in high-containment laboratories can
be traced back to the country’s early efforts to improve public health through research, vaccine
production, and development and implementation of vaccination strategy.1 The work led to success in
antiplague efforts during the 1920s and 1930s, national eradication of smallpox in 1939, and the
successful start of measles and poliomyelitis control through vaccine development followed by mass long-
term vaccinations. That expertise has continued to the present day where the Russian Federation is
home to 19 World Health Organization (WHO) Collaborating Centers including the WHO Collaborating
Centre for Tuberculosis at the Central Tuberculosis Research Institute (CTRI), Russian Academy of
Medical Sciences; the WHO Collaborating Centre for Orthopoxvirus Diagnosis and Repository for Variola
Virus Strains and DNA at the State Research Center of Virology and Biotechnology (“Vector” Center) in
Koltsovo (Novosibirsk Region), under Rospotrebnadzor supervision; and the WHO Collaborating Centre
for Training in Multidrug-Resistant Tuberculosis at the Novosibirsk TB Research Institute.2 The Vector
Center also hosts a WHO Influenza H5 Avian Influenza Reference Center,3 and the WHO National
Influenza Center is functioning actively in the St. Petersburg Institute of Influenza, which since last year
has been supervised by the Ministry of Public Health and Social Development of the Russian Federation.4
Additionally, the Russian Federation also has two World Organization for Animal Health (OIE)
Collaborating Centers5 and three OIE Reference Laboratories, which are responsible for dourine, equine
rhinopneumonitis, and foot and mouth disease.6
The current practice of monitoring, studying, and controlling infectious diseases outbreaks in Russia is
based on the following regulatory documents:
• Charter of Federal Service on Customers' Rights Protection and Human Well-being Surveillance
(Rospotrebnadzor) approved on 30.06.2004,7
• the 2005 International Health Regulations,8 and
• the State Order #60 dated 2 February, 2006.9
1
E.A. Stavskiy, N.B.Cherny, A.A. Chepurnov, S.V. Netesov, Anthology of Some Biosafety Aspects in
Russia (up to 1960), in Anthology of biosafety V. BSL-4 laboratories, J.Y. Richmond, Editor. 1999,
American Biological Safety Association: Mundelein, IL. p. 29-91.
2
WHO. World Health Centers Global Database. [cited April 28, 2011]; Available from:
http://apps.who.int/whocc/Search.aspx.;
State Research Center of Virology and Biotechnology-Vector. [cited 5 May 2011]; Available from:
http://www.vector.nsc.ru/DesktopDefault.aspx?lcid=9&tabindex=1&tabid=52.
3
[cited October 26, 2011]; Available from:
http://www.who.int/influenza/gisrs_laboratory/h5_reflabs/h5_reference_laboratories/en/index.html
4
[cited May 23, 2011]; Available from:
http://www.influenza.spb.ru/en/influenza_surveillance_system_in_russia/who_national_influenza_centre/.
5
OIE. List of Centres: OIE -World Organization for Animal Health. [cited April 28, 2011]; Available from:
http://www.oie.int/our-scientific-expertise/collaborating-centres/list-of-centres/.
6
OIE. List of Laboratories: OIE -World Organization for Animal Health. [cited April 28, 2011]; Available
from: http://www.oie.int/our-scientific-expertise/reference-laboratories/list-of-laboratories/.
7
http://old.rospotrebnadzor.ru/department/regulations/ (Charter of Rospotrebnadzor)
8
International Health Regulations -2005. http://www.who.int/ihr/en
9
Russian State Order #60: http://www.rg.ru/2006/02/17/monitoring-dok.html.
161
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162 Biosecurity Challenges
Building on these primary regulating documents, the special Order of Rospotrebnadzor #88 dated 17
March 2008 issued instructions about the measures on monitoring for infectious and parasitary diseases
agents.10 This last order lists four types of research and monitoring centers:
1. The list of regional centers for monitoring the infectious and parasitic disease agents of
pathogenicity groups 2-4 (roughly equivalent to BSL1-3 according to WHO classification)—
Appendix 1 in;11
2. The list of regional centers for monitoring the infectious and parasitic disease agents of
pathogenicity groups 1-2 (roughly BSL-3-4 according to WHO classification)—Appendix 2 in;12
3. The list of reference centers for monitoring the infectious and parasitic disease agents with
functions under the International Health Regulations (20050—Appendix 3 in;13
4. The list of national centers for verification of diagnostic work and national centers that fulfill the
functions of State Collections of Rospotrebnadzor—Appendix 4 in.14
All Russian BSL-3 and BSL-4 laboratories are listed in these Appendices, including Russia’s 17 regional
anti-plague centers. Additionally, this Order also describes the area of responsibility of each
Institute/Center and charters types of these Institutes/Centers. The special national Sanitary Regulations
(SR) one of which is the SP 1.3.1285-03 on “Safe handling of micro-organisms in pathogenic hazard
groups I-II”,15 whose observance is mandatory, form the foundations of Russian laboratory practices for
these Institutes/Centers as well as public health and educational university laboratories.16 The SR specify
a full spectrum of biosafety practices including disinfection procedures, sewage water testing, safe
transport of pathogens, and safe practices for hospital work. The SR also describe procedures for
obtaining permission to work with recombinant DNA and Hazard Groups I-IV microorganisms from the
State Sanitary-Epidemiological Inspection Committee17 and make provisions for laboratory inspections
and compliance monitoring.18 Hazard groups I, II, II, and IV in the Russian classification system are
roughly equivalent to the WHO’s risk groups IV, III, II, and I, respectively.19
Russia has stringent standards to prevent accidents at high-containment facilities, and the Sanitary and
Epidemiological Regulations SP 1.3.1285-03 on “Safe handling of micro-organisms in pathogenic hazard
groups I-II” describe the procedures to follow in response.20 It is a result of a long history of work with
dangerous pathogens in Russian microbiological laboratories during which time laboratory accidents took
place a few times; some important laboratory infection cases that occurred in Russia between 1950 and
10
Russian State Order #88: http://old.rospotrebnadzor.ru/docs/order/?id=1832.
11
Russian State Order #88: http://old.rospotrebnadzor.ru/docs/order/?id=1832.
12
Russian State Order #88: http://old.rospotrebnadzor.ru/docs/order/?id=1832.
13
Russian State Order #88: http://old.rospotrebnadzor.ru/docs/order/?id=1832.
14
Russian State Order #88: http://old.rospotrebnadzor.ru/docs/order/?id=1832.
15
Russian Sanitary Regulations for special and other dangerous pathogens of 1-2 pathogenicity groups:
http://www.lytech.ru/articles_31.htm.
16
E.A. Stavskiy, B. Johnson, R.J. Hawley, J.T. Crane, N.B. Cherny, I.V. Renau, S.V. Netesov,
Comparative Analysis of Biosafety Guidelines of the USA, WHO, and Russia (Organizational and
Controlling, Medical and Sanitary- Antiepidemiological Aspects). Applied Biosafety, 2003. 8(3): p. 118-
127.
17
Russian Sanitary Regulations for special and other dangerous pathogens of 1-2 pathogenicity groups:
http://www.lytech.ru/articles_31.htm.
18
Russian Sanitary Regulations for special and other dangerous pathogens of 1-2 pathogenicity groups:
http://www.lytech.ru/articles_31.htm. (page 12)
19
E.A. Stavskiy, B. Johnson, R.J. Hawley, J.T. Crane, N.B. Cherny, I.V. Renau, S.V. Netesov,
Comparative Analysis of Biosafety Guidelines of the USA, WHO, and Russia (Organizational and
Controlling, Medical and Sanitary- Antiepidemiological Aspects). Applied Biosafety, 2003. 8(3): p. 118-
127.
20
Russian Sanitary Regulations for special and other dangerous pathogens of 1-2 pathogenicity groups:
http://www.lytech.ru/articles_31.htm.
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163
Appendix E: Country and Region Overviews
1990 are described in the paper of S. Gaidamovich et al.1 As the result of this experience, during the
recent two decades, in the rare cases when an accident occurred, treatment began immediately and the
incident was thoroughly investigated. For example, in May 2004, an experienced technician who worked
at the Vector Center pricked herself with a syringe needle containing blood from a guinea pig infected
with Ebola virus. In spite of extensive prophylaxis and treatment she died. A commission including
experts from two governmental agencies, the Russian Federal Service for Surveillance in the Sphere of
Consumer Rights Protection and Human Well-being (Rospotrebnadzor) and the Federal Medical and
Biological Agency (FMBA), subsequently conducted an investigation that revealed multiple violations of
laboratory regulations by this experienced technician.2 The additional lesson learned from this case was
the need for more thorough training courses for experienced workers to prevent complacency.
Several Russian Universities, in collaboration with Health Canada and the Canadian Science Centre for
Human and Animal Health, recently updated their biosafety curriculum.3 For example:
• The Saratov Anti-Plague Institute developed 13 new advanced training programs including a
specialized primary training program in biosafety, a program for training specialized anti-
epidemic teams to work in emergency situations, and a program for training bacteriologists
and epidemiologists in the field of bioterrorism counteraction.
• A Train the Trainers Biosafety/Biosecurity Program organized with assistance of Canadian
biosafety experts from Health Canada took place November 17-19, 2008 at the Moscow
Medical Academy. As a result, the Moscow Medical Academy added a biosafety component to
their advanced virology course.
• The Vector Institute re-established an advanced course for medical, biological, chemical
(biotechnology), and veterinarian specialists. The 540-hour course focuses on virology, but
also provides a basic microbiological background. The current course includes an expanded
biosafety component as well as educational materials from the WHO and examples of
biosafety regulations from other countries including the United States and Canada. In the
experimental portion of the class, students work with vaccine strains using real laboratory
equipment, real BSL-3 facilities, and real personal protective equipment.
• A few universities in Russia including M. V. Lomonosov Moscow State University and
Novosibirsk State University (NSU) decided to include biosafety, biosecurity, and bioethics
courses in their Master of Biotechnology educational programs. Recently, ISTC project #4060
(Establishment of a Center for personnel training in principles of biosafety in work with viral
agents, on the basis of international recommendations and national biosafety requirements
and guidelines) started at the NSU with the help of Health Canada specialists to assist
Russian specialists to make this Center the most modern in Russia.
Specialists from M. V. Lomonosov Moscow State University, NSU, and a few other Moscow research
institutes have also suggested modernizing the Russian educational standard in biotechnology during
2011-2012.
To facilitate biosafety education, the first Russian Glossary of Biosafety Terms was published in 2007;
another variant of the Glossary was issued later in the same year. Finally, the first English-Russian
Harmonized Dictionary in Biosafety and Biosecurity was published in November 2010.
Furthermore, Russia played a major role in sponsoring and preparing United Nations Security Council
Resolution 1540, which requires all countries to take the necessary steps to prevent the proliferation of
1
S. Ya. Gaidamovich, A. M. Butenko, and H. V. Leschinskaya. Human laboratory Acquired Arbo-, Arena-
and Hantavirus infections. Journal of American Biological Safety Association. -2000. -V.5 (1)-P. 5-11.
2
L. A. Akinfeeva, O. I. Aksionova, I. V. Vasilevich, Z. I. Gin'ko, K. A. Zar'kov, N. M. Zybavichene, L. R.
Katkova, O. P. Kuzovlev, V. I. Kuzubov, L. I. Lokteva, E. I. Ryabchikova. A case of Ebola hemorrhagic
fever. Infektsionnye bolezni.-2005-No.1-P.85-88.
3
Netesov, S.V. The Current Situation with Education in Biosafety and Biosecurity in Russia. in Situation
and Perspectives of Education in the Field of Biotechnology, Biosafety and bioethics at the Novosibirsk
State University and other Russian Universities. 2009. House of Scientists, Novosibirsk, Russia.
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164 Biosecurity Challenges
weapons of mass destruction,4 and hence Russia takes its biosecurity responsibilities very seriously. As
a result, all, “biological materials are securely protected using modern technology, and the necessary
counter-terrorist measures are taken.”5 Furthermore, the national legal framework details procedures to
account for the production, use, storage, and transport of biological weapons and related materials and
specifies how violators can be penalized.6 Additionally, microbiological and virological research facilities
in Golitsino, Pokrov, Vladimir, Koltsovo (Vector Center), Obolensk, and Kazan recently upgraded their
security through their participation in the United States Biological Threats Reduction program,7 and in
collaboration with the International Science and Technology Center (ISTC), seven institutes invested over
$18 million in upgraded operating procedures and physical security.8 During the last three years, two
institutes—Vector Center and the Microbiolgical Center in Obolensk —additionally upgraded their
biosecurity equipment and services.
The Russian Federation will undoubtedly continue its efforts to modernize its microbiological laboratories
and biotechnological facilities in accordance with international standards and new achievements in
biosafety and biosecurity will follow.
CONCLUSIONS:
1. Periodical biosafety and biosecurity upgrades in laboratories working with dangerous pathogens
are needed to better protect the environment, personnel, and to prevent possible terrorism cases.
2. The modernization of educational courses in all areas of biotechnology and medicine should
include basic educational modules on biosafety, biosecurity, and bioethics.
3. The easiest and fastest way to upgrade the national level of biosafety/biosecurity is to study the
modern international recommendations and textbooks in this area, to upgrade national biosafety
regulations and standards, to modify the national educational programs, and to participate
actively in international biosafety meetings and associations.
4
Note verbale dated 26 October 2004 from the Permanent Mission of the Russian Federation to the
United Nations addressed to the Chairman of the Committee. November 2, 2004, Permanent Mission of
the Russian Federation to the United Nations.
5
Second report of the Russian Federation on the implementation of Security Council resolution 1540
(2004). 2004, Permanent Mission of the Russian Federation to the United Nations. (page 6)
6
Second report of the Russian Federation on the implementation of Security Council resolution 1540
(2004). 2004, Permanent Mission of the Russian Federation to the United Nations;
National Research Council (United States). Committee on Prevention of Proliferation of Biological
Weapons., The Biological Threat Reduction Program of the Department of Defense: from foreign
assistance to sustainable partnerships. 2007, Washington: National Academies Press. ix, 109 p.
7
National Research Council (United States). Committee on Prevention of Proliferation of Biological
Weapons., The Biological Threat Reduction Program of the Department of Defense: from foreign
assistance to sustainable partnerships. 2007, Washington: National Academies Press. ix, 109 p. (page
34)
8
Weaver, L.M., Biosafety and Biosecurity Activities of the International Science and Technology Center in
the Republics of the Former Soviet Union: Accomplishments, Challenges, and Prospects. Applied
Biosafety: Journal of the American Biological Safety Association, 2010. 15(2): pp. 56-59.
