E4

OVERVIEW OF HIGH-CONTAINMENT BIOLOGICAL LABORATORIES IN RUSSIA

Michael V. Ugrumov1 and Sergey V. Netesov2
1Councilor 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

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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/.

7http://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.



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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.