Biosafety Assessment of Microbial Strains Used in Biotechnology According to Their Taxonomy

Natalia I. Sheina. PhD, ScD¹*; Elena V. Budanova, PhD²; Yuri P. Pivovarov, PhD, ScD¹; Lyubov I. Mjalina, PhD¹; Lyubov P. Sazonova, PhD¹

¹N.I. Pirogov Russian National Research Medical University, ²I.M. Sechenov First Moscow State Medical University; Moscow, Russia

*Corresponding author:  Prof. Natalia I. Sheina, Department of Hygiene, N.I. Pirogov Russian National Research Medical University, Moscow, Russia. E-mail:

Published: March 17, 2017.  doi: 10.21103/Article7(1)_OA6


A great variety of biotechnological products are now widely used in different ways in agriculture, medicine, food manufacturing and other areas of our life. Industrialized societies now more than ever depend on the use of genetically engineered products, with many of them synthesized using recombinant strains of microorganisms. There is an opinion that microbial strains used in biotechnology are potentially harmful for human health and the environment. Similar to many other countries, we have enacted environmental legislation in an effort to balance the risks and benefits of using biotechnological strains. Although environmental monitoring rules focus mainly on safety assessments of chemicals, the biosafety assessment of microbial strains used in biotechnology is a very important issue as well.
This article summarizes 15 years of research on the biotechnological strains of microbes widely used as producers of various biological substances for industrial purposes, and their environmental and biotechnological applications. In our survey, we tried to evaluate possible adverse effects (general toxicity and damage to the immune system, potential sensitizing effects, and damage to normal microbiota) caused by these microbes. It was shown that microscopical fungi of genera Aspergillus, Penicillium and Candida, and some gram-negative bacteria can affect the immune system and disrupt the normal balance of microbial flora of the intestinal tract in rats. The actinomycetes are less dangerous in that they cause fewer side effects. The investigation data obtained can be used to develop safety and hygienic standards for industrial microbes that will help decrease or minimize the occupational risk of infection or damage to the immune system when working with biotechnological strains of microbes. 

biotechnology ● microbial strains ● biosafety standards ● hygiene regulations

1. Environmental health criteria program. Agreed terms on health effects evolution, risk and hazard assessment of environmental agents. Preliminary draft. Brussels, WHO, 1994.
2. Jongman RHG, ter Braak CJF, van Tonregen OFR. Data Analysis in Community and Landscape Ecology. М., 1999 [in Russian]
3. Rüdel H, Schröder W, von der Trenck KT, Wiesmüller GA.Chemical and biological environmental monitoring series. Preface. Environ Sci Pollut Res Int. 2009;16(5):483-5.
4. Rakhmanin YuА, Bagdasarjan GA, Nemirya BI, Sergeyuk NP. Basic approaches to reglamentation of biological contaminants. Gig Sanit. 2001; (1):6-9. [in Russian].
5. Sergeyuk NP, Suprun IP, Buyanov VV. Sanitary and epidemiological regulation of the industrial microorganisms.  М.: Chernogolovka, 2003. [in Russian].
6. Pivovarov YuP, Myalina LI, Korolik VV. Criteria of pathogenic properties of the strain producers recommended for use in industrial microbiological synthesis. Guidelines. М., 1992. [in Russian].
7. Fedoseeva VN, Poryadin GV, Kovalchuk LV, Cheredeev AN, Kogan VYu. Manual on immunological and allergological methods of examination in hygiene. М., Promedec, 1993. [in Russian].
8. Trakhtenberg IM, Timofeevskaya LA, Kvyatkowskaya IYa. Methods of evaluation of chronic effect of chemical and biological contaminants.  Riga: Zinantne, 1987. [in Russian].
9. Lindner DP, Pobery IA, Rozkin MYa, Efimov VS. Morphometric analysis of the population of the must cells.  Arch Pathol. 1980;62(6):60-4. [in Russian].
10. Budanova EV, Vorob’ev AA, Nesvizhsky YuV, Bykov AA, Boichenko MN, Inozemtseva LO, et al. Human microbial ecology studies in the microbiology, virology and immunology department (Review). Vestn Ross Akad Med Nauk. 2001;(1):68-71. [in Russian].
11. Ivanov NG, Sergeyuk NP, Sheina NI, Skriabina EG, Budanova EV. Maximum permissible concentrations of the microorganisms-producers, bacterial preparations and their components in the ambient and workplace air. М., Federal Centre for Hygiene and Epidemiology, 2007. [in Russian].
12. Kirkwood B, Sterne J. Essential Medical Statistics. The 2nd ed., Blackwell Publishing, 2003, 501 p.
13. Sheina NI. Criteria of intestinal microflora imbalance and evaluation of exposure to industrial germs. Med Tr Prom Ekol.2007;11:21-6. [in Russian].
14. Sheina NI. Toxicological and hygienic characteristics of biotechnological strains of the microorganisms. Vestn Ross State Med Univ. 2007;3(56):66-71. [in Russian].
15. Sheina NI, Budanova EV. Toxicological and hygienic examinations of the industrial strains of microorganisms causing the intestinal microecology imbalance in the animals. Tox Vestn. 2005;(5):23-7. [in Russian].
16. Sheina NI, Budanova EV, Skriabina EG, Ivanov NG. New data on the toxicity and danger of chemicals and biological agents. Penicillium funiculosum VKM F3668D. Tox Vestn. 2006;(6):31-3. [in Russian].
17. Sheina NI, Budanova EV, Skriabina EG, Kolesnikova VV, Goloborodko EV. Microorganism Aspergillus awamori Nakazawa VUD Т-2 1000-U. Tox Vestn. 2006;(6):33-4. [in Russian].
18. Sheina NI, Skriabina EG, Budanova EV. Aspergillus terreus 44-62 – the lovastatin-producing strain. Tox Vestn. 2003;(3):48-9. [in Russian].
19. Sheina NI, Skriabina EG, Budanova EV. Aspergillus awamori BNII of Genetics 120/177, the glucoamylase-producing strain. Tox Vestn. 2003;(3):46-7. [in Russian].
20. Sheina NI, Skriabina EG, Budanova EV. Trichoderma viride 44-11-62/3, the strain producing a range of cellulolytic enzymes. Tox. Vestn. 2003;(4):45-47 [in Russian].
21. Sheina NI, Skriabina EG, Budanova EV, Ivanov NG. Candida tropicalis Y-456, the xylitol-producing strain. Tox Vestn. 2003;(4):47-9. [in Russian].
22. Sheina NI, Skriabina EG, Budanova EV. Bacillus subtilis 103, the strain producing neutral protease. Tox Vestn. 2004;(1):38-9. [in Russian].
23. Sheina NI, Skriabina EG, Budanova EV, Ivanov NG. Bacillus subtilis 65, the strain producing neutral amylase. Tox Vestn. 2004;(1):39-41. [in Russian].
24. Sheina NI, Skriabina EG, Budanova EV, Sergeyuk NP. Bacillus subtilis 72, the strain producing alkaline protease. Tox Vestn. 2004;(1):41-2. [in Russian].
25. Sheina NI, Skriabina EG, Budanova EV. Rhodococcus corallines. Tox Vestn. 2005;(2):36-7. [in Russian].
26. Sheina NI, Skriabina EG, Budanova EV. Pseudomonas caryophilii KM 92-102/1. Tox Vestn. 2005;(2):37-9. [in Russian].
27. Sheina NI, Skriabina EG, Budanova EV. Microorganism Bacillus licheniformis 103. Tox Vestn. 2007;(2):45-6. [in Russian].
28. Sheina NI, Skriabina EG, Budanova EV. Microorganism Penicillium canescens PlPh33 as the strain producing pectin lyase and phytase. Tox Vestn. 2007;(3): 37-9. [in Russian].
29. Sheina NI, Skriabina EG, Budanova EV. About the hygienic regulation of the concentrations of molds in ambient and workplace air. In: Theoretical and practical aspects of sanitary protection of the ambient air. М., 2003: 83-5. [in Russian].
30. Sheina NI, Skriabina EG, Budanova EV, Ivanov NG. B. licheniformis BNII of Genetics 1001 as a bacitracin producer. Tox Vestn. 2003;(5):48-50. [in Russian].
31. Sheina NI, Skriabina EG, Ivanov NG. Comparative characteristics of immunotropic action of industrial strains of microorganisms for their hygienic standardization. Tox Vestn. 2005;(3):12-5. [in Russian].
32. Sheina NI, Skriabina EG, Kolesnikova VV, Budanova EV. Microorganism Bacillus licheniformis 60. Tox Vestn. 2006;(6):30-1. [in Russian].
33. Skriabina EG, Sheina NI. Experimental evaluation of the immunotropic effect of industrial strains of microorganisms. Russ J Immun. 2004; (9 Suppl):123. [in Russian].
34. Budanova EV, Sheina NI, Skriabina EG, Ivanov NG, Vorob'ev AA, Zverev VV. Comparative studies of microbial strains used in biotechnology for the elaboration of biosafety standards.Vestn Ross Akad Med Nauk. 2010;(11):42-6.[in Russian].
35. Budanova EV, Sheina NI. Significance of evaluation of the antibiotic-resistant properties of bacterial producing strains in the hygienic standardization system. Gig Sanit. 2010;(5):45-7. [in Russian].
36. Pivovarov YuP, Sheina NI, Ivanov NG, Korolik VV, Skriabina EG. Problems and perspectives of the hygienic regulation of biotechnological strains of microorganisms. Gig Sanit. 2010;(5):9-12. [in Russian].
37. Sheina NI, Zholdakova ZI, Ivanov NG. Problem in the hygienic regulation and standardization of biotechnological strains in reservoir water. Gig Sanit. 2010;(5):39-42. [in Russian].
38. Sheina NI, Ivanov NG. Investigation of biotechnological strains of microorganisms for their hygienic standardization. Gig Sanit. 2010;(2):89-92. [in Russian].
39. Sheina NI, Ivanov NG. Scientific basis for hygienic classification of risk caused by microorganisms applied in biotechnologies. Med Tr Prom Ekol. 2010;(5):1-5. [in Russian].

The fully formatted PDF version is available.
Download Article
International Journal of Biomedicine. 2017;7(1):51-56. © 2017 International Medical Research and Development Corporation. All rights reserved.