Primary sanitary and hygienic assessment of microorganisms used in biotechnology

Introduction. The use of microorganisms in biotechnological enterprises, agriculture, and forestry can be accompanied by microbial contamination of the environment and have an adverse effect on the human health.

The purpose of the research is to develop and put into practice quantitative criteria for the pathogenicity of biotechnological microorganisms as the first stage in assessing their safety.

Materials and methods. Lethal dose (LD₅₀) and “threshold” (Lim_bact) doses, dissemination in internal organs, toxigenicity, and “pathogenicity enzymes” of thirty-three strains of saprophytic, opportunistic and pathogenic bacteria, 250 strains of 10 genera proposed for use in biotechnology, and 11 strains already used as active biopreparation substances were investigated.

Results. Based on the criteria for primary sanitary and hygienic assessment, microorganisms were selected into three groups: strains recommended for industrial use; strains at risk of application; strains not recommended for use. Among the studied 250 strains of microorganisms proposed for use in biotechnology, 38.9% did not have pathogenic properties and can be used, 41.0% are conditionally pathogenic and are at risk of use, and 20.1% are not recommended for use in biotechnology due to the presence of pathogenic properties. A study of the pathogenic properties of 11 strains of bacteria that are the part of modern biological products showed that they belong to non-pathogenic microorganisms.

Limitations. The development and testing of the criteria for the primary sanitary and hygienic assessment of microorganisms proposed for biotechnology were carried out on a large material (more than 250 strains) with a single exposure to high doses, which did not allow us to assess the specific effects of exposure to strains during long-term exposure and may be the subject of further research.

Conclusion. The criteria for the primary sanitary and hygienic assessment of microorganisms proposed for use in biotechnologies include average lethal and “threshold” doses dissemination in internal organs, toxigenicity and activity of “pathogenicity enzymes”. All planned for use in biotechnology microorganisms should be examined for possible pathogenic properties. Biological products used in real time in the national economy contain only saprophytic microorganisms as an active substance. The problem of biosafety should be solved in the direction of studying the specific effect of microorganisms and biological products on the immune system influence and the state of the microcenosis of the body.

Compliance with ethical standards. The conducted study does not require a conclusion on biomedical ethics since it is a generalization of many years of work of researchers on this issue.

Contribution:
Korolik V.V., Sheina N.I. — concept and design of the study, statistical analysis, writing text, editing;
Mjalina L.I. — сollection and processing of material;
Sazonova L.P. — сollection of material;
Drugova E.D. — material processing.
All authors are responsible for the integrity of all parts of the manuscript and approval of the manuscript final version.

Conflict of interest. The authors declare no conflict of interest.

Acknowledgement. The study had no sponsorship.

Received: May 29, 2022 / Accepted: December 8, 2022 / Published: March 25, 2023