Regulatory Framework for Biological Safety Provision When Working with Microorganisms of the III–IV Pathogenicity Groups

Abstract

Objective of the study was to review the current normative-methodological documentation on the matters of safe handling of pathogenic biological agents (PBA) of the III–IV pathogenicity groups. Materials and methods. We used analytical method for the study. We carried out comparative analysis of the provisions contained in the current regulations approved at different times for different agencies on the matters of air filtering system equipping, usage of microbiological safety cabinets, ensuring hand washing station provision for laboratories, inspection of disinfectants entering a lab, and waste decontamination procedures. Results and discussion. We have considered the provisions of the current documentation that require further refinement and clarification for the future editions of sanitary regulations. Two aspects draw increasing attention: the problem of regulating the inlet and exhaust ventilation system setup in the laboratories of microbiological specialization for work with PBA and the need to devise a consistent coordinated regulatory framework. Examples provided in the paper demonstrate the necessity of adhering to the integrated unified approach to the requirements for biosafety provision in the documents of various agencies; clear wording; harmonized system of normative and technical specifications for laboratory equipment, stating the basic characteristics of microbiological safety cabinets and ventilation systems. The documents should be in compliance with the requirements of various agencies. The maintenance of technical-engineering systems should be performed by the specialists with an appropriate qualification on a regular basis.