ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of October 5, 2022 No. KR DSM-110

About approval of control technique biological risks

According to the subitem 5) Item 2 of article 10 of the Law of the Republic of Kazakhstan "About biological safety of the Republic of Kazakhstan", PRIKAZYVAYU:

1. Approve the enclosed control technique by biological risks.

2. To provide to committee of sanitary and epidemiologic control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) placement of this order on official Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication.

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

3. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

4. This order becomes effective after ten calendar days after day of its first official publication.

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of October 5, 2022 No. KR DSM-110

Control technique biological risks

Chapter 1. General provisions

1. This control technique is developed by biological risks (further – the Technique) according to Item 1 of Article 13, the subitem 5) of Item 2 of Article 10, Item 6 of article 14 of the Law of the Republic of Kazakhstan of May 21, 2022 "About biological safety of the Republic of Kazakhstan" (further – the Law) and determines the procedure for management of biological risks in the sphere of sanitary and epidemiologic wellbeing of the population including assessment of biological risks and development of actions for decrease in biological risks.

2. In this Technique the following concepts are used:

1) biological safety – condition of security of people and separate components of the environment (atmospheric air, surface and underground water, the land surface and soil layer, plant and animal life and other organisms (further – separate components of the environment) from dangerous biological factors, including provided with measures of biological protection;

2) assessment of biological risks – management system element biological risks, representing set of the organizational, analytical and practical actions directed to the prevention of emergence of negative consequences of impact of dangerous biological factors, means, methods, technologies, services in various fields of activity connected with the treatment of pathogenic biological agents;

3) internal assessment of biological risks – system of measures of the subject performing activities for the treatment of pathogenic biological agents (further – PBA), concerning own activities for the treatment of pathogenic biological agents;

4) the treatment of pathogenic biological agents – processes (stages) of work with pathogenic biological agents which are directly directed to allocation (detection), development (creation), production (production), turnover (including import (export), storage, transportation) pathogenic biological agents for the purpose of their research, destruction and (or) development of immunobiological medicines;

5) the specialist performing the treatment of pathogenic biological agents (further – the specialist) – the physical person having technical and professional and (or) postsecondary education and (or) the higher and (or) postgraduate education, and (or) academic degree and allowed in accordance with the established procedure to the treatment of pathogenic biological agents;

6) the subject performing the treatment of pathogenic biological agents (further – the subject) – the legal entity performing the treatment of pathogenic biological agents.

3. Assessment of biological risks is carried out concerning the treatment of pathogenic biological agents, potentially dangerous biological objects, the epidemic and epizootic centers of infectious and (or) parasitic diseases and potentially focal territory.

4. Results of assessment of biological risks are used for development of actions for their decrease to admissible (acceptable) levels in case of which conditions for protection of the population and protection of separate components of the environment from impact of dangerous biological factors are provided.

Chapter 2. Gradation of biological risks

5. The control technique is developed by biological risks taking into account scientific and methodological base and provides gradation of biological risks on their levels.

6. Fundamental factor of gradation of biological risks is classification of pathogenic biological agents on pathogenicity and degree of danger:

1) the I group of pathogenicity – the pathogenic biological agents causing especially dangerous infectious diseases of people and (or) animals with the high mortality rate (lethality) which are easily extending from the infected organism to healthy concerning which there are no vaccines and effective remedies and methods of treatment;

2) the II group of pathogenicity – the pathogenic biological agents causing the infectious and (or) parasitic diseases of people and (or) animals which are easily extending from the infected organism to healthy concerning which effective remedies and methods of treatment and prevention, including vaccines are available. This group is subdivided on the pathogenic biological agents causing especially dangerous infectious diseases, infectious and (or) parasitic diseases;

3) III group of pathogenicity – the pathogenic biological agents causing the infectious and (or) parasitic diseases of people and (or) animals or capable to do considerable harm to plants, characterized by the minimum distribution from the infected organism to healthy concerning which effective remedies and methods of treatment and prevention, including vaccines are available;

4) the IV group of pathogenicity – the pathogenic biological agents causing the infectious and (or) parasitic diseases of people and (or) animals or capable to do harm to plants, not extending from the infected organism to healthy concerning which effective remedies and methods of treatment and prevention, including vaccines are available.

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