ORDER OF THE MINISTER OF SCIENCE AND THE HIGHER EDUCATION OF THE REPUBLIC OF KAZAKHSTAN

of February 26, 2024 No. 86

About approval of the 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 science of the Ministry of science and the higher education of the Republic of Kazakhstan in the procedure established by the legislation:

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

2) placement of this order on Internet resource of the Ministry of science and the higher education 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 science and the higher education 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 science and the higher education of the Republic of Kazakhstan

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

Approved by the Order of the Minister of science and the higher education of the Republic of Kazakhstan of February 26, 2024 No. 86

Control technique biological risks

Chapter 1. General provisions

1. This Control technique is developed by biological risks (further – the Technique) according to the subitem 5) of Item 2 of article 10 of the Law of the Republic of Kazakhstan "About biological safety of the Republic of Kazakhstan" (further – the Law) and determines procedure for management of biological risks when carrying out scientific and (or) scientific and technical activities.

2. In this Technique the following concepts are used:

1) biological safety – the 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) from dangerous biological factors including provided with measures of biological protection;

2) biological risk – probability of damnification to human health, animals, to plants pathogenic biological agents, and also probability of their hit in separate components of the environment;

3) the level of biological safety – the level of prevention of spread of the infectious diseases connected with the address pathogenic biological agents (further – PBA), and ensuring biological safety;

4) assessment of biological risks – the element of management of biological risks also represents 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 by the address with PBA;

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

3. Assessment of biological risks is subdivided on external and internal.

4. Results of assessment of biological risks depending on their level shall be used for development of actions for decrease in biological risk to its admissible (acceptable) level 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.

5. If in the analysis and assessment of biological risk harmful effects on life and health of the person, animals are revealed, however the available scientific data are not enough for determination of degree of biological risk, then department of authorized body in the field of biological safety takes veterinary and sanitary measures for management of biological risk (further – veterinary and sanitary measures).

Veterinary and sanitary measures are based on scientific data, objective assessment of biological risk for life and health of the person, the animals who are determined taking into account international standards (further – standards) in the field of veterinary and sanitary safety.

In case of assessment of equivalence of the applied veterinary and sanitary measures to standards of veterinary and sanitary safety results of researches (including laboratory), monitoring of spread of specific diseases and availability of zones, kompartment, regionalization are considered scientific yielded.

Veterinary and sanitary measures of other states are recognized equivalent in the presence of the following conditions:

1) compliance of the applied veterinary and sanitary measures to standards in the field of veterinary and sanitary safety;

2) ensuring proper level of veterinary and sanitary safety of the territory of the Republic of Kazakhstan from drift and spread of infectious and exotic diseases of animals.

6. When evaluating biological risks data of the epizootic monitoring which is carried out according to the Rules of carrying out epizootic monitoring approved by the order of the Minister of Agriculture of the Republic of Kazakhstan of November 27, 2014 No. 7-1/618 are considered (it is registered in the Register of state registration of regulatory legal acts No. 10021).

7. The gradation of biological risks is based on assessment of biological risks by determination of probability of damnification to human health, animal PBA and weight of the caused consequences.

8. The gradation of biological risks is based on classification of PBA by pathogenicity and degree of danger:

1) I group of pathogenicity – PBA 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, as a rule, concerning which are absent vaccines and effective remedies of therapy;

2) II group of pathogenicity – PBA 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 into PBA, defiant:

especially dangerous infectious diseases;

infectious and (or) parasitic diseases;

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