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Law No. 122-VII ZRK “On biological safety”.

Pays/Territoire
Kazakhstan
Type du document
Législation
Date
2022 (2023)
Source
FAO, FAOLEX
Sujet
Environnement gén.
Mot clé
Législation de base Prévention des risques biotechnologiques Protection de l’environnement Substances dangereuses Risques Autorisation/permis Santé publique Agents de lutte biologique Monitorage Classement/déclassement Collecte de données/déclarations Accès-à-l'information Mise en application
Aire géographique
Mer d’Aral, Asie, Mer Caspienne, Asie Centrale, CEI (Communauté des États indépendants), Europe et Asie Centrale, Nations en développement sans littoral, Asie du Nord
Entry into force notes
This Law enters into force six months after the date of its first official publication.
Résumé

This Law defines the legal basis for state regulation in the field of biological safety of the Republic of Kazakhstan and is aimed at prevention of biological threats. This Law regulates public relations concerning the treatment of pathogenic biological agents, in order to ensure biological safety. Biological safety shall be intended the state of protection of people, individuals and components of the natural environment (atmospheric air, surface and underground waters, earth's surface and soil layer, flora and fauna and other organisms from hazardous biological factors, including those provided by biological protection measures. Biological risk shall be intended the likelihood of causing harm to the health of people and animals, plants with pathogenic biological agents, as well as the likelihood of their entry into individual components of the natural environment. Handling of pathogenic biological agents shall be intended processes (stages) of work with pathogenic biological agents directly aimed at allocation (discovery), development (creation), production (manufacturing), turnover (including import (export), storage, transportation) of pathogenic biological agents for the purpose of their research, destruction and (or) development of immunobiological preparations. Biological safety is ensured in line with the following principles: (a) handling of pathogenic biological agents exclusively in non-military purposes: it is prohibited handling of pathogenic biological agents for the purposes of development (creation), production (manufacturing) and (or) stockpiling, use of bacteriological (biological) and toxin weapons; (b) early recognition of biological threats: state authorities, when exercising powers in the field of biological safety, must be guided by the need for prevention as a priority biological threats, analyze and predict biological threats based on accounting and monitoring data in the field of biological safety; (c) controllability of handling pathogenic biological agents: pathogenic biological agents are handled in accordance with requirements in the field of biological safety, compliance with which is provided within the framework of biological risk management, application of authorization procedure for handling pathogenic biological agents, accounting, monitoring and forecasting (modeling) in the field of biological safety, government control and supervision of compliance with requirements in areas of biological safety; (d) proportionality of government regulation measures: preventive measures in biosafety areas must be proportionate to the degree of hazardousness of biological factors, including in accordance with the criteria and classification in areas of biological safety; and (e) priority of national interests of the Republic of Kazakhstan: it is not allowed acceptance of obligations within the framework of international cooperation that do not correspond to the national interests of the Republic of Kazakhstan that could cause damage to the national security of the Republic of Kazakhstan or leading to loss of independence of the Republic of Kazakhstan. Main problems and threats, strategic goals, main directions, target indicators, objectives and outcome indicators, interdepartmental interaction in the field of biological safety is determined by the Strategy of national security of the Republic of Kazakhstan. State regulation in the field of biological safety is carried out by: (a) implementation of a unified state policy in the field of biological safety; (b) introduction of authorization procedure for handling pathogenic biological agents; (c) carrying out state control and supervision over compliance with requirements in the field of biological safety; (d) biological risk management; and (e) accounting, monitoring and forecasting (modeling) in the field of biological safety. Handling of pathogenic biological agents is based on the classification of pathogenic biological agents according to pathogenicity and degree of hazardousness: (a) pathogenicity group I - pathogenic biological agents that cause particularly dangerous infectious diseases of people and (or) animals with a high level of mortality (lethality), easily spread from an infected person the body to a healthy one, as a rule, for which there are no vaccines or effective therapies; (b) pathogenicity group II - pathogenic biological agents that cause infectious and (or) parasitic diseases in humans and (or) animals, easily spreading from an infected organism to a healthy one, for which effective means and methods of treatment and prevention are available, including vaccines. This group is divided into pathogenic biological agents that cause: particularly dangerous infectious diseases; infectious and (or) parasitic diseases; (c) III group of pathogenicity - pathogenic biological agents that cause infectious and (or) parasitic diseases of humans and (or) animals or can cause significant harm to plants, characterized by minimal spread from an infected organism to a healthy one, for which effective means and methods of treatment are available and prevention, including vaccines; and (d) IV group of pathogenicity - pathogenic biological agents that cause infectious and (or) parasitic diseases of people and (or) animals or can cause harm to plants, as a rule, do not spread from an infected organism to a healthy one, for which effective means and methods of treatment are available and prevention, including vaccines. This Law contains 8 Chapters divided into 32 Articles. Chapter 1 lays down basic provisions. Chapter 2 regards state regulation in the field of biosafety. Chapter 3 establishes general requirements for ensuring biosafety. Chapter 4 establishes state control and supervision over compliance with the requirements in the field of biosafety. Chapter 5 regards collections of microorganisms. Chapter 6 regards social protection of experts and auxiliary staff. Chapter 7 regards scientific and educational activity in the field of biosafety. Chapter 8 lays down final and transitional provisions.

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Site web
adilet.zan.kz