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FEDERAL LAW OF THE RUSSIAN FEDERATION

of December 30, 2020 No. 492-FZ

About biological safety in the Russian Federation

Accepted by the State Duma on December 24, 2020

Approved by the Federation Council on December 25, 2020

This Federal Law establishes bases of state regulation in the field of ensuring biological safety in the Russian Federation and determines package of measures, directed to protection of the population and environmental protection against impact of dangerous biological factors, to prevention of biological threats (dangers), creation and development of monitoring system of biological risks.

Article 1. The basic concepts used in this Federal Law

1. For the purposes of this Federal Law the following basic concepts are used:

1) biological safety - condition of security of the population and the environment from impact of dangerous biological factors in case of which the admissible level of biological risk is provided;

2) dangerous biological factor - the event, condition, property, epidemic, epizootic, epifitotichesky processes or their combination which are the reason of possible impact of pathogenic biological agents (pathogens), parasitic organisms and the objects containing them which are capable to do harm to health of the person, animals and (or) plants, products of animal and (or) plant origin and (or) the environment;

3) biological risk - probability of damnification (taking into account its weight) to health of the person, animals, plants and (or) the environment as a result of impact of dangerous biological factors;

4) the admissible level of biological risk - the level of biological risk in case of which conditions for protection of the population and environmental protection from impact of dangerous biological factors are provided;

5) biological threat (danger) - availability of potentially dangerous biological objects, and also availability internal (being in the territory of the Russian Federation) and external (being outside the territory of the Russian Federation) the dangerous biological factors capable to lead to origin and (or) spread of diseases with development of epidemics, epizooty, epiphytoties, mass poisonings, to exceeding of admissible level of biological risk;

6) biological protection - package of measures for ensuring biological safety, performed for the purpose of prevention or weakening of adverse effect of dangerous biological factors per capita, animals and plant;

7) pathogenic biological agents (pathogens) (further - pathogens) - microorganisms, viruses, belkovopodobny infectious particles (prions), poisons of biological origin (toxins) and other biological agents including created as a result of genetic manipulations, use of technologies of synthetic biology and other directed activities capable to cause pathological process in human body, animal or in plants, and also biological materials which can contain the listed pathogens;

8) pathogenic microorganisms - microorganisms (bacteria, the Archean, mushrooms, protozoa, microseaweed) capable to cause pathological process in human body, animal or in plants;

9) opportunistic microorganisms - microorganisms which can be natural inhabitants of human body of animal or inhabitants of plants and are capable to cause pathological process in case of acquisition of additional properties by them and (or) in case of decrease in resistance of human body, animal, plants;

10) collection of pathogenic microorganisms and viruses - the fund of strains of pathogenic microorganisms and viruses which is created on signs of origin of specific relationship, to impact method on human body, animal or on plants and is supported in viable condition with preserving initial characteristics of strains of pathogenic microorganisms and viruses;

11) strain - the homogeneous culture of species of microorganisms, viruses with certain biological properties which is marked out from natural sources or created as a result of experimental activities including by genetic manipulations;

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