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FEDERAL LAW OF THE RUSSIAN FEDERATION

of July 5, 1996 No. 86-FZ

About state regulation in the field of genetically engineered activities

(as amended on 03-07-2016)

Accepted by the State Duma on June 5, 1996

Article 1. Coverage of this Federal Law

This Federal Law governs the relations in the field of environmental management, environmental protections, providing ecological safety and health protection of the person arising when implementing genetically engineered activities. The procedure of genetically engineered activities and application of its methods to the person, fabrics and cages as a part of its organism, except for genodiagnostik and gene therapy (gene therapy), is not subject of regulation of this Federal Law.

Article 2. Basic concepts

The basic concepts applied in this Federal Law:

genetic engineering - set of methods and technologies, including technologies of receipt of recombinant ribonucleic and deoxyribonucleic acid, on allocation of genes from organism, to implementation of manipulations with genes and to their introduction in other organisms;

gene therapy (gene therapy) - set of the genetically engineered (biotechnological) and medical methods directed to modification of the genetic device of somatic cells of the person for the purpose of treatment of diseases;

genetically engineered activities - the activities performed with use of methods of genetic engineering for the purpose of creation of the gene engineering modified organisms;

genodiagnostika - set of methods on identification of changes in structure of genome;

the gene engineering modified organism - the organism or several organisms, any noncellular, one-celled or multicellular education capable to reproduction or transfer of heritable genetic material, the other than natural organisms, received using methods of genetic engineering and containing genetically engineered materials, including genes, their fragments or combinations of genes;

release of the gene engineering modified organisms to the environment - action or failure to act from which entering of the gene engineering modified organisms into the environment resulted (this concept is not applied to the activities connected with change of heritable genetic material of the person by means of use of methods of genetic engineering for the purposes of gene therapy (gene therapy);

protection biological - creation and use in genetic engineering safe for the person and objects of the environment of combination of biological material which properties exclude undesirable survival of the gene engineering modified organisms in the environment and (or) transfer of genetic information to them;

protection physical - creation and use of the special technical means and acceptances preventing release of the gene engineering modified organisms to the environment and (or) transfer of genetic information by them;

clinical testing - check of efficiency and safety of gene therapy (gene therapy);

control of release of the gene engineering modified organisms to the environment - the activities of authorized federal executive bodies directed to identification and suppression of violations in case of action or failure to act from which entering of the gene engineering modified organisms into the environment, and also on elimination of effects of the revealed violations resulted;

impact monitoring per capita and the environment of the gene engineering modified organisms and the products received using such organisms or containing such organisms - set of actions for collection, processing, the analysis and informing everyone information on impact of the gene engineering modified organisms and the products received using such organisms or containing such organisms on health of the person and state of environment;

the system closed - system of implementation of genetically engineered activities in case of which genetic modifications are brought in organism or the gene engineering modified organisms are processed, cultivated, stored, are used, exposed to transportation, destruction or burial in living conditions of the physical, chemical and biological barriers or their combinations preventing contact of the gene engineering modified organisms with the population and the environment;

system open - the system of implementation of genetically engineered activities assuming contact of the gene engineering modified organisms with the population and the environment in case of their intended release to the environment, application in the medical and alimentary purposes, export and import in case of technology transfer;

transgene organisms - animals, plants, microorganisms, viruses which genetic program is changed with use of methods of genetic engineering.

Article 3. The legislation of the Russian Federation in the field of genetically engineered activities

The legislation of the Russian Federation in the field of genetically engineered activities consists of this Federal Law, other Federal Laws and other regulatory legal acts of the Russian Federation, and also the laws and other regulatory legal acts of subjects of the Russian Federation.

Article 4. Tasks of state regulation in the field of genetically engineered activities

Tasks of state regulation are:

establishment of the main activities of federal bodies of the government, public authorities of subjects of the Russian Federation, local government bodies, legal entities and citizens (physical persons) in the field of genetically engineered activities;

establishment of basic provisions of legal regulation of the relations arising in the field of genetically engineered activities;

determination of the mechanism ensuring safety of citizens and the environment in the course of implementation of genetically engineered activities and use of its results;

establishment of the legal basis of international cooperation of the Russian Federation in the field of genetically engineered activities;

creation of conditions for development of the priority directions in the field of genetically engineered activities.

For realization of the specified tasks federal and regional programs in the field of development of genetically engineered activities are adopted.

Article 5. The main directions of state regulation in the field of genetically engineered activities

The main directions of state regulation in the field of genetically engineered activities are:

improvement of living conditions of the person and protection of his health;

protection and recovery of the environment, preserving biological diversity;

increase in efficiency of agricultural industry;

increase in efficiency of the extracting and processing industry;

ensuring preserving and improvement of personnel structure, professional training of specialists in the field of genetically engineered activities;

impact monitoring per capita and the environment of the gene engineering modified organisms and the products received using such organisms or containing such organisms;

control of release of the gene engineering modified organisms to the environment.

Genetically engineered activities shall be based on the following principles:

safety of citizens (physical persons) and environment;

safety of clinical testing of methods of genodiagnostika and gene therapy (gene therapy) at the level of somatic cages;

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