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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

(The last edition from 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 sphere of environmental management, environmental protection, 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, monocelled 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 consequences 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;

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