On State Regulation In The Field Of Genetic Engineering Activity

Original Language Title: О государственном регулировании в области генно-инженерной деятельности

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RUSSIAN FEDERATION FEDERAL LAW On State regulation in the field gen-engineering activities Adopted by the State Duma on 5 June 1996 class="ed">(In the version of federal laws of 12.07.2000) N 96-FZ; of 30.12.2008 N 313-FZ; 04.10.2010 N 262-FZ , 19.07.2011 N 248-FZ) Article 1. Scope of this Federal Law This Federal Law regulates relations in the field of environmental management, protection of the environment and ensuring ecological safety arising in the implementation of the gen-engineering activities. The procedure for conducting genetic engineering and applying its methods to humans, tissues and cells in its body, with the exception of agnostics and gene therapy (gene therapy), is not regulated of this Federal Law. (In the wording of Federal Law of 12.07.2000) N 96-FZ) Article 2. Basic Concepts Concepts used in this Federal Law: gene engineering-a collection of methods and technologies, including recombinant ribonucleic acid and deoxyribonucleic acids, the release of genes from the body, the manipulation of genes and the introduction of them into other organisms; gene therapy (gene therapy) -aggregate of geo-engineering (biotechnology) and Medical methods aimed at altering the genetic apparatus of human somatic cells for the treatment of diseases; genetically engineered activities-activities carried out using genetic engineering techniques in order to create genetically modified organisms; (In the wording of Federal Law of 04.10.2010). N 262-FZ) agnostic-a set of methods for detecting changes in genome structure; genetically modified organism-organism or several organisms, any non-cellular, single cell or multicellular organism education that is capable of reproduction or transfer of hereditary genetic material, other than natural organisms derived from genetic engineering and containing genetically engineered materials, including genes, fragments or gene combinations; release genetically modified organisms in the environment-action or inaction that resulted in the introduction of genetically modified organisms into the environment (this concept does not apply to activities related to a change in hereditary genetic material of humans through the use of genetic engineering for gene therapy (gene therapy); biological protection is the creation and use of genetic engineering in human genetic engineering and environmental objects of the biological material combination, properties of which exclude unwanted genetically modified organisms in the environment and/or the transfer of genetic information to them; Protection of the physical-creation and use of special equipment; and Admissions that prevent the release of genetically modified organisms into the environment and (or) their transfer of genetic information; clinical trials-the effectiveness and safety of gene therapy (gene therapy); system-to-system implementation genetically modified organisms or genetically modified organisms are processed, cultivated, stored, used, transported, destroyed or buried in the existence of physical, chemical and biological barriers or their combinations to prevent contact of genetically modified organisms with populations and the environment; open-system implementation system Technical and engineering activities involving contact genetically modified organisms with a deliberate release into the environment, medical and nutritional applications, export and import, transfer of technology; transgenic organisms- animals, plants, microorganisms, viruses whose genetic program has been altered using genetic engineering. (Article in the wording of Federal Law from 12.07.2000 N 96-FZ) Article 3. OF THE PRESIDENT OF THE RUSSIAN FEDERATION OF THE PRESIDENT OF THE RUSSIAN FEDERATION Article 4. The tasks of state regulation in the field of gyno-engineering activity State regulation tasks are: establishing the main directions of the federal government Authorities, the State authorities of the constituent entities of the Russian Federation, local authorities, legal entities and citizens (natural persons) in the field of genetic engineering; emerging in the field of genetic engineering activities; Definition of a mechanism to ensure the safety of citizens and the environment in the process of making and using the results of engineering activities; OF THE PRESIDENT OF THE RUSSIAN FEDERATION In order to achieve these objectives, federal and regional development programmes have been adopted. Article 5. The main directions of state in the field of gyno engineering activity are the main directions of state regulation in the field of genetic engineering: Improve the human condition and health of the person; Protection and restoration of the environment, conservation of biological diversity; enhancing agricultural productivity; improving efficiency Extractive and processing industries; To ensure the retention and improvement of personnel, training of specialists in the field of engineering and engineering. Gov-engineering activities should be based on the following principles: the safety of citizens (individuals) and the environment; safety testing of the genodiagnosis tests and gene therapy (gene therapy) at the level of somatic cells. N 96-FZ ) publicly available safety information for engineering activities; mandatory confirmation of compliance with the result of genetic engineering, c by providing complete information about the methods of getting and properties of this product; (In the wording of Federal Law of 30.12.2008 N 313-FZ) State registration of genetically modified organisms for release into the environment and products derived from or containing such organisms organisms. (Paragraph is supplemented by the Federal Law of 04.10.2010). n 262-FZ) Article 6. Work in the field of gne-engineering Genetically-engineering includes: genetic manipulation of molecular, cellular levels with recombinant ribonucleic acid and deoxyribonucleic acid to create genetically modified organisms (viruses, microorganisms, transgenic plants and transgenic animals, as well as their cells); genetic manipulation of molecular, the cellular levels with recombinant Ribonucleic and deoxyribonucleic acid for the purposes of general-agnostic and gene therapy (gene therapy) for humans; all tests of genetically modified organisms, including laboratory, clinical, field, Industrial engineering; genetic engineering; , purchase, sale, exchange, other transactions and other activities related to genetic engineering. Gov-engineering activity III and IV risk levels implemented in closed systems are to be licensed in accordance with the legislation of the Russian Federation. Law of 04.10.2010 N 262-FZ) Article 7. The security system in the field of engineering activity General coordination and development of the security system in the field of genetic engineering is carried out in the manner determined by the Government of the Russian Federation. THE RUSSIAN FEDERATION Legal entities and citizens (natural persons) engaged in gen-engineering activities are obliged to ensure the biological and physical protection of workers of organizations engaged in genetic engineering, environments according to the risk levels of potentially harmful effects of genetic and engineering activities on humans and the environment. Depending on the degree of potential risk involved in the implementation of gen-engineering activities, four risk levels of potentially harmful effects of engineering activities are established for closed systems Human health: I risk corresponds to work that does not pose a risk to human health, and comparable to the risk of working with non-pathogenic microorganisms; II risk level corresponds to work, which pose a slight risk to human health, and comparable to the risk of exposure to opportun-pathogenic micro-organisms; III level of risk corresponds to work that is moderate to human health and comparable to danger in working with micro-organisms, potentially capable of transmission; IV level of risk corresponds to work that is hazardous to human health, and is comparable to the risk of working with highly dangerous infections. Activities carried out with micro-organisms in closed systems over laboratory studies are III or IV level of risk. (Part 5 is no more effective-Federal Law of 04.10.2010. N 262-FZ Legal entities and citizens (natural persons) engaged in genetic engineering conduct risk assessments in planning, preparing and conducting engineering activities. (Part 7 has lost its power-Federal Law of 04.10.2010. N 262-FZ) (Part 8 lost power-Federal Law of 04.10.2010. N 262-FZ ) Genetically modified organisms for release into the environment, as well as products derived from or containing such organisms OF THE PRESIDENT OF THE RUSSIAN FEDERATION (Part added-Federal Law of 04.10.2010. N 262-FZ) Article 8. Requirements for persons who perform Genetically-engineered activities are allowed: nationals (individuals), training and health status comply with the requirements of the safety regulations for engineering activities; legal persons having the appropriate premises, equipment and employees, which comply with the requirements of the second paragraph of this article. (Part Two has lost power-Federal Law of 04.10.2010. N 262-FZ) Article 9. The funding for engineering activities and the security of its implementation The funding of engineering and engineering activities is carried out in accordance with the established procedure through the respective budgets, Trust funds of organizations and funds, as well as other sources not prohibited by the legislation of the Russian Federation. Article 10. Ensuring that information is publicly available about security in engineering activities The security of the engineering activities is publicly available. Legal entities and citizens (natural persons) engaged in gen-engineering activities are required, at the request of the interested persons, to provide information on the level of risk and the measures taken to ensure security of the genetically engineered activities. In this case, the information on gen-engineering activities constituting a State, official or commercial secret is provided in accordance with the established procedure. Article 11: Standardization, certification and declaration Product Engineering Activity (In the Federal Law dated 30.12.2008 N 313-FZ) Products (services) derived from the use of gem-engineering activities must comply with the mandatory environmental, pharmacopoeological requirements, OF THE PRESIDENT OF THE RUSSIAN FEDERATION (In the wording of the Federal Law of 19 July 2011, N 248-FZ) With respect to products derived from genetically modified organisms and subject to mandatory certification or declaration of conformity, a certificate of conformity is issued. The declaration of conformity is adopted in accordance with the procedure established by the legislation of the Russian Federation on technical regulation. (In the wording of Federal Law No. N 313-FZ) Article 12. Responsibility in the field of engineering activity Legal entities and citizens (natural persons) who carry out gen-engineering activities and actions or omissions of which have caused harm to employees The organizations carrying out genetic engineering, the population and the environment are responsible in accordance with the legislation of the Russian Federation. Article 13. Russian Federation's international cooperation in the field of engineering activities Russian Federation concludes international treaties for the further development and strengthening of the international The Conference of the Parties, Article 14. The entry into force of this Federal Law The present Federal Law shall enter into force on the date of its official publication. President of the Russian Federation Yeltsin Moscow, Kremlin 5 July 1996 N 86-FZ