On State Regulation In The Field Of Genetic Engineering Activity

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

Read the untranslated law here: http://pravo.gov.ru/proxy/ips/?doc_itself=&infostr=x&backlink=1&fulltext=1&nd=102042295

RUSSIAN FEDERATION FEDERAL LAW on federal regulation in the area of genetic engineering activity adopted by the State Duma June 5, 1996 year (as amended by the federal laws on Jul 12 2000 N 96-FZ;
from 30.12.2008 N 313-FZ; from 04.10.2010 N 262-FZ;
from 19/07/2011 N 248-FZ), Article 1. The scope of this federal law this federal law regulates relations in the sphere of environmental management, environmental protection and environmental safety Wednesday, arising from the implementation of genetic engineering activity. The order of implementation of genetic engineering activity and application of its methods to man, tissues and cells in the body's composition, with the exception of gene diagnostics and gene therapy (gene therapy) are not regulated by this federal law. (As amended by the Federal law of Jul 12 2000 N 96-FZ), Article 2. Basic concepts Basic concepts used in the present Federal law: genetic engineering-a set of practices and technologies, including technologies for producing recombinant ribonukleinovykh and dezoksiribonukleinovyh acids, to allocate the genes of an organism, the implementation of genetic manipulation and to introduce them to other organisms;
gene therapy (gene therapy)-a set of genetically engineered (biotech) and medical techniques aimed at making changes in the genetic apparatus of somatic human cells in order to treat diseases;
genetic-engineering activities-activities using genetic engineering to create genetically modified organisms; (As amended by the Federal law dated 04.10.2010 N 262-FZ) gene diagnostics-a set of methods for detection of changes in the structure of a genome;
genetically modified organism-organism or a few organisms, any non-cellular, odnokletochnoe or multi cell education, capable to reproduce or transfer of hereditary genetic material differ from natural organisms obtained by genetic engineering techniques and contain genno-ingenernyi material, including genes, their fragments or combinations of genes;
the release of genetically modified organisms into the environment Wednesday-the Act or omission occurred which resulted in the introduction of genetically modified organisms into the environment Wednesday (this concept does not apply to activities related to changing human genetic material inherited through the use of techniques of genetic engineering for the purpose of gene therapy (gene therapy);
biological protection-create and use genetic engineering safe for humans and the environment object Wednesday combination of biological material whose properties foreclose an undesirable survival of genetically modified organisms into the environment Wednesday and (or) the transfer of genetic information;
physical protection-the creation and use of special technical means and techniques to prevent the release of genetically modified organisms into the environment Wednesday and (or) their transfer of genetic information;
clinical trials-testing the effectiveness and safety of gene therapy (gene therapy);
closed system-system of genetic engineering activity in which genetic modifications are made to the organism or genetically-modified organisms cultivated, processed, stored, used, transported or destroyed were subjected to dumping in the face of physical, chemical and biological barriers, or combinations of them, preventing contact of genetically modified organisms and the environment Wednesday;
Open system-system of genetic engineering activity involving contact of genetically modified organisms and the environment Wednesday when their deliberate release into the environment Wednesday, applying for medical and nutritional purposes, exports and imports, with the transfer of technology;
transgenic organisms-animals, plants, microorganisms, viruses, genetic program which changed using techniques of genetic engineering.
(Article in Edition Jul 12 2000 federal law N 96-FZ), Article 3. The legislation of the Russian Federation in the area of genetic engineering legislation of the Russian Federation in the field of genetic engineering activity consists of this federal law and other federal laws and other regulatory legal acts of the Russian Federation, as well as the laws and other normative legal acts of the constituent entities of the Russian Federation.
Article 4. Tasks of State regulation in the field of genetic engineering Tasks of government regulation are: the establishment of the basic directions of activity of federal bodies of State power, bodies of State power of the constituent entities of the Russian Federation, local self-government bodies, legal entities and individuals (natural persons) in the area of genetic engineering;
establishment of basic provisions of a legal regulation of relations in the field of genetic engineering activity;

defining a mechanism to ensure the security of citizens and the environment Wednesday in the implementation process of genetic engineering activity and the use of its results;
the establishment of the legal basis for international cooperation of the Russian Federation in the field of genetic engineering activity;
creation of conditions for the development of priorities in the area of genetic engineering.
To implement these objectives are taken by federal and regional programmes in the field of development of genetic engineering.
Article 5. The main directions of State regulation in the field of genetic engineering, the main directions of State regulation in the field of genetic engineering activity are: improving the human condition and his health protection;
protecting and restoring the environment Wednesday, conservation of biological diversity;
improving the efficiency of agriculture;
improving the effectiveness of the extractive and processing industries;
maintaining and improving the staffing, training specialists in the field of genetic engineering activity.
Genetic-engineering activities must be based on the following principles: security of citizens (natural persons) and natural Wednesday;
the safety of clinical trial methods of Homo-and gene therapy (gene therapy) at the level of somatic cells; (The paragraph is supplemented by federal law from Jul 12 2000 N 96-FZ) of accessibility to information on the safety of genetic engineering activity;
mandatory confirmation of conformity of products containing the results of genetic engineering activity, indicating the full information about the methods and properties of this product; (As amended by federal law N 313-FZ) State registration of genetically modified organisms intended for release Wednesday, as well as products derived from such organisms or containing such organisms. (The paragraph is supplemented by federal law from 04.10.2010 N 262-FZ), Article 6. Work in the area of genetic engineering genetic engineering activities include: genetic manipulation at the molecular, cellular levels involving Recombinant ribonukleinovykh and dezoksiribonukleinovyh acids to create genetically-modified organisms (viruses, microorganisms, transgenic plants and transgenic animals, as well as their cells);
genetic manipulation at the molecular, cellular levels involving Recombinant ribonukleinovykh and dezoksiribonukleinovyh acids for purposes of Homo-and gene therapy (gene therapy) for man;
all kinds of trials of genetically modified organisms, including laboratory, clinical, field, pilot;
utilization of waste products of genetic engineering activity;
purchase, sale, Exchange, other transactions and other activities related to genetic-engineering technologies.
Genetic-engineering activities (III) and (IV) levels of risk, carried out in closed systems, subject to licensing in accordance with the legislation of the Russian Federation.
(Article in the Editorial Office of the Federal law dated 04.10.2010 N 262-FZ) Article 7. The security system in the area of genetic engineering, the overall coordination and development of security systems in the area of genetic engineering are carried out in accordance with the procedure determined by the Government of the Russian Federation.
Legal persons and citizens (natural persons), carrying out genetic-engineering activities to ensure biological and physical protection of workers engaged in genetic engineering activity of the population surrounding the Wednesday in accordance with risk levels of potentially harmful effects of genetic engineering on humans and the environment Wednesday.
Depending on the degree of potential risks arising in the implementation of genetic engineering activity, for closed systems are four levels of risk of potentially harmful effects of genetic engineering on human health: (I) the level of risk corresponds to works that do not constitute a danger to human health, and is comparable to the risk when working with nepatogennymi micro-organisms;
(II) the level of risk corresponds to the works, which are of little danger to human health, and is comparable to the danger in conditionally pathogenic microorganisms;
(III) the level of risk corresponds to the works that represent a moderate risk to human health, and is comparable to the danger in microorganisms, potentially capable of transmission;
(IV) the level of risk corresponds to the works that constitute a danger to human health, and is comparable to the danger when working with activators of especially dangerous infections.
The works carried out with microorganisms in confined systems on a scale higher than laboratory studies relate to the risk level III or IV.
(Part five lapsed federal law from 04.10.2010 N 262-FZ), legal persons and citizens (natural persons), carrying out genetic engineering activities, carry out a risk assessment in the planning, preparation and conduct of genetic engineering activity.

(Part seven repealed Federal Act from 13.10.2010 N 262-FZ)
(Part of the eighth repealed Federal Act from 13.10.2010 N 262-FZ) genetically modified organisms intended for release Wednesday, as well as products derived from such organisms or containing such organisms, is subject to state registration in the order established by the Government of the Russian Federation. (Part is supplemented by federal law from 04.10.2010 N 262-FZ) Article 8. Requirements for persons who conduct genetic-engineering activities into genetic engineering activities allowed: citizens (natural persons), training and health condition which comply with the requirements of the safety rules of genetic engineering activity;
legal persons having appropriate premises, equipment and staff, which comply with the requirements of paragraph 2 of this article.
(Second part repealed Federal Act from 13.10.2010 N 262-FZ) Article 9. Financing of genetic engineering activity and the security of its implementation of the Funding of genetic engineering activity and its security is carried out in the prescribed manner at the expense of the respective budgets, earmarked funds organizations and funds, as well as other sources not prohibited by the legislation of the Russian Federation.
Article 10. Ensuring accessibility to information on the safety of genetic engineering activity Information on the safety of genetic engineering activity are public.
Legal persons and citizens (natural persons), carrying out genetic-engineering activities must, at the request of the persons concerned to provide information on the level of risk and on the measures taken to ensure the safety of genetic engineering activity. Information about genetic engineering activities, constituent state, official or business secret shall be provided in accordance with the established procedure.
Article 11. Standardization, certification and Declaration of conformity of products in the area of genetic engineering (as amended by federal law N 313-FZ) Products (services) obtained using the methods of genetic engineering activity must comply with the mandatory requirements in the field of environmental protection Wednesday, Officinal articles, sanitary-epidemiological requirements and other eligibility requirements of the legislation of the Russian Federation. (As amended by the Federal Act of 19/07/2011 N 248-FZ) in respect of products obtained with the use of genetically modified organisms and subject to compulsory certification or declaration of conformity certificate of compliance is issued or adopted a declaration of conformity in accordance with the legislation of the Russian Federation on technical regulation. (As amended by federal law N 313-FZ) Article 12. Responsibility in the area of genetic engineering, legal persons and citizens (natural persons) who carry out genetic engineering activities and actions or omissions which caused harm to employees performing genetic engineering activity, population, the environment Wednesday, bear responsibility in accordance with the legislation of the Russian Federation.
Article 13. International cooperation of the Russian Federation in the field of genetic engineering activity of the Russian Federation concludes international treaties in order to further develop and strengthen international cooperation in the area of genetic engineering.
Article 14. The entry into force of this federal law this federal law shall enter into force on the day of its official publication.
Russian President Boris Yeltsin in Moscow, the Kremlin July 5, 1996 N 86-FZ