Development of legislation on genetic engineering activities and selection achievements
The human invasion of natural biodiversity is genetic engineering and the development of genetically engineered products, in the field of which problems arise as to how much they must be subject to proper legal regulation. Federal Law of 05.07.1996 No. 86-FZ "On State Regulation in the Field of Genetic Engineering Activities" regulates relations in the sphere of nature management, environmental protection and ensuring environmental safety arising from the implementation of genetic engineering activities. The procedure for the implementation of genetic engineering activities and the application of its methods to humans, tissues and cells within its body is not subject to regulation of this law.
According to Art. 2 of the Law, new basic concepts are used to solve environmental safety problems in genetic engineering:
- genetic engineering - a set of techniques, methods and technologies, including technologies for obtaining recombinant ribonucleic and deoxyribonucleic acids, for extracting genes from the body, manipulating genes and introducing them into other organisms;
- genetic engineering activities - activities carried out using genetic engineering and genetically engineered modified organisms
- a genetically engineered organism - an organism or several organisms, any noncellular, unicellular or multicellular formation capable of reproducing or transferring an inherited genetic material, other than a nature
of organisms, obtained with application of genetic engineering methods and containing genetic engineering material, including genes, their fragments or combinations of genes;
- release of genetically engineered organisms into the environment - action or inaction resulting in the introduction of genetically engineered organisms into the environment;
- Biological protection - the creation and use in genetic engineering of a combination of biological material safe for human beings and environmental objects, the properties of which exclude undesirable survival of genetically engineered organisms in the environment and/or the transfer of genetic information to them;>
- physical protection - the creation and use of special technical means and techniques that prevent the release of genetically engineered organisms into the environment and (or) transfer of genetic information to them;
- transgenic organisms - animals, plants, microorganisms, viruses, whose genetic program is modified using genetic engineering techniques.
Ensuring environmental safety in genetic engineering activities is associated with a clear legal definition of its tasks, directions of state regulation, licensing, development of safety criteria, etc.
The objectives of state regulation in the field of genetic engineering activities are:
- the definition of a mechanism ensuring the safety of citizens and the environment in the process of carrying out genetic engineering activities and using its results;
- establishing the legal basis for US international cooperation in the field of genetic engineering;
- creating conditions for the development of priority areas in the field of genetic engineering.
The main directions of state regulation in the field of genetic engineering activities are: improving the human condition and protecting their health; protection and restoration of the environment, conservation of biological diversity; increase of efficiency of agriculture. Genetic engineering activities should be based on the following principles: the safety of citizens (individuals) and the environment; general availability of information on the safety of genetic engineering activities; certification of products containing the results of genetic engineering activities, indicating full information about the methods of preparation and properties of this product.
As with subsoil use, the main way to ensure state regulation and control is licensing. The law determines the types of genetically engineered activities that are subject to licensing. Works in the field of genetic engineering activities, corresponding to the III and IV level of risk, are carried out on the basis of permits (licenses) issued in accordance with the procedure established by law.
The following types of genetic engineering activities are subject to licensing:
- genetic manipulation at the molecular, cellular levels with the participation of recombinant ribonucleic and deoxyribonucleic acids for the creation of genetically engineered organisms (viruses, microorganisms, transgenic plants and transgenic animals, and also their cells);
- all kinds of tests of genetically engineered organisms, including laboratory, clinical, field, experimental industrial;
- release of genetically engineered organisms into the environment;
- production of preparations obtained using genetically engineered modified organisms
- storage, burial, destruction of genetically engineered organisms and (or) their products;
- utilization of waste from genetic engineering activities; purchase, sale, exchange, other transactions and other activities related to genetically engineered technologies, genetically engineered organisms and (or) their products that do not have a quality certificate or a mark of conformity issued or recognized by the authorized body in including in the field of international activity.
The law provides for a system of safety in the field of genetic engineering, which causes concern around the world. General coordination and development of a security system in the field of genetic engineering activities are carried out in the manner determined by the US Government. Legal entities and citizens (individuals) engaged in genetic engineering activities are obliged to ensure biological and physical protection of employees of organizations engaged in genetic engineering, population, environment in accordance with the levels of risk of potentially harmful effects of genetic engineering activity on humans and the environment Wednesday.
Requirements are established for persons who carry out genetic engineering activities. To engage in genetic engineering activities: citizens (individuals) whose training and health status meet the requirements of safety rules for genetic engineering; legal entities having appropriate premises, equipment and employees that comply with the requirements of the second paragraph of this article.
Information on the safety of genetic engineering activities is public. Legal entities and citizens (individuals) engaged in genetically engineered activities are obliged to provide information on the level of risk and on measures taken to ensure the safety of genetic engineering activities at the request of interested persons. At the same time, information on genetic engineering activities constituting state, official or commercial secrets is provided in accordance with the established procedure.
Next to genetic engineering, biodiversity is invaded by breeding activities, regulation of which is no less urgent. US legislation on breeding achievements regulates property, as well as related personal non-property relations arising in connection with the creation, legal protection and use of selection achievements. A breeding achievement is understood to mean a plant variety, an animal breed.
A breed can be represented by a female or male individual or a pedigree material. Protected breed categories are:
- type, cross lines;
- a pedigree animal - an animal intended for the reproduction of a breed
- tribal material - a pedigree animal, its gametes or zygotes (embryos);
- a commercial animal - an animal used for purposes other than the purposes of reproduction of the breed;
- a protected selection achievement - a plant variety, an animal breed registered in the State Register of Protected Selective Achievements;
- the applicant is a legal entity or an individual who has applied for a patent for a selection achievement.
The right to selective achievement is protected by civil and agrarian legislation and is confirmed by a patent for selection achievement. The patent is granted to a breeding achievement that meets the eligibility criteria and is related to zoological genera and species, the list of which is established by specialized bodies taking into account the international obligations of the United States. An actual problem is the implementation of the requirements for selective achievement testing for distinctness, uniformity, stability, which should be carried out according to the methods and in terms established by the specialized bodies.
The applicant is required to submit for testing the required number of pedigree materials at the address and within the time specified by the specialized bodies. The latter have the right to use the results of tests conducted by the competent authorities of other states with which relevant treaties have been concluded, the results of tests conducted by other US organizations under a treaty with specialized bodies, as well as data submitted by the applicant. If the selection achievement corresponds to the criteria of the guard ability, if the name of the selection achievement is met, the specialized bodies decide on the grant of the patent and make a description of the selection achievement.
The system of registration of the selection achievement in the State Register of Protected Selection Achievements is developing, where the following entries are made: genus, species of the animal; the name of the breed; the date of registration of the breeding achievement and the registration number; name of the patent holder and his address. Under the license agreement (exclusive or non-exclusive license), the patent owner (licensor) transfers the right to use the selection achievement to another person (the licensee) in the manner of calculations stipulated by the contract, or gratuitously. The licensee has the right to use the selection achievement in the territory of the United States during the term of the patent and to perform certain actions, unless otherwise specified by the license agreement.
The state should stimulate the creation and use of breeding achievements, provide authors and business entities that use these achievements, preferential terms of taxation and lending, and other benefits in accordance with US law. Breeding works are of high priority and are conducted mainly at the expense of the US budget.
In order to preserve the selection achievement, the patent holder is obliged to maintain the breed during the term of the patent in such a way that the characteristics indicated in the description of the breed, compiled on the date of their registration in the State Register of Protected Selection Achievements, are preserved. The patent holder is obliged, at the request of specialized bodies, to send pedigree material for carrying out control tests and to provide an opportunity to conduct on-site inspection.
Difficulties occur when fulfilling the requirements for the use of breeding achievements. Inclusion of animal breeds in the State Register of Breeding Achievements admitted for use is carried out by specialized bodies based on the results of state tests on economic utility. For individual genera and species established by specialized bodies, the inclusion of breeds of animals in the State Register of Breeding Achievements admitted for use is conducted on the basis of expert assessments or the applicant's data.
The pedigree material to be sold in the appropriate region of the United States must be provided with a certificate attesting to pedigree, origin and quality. The certificate is issued on pedigree material of the breed, approved for use in the region. For the reproduction of pedigree material for the purpose of export outside the relevant region, there is no need to admit to use in this region. According to the selective achievements included in the State Register of Protected Selection Achievements, the certificate is issued only for breeding material obtained legally.
In the XXI century. genetic engineering and breeding activities is a modern human intrusion into the natural development of natural processes, can be associated with dangerous consequences for humans, natural ecological systems and the entire environment, harm biodiversity, and therefore must be subject to careful legal regulation.
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