The Law of Ukraine “On the State System of Biosafety at the Time of Creating, Testing, Transporting, and Using Genetically Modified Organisms”

The Law of Ukraine “On the State System of Biosafety at the Time of Creating, Testing, Transporting, and Using Genetically Modified Organisms”

Date of entry into force: June 21, 2007

The present Law shall regulate relations between bodies of executive power, producers, sellers (suppliers), developers, researchers, scientists, and consumers of genetically modified organisms and products manufactured according to technologies that provide for their development, creation, testing, research, transportation, import, export, placement on the market, release into the environment, and utilization in Ukraine (hereinafter referred to as the treatment of GMOs) with the support for biological and genetic safety.

Biological safety is a state of the environment for the vital functions of a human where there is no negative impact of its factors (biological, chemical or physical) on the biological structure and function of a human both in the current generation and in the future generations, and also there is no negative irreversible impact on biological objects of the natural environment (the biosphere) as well as on the agricultural plans and animals.

Article 3 of the present Law shall specify that the main principles of government policy in the area of genetic engineering activities and the treatment of GMOs shall be: · the priority of preserving human health and protecting the natural environment as compared with receiving economic benefits from the application of GMOs; · the support for measures to ensure biological and genetic safety at the time of creating, researching and applying in practice GMOs for economic purposes; · oversight of imports of GMOs to the customs territory of Ukraine and products obtained with the help of their use, as well as oversight of their registration and circulation; · the accessibility of information about potential risks of the application of GMOs that are expected to be used in an open system and about measures to ensure biological and genetic safety; · government support for genetic engineering research as well as scientific and practical developments in the area of biological and genetic safety at the time of creating, researching and applying in practice GMOs for economic purposes.

The objectives of the present Law shall be: · to protect human health and the natural environment at the time of carrying out genetic engineering activities and the treatment of GMOs; · to support nationals’ rights for safe utilization of GMOs; · to create conditions for safe practical utilization of GMOs for economic purposes; · to identify rights and obligations of the subjects of regulation in the treatment of GMOs and to specify their responsibility for the violation of the legislation; · to protect individuals in the instance of damages to their health as a result of consuming GMOs; · to establish the essential legal principles for international cooperation in the area of genetic engineering activities and the treatment of GMOs.

Provisions of the present Law shall apply on the territory of Ukraine to legal entities and private individuals that carry out activities related to the treatment of GMOs.

Article 5 of the present Law shall identify the areas of activity that shall be subject to regulation at the time of the treatment of GMOs, namely: · genetic engineering activities that are carried out in a closed system; · genetic engineering activities that are carried out in an open system; · state registration of GMOs and products manufactured with the help of their use; · introduction of GMOs and products manufactured with the help of their use into circulation; · export, import and transit of GMOs.

Article 6 of the present Law shall determine that the enforcement of the present Law shall be ensured by central bodies of executive power within the limits of their powers.

The Cabinet of Ministers of Ukraine shall, in particular: · ensure state regulation and oversight in the area of the treatment of GMOs and genetic engineering activities; · ensure the implementation of measures to provide government support for genetic engineering activities; · guide and coordinate activities of central bodies of executive power and other bodies of executive power in the area of the treatment of GMOs and genetic engineering activities; · organize international cooperation with the aim to ensure safe treatment of GMOs and the development of scientific knowledge in this area; · approve the procedure for state registration of GMOs and products obtained with the help of their use.

The central body of executive power in the area of education and science shall, in particular: · ensure the development of scientific as well as scientific and technical potential in the area of genetic engineering activities; · ensure the protection of international and national patents and other types of intellectual property in the area of the treatment of GMOs, genetic engineering and genetic engineering activities; · develop safety criteria for the treatment of GMOs and genetic engineering activities in closed systems; · develop and improve the system for overseeing the adherence to safety regulations in genetic engineering activities; · carry out licensing of genetic engineering activities in closed systems.

The central body of executive power in the area of ecology and natural resources shall: · carry out state environmental expert examination of GMOs designated for the utilization in an open system; · develop the criteria for the assessment of risks of potential impact that GMOs can have on the natural environment based on scientific principles and international experience; · carry out state registration of means for the protection of plants obtained with the help of using GMOs; · carry out state supervision and exercise state oversight of the observance of measures of biological and genetic safety with respect to biological objects of the natural environment at the time of creating, researching and applying in practice GMOs in an open system; · issue permits for the release of GMOs in an open system.

The central body of executive power in the area of healthcare shall: · develop the criteria for the assessment of risks of potential impact that GMOs and products obtained with the help of their use, including food products, can have on the human health based on scientific principles and international experience; · carry out state sanitary and epidemiologic expert examination of GMOs that are used in open systems in order to justify the conclusion on their biological and genetic safety with respect to a human for the purpose of their state registration; · carry out state supervision and exercise state oversight of the observance of measures of biological and genetic safety with respect to a human at the time of creating, researching and applying in practice GMOs in an open system; · carry out state sanitary and epidemiologic expert examination of products obtained with the help of using GMOs to justify the conclusion on their safety for the life and health of a human; · carry out state registration of GMO-based sources of food products, as well as state registration of food products, cosmetic substances and medications that contain GMOs or were obtained with the help of using GMOs.

The central body of executive power in the area of agricultural policy shall: · ensure state approbation (testing) and state registration of sorts of agricultural plants, breeds of animals, microbiological agricultural and veterinary preparations created on the basis of GMOs; · carry out state supervision and exercise state oversight of the observance of measures of biological and genetic safety with respect to agricultural plants and animals at the time of creating, researching and applying in practice GMOs in open systems at enterprises, in institutions and organizations of the agroindustrial complex, regardless of their subordination and the form of ownership; · carry out state registration of GMO-based sources of fodders, as well as state registration of fodder additives and veterinary preparations that contain GMOs or were obtained with the help of using GMOs; · approve the list of fodders where the content of GMOs should be controlled and the list of the relevant methods for detecting and identifying GMOs; · monitor fodders that were obtained with the help of using GMOs based on the criterion of the presence of only registered GMO-based sources therein.

Genetic engineering activities in a closed system shall be subject to licensing. Licensing of such activities shall be carried out based on the assessment of risks at the time of the treatment of GMOs in a closed system. The procedure for such licensing shall be approved by the Cabinet of Ministers of Ukraine upon suggestion of the central body of executive power in the area of education and science.

Enterprises, institutions and organizations that carry out genetic engineering activities (hereinafter referred to as institutions) shall set up a Commission for biological and genetic safety of genetic engineering works under such an institution (hereinafter referred to as the Commission). The objectives of the Commission shall be to carry out preliminary assessment of risks at the time of planning and preparing genetic engineering works.

A Typical Regulation on the Commission for biological and genetic safety of genetic engineering works shall be approved by the central body of executive power in the area of education and science.

According to Article 13 of the present Law, genetically modified organisms that are used in an open system shall meet the requirements of biological and genetic safety on condition of the adherence to the envisaged utilization technology.

A mandatory condition for the utilization of GMOs in an open system shall be the availability of methods and methodologies for their identification that were developed in line with international standards and approved according to the procedure established in Ukraine.

It shall be prohibited to release GMOs into the natural environment prior to their state registration.

Before state registration, it shall be possible to release GMOs into the natural environment only for the purpose of state approbation (testing). State approbation (testing) of GMOs in an open system shall be carried out exclusively on the basis of a permit that shall be issued by the central body of executive power in the area of ecology and natural resources. Such a permit shall be issued on a disposable basis for carrying out state approbation (testing) of a specifically determined GMO.

The procedure for receiving such a permit and its form shall be approved by the Cabinet of Ministers of Ukraine upon suggestion of the central body of executive power in the area of ecology and natural resources. Such a permit shall indicate specific terms, conditions and deadlines for carrying out state approbation (testing) of a GMO.

The permit for carrying out state approbation (testing) of a GMO in an open system may be cancelled in the instances of receiving scientifically justified information that may result in the re-assessment of risks regarding the impact of GMOs on the human health and the natural environment towards its increase, and also in the instances of violating terms and conditions of such a permit.

Central bodies of executive power shall keep State Registers of GMOs and products manufactured with the help of their use, place them on their own official websites and regularly publish in the mass media.

Article 14 of the present Law shall specify the list of products that shall be registered in State Registers of GMOs: · sorts of agricultural plants and breeds of animals created on the basis of GMOs; · means for the protection of plants obtained with the help of using GMOs; · GMO-based sources of food products, as well as food products, cosmetic substances and medications that contain GMOs or were obtained with the help of using GMOs; · GMO-based sources of fodders, as well as fodder additives and veterinary preparations that contain GMOs or were obtained with the help of using GMOs.

State registration shall be valid for a period of five years and shall be carried out free of charge. Reregistration shall be carried out following the same procedure as state registration. The period for examining registration documents shall not exceed 120 days from the date of their submission, including the deadlines for carrying out the relevant expert examinations.

The size of rates for carrying out expert examinations that shall be the ground for state registration of GMOs and products manufactured with the help of their use shall be approved by the Cabinet of Ministers of Ukraine upon suggestion of the relevant central body of executive power.

State registration of GMOs and products manufactured with the help of their use may be denied in the instance of receiving scientifically justified information regarding their danger to the human health or the natural environment when they are used according to their targeted designation.

Industrial manufacturing and the induction into circulation of GMOs as well as products manufactured with the help of their use shall be prohibited prior to their state registration.

According to Article 16 of the present Law, it shall be prohibited to import GMOs as well as products manufactured with the help of their use to the customs territory of Ukraine prior to their state registration, except for those that are designated for scientific and research purposes or for state approbation (testing). The permit for importing such GMOs designated for scientific and research purposes or for state approbation (testing) shall be issued by the central body of executive power in the area of education and science according to the procedure established by the Cabinet of Ministers of Ukraine.

Violation of the requirements of the present Law as well as regulations and pieces of legislation adopted on the basis thereof shall entail civil, administrative, disciplinary, or criminal responsibility.

Article 18 of the present Law shall establish that responsibility shall be born by individuals that are guilty of: · hiding or twisting information, which could cause or has caused a threat to the life and health of a human or to the natural environment; · failing to observe or violating the requirements of standards, regulations, sanitary standards, and rules for using, transporting, storing, and selling GMOs; · using unregistered GMOs or unregistered products obtained with the help of their use (except for those used for scientific and research purposes); · violating the rules for recycling and destroying GMOs; · failing to fulfill legitimate requirements of officials that carry out state supervision and exercise state oversight.