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Reference on the legal regulation of the handling of radionuclides in Ukraine

Октябрь 27, 2019 By: Профессиональная Юридическая Группа Category: Консультации по отдельным видам деятельности

1. Legal regulation of radionuclide handling in Ukraine
1.1. List of regulatory acts
- Law of Ukraine "On protection of human from the impact of ionizing radiation" of January 14, 1998 No 15/98-BP;
- Law of Ukraine "On the use of nuclear energy and the radiation safety" of February 8, 1995 No 39/95-BP;
- Law of Ukraine "On permitting activities in the field of nuclear energy use" of January 11, 2000 No 1370-XIV;
- Law of Ukraine "On status and social protection of citizens affected by the Chornobyl catastrophe" of February 28, 1991 No 796-XII;
- Law of Ukraine "On protection of environment" of June 25, 1991 No 1264-XII;
- Law of Ukraine "On ensuring sanitary and epidemic well-being of the population" of February 24, 1994 No 4004-XII;
- Law of Ukraine "On radioactive waste handling" of June 30, 1995 No 255/95-BP;
- Law of Ukraine "On the legal regime of the territory that has undergone radioactive contamination as a result of the Chornobyl catastrophe " of February 27, 1991 No 791a-XII;
- The procedure for issuing a permit for the international transportation of radioactive materials, approved by the Resolution of the Cabinet of Ministers of Ukraine of October 03, 2007 No 1196;
- The order of release of radioactive materials from regulatory control in the framework of practical activity, approved by the Order of the State Committee for Nuclear Regulation of Ukraine of July 01, 2010 No 84;
- The procedure for exercising state control over international transfers of dual-use items, approved by the Resolution of the Cabinet of Ministers of Ukraine of January 28, 2004 No 86;
- Nuclear and radiation safety rules for the transportation of radioactive materials (ПБПРМ-2006), approved by the Order of the State Committee for Nuclear Regulation of Ukraine of August 30, 2006 No 132;
- State hygiene standards "Norms of radiation safety of Ukraine (НРБУ-97)", approved by the Resolution of the Chief State Sanitary Doctor of Ukraine of December 01, 1997 No 62;
- Norms of radiation safety of Ukraine. Addendum: Radiation protection from sources of potential irradiation (НРБУ-97/D-2000), approved by the Resolution of the Chief State Sanitary Doctor of Ukraine of July 12, 2000 No 116;
- Order of the Ministry of Health of Ukraine "On approval of the Allowable levels of Cs-137 and Sr-90 radionuclides in food and drinking water (ДР-97)" of August 19, 1997 No 255;
- Basic sanitary rules for ensuring radiation safety of Ukraine, approved by the Order of the Ministry of Health of Ukraine of February 02, 2005 No 54;
- Permissible levels of 137Cs and 90Sr radionuclides in food and drinking water "(ДР-97), approved by the Order of the Ministry of Health of Ukraine of August 19, 1997 No 255;
- State hygiene standards "Permissible levels of 137Cs and 90Sr radionuclides in food and drinking water", approved by the Order of the Ministry of Health of Ukraine of May 03, 2006 No 256;
- Hygienic standard for the specific activity of 137Cs and 90Sr radionuclides in herbal medicinal products (substances) used for the manufacture of medicinal products, approved by the Order of the Ministry of Health of Ukraine of May 8, 2008 No 240;
- Methodological guidelines "Sampling, primary treatment and determination of 90Sr and 137Cs content in food products", approved by the Order of the Ministry of Health of Ukraine of August 11, 2008 No 446;
- The list of sources of ionizing radiation, the activity of which use is exempt from licensing, approved by the Order of the State Inspectorate of Nuclear Regulation of Ukraine of December 03, 2013 No 138;
- The order of state registration of sources of ionizing radiation, approved by the Resolution of the Cabinet of Ministers of Ukraine of November 16, 2000 No 1718;
- Rules for the production (manufacture) and quality control of medicines in pharmacies, approved by the Order of the Ministry of Health of Ukraine of October 17, 2012 No 812;
- Regulation on radiation control of cardboard and paper products, approved by the Order of the State Joint Stock Company "Ukrresursy" of October 04, 1995 No 81;
- Veterinary and sanitary rules for slaughterhouses and farm slaughterhouses approved by the Order of the State Department of Veterinary Medicine of the Ministry of Agrarian Policy of Ukraine of January 14, 2004 No 4;
- Methodological recommendations on the Program of production control over compliance with the requirements of production, storage and transportation of raw milk, approved by the Order of the Chief State Inspector of Veterinary Medicine of Ukraine of September 27, 2012 No 147;
- State standard of Ukraine ДСТУ ISO 18589-1:2015 Measurement of radioactivity in the environment. Soil. Part 1. General guidelines and definitions (ISO 18589-1:2005, IDT);
- State standard of Ukraine ДСТУ ISO 18589-2:2015 Measurement of radioactivity in the environment. Soil. Part 2. Guidelines for choosing a sampling strategy, sampling and pre-treatment (ISO 18589-2:2007, IDT);
- State standard of Ukraine ДСТУ ISO 18589-4:2015 Measurement of radioactivity in the environment. Soil. Part 4. Measurement of plutonium isotopes (plutonium 238 and plutonium 239 + 240) by alpha spectrometry (ISO 18589-4:2009, IDT);
- State standard of Ukraine ДСТУ ISO 18589-5:2015 Measurement of radioactivity in the environment. Soil. Part 5. Measurement of strontium 90 (ISO 18589-5:2009, IDT);
- State standard of Ukraine ДСТУ ISO 18589-6:2015 Measurement of radioactivity in the environment. Soil. Part 6. Measurement of the total activity of alpha radiation and the total activity of beta radiation (ISO 18589-6:2009, IDT).

1.2. Separate provisions for determining the content of radionuclides and their hazards
Law of Ukraine "On protection of human from the impact of ionizing radiation" of January 14, 1998 No 15/98-BP defines the effective dose of radiation as a calculated dose of human exposure, which takes into account the contribution of the effects of exposure of various organs and tissues on the health of the person as a whole. Irradiation is the effect on a person of ionizing radiation, which may be external radiation as a result of practical activity from sources of ionizing radiation outside the body or internal radiation from sources of ionizing radiation that are inside the body. Population irradiation is the radiation experienced by a person from nuclear facilities and sources of ionizing radiation, with the exception of occupational and medical radiation and radiation caused by local natural background radiation. The main radiation dose limit is the maximum permissible level of an individual effective dose of human exposure established by this Law, the excess of which requires the application of human protection measures. Practical activity - the activity of a person in the course of which additional sources of radiation are introduced, or additional ways of irradiation, or the number of people exposed to radiation, which increases the magnitude of radiation, its probability or the number of people exposed, increases. Everyone residing or temporarily residing in Ukraine has the right to be protected from the effects of ionizing radiation. This right is ensured by the implementation of a set of measures to prevent the impact of ionizing radiation on the human body above the established dose limits of radiation, compensation for exceeding the established dose limits of radiation and compensation for damage caused by the effect of ionizing radiation. The basic dose limit for an individual exposure to the population shall not exceed 1 millisievert effective dose of radiation per year, with the average annual effective dose of human exposure attributed to the critical group not to exceed the basic dose limits of this irrespective of the form and conditions. Legal and natural persons carrying out practical activities are obliged to: carry out systematic control over the radiation status of workplaces, premises, territories, in sanitary protection and observation zones, as well as the emissions and discharges of radioactive substances; to develop a justification of compliance with radiation safety standards for new (upgraded) products, materials and substances, technological processes and industries; to plan and implement measures to ensure the protection of human from the effects of ionizing radiation; to control and record individual doses of personnel exposure; organize periodic medical examinations of staff; to regularly inform the staff about the levels of ionizing radiation in the workplace and the value of the radiation doses they receive; timely inform the executive and local self-government bodies, bodies of state regulation of nuclear and radiation safety in case of emergencies, violations of technological regulations that pose a threat to human security; ensure the realization of the rights of citizens and their associations to provide information on the state of protection of human beings against the effects of ionizing radiation. Paragraph 15 of this Law regulates the protection of human from the influence of radionuclides contained in building materials. Pursuant to Paragraph 16 of this Law, the content of radionuclides in food, raw material and drinking water may not exceed the norms approved in the established order. Compensation for exceeding the annual basic dose limit of radiation is provided to persons who reside or temporarily reside in the territory of Ukraine in the cases of: irradiation caused by the influence of practical activity; mistaken or inappropriate exposure of patients to medical intervention; forced consumption of food and drinking water contaminated with radionuclides; radiation hazardous living, working and study conditions. Compensation for exceeding the annual basic dose limit of exposure is set at 1.2 non-taxable minimum incomes of citizens for each millisievert of exceeding of the limit of exposure established by this Law. The reason for payment of compensation to persons for exceeding the annual basic dose limit of irradiation is the fact that the region (city) radiation dose register is exceeded by the fact of exceeding the annual basic dose limit of irradiation not due to the person's own fault. The Cabinet of Ministers of Ukraine shall establish the procedure for providing compensation for exceeding the annual basic dose exposure limit. The damage caused by the impact of ionizing radiation on the life and health of individuals and property of individuals (Paragraph 20 of the Law) shall be compensated. Compensation for the excess of the annual basic dose limit and compensation for damage caused by ionizing radiation shall be provided at the expense of legal entities and individuals as a result of the practice of which exceeded.
Law of Ukraine "On the use of nuclear energy and the radiation safety" of February 8, 1995 No 39/95-BP contains definitions, in particular, of concepts: ionizing radiation source, radiation safety, radiation protection, radioactive materials. Ionizing radiation source is a physical object, other than a nuclear installation containing a radioactive substance, or a technical device that generates or, under certain conditions, can generate ionizing radiation. Radiation safety is the observance of the permissible limits of radiation exposure to personnel, the population and the environment, as established by safety norms, rules and standards. Radiation protection - a set of radiation-hygienic, design, technical and organizational measures aimed at ensuring radiation safety. Radioactive materials are sources of ionizing radiation, nuclear materials and radioactive waste. Compliance with the rules, regulations and standards for nuclear and radiation safety is a must when carrying out any activity in the field of nuclear energy use.
Law of Ukraine "On permitting activities in the field of nuclear energy use" of January 11, 2000 No 1370-XIV refers to radioactive materials any materials containing radionuclides in which the specific activity, as well as the total activity in the case of their transportation, exceeds the limits established by the norms, rules and standards for nuclear and radiation safety. The law provides for the licensing of certain activities, as well as the issuance of certificates of approval in the case of transportation of radioactive materials, state registration of sources of ionizing radiation, the issuance of permits for the transportation of radioactive materials.
Law of Ukraine "On status and social protection of citizens affected by the Chornobyl catastrophe" of February 28, 1991 No 796-XII provides that food and agricultural products are considered suitable for sale and consumption in which the radionuclide content does not exceed the approved permissible levels. Permissible levels of radionuclide content in food and agricultural products are approved by the central executive body, which ensures the formulation of state health policy. Products produced in radioactive contamination zones must have a certificate of conformity to the approved permissible levels of radionuclide, which shall include information on the place of production, the contents of the radionuclides, the responsible manufacturer of those products, and the controller who has verified them for the radionuclide content. The production and sale of products whose radioactive contamination exceeds the permissible levels of radionuclide content, with the exception of products of a scientific-production and research character, shall be prohibited. If the use and processing of products contaminated with radionuclides exceeds the approved permissible levels, it shall be subject to removal and destruction in accordance with the procedure established by the Cabinet of Ministers of Ukraine, with reimbursement of the associated costs by producers of contaminated products. The Cabinet of Ministers of Ukraine provides citizens of Ukraine with full, timely and reliable information on the levels of contamination of radioactive substances in the areas in which they live or work, the degree of contamination of radionuclides in food and property, and on all requirements and conditions for compliance with the radiation safety regime. Public oversight bodies may verify the accuracy of the information provided.
Law of Ukraine "On protection of environment" of June 25, 1991 No 1264-XII contains a norm according to which enterprises, institutions and organizations engaged in economic or other activities related to the use of radioactive substances in various forms and for any purpose, are obliged to ensure environmental safety of these activities, which would exclude the possibility of radioactive pollution of the environment and negative impact on human health in the process of extraction, enrichment, transportation, processing, use and disposal of radioactive substances.
Law of Ukraine "On ensuring sanitary and epidemic well-being of the population" of February 24, 1994 No 4004-XII stipulates that enterprises, institutions, organizations that produce, store, transport, use radioactive substances and sources of ionizing radiation, carry out their disposal, destruction or disposal, are obliged to observe radiation safety standards, relevant sanitary rules, as well as norms established by other legislation containing the requirements of radiation safety. Work with radioactive substances and other sources of ionizing radiation is carried out with the permission of the State Sanitary and Epidemiological Service and other specially authorized bodies. Cases of violations of the norms of radiation safety, sanitary rules of work with radioactive substances, other sources of ionizing radiation, as well as radiation accidents shall be subject to obligatory investigation with the participation of officials carrying out state sanitary and epidemiological supervision.
State hygiene standards "Norms of radiation safety of Ukraine (НРБУ-97)", approved by the Resolution of the Chief State Sanitary Doctor of Ukraine of December 01, 1997 No 62, is the main state document establishing a system of radiation and hygiene regulations to ensure acceptable levels of human exposure. It establishes the principles of justification, non-exceedance and optimization in practical activities, which are accompanied by human exposure. The radiation and hygiene regulations of the first group (concerning the exposure of the population at acceptable levels for the individual and society) set the numerical values of the limits of radiation doses at levels that exclude the possibility of deterministic effects of irradiation and, at the same time, guarantee such low effects, acceptable to both individuals and society at large. Annual effective dose limits and annual equivalent external exposure limits for individual organs and tissues have been established. The limitation of exposure of the population is carried out by regulation and control, in particular, of the content of radionuclides in certain objects of the environment (water, food, air, etc.). Mandatory action levels have been established depending on: the effective specific activity of natural radionuclides in building materials and mineral building materials; activity of natural radionuclides in water sources of economic and drinking water supply; effective specific activity of natural radionuclides in mineral fertilizers; effective specific activity of natural radionuclides in porcelain, earthenware, glass and clay products; Effective specific activity of natural radionuclides in mineral dyes and glaze. Practical activities and/or sources of ionizing radiation in the context of practical activities may be totally or partially exempted from regulatory control. Exemption shall be exercised by the regulatory authorities if the exemption criteria set out in these Hygiene Standards are fulfilled, or if the sources comply with the exemption levels determined by the regulatory authorities on the basis of the exemption criteria mentioned. The values of allowable levels of radionuclides and explanation of the method of their calculation (magnitudes of allowable receipts through respiratory organs, digestive organs, allowable concentrations in drinking water, inflow of radionuclides with drinking water and food) are established.
Order of the Ministry of Health of Ukraine "On approval of the Allowable levels of Cs-137 and Sr-90 radionuclides in food and drinking water (ДР-97)" of August 19, 1997 No 255 contains the formula of calculation and specific values of the permissible levels of 137Cs and 90Sr in food and drinking water.
Basic sanitary rules for ensuring radiation safety of Ukraine, approved by the Order of the Ministry of Health of Ukraine of February 02, 2005 No 54, applies to all types of manufacturing activities, as well as to all situations of interference in which human radiation is produced or may occur at the production and / or in the home by any source of natural and / or artificial origin (except those excluded under article 1.11) from the scope of the Rules). The rules contain many definitions of concepts (including the concept of radionuclide), formulas for calculating individual indicators, the procedure for considering applications of legal and natural persons about the intention to practice with sources of ionizing radiation, the procedure for issuing a sanitary passport, the procedure for sanitary control and sanitary monitoring. Any natural or legal person who has received a Sanitary passport shall be responsible, in accordance with applicable law, for the preparation and implementation of the technical and organizational measures necessary to ensure the requirements and regulations of radiation safety, in connection with the operation of that source, for the operation of that source Sanitary passport has been received. Any natural or legal person who has received a Sanitary passport is obliged to inform the institutions of the State Sanitary and Epidemiological Service of the Ministry of Health of Ukraine of its intention to amend any practical activity, including change of the types of sources specified in the Sanitary Passport, in all cases, even when it is assumed that these changes do not change the level of radiation protection and safety. Such changes may be made only after the relevant written permission of the institutions of the State Sanitary and Epidemiological Service of the Ministry of Health of Ukraine. The basis for monitoring the state of radiation safety in terms of practical activity is dosimetric control at the enterprise. At objects that do not have sufficient experience of control and monitoring and / or do not have the necessary equipment and their own qualified specialists to perform these functions, it is allowed to perform these works by the involved qualified specialists and / or organizations that have sufficient instrumental and methodological base for their performance and are entitled to carry out this activity.
State hygiene standards "Permissible levels of 137Cs and 90Sr radionuclides in food and drinking water", approved by the Order of the Ministry of Health of Ukraine of May 03, 2006 No 256, establish hygienic standards for 137Cs and 90Sr content in food and drinking water, as well as compliance with the specified admissible levels during food production, import, export and circulation. The standards are mandatory for individuals and legal entities whose activities are related to the production, import, export and circulation of food products, provision of services in the field of retail trade in food, in the sphere of wholesale trade and restaurant, catering. Compliance with the Standards is vested in the institutions of the State Sanitary and Epidemiological Service of the Ministry of Health of Ukraine. The standards contain definitions, reference values, permissible levels of radionuclide content in food and drinking water (including beverages) - broken down separately by product. To determine the compliance of food products with the criteria of radiation safety, a compliance indicator is used, the value of which is calculated from the results of measurements of specific activities of 137Cs and 90Sr according to formulas and rules established by these standards. If a food product contains different components that can be attributed to different classification groups (for example, stuffed flour, canned meat, etc.), the radiation control is carried out according to the components determined by the control body. The permissible levels of radionuclide content in the concentrate, in the dilute state, must be equal to the permissible levels of the corresponding natural products.
Hygienic standard for the specific activity of 137Cs and 90Sr radionuclides in herbal medicinal products (substances) used for the manufacture of medicinal products, approved by the Order of the Ministry of Health of Ukraine of May 8, 2008 No 240, applies to dried medicinal herbal raw material (substance) for the production of medicinal products registered in the prescribed manner. The standard regulates the specific activity of 137Cs and 90Sr in a herbal medicinal product (substance) that is harvested, processed, sold on the territory of Ukraine or imported into Ukraine for the production of medicinal products registered in the prescribed manner. Contains a table with the names of medicinal herbs (substances) and indicators of the maximum content of radionuclides 137Cs and 90Sr.
Methodological guidelines "Sampling, primary treatment and determination of 90Sr and 137Cs content in food products", approved by the Order of the Ministry of Health of Ukraine of August 11, 2008 No 446, contain determinations of radionuclide activity, concentration ratio, annual (or equivalent) dose limit, and the like. According to the requirements of the Law of Ukraine "On protection of human from the impact of ionizing radiation", the content of radionuclides in food, raw materials and drinking water should not exceed the approved levels in the established order. Radiation control of food products is carried out in accordance with the requirements of the Law of Ukraine "On protection of human from the impact of ionizing radiation", as well as the Procedure of carrying out the state sanitary and epidemiological examination, approved by the Order of the Ministry of Health of Ukraine of October 09, 2000 No 247. These Methodological instructions sampling of different types of food products and order of measurement of radionuclide activity. Appendix 4 to these Methodological guidelines regulates the procedure for determining the radiation safety of food products (the compliance index and its error are calculated from the results of measurements of the specific activity of radionuclides 137Cs and 90Sr in a food products by a certain formula).

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