Republic of Latvia
Cabinet
Regulation No. 723
Adopted 20 September 2011
Procedures for Licensing Activities with Sources of Ionising Radiation
Issued pursuant to Section 11, Paragraph two,
Clauses 1, 2 and 3, Section 11, Paragraph five,
Section 12, Paragraph two and Section 29,
Paragraph four of the Law On Radiation Safety
and Nuclear Safety
I. General Provision
1. This Regulation prescribes:
1.1. the activities with sources of ionising radiation not requiring a special permit (licence) or a permit because it is not possible to influence such activities by human actions or the potential dose of ionising radiation and the adverse effects of the irradiation are so small that it need not be taken into account from the viewpoint of radiation safety;
1.2. the criteria to be observed when requesting a special permit (licence) or a permit for activities with sources of ionising radiation;
1.3. the procedures by which special permits (licences) and permits for activities with sources of ionising radiation shall be issued;
1.4. the amount and procedures for payment of the State fee;
1.5. the procedures for public discussion of the establishment of ionising radiation objects of national significance or the performance of essential changes therein; and
1.6. the minimum amount of civil legal liability insurance.
II.Activities with Sources of Ionising Radiation for which a Special Permit (Licence) or Permit is not Required
2. A special permit (licence) or permit for activities with sources of ionising radiation (hereinafter – special permit (licence) or permit) shall not be necessary, if the source of ionising radiation is:
2.1. a radioactive substance, if it conforms to at least one of the following conditions:
2.1.1. the total radioactivity of the relevant radionuclide does not exceed the value specified in Annex 1 to this Regulation;
2.1.2. the specific radioactivity per unit weight of the relevant radionuclide does not exceed the value specified in Annex 1 to this Regulation, and the total amount of the radioactive substance does not exceed 1000 kg;
2.2. a cathode-ray tube intended for obtaining visual images, if it conforms to at least one of the following conditions:
2.2.1. the maximum potential difference of the cathode-ray tube does not exceed 30 kV, and under operating conditions that conform to the conditions specified by the manufacturer, the rate of ionising radiation dose created by the cathode-ray tube is less than 1 µSv per hour at a distance of 0.1 m from any accessible part of the surface of the apparatus; or
2.2.2. the potential difference is less than 5 kV;
2.3. electrical apparatus, if it conforms to at least one of the following conditions:
2.3.1. the maximum potential difference of the apparatus does not exceed 30 kV and under operating conditions that conform to the conditions specified by the manufacturer, the rate of ionising radiation dose created by the apparatus is less than 1 µSv per hour at a distance of 0.1 m from any accessible part of the surface of the apparatus; or
2.3.2. the potential difference is less than 5 kV;
2.4. installation or apparatus containing a sealed radioactive source, and the total radioactivity of the radioactive substance contained in the radioactive source, specific radioactivity or both these values of radioactivity for the relevant radionuclide exceed the values indicated in Annex 1 to this Regulation, if under operating conditions that conform to the conditions specified by the manufacturer, the rate of ionising radiation dose created by the source of ionising radiation is less than 1 µSv per hour at a distance of 0.1 m from any accessible part of the surface of the apparatus and the committed effective dose per inhabitant is less than 10 µSv per year;
2.5. smoke detectors in which the americium isotope 241Am is used if the total radioactivity of a single detector does not exceed 74 kBq and the total number of such detectors is 100 units;
2.6. thorium (232Th) alloys in electrodes of luminiscent lamps, discharge tubes and in picture tubes, as well as in filaments of heated gas-filled lamps, if the number of units of the relevant products to be stored in a single undertaking does not exceed 10,000 units per year;
2.7. thorium (232Th) in special alloys in aircraft engines or fire-resistant laboratory installations, if the total mass thereof in a single undertaking or one specific location does not exceed 1 000 kg;
2.8. thorium (232Th) in welding electrodes if the concentration of thorium is less than five per cent and the total amount of such electrodes used in a single undertaking or stored in once specific location or in one year does not exceed 1000 kg;
2.9. tritium (3H) and krypton (85Kr) in luminescent and special lamps, as well as in discharge tubes, the radioactivity of which in one product does not exceed the values indicated in Annex 1 to this Regulation and the total number of units of the relevant products to be stored concurrently in a single undertaking does not exceed 10,000;
2.10. natural radioactive material, the specific radioactivity of which exceeds the values specified in Annex 1 to this Regulation, if such material is not specially treated in order to increase its specific radioactivity and, during performance of activities with such materials, the total dose of ionising radiation received by a person does not exceed 1 mSv per year; and
2.11. a mixture of radionuclides if the amount of part of each radionuclide thereof or the total or specific radioactive amount, which is divided by the value indicated in Annex 1 to this Regulation for the relevant radionuclide, is less than or equal to 1.
3. A special permit (licence) or permit shall not be necessary for:
3.1. the transportation, bringing in from a European Union Member State, bringing out to a European Union Member State, for transit from one European Union Member State to another Member State or for transfer of sources of ionising radiation not containing a radioactive substance; or
3.2. for the lease or alienation of sources of ionising radiation not containing a radioactive substance used in the activities of an operator.
4. If in accordance with Annex 1 to this Regulation in the radionuclide decay process (parent nuclide) other radionuclides (daughter nuclides) indicated in Annex 2 to this Regulation are generated, the values of radioactivity specified in Annex 1 to this Regulation shall apply not only to the parent nuclide but also to the relevant daughter nuclides.In such case, in order to determine whether activities with sources of ionising radiation require a special permit (licence) or a permit, the value specified for the parent nuclide shall be used.
III.Criteria for Requesting a Special Permit (Licence) or Permit
5. A special permit (licence) for activities related to the establishment of an ionising radiation object of national significance or the use of an ionising radiation object of national significance or the performance of significant changes, may be requested by a direct administration authority of the Republic of Latvia, a derived public person, or a commercial company registered in the Republic of Latvia or another European Union Member State.
6. Only a direct administration authority of the Republic of Latvia, a derived public person or a commercial company registered in the Republic of Latvia may be an operator of nuclear installation.
7. Only a direct administration authority of the Republic of Latvia, a derived public person or a commercial company registered in the Republic of Latvia may request a special permit (licence) for the storage of radioactive waste until its disposal, if the planned period of storage exceeds three years, as well as for disposal of radioactive waste.
8. A legal person registered outside the European Union Member States may request a special permit (licence) or permit, if it has been registered in the Republic of Latvia, except the cases referred to in Paragraph 9 of this Regulation.
9. A legal person registered outside the European Union Member States, a natural person who is not a citizen or a national of the European Union, or an international organisation may request:
9.1. a special permit (licence) for temporary importation of a source of ionising radiation for demonstration, calibration, testing, or other similar purposes if the duration of such presence of the source of ionising radiation in Latvia does not exceed 30 days and the applicant for the special permit (licence) already has a special permit (licence) or a permit for the performance of activities with imported sources of ionising radiation in the relevant foreign country; and
9.2. a special permit (licence) or a permit for each separate transit shipment of sources of ionising radiation.
10. In order to receive a special permit (licence) or a permit, an applicant for the special permit (licence) or the permit (hereinafter – applicant) shall:
10.1. ensure conditions for the safe operation and storage of a source of ionising radiation, as well as comply with the technical requirements of the manufacturer set out in the operating documents;
10.2. reduce the risks to the health and safety of an employee or other person, related to the structure and use of a source of ionising radiation, taking into account the effect of the ionising radiation, electric shock and mechanical hazard;
10.3. prepare the measuring instruments appropriate for the specific nature of work;
10.4. ensure the preparedness for radiological emergencies and the prevention of the consequences thereof;
10.5. ensure the compliance of employee qualifications with the duties to be performed;
10.6. ensure the development of a radiation safety and nuclear safety quality assurance programme;
10.7. prepare a storage facility for the source of ionising radiation compliant with the requirements for physical protection; and
10.8. develop an environmental monitoring programme compliant with the use of a source of ionising radiation.
11. For the performance of activities related to medical exposure, the qualification of the work manager shall comply with the following criteria:
11.1. in radio diagnostics:
11.1.1. a certificate of radiologist in radio diagnostics, a certificate of radiologist in radiotherapy or an education in medical physics has been acquired and at least two years work experience with sources of ionising radiation in radio diagnostics, including the time when an education in radiation safety or radiation safety and nuclear safety issues was acquired.If radionuclides are used in radio diagnostics, at least two years work experience in work with radioactive substances in medicine shall be necessary;
11.1.2. a certificate of radiographer certificate has been acquired and at least five years experience with sources of ionising radiation in radio diagnostics, including the time when an education in radiation safety or radiation safety and nuclear safety issues was acquired.If radionuclides are used in radio diagnostics, at least three years work experience in work with radioactive substances in medicine shall be necessary;
11.2. in radiotherapy – a certificate of radiologist in radiotherapy or an education in medical physics has been acquired and at least three years work experience with sources of ionising radiation in radiotherapy, including the time when an education in radiation safety or radiation safety and nuclear safety issues was acquired.If radionuclides are used in radiotherapy, at least three years work experience in work with radioactive substances in medicine shall be necessary; and
11.3. in dentistry – a certificate in the specialty of dentist or a certificate of radiologist, an education in medical physics or radiography has been acquired and at least one year work experience with sources of ionising radiation in radio diagnostics, including the time when an education in radiation safety or radiation safety and nuclear safety issues was acquired.If panoramic dental X-ray pictures are also taken at a dental practice, the dentist is required to have an additional education for the performance of such examinations.
12. For the performance of activities not related to medical exposure, the qualification of the work manager shall comply with the following criteria:
12.1. a higher education has been acquired;
12.2. a course programme developed by an educational establishment has been acquired in the field of radiation safety or a programme in the field of medical physics has been acquired.Additional training in the field of radiation safety and nuclear safety is not necessary if activities are being performed with sources of ionising radiation, the rate of the total ionising radiation dose of which, at a distance of one metre from the source of ionising radiation, is less than or equal to 0,1 Sv/h), and the work manager has acquired training subjects in radiation chemistry, radiochemistry, radiobiology, nuclear physics, radiation physics in a higher education programme or study programmes related to the design and operation of nuclear reactor, nuclear fuel processing cycle or radioactive waste processing undertakings;
12.3. work experience has been acquired in work with sources of ionising radiation, including the time when an education in radiation safety and nuclear safety issues was acquired;
12.3.1. at least one-year experience if activities are performed with sources of ionising radiation, the rate of the total ionising radiation dose of which, at a distance of one metre from the source of ionising radiation, is less than or equal to 0,1 Sv/h); and
12.3.2. at least three years work experience, if activities are performed with sources of ionising radiation not referred to in Sub-paragraph 12.3.1 of this Regulation.
13. A work manager shall require a higher education in veterinary medicine and a veterinary medical practice certificate for the performance of activities related to irradiation in a veterinary medical practice.
14. If the applicant only uses a source of ionising radiation, the servicing of which does not require the direct presence of an employee and the rate of the ionising radiation exposure dose at one metre is less than 1 µSv per hour, the qualification of the work manager shall comply with the following minimum requirements:
14.1. a general secondary or vocational secondary education has been acquired;
14.2. a course programme developed by an educational establishment in the field of radiation safety and nuclear safety has been acquired; and
14.3. at least one-year work experience in work with sources of ionising radiation.
15. In respect of a work manager, an operator shall ensure:
15.1. training in radiation safety issues within the scope of course programmes developed by an educational establishment – not less than once every five years.Such training shall not be necessary if activities are performed with sources of ionising radiation, the rate of the total ionising radiation dose of which, at a distance of one metre from the source of ionising radiation, is less than or equal to 0,1 Sv/h); and
15.1.1. the work manager has acquired study subjects in a higher education programme in radiation chemistry, radiochemistry, radiobiology, nuclear physics, radiation physics in a higher education programme or study programmes related to the design and operation of nuclear reactor, nuclear fuel processing cycle or radioactive waste processing undertakings;
15.1.2. the work manager manages work in a veterinary medical practice; and
15.2. extracurricular training and a test of knowledge if the duties of work or position change, or if new equipment or a new procedure with sources of ionising radiation is introduced at work.
16. In order to perform activities with sources of ionising radiation, an employee shall require at least a general secondary or vocational secondary education and have acquired a course programme developed by an educational establishment in the field of radiation safety and nuclear safety.An employee needs not an additionally acquired programme in the field of radiation safety and nuclear safety, if activities with sources of ionising radiation, the rate of the total ionising radiation dose of which, at a distance of one metre from the source of ionising radiation, is less than or equal to 0,1 Sv/h), are performed by:
16.1. a veterinarian in a veterinary medical practice if he or she has obtained a veterinary medical practice certificate; or
16.2. an employee who has acquired study subjects in radiation chemistry, radiochemistry, radiobiology, nuclear physics, radiation physics in a higher education programme or study programmes related to the design and operation of nuclear reactor, nuclear fuel processing cycle or radioactive waste processing undertakings.
17. The requirements for qualification and education of employees performing activities with sources of ionising radiation in medicine shall be determined by the Medical Treatment Law.
18. In respect of a work manager, an operator shall ensure:
18.1. training (for which a note shall be made in the relevant log) on radiation safety issues not less than once per year;
18.2. training in radiation safety issues within the scope of a course programme developed by an educational establishment not less than once every five years.Repeated training shall not be necessary every five years if activities with sources of ionising radiation, the rate of the total ionising radiation dose of which, at a distance of one metre from the source of ionising radiation, is less than or equal to 0,1 Sv/h), are performed by:
18.2.1. an employee in a veterinary medical practice;
18.2.2. an employee who has acquired study subjects in radiation chemistry, radiochemistry, radiobiology, nuclear physics, radiation physics in a higher education programme or study programmes related to the design and operation of nuclear reactor, nuclear fuel processing cycle or radioactive waste processing undertakings; and
18.3. extracurricular training and a test of knowledge if the duties of work or position change, or if new equipment or a new procedure with sources of ionising radiation is introduced at work.
19. A course programme in the field of radiation safety and nuclear safety co-ordinated with the Radiation Safety Centre of the State Environmental Service (hereinafter – Centre) and the professional association of the relevant sector, shall include:
19.1. for employees:
19.1.1. theoretical studies of the requirements prescribed by regulatory enactments with respect to radiation safety and nuclear safety, and ensuring the protection of the health of employees;
19.1.2. theoretical studies and practical training on safe working methods and radiation safety and nuclear safety;
19.2. for work managers:
19.2.1. theoretical studies of the requirements prescribed by regulatory enactments with respect to radiation safety and nuclear safety, and ensuring the protection of the health of employees;
19.2.2. theoretical studies and practical training on safe working methods and radiation safety and nuclear safety;
19.2.3. theoretical studies and practical training on the evaluation of ionising radiation dose, the culture of radiation safety and nuclear safety, the quality assurance and the quality control;
19.3. a multiple choice test for which a positive grade is received by correctly answering at least 70% of all the questions.
IV.Issue of a Special Permit (Licence) or Permit
20. The applicant shall submit a written application (Chapters II and III of Annex 3) to the Centre for the receipt of a special permit (licence) for activities with sources of ionising radiation.
21. The applicant shall submit a written application (Chapter I of Annex 3) to the Centre for the receipt of a permit for a source of ionising radiation not containing a radioactive substance: