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LEGAL ACTS OF THE REPUBLIC OF LATVIA
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Republic of Latvia

Cabinet
Regulation No. 65
Adopted 28 January 2021

Regulations Regarding Notification, Registration, and Licensing of Activities with Sources of Ionising Radiation

Issued pursuant to
Section 5, Clause 12, Section 11,
Paragraphs four and seven, Section 12,
Paragraph two, Section 13, Paragraph eight,
Section 14, Paragraph one, Section 28,
Paragraph two, and Section 29,
Paragraph four of the law On Radiation
Safety and Nuclear Safety

I. General Provisions

1. The Regulation prescribes:

1.1. the content of course programmes in the field of radiation safety;

1.2. the criteria for the commencement of activities with sources of ionising radiation;

1.3. the activities with sources of ionising radiation not requiring notification 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 exposure are so insignificant that they can be ignored from the radiation safety aspect;

1.4. the activities with sources of ionising radiation requiring notification, and the activities with sources of ionising radiation requiring registration, taking into account the potential adverse effects of the ionising radiation caused by the activity on human health and the environment;

1.5. the procedures for suspending activities with sources of ionising radiation which require notification;

1.6. the procedures for issuing, suspending, and cancelling a registration certificate for activities with sources of ionising radiation, and the term of validity of the registration certificate;

1.7. the procedures for issuing, suspending, and cancelling a licence for activities with sources of ionising radiation, and the term of validity of the licence;

1.8. the amount and payment procedures of the State fee;

1.9. the procedures for public discussions of the creation of ionising radiation objects of national significance or making substantial changes therein;

1.10. the procedures for filling out and submitting a report on activities with sources of ionising radiation, and also the content of such report;

1.11. the minimum qualification requirements for the work manager;

1.12. activities with sources of ionising radiation which require civil liability insurance, and the minimum amount of the civil liability insurance;

1.13. the procedures for liquidating sources of ionising radiation not containing a radioactive substance.

2. Terms used in this Regulation:

2.1. exposure for non-medical imaging purposes - any deliberate exposure of humans for imaging purposes if the primary purpose for the exposure is not to benefit the health of the person exposed;

2.2. exceptional limit - a limit value of radioactivity without exceeding of which the notification regarding activities with sources of ionising radiation is not required;

2.3. accelerator - an apparatus or installation in which particles are accelerated, emitting ionising radiation with energy higher than one megaelectron volt (MeV).

II. Activities with Sources of Ionising Radiation Not Requiring Registration

3. Notification regarding activities with sources of ionising radiation (hereinafter - the notification) shall not be required if the source of ionising radiation is:

3.1. a radioactive materials which complies with at least one of the following conditions:

3.1.1. the total radioactivity for the relevant radionuclide is smaller than the exceptional limit indicated in Annex 1 to this Regulation;

3.1.2. the specific radioactivity for the relevant radionuclide per unit of mass does not exceed the exceptional limit indicated in Annex 1 to this Regulation, and the total quantity of the radioactive substance does not exceed 1 000 kg;

3.2. a cathode-ray tube intended for demonstration of a visual image or an electric apparatus, including an electron microscope, whose maximum potential difference of the electric field does not exceed 30 kilovolts (kV) and the dose rate of ionising radiation caused by it under operating conditions foreseen by the manufacturer is less than 1 microsievert (µSv) per hour within a distance of 0.1 m from any reachable surface point of the apparatus;

3.3. an installation or apparatus which contains a sealed source of radiation, and the total radioactivity, specific radioactivity, or both values of radioactivity of the radioactive substance in this source of radiation for the relevant radionuclide exceed the exceptional limit indicated in Annex 1 to this Regulation, if the dose rate of ionising radiation caused by the source of ionising radiation under operating conditions foreseen by the manufacturer is less than 1 µSv per hour within a distance of 0.1 m from any reachable surface point of the apparatus and the foreseeable effective dose of radiation per an inhabitant is less than 10 µSv per year. Management of radioactive waste shall be ensured after the end of use of a sealed source of radiation in accordance with the laws and regulations regarding the requirements for activities with radioactive waste and materials related thereto;

3.4. a smoke detector in which an americium radionuclide (241Am) is used if the total radioactivity for one detector does not exceed 74 kilobecquerels (kBq) and the total number of smoke detectors installed or stored in one building concurrently does not exceed 100 units;

3.5. thorium (232Th) alloys in electrodes of luminescent lamps, gas discharge pipes, and electron television tubes, and also in filaments of heated gas lamps if the total number of the relevant articles installed or stored in one building concurrently does not exceed 10 000 units per year;

3.6. thorium (232Th) in special alloys in aircraft engines or fire-resistant laboratory installations if the total mass of the relevant alloys stored in one building concurrently does not exceed 1000 kg;

3.7. thorium (232Th) in welding electrodes if the concentration of thorium does not exceed 5 % of the total mass of electrodes and the total mass of such electrodes installed, stored, or used over a year in one building concurrently does not exceed 1000 kg;

3.8. tritium (3H) and krypton (85Kr) in luminescent and fluorescent lamps, and also gas discharge pipes the radioactivity of which in one article does not exceed the exceptional limit indicated in Annex 1 to this Regulation and the total number of the relevant articles installed or stored in one building concurrently does not exceed 10 000 articles;

3.9. a natural radioactive material the specific radioactivity of which exceeds the exceptional limit indicated in Annex 1 to this Regulation if such material has not been specifically processed in order to increase its specific radioactivity, and in performing activities with such material, the total dose of ionising radiation received by one person does not exceed 1 millisievert (mSv) per year;

3.10. a mixture of radionuclides if parts of each radionuclide thereof or its total or specific sum of radioactivity in the total quantity divided by the exceptional limit indicated in Annex 1 to this Regulation for the relevant radionuclide is less than or equal to one.

4. The notification shall not be required regarding the following activities with sources of ionising radiation not containing a radioactive substance which is capable of generating ionising radiation, such as X-rays, neutrons, electrons, or other charged particles:

4.1. purchase;

4.2. transportation or movement;

4.3. importation from a European Union Member State and exportation to a European Union Member State;

4.4. transit;

4.5. export and import.

5. If, in accordance with Annex 1 to this Regulation, radionuclides in continuous balance (daughter nuclides) which are referred to in Annex 2 to this Regulation emerge as a result of the disintegration process of the radionuclide (parent nuclide), the exceptional limit indicated in Annex 1 to this Regulation shall apply not only to the parent nuclide, but also to the relevant daughter nuclides. In this case, in order to determine whether the notification is required regarding activities with sources of ionising radiation, the value specified for the parent nuclide shall be used.

III. Activities with Sources of Ionising Radiation Requiring Notification and Activities Requiring Registration

6. The following activities shall require the notification without further receipt of a registration certificate or licence:

6.1. planned commencement of production of radiopharmaceuticals, performance of nuclear medicine procedures or radiotherapeutic procedures, or use of an accelerator;

6.2. storage of a source of ionising radiation not containing a radioactive substance if it is intended to store the source after its purchase for more than one month;

6.3. use of fixed analytical X-ray equipment, including an X-ray diffractometer or X-ray spectrometer, whose maximum potential difference of the electric field does not exceed 100 kV.

7. The following activities shall require registration:

7.1. trade in, short-term demonstration, calibration, testing of a source of ionising radiation not containing a radioactive substance, or other similar purposes without an intended activity of use;

7.2. activities with sources of ionising radiation in dental practice;

7.3. use of a source of ionising radiation not containing a radioactive substance - osteodensitometry or mammography equipment - for the purposes of medical exposure;

7.4. use of a source of ionising radiation not containing a radioactive substance for the purposes of non-medical exposure if the activities are performed in a specific room according to the plan of the room (assembly plan);

7.5. activities with a source of ionising radiation containing a radioactive material for the purpose of using its radioactivity - a radioactive source if the total radioactivity thereof is equal to or exceeds the exceptional limit specified in Annex 1 to this Regulation by not more than 103 (including) times;

7.6. any other activities with sources of ionising radiation that do not correspond to Paragraphs 3, 4, and 6 of this Regulation and activities specified in the law On Radiation Safety and Nuclear Safety which require licensing.

IV. Criteria for the Commencement of Activities with Sources of Ionising Radiation and Qualification Requirements for Work Managers

8. A licence for activities which are related to the creation or use of an ionising radiation object of national significance, or for making substantial changes may be requested by an institution of direct administration of the Republic of Latvia, a derived public person, and a commercial company registered in the Republic of Latvia or another European Union Member State.

9. An operator of nuclear facility may be an institution of direct administration of the Republic of Latvia, a derived public person, and a commercial company registered in the Republic of Latvia or another European Union Member State.

10. A licence for the storage of radioactive waste until their disposal, if the planned period of storage is more than a year, as well as for the disposal of radioactive waste may be requested by an institution of direct administration of the Republic of Latvia, a derived public person, and a commercial company registered in the Republic of Latvia or another European Union Member State.

11. A legal person registered outside the European Union Member States may request the licence or registration certificate if it is registered with the Commercial Register of the Republic of Latvia, except for the case referred to in Paragraph 9 of this Regulation.

12. A legal person registered outside the European Union Member States or a natural person who is not a citizen or national of a European Union Member State, or an international organisation may request the following:

12.1. the licence or registration for the short-term importation of a source of ionising radiation for demonstration, calibration, testing, or other similar activities if the presence of the source of ionising radiation in Latvia does not exceed 30 days and the applicant for such licence has a licence, a permit, or registration for the performance of activities with the source of ionising radiation to be imported into the relevant foreign country;

12.2. the licence or registration for each individual transit traffic operation of a source of ionising radiation.

13. A performer of the activities notified and referred to in Sub-paragraphs 6.2 and 6.3 of this Regulation:

13.1. shall ensure safe operation and storage of the source of ionising radiation, as well as fulfil the technical requirements indicated in the operational documents of the manufacturer;

13.2. if a source of ionising radiation is handed over to another natural or legal person, shall also hand over all relevant technical documentation concurrently with the source of ionising radiation;

13.3. shall, after termination of its activities, notify the Radiation Safety Centre of the State Environmental Service (hereinafter - the Centre) thereof. The Centre shall, upon receipt of information on termination of activities, remove the information on the user of the source of ionising radiation and the source of ionising radiation from the database.

14. In commencing to use the source of ionising radiation referred to in Sub-paragraph 6.2 of this Regulation, the performer of activities shall submit to the Centre an application for the receipt of a registration certificate or licence for activities with sources of ionising radiation in accordance with Paragraph 36 of this Regulation.

15. After discontinuation of the storage activity, the performer of activities shall, in accordance with Paragraph 53 of this Regulation, liquidate the source of ionising radiation referred to in Sub-paragraph 6.2 of this Regulation if it is not necessary for further activity or if the safety of the source does not conform to the requirements laid down in the laws and regulations in the field of radiation safety.

16. In order to obtain a licence or registration certificate, the applicant for the licence or registration certificate (hereinafter - the applicant) shall ensure the following:

16.1. substantiation of the activities with sources of ionising radiation, taking into account the exposure of employees and residents as well as patients so that the benefits to individuals or public provided by such activities with sources of ionising radiation are greater than the possible damage to health. The licence or registration certificate for activities with sources of ionising radiation in medical exposure may be obtained if the medical devices are placed on the market in accordance with the laws and regulations regarding registration of medical devices and the methods applied are approved in accordance with the laws and regulations regarding the procedures for the approval of medical technologies used in medical treatment and for the introduction of new medical technologies;

16.2. safe operation and storage of the source of ionising radiation, and also shall comply with the technical requirements indicated in the operational documents of the manufacturer;

16.3. assessment and reduction of the risks related to the structure and use of the source of ionising radiation in order to protect the health and life of employees or any other person, taking into account the potential effects of the ionising radiation, electric shock, and mechanical danger;

16.4. measuring equipment which corresponds to the specific nature of the foreseeable activities;

16.5. preparedness for radiological emergencies and elimination of consequences thereof in accordance with the laws and regulations regarding the requirements for the preparedness for a radiological emergency and the response in the event of such emergency;

16.6. conformity of the qualification of employees with the duties to be carried out;

16.7. development of a radiation safety quality assurance programme in accordance with the laws and regulations regarding protection against ionising radiation;

16.8. drawing up of an assembly plan for the placement of a source of ionising radiation and coordination thereof with a certified radiation safety expert or a medical physics expert in accordance with the laws and regulations regarding the procedures for the certification of radiation safety experts and medical physics experts and the duties of experts, and also shall ensure development of a description for the protection against ionising radiation;

16.9. an opinion of a certified radiation safety expert or a medical physics expert that the operating conditions of the room, building, or territory correspond to the conditions of the manufacturer of the source of ionising radiation for the performance of the intended activities, and the planned activities with the source of ionising radiation are reasonable and do not pose direct threats to employees, residents, and the environment (hereinafter - the expert opinion) in accordance with the laws and regulations regarding the procedures for the certification of radiation safety experts and medical physics experts and the duties of experts;

16.10. a storage facility for the source of ionising radiation which corresponds to the laws and regulations regarding the physical protection requirements for sources of ionising radiation;

16.11. development of an environmental monitoring programme which corresponds to the use of a source of ionising radiation in accordance with the laws and regulations regarding the protection against ionising radiation;

16.12. development of a plan for the management of radioactive waste and development of a plan for the dismantling and liquidation of the source of ionising radiation (hereinafter - the dismantling and liquidation plan) in accordance with Annex 3 to this Regulation;

16.13. safety assessment of the activities with radioactive waste in accordance with the laws and regulations regarding requirements for the activities with radioactive waste and materials related thereto.

17. In order to receive a licence for activities with medical and non-medical radiological installations the objective of which is deliberate exposure of humans for non-medical imagining purposes, the applicant shall ensure that the intended activities are assessed and substantiated in the expert opinion, taking into account the following:

17.1. the objective of the exposure, the developed exposure procedures, and the criteria specified for the case where the person will be exposed;

17.2. the benefits obtained as a result of exposure and the potential damage caused by the exposure, and also the benefits obtained and the damage caused in the case where the person is not exposed;

17.3. the suitability of a radiological installation for the exposure in a specific situation;

17.4. the sufficiency of financial, human, and other resources of the applicant in order to perform safe exposure;

17.5. the optimisation of radiation safety when performing exposure with non-medical radiological installations, including the expected dose of the person exposed and the correspondence thereof to the specified dose constraint, and also the education and planned training of staff.

18. In order to obtain a licence for deliberate addition of radioactive substances to the production or manufacturing of goods or import of such goods, the applicant shall ensure that the relevant activities are assessed and substantiated in the expert opinion, taking into account the following:

18.1. the intended use of goods;

18.2. the technical parameters of goods;

18.3. the information on the radioactive substances added and the type of bonding thereof in goods;

18.4. the dose rate at distances within which users will use these goods and the dose rate within a distance of 0.1 m from any surface of goods available to the user;

18.5. the expected dose for daily users of goods.

19. In obtaining the expert opinion referred to in Paragraph 18 of this Regulation, the Centre shall:

19.1. assess it together with other documents for the receipt of the licence and issue the licence, if the activity is substantiated, or take the decision to refuse to issue the licence if the activity is not substantiated upon assessment of the following criteria:

19.1.1. the performance of goods substantiates the intended use thereof;

19.1.2. the design of goods is appropriate to minimise the exposure during normal use of the goods, and also assess the probability and consequences of misuse or accidental exposure and whether any conditions should be applied to technical and physical parameters of the goods;

19.1.3. special safety precautions are not required after the end of service life of goods, and the consumer is provided with information on appropriate management of the goods after the end of service life of the goods;

19.1.4. goods are marked appropriately and the consumer is provided with documentation regarding all necessary instructions for correct use of the goods in accordance with the requirements laid down in the Consumer Rights Protection Law;

19.2. inform contact points of the competent authorities of other European Union Member States of receipt of the assessment of the substantiation of the activity and, upon request, of its decision and the substantiation for it.

20. The operator shall ensure re-assessment of the substantiation for activities with sources of ionising radiation by calling upon an expert if new and significant evidence emerge during use of the source of ionising radiation relating to efficiency of these activities or the potential consequences thereof, or new and important information becomes available on other methods and technologies. The Centre shall, within 30 days after receipt of the expert opinion, assess whether activities with sources of ionising radiation are still substantiated and suspend them if the activities are not substantiated.

21. The applicant shall provide the initial expert opinion prior to the commencement of activities to be registered.

22. The applicant shall provide the initial expert opinion prior to the commencement of activities to be licensed. In order to repeatedly receive a licence for the continuation of activities, a renewed expert opinion shall be required assessing the significant changes in the circumstances which may affect radiation safety, including the history of emergencies and accidents in the operator's work with sources of ionising radiation, the doses received by employees, and changes in the internal management procedures of the operator in respect of the work with sources of ionising radiation.

23. The expert opinion shall not be required for the receipt of a licence for servicing (technical maintenance), installation, repair of sources of ionising radiation not containing a radioactive substance, and also for the provision of dismantling and liquidation services thereof.

24. The applicant shall ensure that the initial dismantling and liquidation plan is developed prior to receipt of the licence or registration certificate for activities with a source of ionising radiation if radioactive waste may result from the activities or a territory, buildings, or other installations related to the use of the source of ionising radiation may become contaminated with radiation. The initial dismantling and liquidation plan shall be reviewed as necessary but at least every five years and supplemented with information obtained from implementing activities with sources of ionising radiation.

25. The operator shall ensure that the final dismantling and liquidation plan is developed prior to receipt of the licence or registration certificate for liquidation of the source of ionising radiation.

26. In order to remove a liquidated source of ionising radiation from the licence or registration certificate or to cancel the licence or registration certificate, the operator shall submit to the Centre a report on dismantling and liquidation of the source in accordance with Annex 3 to this Regulation.

27. The qualification of a work manager who performs activities related to medical exposure shall conform to the following criteria:

27.1. one of the following qualifications in radiodiagnostic practices has been obtained:

27.1.1. a certificate of a doctor-radiologist, a certificate of a doctor-radiotherapist or education of a medical physics expert and a certificate of a medical treatment support person issued by the Union of Professional Organisations of Medical Practitioners of Latvia, and also work experience of at least two years with sources of ionising radiation in radiodiagnostic practices, including the time when education in issues of radiation safety was acquired. If radionuclides are used in radiodiagnostic practices, work experience of at least two years in work with radioactive substances in medicine shall be required;

27.1.2. a certificate of a radiographer and work experience of at least five years with sources of ionising radiation in radiodiagnostic practices or a certificate of an assistant to radiologist and work experience of at least seven years with sources of ionising radiation, including the time when education in issues of radiation safety was acquired. If radionuclides are used in radiodiagnostic practices, work experience of at least three years in work with radioactive substances in medicine shall be required;

27.2. in radiotherapy - a certificate of a doctor-radiologist or education of a medical physics expert and a certificate of a medical treatment support person issued by the Union of Professional Organisations of Medical Practitioners of Latvia, and also work experience of at least three years with sources of ionising radiation in radiotherapy, including the time when education in issues of radiation safety was acquired. If radionuclides are used in radiotherapy, work experience of at least three years in work with radioactive substances in medicine shall be required;

27.3. in dental practice - a certificate in the speciality of a dentist or a certificate of a doctor-radiologist, or education of a medical physics expert or radiographer and work experience of at least one year with sources of ionising radiation in radiodiagnostic practices, including the time when education in issues of radiation safety was acquired. If also cone beam computed tomography is carried out in dental practice, the dentist must have additional education for carrying out of such examinations.

28. The qualification of a work manager who performs activities not related to medical exposure shall conform to the following criteria:

28.1. higher education has been obtained;

28.2. a training course programme in the field of radiation safety or a programme in the field of medical physics has been completed;

28.3. work experience of at least one year with sources of ionising radiation has been acquired, including the time when education in issues of radiation safety was acquired.

29. The qualification of a work manager in veterinary medical practice shall conform to the following criteria:

29.1. higher veterinary medical education has been acquired and a certificate of veterinary practice is valid;

29.2. a training course programme in the field of radiation safety has been completed.

30. If the applicant only uses such source of ionising radiation the servicing of which does not provide for direct presence of employees and the total dose rate of ionising radiation within a distance of one metre is less than 1 µSv/h, the qualification of the work manager shall conform to at least the following minimum criteria:

30.1. general secondary or vocational secondary education has been acquired;

30.2. a training course programme in the field of radiation safety has been completed.

31. The operator shall provide the work manager and the employee with the following:

31.1. training in the issues of radiation safety within the scope of a course programme coordinated with the Centre at least every five years;

31.2. extraordinary training and examination of knowledge if work duties related to the sources of ionising radiation change, and also if new equipment or new procedure is introduced in the work with the sources of ionising radiation.

32. In addition to the training referred to in Paragraph 31 of this Regulation, the operator shall provide the employee with instruction in the issues of radiation safety at least once a year and make a note regarding this in a relevant logbook.

33. An educational institution or the Centre that develops the training course programme in the field of radiation safety referred to in Paragraphs 28, 29, 30, and 31 of this Regulation shall coordinate it with the relevant professional organisation of the sector. The educational institution shall additionally coordinate the course programme with the Centre. The course programme shall include the following:

33.1. for workers:

33.1.1. theoretical training on the requirements of the laws and regulations in radiation safety and nuclear safety and in ensuring health protection of workers;

33.1.2. theoretical and practical training in safe operational procedures, protective equipment, and radiation safety;

33.2. for work managers:

33.2.1. theoretical training on the requirements of the laws and regulations in radiation safety and nuclear safety and in ensuring health protection of workers;

33.2.2. theoretical and practical training in safe operational procedures, protective equipment, and radiation safety;

33.2.3. theoretical and practical training in assessing the dose of ionising radiation, the radiation safety culture, the quality assurance and quality control of radiation safety;

33.3. training multiple-choice test in which a positive evaluation is received if at least 70 % of the questions asked are answered correctly.

V. Notification of Activities with Sources of Ionising Radiation, Issue of the Registration Certificate and Licence

34. The applicant shall submit to the information system of the State Environmental Service an application:

34.1. for the notification of activities with sources of ionising radiation (Chapter I of Annex 4);

34.2. for the receipt of the registration certificate for activities with sources of ionising radiation (Chapter II of Annex 4);

34.3. for the receipt of the licence for activities with sources of ionising radiation (Chapter III of Annex 4).

35. The applicant shall submit an application for the notification of activities with sources of ionising radiation:

35.1. at least six months before commencement of the planned activities referred to in Sub-paragraph 6.1 of this Regulation;

35.2. within 30 days after purchase of a source of ionising radiation not containing a radioactive substance if the applicant stores the source in accordance with Sub-paragraph 6.2 of this Regulation;

35.3. at least 10 working days before commencement of the activities referred to in Sub-paragraph 6.3 of this Regulation.

36. The Centre shall, within 10 working days after receipt of the application referred to in Paragraph 35 of this Regulation, inform the applicant if the Centre has established that it is necessary to receive the registration certificate or licence for the performance of the activities indicated in the application.

37. The applicant shall submit to the Centre an application for the receipt of the registration certificate or licence for activities with sources of ionising radiation within 30 days after purchase of a source of ionising radiation not containing a radioactive substance if the applicant intends to use the source.

38. If the applicant intends to performs activities with several sources of ionising radiation and registration and licensing are required for the activities with such sources of ionising radiation, the applicant shall submit to the Centre an application for the receipt of a licence for all activities with sources of ionising radiation or an application for the receipt of a licence for such activities that require the licence and for the receipt of a registration certificate for such activities that require registration.

39. If the operator has received a licence for activities requiring the licence and registration certificate but intends to perform further only the activities to be registered, the applicant shall keep the licence by submitting to the Centre an application for making amendments to the licence, or submit to the Centre an application for the receipt of the registration certificate.

40. If the operator has received a registration certificate for the performance of activities with sources of ionising radiation but intends to perform further also the activities to be licensed, the applicant shall keep the registration certificate and submit additionally to the Centre an application for the receipt of the licence, or submit to the Centre an application for cancellation of the registration certificate and the receipt of a licence for all activities with sources of ionising radiation.

41. The term of validity of the registration certificate shall not be limited, except for the cases referred to in Paragraph 42 of this Regulation.

42. The Centre shall determine the term of validity of the registration certificate if the applicant:

42.1. requests registration for a specific period of time in the application for the receipt of the registration certificate, specifying the time period;

42.2. plans to import a source of ionising radiation for short-term demonstration, calibration, testing, or other similar purposes, specifying the time period in the application for the receipt of the registration certificate;

42.3. plans to transit a source of ionising radiation containing a radioactive substance, specifying the time period in the application for the receipt the registration certificate;

42.4. plans to export or import a source of ionising radiation containing a radioactive substance, specifying the time period in the application for the receipt of the registration certificate.

43. The term of validity of the licence shall be 10 years, except for the cases referred to in Paragraph 44 of this Regulation.

44. The Centre shall determine the following term of validity of the licence:

44.1. up to three years - for international carriage of sources of ionising radiation containing a radioactive substance, radioactive waste, or spent fuel;

44.2. another time period which is shorter than the time period referred to in Paragraph 43 of this Regulation if the applicant indicates the necessary term of validity of the licence in the application for the receipt of the licence and:

44.2.1. plans to import a source of ionising radiation for demonstration, calibration, testing, or any other similar activities;

44.2.2. plans to transit a source of ionising radiation containing a radioactive substance;

44.2.3. plans to export or import a source of ionising radiation containing a radioactive substance.

45. The applicant:

45.1. who intends to export a high-activity sealed source of radiation shall submit to the Centre the consent of a radiation safety control and supervisory authority of the country of destination that the authority is informed of the planned import of the source;

45.2. who intends to import a high-activity sealed source of radiation shall receive the consent of the Centre. The consent of the Centre may be used for several shipments for up to three years if the shipments are made from the same operator to the same consignee and the same radiation safety control and supervisory authorities are involved therein;

45.3. five days before the shipment, inform the radiation safety control and supervisory authority of the country of destination and the Centre of the planned date of the shipment, the consignor, the consignee, the radionuclide and the total radioactivity (Bq) of the sealed source of radiation and the date of determination thereof, the number of sources to be carried, and the identification numbers, if known.

46. The Centre shall indicate the following in the licence and registration certificate:

46.1. the number, date of issuance, and period of validity of the licence or registration certificate;

46.2. for the operator - a natural person:

46.2.1. the given name, surname;

46.2.2. the personal identity number;

46.3. for the operator - a legal person:

46.3.1. the type of the merchant;

46.3.2. the firm name or name;

46.3.3. the registration number in the Commercial Register;

46.3.4. the legal address;

46.4. for the operator - an institution of direct administration or a derived public person:

46.4.1. the name;

46.4.2. the legal address;

46.5. the activities with sources of ionising radiation;

46.6. the sources of ionising radiation;

46.7. the address, place of performing activities, for example, a department, a block, a room, or a territory in which it is permitted to perform activities with sources of ionising radiation;

46.8. the restrictions which the operator should take into account.

47. If, during examination of the application for the receipt of the registration certificate or licence, the information indicated in Paragraph 46 of this Regulation has changed, the operator shall, within five working days after the change, notify the Centre thereof in writing.

48. The Centre shall issue the licence or registration certificate in the form of an electronic document.

49. In order to repeatedly receive a licence, the operator shall submit an application to the Centre at least three months before the expiry of the term of validity of the licence.

50. In order to make amendments to the licence or changes in the registration certificate, the operator shall submit to the Centre an application in accordance with Annex 4 to this Regulation or an application in free format in accordance with Paragraph 51 of this Regulation:

50.1. within 10 working days after the information referred to in Sub-paragraphs 46.2, 46.3, and 46.4 of this Regulation has changed;

50.2. within 20 working days before changes in the information indicated in Sub-paragraphs 46.5, 46.6, 46.7, and 46.8 of this Regulation.

51. The operator shall submit to the Centre an application in free format if the operator:

51.1. has changed the type of the merchant. The following shall be attached to the application:

51.1.1. a copy of the deed of delivery and acceptance of the source of ionising radiation;

51.1.2. updated information on outsourcing contracts entered into, including on testing and assessment of conformity of the functions of a source of ionising radiation, on electrical safety testing, workplace monitoring, calibration of measuring equipment, inspection of protective equipment, technical maintenance, individual dosimetry of the source of ionising radiation;

51.2. has changed the name or legal address - for a legal person, an institution of direct administration, or a derived public person - or the given name, surname - for a natural person;

51.3. discontinues the use of the source of ionising radiation not containing a radioactive substance and intends to store the source for more than three months. In this case, the operator shall, within 20 working days after commencement of the storage, submit to the Centre an application indicating information on the source of ionising radiation and the address and the room where the source is stored;

51.4. alienates or liquidates the source of ionising radiation not containing a radioactive substance which is used in its activity. In this case, the operator shall, within 20 working days after alienation or liquidation of the source, submit an application to the Centre. The application shall indicate information on the source of ionising radiation, and also a copy of the deed of delivery and acceptance of the source of ionising radiation or a copy of the deed of liquidation shall be appended to the application;

51.5. leases the source of ionising radiation not containing a radioactive substance which is used in its activity. In this case, the operator shall, within 20 working days after lease of the source, submit an application to the Centre. The application shall indicate information on the source of ionising radiation and the person who leases the source of ionising radiation - for a natural person - the given name, surname, personal identity number, for a legal person - the firm name or name and registration number in the Commercial Register, for an institution of direct administration or a derived public person, or an institution thereof - the name.

52. An operator whose licence or registration certificate covers liquidation sources of ionising radiation (hereinafter - the liquidation operator) or an operator who has used the source of ionising radiation not containing a radioactive substance in its activity shall liquidate the source of ionising radiation not containing a radioactive substance.

53. An operator who liquidates the source of ionising radiation not containing a radioactive substance used in its activity or the liquidation operator shall draw up a deed regarding liquidation of the source of ionising radiation. The deed shall contain information on the following:

53.1. the source of ionising radiation;

53.2. the person who has performed liquidation - for a natural person - the given name, surname, personal identity number, for a legal person - the firm name or name and registration number in the Commercial Register, for an institution of direct administration or a derived public person, or an institution thereof - the name;

53.3. the result of the liquidation, for example, irreversible destruction of an x-ray tube of the source of ionising radiation.

54. The liquidation operator shall, within five working days after liquidation of the source of ionising radiation, submit the liquidation deed to the operator.

55. The operator shall, at least five working days before moving the source of ionising radiation containing a radioactive substance to a zone controlled by another operator, inform the Centre thereof in writing.

56. The Centre shall, within five working days after issue of the licence or registration certificate, and also after making amendments to the licence or making changes in the registration certificate, post on the website of the State Environmental Service the information referred to in Paragraph 46 of this Paragraph, except for the information referred to in Sub-paragraph 46.2.2 of this Regulation.

57. The Centre shall issue the licence after the applicant has submitted to the Centre a policy of civil liability insurance of the operator for the performance of activities with radioactive sources the total radioactivity of which exceeds the exceptional limit indicated in Annex 1 to this Regulation by more than 103 times. The minimum sum of the insurance of civil liability of the operator is specified in Annex 5 to this Regulation.

58. If the operator who is a legal person, an institution of direct administration, or a derived public person is reorganised, the Centre may extend the term of validity of the licence or registration certificate for a time period not exceeding three months until the legal person, the institution of direct administration, or the derived public person which is the successor to the rights and obligations of the previous operator in respect of activities with sources of ionising radiation, submits an application and receives a new licence or registration certificate for the relevant activities.

59. If due to safety, technological or economic considerations it is necessary to make such changes in activities with objects of ionising radiation of national significance as a result of which the conditions of the licence must be changed, then until making of amendments to the licence the operator shall:

59.1. prepare an assessment on how the guiding principles of radiation safety and nuclear safety and the laws and regulations in the field of radiation security and nuclear security will be followed;

59.2. at least three months prior to introduction of the planned changes submit an application to the Centre for the making of amendments to the conditions of the licence and append the following to the application:

59.2.1. a complete safety assessment;

59.2.2. an updated plan which has been coordinated with the local government and the State Fire and Rescue Service on the readiness for emergencies and the response in emergency situations which may occur due to changes;

59.2.3. an instruction of radiation safety and nuclear safety and a description of the training programme for employees where security is provided to ensure that the level of exposure is reasonably low by selecting radiation safety and nuclear safety measures which correspond to the planned changes;

59.2.4. a plan and description of such rooms, buildings, or territories in which activities with the source of ionising radiation will be performed if the planned changes affect them;

59.2.5. an updated radiation safety and nuclear safety quality assurance programme;

59.2.6. an assessment of the planned changes in relation to discharge of radioactive substances in the environment, and also an updated description of the scheme of ventilation and sewage systems and of the monitoring system if the planned changes affect them;

59.2.7. a description of the foreseeable changes regarding activities with radioactive waste prior to handing it over for disposal;

59.2.8. an updated description of the physical protection system which has been coordinated with the State Security Service.

60. If a source of ionising radiation is handed over to another operator, all relevant technical documentation shall also be handed over concurrently with the source of ionising radiation.

61. The operator shall retain the following documents:

61.1. the documentation related to the work manager and employees - until the day the employee works with the operator unless the laws and regulations regarding the procedures for performing mandatory health examination and control and registration of the exposure of employees determine another time period for the retention of documents;

61.2. the technical documentation and documents certifying ownership of the source of ionising radiation - for the whole time period of use of the source of ionising radiation;

61.3. until expiry of the term of validity of the licence or registration certificate:

61.3.1. the documents referred to in Chapter II, Sub-paragraphs 5.1.2, 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.7, 5.4.1, 5.4.2, 5.4.3, and 5.4.4 of Annex 4 to this Regulation and the outsourcing contracts entered into for such activities with sources of ionising radiation which are not performed by the operator itself;

61.3.2. the documents referred to in Chapter III, Sub-paragraphs 5.1.2, 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.7, 5.4.1, 5.4.2, 5.4.3, 5.4.4, 5.4.5, 5.4.6, 5.4.7, 5.4.8, and 5.4.9 of Annex 4 to this Regulation and the outsourcing contracts entered into for such activities with sources of ionising radiation which are not performed by the operator itself;

61.4. the results of the last inspection of the individual protective equipment and a valid policy of civil liability insurance of the operator.

VI. Procedures for the Payment of the State Fee and Rates of the State Fee

62. The State fee shall be paid prior to the submission of an application to the Centre, making the payment through a payment service provider which has the right to provide payment services within the meaning of the Law on Payment Services and Electronic Money by using non-cash settlement by transfer or in the payment module in the information system of the State Environmental Service.

63. According to the type of the State fee, the State feel shall be paid in the following amount:

63.1. for the issue of the registration certificate for activities with sources of ionising radiation - EUR 97;

63.2. for the issue of the licence for activities with sources of ionising radiation - EUR 170;

63.3. for making changes in the registration certificate for activities with sources of ionising radiation - EUR 54;

63.4. for making amendments to the licence for activities with sources of ionising radiation - EUR 84;

63.5. for the changes referred to in Paragraph 64 of this Regulation, relief shall be applied to the State fee for making changes in the registration certificate for activities with sources of ionising radiation and for making amendments to the licence for activities with sources of ionising radiation, and the State fee shall be paid in the amount of EUR 10.

64. The State fee in the amount of EUR 10 referred to in Sub-paragraph 63.5 of this Regulation shall be paid if amendments to the licence, including the special permit (licence), are made or changes in the registration certificate are made:

64.1. upon alienating the source of ionising radiation;

64.2. upon terminating the activity with the source of ionising radiation;

64.3. upon changing the name or legal address of the operator;

64.4. upon changing the operator's type of merchant;

64.5. upon changing the type of activity from the use of the source of ionising radiation to the storage thereof;

64.6. upon changing the place of performing activities, for example, a department, a block, a room;

64.7. upon changing the address where the source of ionising radiation is stored;

64.8. upon including an altered source of ionising radiation the x-ray tube or high-voltage generator of which is changed.

65. If the operator has a licence which covers activities to be registered and licensed, and only the activities to be registered remain for the operator after the changes, then the State fee shall be paid in the following amount:

65.1. if the operator chooses to maintain the licence and make amendments to the licence, the operator shall pay the State fee referred to in Sub-paragraph 63.4 of this Regulation for making amendments to the licence for activities with sources of ionising radiation - EUR 84, except for the cases referred to in Paragraph 64 of this Regulation;

65.2. if the operator chooses to register activities, the operator shall pay the State fee referred to in Sub-paragraph 63.3 of this Regulation for making changes in the registration certificate for activities with sources of ionising radiation - EUR 54.

66. If the operator has received the special permit (licence) but the registration certificate or licence is required in accordance with this Regulation, then the Centre shall, upon an application of the operator:

66.1. make amendments to the special permit (licence), and the operator shall pay the State fee referred to in Sub-paragraph 63.3 of this Regulation for making changes in the registration certificate for activities with sources of ionising radiation in the amount of EUR 54 or the State fee referred to in Sub-paragraph 63.4 of this Regulation for making amendments to the licence for activities with sources of ionising radiation in the amount of EUR 84, except for the cases referred to in Paragraph 64 of this Regulation. The operator shall pay the State fee depending on whether the activity with a source of ionising radiation to be included in the special permit (licence) or excluded therefrom is to be registered or licensed;

66.2. cancel the special permit (licence) and issue the licence or registration certificate for activities with sources of ionising radiation, and the operator shall pay the State fee referred to in Sub-paragraph 63.2 of this Regulation for the issue of the licence for activities with sources of ionising radiation in the amount of EUR 170 or the State fee referred to in Sub-paragraph 63.1 of this Regulation for the issue of the registration certificate for activities with sources of ionising radiation in the amount of EUR 97 respectively.

67. If the registration certificate for activities with sources of ionising radiation has been issued to the operator and the operator in addition intends to perform activities which require the licence but the operator chooses to receive the licence for all activities with sources of ionising radiation, the operator shall submit a relevant application to the Centre containing updated information on all activities to be performed and, for the receipt of the licence, pay the State fee referred to in Sub-paragraph 63.2 of this Regulation for the issue of the licence for activities with sources of ionising radiation in the amount of EUR 170.

68. The State fee need not be paid if amendments to the licence, including the special permit (licence), or changes in the registration certificate are made, if:

68.1. the name of the address of performing activities with a source of ionising radiation changes but the source of ionising radiation is not moved;

68.2. the operator leases the source of ionising radiation.

VII. Suspension of the Notified Activities, Suspension and Cancellation of Operation of the Licence and Registration Certificate

69. The Centre shall assess an issue regarding suspension of the notified activities, temporary suspension of operation of the licence and registration certificate, if:

69.1. violations of radiation safety and nuclear safety have been established which may cause a substantial threat or harm to the environment or a human being;

69.2. the operator fails to submit to the Centre the information indicated in the laws and regulations in the field of radiation security and nuclear security within the specified time period;

69.3. activities with sources of ionising radiation are not substantiated;

69.4. the operator has repeatedly violated the radiation safety and nuclear safety requirements laid down in the laws and regulations in the field of radiation safety and nuclear safety over a year.

70. The Centre shall assess the seriousness of the violation and suspend the operation of the issued licence or registration certificate for a period of up to six months.

71. If the Centre suspends the operation of the licence or registration certificate in respect of activities with one or more sources of ionising radiation, then according to the conditions of the licence or registration certificate the operator may perform activities with another source of ionising radiation the operation of which has not been suspended.

72. The Centre shall take the decision to cancel the licence or registration certificate, if it establishes that the operator:

72.1. has discontinued the activity with sources of ionising radiation;

72.2. has changed the type of the merchant, and an application has been received in accordance with Sub-paragraph 51.1 of this Regulation. The Centre shall take the decision to cancel the existing licence or registration certificate and issue a new licence or registration certificate;

72.3. has failed to fulfil the obligations specified in this Regulation and other laws and regulations in the field of radiation safety and nuclear safety, causing a substantial threat or harm to the environment or a human being, or has failed to eliminate the established violations within the time period specified in the decision to suspend the operation of the licence or registration certificate;

72.4. has provided false or misleading information in order to receive the licence or registration certificate;

72.5. performs activities with a source of ionising radiation if the operation of the licence or registration certificate has been suspended in accordance with Paragraph 70 of this Regulation;

72.6. has been excluded from the registers kept by the Enterprise Register of the Republic of Latvia.

73. Information on the notified activities with sources of ionising radiation shall be excluded from the database, if the Centre establishes that the performer of the notified activities:

73.1. has discontinued activities with sources of ionising radiation;

73.2. has been excluded from the registers kept by the Enterprise Register of the Republic of Latvia.

VIII. Procedures for Issuing a Licence for the Creation of Ionising Radiation Objects of National Significance or Making Essential Changes Therein, and Procedures for Public Discussion of the Creation of Ionising Radiation Objects of National Significance or Making Substantial Changes Therein

74. The Centre shall issue a licence for the creation of an ionising radiation object of national significance or making essential changes therein in accordance with the following procedures:

74.1. the licence for the commencement of the creation of an ionising radiation object of national significance or making essential changes therein is issued after the applicant has received a construction permit. If an environmental impact assessment is required for the creation of an ionising radiation object of national significance or making essential changes therein, it shall be carried out prior to submitting the application for the receipt of the licence;

74.2. prior to the commencement of the operation of the object, a licence for inspections of operational parameters is issued, where necessary. In order to receive such licence, the applicant shall additionally append the following to the application:

74.2.1. inspection reports on technical safety of such installations which directly or indirectly affect radiation safety and nuclear safety in the relevant ionising radiation object of national significance;

74.2.2. the plan and schedule of inspections of operational parameters;

74.3. a licence is issued for the commencement of operation of a new ionising radiation object of national significance or for resuming the operation in an essentially changed object.

75. If construction of an object of national significance takes place in accordance with the laws and regulations regarding construction regulations of such structures which are related to radiation safety, then the licence referred to in Sub-paragraph 74.1 of this Regulation shall not be required.

76. The Centre shall, within five working days after receipt of the application and all the documents appended thereto, publish the following information on the website of the State Environmental Service:

76.1. the name of the applicant;

76.2. the name of the activity and the address of the performance thereof;

76.3. the time and place where it is possible to become acquainted with the information contained in the application for the receipt of the licence and the additional materials submitted, except for the data of a natural person included in the application and accompanying documents.

77. Within five working days after submitting the application and all the documents appended thereto to the Centre, the applicant shall:

77.1. publish a notification in the regional newspaper regarding the intended activity according to the region which encompasses the relevant local government where the existing or planned ionising radiation object of national significance is located;

77.2. send a notification to the relevant local government which posts this information on the website of the local government within two working days;

77.3. send a notification regarding the intended activity to the persons who own or possess the immovable properties that border the location of the planned or existing ionising radiation object of national significance or are located in its immediate area of influence.

78. The applicant shall indicate the following in the notice of the intended activity:

78.1. the name of the applicant;

78.2. the name of the activity and the address of the existing or intended place of performing thereof;

78.3. the place where activities with sources of ionising radiation are or will be performed, and also the territories subject to the potential exposure;

78.4. the time and place where the public may become acquainted with the application for the receipt of the licence and accompanying documents, except for the data of a natural person included in the application for the receipt of the licence and accompanying documents;

78.5. the date by which the public may submit written proposals to the Centre.

79. The public may submit their proposals or an opinion on the issuance of the licence or the conditions thereof to the Centre in writing within 14 days after the day of publication of the notice referred to in Paragraph 78 of this Regulation.

80. If the Centre becomes aware of information which was not available initially - at the time of commencing public information - but which may affect the decision to issue the licence, the Centre shall make this information available to the public within two working days by publishing it on the website of the Centre and extending the time period for the public participation by seven days.

81. The Centre shall, within seven days after the end of the time period for public participation, inform the applicant of the proposals and opinions received. The applicant shall, within 10 days, assess the proposals received and submit an explanation to the Centre.

82. The Centre shall assess the proposals made during public discussion and submitted in writing relating to the conditions for the issue of the licence and use them for the preparation of the conditions of the licence. If the public has made a proposal not to issue the licence, the Centre shall only take the decision to issue the licence or reasoned refusal to issue the licence after the applicant has been given a possibility to provide its explanation in accordance with Paragraph 81 of this Regulation.

83. Prior to issuing the licence in the case referred to in Sub-paragraphs 74.2 and 74.3 of this Regulation, the Centre shall verify conformity of substantial technical and operational parameters related to radiation safety and nuclear safety with the project.

84. After taking the decision to issue the licence or to refuse to issue the licence the Centre shall, within five working days, inform the local government electronically thereof in the territory of which it is intended to create an ionising radiation object of national significance or make essential changes therein. The local government shall, within two working days, post this information on the website of the local government.

IX. Report on Activities with Sources of Ionising Radiation

85. The content of a report on activities with sources of ionising radiation has been specified in Annex 6 to this Regulation.

86. The operator shall complete the report in accordance with Paragraph 85 of this Regulation in respect of the changes in the activity of the operator which have occurred in the previous calendar year in accordance with the law On Radiation Safety and Nuclear Safety and shall submit the report to the information system of the State Environmental Service.

X. Closing Provisions

87. The following shall be repealed:

87.1. Cabinet Regulation No. 5 of 3 January 2002, Regulations Regarding the Procedures for Liquidation of Ionising Radiation Equipment not Containing a Radioactive Substance (Latvijas Vēstnesis, 2002, No. 3);

87.2. Cabinet Regulation No. 752 of 22 December 2015, Procedures for Licensing and Registering Activities with Sources of Ionising Radiation (Latvijas Vēstnesis, 2015, No. 254).

88. If the registration certificate or special permit (licence) has been received for storage of a source of ionising radiation not containing a radioactive substance and the source of ionising radiation has not been used, the operator shall not be required to submit a notification in accordance with Sub-paragraph 35.2 of this Regulation but the operator shall, prior to commencement of the use of the source, submit to the Centre an application for making the relevant changes in the registration certificate or making amendments to the special permit (licence).

89. If the registration certificate or special permit (licence) has been received for the performance of the activities referred to in Sub-paragraph 6.3 of this Regulation which require notification of activities in accordance with this Regulation, the operator shall not be required to submit a notification in accordance with Sub-paragraph 35.3 of this Regulation.

90. Special permits (licences) for activities with sources of ionising radiation shall be valid until expiry of the term of validity indicated therein. If the special permit (licence) has been received but the registration certificate or licence is required in accordance with this Regulation, the applicant shall, within 20 days, submit to the Centre an application for making amendments to the special permit (licence) or an application for the cancellation of the special permit (licence) and for the receipt of the registration certificate or licence. In submitting the application for the receipt of the registration certificate, a renewed expert opinion shall not be required if it has been received during the term of validity of the special permit (licence).

91. If the operator to whom the licence or special permit (licence) has been issued for activities with a source of ionising radiation - a medical radiological installation - is engaged in deliberate exposure of humans for non-medical imagining purposes prior to the day this Regulation comes into force, the operator shall, not later than by 30 June 2021, submit to the Centre an application for making the relevant amendments to the licence or special permit (licence).

92. The operators who do not have the dismantling and liquidation plan referred to in Paragraph 24 of this Regulation in place by 31 January 2021 shall develop the initial dismantling and liquidation plan and submit it to the Centre until 31 December 2021.

93. The special permits (licences) for the use or storage of smoke detectors containing plutonium shall be valid until expiry of the term of validity indicated therein. A new licence for the use or storage of smoke detectors containing plutonium shall not be issued, and management of the smoke detectors containing plutonium shall be ensured in accordance with the laws and regulations regarding the requirements for activities with radioactive waste and materials related thereto.

94. The Regulation shall come into force on 1 February 2021.

Informative Reference to the European Union Directives

The Regulation contains legal norms arising from:

1) Council Directive 2006/117/Euratom of 20 November 2006 on the supervision and control of shipments of radioactive waste and spent fuel;

2) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations;

3) Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste;

4) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom.

Prime Minister A. K. Kariņš

Minister for Environmental Protection
and Regional Development A. T. Plešs

 

Annex 1
Cabinet Regulation No. 65
28 January 2021

Exceptional Limits of Radioactivity without Exceeding of Which It is Not Required to Notify Activities with Sources of Ionising Radiation

No. Radionuclide1 Total radioactivity, Bq Specific radioactivity, Bq/g
1. 3H 1 x 109 1 x 106
2. 7Be 1 x 107 1 x 103
3. 14C 1 x 107 1 x 104
4. 15O 1 x 109 1 x 102
5. 18F 1 x 106 1 x 101
6. 22Na 1 x 106 1 x 101
7. 24Na 1 x 105 1 x 101
8. 31Si 1 x 106 1 x 103
9. 32P 1 x 105 1 x 103
10. 33P 1 x 108 1 x 105
11. 35S 1 x 108 1 x 105
12. 36Cl 1 x 106 1 x 104
13. 38Cl 1 x 105 1 x 101
14. 37Ar 1 x 108 1 x 106
15. 41Ar 1 x 109 1 x 102
16. 40K 1 x 106 1 x 102
17. 42K 1 x 106 1 x 102
18. 43K 1 x 106 1 x 101
19. 45Ca 1 x 107 1 x 104
20. 47Ca 1 x 106 1 x 101
21. 46Sc 1 x 106 1 x 101
22. 47Sc 1 x 106 1 x 102
23. 48Sc 1 x 105 1 x 101
24. 48V 1 x 105 1 x 101
25. 51Cr 1 x 107 1 x 103
26. 51Mn 1 x 105 1 x 101
27. 52Mn 1 x 105 1 x 101
28. 52mMn 1 x 105 1 x 101
29. 53Mn 1 x 109 1 x 104
30. 54Mn 1 x 106 1 x 101
31. 56Mn 1 x 105 1 x 101
32. 52Fe 1 x 106 1 x 101
33. 55Fe 1 x 106 1 x 104
34. 59Fe 1 x 106 1 x 101
35. 55Co 1 x 106 1 x 101
36. 56Co 1 x 105 1 x 101
37. 57Co 1 x 106 1 x 102
38. 58Co 1 x 106 1 x 101
39. 58mCo 1 x 107 1 x 104
40. 60Co 1 x 105 1 x 101
41. 60mCo 1 x 106 1 x 103
42. 61Co 1 x 106 1 x 102
43. 62mCo 1 x 105 1 x 101
44. 59Ni 1 x 108 1 x 104
45. 63Ni 1 x 108 1 x 105
46. 65Ni 1 x 106 1 x 101
47. 64Cu 1 x 106 1 x 102
48. 65Zn 1 x 106 1 x 101
49. 69Zn 1 x 106 1 x 104
50. 69mZn 1 x 106 1 x 102
51. 72Ga 1 x 105 1 x 101
52. 71Ge 1 x 108 1 x 104
53. 73As 1 x 107 1 x 103
54. 74As 1 x 106 1 x 101
55. 76As 1 x 105 1 x 102
56. 77As 1 x 106 1 x 103
57. 75Se 1 x 106 1 x 102
58. 82Br 1 x 106 1 x 101
59. 74Kr 1 x 109 1 x 102
60. 76Kr 1 x 109 1 x 102
61. 77Kr 1 x 109 1 x 102
62. 79Kr 1 x 105 1 x 103
63. 81Kr 1 x 107 1 x 104
64. 83mKr 1 x 1012 1 x 105
65. 85Kr 1 x 104 1 x 105
66. 85mKr 1 x 1010 1 x 103
67. 87Kr 1 x 109 1 x 102
68. 88Kr 1 x 109 1 x 102
69. 86Rb 1 x 105 1 x 102
70. 85Sr 1 x 106 1 x 102
71. 85mSr 1 x 107 1 x 102
72. 87mSr 1 x 106 1 x 102
73. 89Sr 1 x 106 1 x 103
74. 90Sr+ 1 x 104 1 x 102
75. 91Sr 1 x 105 1 x 101
76. 92Sr 1 x 106 1 x 101
77. 90Y 1 x 105 1 x 103
78. 91Y 1 x 106 1 x 103
79. 91mY 1 x 106 1 x 102
80. 92Y 1 x 105 1 x 102
81. 93Y 1 x 105 1 x 102
82. 93Zr+ 1 x 107 1 x 103
83. 95Zr 1 x 106 1 x 101
84. 97Zr+ 1 x 105 1 x 101
85. 93mNb 1 x 107 1 x 104
86. 94Nb 1 x 106 1 x 101
87. 95Nb 1 x 106 1 x 101
88. 97Nb 1 x 106 1 x 101
89. 98Nb 1 x 105 1 x 101
90. 90Mo 1 x 106 1 x 101
91. 93Mo 1 x 108 1 x 103
92. 99Mo 1 x 106 1 x 102
93. 101Mo 1 x 106 1 x 101
94. 96Tc 1 x 106 1 x 101
95. 96mTc 1 x 107 1 x 103
96. 97Tc 1 x 108 1 x 103
97. 97mTc 1 x 107 1 x 103
98. 99Tc 1 x 107 1 x 104
99. 99mTc 1 x 107 1 x 102
100. 97Ru 1 x 107 1 x 102
101. 103Ru 1 x 106 1 x 102
102. 105Ru 1 x 106 1 x 101
103. 106Ru+ 1 x 105 1 x 102
104. 103mRh 1 x 108 1 x 104
105. 105Rh 1 x 107 1 x 102
106. 103Pd 1 x 108 1 x 103
107. 109Pd 1 x 106 1 x 103
108. 105Ag 1 x 106 1 x 102
109. 108mAg+ 1 x 106 1 x 101
110. 110mAg 1 x 106 1 x 101
111. 111Ag 1 x 106 1 x 103
112. 109Cd 1 x 106 1 x 104
113. 115Cd 1 x 106 1 x 102
114. 115mCd 1 x 106 1 x 103
115. 111In 1 x 106 1 x 102
116. 113mIn 1 x 106 1 x 102
117. 114mIn 1 x 106 1 x 102
118. 115mIn 1 x 106 1 x 102
119. 113Sn 1 x 107 1 x 103
120. 125Sn 1 x 105 1 x 102
121. 122Sb 1 x 104 1 x 102
122. 124Sb 1 x 106 1 x 101
123. 125Sb 1 x 106 1 x 102
124. 123mTe 1 x 107 1 x 102
125. 125mTe 1 x 107 1 x 103
126. 127Te 1 x 106 1 x 103
127. 127mTe 1 x 107 1 x 103
128. 129Te 1 x 106 1 x 102
129. 129mTe 1 x 106 1 x 103
130. 131Te 1 x 105 1 x 102
131. 131mTe 1 x 106 1 x 101
132. 132Te 1 x 107 1 x 102
133. 133Te 1 x 105 1 x 101
134. 133mTe 1 x 105 1 x 101
135. 134Te 1 x 106 1 x 101
136. 123I 1 x 107 1 x 102
137. 125I 1 x 106 1 x 103
138. 126I 1 x 106 1 x 102
139. 129I 1 x 105 1 x 102
140. 130I 1 x 106 1 x 101
141. 131I 1 x 106 1 x 102
142. 132I 1 x 105 1 x 101
143. 133I 1 x 106 1 x 101
144. 134I 1 x 105 1 x 101
145. 135I 1 x 106 1 x 101
146. 131mXe 1 x 104 1 x 104
147. 133Xe 1 x 104 1 x 103
148. 135Xe 1 x 1010 1 x 103
149. 129Cs 1 x 105 1 x 102
150. 131Cs 1 x 106 1 x 103
151. 132Cs 1 x 105 1 x 101
152. 134mCs 1 x 105 1 x 103
153. 134Cs 1 x 104 1 x 101
154. 135Cs 1 x 107 1 x 104
155. 136Cs 1 x 105 1 x 101
156. 137Cs+ 1 x 104 1 x 101
157. 138Cs 1 x 104 1 x 101
158. 131Ba 1 x 106 1 x 102
159. 140Ba+ 1 x 105 1 x 101
160. 140La 1 x 105 1 x 101
161. 139Ce 1 x 106 1 x 102
162. 141Ce 1 x 107 1 x 102
163. 143Ce 1 x 106 1 x 102
164. 144Ce+ 1 x 105 1 x 102
165. 142Pr 1 x 105 1 x 102
166. 143Pr 1 x 106 1 x 104
167. 147Nd 1 x 106 1 x 102
168. 149Nd 1 x 106 1 x 102
169. 147Pm 1 x 107 1 x 104
170. 149Pm 1 x 106 1 x 103
171. 151Sm 1 x 108 1 x 104
172. 153Sm 1 x 106 1 x 102
173. 152Eu 1 x 106 1 x 101
174. 152mEu 1 x 106 1 x 102
175. 154Eu 1 x 106 1 x 101
176. 155Eu 1 x 107 1 x 102
177. 153Gd 1 x 107 1 x 102
178. 159Gd 1 x 106 1 x 103
179. 160Tb 1 x 106 1 x 101
180. 165Dy 1 x 106 1 x 103
181. 166Dy 1 x 106 1 x 103
182. 166Ho 1 x 105 1 x 103
183. 169Er 1 x 107 1 x 104
184. 171Er 1 x 106 1 x 102
185. 170Tm 1 x 106 1 x 103
186. 171Tm 1 x 108 1 x 104
187. 175Yb 1 x 107 1 x 103
188. 177Lu 1 x 107 1 x 103
189. 181Hf 1 x 106 1 x 101
190. 182Ta 1 x 104 1 x 101
191. 181W 1 x 107 1 x 103
192. 185W 1 x 107 1 x 104
193. 187W 1 x 106 1 x 102
194. 186Re 1 x 106 1 x 103
195. 188Re 1 x 105 1 x 102
196. 185Os 1 x 106 1 x 101
197. 191Os 1 x 107 1 x 102
198. 191mOs 1 x 107 1 x 103
199. 193Os 1 x 106 1 x 102
200. 190Ir 1 x 106 1 x 101
201. 192Ir 1 x 104 1 x 101
202. 194Ir 1 x 105 1 x 102
203. 191Pt 1 x 106 1 x 102
204. 193mPt 1 x 107 1 x 103
205. 197Pt 1 x 106 1 x 103
206. 197mPt 1 x 106 1 x 102
207. 198Au 1 x 106 1 x 102
208. 199Au 1 x 106 1 x 102
209. 197Hg 1 x 107 1 x 102
210. 197mHg 1 x 106 1 x 102
211. 203Hg 1 x 105 1 x 102
212. 200Tl 1 x 106 1 x 101
213. 201Tl 1 x 106 1 x 102
214. 202Tl 1 x 106 1 x 102
215. 204Tl 1 x 104 1 x 104
216. 203Pb 1 x 106 1 x 102
217. 210Pb+ 1 x 104 1 x 101
218. 212Pb+ 1 x 105 1 x 101
219. 206Bi 1 x 105 1 x 101
220. 207Bi 1 x 106 1 x 101
221. 210Bi 1 x 106 1 x 103
222. 212Bi+ 1 x 105 1 x 101
223. 203Po 1 x 106 1 x 101
224. 205Po 1 x 106 1 x 101
225. 207Po 1 x 106 1 x 101
226. 210Po 1 x 104 1 x 101
227. 211At 1 x 107 1 x 103
228. 220Rn+ 1 x 107 1 x 104
229. 222Rn+ 1 x 108 1 x 101
230. 223Ra+ 1 x 105 1 x 102
231. 224Ra+ 1 x 105 1 x 101
232. 225Ra 1 x 105 1 x 102
233. 226Ra+ 1 x 104 1 x 101
234. 227Ra 1 x 106 1 x 102
235. 228Ra+ 1 x 105 1 x 101
236. 228Ac 1 x 106 1 x 101
237. 226Th+ 1 x 107 1 x 103
238. 227Th 1 x 104 1 x 101
239. 228Th+ 1 x 104 1 x 100
240. 229Th+ 1 x 103 1 x 100
241. 230Th 1 x 104 1 x 100
242. 231Th 1 x 107 1 x 103
243. nat. th (232Th) 1 x 103 1 x 100
244. 234Th+ 1 x 105 1 x 103
245. 230Pa 1 x 106 1 x 101
246. 231Pa 1 x 103 1 x 100
247. 233Pa 1 x 107 1 x 102
248. 230U+ 1 x 105 1 x 101
249. 231U 1 x 107 1 x 102
250. 232U+ 1 x 103 1 x 100
251. 233U 1 x 104 1 x 101
252. 234U 1 x 104 1 x 101
253. 235U+ 1 x 104 1 x 101
254. 236U 1 x 104 1 x 101
255. 237U 1 x 106 1 x 102
256. 238U+ 1 x 104 1 x 101
257. nat.U 1 x 103 1 x 100
258. 239U 1 x 106 1 x 102
259. 240U 1 x 107 1 x 103
260. 240U+ 1 x 106 1 x 101
261. 237Np+ 1 x 103 1 x 100
262. 239Np 1 x 107 1 x 102
263. 240Np 1 x 106 1 x 101
264. 234Pu 1 x 107 1 x 102
265. 235Pu 1 x 107 1 x 102
266. 236Pu 1 x 104 1 x 101
267. 237Pu 1 x 107 1 x 103
268. 238Pu 1 x 104 1 x 100
269. 239Pu 1 x 104 1 x 100
270. 240Pu 1 x 103 1 x 100
271. 241Pu 1 x 105 1 x 102
272. 242Pu 1 x 104 1 x 100
273. 243Pu 1 x 107 1 x 103
274. 244Pu 1 x 104 1 x 100
275. 241Am 1 x 104 1 x 100
276. 242Am 1 x 106 1 x 103
277. 242mAm+ 1 x 104 1 x 100
278. 243Am+ 1 x 103 1 x 100
279. 242Cm 1 x 105 1 x 102
280. 243Cm 1 x 104 1 x 100
281. 244Cm 1 x 104 1 x 101
282. 245Cm 1 x 103 1 x 100
283. 246Cm 1 x 103 1 x 100
284. 247Cm 1 x 104 1 x 100
285. 248Cm 1 x 103 1 x 100
286. 249Bk 1 x 106 1 x 103
287. 246Cf 1 x 106 1 x 103
288. 248Cf 1 x 104 1 x 101
289. 249Cf 1 x 103 1 x 100
290. 250Cf 1 x 104 1 x 101
291. 251Cf 1 x 103 1 x 100
292. 252Cf 1 x 104 1 x 101
293. 253Cf 1 x 105 1 x 102
294. 254Cf 1 x 103 1 x 100
295. 253Es 1 x 105 1 x 102
296. 254Es 1 x 104 1 x 101
297. 254mEs 1 x 106 1 x 102
298. 254Fm 1 x 107 1 x 104
299. 255Fm 1 x 106 1 x 103

Note. 1 The symbol "+" or "nat." designates a parent nuclide in balance with the relevant daughter nuclides which are indicated in Annex 2 to Cabinet Regulation No. 65 of 28 January 2021, Regulations Regarding Notification, Registration, and Licensing of Activities with Sources of Ionising Radiation.

Minister for Environmental Protection
and Regional Development A. T. Plešs

 

Annex 2
Cabinet Regulation No. 65
28 January 2021

List of Radionuclides in Continuous Balance

No. Parent nuclide Radionuclides in continuous balance - daughter nuclides
1. 90Sr+ 90Y
2. 93Zr+ 93mNb
3. 97Zr+ 97Nb
4. 106Ru+ 106Rh
5. 108mAg+ 108Ag
6. 137Cs+ 137mBa
7. 134Ce+ 134La
8. 144Ce+ 144Pr
9. 140Ba+ 140La
10. 212Bi+ 208Tl (0,36), 212Po (0,64)
11. 210Pb+ 210Bi, 210Po
12. 212Pb+ 212Bi, 208Tl (0,36), 212Po (0,64)
13. 220Rn+ 216Po
14. 222Rn+ 218Po, 214Pb, 214Bi, 214Po
15. 223Ra+ 219Rn, 215Po, 211Pb, 211Bi, 207Tl
16. 224Ra+ 220Rn, 216Po, 212Pb, 212Bi, 208Tl (0,36), 212Po (0,64)
17. 226Ra+ 222Rn, 218Po, 214Pb, 214Bi, 214Po, 210Pb, 210Bi, 210Po
18. 228Ra+ 228Ac
19. 226Th+ 222Ra, 218Rn, 214Po
20. 228Th+ 224Ra, 220Rn, 216Po, 212Pb, 212Bi,208Tl (0,36), 212Po (0,64)
21. 229Th+ 225Ra, 225Ac, 221Fr, 217At, 213Bi, 213Po, 209Pb
22. nat.Th 228Ra, 228Ac, 228Th, 224Ra, 220Rn, 216Po, 212Pb, 212Bi, 208Tl (0,36), 212Po (0,64)
23. 234Th+ 234mPa
24. 230U+ 226Th, 222Ra, 218Rn, 214Po
25. 232U+ 228Th, 224Ra, 220Rn, 216Po, 212Pb, 212Bi,208Tl (0,36), 212Po (0,64)
26. 235U+ 231Th
27. 238U+ 234Th, 234mPa
28. nat.U 234Th, 234mPa, 234U, 230Th, 226Ra, 222Rn, 218Po, 214Pb, 214Bi, 214Po, 210Pb, 210Bi, 210Po
29. 240U+ 240Np
30. 237Np+ 233Pa
31. 242mAm+ 242Am
32. 243Am+ 239Np

Minister for Environmental Protection
and Regional Development A. T. Plešs

 

Annex 3
Cabinet Regulation No. 65
28 January 2021

Content of the Dismantling and Liquidation Plan and Report

1. The dismantling and liquidation plan shall include information on the following:

1.1. the operator who possesses or owns the source of ionising radiation to be liquidated, and the liquidation operator;

1.2. the source of ionising radiation to be liquidated and the territory, buildings, rooms, related equipment and radioactive contamination thereof which has been assessed when carrying out an inspection of the object where the source of ionising radiation is located;

1.3. the liquidation strategy indicating whether immediate or delayed liquidation is chosen. If the delayed liquidation is chosen, a substantiation for such decision shall be provided and included in the planned timetable of the liquidation process;

1.4. the management and distribution of responsibility of the liquidation process, including in respect of the radiation safety culture, training of employees, contractual relationship, and the planned timetable of liquidation works;

1.5. the need for dismantling, decontamination, and other liquidation works, the performer of such works, and the performance procedures;

1.6. the supervision and maintenance of the object until commencement of dismantling and liquidation where the source of ionising radiation is located;

1.7. the management of radioactive waste;

1.8. the cost assessment of all planned dismantling and liquidation works, and the provision of financial resources;

1.9. the safety assessment of dismantling and liquidation works - expert opinion;

1.10. the environmental impact assessment;

1.11. the measures for the protection of employees, including workplace and individual monitoring, the assessment of expected doses of employees, the labour safety requirements;

1.12. the quality assurance for the organisation of dismantling and liquidation works, document storage, maintenance of records;

1.13. the preparedness for a radiological emergency and the response in the event of such emergency;

1.14. the physical protection of the source of ionising radiation;

1.15. the final examination of the radiological situation, including the conditions to be met for release from the State supervision. It shall include information on, for example, the procedures for taking measurements, taking and processing samples, the methodology for the assessment of results of examination, the procedure for the storage of data.

2. The initial dismantling and liquidation plan referred to in Paragraph 24 of the Cabinet Regulation No. 65 of 28 January 2021, Regulations Regarding Notification, Registration, and Licensing of Activities with Sources of Ionising Radiation, shall include information which is available prior to commencement of activities with sources of ionising radiation while taking into account that all the necessary information is not available prior to commencement of activities with sources of ionising radiation.

3. The final dismantling and liquidation plan referred to in Paragraph 25 of the Regulation shall include all the necessary information in detail.

4. The report on dismantling and liquidation shall include information on the following:

4.1. the fulfilment of the conditions for the release of such object from State supervision where the source of ionising radiation was located;

4.2. the territory, buildings, rooms, related equipment which were not fully liquidated and require further supervision;

4.3. the final radiological condition of the object where the source of ionising radiation was located;

4.4. the dismantling and liquidation works carried out;

4.5. the quantity of radioactive waste produced;

4.6. the doses received by employees;

4.7. all unforeseen situations which could have led to negative consequences, and also on radiological emergencies during dismantling and liquidation works, for example, in relation to the elimination of radioactive contamination and the activities performed to deal with the abovementioned cases;

4.8. the conclusions made during dismantling and liquidation in respect of the selected dismantling and liquidation strategy, solutions, introduced measures for the protection against ionising radiation.

Minister for Environmental Protection
and Regional Development A. T. Plešs

 

Annex 4
Cabinet Regulation No. 65
28 January 2021

Application for the Notification of Activities with Sources of Ionising Radiation, for the Receipt of the Registration Certificate and Licence

I. Application for the Notification of Activities with Sources of Ionising Radiation

1. Information on the applicant submitting the notification regarding activities with sources of ionising radiation:

1.1. for a natural person - the given name, surname, personal identity number, for a legal person - the firm name or name, registration number in the Commercial Register, legal address;

1.2. the telephone number and e-mail address.

2. Information on activities with sources of ionising radiation and the address of performing activities.

3. Information on the source of ionising radiation - the name of the group, model, parameters - and the grounds for the acquisition of ownership rights or rights of use.

4. For notification of the activities referred to in Sub-paragraph 6.1 of this Regulation the following shall be submitted additionally:

4.1. a description of the planned activities and procedures;

4.2. a description of the planned territory, buildings and rooms, taking into account the requirements for radiation safety, physical protection and preparedness for radiological emergencies which are to be met when commencing activities.

II. Application for the Receipt of the Registration Certificate for Activities with Sources of Ionising Radiation

1. Information on the applicant submitting an application for the receipt of the registration certificate for activities with sources of ionising radiation or the necessary changes in the information on the operator:

1.1. for a natural person - the given name, surname, personal identity number, for a legal person - the firm name or name, registration number in the Commercial Register, legal address;

1.2. the telephone number and e-mail address.

2. Information on activities with sources of ionising radiation or the necessary changes in the activities with sources of ionising radiation.

3. Information on the address of performing activities or the necessary changes related to the address of performing activities.

4. Information on the source of ionising radiation or the necessary changes related to the source of ionising radiation:

4.1. the name of the group of the source of ionising radiation not containing a radioactive substance, model, identification numbers, manufacturer, year of manufacturing, parameters, place (room) of performing activities;

4.2. the name of the group of the source of ionising radiation containing a radioactive substance, model, identification number, radionuclide, total radioactivity or specific radioactivity, manufacturer, date of manufacturing, period of validity specified by the manufacturer, container model and number, place (room) of performing activities.

5. The following documents or copies thereof shall be submitted:

5.1. regarding the source of ionising radiation:

5.1.1. technical documentation;

5.1.2. reports on inspections carried out (workplace monitoring, electrical safety testing, inspection of technical parameters, inspection of the accuracy of a patient dose meter);

5.1.3. information on outsourcing contracts entered into, including for the testing and assessment of compliance of the functions of a source of ionising radiation, electrical safety testing, calibration, workplace monitoring, calibration of measuring equipment, inspection of protective equipment, technical maintenance, individual dosimetry of the source of ionising radiation;

5.1.4. information on the grounds for the acquisition of ownership rights or rights of use by indicating the name, issuing body, and date of issue or signing of the document confirming the ownership rights;

5.2. regarding the place of performing activities:

5.2.1. a report on workplace monitoring;

5.2.2. a plan of the room (assembly plan) coordinated with a certified radiation safety expert or a medical physics expert which includes a description of the thickness, material of barriers, additional protection, control room, committed dose or dose rate in a workplace, and the planned workload of the source of ionising radiation. A plan and description of the room, building, or territory need not be submitted, if activities with the source of ionising radiation are to be performed outside buildings and the territory of the undertaking. In other cases the relevant plan shall be submitted in the following scale:

5.2.2.1. a plan of the room (plan of assembly) in the scale M 1:50 or a lesser scale, indicating the location of the source of ionising radiation in the room (windows, doors), and also the purpose of use of such rooms which are located below the room, above the room, and next to the room where the source of ionising radiation is located;

5.2.2.2. plan of the building or its part in the scale M 1:100 or a lesser scale, indicating the location of the source of ionising radiation or indicating premises in which sources of ionising radiation are located with an assembly plan in the scale M 1:50;

5.2.2.3. plan of the territory in the scale M 1:1000 or a lesser scale, indicating the location of the source of ionising radiation;

5.2.3. an opinion of a certified radiation safety expert or a medical physics expert that the operating conditions of the rooms, buildings or territory provided for activities with sources of ionising radiation conform to the conditions of the manufacturer and the planned activities with the source of ionising radiation are substantiated and do not cause direct threats to employees, residents, and the environment;

5.2.4. a radiation safety quality assurance programme;

5.2.5. radiation safety instructions. A description of storage conditions shall also be included for source of ionising radiation containing a radioactive substance;

5.2.6. a report on the inspection of personal protective equipment or confirmation of purchase thereof if the purchase has occurred over the last two years;

5.2.7. a list of measuring instruments, a report on calibration of measuring instruments or confirmation of purchase thereof if the purchase has occurred over the last two years;

5.3. regarding the work manager and employees:

5.3.1. an order for the appointment of the work manager, and information on the work manager: the given name, surname, personal identity number, education, work experience with sources of ionising radiation, training courses in radiation safety. If the work manager performs activities with a source of ionising radiation, information on the mandatory health examination and the classification in category A or B in accordance with the laws and regulations regarding protection against ionising radiation shall also be indicated. The justification for the classification of the worker in category A or B must be available at the operator;

5.3.2. information on each employee who performs activities with a source of ionising radiation or who is in the field of exposure to ionising radiation: the given name, surname, personal identity number, education, training courses in radiation safety, mandatory health examination, classification of the worker in category A or B. Medical physics expert shall also be indicated in the list of employees of a medical treatment institution;

5.4. regarding the radioactive source and waste management:

5.4.1. a description of the intended activities with radioactive waste prior to handing it over to the operator of a radioactive waste management object;

5.4.2. a contract for handing over radioactive waste to the operator of a radioactive waste management object if after the planned activities with sources of ionising radiation or during thereof radioactive waste will be produced, or a confirmation from the manufacturer or supplier that it will be possible to return the sealed sources of radiation to the relevant country after use thereof;

5.4.3. a certification of the payment of the natural resources tax for bringing in of radioactive substances;

5.4.4. a description of physical protection measures;

5.4.5. information about the vehicle and its conformity with the laws and regulations regarding transportation of a source of ionising radiation containing a radioactive substance;

5.5. any additional information, where necessary.

III. Application for the Receipt of the Licence for Activities with Sources of Ionising Radiation

1. Information on the applicant submitting an application for the receipt of the licence for activities with sources of ionising radiation or necessary changes in the information on the operator:

1.1. for a natural person - the given name, surname, personal identity number, for a legal person - the firm name or name, registration number in the Commercial Register, legal address;

1.2. the telephone number and e-mail address.

2. Information on activities with sources of ionising radiation or the necessary changes in the activities with sources of ionising radiation, including:

2.1. change of the special permit (licence) for the licence or registration. If the special permit (licence) is valid but the registration certificate or licence is required in accordance with the Cabinet Regulation No. 65 of 28 January 2021, Regulations Regarding Notification, Registration, and Licensing of Activities with Sources of Ionising Radiation, the operator shall indicate whether it wishes to keep the special permit (licence) and make amendments thereto or obtain the licence or registration certificate;

2.2. change of the licence for the registration certificate. If the operator has a licence which includes activities to be licensed and registered, and after changes the operator is only left with the activities to be registered, the operator shall indicate whether it wishes to keep the licence and make amendments thereto or obtain the registration certificate.

3. Information on the address of performing activities or the necessary changes related to the address of performing activities.

4. Information on the source of ionising radiation or the necessary changes related to the source of ionising radiation:

4.1. the name of the group of the source of ionising radiation not containing a radioactive substance, model, identification numbers, manufacturer, year of manufacturing, parameters, place (room) of performing activities;

4.2. the name of the group of the source of ionising radiation containing a radioactive substance, model, identification numbers, radionuclide, total radioactivity or specific radioactivity, manufacturer, date of manufacturing, period of validity specified by the manufacturer, container model and number, place (room) of performing activities.

5. The following documents or copies thereof shall be submitted:

5.1. regarding the source of ionising radiation:

5.1.1. technical documentation;

5.1.2. reports on inspections carried out - workplace monitoring, electrical safety testing, inspection of technical parameters, inspection of the accuracy of a patient dose meter;

5.1.3. information on outsourcing contracts entered into, including for the testing and assessment of compliance of the functions of a source of ionising radiation, electrical safety testing, calibration, workplace monitoring, calibration of measuring equipment, inspection of protective equipment, technical maintenance, individual dosimetry of the source of ionising radiation;

5.1.4. information on the grounds for the acquisition of ownership rights or rights of use by indicating the name, issuing body, and date of issue or signing of the document confirming the ownership rights;

5.1.5. a policy of civil liability insurance of the operator;

5.2. regarding the place of performing activities:

5.2.1. a report on workplace monitoring;

5.2.2. a plan of the room (assembly plan) coordinated with a certified radiation safety expert or a medical physics expert which includes a description of the thickness, material of barriers, additional protection, existence of a control room, committed dose or dose rate in a workplace, and the planned workload of the source of ionising radiation. A plan and description of the room, building, or territory need not be submitted, if activities with the source of ionising radiation are to be performed outside buildings and the territory of the undertaking. In other cases the relevant plan shall be submitted in the following scale:

5.2.2.1. a plan of the room (plan of assembly) in the scale M 1:50 or a lesser scale, indicating the location of the source of ionising radiation in the room (windows, doors), and also the purpose of use of such rooms which are located below the room, above the room, and next to the room where the source of ionising radiation is located;

5.2.2.2. plan of the building or its part in the scale M 1:100 or a lesser scale, indicating the location of the source of ionising radiation or indicating premises in which sources of ionising radiation are located with an assembly plan in the scale M 1:50;

5.2.2.3. plan of the territory in the scale M 1:1000 or a lesser scale, indicating the location of the source of ionising radiation;

5.2.3. an opinion of a certified radiation safety expert or a medical physics expert that the operating conditions of the rooms, buildings or territory provided for activities with sources of ionising radiation conform to the conditions of the manufacturer and the planned activities with the source of ionising radiation are substantiated and do not cause direct threats to employees, residents, and the environment;

5.2.4. a radiation safety quality assurance programme;

5.2.5. radiation safety instructions. A description of storage conditions shall also be included for source of ionising radiation containing a radioactive substance;

5.2.6. a report on the inspection of personal protective equipment or confirmation of purchase thereof if the purchase has occurred over the last two years;

5.2.7. a list of measuring instruments, a report on calibration of measuring instruments or confirmation of purchase thereof if the purchase has occurred over the last two years;

5.3. regarding the work manager and employees:

5.3.1. an order for the appointment of the work manager, and information on the work manager: the given name, surname, personal identity number, education, work experience with sources of ionising radiation, training courses in radiation safety. If the work manager performs activities with a source of ionising radiation, information on the mandatory health examination and the classification in category A or B in accordance with the laws and regulations regarding protection against ionising radiation shall also be indicated. The justification for the classification of the worker in category A or B must be available at the operator;

5.3.2. information on each employee who performs activities with a source of ionising radiation or who is in the field of exposure to ionising radiation: the given name, surname, personal identity number, education, training courses in radiation safety, mandatory health examination, classification of the worker in category A or B. Medical physics expert shall also be indicated in the list of employees of a medical treatment institution;

5.4. regarding the radioactive source and waste management:

5.4.1. a description of the intended activities with radioactive waste prior to handing it over to the operator of a radioactive waste management object;

5.4.2. a contract for handing over radioactive waste to the operator of a radioactive waste management object if after the planned activities with sources of ionising radiation or during thereof radioactive waste will be produced, or a confirmation from the manufacturer or supplier that it will be possible to return the sealed sources of radiation to the relevant country after use thereof;

5.4.3. a certification of the payment of the natural resources tax for bringing in of radioactive substances;

5.4.4. a description of physical protection measures. It shall also indicate the date when the physical protection plan has been coordinated with the State Security Service if the laws and regulations regarding physical protection of sources of ionising radiation determine such requirement;

5.4.5. a plan for preparedness to radiological emergencies and actions in the event of radiological emergency coordinated with a local government and the State Fire and Rescue Service if the laws and regulations regarding requirements for the preparedness for a radiological emergency and response in the event of such emergency determine such requirement;

5.4.6. an assessment of the planned discharges into the environment and the relevant monitoring programmes, and also schemes of ventilation and sewage systems;

5.4.7. a long-term safety assessment of the storage facility of radioactive waste and safety assessment of such activities of radioactive waste management which are performed prior to disposal of radioactive waste;

5.4.8. a building design of a structure related to radiation safety and other documents the need for which is determined by the laws and regulations governing operation of objects of radioactive waste management or nuclear installations;

5.4.9. a dismantling and liquidation plan of the object containing a radioactive substance and the final report on dismantling and liquidation of the source;

5.4.10. information on the vehicle and its conformity with the laws and regulations regarding transportation of a source of ionising radiation containing a radioactive substance;

5.5. any additional information, where necessary.

Minister for Environmental Protection
and Regional Development A. T. Plešs

 

Annex 5
Cabinet Regulation No. 65
28 January 2021

Minimum Sum of Civil Liability Insurance

No. Activities with a source of ionising radiation Minimum sum of civil liability insurance per year (EUR)
1. Activities with a nuclear installation:
1.1. if thermal output does not exceed 30 MWth 5 691 490
1.2. if thermal output exceeds 30 MWth, but is less than 150 MWth, or electrical output exceeds 10 MWe, but is less than 50 MWe 113 829 750
1.3. if thermal output exceeds 150 MWth or electrical output exceeds 50 MWe 327 260 520
2. Activities with other ionising radiation objects of national significance, including nuclear installations which are not being operated and which do not hold nuclear fuel 1 138 300
3. Activities with radioactive substances the total radioactivity of which from 106 times (excluding) to 109 (including) exceeds the exceptional limits referred to in Annex 1 to Cabinet Regulation No. 65 of 28 January 2021, Regulations Regarding Notification, Registration, and Licensing of Activities with Sources of Ionising Radiation, - high-power sources of ionising radiation 569 150
4. Activities with radioactive substances the total radioactivity of which from 103 times (excluding) to 106 (including) exceeds the exceptional limits referred to in Annex 1 to Cabinet Regulation No. 65 of 28 January 2021, Regulations Regarding Notification, Registration, and Licensing of Activities with Sources of Ionising Radiation, - medium-power sources of ionising radiation 113 830

Minister for Environmental Protection
and Regional Development A. T. Plešs

 

Annex 6
Cabinet Regulation No. 65
28 January 2021

Report on Activities with Sources of Ionising Radiation

I. Report on Activities with Sources of Ionising Radiation not Containing a Radioactive Substance

1. Information on the operator:

1.1. for a natural person - the given name, surname, personal identity number, for a legal person - the firm name or name, registration number in the Commercial Register, legal address;

1.2. the telephone number and e-mail address.

2. Information on the address of performing activities (units) and contact information of the work manager of each unit - the given name, surname, telephone number, e-mail address.

3. Information on sources of ionising radiation not containing a radioactive substance:

3.1. the name, model, identification numbers, status or changes in the status of the group, for example, use, storage, place (room) of performing activities;

3.2. information on workplace monitoring - the performer thereof, date of performance, report number;

3.3. information on electrical safety testing and inspection of technical parameters of medical and dental X-ray equipment - the performer thereof, date of performance, report number.

4. Information on the work manager and employees:

4.1. the given name, surname, personal identity number, position, education of the work manager - level, field, speciality, the issuer, number, period of validity of the professional certificate, work experience with sources of ionising radiation, the organiser, name, and date of training courses in radiation safety, certificate number. If the work manager performs activities with a source of ionising radiation, information on the date of the mandatory health examination and the classification in category A or B in accordance with the laws and regulations regarding protection against ionising radiation shall also be indicated;

4.2. the given name, surname, personal identity number, position of the employee who performs activities with sources of ionising radiation or who is in the field of exposure to ionising radiation, the organiser, name, and date of training courses in radiation safety, certificate number, the date of the mandatory health examination and the classification in category A or B in accordance with the laws and regulations regarding protection against ionising radiation.

5. Information on measuring equipment (measuring instruments) of ionising radiation at the disposal of the operator - the type, model, number, calibration thereof.

II. Report on Activities with Sources of Ionising Radiation Containing a Radioactive Substance

1. Information on the operator:

1.1. for a natural person - the given name, surname, personal identity number, for a legal person - the firm name or name, registration number in the Commercial Register, legal address;

1.2. the telephone number and e-mail address.

2. Information on the address of performing activities (units) and contact information of the work manager of each unit - the given name, surname, telephone number, e-mail address.

3. Information on sources of ionising radiation containing a radioactive substance:

3.1. on sealed sources:

3.1.1. the sealed sources purchased, brought into, or imported over a year - the model, identification number, radionuclide, total radioactivity of the source, container model and number;

3.1.2. the sealed sources in use or storage - the model, identification number, radionuclide, total radioactivity of the source, container model and number; the status, for example, use, storage, place (room) of performing activities, the performer, date of leakproofness test, report number, the performer, date of workplace monitoring, report number;

3.1.3. the sealed sources handed over to the operator of a radioactive waste management object - the model, identification number, radionuclide, total radioactivity of the source, the date and number of the deed of delivery;

3.1.4. the sealed sources sold or handed over to another operator - the model, identification number, radionuclide, total radioactivity of the source, the date and number of the deed of delivery, the name, address, licence number of the recipient of the source;

3.2. on unsealed sources:

3.2.1. the unsealed sources purchased, brought into, or imported over a year - the radionuclide, date of manufacturing, total radioactivity, the firm name or name and registration number of the manufacturer, seller or supplier;

3.2.2. the unsealed sources in use or storage - the radionuclide, date of manufacturing, total radioactivity; the status, for example, use, storage, place (room) of performing activities, the performer, date of workplace monitoring, report number;

3.2.3. the unsealed sources manufactured over a year - the radionuclide, total radioactivity;

3.2.4. the unsealed sources handed over to the operator of a radioactive waste management object - the radionuclide, total radioactivity, the date and number of the deed of delivery;

3.2.5. the unsealed sources released into the environment - the radionuclide, total radioactivity, environment where it is discharged, the date and number of the deed of discharge.

A copy of the discharge act and an evaluation or calculation of discharged radioactivity shall be appended to the report.

The performer, the conditions, assumptions, and programmes used for calculation shall be indicated in relation to discharge of radioactive substances.

The following information shall be provided about the discharge process:

1) household waste or repeated use;

2) place of discharge, an indication as to whether dilution was used.

Discharge of radioactive substances shall be linked to the inventory quantity of radioactive substances in the listing of the operator;

3.2.6. the unsealed sources sold or handed over to another operator - the radionuclide, total radioactivity, the date and number of the deed of delivery, the name, address, licence number of the recipient of the source.

4. Information on the work manager and employees:

4.1. the given name, surname, personal identity number, position, education of the work manager - level, field, speciality, the issuer, number, period of validity of the professional certificate, work experience with sources of ionising radiation, the organiser, name, and date of training courses in radiation safety, certificate number. If the work manager performs activities with a source of ionising radiation, information on the date of the mandatory health examination and the classification in category A or B in accordance with the laws and regulations regarding protection against ionising radiation shall also be indicated;

4.2. the given name, surname, personal identity number, position of the employee who performs activities with sources of ionising radiation or who is in the field of exposure to ionising radiation, the organiser, name, and date of training courses in radiation safety, certificate number, the date of the mandatory health examination and the classification in category A or B in accordance with the laws and regulations regarding protection against ionising radiation.

5. Information on measuring equipment (measuring instruments) of ionising radiation at the disposal of the operator - the type, model, number, calibration thereof.

6. Information on the policy of civil liability insurance of the operator - the issuing body, number, period of validity, insurance limit thereof.

7. Information on physical protection.

III. Report on Trade in, Servicing, Liquidation of Sources of Ionising Radiation Containing and not Containing a Radioactive Substance

1. Information on the operator:

1.1. for a natural person - the given name, surname, personal identity number, for a legal person - the firm name or name, registration number in the Commercial Register, legal address;

1.2. the telephone number and e-mail address.

2. Information on the address of performing activities (units) and contact information of the work manager of each unit - the given name, surname, telephone number, e-mail address.

3. Information on the performed activities with sources of ionising radiation:

3.1. information on the brought into, imported, brought out, and exported unsealed sources - the name, address, licence number of the recipient of the source, the radionuclide, manufacturer and date of manufacturing, total radioactivity;

3.2. information on the brought into, imported, brought out, and exported sealed sources - the name, address, licence number of the recipient of the source, the radionuclide, manufacturer and date of manufacturing, the model, identification number, total radioactivity of the source;

3.3. information on the installed sources of ionising radiation not containing a radioactive substance - the model, identification numbers, the name, address, licence number of the owner of equipment, and the place (room) of performing activities;

3.4. information on the dismantled sources of ionising radiation not containing a radioactive substance - the model, identification numbers, the name, address, licence number of the owner of equipment, and the place (room) of performing activities;

3.5. information on the liquidated sources of ionising radiation not containing a radioactive substance - the model, identification numbers, the name, address, licence number of the owner of equipment, and the place (room) of performing activities;

3.6. information on the sources of ionising radiation not containing a radioactive substance which are owned, possessed or held by the operator - the model, identification numbers;

3.7. information on the transported sources of ionising radiation containing a radioactive substance - the name, address, licence number of the recipient of the source, the radionuclide, total radioactivity, the type of a package used for transportation. Information shall be provided as an annex in the form of a table.

4. Information on the work manager and employees:

4.1. the given name, surname, personal identity number, position, education of the work manager - level, field, speciality, the issuer, number, period of validity of the professional certificate, work experience with sources of ionising radiation, the organiser, name, and date of training courses in radiation safety, certificate number. If the work manager performs activities with a source of ionising radiation, information on the date of the mandatory health examination and the classification in category A or B in accordance with the laws and regulations regarding protection against ionising radiation shall also be indicated;

4.2. the given name, surname, personal identity number, position of the employee who performs activities with sources of ionising radiation or who is in the field of exposure to ionising radiation, the organiser, name, and date of training courses in radiation safety, certificate number, the date of the mandatory health examination and the classification in category A or B in accordance with the laws and regulations regarding protection against ionising radiation.

5. Information on measuring equipment (measuring instruments) of ionising radiation at the disposal of the operator - the type, model, number, calibration thereof.

6. Information on the policy of civil liability insurance of the operator - the issuing body, number, period of validity, insurance limit thereof.

Minister for Environmental Protection
and Regional Development A. T. Plešs


Translation © 2021 Valsts valodas centrs (State Language Centre)

 
Document information
Title: Darbību ar jonizējošā starojuma avotiem paziņošanas, reģistrēšanas un licencēšanas noteikumi Status:
In force
in force
Issuer: Cabinet of Ministers Type: regulation Document number: 65Adoption: 28.01.2021.Entry into force: 01.02.2021.Publication: Latvijas Vēstnesis, 21, 01.02.2021. OP number: 2021/21.10
Language:
LVEN
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