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Radiation Practice Licence

A radiation practice licence is a document which gives a person the right to engage in radiation practices. According to the Radiation Act radiation practices are all activities which increase or may increase the exposure of humans to radiation emanating from an artificial source or from a natural radiation source in cases where natural radionuclides are processed in view of their radioactive, fissile or fertile properties. Such activities include, among others:

  1. the production, processing, use, possession, storage, carriage, import to and export from the state, and interim or final disposal of radioactive substances;
  2. the operation of any electrical equipment emitting ionising radiation and containing components operating at a potential difference of more than 5 kV.

It is prohibited to commence radiation practices or to perform radiation work for which, pursuant to this Act, a radiation practice licence is required, without a radiation practice licence.

Applying the radiation practice licence

To receive a radiation practice licence the applicant delivers to the Environmental Board"s Radiation Safety Department (Kopli 76, 10416 Tallinn, Estonia the keyword “RADIATION PRACTICE LICENCE” written on the envelope) a written application.

Application for Radiation Practice Licence

Relevant data ( i.e. what is important, necessary and possible to bring forward about concrete radiation activity) and documents from the list of Radiation Acts § 18 section 1 are added to the application. Specific requirements about the above-mentioned data and documents are found from the Regulation No. 41 of the Minister of the Environment 29 April 2004 “The Time Limits for Proceedings to Issue, Amend or Revoke Radiation Practice Licences, the Specific Requirements for and Format of Applications for Radiation Practice Licences, and the Format of Radiation Practice Licences” (paragraphs 9-20.1):

  1. Justification, specification and description of the radiation activity (regulation § 9).
  2. Location of the radiation activity and the layout of the building (§ 10).
  3. Specification about the used technology and facility (§ 11).
  4. Radiation source characteristics (§ 12) - Information on the electrical equipment emitting ionising radiation (Annex 2); 4.2 Information on the radiation source and its containing device (Annex 3); 4.3 Information on the unsealed source (Annex 4).
  5. Radioactive waste that are generated in the process of radiation activity and their indications (§ 13).
  6. Neutralizing program of the radiation source (§ 14).
  7. If the license is applied for the managing of radioactive waste, information concerning the methods to be used upon the permanent termination of the information of the management facility (§ 15)
  8. A plan for radiation monitoring and information on the equipment to be used for radiation monitoring (§ 16).
  9. Radiation safety assessment (§ 17) .
  10. Measures assuring the radiation safety (§ 18).
  11. An emergency response plan in case of radiation practices involving high risk (§ 19).
  12. Information on exposed workers (§ 20, Annex 5).
  13. Radiation work code (§ 20.1)
  14. Description of the radiation safety quality system (Radiation Act § 32)  

Amending the radiation practice licence

According to the Radiation Act § 24 the holder of a radiation practice licence shall give prior notice to the Environmental Board's Radiation Safety Department if the holder of the licence intends to:

  1. Implement new or additional radiation sources.
  2. Terminate the use of the radiation source specified in the radiation practice licence.
  3. Deliver the radiation source to another person or dispose of the source as radioactive waste.
  4. Change the radiation practice, or the manner of management, maximum quantities or management facility of produced radioactive waste determined by the radiation practice licence.
  5. Change the location, facilities or premises where the radiation practice is carried out.
  6. Employ a new radiation safety specialist.
  7. Change the radiation practice described in the licence in any other significant manner.

For amending the radiation practice licence the holder of a radiation practice licence shall submit a written application to the Environmental Board's Radiation Safety Department, which includes following information:

  1. The business name, or name and address of the applicant.
  2. The number of the amended radiation practice licence.
  3. The name of the planned amendment in radiation practice.
  4. The date on which the application is submitted and signature of the applicant.

Justification for amending the radiation practice licence, information, description and other relevant data and documents concerning amendments in radiation practice (e.g. information on the source in case of implementation of the new source) must be added to the application. We also require that a copy of the document affirming the payment of the state fee is added to the application in case of amendments in radiation practice legislated in the § 24 clauses 1, 4, 5 or 7 in the Radiation Act .

In the cases when the radiation practice licence holder shall notify the issuer of the licence concerning the amendments specified in the Radiation Act § 24 clauses 4, 5 and 7 which involve a significant change in terms of radiation protection, the Environmental Board's Radiation Safety Department may according to the Radiation Act § 25 section 2 require the holder of the licence to submit an application for a new radiation practice licence.

Application for amending the radiation practice licence with all the necessary documents and data must be sent to the Environmental Board's Radiation Safety Department (Kopli 76, 10416 Tallinn, Estonia the keyword “AMENDING THE RADIATION PRACTICE LICENCE” written on the envelope).  

Import and export of radioactive substances

Import and export of radioactive substances to non-European Union countries

If the radiation practice licence is applied for import of radioactive substance from non-European Union countries or for export from Estonia to non-Europen Union country the applicant delivers to the  Environmental Board's Radiation Safety Department (Kopli 76, 10416 Tallinn, Estonia, the keyword “RADIATION PRACTICE LICENCE” written on the envelope) a written application.

Data and documents fom the Radiation Acts § 18 section 2 are added to the application. Specific requirements about the data and documents are found from the Regulation No. 41 of the Minister of the Environment 29 April 2004 “The Time Limits for Proceedings to Issue, Amend or Revoke Radiation Practice Licences, the Specific Requirements for and Format of Applications for Radiation Practice Licences, and the Format of Radiation Practice Licences” (paragraphs 9-20.1):

1. The justification for and description of the radiation practice.

2. Information on the radiation source.

2.1 Information on the radiation source and its containing device.

2.2 Information on unsealed source.

3. Copy of a contract binded with a company which is importing or exporting radioactive substance, including final user, final using field and specification of the radiation source.

Please add a copy of the document affirming the payment of a state fee to the application of the radiation practice licence.

Transport of radioactive substances between European Union countries

Transport of radioactive substances between European Union countries is regulated with the Council Regulation (EURATOM) No 1493/93 of 8 June 1993 on shipments of radioactive substances between Member States. This Regulation shall apply to shipments of sealed sources between Member States and other relevant sources, whenever the quantities and concentrations exceed the levels laid down in Article 4 (a) and (b) of Directive 80/836/Euratom (changed with a directive 84/467/EURATOM). Prior declaration is needed for transportation of sealed sources. Prior declaration is not necessary for transportation of other radiation sources. A holder of the sealed sources or radioactive waste who intends to carry out a shipment of such sources or waste, or to arrange for such a shipment to be carried out, shall obtain a prior written declaration by the consignee of the radioactive substances. In the declaration consignee has complied to follow all the applicable provisions implemented and relevant national requirements for use of that class of sources in the Member State of destination. The declaration shall be sent by the consignee to the competent authority of the Member State of the recipient.

For import of radioactive substances to the Republic of Estonia a recipient or its authorized representative shall present a written declaration to the Ministry of the Environment.

Declaration for shipment of sealed sources (in English).

The Environmental Board shall verify a declaration.

A state fee for applying and amending the radiation practice licence

According to the State Fees Act § 98 (1) section 1 state fee of 2000 krons shall be paid for the proceeding of a radiation practice licence application.

Amending the raditation practice licence according to the amendments of the radiation practice legislated in the Radiation Act § 24 clausels 1, 4, 5 and 7 a state fee of 1000 krons shall be paid according to the State Fees Act § 98(1) section 2. In case of amendments legislated in § 24 clausels 2, 3 and 6 a state fee is not paid for amending the radiation practice licence. Thus:

1. A state fee of 1000 krons shall be paid for proceeding of amending the radiation practice licence if the holder of the radiation practice licence:

  • implement new or additional radiation sources (Radiation Act § 24 clausel 1);
  • change the radiation practice, or the manner of management, maximum quantities or management facility of produced radioactive waste determined by the radiation practice licence (RA § 24 c 4);
  • change the location, facilities or premises where the radiation practice is carried out (RA § 24 c 5);
  • change the radiation practice described in the licence in any other significant manner (RA § 24 c 7).

2. A state fee is not paid for amending the radiation practice licence in cases of:

  • terminate the use of the radiation source specified in the radiation practice licence (RA § 24 c 2) ;
  • deliver the radiation source to another person or dispose of the source as radioactive waste (RA § 24 c 3);
  • employ a new radiation safety specialist (RA § 24 c 6);
  • the legislation which constituted the basis for the requirements set by the radiation practice licence has been amended (RA § 25 section 1 c 2);
  • the risk category of the radiation practice determined by the licence has changed as a result of measures applied in the course of the radiation practice (RA § 25 section 1 c 3);
  • the information specified in clause 18 (1) 1) of the Radiation Act has changed (RA § 25 section 1 c 4).

A state fee of 1000 krons is paid if the holder of the radiation practice licence shall notify the issuer about the planned amendments specified in § 24 clauses 4, 5 and 7 of the Radiation Act and which involve a significant change in terms of radiation protection and the issuer of a licence obliges the holder of a licence according to § 25 section 2 of the Radiation Act to submit an application for a new radiation practice licence.

A state fee is paid:

Recipient of a payment: Ministry of Finance of the Republic of Estonia
Bank: Sewdbank
Account: 221023778606
Reference number: 2900081693

or

Bank: SEB
Account: 10220034796011
Reference number: 2900081693

Obligations of Holder of Radiation Practice Licence

The holder of a radiation practice licence has the obligation to:

  1. Be responsible for radiation safety and guarantee the physical protection of the radiation sources in the holder’s possession and take an annual inventory of the radiation sources to make sure that the radiation source or its containing device is in its using or maintaining place and is externally in good condition.

It is advisable to limit the number of rooms and buildings in the location of the radiation sources to provide better control over the location and number of the radiation sources. The rooms and buildings where the radiation sources are located must be protected against trespassers and burgalize, option for that would be locking the front and inside doors, windows, gates and fences; provide lighting inside and outside of the building; burglar alarm. There must be access control arranged to the rooms, which involves workers, visitors and business partners systematic faultproof identifying and halting procedure of the trespassers/unidentified persons. Inspection of the radiation source done at least once in a year must confirm that the radiation source is externally in good condition and the location assigned in the radiation practice licence has not changed.

  1. Prepare the rules necessary for performing radiation practices and instructing exposed workers; provide training and radiation safety instruction for exposed workers commensurate with the nature of their work and workplace conditions.

Holder of a radiation practice licence enforces the rules necessary for performing radiation practice in Estonian. In case of necessity, additionally in a language, which is spoken by the majority of the exposed workers. Preparing the rules must consider the nature of the exposed work. Following the rules must ensure sufficient radiation safety and protection of the workers and other persons in the normal working conditions and in potential dangerous situations of the radiation source. Instruction rules for the exposed workers must contain information on the instructor, frequency and preserving the instruction data. Requirements for the exposed work rules and instruction is legislated with the regulations of the Minister of the Environment No. 41 of 29 April 2004 and No. 86 of 8 July 2004.

  1. Keep account of all radiation sources in the holders responsibility, their location and handover, take an annual inventory of the radiation sources and submit the results of the inventory to the Environmental Board"s Radiation Safety Department by 1 March of the following year. If it is not noted in other ways in the conditions of the radiation practice licence, account documents must include information on radiation source that is insisted on a basis of the Radiation Act when applying the radiation practice licence.

Keeping account of radiation sources must contain information on radiation sources and additional data on receiving or handover of the radiation source. In a process of keeping account, the location of the radiation sources given in the radiation practice licence and existent of the access control, are checked. The holder of a radiation practice licence submit the results of the annual inventory once in a year to the Environmental Board"s Radiation Safety Department by 1 March of the following year according to the form.

  1. Organize the medical examination of exposed workers.

According to the Regulation of the Minister of the Social Affairs No. 74 of 24 April 2003 “Occupational Health Inspection Requirements” § 5 the health control of the exposed worker shall start with primary health inspection during the first month since commencement of employment and during a period given by the occupational health doctor onward but not fewer than once in three years and in case of the under-aged employee not fewer than once in two years.

According to the Article 31 of the Councils Directive 96/29/Euratom of 13 May 1996, which legislates main safety procedures for the protection of the workers and rest of the populations health against the the ionizing radiation, regular health inspection of the category A exposed worker must be done at least once in a year. At the same time suggestions of an aknowledged doctor must be considered when assigning frequency of these inspections. The type of health inspections depends above all on the type of work and concrete employee"s health condition. The holder of a radiation practice licence may specify the regulation of the health inspection in the institution.

  1. Make sure that the recipient has a proper radiation practice licence before handing over the radiation source.

Radiation source may be handed over to any institution which holds valid radiation practice licence for using and maintaining of given radiation source or can storage radioactive waste.

  1. Render a radiation source harmless after its use is terminated pursuant to the plan for rendering the radiation source harmless submitted in the application for the licence.

The plan for rendering the radiation source harmless includes an overview of the actions which shall be carried out after the termination of the use of radiation source. Information on the termination procedures of the use of radiation source shall be presented in the plan, in other words actions like dismantling, maintaining, transporting, handing over shall be mentioned. To provide radiation safety and safety of the radiation source the given rooms must be used for maintaining. Maintaining is time limited legislatively, therefore handing over the radiation source to the recipient holding the radiation practice, for example to the manager of radioactive waste, to the manufacturer of the apparatus containing radioactive substances or radioactive substances or to any other adequate licence holder like managers of the electric- and electronical devices or to the manufacturer according to the contract, must be anticipated.

A schedule is added to the plan which determines a period within, starting from termination of the use of radiation source shall be handed over to a person or manufacturer who holds a radiation practice licence or any other adequate licence. An act is composed for proving the given procedure about handing over the radiation source, copy of an act is presented to the Environmental Board's Radiation Safety Department.

When handing over a radiation source, which is radioactive substance or apparatus containing radioactive substances, to the manager of radioactive waste the transference-receiving act (further act) is composed in three copies. One of the copies stays to the transferee, the other one goes to the manager of radioactive waste together with transferred waste and the third is sent to the Environmental Board"s Radiation Safety Department by the transferee, which enrolls data from the act to the registers of radiation sources and radioactive waste. The manager of radioactive waste in Estonia is a national joint-stock company A.L.A.R.A which is under the administrative territory of the Ministry of Economic Affairs and Communications.

Unusable electronical equipment shall be handed over to the manager of the electrical- and electronic waste, which in Estonia is AS Kuusakoski. Electrical- and electronic equipment and their waste collecting is legislated in the Regulation No 376 of the Government of the Republic of Estonia of 24 December 2004 “Requirements and Procedure for Marking Electrical and Electronic Equipment, Requirements, Procedure and Targets for Collection, Return to Producers and Recovery or Disposal of Waste Electrical and Electronic Equipment, and Time Limits for Reaching Targets".

  1. Alleviate the consequences of emergencies.

The main reason, which can create radiation hazardous situation is ignoring the safety rules when working with the radiation source. The holder of a radiation practice licence has the obligation to implement measurements to alleviate the consequences and assure the safety of the workers. Means of alleviation of the consequences are closing in the hazardous zone to reduce a chance of the surfaces contamination with radioactive substances and possible radiation from the radiation source; evacuation of the workers and visitors to a safe distance; restoring the normal work of the institution or stabilizing of the situation. To prevent the consequences the following must be considered when planning the radiation activity: appropriate location of the radiation source in the premises; material and thickness of the rooms walls, ceiling, floor and widows; location of the work places; rules for working with the radiation source; analysis of the possible incidents and emergencies; means of personal protection and their availability in case of any accident or emergency.

  1. Ensure the regular control and calibration of measuring instruments used and be responsible for their fitness for use and appropriate use.

According to an international practice the measuring instruments used in the field of radiation protection are calibrated at least once in two years. Calibration of the measuring instruments guarantees that the results of the measurements done in different places, measuring the same dimension, can be compared and tracing of the measurements results is provided. Measuring instruments used in radiation protection are not calibrated in Estonia. Nearest possibilities for that are in Latvia and in Finland.

  1. Guarantee that all building design documentation concerning facilities is reviewed, and that new radiation sources to be used are approved beforehand by a qualified expert.

Basis of the classification of the radiation practice into the risk categories is the effective dose received by an exposed worker in a year. High risk radiation practices is an activity through which an exposed worker receives or is liable to receive an effective dose exceeding mSv in a year. Regardless of an effective dose received by a an exposed worker using a high activity sealed source, the operation, closure and decommissioning of any facility involved in the nuclear fuel cycle and managing of radioactive waste are classified as high risk radiation practices. Regulation No. 113 of the Minister of the Environment of 7 September 2004: “Requirements for the Rooms Where the Radiation Sources Are Situated and for Labeling Thereof and for the Working Rules for the Performance of Radiation Practices” legislates the activity levels for some radionuclides which classifies equal or bigger values into the high activity radiation sources class.

The issuer of a radiation practice licence has a right to evaluate the risk category referred by the applicant and assign a different category in necessity during the proceeding of the radiation practice licence application.

Appropriateness of an existing facility must be assessed for the planned radiation practice in case of implementation of new or additional radiation source. Radiation safety assessment must be checked also and amended in necessity.

  1. Provide certification, at the request of competent authorities, of the legality of the possession of radioactive substances or radiation apparatuses containing radioactive substances.

The legality of the possession is provided by the delivery note which allows to identify the apparatus and with the documents proving its formality.

  1. Prepare an emergency plan if the person engages in high risk radiation practices and test the plan pursuant to the requirements and with the frequency established by legislation.

We suggest the institutions involving high risk radiation practice to base on the requirements assigned in the Regulation No. 41 of the Minister of the Environment of 29 April 2004: “The Time Limits for Proceedings to Issue, Amend or Revoke Radiation Practice Licences, the Specific Requirements for and Format of Applications for Radiation Practice Licences, and the Format of Radiation Practice Licences” when composing the emergency plan, and Regulation No. 55 of the Minister of Internal Affairs of 12 May 2003 “Requirements for dangerous and catastrophe risk enterprises factsheet, risk report and emergency resolving plans and keeping the list of the catastrophe risk enterprises” to use additionally for composing and presenting.

Obligations of Holder of Radiation Practice Licence - Inventory of the radiation sources 

The holder of a radiation practice licence must keep account of all radiation sources in the holders responsibility, their location and handover, take an annual inventory of the radiation sources and submit the results of the inventory to theEnvironmental Board's Radiation Safety Department by 1 March of the following year.

If it is not noted in other ways in the conditions of the radiation practice licence, account documents must include information on radiation source that is insisted on a basis of the Radiation Act when applying the radiation practice licence.

The results of the inventory shall be submitted accoding to the form, which consists of front page and the form containing information on radiation source. Adequate number of rows shall be added to the form in case of more than one radiation source.

Forms for the Inventory results of the radiation sources:

  1. Front page of the inventory results.
  2. Information on the electrical equipment emitting ionising radiation.
  3. Information on the radiation source and its containing device.
  4. Information on unsealed source.


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