ROMANIAN GOVERNMENT NATIONAL COMMISSION FOR NUCLEAR ACTIVITIES CONTROL

ROMANIAN GOVERNMENT NATIONAL COMMISSION FOR NUCLEAR ACTIVITIES CONTROL Romanian Ionizing Radiation Sources Database Maria GHEORGHE Ionizing Radiation Authorization Division International Workshop on National Sources Registry, 20 -23 March 2017, Vienna

Law nr. 111/1996, on the Safe Deployment, Regulation, Authorization and Control of Nuclear Activities, with the amendments The competent national authority which has responsibilities of regulation, authorization and control of nuclear activities is National Commission for Nuclear Activities Control (CNCAN) Legal entity, headed by a President who is State Secretary and coordinated by the Prime Minister www. cncan. ro

Compartimentul Control Managerial Compartimentul audit intern Compartmentul Juridic Compartimentul Relatii Publice Serviciul Managemen-tul Resurselor 3 Compartimentul documente clasificate informatica Consiliul de conducere si autorizare Serviciul Relatii Internationale Zona 4 Bucuresti-Ilfov Zona 3 Transilvania Zona 2 - Muntenia DIRECTIA AUTORIZARE UTILIZARE RADIATIII IONIZANTE (12) Zona 1 - Moldova Compartimentrul Registrul de Doze si Surse . Serviciul Surse Industriale si altele Serviciul Surse Medicale Radiological Emergency Office DIRECTIA SECURITATE NUCLEARA Staff Authorization Section Radiation Protection, Radioactive Waste and Decommissioning Section Nuclear Regulations and Standards Section Cernavoda NPP Surveillance Section Nuclear Safety Assessment Section COMISIA NATIONALA PENTRU CONTROLUL ACTIVITATILOR NUCLEARE ORGANIGRAMA PRESEDINTE Comitetul pentru situatii de urgenta Directia Generala Reglementare, Autorizare si Control Activitati Nucleare DIRECTIA SUPRAVEGHERE UTILIZARE RADIATIII IONIZANTE (19)

The legal framework Law nr. 111/1996, with the amendments, republished on 2006, on Safe Deployment, Regulation, Authorization and Control of Nuclear Activities. Radiological Safety Fundamental Regulation/ 24 January 2000, published in the Official Gazette no. 404 bis of 29 August 2000. Specific Regulations

Law nr. 111/1996, with the amendments on the Safe Deployment, Regulation, Authorization and Control of Nuclear Activities. Art. 1 The object of the law: regulation, authorization and control of nuclear activities for exclusively peaceful purposes so that they should meet the nuclear safety conditions set for protection of occupationally exposed workers, of the patient, of population, of environment and of the property with minimal risks in compliance with regulations and with the observance of the obligations proceeding from agreements and conventions Romania is a party to.

The purposes of the Law no. 111/1996: 1. To submit to CNCAN’s control all the radiation sources on the Romania territory; 2. To assure the regulatory control of all sources, in a way which permits the control of the sources inventory of the sources and traceability 3. To prevent unauthorised use of radiation sources in Romania and to enforce the applicable regulations and terms of licences, including suspension, modification or revocation; 4. To predict an effective answer in the situation of out of control sources which are discovered and reported. 5. To plan the mitigation of consequences in case of radiological accident or incident.

RADIOLOGICAL SAFETY FUNDAMENTAL NORMS issued in 2000, are in compliance with: • INTERNATIONAL BASIC SAFETY STANDARDS FOR PROTECTION AGAINST IONIZING RADIATION AND FOR THE SAFETY OF RADIATION SOURCES, Safety Series No. 115, IAEA • COUNCIL DIRECTIVE 96/29/EURATOM laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation • ICRP Publication 60

REGULATIONS 3 NORMS - approved by Order of the President of CNCAN - published in the Official Gazette of Romania - mandatory for all applicants or licensees - in compliance with international recommendations (IAEA, ICRP, EC) at date

The Main Specific Regulations (1) • Radiological Safety Fundamental Norms/24 January 2000, approved by Order no. 14 on 24 January 2000 of the CNCAN President and published in Official Gazette no. 404 bis on 29 August 2000 • Norms of Radiological Safety on Operational Radiation Protection of outside Workers approved by Order no. 353 on 20 August 2001 of the CNCAN President and published in Official Gazette, Part I, no. 764 bis, on 30 November 2001 • Radiological Safety Norms - Licensing Procedures, approved by Order no. 366 on 22 September 2001 of the CNCAN President and published in Official Gazette, Part I no. 764 bis on 30 November 2001

The Main Specific Regulations (2) • Norms on protection of individuals against ionizing radiation in relation to medical exposures, approved by MSF and CNCAN Common Order no. 285/79/2002 and published in Official Gazette, Part I, no. 446 bis on 25 June 2002 • Norms on issuing of exercising permits of nuclear activities and designation of radiation protection qualified experts approved by Order no. 202/15. 10. 2002 of the CNCAN President and published in Official Gazette, Part I, no. 936 bis on 20 December 2002 • Norms on Operational Radiation Protection on Deployment of Non-destructive Testing Practice with Ionizing Radiation, approved by Order no. 155 on 02. 10. 2003 of the President of National Commission for Nuclear Activities Control, published in Official Gazette no. 873 on 09. 12. 2003

The Main Specific Regulations (3): • Norms of Radiological Safety on Radiotherapy Practice, approved by Order no. 94 on 14. 04. 2004 of the President of National Commission for Nuclear Activities Control, published in Official Gazette no. 532 on 14. 06. 2004 • Norms of Radiological Safety for Nuclear Gauges, approved by Order no. 144 on 05. 2004 of the President of National Commission for Nuclear Activities Control, published in Official Gazette no. 534 on 15. 06. 2004 • Norms on Designation of Notified Bodies for nuclear domain , approved by Order no. 274 on 06. 08. 2004 of the President of National Commission for Nuclear Activities Control, published in Official Gazette no. 745 on 17. 08. 2004 • Norms of Radiological Safety on Nuclear Medicine, approved by Order no. 358/18. 10. 2004 of the President of National Commission for Nuclear Activities Control, published in Official Gazette no. 139 on 15/02/2005

The Main Specific Regulations (4) • Normative of granting and utilization of ionizing radiation protection individual equipment, approved by Order no. 421/2004 on 22/12/2004, published in Official Gazette no. 107 on 02/02/2005 • Norms on orphan sources and control of high activity sealed sources, approved by Order no. 356/2005, published in Official Gazette no. 1109 on 08/12/2005 • Norms of radiological safety on interventional and diagnostic radiology practices, approved by Order no. 173 on 16. 10. 2003 of the CNCAN President, published in Official Gazette no. 924 on 23. 12. 2003 • Regulation on medical physics expert, approved by Common Order no. 1272/266/2006 of the Minister of Public Health and of the President of National Commission for Nuclear Activities Control and published in Official Gazette, Part I, no. 906 on 07 November 2006

AUTHORIZATION PROCCES IONIZING RADIATION (SOURCE/DEVICE) TYPE APPROVAL PERSONNEL DOSIMETRIC APPARATUS AUTHORIZATION DEVICE USED FOR PROTECTION AGAINST IONIZING RADIATION PRACTICE REGISTRATION LICENSE ALL ACTIVITIES TOGETHER (SINGLE STEP) STEP BY STEP

GENERAL REMARKS: • all practices and sources have to be authorized • licence prior to practice • issued for specific purpose and site • limited validity (generally 5 years, registration 10 years) • specified sources and devices • specified personnel responsible for radiation protection - RPO • may be conditioned • legal rights given by licence can not be transferred to a third person Personnel work permit • personalized • compulsory • limited validity (5 years) • for specific (group of) practice issued on the basis of an evaluation and examination of person radiological safety knowledge • organized on three levels: • - LEVEL 1 issued by license holder for exposed workers • issued by CNCAN for personnel involved in low associated radiological risk activities • - LEVEL 2 issued by authority for personnel responsible for • radiological safety • - LEVEL 3 issued by authority for qualified experts

FOLLOW UP THE DEVICE/RADIATION SOURCE THROUGH THE DEPLOYMENT OF THE ACTIVITIES TYPE APPROVAL PRODUCTION IMPORT SUPPLY TRANSFER EXPORT HOLDING SITING CONSTRUCTION USE NEW USER PRACTICE DECOMMISSIONING LEASING RADIOACTIVE WASTE FINAL DISPOSAL END OF THE ACTIVITY HANDLING TRANSPORT MAINTENANCE REPAIR

Distribution of companies/institutions involved in radiological activities in Romania AB - 58 AR - 60 AG - 68 BC - 60 BH - 69 BN - 24 BT - 22 BR - 26 BV - 90 Bucuresti - 805 BZ - 34 CL - 31 CS - 29 CJ - 122 CT - 99 CV - 19 DB - 47 DJ - 80 GL - 57 GR - 17 GJ - 26 HR - 35 HD - 81 IL - 18 IS - 124 IF - 31 MM - 39 MH - 37 MS - 55 NT - 50 OT - 27 PH - 103 SJ - 22 SM - 21 SB - 58 SV - 44 TR - 22 TM - 83 TL - 19 VL - 39 VS - 28 VR - 24 Companii straine - 18

The central evidence of all radiation sources was maintained, during the period 2000 -2010, by CNCAN database - EVNUC - NUCLEAR EVIDENCE (developed in MS Access) CNCAN needs, in compliance with international standards: • National Source Registry – in EVNUC were not enough information about radioactive sources - no categorizations of them • Remote access for CNCAN inspectors – from every country district • Permanent updated of the database concerning: v Individual dose monitoring reported by the accredited dozimetric body and the licensee v Radioactive sources modifications (mainly for Ir-192 used in afterloading HDR brachytherapy – reported by the suppliers) v Radioactive waste management reported by radioactive waste depository In 2007, a project for a new database was started as an upgraded of EVNUC database; it is the result of a PHARE project supplemented by additional Romanian financing CNCAN had a contract with a Romanian IT firm that developed the application

CNCAN Database Information System (CNCAN/DAURI) v. The DIS was completed and implemented in November 2010: - the training of the CNCAN users was done by the IT firm, which covers also the assistance support for 2 years - the data from EVNUC were transferred in the new database (DAURI), but for radioactive sources no enough information were in EVNUC, for categorization of sources v. The access of the new database DAURI is for 3 levels: ØAdministrator ØCNCAN users – radiological safety experts who assess the documentation and issue the licence and also inspectors spread in the whole country ØPublic users (external users shall have limited and controlled access, attributed by CNCAN) – stakeholders such as licensees or suppliers of radioactive sources or accredited dozimetric body or radioactive waste depository users

§ it is an SQL database used in a CNCAN network with controlled internet access, protected by user password and SSL certificate § it is designed in a proper software for future modifications, consisting in additional tables or fields §is a web based workflow application that take into account the different procedures followed by CNCAN staff in order to carry out their duties and of the data which are needed (either to be retrieved or to be stored in the database back end) during the carrying out of each one of these procedures. §provide support for Ionizing Radiation Authorization Division and Ionizing Radiation Surveillance Division (county resident inspectors) in carrying out their daily operations.

The main scopes of the application is: • the recording of all information regarding the authorization files, on electronic support, • to provide a search tool for all these registrations, • report generating based on all these registrations. The new software is secured for web navigation and provides user access levels (permissions defined by the database administrator)

Installation v. Equipment v. Component v. Radioactive Sources (sealed or unsealed) v. Transport package v. Materials and devices used for the protection from ionizing radiation Equipment • Equipment name • Type Approval number • Serial number • Production year

The window for selecting of equipment components It is necessary to fill the information: • Component name • State – normal, disjointed, transferred, etc • Serial number • Type approval number • Parameters • Features

Radioactive sources • Source type • Status (normal, sent to the radwaste depository, etc) • Serial number • Production year • Type Approval number • Activity • Measurement date • Source category • Practice category

The window for searching of radioactive sources by: • source type and model, • capsule model, • chemical and physical parameters, • maximum activity, • radionuclide, • security class, • ISO classification, • manufacture of source and his country

Radioactive Sources To add a radioactive source in the database, it is necessary to select: • source type and model, • capsule model, • chemical and physical parameters, • maximum activity, • radionuclide, • security class, • ISO classification, • manufacture of source and his country

Radioactive Source Registry The database includes the fields for initial activity of the source and the date of the activation, so that the activity can be calculated automatically in any moment. The result is compared with the IAEA and UE categorization & security levels: üIAEA "Code of Conduct on the Safety and Security of Radioactive Sources" and IAEA-TECDOC-1344 "Categorization of Radioactive Sources“ üCouncil Directive 2003/122 EURATOM on the control of high activity sealed radioactive sources and orphan sources The source is classified automatically by IAEA requirements and by UE Directive no. 122/2003 regarding the high activity sealed sources.

Report for radioactive source classification based on: • radionuclide, • type of practice • activity type, • source type/model, etc

General Report Filter fields: • Juristic person name • File type (new authorization, renew authorization, modification) • Authorization type (sitting, construction, use, transport, leasing, transfer, holding, handling) • Authorization State (valid, expired) • Practice type (radiotherapy, X-ray diagnostic, nuclear medicine, nondestructive control) • CNCAN users • Equipment • Components • Radioactive sources • Transport package • Producer (manufacture) • Time period for license issuing • Time period for expiration date

Public Section ØThe database offers the possibility of the Public Section, for: • online report by the public users (licenses for use and supplier) for sealed radioactive source with short life time (for example: Ir 192). • report for returned radioactive waste to the manufacturer/supplier or delivered to radioactive waste treatment facilities (radwaste depository). ØWhen a source is sent to the radwaste depository, automatically information is sent in a section of radwaste in the database. This section of radwaste is created as a new section of the database. ØA “Professionally exposed personnel” window is created for the National Registry of Doses in which the authorization holders must insert the yearly dose records of the professionally exposed personnel. The inserted record is automatically validated following application of criteria such as reporting all data accompanying higher than 20 m. Sv yearly doses, verifying consistency and unicity of the individual code number, etc.

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