1. RER/9/096 Regional Planning Meeting “Strengthening National Infrastructures for the Control of Radiation Sources” (TSA-1), (Phase II) Country: Bulgaria 19-20 March 2009 IAEA, Vienna

2. Legislation Regulations and Guidance Act on the Safe Use of Nuclear Energy (ASUNE) Act on Health Act on Environmental Protection Basic Secondary Legislation for radiation protection - 52 regulations totally Regulation on the Basic Standarts of Radiation Protection (IBSS-96, EU - Directive 96/29, Directive 97/43, Directive 90/641) Regulation on Radiation Protection in Activities Related to the Use of Sources of Ionizing Radiation (IBSS-96, EU - Directive 96/29, Directive 122/2003) Regulation for Safe Transport of Radioactive Meterials (IAEA, ADR) Regulation for safe management of RAW (IAEA) Regulation on individual monitoring of occupational exposure (IAEA, EU)Regulation on individual monitoring of occupational exposure (IAEA, EU) Regulation for Radiation Protection of Patients in Medical Exposure (IAEA, EU) Other specific regulations (more of them are old) Basic Legislation is in accordance with the IAEA recommendations and European legislation in the radiation protection area

3. Main developments, changes, ongoing activities in the regulatory framework - 2008 Draft for amendment of the ASUNE – submitted for approval to the Council of Ministers (the new ASUNE is expected to be published in 2009) Amendment of the Regulation on Radiation Protection in Activities Related to the Use of Sources of Ionizing Radiation (according to EU Directive 122/2003) Amendment of the Regulation on Radiation Protection of Patients in Medical Exposure (according to EU Directive 97/43) Drafts for amendment of other Regulations (3 in number) related to ASUNE National Report on Radiation Protection in the Republic of Bulgaria National Report for the implementation of the “Code of conduct on the safety and security or radioactive sources” Action Plan for Implementation of the European Union Legislation - 2007/2008 (this Action Plan includes 18 normative acts in the field of radiation protection taking into account good European practices in this field) National Register of Sources of Ionising Radiation (NRSIR) Three projects related to the management of high-activity sources, release from the regulatory control of NORM and safe transport of radioactive materials Guidance for prevention of incidents with radioactive scrap metal

4. National infrastructure The Regulatory body The National Infrastructure is developed in accordance with the IAEA recommendations (IBSS-96, GS-R-1), EU Legislation (Directive 96/29/EURATOM) and “Code of conduct on the safety and security or radioactive sources” Bulgarian Nuclear Regulatory Agency (BNRA) is the State Regulatory Body responsible for safe use of nuclear energy and sources of ionising radiation (SIR) and for safe management of Radioactive Waste (RAW) and Spent Fuel. The BNRA Chairman is an independent specialised authority of the executive power and is vested with competencies, as specified by the ASUNE. He has the same status as a Bulgarian ministry. The BNRA Chairman is a “ Primary Distributor of Budgetary Credits” - for 2008 the BNRA budget is about 4 000 000 EUR The BNRA currently employs 102 persons and exercises its authority and carries out its assigned functions without compromising its regulatory responsibility and independence (BNRA structure is given in Annex 1) The BNRA has acquired a training centre and provides training to its staff The BNRA organises education for implementation of the new radiation protection legislation for its staff and for external persons There are 6 specialised state control bodies (MH,MI,MEW,MES,MAF,SAMTC)

5. NRA Organizational structure

6. Notification, Authorization, Licensing, Inspections, Enforcement The activities related to the use of ionising radiation can be performed only after obtaining the respective licenses and permits from the BNRA The licensing regime is regulated by the “Regulation on Issuing Licenses and Permits for the Safe Use of Nuclear Energy” The notification is the first obligatory step in the licensing process The BNRA issues four types of licenses for practices with SIR and five types of permits for activities with SIR (1 392 licensees controlled by BNRA)The BNRA issues four types of licenses for practices with SIR and five types of permits for activities with SIR (1 392 licensees controlled by BNRA) The licenses and permits contain general and special conditionsThe licenses and permits contain general and special conditions The BNRA inspectors perform inspection activity in accordance with the established “Instruction for Carrying out Inspections at Sites with SIR”The BNRA inspectors perform inspection activity in accordance with the established “Instruction for Carrying out Inspections at Sites with SIR” The planned inspections are carried out under an established annual plan. The scope and intervals of the inspections are differentiated and determined according to category 1 to 5 of the respective SIR and the complexity of the practices The implementation of the legislative requirements and the conditions of the permits issued by the BNRA Chairman are ensured by administrative sanctions (penalty acts and fines) and administrative enforcement measures according to the ASUNE. The inspector’s prescriptions are mandatory 314 inspections are performed, 74 prescriptions are given, 4 penalty acts are imposed during 2008 (there are 1683 facilities with SIR registered by BNRA)

7. Challenges in the Radiation Protection Area 1. The new ICRP publication № 103 (2007) 2. Revision of the EURATOM Basic Safety Standards (EBSS - Directive 96/29) and Consolidation of other Community Legislation for Radiation Protection The draft of new EURATOM Basic Safety Standards will be ready at the end of 2009 and includes : -Change of the regulatory control system (graded approach to regulatory control and harmonization of exemption and clearance concepts); -Requirements for control over NORM-industries; -Establishment of the Dose Constraints and Reference Levels for planned, existing and emergency exposure situations (according to ICRP № 103); -Requirements for control over radon, building materials, residues from past practices, orphan sources, closed disposal sites 3. Revision of the IAEA Basic Safety Standarts (IBSS-96) The draft 1 of the new IBSS is prepared by IAEA. In 2010 the new IBSS is expected to be published ! 4. Consolidation of the new EBSS and the new IBSS

8. Plans for the coming period 2009-2011 1.Upgrading of the Radiation Protection Legislation (according to the National Action Plan for Implementation of the European Union Legislation – 18 acts). 2.Review of the National Radiation Protection Legislation based on the ICRP № 103 and the new IBSS and EBSS (after 2010). 3.Improvement of the regulatory mechanisms for adequate and effective control of SIR in compliance with the requirements of newest IAEA recommendations and the EU legislation. 4.Establishment and Development of a National Long Term Strategy for safe management and strengthening control of the radioactive sources. 5.Education and Training for implementation of the IAEA recommendations and the EU legislation concerning radiation protection and safety of SIR. 6.Consultations with IAEA experts concerning points №№ 1, 3 and 4. 7.Upgrading of the National Register of SIR (visualisation of the registered data on geography maps) 8.Implementation of the relevant suggestions resulted from 3 PHARE projects 9.Organisation of seminars and workshops with the IAEA assistance and with the participation of IAEA experts (concerninig points №№ 1 to 8 !).