1. LEGAL and REGULATORY FRAMEWORK for NUCLEAR and RADIATION SAFETY in BULGARIA General overview Dr. M. Mateeva – Chief Inspector R. Markova-Mihaylova – Chief Inspector BULGARIAN NUCLEAR REGULATORY AGENCY IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014

2. NUCLEAR INDUSTRYNUCLEAR INDUSTRY NUCLEAR LEGISLATIONNUCLEAR LEGISLATION DRAFTING OF NUCLEAR REGULATIONSDRAFTING OF NUCLEAR REGULATIONS NUCLEAR REGULATORY AUTHORITYNUCLEAR REGULATORY AUTHORITY AUTHORIZATIONSAUTHORIZATIONS MINISTRY OF HEALTH - NCRRPMINISTRY OF HEALTH - NCRRP IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014 (Bulgaria) Page 2 CONTENTS

3. Nuclear facilities: Kozloduy Nuclear Power Plant; Spent Fuel Storage Facilities; Research Reactor IRT-2000; Radioactive Waste Management Facilities. Application of Sources of Ionising Radiation: Industry; Medicine; Scientific purposes (research, education, agriculture); Other applications (control, measurement, etc.). IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014 (Bulgaria) Page 3 NUCLEAR INDUSTRY

4. Act on the Safe Use of Nuclear Energy (ASUNE) The Act regulates the social relations associated with the State regulation of the safe use of nuclear energy and ionizing radiation and with the safety of radioactive waste management and spent fuel management, as well as the rights and duties of licensees implementing these activities, to ensure nuclear safety, radiation protection and physical protection. Adopted by the Parliament 2002, Amended and supplemented 2013Regulations 21 Regulations on implementation of the ASUNE Adopted by the Council of Ministers Regulatory guides 10 Regulatory guides - The safety guides interpret the requirements established by the regulations on the application of the ASUNE. Their objective is to help the applicants to better understand the criteria used by the BNRA to assess the set of documents justifying the safety of the facilities and activities, and the practice ensuring safety. The Guides are of a recommendatory nature. The application and use of other methods and criteria for justification of safety is acceptable. In such cases the BNRA needs to be adequately convinced that safety has not been compromised. Issued by the BNRA Chairman www.bnra.bg www.bnra.bg IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014 (Bulgaria) Page 4 NUCLEAR LEGISLATION

5. The procedure takes about two years: 1)Decision for drafting a new regulation/revision of existing regulation; 2)The BNRA forms a Working Group; 3)Once the first draft exists it is distributed to the interested parties for informal commenting; 4)Once the informal commenting process is finished, the final draft is delivered to the different ministries and published on the BNRA website and the portal for public consultations and commenting (www.strategy.bg). The commenting period is a minimum of two weeks, in many cases one month; 5)Finally, the revised draft goes to the Council of Ministers (CM) and is adopted provided unanimous approval is obtained. Approved regulations are published on the BNRA website. Regulations are periodically (two years at the latest) reviewed. Currently there is a BNRA plan for revision of existing regulations on nuclear power plants, research reactors, decommissioning, special statutory zones, etc. IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014 (Bulgaria) Page 5 PROCEDURE OF DRAFTING A NUCLEAR REGULATION

6. State regulation of the safe use of nuclear energy and ionising radiation, the safety of radioactive waste management and the safety of spent fuel management is carried out by the Chairman of the Nuclear Regulatory Agency. The Chairman is an independent specialised authority of the executive power and is vested with competencies as specified by ASUNE. In the work thereof, the Chairman shall be assisted by an Administration organised in the Nuclear Regulatory Agency. IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014 (Bulgaria) Page 6 NUCLEAR REGULATORY AUTHORITY

7. The BNRA Chairman shall issue for: The licences shall be valid for a period of 10 years, and permits for single activities are issued with an appropriate validity according to the specific case. IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014 (Bulgaria) Page 7 AUTHORIZATIONS Nuclear Facilities (NF)Sources of Ionising Radiation (SIR) A PERMIT A PERMIT for: siting of a NF (site selection); design of a NF; construction of a NF; commissioning of a NF. A PERMIT A PERMIT for: construction of a site with SIR, assembling and preliminary testing, conducted on the basis of design specification and provisions for radiation protection; decommissioning of a site possessing radioactive substances; temporary storage of radioactive substances generated during the performance of practices involving SIR or associated with such practices; permit for a single or transit transport of radioactive substances; import and export of SIR, including items involving SIR if they do not constitute “dual-use” items within the meaning given by the Defense-Related Products and Dual- Use Items and Technologies Export Control Act. A LICENSE A LICENSE for: operation of a NF; decommissioning of a NF. A LICENSE A LICENSE for: use of radioactive substances and other SIR for economic, medical or scientific purposes and for carrying out of process control functions; manufacture of SIR; handling of SIR for the purpose of maintenance, assembly, dismantling, measurement, construction and repair activities and services; transport of radioactive substances.

8. HEALTH ACTHEALTH ACT The Act shall regulate the social relations concerning the protection of the citizens' health. THE NCRRPTHE NCRRP The NCRRP is a specialized state health control authority of the Ministry of Health in Bulgaria. The Center acts in the area of ionizing radiation and health monitoring of radiation exposed population groups (occupational radiation protection and radiation protection and safety related to medical applications). IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014 (Bulgaria) Page 8 MINISTRY OF HEALTH National Center for Radiobiology and Radiation Protection (NCRRP)

9. IAEA Workshop on Drafting Regulations, 3 Nov – 14 Nov 2014 (Bulgaria) Page 9 THANK YOU FOR YOUR ATTENTION!