Regional Workshop Drafting School for Regulations Radiation Safety

Regional Workshop Drafting School for Regulations Radiation Safety Stream RER/9/141: Improving National Infrastructure for Safety Republic of Bulgaria Page 1 IAEA School for Drafting Regulations, 10 -21 July 2017

Deyana Dosieva Head, Radiation Protection Department, BNRA, Bulgaria Pepa Stoyanova State Inspector, Lawyer Licensing Division, BNRA, Bulgaria Both involved in the following current activities of BNRA: • Preparation of the draft amendment to the Act on the Safe Use of Nuclear Energy • Drafting of the new Regulation on Radiation Safety to replace the existing Regulation on Basic Norms for Radiation Protection • Preparation of the draft amendment to the Regulation on the Procedure for Issuing Licenses and Permits for the Safe Use of Nuclear Energy During the School we intend to finalize the last mentioned Regulation, which have to be brought in line with the rest of the drafts indicated above and should comply with the respective European Union directives and present IAEA guidance Republic of Bulgaria Page 2 IAEA School for Drafting Regulations, 10 -21 July 2017

Ø PRIMARY LEGISLATION Constitution, Ratified International Instruments Legislation in field of protection of environment and human health Act on the Safe Use of Nuclear Energy (Nuclear Act) o adopted 2002, essentially amended 2010 Ø Regulatory framework o Chapter Three AUTHORISATION PROCESS - establishing basic rules and requirements in terms of the authorization procedure, including NUCLEAR FACILITIES (NF) and SOURCES OF IONISING RADIATION (So. IR) o Chapter Five REGULATORY CONTROL Republic of Bulgaria Page 3 IAEA School for Drafting Regulations, 10 -21 July 2017

Ø SECONDARY LEGISLATION (developed 2002 -2005) 24 regulations on the implementation of the Nuclear Act, incl. ü Radiation protection issues are covered mainly by: • Regulation on Basic Norms for Radiation Protection (establishing basic requirements for radiation protection - criteria and levels of exemption from regulation, clearance, justification of practices, dose constrains, limitation of doses, optimization of protection, occupational, medical and public exposures, etc. ) • Regulation on Radiation Protection during Work Activities with Materials with Increased Concentration of Natural Radionuclides Ø REGULATORY GUIDES – non-mandatory, based on IAEA documents, giving detailed recommendations, procedural or practical manuals Republic of Bulgaria Page 4 IAEA School for Drafting Regulations, 10 -21 July 2017

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Ø The Chairman of BNRA is vested with the power to initiate Ø Ø Ø the development of drafts of legal instruments and to propose amendments of those documents (Art. 5, Point 17, Nuclear Act) Any draft amendment to the Nuclear Act should be considered and approved by the CM and submitted to the Parliament for adoption New regulations and draft amendments to regulations should be approved by the CM The drafts have to be accompanied by a report containing the grounds for the development of the respective statutory instrument and impact assessment ü most of the drafts and documentation packages are prepared by BNRA staff The draft proposals have to be coordinated with the respective ministries and agencies and made public through the website of BNRA After the adoption by the Parliament/CM the legal instruments have to be promulgated in the State Gazette Republic of Bulgaria Page 6 IAEA School for Drafting Regulations, 10 -21 July 2017

Ø According to the Nuclear Act all important activities involving use of NF and So. IR are covered by notification and authorisation regime, which is applied by the Chairman of BNRA Ø The authorisation regime is entitled to guarantee, inter alia, compliance with the radiation protection standards and requirements and is based on a graded approach Ø AUTHORISATIONS in respect of activities involving So. IR: • LICENSES - for use of So. IR for economic, medical, scientific purposes; for manufacture of So. IR; for handling of So. IR for the purpose of maintenance, dismantling, measurement, construction or other services, etc. • PERMITS - for location of an entity/facility with a So. IR at a specific site; for construction of an entity/facility with sources of ionizing radiation, etc. Ø NOTIFICATION - for the cases where it has been proven that the probability of occurrence of harmful health effects is insignificant, according to the criteria stipulated by law Republic of Bulgaria Page 7 IAEA School for Drafting Regulations, 10 -21 July 2017

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In accordance with the powers granted by Nuclear Act, the Chairman of BNRA approved a Program for the updating of statutory instruments (by Order No RD-22 -208/24. 11. 2016) The updating process will affect Nuclear Act and the regulations, which have already been mentioned and should take into account: Ø The need for the implementation of Council Directive 2013/59/EURATOM 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 Ø Present IAEA guidelines and the results of IRRS mission to Bulgaria (2013) and Follow-up IRRS mission (2016) Ø The operating experience gained from the application of the Nuclear Act and the respective regulations Republic of Bulgaria Page 9

• The following main changes are planned to be performed Ø Introduction of three-level Regulatory process based on a graded approach, encompassing: • • • Notification Regime Registration Regime Issuing a permit or a license Ø Inclusion of additional activities subject to regulatory control: • practices involving non-medical imaging exposure Ø Amendments to the system of exercising control over the fulfilment of statutory and regulatory requirements ØThese amendments should reflect, inter alia, the Regulation on the Procedure for Issuing Licenses and Permits for the Safe Use of Nuclear Energy, which is our primary objective now Republic of Bulgaria Page 10 IAEA School for Drafting Regulations, 10 -21 July 2017

Ø The regulation to be finalised prescribes for the steps of the notification and authorisation process and stipulates the set of documentation necessary for issuing the respective authorisations Ø In this respect the Regulation is of procedural nature, which determines that it is a prescriptive rather than performance-based Ø At the same time, we are really striving to formulate less regulated and sufficiently flexible and clear provisions based on graded approach and reducing the administrative and regulatory burden Ø By finalising the work on the amendment of the regulation we will finalise the package of legislative amendments involving predominantly the authorization regime for So. IR, which will have to be applied in a system, aiming to build consistent and up-to-date regulatory framework Republic of Bulgaria Page 11 IAEA School for Drafting Regulations, 10 -21 July 2017