State Nuclear Regulatory Inspectorate of Ukraine Regional Workshop

State Nuclear Regulatory Inspectorate of Ukraine Regional Workshop on Drafting Regulations on Radiation Safety Vienna, Austria 3 – 14 November 2014 Country: UKRAINE RUSLANA Tripailo GORIEVA Svitlana

Content 1. Status of the legislative and regulatory framework for radiation safety 2. The regulatory approach to the drafting and implementation of regulations 3. The number and nature of facilities and activities subject to regulation Conclusions 2

1 Status of the legislative and regulatory framework for radiation safety q The State Nuclear Regulatory Inspectorate of Ukraine (SNRIU) is Ukrainian only (from 2012) regulatory authority that is competent for radioactive sources safety and security regulation. q SNRIU is effectively independent and reporting to the Government. q The one of the main basis functions of the SNRIU is to establish safety criteria, requirements and conditions for nuclear energy use (rule-making). 3

1 Status of the legislative and regulatory framework for nuclear, waste and radiation safety (cont. ) q The nuclear legislative framework is governed by a set of laws; q The main is one the on Law Use of Nuclear Energy and Radiation Safety (Nuclear Law, 1995); q The Nuclear Law sets out the main principles for nuclear safety and radiation protection as in IAEA Safety Fundamentals; q Nuclear law specify the main responsibilities of a regulatory authority to ensure nuclear and radiation safety; q This law to establish the priority of human and environmental safety, rights and duties of the public in the area of nuclear energy, regulate the use of nuclear facilities and radiation sources, etc. 4

1 Status of the legislative and regulatory framework for radiation safety (cont. ) The following Laws of Ukraine are the basis for nuclear and radiation safety: – Law on Physical Protection of Nuclear Facilities, Nuclear Material, Radioactive Waste, and Other Sources of Ionizing Radiation; – Law on Authorization Activity in Nuclear Energy Use; – Law on Human Protection against Impact of Ionizing Radiation; – Law on Radioactive Waste Management; – Law on Decision Making Procedure on Siting, Design Construction of Nuclear and RAW Facilities of National Importance – Law on Uranium Mining and Milling – Law on State Supervision etc. 5

1 Status of the legislative and regulatory framework for radiation safety (cont. ) System of regulations on nuclear and radiation safety has multilevel structure, where regulatory acts are in groups depending on object of regulation: • General issues – mainly procedural in development and establishment of regulatory requirements – 15; • General nuclear safety – 18; • Safety of nuclear installations – 71; • Safety of sources of ionizing radiation – 33; • Safety in transport – 16; • Safety of RAW management – 22; • Safety in mining and milling – 15; • Non-proliferation and safeguards – 17; • Physical protection – 12; • Emergency preparedness and response – 23. 6

2. The regulatory approach to the drafting and implementation of regulations Development of Regulations General national system of regulations development in the area of nuclear energy use, nuclear and radiation safety has hierarchical system, which foresees subordination of the low level document requirements to the relevant requirements of the highest hierarchical levels 7

Hierarchical pyramid of regulatory acts in the line of “Safety control of Radiation Sources» LEVEL І Law «On permissive activity in the field of nuclear energy use» Law «On human protection against ionizing radiation” Law «On nuclear energy use and radiation safety» LEVEL ІІ Criteria for exempted from licensing of IRS activity on use, Decree of GU 16. 11. 2011 № 1174 Technical regulations of sealed RS» Decree of GU 05. 12. 2007 № 1382 Procedure of state registration of IRS, Decree GU of 16. 11. 2000 № 1718 LEVEL ІІІ Sub-level 1 General requirements of safety works with ionizing radiation sources (draft) «Radiation safety norms of Ukraine» (НРБУ-97) «Sanitary rules of radiation safety assurance of Ukraine» (ОСПУ – 2005) Sub-level 2 Requirements and conditions of safety List of IRS activity on use of which is exempted from licensing, . (draft) (licensing conditions) of use of IRS Order of SNRIU 125 of 22. 12. 2002 Requirements and Procedure for clearance and Exemption of RM from Regulatory Control within the framework of practical activities. Order of SNRIU No. 84 of 01. 07. 2010. The order of training and check knowledge in radiation protecting area (NO) General Requirements to quality system of nuclear energy use, Order of 19. 12. 2011 № 190 Requirements to quality system of IRS use in medicine, Order of SNRIU of 03. 10. 2008 № 166 Requirements to annual safety analysis report of activity with use of IRS , Order SNRIU of 02. 12. 2002 № 125 conditions of activity with use of IRS in radiation therapy 28. 12. 2007 № 193 Safety Requirements of liner accelerators, Order of SNRIU of 05. 08. 2013 № 83 Requirements and conditions of safety (licensing conditions) of use of PET (draft) ) The licensing Procedure of separate types of activity in the field of nuclear energy, Order of SNRIU of 06. 08. 2012 № 153, Requirements and conditions of safety (licensing conditions) of implementation of activity on production of IRS , Order of 20. 03. 2001 No. 111 Requirements on safety analysis Requirements and Safety Requirements and annual report for production of conditions of safety Conditions for use RS in radioisotope defectoskope Order of SNRIU of ionizing radiation sources, Order (licensing conditions) for coal-mining industry (NO) № 122 of 29. 12. 2001 21. 09. 2010 № 121 Requirements and conditions of safety (licensing conditions) of use of X-ray diagnostic (No) Requirements and conditions of safety (licensing conditions) of nuclear medicine (NO) Requirements on safety analysis report for production of ionizing radiation sources. Order № 62 of 17. 08. 2001. LEVEL IV Recommendations on control of espouse dose of patients for diagnostic procedures (NO) Recommendations on assessment a licenses documents of use and produce of IRS, Order of 04. 06. 2004 № 99 Recommendations on control of radiation parameters of medical X-ray equipments (NO)

2. The regulatory approach to the drafting and implementation of regulations(cont. ) As a result of work on Hierarchy pyramid of regulatory acts the following was defined: – Hierarchy of normative basis; – List of regulations to be developed; – List of regulations to be reviewed; – Priorities in development/ review of regulations. 9

2. The regulatory approach to the drafting and implementation of regulations To settle all issues on normative regulation of nuclear and radiation safety Working Commission on normative regulation of the SNRIU as a joint advisory authority was established (order of the SNRIU № 87 of 26 July 2002) 10

2. The regulatory approach to the drafting and implementation of regulations (cont. ) Regulatory acts are developed according to the Annual Plan on normative regulation of the SNRIU and relevant orders of the Government and in case of adoption of a new law which is followed by the necessity to develop normative act. Plans for next year are approved and published on through website of the SNRIU (www. snrc. gov. ua) Procedure for development and approval of regulations and standards on nuclear and radiation safety (Resolution of the Cabinet of Ministers of Ukraine of 8 February 1997 N 163) Regulations on nuclear and radiation safety are approved by the order of the state regulatory authority. Regulatory acts are subject to state registration in the Ministry of Justice of Ukraine. 11

2. The regulatory approach to the drafting and implementation of regulations (cont. ) Process of regulations development : § 1 st stage is development terms of reference for regulatory act; § In case of regulatory act complexity research is carried out; § Draft regulatory act is sent for comments to other executive authorities, organizations and enterprises including operating organizations; § Final version of the draft is posted on the web-site of SNRCU for public discussion; § Final versions of the most important regulations are discussed by the SNRCU Board based on the decision of SNRCU Chairperson; § When approving a document a date of entry into force is being set taking into account a period needed for entry into force preparatory actions; § Approved regulatory document is made public. 12

3. The number and nature of facilities and activities subject to regulation (by March 2014): § 4624 users of the radioactive sources (RS) § 12 156 radioactive sources and 12 867 generators registered by the National Register of RS § All 5 categories RS are in use: § 1443 first category sources are used in teletherapy and irradiation facilities § Spheres of use - medicine, industry (gauges, radiography and well lodging devices etc), science Building International Coalition on Alternative Technology, VCDNP, 17. 10. 14

Important task on this workshop: Review the «Basic Safety Requirements and Conditions in the conduct of activity in the use of ionizing radiation sources» Approved by the Order of SNRIU of 02. 12. 2002 No 125

What was done in previous? Requirements and conditions use of IRS in radiation therapy (Order of SNRIU of 28. 12. 2007 №. 193) Requirements to quality system of IRS use in medicine (Order of 03. 10. 2008 № 166) Safety Requirements of Electron, X-ray irradiation facilities (Order of SNRIU of 05. 08. 2013 № 83 ) Safety Requirements and rules for PET-technology (draft, will be approved in 2014) 15

What was done previous ? . . (cont) Safety Requirements and conditions for safety in Industrial Radiography Order of SNRIU 21. 09. 2010 № 121 Procedure for clearance and Exemption of Radioactive Materials from Regulatory Control within the framework of practical activities Order of SNRIU of 01. 07. 2010 No. 84 16

Annual Plan on 2014… General requirements of safety works with ionizing radiation sources (draft, will be approved in 2015) The Order of Training in Radiation Protection and the Safe Use of Radiation Sources (approved the Order of SNRIU 10 October 2014 № 143 ) 17

Feedback and lessons learned regarding conduct of past Schools The Schools of Drafting Regulations let a got: ü Excellent opportunities of working with IAEA standards and EC directive during the Schools of Drafting Regulations ü excellent experience and useful practical skills in drafting regulations ü Good result in drafting regulations during a month (best then yearly in our country) ü Excellent opportunities of experience exchange of Member States Our achievements: two regulations was approved and one regulation will be approved in December 2014 18

CONCLUSION q Ukrainian regulations and guidance are prepared in compliance with IAEA standards and new EC Directive (2013); q For each field of regulation (including RS usage) logical systematic analysis of regulations was provided: q Legislation pyramid was built identifying gaps; q Strategic plan for regulations development was produced (for RS usage plan includes development of activity specific regulations review/development); q Priorities for regulations elaboration were established. q Periodical review and improving the Legislation pyramid 19

Thank you for your attention! 20