Republic of Serbia Negotiating Group on Energy BILATERAL SCREENING MEETING Examination of the Preparedness of Serbia in the field of Chapter 15 Energy Sectoral framework Nuclear energy RADIATION PROTECTION European integration, international cooperation and legal affairs Department Brussels, 11-12 June 2014
EU legislation Euratom Treaty Chapter III: Health and Safety Council Directive 2013/59/Euratom of 5 December 2013 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 Council Regulation 1493/93/Euratom of 8 June 1993 on shipments of radioactive substances between Member States Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for the early exchange of information in the event of a radiological emergency 2
EU legislation Commission Regulation (EC) No 1609/2000 of 24 July 2000 establishing a list of products excluded from the application of Council Regulation (EEC) No 737/90 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station Commission Regulation (EC) No 1635/2006 of 6 November 2006 laying down detailed rules for the application of Council Regulation (EEC) No 737/90 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power-station Council Regulation (EC) No 733/2008 of 15 July 2008 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station 3
EU legislation Council Regulation (EC) No 1048/2009 of 23 October 2009 amending Regulation (EC) No 733/2008 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station Council Regulation (Euroatom) No 3954/87 of 22 December 1987 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feeding stuffs following a nuclear accident or any other case of radiological emergency Council Regulation (EEC) No 2219/89 of 18 July 1989 on the special conditions for exporting foodstuffs and feeding stuffs following a nuclear accident or any other case of radiological emergency Council Regulation (Euratom) 2218/89 of 18 July 1989 amending Regulation (Euratom) No 3954/87 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency 4
EU legislation Commission Regulation (Euratom) No 944/89 of 12 April 1989 laying down maximum permitted levels of radioactive contamination in minor foodstuffs following a nuclear accident or any other case of radiological emergency Commission Regulation (Euratom) 770/90, of 29 March 1990, laying down maximum pormitted levels of radioactive contamination of feedingstuffs following a nuclear accident or any other case of radiological emergency Directive 2013/51/Euratom laying down requirements for the protection of the health of general public with regard to radioactive substances in water intended for human consumption Commission Recommendation 2001/982/Euratom on the protection of the public against exposure to radon in drinking water supplies 5
Serbian legislation Law on radiation protection and nuclear safety (Official Gazette of RS No. 36/09 and 93/12) Rulebook for establishing Programme of systematic environmental radioactivity examination (Official Gazette of RS No. 100/10) Rulebook on radioactivity monitoring (Official Gazette of RS No. 97/11) Rulebook for establishing programme of early warning of emergency (Official Gazette of RS No. 70/11) Rulebook on records on performed activities in the field of ionizing radiation protection (Official Gazette of RS No. 17/11) Rulebook on registration and notification of sources of ionising radiation (Official Gazette of RS No. 25/11) 6
Serbian legislation Rulebook for establishing programme of additional training and specialized education of occupationally exposed persons and persons responsible for implementation of radiation protection measures (Official Gazette of RS No. 31/11) Rulebook on limits of radioactive contamination of people, working and living environment and ways of performing decontamination (Official Gazette of RS No. 38/11) Rulebook on radioactivity control of goods during the import, export and transit (Official Gazette of RS No. 44/11) Rulebook on conditions for obtaining decision to perform activities in the field of radiation protection (Official Gazette of RS No. 61/11) Rulebook on conditions for obtaining licence to perform radiation practice (Official Gazette of RS No. 61/11) 7
Serbian legislation Rulebook on limits of radionuclides content in drinking water, foodstuffs, feeding stuffs, medicines, general use products, construction materials and other goods that are put on market (Official Gazette of RS No. 86/11, 97/13) Rulebook on limits of exposure to ionizing radiation and measurements for assessment the exposure levels (Official Gazette of RS No. 86/11) Rulebook on the records of ionizing radiation sources, professionally exposed persons, patients exposure to ionizing radiation and radioactive waste (Official Gazette of RS No. 97/11) Rulebook on application of the ionising radiation sources in medicine (Official Gazette of RS No. 1/12) 8
Institutional framework Ministry of Agriculture and Environmental Protection Ministry of Education, Science and Technological Development Safety Agency (SRPNA) 9
Institutional framework Ministry of Agriculture and Environmental Protection Responsible for radiation protection The control over the SRPNA's work in performing the entrusted operations, within its scope and in accordance with the regulations governing the government administration Inspection control over implementing radiation protection measures SRPNA s budget Ministry of Education, Science and Technological Development Responsible for nuclear safety and radioactive waste management The control over the SRPNA's work in performing the entrusted operations, within its scope in accordance with the regulations governing the government administration Inspection control over implementing nuclear safety measures and RWM 10
Institutional framework - SRPNA Established in December 2009 by Law on radiation protection and nuclear safety (Official Gazette of RS No. 36/09 and 93/12) passing bylaws for implementing Law passing programmes defined by Law (preparing drafts of programmes for radiation and nuclear safety and security and radioactive waste management) preparing the draft Action Plan in the Case of an Accident producing instructions and procedures required for implementing radiation and nuclear safety and security measures issuing, extending and revoking licences for performing a radiation practice or nuclear activity keeping the registries and centralised records 11
Institutional framework monitoring the radioactivity levels and their changes and assessing their impact on the population and the environment ; ordering the implementation of required measures and monitoring their execution publishing the annual report on the exposure levels of the population to ionising radiation in the Republic of Serbia conducting the cooperation with responsible government authorities in its scope of activities conducting independently or in coordination with the responsible government authorities the cooperation with the IAEA and other international bodies and the responsible authorities of other countries regarding the enforcement of this Law giving opinions at the request of the responsible government authorities regarding the joining to the international conventions and other agreements in the field of radiation and nuclear safety and security Etc. 12
Authorised Technical Organisation Radiation protection Authorised Technical Organisation Based on the fulfilment of required conditions, SRPNA authorises legal persons for performing radiation protection activities Authorisation for Performing Radiation Protection Activities, Rulebook on conditions for obtaining decision to perform activities in the field of radiation protection (Official Gazette of RS No. 61/11) 15 authorised Authorised Technical Organisations for 6 radiation protection activities, 33 decisions 13
Implementation Authorisation for Performing Radiation Protection Activities Number of authorised institutions radioactivity monitoring measurements 12 development of project of radiation safety and security measures 5 measurements to assess the levels of exposure to ionizing radiation of occupationally exposed persons, patients and population additional training and specialized education of occupationally exposed persons and persons responsible for implementation of radiation protection measures measurements in order to control the quality management system of ionising radiation protection measures decontamination of working and living environment 3 7 4 2 14
Euratom Treaty Article 35/36 environmental monitoring Radioactivity monitoring in Serbia Law, Articles 9-11 stipulate obligations for performing Radioactivity monitoring Radioactivity monitoring of the environment in the Republic of Serbia includes: Systematic examination of the radioactivity in normal circumstances Examination of the radioactivity on suspicion of an emergency, and in the course of an emergency SRPNA publishes the Annual Report on the Level of Public Exposures to Ionizing radiation, based on the results of environmental monitoring as well as on other available data 15
Euratom Treaty Article 35/36 environmental monitoring RADIOACTIVITY MONITORING Aerosol Fallout The aerosol samples for examination of radionuclides content are collected at 7 locations The precipitation samples are collected at 9 locations Drinking water River water, sediment Food and feedingstuff Indoor radon The samples of drinking water from a water supply system for the settlements with more than 100,000 inhabitants are collected on the daily basis The samples of surface waters for examination of radionuclides content are collected on the daily basis in the following rivers: Danube, Sava, Nišava, Tisa, Timok, Drina Radionuclides content in foodstuff is examined in the samples of meat, milk, dairy products, cereals, vegetables and fruit. The food samples are collected at 7 location Indoor radon measurements are performed once a year in 45 homes and 24 schools and kindergartens in 7 cities 16
Euratom Treaty Article 35/36 environmental monitoring RADIOLOGICAL EARLY WARNING SYSTEM OF THE REPUBLIC OF SERBIA Gamma dose rate equivalent Ambient gamma dose rate equivalent in the air is measured daily, throughout 24h a day, at 8 locations Precipitation 17
Council Directive 2013/59/Euratom Council Directive 2013/59 in national legislation: Subject matter and Scope Definitions System of radiation protection Requirements for radiation protection education, training and information Justification and Regulatory control of practices Occupational exposures Medical exposures Public exposures General responsibilities of Member States and competent authorities and other requirements for regulatory control 18
Council Directive 2013/59/Euratom Subject matter and Scope The concept of planned, existing and emergency exposure situations is not introduced into national legislation Definitions The majority of terms exist in national legislation Terms concerning emergency exposure situation are not fully harmonised Definition of disused source does not exist 19
Council Directive 2013/59/Euratom System of radiation protection Significantly transposed general principles of radiation protection (justification, optimisation, dose limitation) age limit for exposed workers protection of pregnant and breastfeeding workers The tools for optimisation are not fully align with new concept of the Directive: dose constraints for all exposed categories reference levels dose limits for the lens of the eye consultation with ICRP Publication 116 about estimation of doses 20
Council Directive 2013/59/Euratom Requirements for radiation protection education, training and information Significantly transposed general responsibilities for the education training and provision of information, training of exposed workers and information provided to them prior information and training for emergency workers education, information and training in the field of medical exsposure Requirements for the training of workers potentially exposed to orphan sources are not transposed in national legislation (Article 16.2) 21
Council Directive 2013/59/Euratom Justification and Regulatory control of practices Significantly transposed justification and prohibition of practices graded approach to regulatory control notification registration licencing Not transposed Practices involving non-medical imaging exposure of humans Practices involving consumer products Practices involving NORM materials The exemption and clearence criteria regarding new elements of Directive do not match existing criteria in national legislation (still the same as in Directive 96/29) 22
Council Directive 2013/59/Euratom Occupational exposures Significantly transposed occupational protection of exposed workers classification of workplaces controlled areas, supervised areas radiological surveillance of the work place categorisation of exposed workers individual monitoring recording and reporting of results medical surveillance of exposed worker prohibition to employ or classify unfit workers medical records special medical surveillance emergency occupational exposure 23
Council Directive 2013/59/Euratom Occupational exposures Outside workers- partially transposed Provisions are not fully aligned with the requirements of Directive outside worker is any person performing any sort of radiation practice in a controlled area, but not employed as an occupationally exposed person by the license holder responsible for the implementation of radiation safety measures within such controlled zone requirement for a license holder to keep records of individual exposures of professionally exposed persons to ionizing radiation and outside workers license holder may employ outside workers only if such persons fulfill the requirements specified in national legislation Specially authorized exposures are not transposed Provisions concerning radon in workplaces, indoor exposures, action plan (Articles 54, 74, 103, Annex XVIII) are not transposed 24
Council Directive 2013/59/Euratom Medical exposures Significantly transposed justification optimisation responsibilities procedures, QA/QC education and training equipment criteria special practices special protection during pregnancy and breastfeeding estimates of population doses Accidental and unintended exposures are not transposed 25
Council Directive 2013/59/Euratom Public exposures Protections of members of the public are not transposed in all details as stipulated in articles 65-67 of Directive, regarding the assessment of doses from identified practices, monitoring of radioactive discharges, tasks for the undertaking Articles related to information to the public in the event of an emergency are fully transposed in Draft version of National Radiation Emergency Plan (NREP) 26
Council Directive 2013/59/Euratom Public exposures Draft version of National Radiation Emergency Plan (NREP) IAEA Emergency Preparedness Review (EPREV) mission, June 2012 assessment of the Serbian legislation, arrangements and capability to respond to possible radiological emergencies on the basis of international standards and the EU acquis for emergency preparedness response and development of interim arrangements to respond to possible radiological emergencies main areas considered: emergency management emergency preparedness radiation protection law enforcement medical response public information national capability to support and provide training to local response teams 27
Council Directive 2013/59/Euratom Public exposures Provisions concerning contaminated areas in the existing exposure situation are not transposed lasting exposure, building materials, etc 28
Council Directive 2013/59/Euratom General responsibilities of Member States and competent authorities and other requirements for regulatory control Partially transposed Article 76, requirements for the regulatory body neither radiation protection expert, medical physics expert nor the criteria for their recognition are identified in national legislation occupational health service, not in all aspects as required by Directive RPO, dosimetry services,... significatly transposed activity values defining high activity sealed sources are not in compliance with Directive (still the same as in HASS 122/2003) Provisions of Annex XVI are not transposed the provisions concerning orphan sources are not fully transposed Specialised technical advice and assistance, arrangements for raising general awareness, developing guidances (Article 92) 29
Council Directive 2013/59/Euratom General responsibilities of Member States and competent authorities and other requirements for regulatory control Financial security system for covering orphan sources is not established The import/export control of metal products to detect contamination is in place Border control (RPM), dosimetry control at scrap metal yards, steel plants, etc. Emergency management system is covered by Draft version of NREP International cooperation is regulated by the Conventions: Convention on Early Notification of Nuclear Accidents (Official Gazette of FRY, No. 15/89) Convention on Assistance in the Case of a Nuclear Incident or a Radiological Emergency, (Official Gazette of FRY, No. 4/91) System of enforcement: Inspection for radiation protection in the Ministry of Agriculture and Environmental Protection Inspection for nuclear safety and radioactive waste management in the Ministry of Education, Science and Technological Development 30
SRPNA is keeping records of: Implementation sources of ionising radiation and their users licence holders occupationally exposed persons radioactive waste other data relevant for radiation protection, radiation and nuclear safety and security etc. In 2013 - Regulatory Authority Information System (RAIS) During 2013/2014 started with training of SRPNA staff for using RAIS 31
Implementation Licencing for performing a radiation practice 1 61 1 2 4 3 medicine industry veterinary 34 servicing 4 trade/ servicing 48 261 trade production production /servicing scientific research control of goods and consignments 32
Council Regulation 1493/93/Euratom SRPNA DIRECTORATE FOR TRANSPORTATION OF DANGEROUS GOODS Permits for the import, export and transit of radioactive materials Permits for transport of class 7 of dangerous goods, according to the Law on the Transport of Dangerous Goods (Official Gazette RS, 88/10) Council Regulation 1493/93/Euratom is partially harmonized Serbian legislation: Terminology is not fully harmonised The process of shipment includes more than two legal entities The declaration form is a part of necessary documentation for issuing unique permit The declaration form contains less information than proposed by Regulation 1493/93/Euratom 33
Implementation Number of issued permits for import, export and transit of ionizing radiation sources (radioactive materials and X-ray generators) - since August 2010 Permits August 2010 May 2014 Import 982 Export 174 Transit 74 34
European Community Radiological Information Exchange ECURIE System (Council Decision 87/600) Republic of Serbia is a part of the Convention on Early Notification of a Nuclear Accident since 2002 Rulebook for establishing programme of early warning of emergency (Official Gazette of RS No. 70/11) establishes an Early Warning System that ensures the continuous measurement of ambient gamma dose rate in air at 8 locations, and the timely notification of an accident The results are displayed every 30 minutes on the SRPNA web site 35
European Community Urgent Radiological Information Exchange ECURIE System (Council Decision 87/600) EUropean Radiological Data Exchange Platform Serbia provides ambient gamma dose rate and radiological monitoring data from national surveillance networks to the European Radiological Data Exchange Platform (EURDEP) since January 2011 By regular diplomatic means, as a candidate country, the Republic of Serbia will request ECURIE membership 36
Chernobyl Foodstuffs Regulations Regulations 733/2008, 1609/2000, 1635/2006, 1048/2009 Permitted radioactivity levels of foodstuff placing in the market in accordance with dose criteria for population in national legislation There are no other limits of contaminations for foodstuffs, feeding stuffs nor for imported products Republic of Serbia are on the list of third countries of the EU according the Commission Regulation No 1635/2006 37
Future accidents Regulations 3954/87, 2219/89, 2218/89, 944/89, 770/90 Permitted levels of radioactive contaminations of foodstuffs and feedingstuffs following nuclear accident required by national legislation are aligned with Council Regulations No 3954/87, 944/89 and 770/90 (not with 2218/89, 2219/89) Rulebook on limits of radionuclides content in drinking water, foodstuffs, feeding stuffs, medicines, general use products, construction materials and other goods that are put on market (Official Gazette of RS No. 86/11, 97/13) 38
Future accidents activity limits [Bq/kg] or [Bq/l] Milk and dairy products Foodstuffs except less commonly used foodstuffs Minor foodstuffs 90 Sr 125 750 7500 131 I 500 2000 20000 Alfa unstable isotopes of plutonium, transplutonium elements, particularly 239 Pu, 241 Am All other nuclides with a half-life above 10 days, especially 134 Cs, 137 Cs (excluding 14 C i 3 H) 20 80 800 1000 1250 12500 39
Directive 2013/51/Euratom laying down requirements for the protection of the health of general public with regard to radioactive substances in water intended for human consumption Radionuclide Derived Concentration (Bq/l) C-14 2,3E+02 Co-60 Sr-90 4,0E+01 4,9E+00 I-131 6,2E+00 Cs-137 Cs-134 Pb-210 Ra-224 Ra-226 Ra-228 Th-232 7,2E+00 1,0E+01 2,0E-01 2,1E-01 4,9E-01 2,0E-01 5,9E-01 Not transposed in national legislation Derived concentration of individual radionuclides in drinking water Rulebook on limits of radionuclides content in drinking water, foodstuffs, feeding stuffs, medicines, general use products, construction materials and other goods that are put on market (Official Gazette of RS No. 86/11, 97/13) 40
Radon measurements Radon in national legislation Programme of systematic environmental radioactivity examination establishes locations and number of measurements of indoor radon Indoor radon measurements are performed once a year in homes and schools and kindergardens in 7 cities Rulebook on limits of exposure to ionizing radiation and measurements for assessment the exposure levels (Official Gazette of RS No. 86/11) establishes intervention levels for radon in workplaces to 1000 Bq/m 3, and intervention levels for chronic exposure to radon in homes to 200 Bq/m 3 for newly built and 400 Bq/m 3 for existing buildings 41
Future steps in Harmonization with EU acquis Additional efforts needed for full alignment with EU acquis: Future transposition of new concept and missing elements of new 2013/59 Directive into national legislation Adoption of Draft version of National Radiation Emergency Plan (NREP) Establishing RAIS system Adoption of Radiation Safety and Security Programme Enhancing the capacity of Regulatory Body and regulatory infrastructure in the field Improving the implementation of existing legislation 42
t Thank you for your attention Safety Agency European integration, international cooperation and legal affairs Department 43