IAEA School for Drafting Regulations on Radiation Safety

IAEA School for Drafting Regulations on Radiation Safety - 2018 ALBANIA Legal Framework and Regulations for Radiation Safety

Outline Country presentation should cover: 1) Current status of the Radiation Safety Infrastructure 2) Overview of the legal and regulatory framework for radiation safety in your country: • The Legal Pyramid showing the hierarchy of Laws, Acts, Regulations and Guides, as applicable • The Regulatory Body (structure, independence, staff …) • List of relevant radiation safety requirements and regulations 3) An overview of the existing regulatory requirements (regulations and guides) 4) Process to establish or revise regulations - Overview of the process - Current activities in regulations development 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 2

Current status of the Radiation Safety Infrastructure • Legislation and regulations; • Regulatory authority empowered to authorize and inspect regulated activities and to enforce the legislation and regulations; • Resources and adequate numbers of trained staff. • Appropriate equipments 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 3

Overview of the legal and regulatory framework for radiation safety in your country • The Legal Pyramid showing the hierarchy of Laws, Acts, Regulations and Guides, as applicable 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 4

Overview of the legal and regulatory framework for radiation safety in your country • The Regulatory Body (structure, independence, staff …) COUNCIL OF MINISTERS Ministry of Health and Social Protection Radiation Protection Commission Authorized Agencies Radiation Protection Office Legislation Licensing Institute of Applied Nuclear Physics Institute of Public health Inspection enforcement Instrument calibration Personal dosimetry Environment control waste management Training Medical Surveillance Medicine Waste facilities Industry research Institute of radiation Protection Expertise and training 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 5

Overview of the legal and regulatory framework for radiation safety in your country • RADIATION PROTECTION COMMISSION (Regulatory Body Ionizing Radiation sources ) • RADIATION PROTECTION OFFICE (Executive Body) 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 6

Radiation Protection Commission Responsibility • Prepares regulations, and issues guides and Codes of Practice for radiation protection and safety; • Oversees enforcement; • Issues licenses; • Technical advisory of all national and local authorities for immediate enforcement of necessary procedures for mitigation of the effects of nuclear accidents; • Makes recommendations and proposals for the improvement of the radiation protection legislation; • Cooperates with national and international organizations on radiation protection issues; • Defines the structure of the RPO; • Nominates/dismissal of the Chairman of PRO; and • Cooperates with the State Labor Inspectorate and Health Inspectorate 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 7

Radiation Protection Office Responsibility • Assess and prepare the information on licensee application and submit for approval/ suspension/denied to RPC; • Enforcement; • Inspection; • Collection of information and performance of necessary analysis and measurements for radiation protection control; and • Preparation of relevant information, including reports for RPC meetings. • Keeps national inventory of ionizing radiation sources; 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 8

Current status of the Radiation Safety Infrastructure • Law No. 10379, date 24. 02. 2011 Republic of Albania adhere in the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management (entered in force 27. 09. 2011) • Law No. 10380, dated 24. 02. 2011 Republic of Albania adhere in the Convention on Nuclear Safety. (entered in force 27. 09. 2011) • Law No. 9026, dated 13. 3. 2003 Republic of Albania adhere in the Convention on Early Notification of a Nuclear Accident accession ( entered in force 30. 10. 2003) 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 9

Current status of the Radiation Safety Infrastructure • Law No. 9015, dated 20. 2. 2003 Republic of Albania adhere in the Convention on Assistance in the Case of a Nuclear Accident or Radiological Emergency (entered in force 30. 05. 2003) • • Law No. 8853, dated 31. 01. 2002 Republic of Albania adhere in the Convention on the Physical Protection of Nuclear Material (entered in force 04. 2002). Law No. 88 dated 21. 02. 2013 Republic of Albania adhere in the Amendment of the Convention on the Physical Protection of Nuclear Material (entered in force 08. 05. 2016) 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 10

• • Current status of the Radiation Safety Infrastructure 1995 New framework Law No. 8025 Regulatory Body (duty and responsibility), Authorization , Inspection and Enforcement 2008 Amendments to the Law No 9973, date July 28 th 2008 Security Issues , Regulations approved by Decision of Council of Ministers , Increase Independence of RPC Inventory of sources 1996 July Established Radiation Protection Office 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 11

Overview of the legal and regulatory framework for radiation safety in your country • List of relevant radiation safety requirements and regulations • Regulation No. 615 , date 16. 11. 2016 on “Safe transport of radioactive materials” • Regulation No. 638, date 7. 9. 2016 on “Safe management of radioactive waste in the Republic of Albania” • Regulation No 877, date 30. 10. 2015 on “ Physical Protection of the radioactive sources in Republic of Albania” • Regulation No. 956 dated 25. 11. 2015 on “ Guidance levels for the indoor radon concentration and the concentration of radio nuclides in goods, aiming to protect the public” • Regulation No. 404 dated 18. 06. 2014 on “Basic rules of radiological installations in medicine” 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 12

Overview of the legal and regulatory framework for radiation safety in your country • Regulation No. 229, dated 20. 03. 2013 on “medical exposures control ” • Regulation No. 481, dated 25. 07. 2012 on “public exposure control” • Regulation No. 590, dated 18. 08. 2011 on “occupationally exposed control” • Regulation No. 543, dated 7. 7. 2010 on “Safe handling with ionizing radiation sources” • Regulation No. 9, dated 7. 01. 2010 on “Categorization of radioactive sources in the Republic of Albania” • Regulation No. 10, dated 7. 01. 2010 on “Licensing and Inspection of the Activities with Ionizing Radiation” 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 13

Overview of the legal and regulatory framework for radiation safety in your country • Strategic steps for safe management of radioactive waste in the Republic of Albania”, No. 435, dated 14. 10. 2015 • National Policy for radioactive waste management” No. 1319/3 date 25 March 2013. 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 14

Overview of the legal and regulatory framework for radiation safety in your country • Requirements for Control of Import export procedures for Cat 1 and 2 based to Code of Conduct No. 134 Date 12 April 2011 • Decision of Council of Ministers on Control of import export of radioactive material No. 158, date 13. 2. 2008 include DSRS • Code of conduct for safety and security of radioactive sources No. 1388 dated 14. 04. 2004 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 15

Overview of the legal and regulatory framework for radiation safety in your country • Authorization procedures are in place, Review and assessment. . • Inspection procedures are in place, Annual inspection program • Based on the risk of radioactive sources and past performance of the licensee, is define the frequency of the inspection • E-inspections is in the process of implementation • There are clear procedures to enforce regulatory requirements • Clear enforcement action based on the nature of non compliance and implications for safety, instructions, sanctions, suspensions • Cooperation with other national Bodies in process 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 16

Process to establish or revise regulations 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 17

Overview of the process • Every year RPC prepares and approves the action plan for reviewing or drafting legislation • Based on this, established the working group. WG is responsible to collect all the information (national legislation or international references), which are important for preparing the first draft. • The first draft sent for comments at RPO staff and based on their suggestions or recommendation WG prepares the second draft. • The second draft sent for further comments at RPC. Their comments reflected in the document and they approves in principle third draft. • The third draft publish for one month to the web page for comments from the public. RPO collect the comments from public if they have and RPC has to take a decision if the comments should reflected or not in the legislation. 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 18

Overview of the process • After that the draft sent through Ministry of Health and Social Protection to Ministry of Lines, for further comments and recommendations. • After comments and recommendations done by Ministry of lines, RPO in collaboration with the Legal Directorate in the Ministry of Health and Social Protection, reflect them in the regulation and prepares the final draft of regulation. • The final draft sent for approval at Council of Ministries and after that the regulation enter in force and publish in the web page. 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 19

• Thank you for your attention!! 2018 IAEA School for Drafting Regulations - Radiation Safety ALBANIA 20