1. Vienna 10-14 November 20141 Regional Workshop School for drafting regulations IAEA’s Headquarters Vienna, Austria, 10 to 14 December 2014 R PACI RPC

2. Vienna 10-14 November 20142 National policy and strategy for safety In process of establishing the working group Establishment of a framework for safety The government shall establish and maintain an appropriate governmental, legal and regulatory framework for safety within which responsibilities are clearly allocated. (paras 2.5, 2.6) Indicate: a.Who are the regulators for different modes of transport in your country, b.What regulations are in force in each case, and c.What is the review process applied. - Issuing regulations

3. Vienna 10-14 November 20143 1995 New framework Law No 8025 Regulatory Body(duty and responsibility), Authorization, Inspection and Enforcement Transport of rad materia……l 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 Promulgation of radiation protection law & regulations

4. Vienna 10-14 November 20144 DCM No 510 Date 13 maj 2008 for funcioning of RPC Independence Main Articles -Composition and members -Organization of meetings -Mandate of members -Financing Promulgation of radiation protection law & regulations

5. 5 Radiation Protection Infrastructure Ministry of Health Radiation Protection Commission Authorized Agencies Radiation Protection OfficeLegislation Licensing Center of Applied Nuclear Physics Institute of Public health Calibration expertise Dosimetry Environment control WASTE MANAGEMENT Training Medical Surveillance Inspection enforcement Radiology Radiotherapy Nuclear medicine Industry research etc COUNCIL OF MINISTERS Institute of radiation Institute of radiation Protection Expertise and training 5 Vienna 10-14 November 2014

6. 6 Radiation Protection Commission (Regulatory Body Ionizing Radiation sources ) Radiation Protection Office (Executive Body) Structure 2.Establishment of a National Regulatory Authority

7. Vienna 10-14 November 20147 Some responsibilities...... Prepare regulations, and approves guides and codes of practices for radiation protection Oversees the enforcement of the provisions related with radiation protection. Issues the licences Technical management Organisation for Radiological emergency Etc....... Radiation Protection Commission

8. Vienna 10-14 November 20148 DECISION of CM No.9, date 7.1.2010 Approval of the Regulation“ O n the categorization of radioactive sources in the Republic of Albania, in function of the radiation protection, safety and security of ionizing radiation sources” -Objective of the regulation, -Basic elements for the assessment of the categorization, -The effects of the radioactive materials according to the categorization, -Categorization of the radioactive materials Promulgation of radiation protection law & regulations

9. Vienna 10-14 November 20149 Decision No.488, date 23.6.2010 Approval of the Regulation “On the safe transport of the radioactive materials” -The object of the regulation, -Definitions, -Notification for transport, -Classification of the packages, -Contamination Limit levels, Limit radiation levels during the transport, -Transport Categorization, Package label, Additional conditions, Accompanying documentation during the transport -Passage through custom, Final provisions -Values of the radionuclides for the transport -Limit Activity for the excepted packaging. -Perform of radioactive danger and labels of transport categories Promulgation of radiation protection law & regulations

10. Vienna 10-14 November 201410 Regulation “On the safe transport of the radioactive materials” Definitions a) A1 is the value of the maximal activity of the radioactive materials in special form for each radionuclide that can be transported in type A packaging. b) A2 is the value of the maximal activity of the radioactive materials for each radionuclide, excluding those in special form, that can be transported in type A packaging. c) the consignor,the transporter, the consignee, packaging package, special vehicle, Special form radioactive material, Transport index Promulgation of radiation protection law & regulations

11. Vienna 10-14 November 201411 Notification for transport The transport of the radioactive materials should be carried out after the notification and the special authorization issued by Radiation Protection Office. The notification near RPO should be done 1 week before the transport at least. As the transport is carried out the transporter has the obligation to represent to the RPO a copy of the delivery documentation signed by the consignee Promulgation of radiation protection law & regulations

12. Vienna 10-14 November 201412 Classification of the packages 1.The classification of the packages is related to the qualities of radioactive material that shall be transported and to the requirements that they should to fulfil in the conditions of a normal transport and accident conditions that can be occurred during this transport. 2.The consignor is responsible of the use of the appropriate packaging ( according to the international standards ( TS-R-1 IAEA) taking into account the characteristics of the radioactive materials that shall be transported. Promulgation of radiation protection law & regulations

13. Vienna 10-14 November 201413 Clasification of the packages The packages for transport of radioactive materials are classified as follows: a) Exempted package is a package with consuming items or instruments that contain radioactive materials with activity not more than the values shown in table II attached. For the postal transport the total activity in every exempted package should not exceed one tenth of limitation specified in table II. b) Industrial package (IP-1, IP-2, IP-3) is a packaging containing low specific activity (LSA) or surface contaminated objects (SCO). Promulgation of radiation protection law & regulations

14. Vienna 10-14 November 201414 Clasification of the packages The packages for transport of radioactive materials are classified as follows: Type A package is a packaging containing an activity up to A1 if special form radioactive material or up to A2 if not special form radioactive material. Type B(U) and B(M) package are packaging containing : Type C package means package containment with : Promulgation of radiation protection law & regulations

15. Vienna 10-14 November 201415 Contamination Limit levels 1. The level of outside surface package non-fixed contamination (easy clean) does not exceed the following levels: a) 4 Bq cm -2 for beta and gamma emitters and low toxicity alpha emitters; b) 4 Bq cm -2 for all other alpha emitters. 2. These limit levels are applicable for average areas with a surface of 300 cm2 for each part of surface Promulgation of radiation protection law & regulations

16. Vienna 10-14 November 201416 Limit radiation levels during the transport a) Radiation level for the exempted packages must be no greater than 5 μSv/h at the surface of the package. b) Radiation level for the type A, B(U) and B(M) package, must be no greater than 2 mSv/h at any point on the outside surface of the package. c) Radiation level for the packages put in one vehicle must be such as in normal transport conditiond not be greater that 2 mSv/h at any outside surface point of the vehicle and 0.1 mSv/h at 2 m distance from the outside surface of the vehicle.. d) In the case of empty packaging, the package may be transported as an excepted package. Promulgation of radiation protection law & regulations

17. Vienna 10-14 November 201417 Transport Categorization 1.Each package, apart the excepted packages, should be included in one of the following categories, paying attention to the radiation levels at outside surface of the package as well the transport index: Promulgation of radiation protection law & regulations Transport CategorizationHigher radiation level at outside surface of the package Index of transport I – WHITETo 0.005mSv/h0 II – YELLOWFrom 0.005mSv/h to 0.5mSv/h0 to 1 III – YELLOWFrom 0.5mSv/h to 2mSv/h1 to 10 III – YELLOWFrom 2 mSv/h to 10mSv/h In special conditions approved by RPO More than 10

18. Vienna 10-14 November 201418 Package label Apart from excepted packages, packages should be indicated by placing a label, according to the models in regulation Accompanying documentation during the transport The transport documentation accompanying the cargo f the radioactive material should have the following information: a) declaration from the consignor of the package if radioactive material indicating that packaging and labelling are done in compliance with the relevant regulation; b) names and correct address of the consignor, transporter, and consignee of the package; Promulgation of radiation protection law & regulations

19. Vienna 10-14 November 201419 Accompanying documentation during the transport c) name and date of the issuing licenses for the consignor, transporter, and consignee of the package; d) the name and symbol of each radionuclide transported and their activity; e) description of the physical and chemical form of the radioactive material, as well as radioactive material special form or not; f) the category of package (I-WHITE, II-YELLOW or III-YELLOW); g) transport index; 2. All the accompanying documents should have the signature and the seal of the subject involved in the procedures of the transport. RPO has the right to exercise the control related to the correct transport documentation, security, safety and radiation protection, at any time to the licensed subjects. Promulgation of radiation protection law & regulations

20. Vienna 10-14 November 201420 Passage through custom 1. Custom authority, in collaboration with Radiation Protection Commission, defines the areas and the criteria to fulfil to guarantee the radiation protection and physical security. 2. Import and export of the packaging of radioactive materials by the licensed subjects, as well as the corresponding action at custom authorities are fulfilled based on an special approval from RPO, presented original any case the subjects import/export radioactive materials Promulgation of radiation protection law & regulations

21. Vienna 10-14 November 201421 a.Who are the regulators for different modes of transport in your country, The transport of radioactive sources in Albania is regulated also by the law No. 118 date 26.12. 2012 “On transport of dangerous goods”. Article 8 (Approval for packaging) define that the approval for the packaging which is used for transport of radioactive materials is given by the Radiation Protection Commission. In article 21 (Obligations of the carrier in case of loss of goods) in case of accidents or incidents in the transport of radioactive substances, except the National Operations Center for Civil Emergencies should be informed even the Radiation Protection Commission, as well as other organizations. Article 23 (Authorizations to transport) clarify that the authorization to transport Radioactive materials is approved by the of Radiation Protection Commission (RPC) - Issuing regulations

22. Vienna 10-14 November 201422 Article 23 ( point 4) define that entity, whose activity is related to the use of….. radioactive substances, can be given authorization for multiple transports of these substances, which is valid up to six months for radioactive substances. Such authorization is granted unless the condition that the transport is performed on the same day of the week, at the same hour, on the same route from origin to destination, with the same tool / vehicles and with the same driver. Article 52 define supervision inspection 1. Inspection supervision for the implementation of this Law and regulations adopted for the transport of radioactive substances is performed, respectively, by inspectors of the Office of Radiation Protection. - Issuing regulations

23. Vienna 10-14 November 201423 What is the review process applied. There is a Aplicatin for permission approved Issuing of approvals Transport in Albania is performed only when the company has the license and the permission Transport permission For RADIOACTIVE SOURCES No________Date_____________________ Based on Law “On ionizing radiation protection”, no. 8025, date 9.11.1995 amended and regulation “On the safe transport of the radioactive materials” no.488, date 23.6.2010: - Issuing regulations

24. Vienna 10-14 November 201424 Physical Legal Person, with representative Is permitted to transport,Radioactive material Radionuclide Total activity The company destination and use From To Invoice No. / Date or approximate period of transport This permit accompanies the transport of radioactive source / s from departure to destination. Is valid for 2 weeks from the date of issue. After transporting the physical / legal person is obliged within one week to notify RPO by writen for carrying out the actions to the source/s destination. Requested by Fulfilled by - Issuing regulations

25. Vienna 10-14 November 201425 a.Radioactive materials used in your country All types of cat ! a.Type and quantity of facilities using radioactive materials b.Nuclear medicine,NDT, research,radiotherapy c.Types of packages used A mainly but sometimes B d.Number of packages transported by year 200 packages e.More relevant shipments Nuclear medicine I and Tc f.Point of entry, exit, transit routes Air g.Who can inspect packages/shipments RPC 1.On road not comon 2.At sea ports and on ships 3.At airports and on aircraft often Monitoring of transport operations

26. Vienna 10-14 November 201426 Notifications : –Consignor, Consignee, Dates, routes, final destination –Marked in regulation for transport Certificates –Dangerous goods declaration,Yes even dual use – Approval certificates for packages / materials No really we accept the foreign certeficaes Inspections –What inspections are required if any? Who inspects what? –Permission for transport Import-export of radioactive materials

27. Vienna 10-14 November 201427 a.How are the responsibilities established in your country for he transport of radioactive material? Mainly all responsibilities are clearly established by regulations Establishing responsibilities

28. Vienna 10-14 November 201428 Transport regulations in paras 311 to 314, and GSR Part 1 in Requirement 36, establish provisions for training and communication. Is the appropriate training available (for all modes of transport) a.For Consignors no b.For Carriers no c.For First Responders yes through dep of emergency d.For Radiation Workers Yes e.For Regulators Yes Training and distribution of information

29. Vienna 10-14 November 201429 a.Do you have a national response plan? Yes b.Is response to transport accidents/incidents covered in that? yes c.Are the proper authorities involved? Not clearly d.Is the appropriate equipment available? Yes e.Are responders properly trained? Not really f.Do you have notification requirements? yes g.What about members of the public? What means h.When was the last emergency exercise for transport? No emergency in transport up to now i.Have you exercised the response plan? Yes top table and field exercise Emergency planning and exercises

30. Vienna 10-14 November 201430 For your country, who is responsible for: a.Verification of compliance of packages: Documentation, Labelling, Doses RPC and custom Procedures for legal movement f rad mat at border a.Verification of Shipments: Approval, Marking for transport RPC a.Compliance for carriers RPC inspection prcess even b.Notification: How do you know if an incident has occurred? They have responsibility o inform us by law Compliance assurance and enforcement

31. Vienna 10-14 November 201431 6. Finally, what do you see as your greatest challenges when it comes to the safe transport of radioactive material in your country? Review of regulations taking onto account EU requirements Inspecting process in transport Etc... Promulgation of radiation protection law & regulations

32. 32 Thank you for attention Vienna 10-14 November 2014