Radiation Protection Regulations: Governance and Implementation

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

2. - Issuing regulations 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: Who are the regulators for different modes of transport in your country, What regulations are in force in each case, and What is the review process applied. Vienna 10-14 November 2014

3. Promulgation of radiation protection law & regulations 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 Vienna 10-14 November 2014

4. Promulgation of radiation protection law & regulations DCM No 510 Date 13 maj 2008 for funcioning of RPC Independence Main Articles -Composition and members -Organization of meetings -Mandate of members -Financing Vienna 10-14 November 2014

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

6. 2.Establishment of a National Regulatory Authority Radiation Protection Commission (Regulatory Body Ionizing Radiation sources ) Radiation Protection Office (Executive Body) Structure Vienna 10-14 November 2014

7. Radiation Protection Commission 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....... Vienna 10-14 November 2014

8. Promulgation of radiation protection law & regulations 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 Vienna 10-14 November 2014

9. Promulgation of radiation protection law & regulations 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 Vienna 10-14 November 2014

10. Promulgation of radiation protection law & regulations 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 Vienna 10-14 November 2014

11. Promulgation of radiation protection law & regulations 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 Vienna 10-14 November 2014

12. Promulgation of radiation protection law & regulations Classification of the packages 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. 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. Vienna 10-14 November 2014

13. Promulgation of radiation protection law & regulations 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). Vienna 10-14 November 2014

14. Promulgation of radiation protection law & regulations 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 : Vienna 10-14 November 2014

15. Promulgation of radiation protection law & regulations 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 Vienna 10-14 November 2014

16. Promulgation of radiation protection law & regulations 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. Vienna 10-14 November 2014

17. Promulgation of radiation protection law & regulations Transport Categorization 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: Vienna 10-14 November 2014

18. Promulgation of radiation protection law & regulations 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; Vienna 10-14 November 2014

19. Promulgation of radiation protection law & regulations 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 formof 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. Vienna 10-14 November 2014

20. Promulgation of radiation protection law & regulations 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 Vienna 10-14 November 2014

21. - Issuing regulations 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) Vienna 10-14 November 2014

22. - Issuing regulations 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 . Vienna 10-14 November 2014

23. - Issuing regulations 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: Vienna 10-14 November 2014

24. - Issuing regulations 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 Vienna 10-14 November 2014

25. Monitoring of transport operations Radioactive materials used in your country All types of cat ! Type and quantity of facilities using radioactive materials Nuclear medicine ,NDT, research,radiotherapy Types of packages used A mainly but sometimes B Number of packages transported by year 200 packages More relevant shipments Nuclear medicine I and Tc Point of entry, exit, transit routes Air Who can inspect packages/shipments RPC On road not comon At sea ports and on ships At airports and on aircraft often Vienna 10-14 November 2014

26. Import-export of radioactive materials 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 Vienna 10-14 November 2014

27. Establishing responsibilities How are the responsibilities established in your country for he transport of radioactive material? Mainly all responsibilities are clearly established by regulations Vienna 10-14 November 2014

28. Training and distribution of information 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) For Consignors no For Carriers no For First Responders yes through dep of emergency For Radiation Workers Yes For Regulators Yes Vienna 10-14 November 2014

29. Emergency planning and exercises Do you have a national response plan? Yes Is response to transport accidents/incidents covered in that? yes Are the proper authorities involved? Not clearly Is the appropriate equipment available? Yes Are responders properly trained? Not really Do you have notification requirements? yes What about members of the public? What means When was the last emergency exercise for transport? No emergency in transport up to now Have you exercised the response plan? Yes top table and field exercise Vienna 10-14 November 2014

30. Compliance assurance and enforcement For your country, who is responsible for: Verification of compliance of packages: Documentation, Labelling, Doses RPC and custom Procedures for legal movement f rad mat at border Verification of Shipments: Approval, Marking for transport RPC Compliance for carriers RPC inspection prcess even Notification: How do you know if an incident has occurred? They have responsibility o inform us by law Vienna 10-14 November 2014

31. Promulgation of radiation protection law & regulations 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... Vienna 10-14 November 2014

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