1. 6 . Notification and Authorization. Graded Approach

1. 1.6. Notification and Authorization. Graded Approach “School for Drafting Regulations on Radiation Safety, IAEA - Module 1 Regulatory framework for safety, authorization and inspection October 2012

2. Objective • To provide understanding of the authorisation process and the regulations and procedures for its implementation. Notification & Authorization. Graded Approach

3. Contents • Exemption • Notification • Authorization • Graded approach Notification & Authorization. Graded Approach

4. Exemption. GSR Part3 Exemption • The government or the regulatory body shall determine • which practices • or which sources within practices are to be exempted • from some or all of the requirements of these Standards, including the requirements for notification, registration or licensing, • Basis for this determination - the criteria for exemption or any exemption levels specified by the regulatory body CRITERIA AND LEVELS - GSR PART 3 Notification & Authorization. Graded Approach

5. Exemption Exempted facilities and activities Regulated facilities and activities Exempted Exempted Notification & Authorization. Graded Approach

6. Clearance Radioactive discharges Radioactive material clearance Regulated facilities and activities Radioactive decay storage or radioactive waste disposal Notification & Authorization. Graded Approach

7. Notification and Authorization. GSR Part3 The regulatory body shall establish a regulatory system for protection and safety that includes: • (a) Notification and authorization; • … Notification & Authorization. Graded Approach

8. Notification and Authorization. GSR Part3 Notification and authorization • Any person or organization intending to operate a facility or to conduct an activity shall submit to the regulatory body, as appropriate, a notification or an application for authorization. NOTIFICATION = APPLICATION NOTIFICATION = LIST OF INTENT NOTIFICATION = … Notification & Authorization. Graded Approach

9. Notification and Authorization. Requirements for notification • Clear identification of the person making the notification; • Clear specification of the practice; • Clear specification of the source(s) to be used in the practice: • form of radioactive source(s), radionuclide(s), identification number, location, activity • X ray equipment - manufacturer, model, serial number, location and power Notification & Authorization. Graded Approach

10. Notification and Authorization. GSR Part3 • Are there any cases when notification is sufficient for regulatory body? • When is notification alone enough? Notification & Authorization. Graded Approach

11. Notification and Authorization. GSR Part3 When Is notification alone enough? Example of graded approach • Notification alone is sufficient provided that • the exposures expected are unlikely to exceed a small fraction, as specified by the regulatory body, of the relevant limits, • the likelihood and magnitude of potential exposures and any other potential detrimental consequences are negligible. Notification & Authorization. Graded Approach

12. Notification and Authorization. GSR Part3 When Is notification alone enough? • Example: • 5 category gas chromatography detector source, 5 mCi Ni-63 • 5 category Gd-153 PET calibration sources, less than 1 mCi (shown in a carrying case) Notification & Authorization. Graded Approach

13. Notification and Authorization. Plans for the facility or activity Proceed Yes Exempted ? No No Notification Proceed Yes Is notification enough? No Notification & Authorization. Graded Approach

14. Notification and Authorization. GSR Part3 Authorization: registration or licensing • Any person or organization intending to carry out any of the actions specified in … shall, unless notification alone is sufficient, apply to the regulatory body for authorization, which shall take the form of either registration or licensing. Notification & Authorization. Graded Approach

15. Notification and Authorization. GSR Part3 Authorization: registration or licensing • Any person or organization applying for authorization: • Shall submit to the regulatory body the relevant information necessary to support the application; • Shall refrain from carrying out any of the actions specified in … until the registration or license has been granted; • Shall assess the nature, likelihood and magnitude of the expected exposures due to the source and shall take all necessary measures for protection and safety; Notification & Authorization. Graded Approach

16. Notification and Authorization. GSR Part3 Authorization: registration or licensing (cont’d) • Any person or organization applying for authorization: • Shall, if there is a possibility for an exposure to be greater than a level as specified by the regulatory body, have a safety assessment made and submitted to the regulatory body as part of the application; • Shall, as required by the regulatory body, have an appropriate prospective assessment made for radiological environmental impacts, commensurate with the radiation risks associated with the facility or activity. Notification & Authorization. Graded Approach

17. Notification and Authorization. GSR Part 1 Authorization of facilities and activities by the regulatory body • The regulatory body shall issue guidance on the format and content of the documents to be submitted by the applicant in support of an application for an authorization... Notification & Authorization. Graded Approach

18. Notification and Authorization. GSR Part 1 Requirement 23: Authorization of facilities and activities by the regulatory body • Any subsequent amendment, renewal, suspension or revocation of the authorization for a facility or an activity shall be undertaken in accordance with a clearly specified and established procedure, and shall make provision for the timely submission of applications for the renewal or amendment of the authorization Notification & Authorization. Graded Approach

19. Notification and Authorization. Exercise – 10 minutes 1. What provisions in the law, which regulations, guides and procedures are needed to provide for notification and authorization? HELP: Use as a reference GSR Part 3 requirements para 3.7,3.8,3.9,3.10 and GSR Part 1 requirements 23, 24. 2. Prepare the list of regulations, guides and procedures and discuss with your neighbor or trainer Notification & Authorization. Graded Approach

20. Notification and Authorization. GSR Part3 • Exemption criteria and levels • Procedure for decision making for exemption from some or all of the requirements • Regulation for the notification and authorization procedure (including subsequent amendment, renewal, suspension or revocation of the authorization) • Guidance for the format and content (including application form) documents to be submitted by the applicant in support of an application for an authorization • Guidance to assess the nature, likelihood and magnitude of the expected exposures due to the source • Requirements for protection and safety for certain activities and facilities • Guidance for the safety assessment (if there is a possibility for an exposure to be greater than a level as specified by the regulatory body) • Guidance for appropriate prospective assessment made for radiological environmental impacts (commensurate with the radiation risks associated with the facility or activity) • … + GRADED APPROACH Notification & Authorization. Graded Approach

21. Authorization Proceed Yes Is notification enough? No Apply for the authorization Authorized to work after registration Yes Is registration enough? No Apply for license Authorized to work after license is granted Notification & Authorization. Graded Approach

22. Authorization Allowed to work Yes Is notification enough? No GRADED APPROACH Apply for the authorization Allowed to work after registration Yes Is registration enough? No Apply for license Allowed to work after license is granted Notification & Authorization. Graded Approach

23. Graded approach. GSR Part3 The regulatory body shall adopt a graded approach to the implementation of the system of protection and safety, such that the application of regulatory requirements is commensurate with the radiation risks associated with the exposure situation. Notification & Authorization. Graded Approach

24. Graded approach. GSR Part3 Example of the requirement for graded approach • The application of the requirements for protection and safety in planned exposure situations shall be commensurate with • the characteristics of the practice or the source within a practice, • with the magnitude and likelihood of the exposures. Notification & Authorization. Graded Approach

25. Graded approach. GSR Part3 Example of the requirement for graded approach The application of the regulatory requirements of these Standards shall: • conform to any requirements specified by the regulatory body, in accordance with a graded approach; • however, not all the requirements of these Standards are relevant for every practice or source, nor for all the actions specified in para. 3.5. Notification & Authorization. Graded Approach

26. Graded approach. Radiological risk Radiological risk can be assessed by different tools. Example 1 - the Risk Analysis Matrix Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

27. Graded approach. Radiological risk Radiological risk can be assessed by different tools. Example 2 – another possibility to apply the graded approach is based on categorization of sources and practices according to the associated risk Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

28. Categorizes Radioactive Sources According to Risk (1category) Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

29. Categorizes Radioactive Sources According to Risk (2 category) Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

30. Categorizes Radioactive Sources According to Risk (3 category) Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

31. Categorizes Radioactive Sources According to Risk (4 category) Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

32. Source Category Risk Descriptions Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

33. Graded approach. Radiological risk Example 3. National risk-informed classification of radiation practices Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

34. Graded approach. Application for authorization • Graded approach is a basic tool to optimize regulatory resources Notification & Authorization. Graded Approach

35. Graded approach. Application for authorization • At the early stage of regulatory system development, when resources are minimum – notification is broadly applied with the condition when the application for the authorization should be provided to the regulatory authority Notification & Authorization. Graded Approach

36. Graded approach. Application for authorization • Different authorization procedures for different facilities and activities • Registration or licensing? • No answer in GSR Part 3 requirements • No clear difference in the “Definitions” (registration - a form of authorization for practices of low or moderate risks whereby the person or organization responsible for the practice has, as appropriate, prepared and submitted a safety assessment of the facilities and equipment to the regulatory body. The practice or use is authorized with conditions or limitations as appropriate) Notification & Authorization. Graded Approach

37. Graded approach. Application for authorization • Registration or licensing? • Advice in GSR Part 3 footnote for typical practices that are amenable to registration: Practice complexity Notification & Authorization. Graded Approach

38. Graded approach. Application for authorization Type of Control Risk level Practice Complexity Notification, or Authorization by Registration Low Simple Authorization by Licensing High Complex Notification & Authorization. Graded Approach

39. Graded Levels of Authorization Authorization by: Registration. Licensing Modern tendency - registration and licensing are similar procedures that even can have the same name, but the graded approach is applied Regulatory Effort Increases Requirements for the safety assessment and licensing conditions become more severe Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

40. Graded Levels of Authorization Licensing can be graded to provide additional safety information to the Regulatory Body about a proposed action: Licensing of facility’s life cycle stages is used where each stage can be started after regulatory review proved safe completion of the previous stage and licensee demonstrated safety of the next stage (e.g. radiotherapy department construction and operation). Regulatory Effort Increases Requirements for the safety assessment and licensing conditions become more severe Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

41. Graded Levels of Authorization Regulatory body shall have the power to include specification of the conditions necessary for safety into the license (some countries have general law prohibition to do this) Licensing conditions are graded according to the specific practice Licensing conditions provide additional safety requirements for concrete licensee Regulatory Effort Increases licensing conditions become more detailed and severe Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

42. Graded Levels of Authorization Licensing can be graded to provide additional safety information to the Regulatory Body about a proposed action: Licensing with condition: List of certain operations that are important for the safety requirement to obtain special permissions to start operations from this list Regulatory Effort Increases Requirements for the safety assessment and licensing conditions become more severe Notification & Authorization. Graded Approach IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

43. Graded Levels of Authorization Notification & Authorization. Graded Approach • The extent of information required by the RB in an application • The limits, conditions and controls imposed on the authorization by the RB Should be in accordance with a graded approach. • GSR Part 1 – Paragraph 4.33“… the applicant shall … submit a safety assessment, which shall be reviewed and assessed by the regulatory body …. The extent of the regulatory control applied shall be commensurate with the radiation risks … in accordance with a graded approach.” IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

44. Graded approach • Graded approach is used not only for authorization but for all regulatory processes: different regulatory procedures for different facilities and activities Notification & Authorization. Graded Approach

45. Graded approach • Graded approach is used for establishing regulatory requirements • 1 way - specific for the facility and activity set of requirements that is chosen from the full set of requirements Example: generators use – no radioactive waste management program, no assessment for environment impact is required Example: 3 category radioactive sources use - no safety assessment could be required • 2 way - specific requirements are applicable Example: Individual exposure monitoring program requirements strongly vary depending from on activities and facilities Notification & Authorization. Graded Approach

46. Additional Information IAEA-TECDOC-1525 • IAEA-TECDOC-1525 Notification and Authorization for the Use of Radiation Sources (Supplement to IAEA Safety Standards Series No. GS-G-1.5) Notification & Authorization. Graded Approach

47. Additional Information IAEA-TECDOC-1525 Notification & Authorization. Graded Approach

48. Additional Information IAEA-TECDOC-1525 Notification & Authorization. Graded Approach

49. Additional Information IAEA-TECDOC-1525 • GUIDELINESS FOR APPLICANTS ON AUTHORIZATION • GUIDELINES FOR REVIEW AND ASSESSMENT OF APPLICATIONS FOR AUTHORIZATION for • diagnostic radiology & dental practices • nuclear medicine • radiotherapy • industrial radiography • Irradiators • gauges for well logging Notification & Authorization. Graded Approach

50. Further Reading and References • Governmental, Legal and Regulatory Framework for Safety, No. GSR Part 1, General Safety Requirements Part 1, (2010) • Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, INTERIM EDITION, No. GSR Part 3 (Interim), General Safety Requirements Part 3, (2011) • Regulatory Control of Radiation Sources Safety Guide, IAEA, Safety Standards Series No GS-G-1.5, IAEA, 2005 • Safety of Radiation Generators and Sealed Radioactive Sources Safety Guide, IAEA Safety Standards Series No RS-G-1.10, 2006 • Categorization of Radioactive Sources Safety Guide, IAEA Safety Standards Series No RS-G-1.9, IAEA, 2005 • Notification and Authorization for the Use of Radiation Sources (Supplement to IAEA Safety Standards Series No. GS-G-1.5), IAEA-TECDOC Series No 1525, 2007 Notification & Authorization. Graded Approach