1. AuthorizationAuthorization

2. Authorization Objectives To provide understanding of the authorization process and the procedures for its implementation

3. Authorization Contents Part I:Categorization of sources Registration and licensing Review and assessment of application Role of the regulatory staff Part II:Safety assessment plans Part III:Content of a licence Duration of authorization Termination of authorization

4. Authorization Part I

5. Categorization of sources Why categorization ? Controls to be applied should be commensurate with radiological risks that the sources and materials present. Of particular concern are those radiation sources which have the potential for causing significant harm to persons or have the potential for widespread contamination. Categorization is a tool that can be used in authorization and other relevant decision-making processes.

6. Categorization of sources Use of categorization in authorization process Authorization by registration or licensing Security requirements in: - manufacture - transport - storage - use - transfer and repair - decommissioning and disposal Emergency preparedness

7. Categorization of sources Bases of categorization Level of activity Construction and properties of radiation source Probability of accidents causing: - serious injury to persons - increased exposure to worker - increased exposure to public - contamination Management of safety and security Type of use (fixed/mobile)

8. Categorization of sealed sources (IAEA TECDOC 1191) Industrial radiography Teletherapy Irradiators Brachyterapy Fixed industrial high-activity gauges Well logging Fixed industrial low-activity gauges CategoryType of use 1 2 3

9. Categorization of sealed sources Category 1 l Significant hazard possible l Detailed information to be submitted in application - Conditions of use - Construction and operation of the facility - Training and competence of users - Control mechanisms to assure safety and security - Disposition of disused sources - Patient protection - Preparedness plans for accidents

10. Notification and authorization Practice or source proposed Excluded?Proceed Notification only required Exempted? Notify Proceed Yes No

11. Notification and authorization (cont’d) Apply for authorization Notification only required Suitable for registration Obtain licence Proceed Yes No Proceed

12. Authorization by registration Registration is simple and efficient authorization mechanism. Suitable if: Safety is ensured by the design of facilities and equipment Operation procedures are are simple to follow Radiation safety training requirements are minimal Practice is routinely operated Few safety problems are known within operations Number of users is large

13. Authorization by registration Examples of practices and devices adequate for registration: Dental X-ray diagnostics Low-activity sealed sources X-ray fluorescence Distribution of consumer products Static eliminator * Electron microscope * *) Notification only ?

14. Authorization by registration The Regulatory Authority should: 1. Establish the safety requirements which must be met as a precondition for registration. and/or 2. Conduct a generic safety assessment of equipment and related operating procedures provided by a supplier or manufacturer. Depending on the nature of the practice, one or the other or a combination of both may be used.

15. Authorization by registration Application for registration should include: Identification of the source and equipment to be utilized The location of use The name of a person responsible for radiation safety Agreement to follow the applicable operating, maintenance and disposal requirements Authority should record the information in register (database) for regulatory purposes.

16. Notification / Registration / Licensing Type of ControlRisk levelComplexity of practice Notification LowSimple Authorization by registration Authorization by licensing HighComplex

17. Authorization by licensing Application shall include: Detailed information of the use of source Radiation protection provisions Provisions for source safety and security Assessment of exposures Arrangements for handling waste

18. Authorization by licensing Examples of practices and devices adequate for licensing: Medical applications Industrial radiography Industrial irradiators High-activity gauges Use of unsealed sources Manufacturing of sources Storage of radioactive material or waste and disposal

19. Authorization by licensing Multi-stage licensing may be suitable for practices involving construction of facilities. Commercial product irradiators Teletherapy facilities Waste management and disposal facilities Regulatory Authority should also consider the financial capability of the applicant to comply with regulations. e.g. decommissioning and waste management

20. Review and assessment The applicant is responsible for submitting a detailed information of radiation safety. The application shall be reviewed and assessed by the Regulatory Authority in accordance with clearly defined procedures.

21. Review and assessment Responsibilities of the Regulatory Authority Guidance on format and content of the application (application forms, required supplements) Recording of all documents Acquiring further information from the applicant if necessary (time-limits) Decision on the basis of review and assessment (licence granted / not granted) The basis for the decision shall be formally recorded

22. Review and assessment Procedures of the Regulatory Authority may be defined in the Standards or in the quality manual. Review and assessment of the application Responsibilities within the organization(s) Recording and security of documents Procedures to anneal, renew or to suspend an authorization Filing system of authorization

23. Authorization process Application received & recorded Forms and guidance to applicant Further info required if necessary Assessment according to defined procedures Decision approved by responsible officer Decision to applicant (granted/not granted) Recording and filing

24. Safety assessment of sources Information required in the application: Location of the operation site - Street address - Place of storage for mobile sources Identification and safety of sources - Model and serial numbers - Certification of compliance with standards (leak test) Arrangements to dispose of the source Description about the safety instructions NOTE: The application must be signed by the legal person

25. Review and assessment By review the Regulatory Authority shall satisfy itself that: The application demonstrates the safety of the facility or proposed activity. The information is accurate and in compliance with regulatory requirements. The technical solutions have been proven or qualified and are capable of achieving the required level of safety.

26. Authorization file Authorization file should include : The documents submitted by the applicant The list of those and all other relevant documents - Also appropriate phone calls and e-mails should be recorded Memorandum about the facts that the decision is based on, including references to regulations Archive copy of the final decision (licence)

27. Role of the regulatory staff Requirements for staff members Professionalism Independence Inquisitiveness Helpfulness Assertiveness

28. Role of the regulatory staff Decision making Regulatory decisions should have transparency and clarity. Decisions should be timely, especially when corrective actions are required. Procedures should be established within the Regulatory Authority organization for prompt decision making.

29. Authorization Part I References IAEA, Categorization of Radiation Sources, IAEA-TECDOC- 1191, Vienna (2000). IAEA, Organization and Implementation of a National Regulatory Infrastructure…, IAEA-TECDOC-1067, Vienna (1999). IAEA, Assessment by Peer Review of…, IAEA-TECDOC- 1217, Vienna (2001). IAEA, Legal and Governmental Infrastructure for …, Safety Standards Series No.GS-R-1 (Draft, version 20.2.2000).

30. Exercise Authorization Part I Choose adequate level of authorization for each practice N = Notification only required (Yes/No) R = Registration required (Yes/No) L = Licensing required (Yes/No)