1. Management System Part II: Inventory of Radiation Sources – Regulatory Authority Information System (RAIS)

2. RAIS Development and operation of RAIS depends on: Notifications Categorization of Radiation Sources Inventory of Radiation Sources and Users/Locations

3. Notification - Form Contents of the form Name and Address of the Legal Person Name and Address of the Organization Nature of the Practice in which source is used (cont.)

4. Notification - Form Identification of each source (a) Radionuclide Activity Chemical Form Sealed Source (if yes, Manufacturer/Model) (b) Radiation Generating Equipment Manufacturer, Model Operating Potential Nature of Equipment in which source is installed Date Signature for Legal Person

5. Notification New regulatory authority should (1/3) prioritize the need for gaining regulatory control over practices in terms of likelihood and magnitude of potential exposures identify and list likely source users provide documented requests for notification to all likely source users and request replies follow up likely source users telephonically or by on-site visits, if there is no response to the request for notification

6. Notification New regulatory authority should (2/3) follow up on cases where a negative response was provided to the request for notification, but where the regulatory authority has contradictory information or other reasons to believe that the respondent may possess sources document and log into the inventory all cases where sources (either in use/storage/abandoned) or source users are identified

7. Notification New regulatory authority should (3/3) periodically update the source inventory with new information develop and implement a process to check on the accuracy of the notification/inventory system, with an emphasis on sources or practices with higher risks be able to identify and locate every source (either directly through its own inventory or through licensees/registrants inventories) subject to its regulatory control

8. Categorization of sources Categorization is relevant to decisions in bringing sources under control guide the application of a regulatory infrastructure  prioritize a regulatory authority’s resources and training activities  guide the degree of detail necessary for a safety assessment  serve as a measure of the intensity of effort which should be applied to the safety and security of a particular type of source

9. Categorization of sources IAEA-TECDOC 1191, Categorization of Radiation Sources (Dec 2000) Develops a categorization scheme for radiation sources

10. Categorization of sources IAEA-TECDOC 1191 The report focuses on sealed sources in industry, medicine, research and teaching, agriculture, and military applications Issues of safety and security for radiation sources may arise during each stage of the life of a source, including, for example, manufacture, supply, transport, use, storage, transfer, repair, and decommissioning and disposal The categorization scheme is based on a number of factors including the potential for causing serious injury or contamination and the probability of such accidents occurring.

11. Categorization of sources Source Attributes Radiological properties type of radiation, half life, energy of radiation, source activity. Form of the material physical and chemical form, sealed or unsealed, risk of contamination in event of accident, toxicity of material Practice or conditions of use fixed facility or mobile, type of application, design and construction, source size, presence of shielding, and operational factors e.g. moved from shielding to do task.

12. Categorization of sources Exposure scenarios types of exposure scenarios that are available in use or if control lost, presence of stochastic or deterministic effects, ability to detect source if lost, historical records of accidents. End of life disposal options, cost and availability of these options, traceability of sources, frequency with which there may be disused sources or spent sources, and net probability source will be lost from regulatory control regime.

13. Categorization of Sources Category 1: Industrial radiography, teletherapy, irradiators Sources in this category present significant hazards which require examination of the conditions of use, the construction and operation of the facility training and competence of users, control mechanisms that the user will apply to assure safety and security detailed safety assessment would be expected to support the authorization of the source or device, and also of the facility when the use is in a fixed location.

14. Categorization of Sources Category 2: HDR Brachytherapy, fixed industrial gauges with high activity sources, well logging, LDR brachytherapy The level of intensity applied to the review and assessment of an application for authorization might be somewhat less than that expected for Category 1. Although the quantities of radioactive material may be lower, other source attributes, such as portability and accessibility will remain critical, including the potential loss of accountability and presence of reasonable options for the disposal of disused or spent sources.

15. Categorization of Sources Category 3: Fixed industrial gauges involving lower activity sources In many cases, safety and security during operations is a function of the device construction. A detailed review of a particular application for use will not be needed. However, the Regulatory Authority will need to remain mindful of end of life issues where there may be the potential for a loss of regulatory control if accountability is not maintained.

16. Regulatory authority Information System (RAIS) Module 1: Inventory of Radiation Sources and Installations Lists all radiation sources within an installation, classified by practice Covers installations having a given type of equipment, for a given practice Covers multiple radiation sources Tracks history of a source until returned to the supplier or managed as radioactive waste

17. Regulatory authority Information System (RAIS) Module 2: Authorization Tracks the administrative status of an installation, from initial application to its authorization, including pre-operational inspections Covers authorization related to transfers of radiation sources between authorizations Allows the regulatory authority to issue authorization documents through RAIS

18. Regulatory authority Information System (RAIS) Module 3: Inspection and Enforcement Inspections carried out within specified time periods Inspections that should be done over a future time period Assists in monitoring follow-up actions and deadlines Allows the regulatory authority to issue inspection reports through RAIS

19. Regulatory authority Information System (RAIS) Module 4: Individual Dose Monitoring Calculates estimates of the effective dose to workers from measured individual dose records Lists doses to workers at each installation Computes total doses for workers employed at more than one installation Stores the dose histories of workers

20. Regulatory authority Information System (RAIS) Module 5: Performance Indicators REGULATORY AUTHORITY INDICATORS  Lists authorizations processed  Displays average time for processing an authorization, classified by practice  Lists inspections, by practice, geographic area or inspector; enforcement actions; ongoing actions/deadlines LICENSEE INDICATORS  Displays average occupational doses by practice, doses exceeding dose constraints or investigation levels  Stores history of incidents and non-compliance  Stores history of enforcement actions

21. Regulatory authority Information System (RAIS) Search and reporting capabilities (1/3) sources report by installation installation reports by practice installation report by authorization type frequency of inspection by category report report on inspections by practice inspections made, pending and outstanding list of inspections by inspector name

22. Regulatory authority Information System (RAIS) Search and reporting capabilities (2/3) number of sealed sources by nuclide total activity of sealed sources by nuclide number of accelerators by practice number of authorizations by practice number of pending authorizations average time for granting authorizations the number of enforcement letters by practice/period

23. Regulatory authority Information System (RAIS) Search and reporting capabilities (3/3) number of proposals for penalties by practice/period number of findings by practice number of monitored workers maximum accumulated dose by practice annual effective dose distribution number of workers