1. Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources A Selection of Exercises

2. Slide 2 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Compare the elements and concepts of your legislation with the IAEA sample legislation. Exercise 1 - Legislation Are some elements or concepts missing? Are some additional elements included (e.g. those in the IAEA sample regulations)?

3. Slide 3 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises A Regulatory Authority is established by legislation to control radiation safety. As there are no such services available in the country, the Regulatory Authority is also to operate a national dosimetry service and a national waste repository. Exercise 2 - Regulatory Authority What administrative and other measures should be considered to ensure the effective independence of regulatory actions (e.g. decisions, inspections, enforcement).

4. Slide 4 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Are some elements or concepts missing? Are some additional elements included? Compare the elements and concepts of your regulations with the IAEA sample regulations. Exercise 3 - Regulations

5. Slide 5 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises A moisture/density gauge includes a 300 MBq Cs-137 source and a 1.48 GBq Am-Be source. Exercise 4 - Categorization What is the appropriate category for such a device?

6. Slide 6 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Some sources and practices could be exempted from authorization and a “Notification only” procedure used to provide sufficient control. Exercise 5 - Notification Discuss:- the criteria to exempt these sources and practices from authorization the reasons why they are not suitable to be totally exempted from all regulatory control List sources and practices for which the notification could be the only requirement.

7. Slide 7 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Choose the appropriate level of authorization for these practices N = Notification onlyR = RegistrationL = Licensing Exercise 6 - Notification

8. Slide 8 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Draft a checklist to assess an application for: a)Export authorization of Category 1 source b)Import authorization of Category 1 source Exercise 7 - Import/export authorization

9. Slide 9 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises A hospital is planning to construct a new diagnostic room from an empty storage room and furnish it with new x-ray equipment. Exercise What kind of information and which documents should be supplied to the Regulatory Authority to apply for an amendment to an existing licence? Exercise 8 - Authorization

10. Slide 10 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises The regulatory authority grants a licence for a radiotherapy practice, accepting a report from a qualified expert submitted by the applicant that the design and construction of the premises will ensure compliance with the prescribed dose limits. However, a survey later performed by the authority’s inspectors finds occupational and public doses in excess of the limits. Exercise 9 - Authorization Discuss possible causes for the high doses. What actions might the regulatory authority take? Where does responsibility for the apparent error lie?

11. Slide 11 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 10 - Co-ordination and co-operation A mining company with several fixed radioactive gauges temporarily closes down its operations for a 3 year period during a downturn in the industry. The legal person advises that they intend appointing a caretaker to minimise the risk of theft and vandalism. What are the responsibilities of the legal person in respect of the gauges? What additional conditions might the regulatory authority impose on the licence and why?

12. Slide 12 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 11 - Co-ordination and co-operation The regulatory authority approves the incineration of low ‑ level radioactive waste arising from medical and research use. However, the government’s environmental protection authority rejects the decision and bans the incineration of such waste leaving burial as the only option. How might the authority deal with this situation?

13. Slide 13 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 12 - Co-ordination and co-operation Your country’s regulation of radiation safety on mine sites is vested in a regulatory authority separate to the authority that governs all other categories of radiation use. The mining authority decides that the practice of industrial radiography and the use of radioactive gauges on mine sites will be required to conform to unique requirements. ie those requirements will differ significantly from those imposed on the same user groups at locations subject to your regulatory authority. Discuss

14. Slide 14 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 13 - Co-ordination and co-operation In attempting to enforce your legislation you find some users who refuse to apply for a licence because they believe the fees are too high and that their qualifications are such that they should not be subject to regulation. What actions might the regulatory authority take to ensure their compliance?

15. Slide 15 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Choose an appropriate inspection interval for each practice 1-3 years; 3-5 years; 5-10 years; No inspections Exercise 14 - Inspection

16. Slide 16 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Prepare a simple checklist for a regular inspection of an industrial radiography NDT-service using portable 192 Ir sources. Inspections are to be performed while the NDT-service company is working in a customer’s premises. The checklist should cover the most important radiation protection and safety issues, and contain, for example,10-20 items which can be checked, even by a less experienced inspector. Exercise 15 - Inspection

17. Slide 17 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Two workers are exposed to radiation during work in the vicinity of a level gauge (370 MBq 137 Cs source). The level gauge had been dismantled from the side of a silo and the shutter was left open so that the workers were in the radiation beam. Fortunately, the working times in the beam were small and the workers’ effective dose was estimated at less than 1 mSv. However, investigations showed that the owner of the device did not have a licence. The source is now stored at the premises of the operator. Exercise 16 - Enforcement What is appropriate enforcement action?

18. Slide 18 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 17 - Enforcement A telephone dealer was selling covers of mobile phones with a radiation hazard marking on them. The variety of goods sold by the dealer involved many covers, specially meant to attract young people. What is appropriate enforcement action?

19. Slide 19 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 18 - Enforcement The conditions of a licence for a nuclear medicine practice require that a qualified nuclear medicine physician be present on the premises when radioactive substances are administered to patients. The regulatory authority learns that the sole physician has gone overseas for 3 months and no alternative arrangements for a responsible medial practitioner to be on site have been made. Discuss actions that the regulatory authority might take.

20. Slide 20 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises An inspector of the Regulatory Authority receives a phone call from the owner of a scrap metal yard who reports that he has a device containing radioactive material. Originally, the device was a metal frame more than 1.5 metres long weighing approximately 100-200 kg but during handling it was cut into two pieces. This revealed lead inside the tube-shaped metal frame. Exercise 19 - Emergency Response

21. Slide 21 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise (cont) - Emergency Response A label fixed onto the frame, with warning signs and texts in English, led the scrap yard owner to suspect a radiation hazard. Using a hand held radiation survey meter, the owner measured dose rate levels of the order of 1 mSv/h near the device. Elevated levels, up to 50  Sv/h, were also measured in a few locations 10-20 metres from the device. What actions should be taken by the inspector?

22. Slide 22 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 20 - Information Dissemination An inspector of the Regulatory Authority receives a phone call from the owner of a scrap metal yard who reports that a device containing radioactive material is in the scrap yard. Originally, the device was a metal frame more than 1.5 metres long weighing approximately 100-200 kg but during handling it was cut into two pieces. This revealed lead inside the tube-shaped metal frame.

23. Slide 23 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise (cont) - Information Dissemination A label fixed onto the frame with warning signs and texts in English led the scrap yard owner to suspect a radiation hazard. With a hand held radiation meter he measured dose rate levels of the order of 1 mSv/h near the device. Elevated levels, up to 50  Sv/h, were also measured in a few locations 10-20 metres from the device. What facts should be included in a news release? Assume the radioactive source is secured and preliminary investigation results are available.

24. Slide 24 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 21 - Information Dissemination A patient who has undergone extensive interventional radiology procedures develops a radiation burn which later becomes ulcerative. His medical practitioner assures the patient that the procedures were necessary and conducted competently. On the basis of this advice, the patient decides that the x ‑ ray equipment must be faulty and initiates legal action against the regulatory authority for licensing the x ‑ ray equipment that “caused” his injuries. Discuss the regulatory authority’s possible response to such an action.

25. Slide 25 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises A new radiation therapy facility is starting the operation. What type of technical services should be in place to effectively implement the radiation safety program ? Which services may be needed by the Regulatory Authority during the review and assessment of the application for authorization ? Exercise 22 - Technical Services

26. Slide 26 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises The Regulatory Authority and the national Customs Authorities have agreed to prepare a Memorandum of Understanding to prevent unauthorized shipments of radioactive substances across the national borders. As an expert in the Regulatory Authority you are asked to prepare a draft document. Exercise 23 - Co-ordination and co-operation What issues should be included?

27. Slide 27 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises Exercise 24 - Co-ordination and co-operation Authorities in your neighbouring country report that wrist watches containing radioactive parts ( 60 Co) are on sale to the public. Assume that you have to take action to find out if the same watches exist in your country and, if so, proceed to withdraw them from the market. Which organizations and institutes would you co-operate with, to solve the task ?

28. Slide 28 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Exercises What would be the most important topics for internal guidance (a Quality Manual) for a new Regulatory Authority being established? Exercise 25 - Management Systems