1. Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Regulatory Authority

2. Slide 2 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 To understand the essential functions and responsibilities of the Regulatory Authority Objectives

3. Slide 3 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 responsibilities; interaction and co-operation; independence; functions; regulatory program; technical services and expert assistance. Contents Regulatory Authority:-

4. Slide 4 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 the Authority’s responsibilities and functions; provisions for authority, power and resources. Regulatory Authority The legislation should specify:- the establishment and funding of an effectively independent Regulatory Authority for the control of radiation safety;

5. Slide 5 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 However, regulatory functions and responsibilities sometimes are divided among several government authorities. eg:- Division of responsibilities A single Regulatory Authority responsible for all aspects of radiation safety is most desirable. transport environment public health and safety occupational safety

6. Slide 6 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 overlapping of authority is minimized; conflicting requirements from separate authorities are prevented; the users of sources understand which of their activities are subject to various authorities. Division of responsibilities (cont) gaps in protection and safety are prevented; Where responsibilities are divided, legislation should establish clear lines of authority and responsibility so that:-

7. Slide 7 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 Relevant regulatory authorities should establish a system of liaison and working procedures to ensure co-ordination and co-operation including, where appropriate, the development of Memoranda of Understanding (MoU) between government agencies. Division of responsibilities (cont)

8. Slide 8 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 The Regulatory Authority must co-operate with other relevant authorities, advise and provide them with information on safety matters. Interaction with other national bodies

9. Slide 9 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 Consumer Protection Agency Regulatory Authority Defence Forces Educational Authorities Emergency Co-ordination Authority Environmental Protection Authority Fire Services Customs Authority Food / Agriculture Authority Health Ministry Local Government Authorities

10. Slide 10 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 Mining / Minerals regulation Regulatory Authority Oil / Gas - exploration & regulation Police Services Power generation Professional & Registration Bodies Sewerage Authority National Standards Authority Transport Regulation Water Supply Authority

11. Slide 11 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2

12. Slide 12 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2

13. Slide 13 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2

14. Slide 14 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2

15. Slide 15 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 The Regulatory Authority also should have arrangements on an international level. Co-operation on international level Bilateral agreements Multilateral agreements

16. Slide 16 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 Is established by Government through legislation. Independence of the Regulatory Authority The Authority’s functions and responsibilities are kept completely distinct from those of any other party. There is clear separation of the Authority’s functions from those of other government agencies or other organizations having responsibility for development and promotion of regulated practices.

17. Slide 17 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 Avoidance of engagement in activities with regulated operators which could endanger the Authority’s independence. For example:- –consultant services; –any financial agreements or support. Independence of the Regulatory Authority (cont) There needs to be clear separation of the Regulatory Authority from practices and others subject to regulation (ie from licensees, manufacturers, etc.)

18. Slide 18 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 from those subject to regulation:- Licensees Regulatory Authority Manufacturers Laboratory services Training services Waste facilities Others Health services Independence of the Regulatory Authority (cont)

19. Slide 19 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 If the Regulatory Authority has functions such as:- testing and quality control measurements; initiating safety related research and development; providing personnel monitoring services, Independence of the Regulatory Authority (cont) care must be taken to ensure that all conflicts with the main regulatory functions are avoided and that the prime responsibility of the radiation user for safety is not diminished.

20. Slide 20 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 establish regulations and issue guidance documents and advice; require operators to conduct safety assessments; require necessary information from the operator; issue, amend, suspend or revoke authorizations; Empowering the Regulatory Authority develop safety principles and criteria; The Regulatory Authority shall be empowered to:-

21. Slide 21 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 enter a site or facility at any time to carry out inspections; The Regulatory Authority shall be empowered to:- Empowering the Regulatory Authority (cont) inspect relevant facilities and documents; enforce the regulatory requirements; communicate directly with government authorities;

22. Slide 22 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 obtain necessary documents from other organizations; The Regulatory Authority shall be empowered to:- independently communicate to the public its regulatory requirements, decisions and opinions, and their basis. Empowering the Regulatory Authority (cont)

23. Slide 23 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 liase and co-ordinate with other government or non- government authorities having competence in health and safety, environmental protection, security and transport; liase with regulatory authorities of other countries and with international organizations to promote co-operation. The Regulatory Authority shall be empowered to:- inform other government bodies, national and international organizations, and the public, on incidents, accidents and other safety related abnormal occurrences; Empowering the Regulatory Authority (cont)

24. Slide 24 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 implementing procedures for notification and authorization; providing for exclusions and exemptions; performing inspections and other compliance monitoring; taking enforcement actions in the event of violations of requirements; investigating accidents and managing emergencies; disseminating information on protection and safety. The Regulatory Program shall include:- preparing regulations for radiation protection and safety;

25. Slide 25 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 for creating or modifying conditions of an authorization or of a class of authorizations; for providing guidance to the radiation users; to ensure that proprietary information is safeguarded; to ensure that appropriate explanations are provided to applicants for the rejection of authorizations; Internal Procedures The Regulatory Authority shall establish procedures:- for receiving and assessing notifications and applications for registration or licence;

26. Slide 26 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 to ensure that user experience (incidents, accidents, etc.) is appropriately analyzed and that any lessons to be learned are disseminated; to ensure that records relating to the safety of facilities and radiation practices are retained and retrievable; Internal Procedures (cont) The Regulatory Authority shall establish procedures:- for communication with, and the provision of, information to other governmental bodies, international organizations and the public;

27. Slide 27 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 establish, and inform the operator of, any requirements for regular safety reassessments or periodic reviews; ensure government is kept informed of important radiation safety issues; verify the qualifications, training and experience of personnel responsible for the safe operation of the facility or practice. Internal Procedures (cont) The Regulatory Authority shall establish procedures to:- ensure that its regulatory criteria are adequate and valid, and that international standards are taken into account;

28. Slide 28 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 dosimetry services laboratory services calibration services waste management medical services training services expert assistance Technical Services Technical services include:-

29. Slide 29 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 Essential technical services (for both radiation users and the Regulatory Authority) should be available within the State. Technical Services (cont) External technical services may be used but require Regulatory Authority approval.

30. Slide 30 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 The use of consultants shall not relieve the Regulatory Authority of any of its responsibilities. The Regulatory Authority’s responsibility for making decisions and recommendations shall not be delegated. Expert Assistance Consultants should be effectively independent of the operator. Consultants

31. Slide 31 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 Advisory bodies are established either on a temporary or permanent basis to give independent expert opinion or advice (e.g on technical or ethical issues). Advice offered shall not relieve the Regulatory Authority’s responsibility for making decisions. Advisory bodies may be formally appointed by Government or the Regulatory Authority. Expert Assistance (cont) Advisory Bodies

32. Slide 32 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 who are appropriately qualified; and who have received appropriate training. Regulatory Authority Personnel and Training In order to properly fulfil its statutory obligations:- the Regulatory Authority requires an appropriate number of personnel;

33. Slide 33 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 IAEA, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport. Safety Standards Series No.GS-R-1, IAEA, Vienna (2000). IAEA, Organization and Implementation of a National Regulatory Infrastructure Governing Protection against Ionizing Radiation and the Safety of Radiation Sources, IAEA-TECDOC-1067, Vienna (1999). IAEA, Assessment by Peer Review of the Effectiveness of a Regulatory program for Radiation Safety, IAEA-TECDOC-1217, Vienna (2001). References

34. Slide 34 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-2 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 running a national dosimetry service and a national waste repository. What administrative and other measures should be considered to ensure the effective independence of regulatory actions (e.g. decisions, inspections, enforcement)? Exercise