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

2. Slide 2 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Basic purpose of the legislation. Elements and concepts to be included in legislation. IAEA sample legislation. Objectives

3. Slide 3 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 radiation exposure might cause harmful health effects to people; the health and safety of people needs to be protected while permitting beneficial uses of radiation. Basic Purpose of Legislation Legislation should recognize that:- uses of radiation introduce important benefits in medicine, industry and research;

4. Slide 4 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Uncomplicated The need for subsequent amendments should be minimised. Elements and Concepts of Legislation Enabling legislation Basic legal document enacted by the national legislative body. Consistent with national situation The realistic expectations and effective use of resources are more important than “an ideal system”.

5. Slide 5 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 scope of the legal framework; Elements and Concepts of Legislation (cont) establishment of regulatory authority; allocation of responsibilities; establishment of fundamental protection principles and structures; interagency co-ordination and co-operation; mechanism for appealing; establishment of services and facilities needed (if not otherwise available).

6. Slide 6 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 The legislation should:- apply to all situations involving exposure or the potential for exposure to ionising radiation; Scope of the Legislation provide for exclusions (eg 40 K in the human body,etc); and exemptions (specific criteria and values to be defined in regulations).

7. Slide 7 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Independence The Regulatory Authority should have formal independence from promotional and regulated activities. While not always possible, effective independence is desired. Establishment of a Regulatory Authority Funding The Authority should be funded from the state budget. Funding should not be linked to fees raised (i.e. from authorizations, inspections, etc.)

8. Slide 8 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Powers and responsibilities:- to issue regulations; Establishment of a Regulatory Authority (cont) supervisory and enforcement powers; to decide on exclusions and exemptions; to decide on detailed conditions for authorization; to assist in emergency response.

9. Slide 9 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Relationship to other laws Laws on Nuclear Energy, Safety in Mining, Labour Protection, Environmental Protection, Medical practices, Transport,etc. Allocation of Responsibilities Allocation of responsibilities Ministries of Health, Trade and Industry, Environment, Internal Affairs, etc

10. Slide 10 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 System of authorization and notification System of protection of workers Establishment of fundamental protection principles and structures Fundamental principles Justification of practices, optimisation of protection, dose limitation Obligations of the responsible party Prime responsibility of safety

11. Slide 11 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Authorization for the Regulatory Authority to enter into agreements with other regulatory bodies Interagency co-ordination and co-operation Link between Customs Authorities and the Regulatory Authority Prevention of gaps and overlaps through appropriate Memoranda of Understanding

12. Slide 12 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 A mechanism is required to enable appeals to be made against decisions taken by the Regulatory Authority. Appeals

13. Slide 13 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Services and facilities essential for radiation safety, i.e. personal dosimetry; Establishment of services and facilities Such services and facilities might be provided through legislation if they otherwise are not available. training services; environmental monitoring; facilities for waste storage and disposal; radiation measurement and calibration services.

14. Slide 14 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Elements and concepts scope of legal framework; establishment and empowerment of the Regulatory Authority; allocation of responsibilities; co-operation and co-ordination. IAEA Sample Legislation 1 1 IAEA TECDOC 1067

15. Slide 15 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 IAEA-TECDOC-1067 Introduction of sample legislation and regulations, p.27 - 28 Sample legislation, p. 29 - 33 References

16. Slide 16 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 2-1 Are some elements or concepts missing? Are some additional elements included (e.g. those in the IAEA sample regulations)? Exercises (Legislation) Compare the elements and concepts of your legislation with the IAEA sample legislation.