1. IAEA International Atomic Energy Agency Regulations Part I: Role and Structure of Regulations Day 8 – Lecture 5(1)

2. IAEA 2 Provide an understanding of the role of regulations, their content and structure. Discuss the derivation of national regulations from international standards. Discuss the IAEA sample regulations. Objectives

3. IAEA 3 Performance versus prescriptive regulations: advantages and disadvantages. Structure of regulations: administrative requirements, performance regulations, prescriptive regulations / guidance. Contents

4. IAEA 4 Performance regulations: give general requirements; specify overall radiation safety requirements and basic operational parameters. Role and Structure of Regulations Prescriptive Regulations: give detailed requirements; state how to achieve radiation safety.

5. IAEA 5 Role and Structure of Regulations (cont) Most regulations contain both types: i.e. some are more performance oriented, other descriptive oriented

6. IAEA 6 1.Minimizing Doses (a)The registrant or licensee shall plan and manage work practices so that occupational and public radiation doses are kept as low as reasonably achievable (the ALARA principle) and shall achieve this through the use of suitable workplace and individual monitoring using recognized measurement techniques. Performance Regulations - Example (b)The records prescribed by the Regulatory Body shall be maintained to demonstrate compliance with this regulation.

7. IAEA 7 Advantages easy to develop; Performance Regulations (cont) are focused on objectives: i.e. what should be achieved in terms of protection and safety; applicable to a range of practices; easily adapted to evolving circumstances and technology (i.e. do not need to be changed frequently).

8. IAEA 8 Disadvantages need to be interpreted in relation to each practice; time and skill is needed from both regulatory staff and the users. Performance Regulations (cont)

9. IAEA 9 2.Restrictions on the use of Radioactive Substances Prescriptive Regulations - Examples (1)A person shall not administer nor authorize the administration of a radiation source for the treatment or diagnosis of human beings unless that person is a medical practitioner acting under a licence issued by the Regulatory Body. (2)A person shall not use a radiation source for industrial radiography unless he does so under a licence issued by the Regulatory Body and in compliance with the “Safety Guide on using Radiation Sources for Industrial Radiography” issued by the Regulatory Body.

10. IAEA 10 Prescriptive Regulations: define exactly how to achieve adequate dose restrictions; Prescriptive Regulations may define where to conduct workplace monitoring; may define what type of instruments shall be used; may define how and what type of records should be maintained; may be specific to certain types of practices.

11. IAEA 11 Advantages easy to determine when requirements are met; Prescriptive Regulations (cont) reduce time and skills necessary to conduct a licensing review or an inspection; enable authorization and inspection process to focus on simple verification of compliance.

12. IAEA 12 Disadvantages can drive a “compliance culture” instead of a “safety culture”; Prescriptive Regulations (cont) can be difficult to prepare; require considerable practice specific knowledge and experience; may be narrowly applicable to a specific practice; need to be regularly amended to keep pace with changes in technology.

13. IAEA 13 Codes of Practice: are usually developed and issued by the Regulatory Body; Practice Specific Guides give practice specific advice on how to achieve protection and safety requirements defined in legislation or regulations; are not necessarily legally binding (also other procedures might be followed to achieve the same protection and safety goals).

14. IAEA 14 Codes of Practice may be developed for: radiation therapy; Practice Specific Guides (cont) diagnostic radiology; use of radiation in Industry; research, education and commerce; radionuclide laboratories; other practices.

15. IAEA 15 Model Regulations for the use of radiation sources and for the management of the associated radioactive waste. Draft: 2012-04-04. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements Part 1 (GSR Part 1). Vienna 2010. Handbook on Nuclear Law: Volume 1 & 2 (2010). References