Regulations Part I Role and Structure of Regulations

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

Objectives • 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. IAEA 2

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

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

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

Performance Regulations - Example 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. (b) The records prescribed by the Regulatory Body shall be maintained to demonstrate compliance with this regulation. IAEA 6

Performance Regulations (cont) Advantages • easy to develop; • 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). IAEA 7

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

Prescriptive Regulations - Examples 2. Restrictions on the use of Radioactive Substances (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. IAEA 9

Prescriptive Regulations: • define exactly how to achieve adequate dose restrictions; • 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. IAEA 10

Prescriptive Regulations (cont) Advantages • easy to determine when requirements are met; • 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. IAEA 11

Prescriptive Regulations (cont) Disadvantages • can drive a “compliance culture” instead of a “safety culture”; • 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. IAEA 12

Practice Specific Guides Codes of Practice: • are usually developed and issued by the Regulatory Body; • 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). IAEA 13

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

References • 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). IAEA 15