1. IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Strategies for Effective and Sustainable Regulatory Control – Part I RIDM – Radiological Risk

2. Slide 2 Objective  The goal of this presentation is to introduce the concept of graded approach to the performance of the key regulatory functions. This means that the regulatory body performs its regulatory functions on a risk informed basis – allocating more effort where risks are greater IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

3. Slide 3IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Contents  Regulating smarter  Graded approach requirements in GSR Part 1  Cross-cutting ‘Themes’ for the graded approach modules

4. Slide 4IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Regulating Smarter!  Most regulatory bodies, especially those that are recently established or struggling to cope with a wide scope of responsibilities often attempt to perform all regulatory functions in a uniform way.  This means, for example, that there is one approach to authorization and all applications are processed and reviewed in the same way; that low risk sources are inspected as frequently as high risk sources.  For our purposes we may call this ‘first generation’ regulation  Result: The regulatory body is swamped with tasks  Task priority is often based on what is the most overdue.

5. Slide 5IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Regulating Smarter (cont’d)  By taking a graded approach the regulatory body maintains the regulatory framework and authorizes, inspects and enforces compliance on a risk informed basis  By taking a graded approach the regulatory body allocates more effort where risks are greater  A graded approach is equivalent to implementing risk-informed decision making  For our purposes, we may call this is ‘second generation’ regulation  Call it “regulating smarter”

6. Slide 6IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Regulating Smarter (cont’d)  But there is also a third approach…  In addition to the graded approach, the RB may identify the most important problems that it faces analyze the problems on the basis of risk and address them in collaboration with the relevant sector of the regulated industry.  For example by focusing on regulatory problems with the oil and gas or industrial radiography industries in consultation with each industry  This may be called ‘third generation’ regulation

7. Slide 7IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources What does GSR Part 1 say about a graded approach?  GSR Part 1 requires a graded approach in the implementation of all regulatory functions Requirement 1: Establish national policy and strategy for safety “The government shall establish a national policy and strategy for safety, the implementation of which shall be subject to a graded approach in accordance with national circumstances and with the radiation risks associated with facilities and activities…” Paragraph 4.3 “The objective of the regulatory functions is the verification and assessment of safety in compliance with regulatory requirements. The performance of regulatory functions shall be commensurate with the radiation risks associated with facilities and activities, in accordance with a graded approach.”

8. Slide 8IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources GSR Part 1 Requirements (cont’d)  GSR Part 1 includes also requirements on the implementation of a graded approach to: Regulations and guides Authorization Review and Assessment Inspection Enforcement  Strategies for the application of graded approach to these regulatory function will be addressed in dedicated lectures

9. Slide 9IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Themes of the “Graded Approach”  There are several cross-cutting themes in all of the lectures on strategies for the application of ‘graded approach’ : Theme 1: Regulatory resources are limited so you can’t treat all regulatory tasks in the same way Theme 2: Risk-informed decision making provides a systematic way of setting priorities Theme 3: Communication and consultation are a lot of work, but they payoff in better decisions that are more defensible Theme 4: For moderate risk sources and practices, a disproportionate amount of regulatory effort is often needed to come to decisions

10. Slide 10IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Theme 1  Regulatory resources are limited so you can’t treat all regulatory tasks in the same way The RB needs to focus its limited resources on high risk sources and practices and find ways of expending fewer resources on low risk sources and practices The Regulatory Body can’t do everything…

11. Slide 11IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Theme 2  Risk-informed decision making provides a systematic way of setting priorities. Most risk-informed decision making is not complex or time- consuming; it is simple and intuitive. But a more systematic and complex approach to risk-informed decision making may from time to time, be necessary.

12. Slide 12IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Theme 3  Communication and consultation are a lot of work, but they payoff in better decisions that are more defensible. Ongoing communication with the public and the regulated industry is a key activity of every regulatory body. Consultation is a more periodic activity than communication, but consultation is essential to obtain industry ‘buy-in’ to regulatory initiatives and to obtain better information for use in systematic risk-informed decision making

13. Slide 13IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Communication and consultation are key components of the risk management process  Generic Risk Management Process Informal and intuitive

14. Slide 14IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Theme 4  Theme 4: For moderate risk sources and practices, a disproportionate amount of regulatory effort is often needed to come to decisions. There is seldom much disagreement about the need to regulate high risk sources and practices Similarly, there is usually acceptance that less regulatory effort needs to be devoted to low risk sources and practices. However, for moderate risks:  people who are risk averse will want to treat moderate risk items as if they were high risk.  people who are risk tolerant will want to treat moderate risk items as though they were low risk.  The RB needs strategies to help make such decisions!

15. Slide 15 Regulatory Decisions for Moderate Risks A series of lectures are intended to help make decisions in the moderate region of the Risk Analysis Matrix Likelihood Consequence NegligibleMinorModerateMajorExtreme Almost certainMVH EE LikelyMHVH E PossibleLMHVH UnlikelyLMMHVH RareLLLMH IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

16. Slide 16IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Exercise  Can you discuss your understanding of the graded approach?  What are its benefits?  How has your regulatory body implemented the graded approach in your country?

17. Slide 17IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources Summary  Graded approach to the performance of regulatory functions is incorporated into IAEA Safety Standards  Strategies for ‘graded approach’ help to ‘regulate smarter’  The use of RIDM enables a: Systematic, consistent and transparent regulatory program Optimization and integration of regulatory effort and resources Regulatory burden on licensees is commensurate with their level of compliance.  The regulatory body needs strategies to make regulatory decisions for moderate risks  Communication and consultation with the interested parties are key components of the risk management process.

18. Slide 18IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources More Information  GSR Part 1: Governmental, Legal and Regulatory Framework for Safety  The IAEA Code of Conduct on the Safety and Security of Radioactive Sources  GS-G-1.5 Regulatory Control of Radiation Sources (Safety Guide)  IAEA-TECDOC-1526, Inspection of Radiation Sources and Regulatory Enforcement