1. IAEA International Atomic Energy Agency

2. IAEA Outline Responsibilities and functions of the regulatory body Objectives of regulatory functions Organizational structure Effective independence Staffing and competence Advisories and support Liaison with authorized parties Stability and consistency Record keeping Communications USNRC IRRS Training - Reviewing Regulatory Responsibilities2

3. IAEA Learning objectives After finishing this lecture the trainee will: Know what are the objectives of the regulatory function. Understand the organizational structure, staffing and competence, advisory bodies, support organizations, liaison with other parties, stability and consistency of the regulatory body and its necessary provisions for record keeping and communication with other parties. USNRC IRRS Training - Reviewing Regulatory Responsibilities3

4. IAEA IRRS Module 3 Responsibilities and functions of the regulatory body IAEA GSR Part 1, pages 17-22 & 35 IAEA GSR Part 1, pages 17-22 & 35 USNRC IRRS Training - Reviewing Regulatory Responsibilities 4

5. IAEA Objectives of regulatory function Safety is optimized Safety assessment proves adequate level of safety Sites for facilities are suitable Facilities meet regulatory requirements Facilities are operated within operating limits Human, organizational, financial and technical resources are available are regulated Shutdown and decommissioning are regulated USNRC IRRS Training - Reviewing Regulatory Responsibilities5

6. IAEA Organizational structure and resources The regulatory body shall structure its organization and manage its resources so as to discharge its responsibilities and perform its functions effectively. The regulatory body shall structure its organization and manage its resources so as to discharge its responsibilities and perform its functions effectively. This shall be accomplished in a manner commensurate with the radiation risks associated with facilities and activities This shall be accomplished in a manner commensurate with the radiation risks associated with facilities and activities. Requirement 16; 2006-2013 referenced 16 times. USNRC IRRS Training - Reviewing Regulatory Responsibilities6

7. IAEA Sufficiency of human and financial resources Organizational structure Sufficiency of resources and organizational structure should be given in the Advance Reference Material. Get familiar with the web site of the regulatory body USNRC IRRS Training - Reviewing Regulatory Responsibilities7 Recommendation of Experienced Reviewers Give particular attention to:

8. IAEA Example (organization) USNRC IRRS Training - Reviewing Regulatory Responsibilities8

9. IAEA Effective independence The regulatory body shall perform its functions in a manner that does not compromise its effective independence. Requirement 17; 2006-2013 referenced 7 times. USNRC IRRS Training - Reviewing Regulatory Responsibilities9

10. IAEA Independent decision making Functional separation from undue influence Integrity of staff USNRC IRRS Training - Reviewing Regulatory Responsibilities10 Recommendation of Experienced Reviewers Give particular attention to:

11. IAEA Example (effective independence) USNRC IRRS Training - Reviewing Regulatory Responsibilities11

12. IAEA Staffing and competence commensurate with the nature and the number of facilities and activities to be regulated, to perform its functions and to discharge its responsibilities. The regulatory body shall employ a sufficient number of qualified and competent staff, commensurate with the nature and the number of facilities and activities to be regulated, to perform its functions and to discharge its responsibilities. Requirement 18; 2006-2013 referenced 52 times. USNRC IRRS Training - Reviewing Regulatory Responsibilities12

13. IAEA Staffing and competence A human resources plan shall be developed It shall cover recruitment, rotation of staff and a strategy to compensate for the departure of qualified staff. A process shall be established to develop and maintain the necessary competence and skills. USNRC IRRS Training - Reviewing Regulatory Responsibilities13

14. IAEA Sufficiency and competence of staff Long term human resource planning Knowledge management (coordinate with subchapter 4.3) A computer demonstration of the Regulators administrative systems should be provided USNRC IRRS Training - Reviewing Regulatory Responsibilities14 Recommendation of Experienced Reviewers Give particular attention to:

15. IAEA Examples (staffing and competence) USNRC IRRS Training - Reviewing Regulatory Responsibilities15

16. IAEA Example (training) USNRC IRRS Training - Reviewing Regulatory Responsibilities16

17. IAEA Advisory bodies and support organizations The regulatory body shall obtain expert advice or services in support of its regulatory functions This shall not relieve the regulatory body of its assigned responsibilities. Could be dedicated or contractual arrangement. interests shall be Avoidance of the conflict of interests shall be taken care of. Requirement 20; 2006-2013 referenced 46 times. USNRC IRRS Training - Reviewing Regulatory Responsibilities17

18. IAEA Handling of conflicts of interest The regulatory body as an intelligent customer Representatives from advisory bodies and support organizations should be interviewed USNRC IRRS Training - Reviewing Regulatory Responsibilities18 Recommendation of Experienced Reviewers Give particular attention to:

19. IAEA Example (conflict of interest) USNRC IRRS Training - Reviewing Regulatory Responsibilities19

20. IAEA Liaison with authorized parties The regulatory body shall establish formal and informal mechanisms of communication with authorized parties on all safety related issues. The regulatory body shall establish formal and informal mechanisms of communication with authorized parties on all safety related issues. Mutual understanding and respect shall be fostered. Mutual understanding and respect shall be fostered. Through communication the common objectives in ensuring safety should be achieved. Through communication the common objectives in ensuring safety should be achieved. Requirement 21; 2006-2013 referenced 5 times. USNRC IRRS Training - Reviewing Regulatory Responsibilities20

21. IAEA Meeting types and schedules Nature of relationship Representatives from authorized parties should be interviewed Carefully check possible interfaces with Module 4 review results! USNRC IRRS Training - Reviewing Regulatory Responsibilities21 Recommendation of Experienced Reviewers Give particular attention to:

22. IAEA Stability and consistency The regulatory body shall ensure that regulatory control is stable and consistent. Decisions shall be based on policies, principles, criteria and procedures. Decisions must be justifiable. Consistency in the decision making builds confidence among stakeholders. Requirement 22; 2006-2013 referenced 21 times. USNRC IRRS Training - Reviewing Regulatory Responsibilities22

23. IAEA Predictability of the regulatory body (in the sense of the consistency of its decision making based on regulations) Process and transparency of change in regulatory requirements (coordinate with Modules 4 and 9) USNRC IRRS Training - Reviewing Regulatory Responsibilities23 Recommendation of Experienced Reviewers Give particular attention to:

24. IAEA Example (consistency in decision) USNRC IRRS Training - Reviewing Regulatory Responsibilities24

25. IAEA Record keeping The regulatory body shall keep records relating to the safety. The regulatory body shall keep records relating to the safety. Registers of: Registers of: Sealed radioactive sources and radiation generators Sealed radioactive sources and radiation generators Occupational doses; Occupational doses; The safety of facilities and activities; The safety of facilities and activities; Records that might be necessary for the shutdown and decommissioning; Records that might be necessary for the shutdown and decommissioning; Events Events Inventories of radioactive waste and of spent fuel etc. Inventories of radioactive waste and of spent fuel etc. Requirement 35; 2006-2013 referenced 6 times. USNRC IRRS Training - Reviewing Regulatory Responsibilities25

26. IAEA Example (record keeping) USNRC IRRS Training - Reviewing Regulatory Responsibilities26

27. IAEA Scope of records to be kept Management of records Coordinate with IRRS Module 4 USNRC IRRS Training - Reviewing Regulatory Responsibilities27 Recommendation of Experienced Reviewers Give particular attention to:

28. IAEA Communication and consultation with interested parties The regulatory body shall inform and consult interested parties and the public about the possible radiation risks and about its work. The authorized party also has an obligation to inform the public about the possible radiation risks. Requirement 36; 2006-2013 referenced 15 times. USNRC IRRS Training - Reviewing Regulatory Responsibilities28

29. IAEA Information policy, including interfaces with the media Types of meetings with interested parties and the public Use of the regulator’s website Issue of regulatory reports Liaison with interested parties within the vicinity of authorized facilities USNRC IRRS Training - Reviewing Regulatory Responsibilities29 Recommendation of Experienced Reviewers Give particular attention to:

30. IAEA Example (communication) USNRC IRRS Training - Reviewing Regulatory Responsibilities30

31. IAEA FYI! Requirements 19 and 23 to 34 of the GSR Part 1 (Management System, Authorization, Review and Assessment, Inspection, Enforcement, Regulations and Guides) are covered by other Training Lectures and IRRS Modules! USNRC IRRS Training - Reviewing Regulatory Responsibilities31

32. IAEA Summary When reviewing Responsibilities of the Regulatory Body focus should be on: Organizational structure Independence Staffing and Competence Advisory bodies and TSOs Stability and consistency Record keeping Communication with others USNRC IRRS Training - Reviewing Regulatory Responsibilities32

33. IAEA THANK YOU FOR YOUR ATTENTION USNRC IRRS Training - Reviewing Regulatory Responsibilities33 Photo: V. Friedrich This activity is conducted by the IAEA, with funding by the European Union. The views expressed in this presentation do not necessarily reflect the views of the European Commission