1. IAEA International Atomic Energy Agency Reviewing Governmental and Regulatory Responsibilities (IRRS Modules 1, 2 and 3) BASIC IRRS TRAINING Lecture 9

2. IAEA Outline Learning Objectives Responsibilities and functions of the government Framework for safety The Regulatory Body Emergency Preparedness Decommissioning and waste management Competence for safety Safety Security and Safeguards The Global Safety Regime Responsibilities and functions of the regulatory body Organizational structure Effective independence Staffing and competence Advisories and support Liaison with authorized parties Stability and consistency Record keeping Communications Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities2

3. IAEA Learning objectives After finishing this lecture the trainee will: Know what is national policy and strategy for safety. Understand what kind of governmental, legal and regulatory framework is needed. Understand the importance of the regulatory body and of its independence. Know that the prime responsibility for safety lies with the authorized party. Understand that different authorities fulfilling regulatory duties have to be properly coordinated. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities3

4. IAEA Learning objectives – cont. After finishing this lecture the trainee will: Understand the importance of provisions for reduction of risks due to unregulated sources. Know that the provisions must be in place for decommissioning of facilities and management of radioactive waste and spent nuclear fuel. Understand the importance of maintaining the competence for safety Understand the importance of interfaces between safety, security and safeguards. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities4

5. IAEA Learning objectives – cont. After finishing this lecture the trainee will: Understand the importance of provisions for technical services. Understand the importance of international obligations. Understand the importance of operating experience feedback. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities5

6. IAEA Introduction This Training Lecture covers three IRRS Modules: Module 1: Responsibilities and functions of the government Module 2: The global safety regime Module 3: Responsibilities and functions of the regulatory body The basis is IAEA Safety Standard GSR Part 1: Governmental, Legal and Regulatory Framework for Safety Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities6 More on IAEA Standards in Lecture 2!

7. IAEA How to read the following slides? There is a line under the title with the GSR Part 1 Requirement number looking like this: Requirement 7; 2006-2013 referenced 11 times. This is how many times that Requirement was referenced during IRRS missions between 2006 and 2013. It indicates the practical importance of that Requirement in the IRRS missions. Recommendation of Experienced Reviewers Give particular attention to: On those slides lists of the most important issues, that have been recognized by experienced IRRS reviewers during a series of Consultancies in 2012 are given. Some slides have the following title: Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities7

8. IAEA Review Methods – short reminder Three basic methods to acquire sufficient information for an objective review: A review of written material. Interviews with personnel and other officials. Direct observation of regulatory body activities in the office and at facilities. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities8 More on Review Methods in Lecture 5!

9. IAEA Review is assisted by Report Template The Standard Mission report Template gives guidance and assistance in the interviews and in writing the report Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities9 More on Report Template in Lecture 7!

10. IAEA A senior government representative responsible for safety within the State Administration should be interviewed The Head of the Regulatory Body should also be interviewed Verify, through examples, that the IAEA requirements are not only transposed into the regulatory infrastructure but are also correctly implemented. Recommendation of Experienced Reviewers Give particular attention to: Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities10

11. IAEA IRRS Module 1: Responsibilities and functions of the government IRRS Module 1: Responsibilities and functions of the government IAEA GSR Part 1, pages 3-14 IAEA GSR Part 1, pages 3-14 Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities11

12. IAEA National policy and strategy for safety There should be the national policy and strategy for safety in place It should follow IAEA Safety Fundamentals It should be graded to the national circumstances Could be implemented by different means (laws, statutes, rules...) Requirement 1 2006-2013 referenced 12 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities12

13. IAEA National strategy for safety shall include Long term commitment to safety; International legal instruments (conventions); Governmental, legal and regulatory framework; Provision for human and financial resources; Provision and framework for research and development; Mechanisms for taking account of social and economic developments; Promotion of leadership and management for safety, including safety culture. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities13

14. IAEA A senior government representative responsible for safety within the State Administration should be interviewed Long term commitment to safety...... which is promulgated as a statement (document)! Radwaste and spent fuel management policy and strategy should be included There should be a basis for graded approach set! Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities14 Recommendation of Experienced Reviewers Give particular attention to:

15. IAEA Establishment of a framework for safety The government shall establish and maintain an appropriate governmental, legal and regulatory framework for safety. Responsibilities shall be clearly allocated. Appropriate laws and statutes shall be promulgated. Requirement 2 2006-2013 referenced 37 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities15

16. IAEA Framework for safety shall include The safety principles for protecting people The types of facilities and activities that are included The type of authorization Involvement of interested parties in decision making; Provision for assigning responsibility to the persons and for ensuring the continuity of responsibility The establishment of a regulatory body Provision for review and assessment The authority and responsibility for promulgating regulations and preparing guides Provision for inspection and enforcement Provision for appeals against decisions of the regulatory body; Provision for preparedness for, and response to, a nuclear or radiological emergency; Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities16

17. IAEA Framework for safety shall include Provision for an interface with nuclear security; Provision for an interface with the safeguards system Provision for the competence for ensuring safety; Responsibilities in respect of financial provision for the management of radioactive waste and of spent fuel, and for decommissioning of facilities The criteria for release from regulatory control; The specification of offences and the penalties; Provision for controls on the import and export of nuclear material and radioactive material. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities17

18. IAEA Legally binding framework for safety covering all types of activities and facilities Requirements for authorization Legal responsibility for safety Establishment of a Regulatory Body Legal and financial provisions for management of radioactive waste and spent fuel Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities18 Recommendation of Experienced Reviewers Give particular attention to:

19. IAEA The regulatory body The government shall establish and maintain a regulatory body with the competence and the resources to fulfill its obligation for the regulatory control. The regulatory body shall be effectively independent in its decision making and shall have functional separation from entities having responsibilities or interests that could unduly influence its decision making. Requirement 3&4; 2006-2013 referenced 35 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities19

20. IAEA Independence Regulatory Body will not be entirely separate from other governmental bodies. However, it should be able to make decisions without undue pressure from promoters of activities. Should have sufficient staff and resources. Several authorities may represent a Regulatory Body Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities20

21. IAEA Legal authority Necessary competence and resources Effective independence as provided by the legal basis Free from conflicting responsibilities Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities21 Recommendation of Experienced Reviewers Give particular attention to:

22. IAEA Prime responsibility and compliance with regulations for safety Prime responsibility for safety shall be with the person or organization responsible for a facility or an activity (Licensee). Regulatory Body shall have authority to require Licensee to comply with regulatory requirements Compliance with regulations does not relieve the Licensee of its prime responsibility for safety Requirement 5&6; 2006-2013 referenced 10 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities22

23. IAEA Prime legal responsibility for safety to the person/organization responsible for a facility/activity Authorized party always responsible Responsibility for safety covers all stages in the lifetime of the facility/activity Transfer of responsibility for safety only after approval by the regulatory body Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities23 Recommendation of Experienced Reviewers Give particular attention to:

24. IAEA Coordination of different authorities Where several authorities have responsibilities for safety they shall be effectively coordinated to avoid any omissions or undue duplication and to avoid conflicting requirements being placed on authorized parties. Where several authorities have responsibilities for safety they shall be effectively coordinated to avoid any omissions or undue duplication and to avoid conflicting requirements being placed on authorized parties. Examples of different authorities: Safety of workers and the public; Protection of the environment; Radiation in medicine, industry and research; Emergency preparedness and response; Management of radioactive waste Liability for nuclear damage Nuclear security; Safeguards system; Safety in relation to water use and the consumption of food; Land use, planning and construction; Safety in the transport of dangerous goods. etc Requirement 7; 2006-2013 referenced 7 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities24

25. IAEA Responsibilities and functions of each authority are legally specified Appropriate and documented coordination and liaison among the authorities Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities25 Recommendation of Experienced Reviewers Give particular attention to:

26. IAEA Emergency Preparedness and Response The government shall make provision for emergency preparedness to enable a timely and effective response in a nuclear or radiological emergency. The government shall make provision for emergency preparedness to enable a timely and effective response in a nuclear or radiological emergency. Clear responsibilities for decision making in an emergency shall be assigned. Clear responsibilities for decision making in an emergency shall be assigned. Provision for effective liaison between Licensees and authorities shall be in place. Provision for effective liaison between Licensees and authorities shall be in place. Requirement 8; 2006-2013 referenced 12 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities26

27. IAEA Reducing existing or unregulated radiation risks T here shall be an effective system in place to reduce undue radiation risks associated with unregulated sources and contamination from past activities or events. Orphan sources, historical sources, post-accident conditions... Special organization to take care of them Regulatory Body sets rules Requirement 9; 2006-2013 was not referenced! Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities27

28. IAEA Protections against radiation risks not being under regulatory control Unacceptable risk as a consequence of an accident, discontinued practice, inadequate control related to radiation sources Role of the regulatory body in such cases Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities28 Recommendation of Experienced Reviewers Give particular attention to:

29. IAEA Decommissioning and the mana- gement of r. waste and of spent fuel The government shall make provision for the safe decommissioning of facilities, the safe management and disposal of radioactive waste arising from facilities and activities, and the safe management of spent fuel. The government shall make provision for the safe decommissioning of facilities, the safe management and disposal of radioactive waste arising from facilities and activities, and the safe management of spent fuel. Requirement 10; 2006-2013 referenced 5 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities29

30. IAEA Decommissioning, RW and SF Should be part of national strategy RW could be of different types The interdependences of the steps in the management process for shall be recognized Control after closure of disposal facility shall be clearly assigned Financial provisions shall be assured Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities30

31. IAEA Included in the governmental policy and strategy Interim targets and end states Governmental provisions for appropriate research and development programmes Interdependences in the management of radioactive waste Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities31 Recommendation of Experienced Reviewers Give particular attention to:

32. IAEA Competence for safety The government shall make provision for building and maintaining the competence of all parties having responsibilities in relation to the safety of facilities and activities. The government shall make provision for building and maintaining the competence of all parties having responsibilities in relation to the safety of facilities and activities. Sufficient number of suitably qualified and experienced staff shall be made available. Sufficient number of suitably qualified and experienced staff shall be made available. Requirement 11; 2006-2013 referenced 14 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities32

33. IAEA Required for all parties with safety responsibilities Licensees Regulatory body Research and development centres Definition of necessary competence levels Arrangements for professional training programmes Requirements for provision of sufficient number of suitably qualified and experienced staff Provisions for appropriate research and development programmes Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities33 Recommendation of Experienced Reviewers Give particular attention to:

34. IAEA Safety, security and safeguards Safety – protect people and environment from ionizing radiation Safeguards – Prevention of spread of nuclear weapons Security – Protect nuclear and radioactive material from malicious acts Requirement 12; 2006-2013 referenced only once.. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities34

35. IAEA Safety, security and safeg uards The government shall ensure that adequate infrastructural arrangements are established for interfaces of safety with arrangements for nuclear security and with the State system of accounting for, and control of, nuclear material. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities35

36. IAEA Provision of technical services The government shall make provision, where necessary, for technical services in relation to safety, such as services for personal dosimetry, environmental monitoring and the calibration of equipment. The government shall make provision, where necessary, for technical services in relation to safety, such as services for personal dosimetry, environmental monitoring and the calibration of equipment. Requirement 13; 2006-2013 referenced only once. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities 36

37. IAEA IRRS Module 2 The Global Nuclear Safety Regime IAEA GSR Part 1, pages 15-16 IAEA GSR Part 1, pages 15-16 IRRS Module 2 IAEA GSR Part 1, pages 15-16 IAEA GSR Part 1, pages 15-16 Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities 37

38. IAEA International cooperation The government shall fulfill its respective international obligations, participate in the relevant international arrangements, including international peer reviews, and promote international cooperation to enhance safety globally. International conventions, Codes of conduct, IAEA Safety Standards, International Peer Reviews, Multi- and bilateral cooperation Requirement 14; 2006-2013 referenced 8 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities38

39. IAEA International conventions Codes of conduct Use of and participation in development of IAEA Safety Standards International peer reviews Multilateral and bilateral cooperation programmes Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities39 Recommendation of Experienced Reviewers Give particular attention to:

40. IAEA Sharing of operating and regulatory experience Lessons shall be learned from operating and regulatory experience, including experience in other States. nt authorities. Lessons learned shall be disseminated to Licensee, the regulatory body and other relevant authorities. Requirement 15; 2006-2013 referenced 21 times. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities40

41. IAEA Reporting of operating and regulatory experience Receiving of information from other states and authorized parties Dissemination of lessons learned and their use Feedback on measures taken in response to information received Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities41 Recommendation of Experienced Reviewers Give particular attention to:

42. 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 Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities 42

43. 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 Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities43

44. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities44

45. 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 Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities45 Recommendation of Experienced Reviewers Give particular attention to:

46. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities46

47. IAEA Independent decision making Functional separation from undue influence Integrity of staff Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities47 Recommendation of Experienced Reviewers Give particular attention to:

48. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities48

49. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities49

50. 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 Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities50 Recommendation of Experienced Reviewers Give particular attention to:

51. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities51

52. IAEA Handling of conflicts of interest The regulatory body as an intelligent customer Representatives from advisory bodies and support organizations should be interviewed Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities52 Recommendation of Experienced Reviewers Give particular attention to:

53. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities53

54. IAEA Meeting types and schedules Nature of relationship Representatives from authorized parties should be interviewed Carefully check possible interfaces with Module 4 review results! Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities54 Recommendation of Experienced Reviewers Give particular attention to:

55. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities55

56. 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) Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities56 Recommendation of Experienced Reviewers Give particular attention to:

57. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities57

58. IAEA Scope of records to be kept Management of records Coordinate with IRRS Module 4 Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities58 Recommendation of Experienced Reviewers Give particular attention to:

59. 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. Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities59

60. 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 Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities60 Recommendation of Experienced Reviewers Give particular attention to:

61. 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! Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities61

62. IAEA Summary (1) When reviewing Responsibilities and functions of the government focus should be on: National policy and strategy for safety Framework for safety Prime responsibility for safety Coordination of different authorities Emergency preparedness Regulatory control of sources Regulatory control of radioactive waste and decommissioning Maintenance of Competence for safety Interface between Safety, Security and Safeguards Provisions of technical services

63. IAEA Summary (2) When reviewing Global Safety Regime focus should be on: International involvement of the government Operating experience feedback

64. IAEA Summary (3) 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

65. IAEA THANK YOU FOR YOUR ATTENTION Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities65 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

66. IAEA Discussion Explain the elements that are creating the national Framework for safety Explain the main international instruments that are trying to harmonise nuclear safety around the World Describe the main functions of a Regulatory Body Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities66