1. Reviewing Governmental and Regulatory Responsibilities
BASIC IRRS TRAINING
Lecture 9
Reviewing Governmental and Regulatory Responsibilities
(IRRS Modules 1, 2 and 3)

2. 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 Responsibilities

3. 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 Responsibilities

4. 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 Responsibilities

5. 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 Responsibilities

6. More on IAEA Standards in Lecture 2!
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
More on IAEA Standards in Lecture 2!
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

7. 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; referenced 11 times.
This is how many times that Requirement was referenced during IRRS missions between 2006 and It indicates the practical importance of that Requirement in the IRRS missions.
Some slides have the following title:
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

8. 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.
More on Review Methods in Lecture 5!
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

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

10. The Head of the Regulatory Body should also be interviewed
Recommendation of Experienced Reviewers Give particular attention to:
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

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

12. National policy and strategy for safety
Requirement 1
referenced 12 times.
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 ...)
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

13. 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 Responsibilities

14. Long term commitment to safety ...
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

15. Establishment of a framework for safety
Requirement 2
referenced 37 times.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

16. 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 Responsibilities

17. 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 Responsibilities

18. Requirements for authorization Legal responsibility for safety
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

19. The regulatory body
Requirement 3&4; referenced 35 times.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

20. 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 Responsibilities

21. Necessary competence and resources
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

22. Prime responsibility and compliance with regulations for safety
Requirement 5&6; referenced 10 times.
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
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

23. Authorized party always responsible
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

24. Coordination of different authorities
Requirement 7; referenced 7 times.
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
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

25. Responsibilities and functions of each authority are legally specified
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

26. Emergency Preparedness and Response
Requirement 8; referenced 12 times.
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.
Provision for effective liaison between Licensees and authorities shall be in place.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

27. Reducing existing or unregulated radiation risks
Requirement 9; was not referenced!
There 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
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

28. Protections against radiation risks not being under regulatory control
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

29. Decommissioning and the mana-gement of r. waste and of spent fuel
Requirement 10; referenced 5 times.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

30. 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 Responsibilities

31. Included in the governmental policy and strategy
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

32. Competence for safety
Requirement 11; referenced 14 times.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

33. Required for all parties with safety responsibilities
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

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

35. Safety, security and safeguards
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 Responsibilities

36. Provision of technical services
Requirement 13; referenced only once.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

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

38. International cooperation
Requirement 14; referenced 8 times.
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
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

39. International conventions Codes of conduct
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

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

41. Reporting of operating and regulatory experience
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

42. IRRS Module 3 Responsibilities and functions of the regulatory body
IAEA GSR Part 1, pages & 35
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

43. 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
Shutdown and decommissioning are regulated
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

44. Organizational structure and resources
Requirement 16; referenced 16 times.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

45. Sufficiency of human and financial resources Organizational structure
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

46. Effective independence
Requirement 17; referenced 7 times.
The regulatory body shall perform its functions in a manner that does not compromise its effective independence.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

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

48. Staffing and competence
Requirement 18; referenced 52 times.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

49. 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 Responsibilities

50. Sufficiency and competence of staff Long term human resource planning
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

51. Advisory bodies and support organizations
Requirement 20; referenced 46 times.
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.
Avoidance of the conflict of interests shall be taken care of.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

52. Handling of conflicts of interest
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

53. Liaison with authorized parties
Requirement 21; referenced 5 times.
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.
Through communication the common objectives in ensuring safety should be achieved.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

54. Meeting types and schedules Nature of relationship
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

55. Stability and consistency
Requirement 22; referenced 21 times.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

56. Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

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

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

59. Communication and consultation with interested parties
Requirement 36; referenced 15 times.
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.
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

60. Information policy, including interfaces with the media
Recommendation of Experienced Reviewers Give particular attention to:
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 Responsibilities

61. 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 Responsibilities

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

64. 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. THANK YOU FOR YOUR ATTENTION
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
Photo: V. Friedrich
Basic IRRS Training - Reviewing Governmental and Regulatory Responsibilities

66. 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 Responsibilities