1. International Atomic Energy Agency School for Drafting Regulations on Radiation Safety RER/9/096 Vienna, 3 May, 2010 Adriana Nicic, Regulatory Activities Section, NSNI Role and Attributes of Good Regulations

2. International Atomic Energy Agency Current and Future Status of Safety Standards Governmental, Legal and Regulatory Framework for Safety - GSR, Part 1 Regulatory Strategies Attributes of Good Regulations Conclusions Overview

3. International Atomic Energy Agency IAEA Obligation IAEA Statute (Article III.A.6) “To establish or adopt… [in consultation with…] standards of safety for the protection of health and minimization of danger to life and property” “…and to provide for the application of these standards”

4. International Atomic Energy Agency IAEA Safety Standards Safety Guides Safety Requirements Safety Fundamentals

5. International Atomic Energy Agency Current Status of Safety Requirements

6. International Atomic Energy Agency Governmental and Regulatory Framework

7. International Atomic Energy Agency “Milestones” document IAEA NG-G-3.1 IAEA SAFETY STANDARDS GUIDES REQUIREMENTS FUNDAMENTALS IAEA Nuclear Power Support Group’s BROCHURE International Nuclear Safety Group’s REPORT-22 Safety Infrastructure Guide DS424 “Establishing a Safety Infrastructure for a National Nuclear Power Programme” Safety Guide

8. International Atomic Energy Agency Structure of Long Term Set of Safety Requirements Part 1 Governmental and Regulatory Framework Part 2 Leadership and Management for Safety Part 4 Safety Assessment for Facilities and Activities Part 5 Predisposal Management of Radioactive Waste Part 6 Decommissioning and Termination of Activities Part 7 Emergency Preparedness and Response Specific Safety RequirementsGeneral Safety Requirements Part 3 Radiation Protection and Safety of Radiation Sources 1. Site Evaluation for Nuclear Installations 3. Safety of Research Reactors 4. Safety of Nuclear Fuel Cycle Facilities 5. Safety of Radioactive Waste Disposal Facilities 6. Safe Transport of Radioactive Material 2. Safety of Nuclear Power Plants 2.1 Design and Construction 2.2 Commissioning and Operation

9. International Atomic Energy Agency Structure of Reference Set of Safety Guides for Long Term Long Term Set of Safety Guides prepared: General Safety Guides Facilities and Activities Specific Safety Guides Safety Guides GS-G-1.1 to GS- G-1.4 (and additional guidance) will become additional material in the General Safety Guide #2 – “General Regulatory Control of Facilities and Activities”

10. International Atomic Energy Agency Governmental, Legal and Regulatory Framework for Safety – GSR, Part 1 GSR, Part 1, approved by Board of Governors (March 2010) Supersedes GS-R-1, legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety

11. International Atomic Energy Agency Governmental, Legal and Regulatory Framework for Safety Establishes international consensus requirements to apply the fundamental safety objectives and principles establishes in SF-1, the IAEA Safety Fundamentals

12. International Atomic Energy Agency Fundamental Safety Principles Principle 1: Responsibility for safety Principle 2: Role of government Principle 3: Effective Leadership and Management for Safety

13. International Atomic Energy Agency Governmental, Legal and Regulatory Framework for Safety Covers all phases of the lifetime of facilities and duration of activities until release from regulatory control Does not apply to military or defence related activities unless so decided by the Member State, nor does it apply to nuclear security

14. International Atomic Energy Agency General Considerations - Government

15. International Atomic Energy Agency Responsibilities and Functions of the Government 1.National policy and strategy for safety 2.Establishment of a framework for safety 3.Establishment of a regulatory body 4.Independence of the regulatory body 5.Prime responsibility for safety

16. International Atomic Energy Agency Responsibilities and Functions of the Government 6.Compliance with regulations and responsibility for safety 7.Coordination of different authorities with responsibilities for safety within the regulatory framework for safety 8.Emergency preparedness and response 9.System for protective actions to reduce existing or unregulated radiation risks

17. International Atomic Energy Agency Responsibilities and Functions of the Government 10.Provision for the decommissioning of facilities and the management of radioactive waste and of spent fuel 11.Competence for safety 12.Interfaces of safety with nuclear security and with the State system of accounting for and control of nuclear material 13.Provision of technical services

18. International Atomic Energy Agency The Global Safety Regime 14.International obligations and arrangements for international cooperation 15.Sharing of operating experience and regulatory experience

19. International Atomic Energy Agency General Considerations – Regulatory Body

20. International Atomic Energy Agency Responsibilities and functions of regulatory body 21 requirements related to responsibilities and functions of regulatory body Requirement 16 – 18 relates to organizational structure, independence, staffing, competence, liaison with advisory bodies and other regulators Requirement 19 – 22 related to management system and liaison with other interested parties

21. International Atomic Energy Agency Responsibilities and functions of regulatory body Requirement 23-34 relates to core functions of regulatory body Requirement 35 – 36 related to safety records and communication

22. International Atomic Energy Agency Requirement 23 - Authorization Authorization by the regulatory body, including specification of the conditions necessary for safety, shall be a prerequisite for all those facilities and activities that are not either explicitly exempted or approved by means of notification process.

23. International Atomic Energy Agency 1/21/2016 23 ◄ Demonstration of safety R24 1.Authorization of activities 2.Diff types, stages and lifetimes 3.Commensurate with hazard 4.Guidance on format & content 5.Submit safety case 6.Impose limits, conditions 7.Provision for appeal 8.Provision of amendment 9.Formal record of decisions Requirement 24 –Demonstration of Safety

24. International Atomic Energy Agency Requirement 25 – Review and Assessment The regulatory body shall review and assess relevant information to determine whether facilities and activities comply with regulatory requirements and the conditions specified in the authorization. This review and assessment of information shall be performed prior to authorization and again over the lifetime of the facility or duration of the activity as specified in regulations promulgated by the regulatory body or in the authorization.

25. International Atomic Energy Agency 25 ► Graded approach R26 1.Commensurate with hazard 2.In accordance with stages 3.Purpose to comply requirements To acquire understanding of design Accurate, proven Risk at normal, anticipated, accident Site conditions Best practices Management system Competence of operators Arrangement for protection of workers EPP Nuclear security Concept of defense in depth Operating experience feedback Info from Inspection Risk other then radiation Requirement 26 – Graded Approach

26. International Atomic Energy Agency Requirement 27 - Inspection The regulatory body shall carry out inspections of facilities and activities to verify that the authorized party is in compliance with the regulatory requirements and with the conditions specified in the authorization

27. International Atomic Energy Agency 27 Types of Inspection R28 1.Prime Responsibility 2.Inspection do not diminish 3.Inspection Program 4.Results of inspection 5.SSC 6.MS 7.Operational activities 8.Records 9.Liaisons with contractors 10.Safety culture Graded approach R29 Requirement 28, 29 – Graded Approach, Types of Inspection

28. International Atomic Energy Agency Requirement 30 - Enforcement The regulatory body shall establish and implement an enforcement policy within the legal framework for responding to non-compliance by authorized parties with regulatory requirements or with any conditions specified in the authorization.

29. International Atomic Energy Agency 1/21/2016 29 ► Corrective action R31 1.Response to non-compliance 2.Verbal notification, written.. 3.Identify non-compliance 4.Remedying non-compliance 5.Criteria for corrective action 6.On-site inspectors power Requirement 31 –Corrective Action

30. International Atomic Energy Agency Requirement 32 – Regulations and Guides The regulatory body shall establish or adopt regulations and guides to specify the principles, requirements and associated criteria for safety upon which its regulatory judgments, decisions and actions are based

31. International Atomic Energy Agency 1/21/2016 31 ◄ Review of regulation R33 Promotion of regulation R34 Requirement 33 and 34 – Preparation of Regulations 1.Process for regulations 2.Consultation 3.International standards 4.Feedback from experience 5.Framework for authorization 6.Consistent 7.Comprehensive 8.Graded approach

32. International Atomic Energy Agency Regulatory Strategies What is a regulatory strategy? An approach to regulation that determines the overarching types of demands that are made on licensees/ applicants It is more specific than a regulatory mandate—which is the scope of responsibility given by the government to the regulator, and More general than regulatory methods—which are the ways that the regulator determines if operators are fulfilling demands (inspections, document reviews etc.)

33. International Atomic Energy Agency Importance of Regulatory Strategies Strategies affect the behavior of licensees and therefore have an impact on safety Development of regulatory framework is based upon the adopted strategy Strategies are a major determinant of how a regulator carries out oversight e.g. resources used, types of expertise needed

34. International Atomic Energy Agency Context Influencing the Regulatory Strategy Regulatory mandate Nature of the nuclear industry Culture and history of the country, of the regulatory agency, and of the facilities and activities being regulated

35. International Atomic Energy Agency Alternative Regulatory Strategies Prescriptive Case-based Outcome-based Risk-based Process-based Licensee self-assessments

36. International Atomic Energy Agency Attributes of Good Regulations WORKING on it…………..

37. International Atomic Energy Agency Conclusions

38. International Atomic Energy Agency Thank you!