1. IAEA International Atomic Energy Agency Governmental, Legal and Regulatory Framework for Safety and Regulatory Functions William Kennedy Research Reactor Safety Section Division of Nuclear Installation Safety Lisbon, Portugal 04/11/2015

2. IAEA Contents IAEA safety standards for research reactors (RRs) GSR Part 1, Governmental, Legal and Regulatory Framework for Safety (2010) Functions of the regulatory body IAEA safety guides for implementing GSR Part 1 Concluding remarks

3. IAEA Categories and Structure of the IAEA Safety Standards Two categories Thematic: Areas of a cross-cutting nature Facility-specific: Nuclear power plants (NPPs), research reactors (RRs), fuel cycle facilities, etc. The structure consists of a small number of thematic safety standards and a larger number of facility-specific safety standards.

4. IAEA Long-term Structure of the IAEA Safety Standards The structure ensures a logical relationship between the IAEA Safety Standard “Fundamental Safety Principles (SF-1),” and the IAEA Safety Requirements and Safety Guides.

5. IAEA IAEA Safety Standards for Research Reactors The IAEA Safety Standards for RRs reflect international consensus on what constitutes a high level of safety, and: Serve as the basis for IAEA safety review services and assistance; Cover all areas important to the safety of RRs; Provide guidance for effective implementation of the “Code of Conduct on the Safety of Research Reactors”; Should be used by all organizations involved in RRs, including the operating organization, regulatory body, users, designers and vendors; Use regulatory language to facilitate their incorporation into national safety regulations and guides

6. IAEA IAEA Safety Standards for Research Reactors

7. IAEA IAEA Safety Standards for Research Reactors

8. IAEA SF-1, Fundamental Safety Principles Objective is to establish the fundamental safety objective, safety principles and concepts that provide bases for the IAEA’s safety standards and its safety related programme. Applies to all circumstances that give rise to radiation risks. Applicable throughout the lifetime of all facilities and activities.

9. IAEA SF-1, Fundamental Safety Principles The fundamental safety objective is to protect people and the environment from harmful effects of ionizing radiation. Ten safety principles on the basis of which safety requirements are developed

10. IAEA SF-1, Fundamental Safety Principles Principle 2: Role of government An effective legal and governmental framework for safety, including an independent regulatory body, must be established and sustained. The government is responsible for the adoption within its national legal system of such legislation, regulations, and other standards and measures as may be necessary to fulfil all its national responsibilities and international obligations effectively, and for the establishment of an independent regulatory body.

11. IAEA GSR Part 1 General Safety Requirements that apply to all facilities and activities 36 requirements covering: Responsibilities and functions of the government (State); The global safety regime; Responsibilities and functions of the regulatory body.

12. IAEA GSR Part 1, Government The government (State) establishes the national policy for safety by means of different instruments, statutes and laws. Long term commitment to safety; Mechanisms for implementation; Account shall be taken of: Fundamental safety principles; Binding international legal instruments; Scope of the framework for safety; Human and financial resources; Social and economic developments; Management and leadership for safety.

13. IAEA GSR Part 1, Government The government establishes the framework for safety through statutes and laws, which sets out: Safety principles; Type of facilities and activities covered; Type of and rationale for authorizations; Legal responsibility for safety; Establishment of a regulatory body; Review and assessment; Developing regulations and guidance;

14. IAEA GSR Part 1, Government The government establishes the framework for safety through statutes and laws, which sets out: Inspection and enforcement; Emergency preparedness and response; Interface with nuclear security; Acquiring and maintaining competence; Release from regulatory control; Offences and penalties.

15. IAEA GSR Part 1, Government Requirements: Establishment of a regulatory body; Independence of the regulatory body; Prime responsibility for safety; Compliance with regulations and responsibility for safety; Coordination of authorities; Emergency preparedness and response; Decommissioning; Competence for safety; Interface with nuclear security; Technical services

16. IAEA GSR Part 1, Global Safety Regime International obligations and arrangements for international cooperation: Conventions; Codes of Conduct; Safety standards; Peer reviews; Bilateral and multilateral cooperation; Sharing of operating experience and regulatory experience

17. IAEA GSR Part 1, Regulatory Body Requirements: Organizational structure of the regulatory body and allocation of resources; Effective independence in the performance of regulatory functions; Staffing and competence of the regulatory body; The management system of the regulatory body; Liaison with advisory bodies and support organizations; Liaison between regulatory body and authorized parties;

18. IAEA GSR Part 1, Regulatory Body Requirements: Stability and consistency of regulatory control; Authorization of facilities and activities by the regulatory body; Review and assessment of information relevant to safety; Graded approach to review and assessment of a facility or an activity; Inspection of facilities and activities; Types of inspection of facilities and activities; Graded approach to inspection of facilities and activities;

19. IAEA GSR Part 1, Regulatory Body Requirements: Establishment of enforcement policy; Requiring of corrective action by authorized parties; Regulations and guides; Review of regulations and guides; Promotion of regulations and guides to interested parties; Safety-related records; Communication and consultation with interested parties.

20. IAEA Authorization (Licensing) Process For all facilities and activities, a license or other prior authorization shall be in force. The authorization shall only be issued when the regulatory body is satisfied that there is compliance with regulations and adequate protection of people and the environment. Functions of the Regulatory Body

21. IAEA Review and Assessment Review and assess the information submitted by applicants to: Demonstrate safety prior to authorization; Demonstrate safety periodically during operation; Determine whether the facility or activity complies with the relevant safety objectives and criteria; Verify conditions upon which the authorization was given. Develop and implement its own programmes for review and assessment of the facilities, as a confirmatory measure. Functions of the Regulatory Body

22. IAEA Inspection Carry out inspections to verify that the licensee is in compliance with regulations, regulatory requirements and the conditions upon which authorization was given. These inspections shall include routine and non-routine inspections. These inspections shall cover surveillance, in service inspection and maintenance conducted by the licensee, as well as safety related hardware and activities. Functions of the Regulatory Body

23. IAEA Enforcement Carry out appropriate enforcement actions when there is evidence of non-compliance with regulations, regulatory requirements or any condition upon which the authorization was given. Functions of the Regulatory Body

24. IAEA Regulatory Approach, Regulations and Guides Determine the regulatory approach. Establish, promote or adopt regulations, safety principles, associated criteria and guides upon which regulatory actions are based. Keep documents up-to-date, taking into consideration internationally endorsed standards and recommendations. Functions of the Regulatory Body

25. IAEA Information and Public Communication Set up appropriate means of informing the public and other interested parties, and the media about the safety aspects of RRs and about regulatory processes. Consult parties in the vicinity and other interested parties, as appropriate, in an open and inclusive process. Functions of the Regulatory Body

26. IAEA GS-G-1.1: Organization and Staffing of the Regulatory Body for Nuclear Facilities Provide recommendations for national authorities on the appropriate management system, organization and staffing for the regulatory body responsible for the regulation of nuclear facilities in order to achieve compliance with the applicable safety requirements; Regulatory independence and funding; Organization of the regulatory body; Staffing of the regulatory body; Training of regulatory staff.

27. IAEA GS-G-1.2: Review and Assessment of Nuclear Facilities by the Regulatory Body Provides recommendations for regulatory bodies on reviewing and assessing the various safety related submissions to determine whether the facility complies with the applicable safety objectives and requirements; Covers the nuclear facility at different stages in its lifetime, including siting, design, construction, commissioning, operation and decommissioning or closure; Review and assessment process; Performance of review and assessment; Monitoring the review and assessment.

28. IAEA GS-G-1.3: Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body Provides recommendations on the inspection of nuclear facilities, regulatory enforcement and related matters; The regulatory body should have a high level of confidence that operators have the processes in place to ensure compliance and that they comply with legal requirements, including the safety objectives and regulatory requirements; Objectives of inspection and enforcement; Management of inspections; Performance of regulatory inspections; Regulatory enforcement; Assessment of activities.

29. IAEA GS-G-1.4: Documentation for Use in Regulating Nuclear Facilities Provide recommendations for regulatory bodies and operating organizations on the documentation to be prepared for regulatory processes, and on how to ensure that such documentation is of sufficient quality and provides correct information in an appropriate way to serve its intended purpose; Overview of documentation; Regulations and guides; Documents produced by the operating organization; Documents produced for a specific facility by the regulatory body.

30. IAEA SSG-12: Licensing Process for Nuclear Installations Provides Recommendations on developing the basis of a licensing process to be applied by regulatory bodies for granting licenses for nuclear installations and their activities, including some aspects of regulatory control; Provides information on the topics and documents that should be considered in the licensing process throughout the lifetime of the nuclear installation; General recommendations on the licensing process; Steps of the licensing process.

31. IAEA NS-R-4: Safety of Research Reactors NS-R-4, Safety of Research Reactors: Provide a basis for safety; Provide a basis for safety assessment at all stages in the lifetime of a RR; Establish requirements related to regulatory control, the management of safety, site evaluation, design, operation and decommissioning; Emphasis is placed on the safety requirements that shall be met rather than on the ways in which they can be met.

32. IAEA NS-R-4: Safety of Research Reactors Regulatory Supervision Management and Verification of Safety Site Evaluation Design Operation RRs with power levels in excess of several tens of megawatts, fast reactors, and RRs using an experimental device, such as a high-pressure and temperature loop or a cold neutron source, may require application of safety standards for NPPs or additional safety measures. Decommissioning

33. IAEA IAEA safety standards for regulation of RRs IAEA safety standards specific to research reactors and other IAEA safety standards related to regulation of nuclear facilities can be used for developing the regulatory framework and requirements for RRs. NS-R-4 specifies the safety requirements for RRs, which should be adapted for the specific needs of the Member State and its facilities. SSG-22 should be used to apply a graded approach to NS-R-4. SSG-20 provides guidance on safety analysis and the contents of the safety analysis report for various stages in the RR lifetime.

34. IAEA Using NS-R-4 for regulatory requirements for RRs NS-R-4 is general in nature, in that it is meant to cover all types and power levels of RRs. The requirements must be adapted in a specific manner to fit the needs of the Member State. Regulatory requirements should be clear and specific so the operating organization understands what is expected. Regulatory requirements should be written so that determination of compliance is straightforward and not subject to interpretation. For a variety of facilities, regulatory requirements should cover all facilities or specific requirements should be developed for different categories of facilities.

35. IAEA SSG-20: Safety Assessment of RRs and Preparation of the Safety Analysis Report Provides guidance on the preparation, review and assessment of the safety analysis report (SAR) Provides guidance on the initial licensing process for new RRs, and also on re-licensing and periodic safety reviews of existing RRs

36. IAEA SSG-22: Use of a Graded Approach in the Application of the Safety Requirements for RRs Provides guidance for grading the application of the safety requirements to account for the differences in RR designs, operation and utilization programmes Covers using a graded approach throughout the various stages of the lifetime of a RR without compromising safety Can be used by use by regulatory bodies, operating organizations and other organizations involved in the design, construction and operation of research reactors

37. IAEA IAEA Safety Standards and Supporting Publications for RRs Available Online IAEA Safety Standards homepage: http://www-ns.iaea.org/standards/default.asp?s=11&l=90 IAEA Safety Standards for RRs: http://www-ns.iaea.org/standards/documents/default.asp?s=11&l=90&sub=20&vw=9#sf IAEA Safety Report Series: http://www-pub.iaea.org/books/IAEABooks/Series/73/Safety-Reports-Series IAEA TECDOCs: http://www-pub.iaea.org/books/IAEABooks/Series/34/Technical-Documents

38. IAEA Concluding Remarks Establishment of a governmental, legal and regulatory framework for safety is essential to fully apply the Code of Conduct on the Safety of Research Reactors and achieve the highest level of safety for RRs. The IAEA safety standards for RRs and other IAEA safety standards should be applied for regulatory programmes in a specific manner taking into account the facilities that will be regulated and using a graded approach.

39. IAEA Thank you for your attention.