1. IAEA International Atomic Energy Agency School of Drafting Regulations – November 2014 Government and Regulatory Body Functions and Responsibilities IAEA – Departments of Technical Cooperation and Nuclear Safety & Security Stephen Evans Project Officer, Division of Nuclear, Radiation, Waste and Transport Safety (NSRW)

2. IAEA IAEA Thematic Safety Area 1 (TSA1) ‘Regulatory Infrastructure’ comprises 14 elements i.e.: 1.Legislation 2.Regulations and Guidance 3.Regulatory Body Establishment and Independence 4.Regulatory Body Funding 5.Regulatory Body Staffing and Training 6.National Coordination and Cooperation 7.International Cooperation 8.Notification and the National Register of Sources 9.Authorisation 10.Safety and Security of Radioactive Sources 11.Inspection 12.Enforcement 13.Information Management 14.Quality Management The Essential Elements of a National Infrastructure for Safety (TSA-1)

3. IAEA GSR Part-1, Chapter 2; ‘Responsibilities and Functions of the Government’: TSA-1, Element 1 ‘Legislation’ Government establishes national policy for safety by means of different instruments, statutes and laws. Typically, the regulatory body, as designated by government, is charged with implementation of policies by means of a regulatory programme and a strategy set forth in its regulations or in national standards. In addition, government establishes laws and adopts policies specifying the responsibilities and functions of different governmental entities in respect of safety and emergency preparedness and response.

4. IAEA GSR Part-1, Chapter 2; ‘Responsibilities and Functions of the Government’: TSA-1, Element 1 ‘Legislation’ GSR Part-1 Requirement 2: Establishment of a framework for safety. The government shall establish and maintain an appropriate governmental, legal and regulatory framework for safety within which responsibilities are clearly allocated. GSR Part-1 Requirement 2, paragraphs 2.1 through 2.6 are the prime references for TSA-1 Element 1

5. IAEA GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’: TSA-1, Element 2 ‘Regulations and Guidance’ GSR Part-1, Chapter 4, 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 judgements, decisions and actions are based. GSR Part-1 Chapter 4, Requirement 33: Review of Regulations and Guides Regulations and guides shall be reviewed and revised as necessary to keep them up to date, with due consideration taken of relevant international safety standards and technical standards and of relevant experience gained.

6. IAEA GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’: TSA-1, Element 2 ‘Regulations and Guidance’ GSR Part-1 Chapter 4, Requirement 34: Promotion of Regulations and Guides to Interested Parties The regulatory body shall notify interested parties and the public of the principles and associated criteria for safety established in its regulations and guides, and shall make its regulations and guides available. GSR Part-1 paragraphs 4.61 and 4.62 are the prime references for TSA-1 Element 2

7. IAEA GSR Part-1, Chapter 2; ‘Responsibilities and Functions of the Government’: TSA-1, Element 3 ‘Regulatory Body Establishment and Independence’ GSR Part-1 Chapter 2, Requirement 3: Establishment of a Regulatory Body The government, through the legal system, shall establish and maintain a regulatory body and confer on it the legal authority and provide it with the competence and resources necessary to fulfil its statutory obligation for regulatory control of facilities and activities.

8. IAEA TSA-1, Element 3 ‘Regulatory Body Establishment and Independence’ GSR Part-1 paragraphs 2.7 through 2.13 and 4.6 through 4.10 are the prime references for TSA-1 Element 3 GSR Part-1 Chapter 2, Requirement 4: Independence of the Regulatory Body The government shall ensure the regulatory body is effectively independent in its safety related decision making and that it has functional separation from entities having responsibilities or interests that could unduly influence its decision making. GSR Part-1, Chapter 2; ‘Responsibilities and Functions of the Government’: GSR Part-1 Chapter 2, Requirement 17: Effective independence in the performance of regulatory functions The regulatory body shall perform its functions in a manner that does not compromise its effective independence.

9. IAEA TSA-1, Element 4 ‘Regulatory Body Staffing and Training’ GSR Part-1 paragraphs 4.11 through 4.13 are the prime references for TSA-1 Element 4 GSR Part-1 Chapter 4, Requirement 18: Staffing and Competence of the Regulatory Body: 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. GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’:

10. IAEA TSA-1, Element 5 ‘Regulatory Body Funding’ GSR Part-1 paragraph 2.8 is the prime reference for TSA-1 Element 5 GSR Part-1 Chapter 2, Requirement 3: Establishment of a Regulatory Body The government, through the legal system, shall establish and maintain a regulatory body and confer on it legal authority and provide it with the competence and resources necessary to fulfil its statutory obligation for the regulatory control of facilities and activities. GSR Part-1, Chapter 2; ‘Responsibilities and Functions of the Government’: GSR Part-1 Chapter 2, Requirement 4: Independence of the Regulatory Body The government shall ensure the regulatory body is effectively independent in its safety related decision making and has functional separation from entities having responsibilities or interests that could unduly influence its decision making.

11. IAEA TSA-1, Element 6 ‘Coordination and Cooperation at the National Level’ GSR Part-1 paragraphs 2.18 and 2.19 are the prime references for TSA-1 Element 6 GSR Part-1 Chapter 2, Requirement 7: Coordination of Different Authorities with Responsibilities for Safety within the Regulatory Framework for Safety Where several authorities have responsibilities for safety within the regulatory framework for safety, the government shall make provision for the effective coordination of their regulatory functions, to avoid any omissions or undue duplication and to avoid conflicting requirements being placed on authorized parties. GSR Part-1, Chapter 2; ‘Responsibilities and Functions of the Government’:

12. IAEA TSA-1, Element 7 ‘International Cooperation’ GSR Part-1, Chapter 3, Requirement 14: International Obligations and Arrangements for International Cooperation Government shall fulfil its respective international obligations, participate in relevant international arrangements, including international peer reviews and promote international cooperation to enhance safety globally. GSR Part-1, Chapter 3; ‘The Global Safety Regime’: GSR Part-1, Chapter 3, Requirement 15: Sharing of Operating Experience and Regulatory Experience The RB shall make arrangements for analysis to be carried out to identify lessons learned from operating experience and regulatory experience, including experience in other States, and for dissemination of lessons learned and their use by authorized parties, the regulatory body and other relevant authorities. GSR Part-1 paragraphs 3.1 through 3.5 are the prime references for TSA-1 Element 7

13. IAEA TSA-1, Element 8 ‘Notification and the National Register of Sources’ GSR Part-3 paragraph 3.7 is the prime references for TSA-1 Element 8 GSR Part-1, Chapter 4, Requirement 23: Authorization of Facilities and Activities by the Regulatory Body 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 a notification process. This element is not so fixedly based in the IAEA Standards. It is more readily associated with functions of the RB and good practice. However, both GSR Part-1 and GSR Part-3 make reference to notification, with examples below: GSR Part-3, Chapter 3 Requirement 7: Notification and Authorization Any person or organization intending to operate a facility or to conduct an activity shall submit to the regulatory body, as appropriate, a notification or an application for authorization.

14. IAEA TSA-1, Element 9 ‘Authorisation’ GSR Part-1 paragraphs 4.29 through 4.39 and GSR Part-3 paragraphs 2.30, 3.7 and 3.8 are prime references for TSA-1 Element 9 GSR Part-1, Chapter 4, Requirement 24: Demonstration of Safety for the Authorization of Facilities and Activities The applicant shall be required to submit an adequate demonstration of safety in support of an application for the authorization of a facility or an activity. GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’ and GSR Part-3: GSR Part-1, Chapter 4, Requirement 23: Authorization of Facilities and Activities by the Regulatory Body 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 a notification process.

15. IAEA TSA-1, Element 10 ‘Safety and Security of Radioactive Sources’ GSR Part-1 paragraphs 2.39 and 2.40, CoC 2004 and GIERS are the prime references for TSA-1 Element 10 GSR Part-1, Chapter 2 and the Code of Conduct on the Safety and Security of Radioactive Sources: GSR Part-1, Chapter 2, Requirement 12: Interfaces of Safety with Nuclear Security and with the State System of Accounting for, and Control of, Nuclear Material The government shall ensure that, within the governmental and legal framework, 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. This element of TSA-1 is primarily addressed through the guidance of the Code of Conduct on the Safety and Security of Radioactive Sources (CoC 2004) and its associated Guidance on the Import and Export of Radioactive Sources (GIERS). However, both these guidance documents have their origins in GSR Part-1.

16. IAEA TSA-1, Element 11 ‘Inspection’ GSR Part-1, Requirement 27: Inspection of Facilities and Activities 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. GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’: GSR Part-1, Requirement 28: Types of Inspection of Facilities and Activities Inspections of facilities and activities shall include programmed inspections and reactive inspections; both announced and unannounced.

17. IAEA TSA-1, Element 11 ‘Inspection’ GSR Part-1 paragraphs 4.49 through 4.53 are prime references for TSA-1 Element 11 GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’: GSR Part-1, Requirement 29: Graded Approach to Inspections of Facilities and Activities Inspections of facilities and activities shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach.

18. IAEA TSA-1, Element 12 ‘Enforcement’ GSR Part-1 paragraphs 4.54 through 4.60 are the prime references for TSA-1 Element 12 GSR Part-1, Requirement 30: Establishment of an Enforcement Policy 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. GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’: GSR Part-1, Requirement 31: Requiring of Corrective Action by Authorized Parties In the event that risks are identified, including risks unforeseen in the authorization process, the regulatory body shall require corrective actions to be taken by authorized parties.

19. IAEA TSA-1, Element 13 ‘Information Management’ GS-R-3 (GSR Part-2 imminently) and GSR Part-1 paragraphs 4.14 through 4.17 are the prime references for TSA-1 Element 13 GSR Part-1, Requirement 19: The Management System of the Regulatory Body The regulatory body shall establish, implement and assess and improve a management system aligned with its safety goals and that contributes to their achievement. GS-R-3 (GSR Part-2) in its entirety GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’: GS-R-3 is the current IAEA safety standard document dedicated to management systems. Its extensively revised successor, GSR Part-2 ‘Leadership and Management for Safety’ will be published soon. It addresses the full scope of information and quality management.

20. IAEA TSA-1, Element 14 ‘Quality Management’ GS-R-3 (GSR Part-2 imminently) and GSR Part-1 paragraphs 4.14 through 4.17 are the prime references for TSA-1 Element 14 GSR Part-1, Requirement 19: The Management System of the Regulatory Body The regulatory body shall establish, implement and assess and improve a management system aligned with its safety goals and that contributes to their achievement. GS-R-3 (GSR Part-2) in its entirety GSR Part-1, Chapter 4; ‘Responsibilities and Functions of the Regulatory Body’: GS-R-3 is the current IAEA safety standard document dedicated to management systems. Its extensively revised successor, GSR Part-2 ‘Leadership and Management for Safety’ will be published soon. It addresses the full scope of information and quality management.

21. IAEA International Atomic Energy Agency Thank you for your attention