Advanced Workshop “School for Drafting Regulations on Radiation Safety”

1. Advanced Workshop “School for Drafting Regulations on Radiation Safety” Regulatory Infrastructure Stephen EvansRegulatory Infrastructure and Transport Safety Section Division of Radiation and Waste SafetyDepartment of Nuclear Safety and Security 20 December 2019

2. Regulatory Infrastructure Who, What, Why, Where, When? • What is a regulatory infrastructure? • How is it established? • What is its purpose? • What is its scope? • Who is responsible for it? • How is its authority determined? • Who benefits from it? • How is it maintained? • How is its effectiveness assured? • How is its effectiveness measured? • The 14 Elements of Regulatory Infrastructure

3. Regulatory Infrastructure Q: What is a regulatory infrastructure? (In the context of safety in the operation of facilities and use of radiation sources) A1: It is the elements of a legal and governmental framework for safety for the entire range of facilities and activities (from the use of a limited number of radiation sources to a nuclear power programme) taking into account the circumstances pertaining to the State and the radiation risks associated with its facilities and activities.

4. Regulatory Infrastructure Q: How is a regulatory infrastructure established? • A2: Government shall establish and maintain an appropriate governmental, legal and regulatory framework for safety within which responsibilities are clearly allocated. • Promulgation of legislation to make provision for an effective governmental, legal and regulatory framework for safety. • Clear specification of the responsibilities and functions of each authority within the governmental, legal and regulatory framework for safety

5. Regulatory Infrastructure Q: How is a regulatory infrastructure established? • A3: Establishment of a regulatory body. • The government, through the legal system, shall establish and maintain a regulatory body and shall confer on it the legal authority and provide it with the competence and the resources necessary to fulfil its statutory obligation for the regulatory control of facilities and activities.

6. Regulatory Infrastructure Q: How is a regulatory infrastructure established? • A4: Independence of the regulatory body. • The government shall ensure that 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.

7. Regulatory Infrastructure Q: How is a regulatory infrastructure established? • A5: Prime responsibility for safety. • The government shall expressly assign the prime responsibility for safety to the person or organisation responsible for a facility or an activity and shall confer on the regulatory body, the authority to require such persons or organisations to comply with stipulated regulatory requirements, as well as to demonstrate such compliance.

8. Regulatory Infrastructure Q: How is a regulatory infrastructure established? • A6: Compliance with regulations and responsibility for safety. • The government shall stipulate that compliance with regulations and requirements established or adopted by the regulatory body does not relieve the person or organization responsible for a facility or activity of its prime responsibility for safety.

9. Regulatory Infrastructure Q: How is a regulatory infrastructure established? • A7: 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.

10. Regulatory Infrastructure Q: What is the purpose of the regulatory infrastructure? • A8: The framework for safety shall set out the following: • Safety principles for protecting people – individually and collectively – society and the environment from radiation risks, both at present and in the future. • The types of facilities and activities to be included in the scope. • The types of authorisation required for the various facilities and activities, in accordance with a graded approach. • The rationale for authorisation of new facilities and activities. • Provision for the involvement of interested parties in the decision-making process.

11. Regulatory Infrastructure Q: What is the purpose of the regulatory infrastructure? • A8: The framework for safety shall set out the following: • Provision for assigning legal responsibility to persons or organisations responsible for facilities and activities and for ensuring continuity of responsibility where activities are carried out by several persons or organisations successively. • The establishment of a regulatory body. • Provision for review and assessment of facilities and activities, in accordance with a grade approach. • The regulatory body authority and responsibility for promulgating regulations and guidance. • Provision for inspection of facilities and activities.

12. Regulatory Infrastructure Q: What is the purpose of the regulatory infrastructure? • A8: The framework for safety shall set out the following: • Provision for appeal against regulatory decisions. • Provision for preparedness and response to nuclear or radiological emergency. • Provision for interface with nuclear security. • Provision for the interface with a system for accounting and control of nuclear material. • Provision for acquiring and maintaining necessary competence for ensuring safety.

13. Regulatory Infrastructure Q: What is the purpose of the regulatory infrastructure? • A8: The framework for safety shall set out the following: • Responsibilities and obligations in respect of financial provision for the management of radioactive waste and of spent fuel and for decommissioning of facilities and activities. • The criteria for release from regulatory control. • The specification for offences and the corresponding penalties. • Provisions for controls on the import and export of nuclear material and radioactive material and for their tracking within and, to the extent possible, outside national boundaries. • Clear specification of the responsibilities and functions of each authority within the governmental, legal and regulatory framework for safety.

14. Regulatory Infrastructure Q: What is the scope of a regulatory infrastructure? • A7: 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.

15. Regulatory Infrastructure Q: Who is responsible for the regulatory infrastructure? • A7: 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.

16. Regulatory Infrastructure Q: How is the authority of the regulatory infrastructure determined? • A7: 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.

17. Regulatory Infrastructure Q: Who benefits from the establishment and functioning of the regulatory infrastructure? • A7: 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.

18. Regulatory Infrastructure Q: How is the regulatory infrastructure maintained? • A7: 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.

19. Regulatory Infrastructure Q: How is regulatory effectiveness ensured? • A7: 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.

20. Regulatory Infrastructure Q: How is regulatory effectiveness measured? • A7: 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.

21. Regulatory Infrastructure The Fourteen Elements of Regulatory Infrastructure for Safety • Legislative and Statutory Framework • Legislation • Regulations and guides • Regulatory Body establishment and independence • Regulatory Body funding • Staffing and training • Cooperation at the national level • International cooperation

22. Regulatory Infrastructure The Fourteen Elements of Regulatory Infrastructure for Safety • Activities of the Regulatory Body • Notification and national register • Authorization • Safety and security of radioactive sources • Inspection • Enforcement • Information management • Quality management

23. Thank you for your attention