1. IAEA International Atomic Energy Agency LICENSING OF RADIOACTIVE WASTE MANAGEMENT FACILITIES Luc Baekelandt (lucbaekelandt@telenet.be) Safety of radioactive waste management facilities Amman (Jordan), 14-18 December 2014

2. International Atomic Energy Agency Content Basic framework Parties involved Licensing process (application, review, decision) The licence Follow-up activities LB/Licensing/Amman 2014-12-15/01

3. International Atomic Energy Agency Reference Documents (1) National laws and regulations SF-1, Fundamental Safety Principles (2006) GSR part 1, Governmental, legal and regulatory Framework for Safety (2010) GSR part 3, Radiation Protection and Safety of Radiation sources: International Basic safety standards (2014) GSR part 4, Safety Assessment for facilities and activities (2009) GSR part 5, Predisposal management of radioactive waste (2009) SSR-5, Disposal of Radioactive Waste (2011) LB/Licensing/Amman 2014-12-15/02

4. International Atomic Energy Agency Reference Documents (2) SSG-12, Licensing process for nuclear installations (2010) LB/Licensing/Amman 2014-12-15/03 TECDOC-1619, Licence applications for LILW predisposal facilities: a guide for operators (2009)

5. International Atomic Energy Agency Introduction Authorization / Licensing Activities/facilities from very low risk to high potential risk Conditions attached to the licence Extent of control is commensurate with potential magnitude and nature of hazard (graded approach) Authorization procedures from notification/registration to multistage licensing  siting, construction, commissioning, operation, decommissioning / closure LB/Licensing/Amman 2014-12-15/04

6. International Atomic Energy Agency Established legal and regulatory framework Safety requirements and criteria Activities and facilities requiring a licence (siting, design, construction, operation, decommissioning / closure) Responsible authorities Involvement of stakeholders (e. g. waste producers) and the public Licensing procedure Procedure for refusal and appeal Mechanisms for amendment and withdrawal of a licence LB/LicensingAmman 2014-12-15/05

7. International Atomic Energy Agency Parties involved in the licensing process Applicant Regulatory Body Interested parties  Local municipalities  Parliament  Waste generators Public LB/Licensing/Amman 2014-12-15/06

8. International Atomic Energy Agency Responsibility of the Regulatory Body (1) 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. LB/Licensing/Amman 2014-12-15/07

9. International Atomic Energy Agency Responsibility of the Regulatory Body (2) to verify competence of individuals having responsibilities for the safety of authorized facilities and activities to set limits, conditions and controls on the authorized party’s activities establish process for appeal against regulatory decisions (authorization or condition attached to it) to review the safety assessment submitted by the applicant in accordance with clearly specified procedures, and in accordance with a graded approach to issue guidance on the format and content of documents LB/Licensing/Amman 2014-12-15/08

10. International Atomic Energy Agency Responsibility of the Regulatory Body (3a) in case of stepwise licensing: completed stages have to be subject to review and assessment, with account taken of feedback from the previous stages LB/Licensing/Amman 2014-12-15/09

11. International Atomic Energy Agency Stepwise licensing (RWM facility) LB/Licensing/Amman 2014-12-15/10 construction activities operation D & D T0T0 T3T3 T2T2 T1T1 T 0 = date the licence is granted, start of construction activities T 1 = start of operation, possibly amendment of licence or new licence T 2 = start of decommissioning and dismantling, possibly amendment of licence or new licence T 3 = end of decommissioning and dismantling, withdrawal of the licence

12. International Atomic Energy Agency Stepwise licensing (disposal facility) LB/Licensing/Amman 2014-12-15/11 construction activities operation T0T0 T3T3 T2T2 T1T1 T 0 = date the licence is granted, start of construction activities T 1 = start of operation, possibly amendment of licence or new licence T 2 = start of closure activities, possibly amendment of licence or new licence T 3 = facility is closed, start of (institutional control), possibly amendment of licence or new licence T 4 = removal of control, possibly withdrawal of the licence closure activities institutional control

13. International Atomic Energy Agency Responsibility of the Regulatory Body (3b) reconsider and/or renew license, e. g. as a result of a change in the conditions under which the authorization was granted subsequent amendment, renewal, suspension or revocation of the authorization in accordance with clearly specified and established procedure; feedback from regulatory actions and operational performance to be taken into account record formally the basis for its decisions, inform the applicant and provide him with justification LB/Licensing/Amman 2014-12-15/12

14. International Atomic Energy Agency Responsibility of the Regulatory Body (4) Requirement 3: Responsibilities of the regulatory body The regulatory body shall establish the requirements for the development of radioactive waste management facilities and activities and shall set out procedures for meeting the requirements for the various stages of the licensing process. The regulatory body shall review and assess the safety case and the environmental impact assessment for radioactive waste management facilities and activities, as prepared by the operator both prior to authorization and periodically during operation. The regulatory body shall provide for the issuing, amending, suspension or revoking of licences, subject to any necessary conditions. The regulatory body shall carry out activities to verify that the operator meets these conditions. Enforcement actions shall be taken as necessary by the regulatory body in the event of deviations from, or noncompliance with, requirements and conditions. LB/Licensing/Amman 2014-12-15/13

15. International Atomic Energy Agency Responsibility of the Regulatory Body (5) Requirement 3: Responsibilities of the regulatory body The regulatory body shall establish the regulatory requirements for the development of different types of disposal facility for radioactive waste and shall set out the procedures for meeting the requirements for the various stages of the licensing process. It shall also set conditions for the development, operation and closure of each individual disposal facility and shall carry out such activities as are necessary to ensure that the conditions are met. LB/Licensing/Amman 2014-12-15/14

16. International Atomic Energy Agency Responsibility of the Applicant (1) 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. LB/Licensing/Amman 2014-12-15/15

17. International Atomic Energy Agency Responsibility of the Applicant (2) Requirement 4: Responsibilities of the operator Operators shall be responsible for the safety of predisposal radioactive waste management facilities or activities. The operator shall carry out safety assessments and shall develop a safety case, and shall ensure that the necessary activities for siting, design, construction, commissioning, operation, shutdown and decommissioning are carried out in compliance with legal and regulatory requirements. LB/Licensing/Amman 2014-12-15/16

18. International Atomic Energy Agency Responsibility of the Applicant (3) Prepare and submit documentation to:  demonstrate compliance with safety principles (e.g. defence in depth, containment and isolation, passive safety, optimization of design)  justify and demonstrate compliance with safety requirements and criteria (e.g. dose/risk constraints) of the proposed activity/facility  demonstrate availability of human and financial resources  long-term arrangements (institutional control) Consult with regulatory body Consult with other stakeholders (public) LB/Licensing/Amman 2014-12-15/17

19. International Atomic Energy Agency Licensing Approach Type of regulation  Prescriptive  Non-prescriptive Type of licence  According to the stage of development of the facility  One general licence for development  A set of licences for siting, construction, commissioning, operation, and decommissioning / closure  Re-assessment and re-licensing  new licence conditions  upgrading LB/Licensing/Amman 2014-12-15/18

20. International Atomic Energy Agency Licensing Procedure (1) Includes all steps  from initial application to a final decision  periodic re-licensing procedure  application to amend licence conditions  appeals Defines parties to be involved at each stage (e.g. hearings) Defines the timeframes for review and final decision Describes the regulatory body / applicant interface LB/Licensing/Amman 2014-12-15/19

21. International Atomic Energy Agency Licensing Procedure (2) Submission Documentation according to the legal requirements  Basic information:  Identification of the (future) operator  Description of the site  Description of the facility, its systems and components  Safety assessment  Supporting documentation (e.g. results of peer reviews) Approval(s) of competent authorities e.g. highways authority, nature conservancy Results of consultations (e.g. public) LB/Licensing/Amman 2014-12-15/20

22. International Atomic Energy Agency Licensing Procedure (3) Submission (continued) Safety case  Safety assessment report  Environmental impact assessment report  Supporting arguments  Derivation of waste acceptance requirements  Operational limits and conditions  Proposed arrangements for decommissioning and dismantling, and for post-closure institutional control LB/Licensing/Amman 2014-12-15/21

23. International Atomic Energy Agency Licensing Procedure (4) Submission (continued) Operational documentation  Radioactive waste management programme  Radiation protection programme, including monitoring  Management systems  Record keeping  Emergency preparedness  Security plan  Training programmes  Programme for involving the public and building confidence Justification of resources (human/financial) LB/Licensing/Amman 2014-12-15/22

24. International Atomic Energy Agency Licensing Procedure (5) Review of the application Regulatory Body programme for review and assessment Review of documentation  Internal (independent assessment)  External (independent expert(s), international peer review) Comments and Requests for additional information Request for additional studies and investigations On-site visits Review of additional documentation + consultation of interested parties LB/Licensing/Amman 2014-12-15/23

25. International Atomic Energy Agency Licensing Procedure (6) Review of the application (continued) Timeframes  For review (incl. peer review)  Presentations of comments, request for additional information  Consideration of the comments and submission of the required information to the regulatory body for evaluation  Final review and decision on granting a licence LB/Licensing/Amman 2014-12-15/24

26. International Atomic Energy Agency Licensing Procedure (7) Review of the application (continued) Regulatory body/ applicant interface  Licensing programme prior to submission  Schedule the main activities  Agree the scope and content of the main documents  Methodology for comment and query tracking  Agree contact persons  Effective incorporation of comments and recommendations  Detailed face-to-face discussions may help but these should focus on clarification and should be kept formal LB/Licensing/Amman 2014-12-15/25

27. International Atomic Energy Agency Licensing Procedure (8) Decision: grant licence or refuse licence With strong justification and clear basis Well documented Documentation preserved and archived Dissemination of information to the relevant competent authorities LB/Licensing/Amman 2014-12-15/26

28. International Atomic Energy Agency Contents of the licence Basis  Legal basis (law, regulations)  Application documentation Facility and Operator:  New  Old (with or without a licence) – link to previous licence and conditions Authorized activity  Specific activity – siting, upgrading  Conditions – periodic reassessment of safety  Timeframes – period of validity  Registration number and link to other licences LB/Licensing/Amman 2014-12-15/27

29. International Atomic Energy Agency After granting of a licence... (1) Regulatory control of operation  Inspection  Review and evaluation of safety  Periodic safety review LB/Licensing/Amman 2014-12-15/28

30. International Atomic Energy Agency After granting of a licence... (2) Licence modifications  Amendment  Change of operator, subcontracting  Based on results of reassessment  Change of limits and conditions  Safety related changes in design  Renewal  to permit continued operation  Withdrawal  Violations of safety requirements, criteria  Unfulfilled licence conditions LB/Licensing/Amman 2014-12-15/29

31. International Atomic Energy Agency After granting of a licence... (3) Termination of activities  Amendment  To authorize decommissioning and dismantling  Withdrawal  When decommissioning/dismantling is completed (no radiation risks anymore) LB/Licensing/Amman 2014-12-15/30

32. International Atomic Energy Agency Summary Effective licensing requires  Clear procedure and allocation of responsibilities  Dialogue between operators and regulators starting before the formal application  Active commitment of both operator and regulator  Effective consultation with the public and, more particularly, with the representatives of affected communities LB/Licensing/Amman 2014-12-15/31

33. IAEA Thank you! 33