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

2. International Atomic Energy Agency Content Introduction Overview of relevant IAEA Safety Standards General considerations GSR Part 1, requirements 25 and 26 Primary objectives of the regulatory review Secondary objectives of the regulatory review Management of the review process LB/Review process/Amman 2014-12-15/01

3. International Atomic Energy Agency Introduction The overall goal of the regulatory review is to verify that the facility or activity will not cause an unacceptable adverse impact on human health or safety, or on the environment, both now and in the future. The regulatory review constitutes a key component of the decision making process. It is crucial to public acceptance. The quality of the review process enhances confidence in: the credibility of the regulator the regulatory process the review findings and the regulatory decision LB/Review process/Amman 2014-12-15/02

4. International Atomic Energy Agency Relevant IAEA Safety Requirements (1) GSR Part 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. The regulatory body has to review the safety assessment submitted by the applicant in accordance with clearly specified procedures, and in accordance with a graded approach. LB/Review process/Amman 2014-12-15/03

5. International Atomic Energy Agency Relevant IAEA Safety Requirements (2) GSR Part 1, Requirement 25 - Review and assessment of information relevant to safety The regulatory body shall review and assess relevant information — whether submitted by the authorized party or the vendor, compiled by the regulatory body, or obtained from elsewhere — 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 the duration of the activity, as specified in regulations promulgated by the regulatory body or in the authorization. LB/Review process/Amman 2014-12-15/04

6. International Atomic Energy Agency Relevant IAEA Safety Requirements (3) GSR Part 1, Requirement 26 - Graded approach to review and assessment of a facility or an activity Review and assessment of a facility or an activity shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach. LB/Review process/Amman 2014-12-15/05

7. International Atomic Energy Agency Relevant IAEA Safety Requirements (4) GSR Part 3, Requirement 3 - Responsibilities of the regulatory body The regulatory body shall establish or adopt regulations and guides for protection and safety and shall establish a system to ensure their implementation. The regulatory system for protection and safety shall include review and assessment of facilities and activities. LB/Review process/Amman 2014-12-15/06

8. International Atomic Energy Agency Relevant IAEA Safety Requirements (5) GSR Part 5, Requirement 3 - Responsibilities of the regulatory body …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... LB/Review process/Amman 2014-12-15/07

9. International Atomic Energy Agency General considerations (1) The regulatory body shall review and assess the particular facility or activity in accordance with the stage in the regulatory process: initial review, subsequent reviews, reviews of changes to safety related aspects of the facility or activity, reviews of operating experience, or reviews of long term operation, life extension, decommissioning or release from regulatory control. The depth and scope of the review and assessment of the facility or activity by the regulatory body shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach. LB/Review process/Amman 2014-12-15/08

10. International Atomic Energy Agency General considerations (2) Important prerequisites well-defined role and responsibilities of the regulatory body well-defined, structured and independent review process openness and transparency framework for involvement of interested parties in the decision-making process experienced and multidisciplinary regulatory review team clearly defined regulatory requirements against which the acceptability of the assessment findings will be judged LB/Review process/Amman 2014-12-15/09

11. International Atomic Energy Agency General considerations (3) Regulatory Body / Licensee Interface Mutual understanding and respect between the regulatory body and the operator, and a frank, open and yet formal relationship, shall be fostered. Establishment and maintenance of a good dialogue facilitates better understanding of the regulatory requirements, the appropriate application of these requirements and demonstration of compliance. An effective interface between both parties also contributes to confidence building in other stakeholders. LB/Review process/Amman 2014-12-15/10

12. International Atomic Energy Agency GSR Part 1, requirements 25 and 26 (1) The regulatory body shall acquire an understanding of the design of the facility or equipment, the concepts on which the safety of the design is based and the operating principles proposed by the applicant, to satisfy itself that: the available information demonstrates the safety of the facility or the proposed activity and the optimization of protection the information provided is accurate and is sufficient to permit confirmation of compliance with regulatory requirements operational and technical provisions, and in particular any novel provision, have been proved or qualified by experience or testing, or both, and will enable the required level of safety to be achieved LB/Review process/Amman 2014-12-15/11

13. International Atomic Energy Agency GSR Part 1, requirements 25 and 26 (2) The regulatory body shall assess all radiation risks associated with normal operation, anticipated operational occurrences and accident conditions, prior to operation of the facility or conduct of the activity, and periodically throughout the lifetime of the facility or the duration of the activity, to determine whether radiation risks are as low as reasonably achievable. Any proposed modification that might significantly affect the safety of a facility or activity shall be subject to a review and assessment by the regulatory body. LB/Review process/Amman 2014-12-15/12

14. International Atomic Energy Agency GSR Part 1, requirements 25 and 26 (3) Considerations and factors to be taken into account: (1) The regulatory requirements; LB/Review process/Amman 2014-12-15/13 Waste management policy/strategy and principles Safety requirements Radiological and non-radiological Dose/risk constraints Intervention criteria Technical requirements Safety indicators Defense in depth, passive safety etc. Safety assessment approach, methodology Scenarios analysis etc. Managerial requirements

15. International Atomic Energy Agency GSR Part 1, requirements 25 and 26 (4) Considerations and factors to be taken into account (cont’d): (2) The nature and categorization of the associated hazards; (3) The site conditions and the operating environment; (4) The basic design of the facility or the conduct of the activity as relevant to safety; (5) The records provided by the authorized party or its suppliers; (6) Best practices; (7) The applicable management system; (8) The competence and skills necessary for operating the facility or conducting the activity; LB/Review process/Amman 2014-12-15/14

16. International Atomic Energy Agency GSR Part 1, requirements 25 and 26 (5) Considerations and factors to be taken into account (cont’d): (9) Arrangements for protection (of workers, the public and the environment); (10) Arrangements for preparedness for, and response to, emergencies; (11) Arrangements for nuclear security; (12) The system of accounting for, and control of, nuclear material; (13) The relevance of applying the concept of defence in depth to take into account inherent uncertainties (e.g. for the long term disposal of waste); LB/Review process/Amman 2014-12-15/15

17. International Atomic Energy Agency GSR Part 1, requirements 25 and 26 (6) Considerations and factors to be taken into account (cont’d): (14) Arrangements for the management of radioactive sources, radioactive waste and spent fuel; (15) Relevant research and development plans or programmes relating to the demonstration of safety; (16) Feedback of operating experience nationally and internationally, and especially of relevant operating experience from similar facilities and activities; (17) Information compiled in regulatory inspections; (18) Information from research findings; (19) Arrangements for the termination of operations. LB/Review process/Amman 2014-12-15/16

18. International Atomic Energy Agency GSR Part 1, requirements 25 and 26 (7) For an integrated safety assessment, the regulatory body shall organize the results obtained in a systematic manner. Risks that are not related to radiation may arise in the operation of facilities or the conduct of activities. They shall be taken into consideration in the decision-making process. The regulatory body shall record the results and decisions deriving from reviews and assessments, and shall take appropriate actions as necessary. LB/Review process/Amman 2014-12-15/17

19. International Atomic Energy Agency Primary Objectives of the regulatory review (1)  to verify that the applicant has evaluated adverse impacts on health, safety and the environment and demonstrated that these would not be unacceptable  to verify that the results of the safety assessment and the assumptions are in accordance with accepted radioactive waste management principles and regulatory requirements  to ensure that relevant measures and contingencies to mitigate unlikely potential effects have been identified and considered, and that adequate follow-up plans for their implementation have been developed LB/Review process/Amman 2014-12-15/18

20. International Atomic Energy Agency Primary Objectives of the regulatory review (2)  to determine whether the safety case provides an appropriate basis to demonstrate that the proposed facility will be operated safely or the proposed activity conducted safely, in particular by identifying any limits, conditions and controls that will need to be applied to support safe operation of the facility or conducted of the activity  to determine whether issues required by the regulatory body to be addressed by the operator have been clearly identified LB/Review process/Amman 2014-12-15/19

21. International Atomic Energy Agency Primary Objectives of the regulatory review (3)  to identify any unresolved issues and to verify that plans for resolving these issues have been developed  to ensure that follow-up and monitoring programmes are identified and adequate  to support the decision making process and to enhance confidence in the regulatory process LB/Review process/Amman 2014-12-15/20

22. International Atomic Energy Agency Primary Objectives of the regulatory review (4) In establishing the objectives for a review of the safety case, the regulatory body should take account of the status of the facility (e.g. whether the facility is proposed, under development, operational, undergoing re-assessment, closed or under long term surveillance) and the associated context for the safety assessment. LB/Review process/Amman 2014-12-15/21

23. International Atomic Energy Agency Secondary Objectives of the regulatory review (1) To verify that the safety case: has been developed within an appropriate context is sufficiently complete, given the status of the waste policy and strategy is sufficiently transparent in its presentation of data and information has been prepared by competent personnel applying a suitable management system that provides confidence in the quality of the operator’s safety assessment is based on appropriate assumptions and makes use of adequate assessment techniques demonstrates an adequate understanding of the facility or activity LB/Review process/Amman 2014-12-15/22

24. International Atomic Energy Agency Secondary Objectives of the regulatory review (3) To verify that the safety case (cont’d): clearly describes how the identification, establishment, justification and optimization of safety measures, limits, controls and conditions were performed and that adequate defence in depth is provided clearly identifies the uncertainties and addresses them adequately provides an adequate assessment and supporting justification that protection is optimized and risks are as low as reasonably achievable includes adequate consideration of the justification and optimization of remedial measures for existing facilities, if applicable. LB/Review process/Amman 2014-12-15/23

25. International Atomic Energy Agency Secondary Objectives of the regulatory review (4) To verify that the safety case (cont’d): appropriately applies the graded approach to the requirements applied to the safety case for the facility or activity addresses all relevant factors of the management system to be applied for the siting, construction, commissioning, operation, shutdown, decommissioning or closure of the facility, as appropriate provides for adequate planning of emergency preparedness measures LB/Review process/Amman 2014-12-15/24

26. International Atomic Energy Agency Secondary Objectives of the regulatory review (5) To verify that the safety case (cont’d): provides for adequate planning of surveillance and maintenance measures demonstrates that good engineering practices with adequate defence in depth have been used in developing the design of the facility or activity. defines a programme for future development of the safety case for the facility or activity LB/Review process/Amman 2014-12-15/25

27. International Atomic Energy Agency Considerations when defining scope and objectives (1) The important safety issues for the site; The extent of the safety information provided by the operator, and the resources available to the regulatory body to evaluate the information; Whether the review will consider only radiological impacts on humans or will consider other impacts as well, for example impacts relating to hazardous waste; Whether the review will consider impacts on the public, on workers and on non-human species in addition to the overall impact of the facility on the environment; LB/Review process/Amman 2014-12-15/26

28. International Atomic Energy Agency Considerations when defining scope and objectives (2) Which parts of the safety case documentation should be the focus of the review; The use to be made of the results of the regulatory review; for example, whether they will be used as part of communication on licensing between the operator and other interested parties, or for licensing of the facility or to establish conditions at an existing facility. LB/Review process/Amman 2014-12-15/27

29. International Atomic Energy Agency Management of the Review Process (1) The management of the review of a safety case should be treated as a project in itself, to which the standard principles of good project management apply. It begins with the choice of the review team and the designation of a team leader. The regulatory body should have personnel with expertise and hands-on experience in safety assessment of radioactive waste management facilities and should have either in house expertise or should have access to specialists in all the necessary disciplines involved in such assessment. Anyhow, the results of the review are the responsibility of the regulatory body, which should take ‘ownership’ of the results. LB/Review process/Amman 2014-12-15/28

30. Main areas of expertise of the review team Radioactive waste characterization, treatment, conditioning and packaging; Hazard identification and categorization; Structural integrity; Geosciences (hydrogeology, geology, geotechnical, geochemistry etc.); Contaminant transport; Radiological protection; Management system; Security and safeguards; Etc. LB/Review process/Amman 2014-12-15/29

31. International Atomic Energy Agency Management of the Review Process (2) The regulatory review process should be free from conflicting interests, and the team of reviewers should not allow themselves to become unduly influenced during the review process by internal and external considerations that are outside the scope and terms of reference of the review. The regulatory review should be conducted using a level of resources that is commensurate with the level of complexity of the safety case and the potential risks associated with the facility or activity under consideration LB/Review process/Amman 2014-12-15/30

32. International Atomic Energy Agency Management of the Review Process (3a) The scope and the objective of the review must be defined and the applicable regulations and guides must be identified. In this regard, a graded approach is to be applied.. LB/Review process/Amman 2014-12-15/31

33. Graded approach (1) The level of scrutiny and scope of the regulatory review of a safety case should follow a graded approach. To facilitate the application of the graded approach, the regulatory body should consider establishing a set of deterministic screening criteria to categorize facilities or activities according to their safety significance on the basis of the following criteria. Maintenance waste candidate for clearance Spent fuel storage facility LB/Review process/Amman 2014-12-15/32

34. Graded approach (2) The likelihood and magnitude of exposures of workers and/or members of the public arising from planned processes, or from anticipated operational occurrences or accidents; Operator aspects e.g. the operator’s record of performance and their relevant experience in: the design or operation of the facility or activity or other similar facilities or activities; in development of safety cases; and the complexity of the organization; LB/Review process/Amman 2014-12-15/33

35. Graded approach (3) The complexity, safety significance and maturity of the proposed processes; Relevant experience from similar facilities or activities (national and international); The scope of the facility or activity being assessed (e.g. a stage of a larger project, a single large project, or a modification); Technical or safety concerns of other competent authorities; LB/Review process/Amman 2014-12-15/34

36. International Atomic Energy Agency Management of the Review Process (3b) The regulatory review process should be structured and traceable with clearly defined roles and responsibilities and decision making processes. A review plan will be necessary to guide the procedural and technical aspects of the review.. LB/Review process/Amman 2014-12-15/35

37. Main steps of the review (1) A regulatory review will normally have four phases: 1. An inception phase, prior to receipt of any documents from the developer / operator (initial planning); 2. An initial, preliminary review phase, during which the regulator will make an initial evaluation of the submitted documents; Review for completeness in terms of regulatory requirements; Structure and logic of the document; Clearly written; Traceable to supporting documents and references List of contributors; This checking will be documented and a series of detailed review comments should be prepared, which may require additional information. LB/Review process/Amman 2014-12-15/36

38. Main steps of the review (2) 3. A main technical, detailed review phase; Step by step review; Independent calculations (where appropriate); Conclusions and recommendations; 4. A completion phase. The completion phase of the review will include the development of a final review report. LB/Review process/Amman 2014-12-15/37

39. International Atomic Energy Agency Management of the Review Process (3c) Communication between team members and co-ordination should be ensured. A process to resolve conflicting views must be in place.. LB/Review process/Amman 2014-12-15/38

40. Internal screening of the review comments Comments generated by individual team members have to be discussed by team members before they are sent to the implementer. This is to: Determine the relative significance of the comments, Ensure appropriate level of consistency, Prevent unnecessary duplication, Keep the review team informed of the review results and the main issues associated with the safety assessment. This process can lead to internal and external conflicts that have to be resolved using appropriate conflict resolution approaches. LB/Review process/Amman 2014-12-15/39

41. International Atomic Energy Agency Management of the Review Process (3d) The review comments need to be compiled, documented and analyzed. Follow-up actions and the ultimate resolution of each comment needs to be tracked. LB/Review process/Amman 2014-12-15/40

42. International Atomic Energy Agency Management of the Review Process (4) In the review process it should be ensured that the rationale and judgments as to whether or not the arguments presented in the safety case and safety assessment are adequately supported by the underlying science and technology; whether those arguments are in accordance with regulatory requirements and expectations should be documented. A formal process should be established to identify issues for which resolution is necessary by the operator, and a mechanism to track the further consideration and resolution of the issues. LB/Review process/Amman 2014-12-15/41

43. International Atomic Energy Agency Management of the Review Process (5) Communication between the operator and the regulatory body should be maintained throughout the regulatory review processes. Comments and questions should be delivered within a reasonable, defined time-frame, in a form that the applicant can act upon. Additional documentation must be reviewed and integrated in the process. LB/Review process/Amman 2014-12-15/42

44. International Atomic Energy Agency Management of the Review Process (6) The regulatory review process should include a framework for consultation with interested parties with well defined consultation steps, rules of procedure and decision making processes. LB/Review process/Amman 2014-12-15/43

45. Compilation and communication of the review comments Comments should be grouped under topics consistent with the structure of the safety case or presented in a chronological manner; Comments should be identified with an ID number for future tracking; Comments should be sent along with a summary report highlighting the main deficiencies and associated significance; All communication with the operator should be through the team leader who is designated as single point of contact; LB/Review process/Amman 2014-12-15/44

46. The review process Given the scope and multi-disciplinary character of safety assessment reviews, it is important to ensure traceable documentation of all review comments and assessments, and of the resolution of issues identified during safety assessment reviews Collection of comments filled in a standard form (comments will be ranked and classified) Sent to the Applicant Applicant answers Evaluation of the applicant answer Comment resolved Final documentation of the process Yes Additional Information required Rejected No Documentation of the process Rejected comments Selected comments Final comments (ranked and classified) No YES Final decision Internal evaluation in side the Review Team LB/Review process/Amman 2014-12-15/45

47. Final Review Report Background to the review Main results of the evaluation High-level issues Main technical areas Compliance with regulations and guides Issues to be considered in licensing Unresolved issues and uncertainties Conclusions List of references LB/Review process/Amman 2014-12-15/46

48. Final Review Report Background to the review, including: summary information about the site, the regulatory framework in which the review was conducted, the purpose of the review, the approach to the review, and the review process followed. LB/Review process/Amman 2014-12-15/47

49. Final Review Report Key review findings concerning high level issues such as: the safety strategy, the context, approach and results for the safety case and safety assessment, the treatment of uncertainties (in scenarios, models, parameters), risk management and optimization, appropriate limits and conditions, the programme for the future development of the safety case. LB/Review process/Amman 2014-12-15/48

50. Final Review Report Key review findings concerning the main technical areas of review, such as: the characterization and modelling of waste inventories and waste streams, aspects of engineering, chemistry, geology, hydrogeology, meteorology and biosphere. Key review findings concerning compliance with the regulatory requirements and guides. LB/Review process/Amman 2014-12-15/49

51. Final Review Report Conclusions of the review with regard to issues to be considered in licensing or authorization, such as: further information to be provided by the developer or operator, revised safety assessment work, monitoring and other controls on the site or the waste, restrictions on the waste inventory, risk management, and waste acceptance criteria. LB/Review process/Amman 2014-12-15/50

52. Final Review Report A list of unresolved issues and uncertainties. Conclusions A list of references, including reference to documents considered in the review, and underlying review reports that support the final review report. Appropriate information to demonstrate the credibility of the individuals making up the review team. LB/Review process/Amman 2014-12-15/51

53. Final Review Report In documenting the review comments and evaluations, the following should be mentioned: The approach taken in the development of the safety case and the results of that approach; The basis for the comments, using a standard format; each comment should be given a unique identifier for ease of cross-reference; The relevance of the comment to safety; Actions necessary to resolve the issues identified in the review comments. LB/Review process/Amman 2014-12-15/52

54. IAEA Thank you! 54