1. IAEA International Atomic Energy Agency

2. IAEA Outline of the presentation Learning objectives General notes on reviewing review and assessment in IRRS mission Objectives and scope of review and assessment Regulatory management of review and assessment Manpower and technical resources for review and assessment Bases for and performing of review and assessment Reporting and use of results of review and assessment 2USNRC IRRS Training - Reviewing Review and Assessment

3. IAEA Learning objectives After finishing this lecture the trainee will: Get understanding about the contents to be reviewed in the scope of the IRRS Module 6 Recognize the interfaces and necessary coordination with several other IRRS modules Understand the importance and the main objectives of the regulatory review and assessment (R&A) Recognize the importance of a graded approach in R&A Know about regulatory management of R&A 3USNRC IRRS Training - Reviewing Review and Assessment

4. IAEA Learning objectives – cont. After finishing this lecture the trainee will: Recognize the importance of comprehensiveness in R&A associated with various facilities and activities and various authorizations steps Know about expected manpower and technical resources for R&A, including use of external technical support and use of computational tools Know about the bases (reference documents and other sources of information) for R&A Know about scope and performance of R&A Know about reporting and use of results of R&A 4USNRC IRRS Training - Reviewing Review and Assessment

5. IAEA Introduction This training lecture covers IRRS Module 6: Review and assessment (R&A) Module 6 of IRRS mission should verify : Whether the relevant regulatory processes required for the area of review and assessment are in place Whether these processes ensure compliance with more specific technical requirements for different kinds of authorizations 5USNRC IRRS Training - Reviewing Review and Assessment

6. IAEA GENERAL NOTES USNRC IRRS Training - Reviewing Review and Assessment6

7. IAEA IAEA Safety Standards for relevant regulatory processes The main bases for the regulatory processes are IAEA Safety Standards GSR Part 1: Governmental, Legal and Regulatory Framework for Safety GSR Part 1: Governmental, Legal and Regulatory Framework for Safety GS-G-1.2: Review and Assessment of Nuclear Facilities by the Regulatory Body GS-G-1.2: Review and Assessment of Nuclear Facilities by the Regulatory Body However, more that 40 % of IRRS findings in the area of review and assessment refer to IAEA Standards other than GSR Part 1(see below) 7USNRC IRRS Training - Reviewing Review and Assessment

8. IAEA IAEA Safety Requirements for various facilities and activit ies GSR Part 4: Safety Assessment for Facilities and Activities NS-R-3: Site Evaluation for Nuclear Installations SSR-2/1: Safety of NPPs: Design (ex NS-R-1) SSR-2/2: Safety of NPPs: Commissioning and Operation (ex NS-R-2) NS-R-4: Safety of Research Reactors NS-R-5: Safety of Nuclear Fuel Cycle Facilities GSR Part 3: Radiation Protection and Safety of Radiation Sources WS-R-5: Decommissioning of Facilities Using Radioactive Material 8 USNRC IRRS Training - Reviewing Review and Assessment

9. IAEA IAEA Safety Requirements for various facilities and activities SSR-6: Regulations for the Safe Transport of Radioactive Material - 2012 Edition Specific Safety Requirements GSR Part 5: Predisposal Management of Radioactive Waste SSR-5: Disposal of Radioactive Waste Specific Safety Requirements And a large number of IAEA Safety Guides 9USNRC IRRS Training - Reviewing Review and Assessment

10. IAEA References to the standards In the missions between 2006 and 2013 to nuclear countries Module 6 (R&A) referred 82 times to GSR Part 1 67 times to other IAEA safety standard documents Distribution of other major references: USNRC IRRS Training - Reviewing Review and Assessment 10

11. IAEA Interfaces with other IRRS modules Review in this module may have interfaces with several other IRRS modules, so that there is a potential for overlapping among the modules, strong coordination needed To minimize repetition and overlapping review in this module should be strongly focused on specific provisions relevant to review and assessment only, with reference made to more general modules 11 USNRC IRRS Training - Reviewing Review and Assessment

12. IAEA Interfaces with other IRRS modules The relevant IRRS modules are: Module 1 (coordination among different authorities involved) Module 3 (staffing, liaison with TSO and with authorized parties specific) Module 4 (relevant management processes) Module 5 (acceptance criteria, scope of review and assessment for different authorizations) Module 7 (specific inspections for review and assessment) Module 9 (regulations and guides specific for review and assessment) 12 USNRC IRRS Training - Reviewing Review and Assessment

13. IAEA Review Methods – short reminder Training Lecture 10 – Methodology of review Review Methods are explained in detail in Training Lecture 10 – Methodology of review Summary: There are three basic methods to acquire sufficient information for an objective review: A review of written material. Interviews with personnel and other officials. Direct observation of regulatory body activities in the office and at facilities. 13 USNRC IRRS Training - Reviewing Review and Assessment

14. IAEA USNRC IRRS Training - Reviewing Review and Assessment14 Review is assisted by Report Template Training Lecture 7 – Report writing As presented in Training Lecture 7 – Report writing the Standard Mission report Template gives guidance and assistance in the interviews and in writing the report

15. IAEA How to read the following slides? There is a line under the title with the GSR Part 1 Requirement number looking like this: Requirement 7; 2006-2013 referenced 13 times. This is how many times that Requirement was referenced during IRRS missions to nuclear countries between 2006 and 2013. It indicates the practical importance of that Requirement in the IRRS missions. Recommendation of Experienced Reviewers Give particular attention to: On those slides lists of the most important issues, that have been recognized by experienced IRRS reviewers during a series of Consultancies in 2012 are given. Several slides have the following title: 15USNRC IRRS Training - Reviewing Review and Assessment

16. IAEA Recommendation of Experienced Reviewers Give particular attention to: Persons to be interviewed: head and staff of the relevant regulatory unit staff who performed the self-assessment in the area of R&A representatives of the TSO (if applicable) Verify, through examples, that the IAEA requirements are also correctly implemented Examples of implementation Typical submissions by applicants Regulatory review plan(s) Tracking of issues identified during the R&A process Results of independent audit calculations Review reports including justification of decisions 16USNRC IRRS Training - Reviewing Review and Assessment

17. IAEA OBJECTIVES AND SCOPE USNRC IRRS Training - Reviewing Review and Assessment 17

18. IAEA Objectives of R&A by the regulatory body Review and Assessment (R&A) is one of the main regulatory functions The primary objective of the regulatory review is to verify that the relevant safety objectives, safety principles, criteria and requirements are met and correctly implemented The responsibility to demonstrate the fulfillment of safety requirements rests with the applicant The applicant has the obligation to provide all necessary justification and analysis to the regulatory body The regulatory may decide to perform independent audit calculations for checking licensee’s submission 18USNRC IRRS Training - Reviewing Review and Assessment

19. IAEA Review and assessment of information relevant to safety The regulatory body shall review and assess relevant information submitted by the authorized party 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 shall be performed prior to authorization and again over the lifetime of the facility or the duration of the activity, as specified in regulations or in the authorization. GSR Part 1 Requirement 25 ; 2006-2013 referenced 50 times. 19USNRC IRRS Training - Reviewing Review and Assessment

20. IAEA Example (setting regulations) USNRC IRRS Training - Reviewing Review and Assessment20

21. IAEA 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. GSR Part 1 Requirement 26: 2006-2013 referenced 34 times. 21 USNRC IRRS Training - Reviewing Review and Assessment

22. IAEA Example (graded approach) USNRC IRRS Training - Reviewing Review and Assessment22

23. IAEA Details of the Requirements (1) R&A for all stages of authorization of facility or activity Depth and scope shall be commensurate with the radiation risks (graded approach) The regulatory body shall assess all radiation risks associated with all plant states, periodically throughout the lifetime of the facility R&A of any proposed modification that might significantly affect the safety of a facility or activity 23USNRC IRRS Training - Reviewing Review and Assessment

24. IAEA Example (important modifications) USNRC IRRS Training - Reviewing Review and Assessment24

25. IAEA Details of the Requirements (2) R&A of technical and other documents submitted by the applicant to see compliance with safety requirements Integrated safety assessment including trends and conclusions from inspections and providing feedback, periodically Recording results and decision for further actions and feedback for the regulatory process USNRC IRRS Training - Reviewing Review and Assessment25

26. IAEA Facilities and activities (1) … subject to R&A: all facilities and activities in the scope of the IRRS mission, thus may be Nuclear power plants Other reactors (RRs, critical assemblies) Fuel enrichment and fuel manufacturing facilities Spent fuel reprocessing plants Spent fuel repository, radioactive waste management facilities Decommissioning and closure of nuclear facilities Site rehabilitation 26 USNRC IRRS Training - Reviewing Review and Assessment

27. IAEA Example (RB R&A) USNRC IRRS Training - Reviewing Review and Assessment27

28. IAEA Facilities and activities (2) Nuclear and irradiation facilities for medicine, industry, research Mining and processing of radioactive ores Transport of nuclear and radioactive materials 28 USNRC IRRS Training - Reviewing Review and Assessment

29. IAEA Stages for nuclear facilities … subject to R&A: all stages in the scope of the IRRS mission, thus may be Site evaluation Design, construction, manufacture, installation Particular stages of commissioning Operation, including assessment of events Reconstruction or design modifications Comprehensive reassessments (e.g. PSR, life time extension, power uprating) Decommissioning Closure of a waste disposal facility Release from regulatory control 29 USNRC IRRS Training - Reviewing Review and Assessment

30. IAEA Example (PSR) USNRC IRRS Training - Reviewing Review and Assessment30

31. IAEA Example (PSR) - 2 USNRC IRRS Training - Reviewing Review and Assessment31

32. IAEA The IRRS mission may deal with several facilities in the country and the mission report could become unnecessarily large It seems therefore practical to develop first the comprehensive description of the situation for major installations (usually NPPs), for other less risk significant installations just to characterize the differences in review and assessment Recommendation of Experienced Reviewers Give particular attention to: 32 USNRC IRRS Training - Reviewing Review and Assessment

33. IAEA REGULATORY MANAGEMENT USNRC IRRS Training - Reviewing Review and Assessment33

34. IAEA 34 Effective review and assessment should be planned The 3 elements of assessment/review process: Planning the assessment Gathering information Analysing & communicating USNRC IRRS Training - Reviewing Review and Assessment

35. IAEA When reviewing regulatory management of R&A attention should be devoted to The documents subject to R&A, rules of prioritization Applicability of the management system for R&A R&A of major submissions in separate projects Availability of internal guidance for R&A Availability of the regulatory body’s R&A plan Interfaces between R&A and inspections Monitoring (tracking) of the R&A process Quality control of R&A processes and documents Recommendation of Experienced Reviewers Give particular attention to: 35 USNRC IRRS Training - Reviewing Review and Assessment

36. IAEA 36 The regulatory body is expected To have adequate number of competent R&A staff Staff should be adequately trained for R&A To acquire suitable computational tools To obtain technical expertise from external resources USNRC IRRS Training - Reviewing Review and Assessment

37. IAEA … when reviewing manpower and technical resources for R&A Availability of qualified internal manpower and organizational arrangements of R&A Staff specific training in the area of R&A Availability of external independent resources for R&A, including TSO, consultants, cooperation at the international level Use of advisory bodies/committees Use of specific tools (computer codes, experiments) Information exchange by reviewers and inspectors Recommendation of Experienced Reviewers Give particular attention to: USNRC IRRS Training - Reviewing Review and Assessment37

38. IAEA BASIS FOR AND PERFORMING OF R&A USNRC IRRS Training - Reviewing Review and Assessment38

39. IAEA 39 Reference documents for R&A Most typically, the regulatory body develops its own regulations and guides At the international level, the IAEA Safety Standards, regulations and guides from other countries can be used. Regulatory body can use other technical documents existing within the country such as codes, guides, standards, design reports, research reports etc USNRC IRRS Training - Reviewing Review and Assessment

40. IAEA Example (regulations) USNRC IRRS Training - Reviewing Review and Assessment40

41. IAEA … when reviewing the bases for review and assessment Availability of relevant and consistent regulation/ guidance for performing safety assessment by the licensees Its compatibility with IAEA safety standards Scheduling submissions by the licensees Availability of specific regulations/guidance on scope and quality of deterministic/probabilistic safety analysis Availability of radiological (high-level) and technical (derived) acceptance criteria for all plant states Use of feedback from previous reviews Regulatory access to additional information if needed Recommendation of Experienced Reviewers Give particular attention to: USNRC IRRS Training - Reviewing Review and Assessment41

42. IAEA 42 Regulatory review and assessment Regulatory review should include: Compliance with national regulations (formal and content) Completeness of documentation Internal consistency Required depth and details Correctness of acceptance criteria for the safety analyses Correctness of safety analyses (methodology, assumptions, approximations, enveloping etc.) USNRC IRRS Training - Reviewing Review and Assessment

43. IAEA 43 Regulatory review of safety analysis and regulatory audit analysis The regulatory body performs review of safety analysis submitted by the applicant/licensee Safety analysis shall be independently verified by the operator or a qualified organization on his behalf, prior to submission to the regulatory body Independent verification by the regulatory body shall be a separate process after verification by the operator no strict requirement for that, but may be useful (c.f. GS-G-2, Sec. 3.38) by graded approach USNRC IRRS Training - Reviewing Review and Assessment

44. IAEA 44 Inspection during licensing During the authorization process regulatory inspections are carried on Inspections are aimed to supplement and verify information for R&A should be linked to R&A should involve reviewers USNRC IRRS Training - Reviewing Review and Assessment For more on inspection see in Lecture 14!

45. IAEA Performance of the review and assessment, in specific to Regulatory methods for verification of comprehensiveness and quality of safety assessment submitted (including independent verification by the licensee) Verification of computer codes and models Verification of the scope and quality of safety analysis Scope of regulatory R&A associated with various kinds of facilities and activities Specific purpose R&A activities (PSR, OEF, facility modifications, power uprates, life time extension) Recommendation of Experienced Reviewers Give particular attention to: USNRC IRRS Training - Reviewing Review and Assessment45

46. IAEA REPORTING AND USE OF RESULTS USNRC IRRS Training - Reviewing Review and Assessment46

47. IAEA 47 Reporting the results of review and assessment Results of R&A are recorded via document control system The results of regulatory safety evaluation shall be reported in a safety evaluation report The document shall include evidence of: basis and references assumed for the review completeness of the review results of review USNRC IRRS Training - Reviewing Review and Assessment

48. IAEA … reporting and use of results of review and assessment: Use of databases and document control system for easy retrieval Documentation of review process and bases for regulatory decisions, including use of feedback from previous R&A Transfer of information and use of results by decision makers USNRC IRRS Training - Reviewing Review and Assessment48 Recommendation of Experienced Reviewers Give particular attention to:

49. IAEA 49 Summary (1) Review and assessment belongs to the main regulatory functions which must be performed before issuing any authorization The primary purpose of the regulatory review and assessment is to verify that all relevant safety requirements and criteria are met IRRS mission should verify both availability of relevant regulatory processes as well as effectiveness of these processes to ensure compliance with safety requirements USNRC IRRS Training - Reviewing Review and Assessment

50. IAEA 50 Summary (2) Review and assessment should cover all facilities and activities in the country (in accordance with the agreed scope of the mission) and all life time stages of facilities Processes of review and assessment should be adequately covered by the regulatory management system For performing review and assessment the regulatory body should have adequate number of well trained and competent staff, usually complemented by external support USNRC IRRS Training - Reviewing Review and Assessment

51. IAEA 51 Summary (3) Major review and assessment tasks (SAR, PSR, power uprates, life time extension) require careful planning and management as special regulatory projects Rules and acceptance criteria for review and assessment should be expressed in regulations and guides available to the licensees Review and assessment should cover both safety analysis (deterministic and probabilistic) as well as assessment of all other factors important to safety USNRC IRRS Training - Reviewing Review and Assessment

52. IAEA 52 Summary (4) Operational experience feedback should also be considered as a part of review and assessment processes Inspections represent source of information and verification tool for review and assessment, communication between these two areas should be ensured Results of review and assessment should be recorded in documents managed by a document control system USNRC IRRS Training - Reviewing Review and Assessment

53. IAEA THANK YOU FOR YOUR ATTENTION USNRC IRRS Training - Reviewing Review and Assessment53 Photo: V. Friedrich This activity is conducted by the IAEA, with funding by the European Union. The views expressed in this presentation do not necessarily reflect the views of the European Commission