Reviewing Authorization and Review and Assessment Functions of the Regulatory Body

1. BASIC IRRS TRAININGLecture11 Reviewing Authorization and ReviewandAssessmentFunctions of the Regulatory Body (IRRS Modules 5, and 6)

2. Outline • Learning objectives • Introduction • Complexity of the regulatory functions modules • Authorization (types, process, facilities and activities) • Review and Assessment (general notes, objectives and scope, graded approach, facilities and activities, stages, basis, related inspections) • Examples from previous missions Basic IRRS Training - Reviewing Authorization,

3. Learning objectives After finishing this lecture the trainee will: • Get understanding about the contents to be reviewed in the scope of the IRRS Modules 5 and 6 • Understand that the review should address authorizations in different stages of a nuclear facility like nuclear power plants. • Understand that as authorizations, review and assessment are interconnected, their respective review during IRRS also need coordination. • Understand the concept of graded approach in authorization and reviewandassessment. Basic IRRS Training - Reviewing Authorization

4. 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 the need for 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 the scope and performance of R&A Know about reporting and use of results of R&A Understand again the importance of a graded approach Basic IRRS Training - Reviewing Review and Assessment

5. Introduction This Training Lecture covers two IRRS Modules: Module 5: Authorization Module 6: Review and Assessment

6. Complexity of the regulatorycoreactivitymodules Complexity of the review depends on complexity of the nuclear programme in the country Each module has its core part (left) and subchapters depending on types of activities or facilities (right) Nuclear power plants are so reviewed together with the general process reviews

7. Use of report template Report Template shell be presented in Lecture 7! For repeated use of this lecture, it is noted that the Standard Mission Report Template shall guide and assist interviews and writing. Basic IRRS Training - Reviewing Management System

8. IRRS Module 5:Authorization 8 Basic IRRS Training - Reviewing Authorization

9. Authorization Authorization by the regulatory body shall be a prerequisite for all facilitiesand activities. The applicant shall be required to submit an adequate demonstration ofsafety. GSRPart 1, Requirements 23 & 24In 2006-2013, in missions to nuclear countries , referenced 17 & 71 times respectively. 9

10. Types and theprocess

11. Types of authorizations Different types for different stages:site evaluation, design, construction, commissioning, operation, shutdown, decommissioning ... Authorizations for different activities:operation, maintenance, engineering activities ... Basic IRRS Training - Reviewing Authorization

12. Authorization process License amendment, renewal, revocation Independent verification of the safety assessment and traceability of decisions Requirements reflecting graded approach Clear criteria, requirements, safety objectives and independent assessment Basic IRRS Training - Reviewing Authorization,

13. Inspection during licensing • During the authorization process regulatory inspections are carried on. • Inspections • are aimed to supplement and verify informationfor R&A • should be linked to R&A • should involve reviewers For more on inspection see in Lecture 12! Basic IRRS Training - Reviewing Review and Assessment

14. Recommendation of Experienced ReviewersGive particular attention to: Coordinate with Modules 3 &4: Clearly defined roles of stakeholders (government, regulatory body, other regulators ...) Competence available to regulatory body Interfaceswith others involved in licensing [The licenseapplicant, advisory boards, Technical Support Organizations (rules applied to avoidconflict of interest), public, etc.] Basic IRRS Training - Reviewing Authorization, 14

15. Examples (Req. 23 - Authorization)

16. Examples (Req. 24 - Demonstration)

17. Facilities and activities For each facility or activity check the situation with respect to standards mentioned below For NPPs the scope of the review is usually quite standard and similar in different countries. For other facilities the scope of the review could be very broad and different from each other. 17

18. Synonyms or subsets? What is the relationship among the expressions: authorization, licensing, certification, approval? Authorization includes: licensing, certification, registration Authorization is a more formal process than approval (IAEAGlossary)

19. Facilityspecifics

20. Authorization of nuclear power plants IAEA safety standards:SSR-2/1 Design, SSR-2/2Commissioning and Operation, NS-R-3 Site Evaluation, SSG-12 Licensing Process Recommendation of Experienced ReviewersGive particular attention to: • Application for authorization • Definition of the safety case • Documentation of the licensing basis • Ageing management 20

21. Authorization of research reactors IAEA safety standards :NS-R-4, CoC Research Reactors, NS-R-3, SSG-12 Recommendation of Experienced ReviewersGive particular attention to: • Ageing management • Safety committees, lines of authority and communications • Influence on DBA by experiments and experimental devices • Role of the reactor manager • Licensing of personnel For titles and descriptions of standards see Lecture 2! Basic IRRS Training - Reviewing Authorization 21

22. Authorization of fuel cycle facilities IAEA safety standards :NS-R-5, NS-R-3, SSG-12, SSG-5, SSG-6, SSG-7, SSG-15 Describe specificauthorization requirements for facilities available in the host country. FCF’s: processing, refining, conversion, enrichment,fabrication of UOX and MOX fuel, SF storage, SF reprocessing, fuel cycle research and developmentinstallations 22 Basic IRRS Training - Reviewing Authorization,

23. Examples Research reactor: Fuel cycle facility:

24. IRRS Module 6:Review and Assessment Basic IRRS Training - Reviewing Review and Assessment, 24

25. Introduction Module 6 of IRRS(Review and Assessment) mission should verify : Whether the relevant regulatory processesrequired for the area of review and assessment are in place Whether these processes ensure compliance with thespecific technical requirements for allkinds of authorizations Basic IRRS Training - Reviewing Review and Assessment

26. General notes Basic IRRS Training - Reviewing Review and Assessment

27. 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 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) Basic IRRS Training - Reviewing Review and Assessment

28. 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: Basic IRRS Training - Reviewing Review and Assessment

29. IAEA Safety Requirements for various facilities and activities 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 GSR Part 6: Decommissioning of Facilities Basic IRRS Training - Reviewing Review and Assessment

30. 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 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 supportingcalculations Review reports including justification of decisions Recommendation of Experienced ReviewersGive particular attention to: Basic IRRS Training - Reviewing Review and Assessment

31. Objectives and scope Basic IRRS Training - Reviewing Review and Assessment

32. 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 metand 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 regulator may decide to perform independent audit calculations for checking licensee’s submission Basic IRRS Training - Reviewing Review and Assessment

33. 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; in 2006-2013 referenced 50 times. Basic IRRS Training - Reviewing Review and Assessment

34. Example (setting regulations) Basic IRRS Training - Reviewing Review and Assessment

35. 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: In2006-2013 referenced 34times. Basic IRRS Training - Reviewing Review and Assessment

36. Example (graded approach) Any comment to this finding? The same examplewasusedto illustrate demonstration for authorization Basic IRRS Training - Reviewing Review and Assessment

37. R&A of modificationsubmittals R&A of any proposed modification that might significantly affect the safety of a facility or activityshould be inplace Basic IRRS Training - Reviewing Review and Assessment

38. Example (important modifications) Basic IRRS Training - Reviewing Review and Assessment

39. Facilities and activities … subject to R&A: all facilities and activities in the scope of the IRRS mission, thus itmay include 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 … Basic IRRS Training - Reviewing Review and Assessment

40. Example (RB R&A) Basic IRRS Training - Reviewing Review and Assessment

41. Stages for nuclear facilities … subject to R&A: all stages in the scope of the IRRS mission, thus itmay include 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 Release from regulatory control Basic IRRS Training - Reviewing Review and Assessment

42. Example (PSR) Basic IRRS Training - Reviewing Review and Assessment

43. Example (PSR) - 2 Basic IRRS Training - Reviewing Review and Assessment

44. Regulatory management Basic IRRS Training - Reviewing Review and Assessment

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

46. When reviewing regulatory management of R&A attention should be devoted to Applicability of the management system for R&A R&A of major submissions (SAR, PSR, poweruprate, lifetimeextension) 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 ReviewersGive particular attention to: Basic IRRS Training - Reviewing Review and Assessment

47. 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 Basic IRRS Training - Reviewing Review and Assessment

48. … 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 ReviewersGive particular attention to: Basic IRRS Training - Reviewing Review and Assessment

49. Basis for and performing of r&A Basic IRRS Training - Reviewing Review and Assessment

50. Basic itemsinreviewing R&A When reviewing the R&A activity the following key aspects are to be considered: • Reference documents (regulations and guides, IAEA Safety Standards, other technical documents) • TheR&A process (checking compliance, completeness, consistency, depth, acceptance criteria) • Processing safety analyses (independent verification by applicant and by the RB) • Regulatory inspections during licensing • Recording and reporting (safety evaluation report) Basic IRRS Training - Reviewing Review and Assessment