VN/RA/01 Task 1&2 Workshop Hanoi, October 2012 Confidential Ilari Aro Ref. to Janne Nevalainen

1. Licensing and safety assessment of a new NPP’s design - steps and documents to be reviewed in each step VN/RA/01 Task 1&2 Workshop Hanoi, October 2012 Confidential Ilari Aro Ref. to Janne Nevalainen STUK

2. Outline • Licensing steps and processes in Finland • environmental impact assessment • feasibility studies and preliminary safety assessment • Decision-in-principle • construction license • operating license • Documents to be reviewed in each step • Requirements for the documentation • Goals of the (document) review • Conclusions

3. Licensing steps

4. NPP licensing steps in Finland (three step licensing) • environmental impact assessment (EIA) • decision in principle (DiP) • construction license (CL) • operating license (OLA) Operating License Construction Construction License Bidding & site preparation technical stage political stage Decision in Principle Feasibility studies Environmental impact assessment

5. Regulatory review of the design is conducted in several phases – in gradually increasing depths in each step • Enviromental Impact Assessment: NPP site safety issues which are in general level presented in EIA programme and report. • Feasibility Studies: Design topics chosen mainly by the license applicant - identification of possible “show stoppers” in licensing point of view (plant lay-out, air craft crash protection, design basis accidents and application of redundancy, diversity and separation principles, I&C design, SAM) • Decision in Principle: Basic design requirements and main safety features of each proposed alternative design, selected NPP sites and licensees organisation are reviewed before STUK presents its preliminary safety assessment • Construction License: Design criteria and conceptual design of the plant, safety relevant systems and systems integration are reviewed before STUK presents safety assessment – this includes both deterministic safety analysis and Probabilistic Risk Assessment (PRA) • During construction: Detailed design review of systems, structures and components is conducted during construction – along progress of the design work. • Operation License:Final technical documentation including modifications made during construction and commissioning, management system for operation

6. Licensing processes with main stakeholders

7. Environmental Impact Assessment Ministry of Employment and the Economy (MEE) is the liaison authority in the EIA process Issues EIA Programme Updates Programme Issues an EIA report EIA Completed Utility Asks statements on the Programme Issues Statement on Programme Submits EIA for Statement Issues Final Statement on EIA MEE Statement on Programme Statement on EIA STUK Municipalities Statements on Programme Statements on EIA Authorities Statements on Programme Statements on EIA Public Statements on Programme Statements on EIA

8. Decision in Principle Ministry of Employment and the Economy (MEE) is the liaisonauthorityin the DiPpreparationprocess Application for DIP DIP Utility No DIP DIP Asks Statements Public Hearings Prepares Decision for Government MEE Statement on Safety STUK Statement on Siting Municipalities Authorities Statements on Application Public Statements on Application Government Decision No Government Yes Ratification Yes Parliament No

9. Construction and Operating Licenses Ministry of Employment and the Economy (MEE) is the liaison authority in CL and OL process Application for CL or OL CL or OL Utility CL or OL Rejected CL or OL Approved Asks Statements Prepares Decision for Government MEE Statement on Safety STUK Statement on Application Municipalities Authorities Statements on Application Public Statements on Application Government Decision Government Yes No

10. STUK’s Safety Assessment STUK co-ordinates its own independent safety assessment work Licensing Documentation Updated Documentation STUK’s Statement Utility STUK’s Statement MEE Review and Assessment Safety Assessment (*) STUK Requests for Additional info Statement on Safety Independent Analysis/Review TSOs Statements on STUK’s work ACNS MI Statements on PP and EP plans (*) STUK’s safety assessment is based on Government Decrees and YVL-guides TSO = Technical Support Organisation ACNS = STUK’s Advisory board on Nuclear Safety MI = Ministry of the Interior

11. Documents to be reviewed in each step

12. Enviromental Impact Assessment (EIA) documents EIA procedure • Co-ordinating authority is Ministry of Employment and the Economy (MEE) • In accordance with environmental legislation • EIA Programme for STUK statement • EIA Report for STUK statement • -> EIA is an input for DiP-process Construction and land use planning • In accordance with land use and building legislation • Regional plans, master plans and local plans of NPP sites for STUK statements. • Impact of local conditions on safety as well as physical protection and emergency preparedness are to be taken into account.

13. Decision in Principle Documentation Documentation submitted to STUK (Nuclear Energy Degree, NED, § 24) • Outline of the technical principles of the planned nuclear facility • Description of the safety principles • Outline of the ownership and occupation of the site planned for the nuclear facility • Description of settlement and other activities and town planning arrangements • Description of the suitability of the planned location for its purpose, taking account of the impact of local conditions on safety, security and emergency response arrangements, and the impacts of the nuclear facility on its immediate surroundings • EIA assessment report • Outline plan on nuclear fuel management • Outline of the applicant's plans and the available methods for nuclear waste management • Any other information considered necessary by the authorities: • Outline plans on management system ensuring safety and quality management and good safety culture during the construction and operating stages • Outline plans how to allocate adequate and competent personnel resources for the different stages of the project.

14. Construction License (CL) Documents • Documentation submitted to STUK (NED § 35) • Preliminary Safety Analysis Report • Probabilistic Risk Analysis • Safety Classification • Quality Management • Preliminary plan for physical protection • Preliminary plan for emergencies • Plan for safeguards control • STUK’s oversight possibilities • Other documents • License applicant’s safety assessment • Assessment on the compliance with regulations • An applicant for a licence shall also provide the Radiation and Nuclear Safety Authority with any other reports that the STUK considers necessary.

15. Operation License (OL) Documents • Documentation submitted to STUK (NED § 36) • Final Preliminary Safety Analysis Report • Probabilistic Risk Analysis • Safety Classification - classification document • Quality Management programme for the facility operation • Technical Specifications - provide operating restrictions result from component failures and requirements for testing • Summary programme for periodic inspections • Plans for physical protection and emergencies • Plan for safeguards control • Administrative rules for the nuclear facility • Programme for radiation monitoring in the environment • Description of how safety requirements are met • Programme for ageing management • In addition, the applicant must provide STUK with any other information considered necessary by the Radiation and Nuclear Safety Authority.

16. Requirements for the documentation

17. General requirements for the licensing documentation in regulatory guides • Regulatory YVL guidelines gives requirements for licensing documentation - what, when and how it shall be submitted • design of the plant, systems, structures and components, • safety demonstration of the design, • manufacturing, construction, QA, QC, etc. • Therefore • Most of the YVL guides have to be known by the licensee/vendor to be able to timely submit a documentation capable of “once through” regulatory approval • Discussions on the content and scope of the documentation with the regulator are needed, and probably pilot/master document prior “bulk production” of system documentation, construction plans for structures and components

18. General requirements for the design documentation • Prerequisites for “Once through” design documentation - for example • uses specific, unambiguous wording for the design and design requirements (no phrases like “in principle”, “and/or”, “mainly” etc.) - in other words explicit, verifiable design criteria and requirements • includes clear references to supporting analyses (and also submittal of references) • gives clear references to applied design standards (no use of phrases like “will be followed in principle” etc.) • design documentation creates an entity (system, component, structure) • If the text is not specific enough, • regulator is not able to approve it or at least give specific approvals, • results in prolonged regulatory review and approval

19. Final Safety Analysis Report - content • No specific YVL guideconcerning the contentorformat – from the decreeonegets general idea about the content • Earlierreferencehasbeen made to US NRC standardformat - accordingly US NRC Standard ReviewPlanshavebeenutilized as referencematerials • Currentlyreference is made to the IAEA Safety Guide No. GS-G-4.1 on content and format • WENRA haspresentedguidance for SAR withreference to the IAEA

20. Safety Analysis Report: WENRAReference levels 1. Objective • The Licensee shall provide a SAR and use it as a basis for continuous support of safe operation. • SAR: a consistent safety document or integrated set of documents constituting the licensing basis of the plant and updated under control of the regulatory body • The Licensee shall use the SAR as a basis for assessing the safety implications of changes to the plant or to operating practices. 2. Content of the SAR (next slides) 3. Review and update of the SAR • The licensee shall update the SAR to reflect modifications, new regulatory requirements, and relevant standards, as soon as practicable after the new information is available and applicable.

21. WENRAReference level(2)Content: SAR shall describe • plant site, plant layout and normal operation; and demonstrate how safety is achieved • safety functions; all safety systems and safety-related structures, systems and components; their design basis and functioning in all operational states, including shut down and accident conditions • applicable regulations codes and standards • plant organization and the management of safety • evaluation of the safety aspects related to the site • general design concept and the approach adopted to meet the fundamental safety objectives • safety analyses performed to assess the safety of the plant in response to postulated initiating events against safety criteria and radiological release limits

22. WENRAReference level(2)Content: SAR shall describe • emergency operation procedures and accident management guidelines, the inspection and testing provisions, the qualification, and training of personnel, the operational experience feedback programme, and the management of ageing • technical bases for the operational limits and conditions. • policy, strategy, methods, and provisions for radiation protection • emergency preparedness arrangements • on-site radioactive waste management provisions • decommissioning and end-of-life aspects are taken into account during operation

23. IAEA Safety Guide: contents of SAR • Chapter I: Introduction • Chapter II: General plant description • Chapter III: Management of safety • Chapter IV: Site evaluation • Chapter V: General design aspects • Chapter VI: Description and conformance to the designof plant systems • Chapter VII: Safety analyses • Chapter VIII: Commissioning • Chapter IX: Operational aspects • Chapter X: Operational limits and conditions • Chapter XI: Radiation protection • Chapter XII: Emergency preparedness • Chapter XIII: Environmental aspects • Chapter XIV: Radioactive waste management • Chapter XV: Decommissioning and end of life aspects

24. Flexibility in FSAR practices: three NPP’s, three different FSAR practices • TVO BWR’s follow Swedish practice in FSAR: general part, system description part and topical reports • Fortum VVER’s follow US NRC standard format; system descriptions included • STUK has four FSAR pieces in paper form (official); Loviisa FSAR is also in electric form (unofficial); TVO BWR’s have updating going on towards electric form; • a new plant - a new practice: SAR follows US NRC standard format + STUK and IAEA supplements; STUK has two paper copies and electric copy (unofficial pdf version)

25. Contents of SAR of OL3 • The Preliminary Safety Analysis Report (PSAR) follows the intent of US NRC Regulatory Guide 1.70 rev. 3, also including descriptions of non safety plant items. • The role of the PSAR is to provide STUK with comprehensive documentation for the first stage of licensing. • The activities that will be performed in the scope of the construction permit such as the further design of systems, structures and components are dealt with in the PSAR and the associated Topical Reports. • The licensing procedure is an ongoing process during which the contents of the Safety Analysis Report are developed into the final version (FSAR). • The FSAR will then describe the final state of the systems, structures and components and demonstrate final results of all the analyses performed.

26. US NRC Regulatory Guide 1.70 rev. 3+:Contents of SAR • INTRODUCTION AND GENERAL DESCRIPTION OF PLANT • SITE CHARACTERISTICS • GENERAL DESIGN BASES OF STRUCTURES, COMPONENTS, EQUIPMENT AND SYSTEMS • REACTOR • REACTOR COOLANT SYSTEM AND CONNECTED SYSTEMS • CONTAINMENT AND ENGINEERED SAFETY FEATURES • INSTRUMENTATION AND CONTROL • ELECTRIC POWER • AUXILIARY SYSTEMS • STEAM AND POWER CONVERSION SYSTEM • RADIOACTIVE WASTE MANAGEMENT • RADIATION PROTECTION • CONDUCT OF OPERATIONS • PLANT COMMISSIONING • ACCIDENT ANALYSES • TECHNICAL SPECIFICATIONS • QUALITY ASSURANCE • HUMAN FACTORS ENGINEERING (+) • PROBABILISTIC RISK ASSESSMENT AND SEVERE ACCIDENT EVALUATION FOR NEW REACTORS (+)

27. Contents of safety system descriptions (ref. to YVL 2.0) • Content of PSAR of Safety Class 1, 2 and 3 systems and, where necessary, of Safety Class 4 systems: • system design bases and principles • system functions, operating principles and essential design parameters • a description of a system’s importance in the accomplishment of a safety function proper if the system supports a system performing a safety function • the separation principles of a system and its components (compartments, shielding) and their preliminary location at the plant • requirements and dependencies arising from other systems, including auxiliary and support systems • the reliability target of the safety function to the implementation of which the system contributes • a description of analyses and tests that have been or are to be made to demonstrate system operation • designer’s preliminary safety assessment • licensee’s own safety assessment

28. OL3 PSAR content and structure • In addition to the 17 Chaptersrequiredby US NRC Regulatory Guide 1.70 Rev.3 • Chapter 18, “Human Factors Engineering” ; • Chapter 19, “ProbabilisticSafetyAssessment and • Chapter 20, “Decommissioning” havebeenadded to meet the state-of–the-artrequirements for licensingdocumentation. • The Contentsmeet the intent of the IAEA Safety Standard SeriesSafety Guide GS-G-4.1 “Format and Content of SAR for Nuclear Power Plants.

29. Review procedures • There is no detailedregulatoryguidancehow to perform the review – such as US NRC Standard ReviewPlans • STUK Project Planhasbeendeveloped and containsguidance for the reviewwork • Criteria is providedby YVL Guide system – ifdomesticregulatorycriteria is lackingforeignstandardsareused • IAEA Safety Guide providescontent and format – for complianceinspection

30. documentation required by NE Act section 35 • PSAR, PSA, Safety Classification, QA, Safeguards, Emergency and Security plans, others • about 5000 pages

31. Process to review : STUK Project Plan Key document is a Project Planincluding • Project organization and • Appendix 4: Handling of applicationdocumentsrelated to Construction Licenseapplicationincluding • Nomination of coordinators for reviewingdocuments • Coordinatorsnominatereviewers for documents and schedule • PSAR is divided on the basis of main chapters to the managers of correspondingsubprojects; theycoordinate inside theirsubproject and betweensubprojects and theynominate the reviewers for eachsubchapters • Reviewersprovidereviewresults in the form of memorandum and at the end, SubprojectManagerwritesInspectionReportincludingcriteria • PSAR coordinatorcollectsallsubprojectmanagers’ contributions and compiles PSAR InspectionReport • On the basis of InspectionReportscoordinatorswritedraftregulatorydecisions and memorandums of theirregulatorybases

32. Reactor, safety functions, systems and analyses Radiation safety and emergency preparedness

33. During the review • During the review, the keyinstrumentbetween the regulatorybody, operatingorganization and plantvendor is List of Findingswhereallnumberedfindings and commentswerelistedchapterbychapteraccording to list of contents. • Theselistsweresent to powercompany and further to vendor and returnedwithanswers of vendor. Whennecessary, common meetingswereorganized to handlequestions, findings and comments as well as answers of vendor to providefullunderstanding of the issue. • Finally, Lists of Findingswereclosed and remainingissueswerehandledduring the nextphase, whenfurtherdevelopedsystemdescriptionswereprovidedaftergranting of Construction License. • Openissuesweretaken into accountwhen PSAR ReviewReportwasdrafted. Since the plantwasfirst of itskind (prototype), practicallyallsystemdescriptionsneededfurtherdevelopment and thiswasspecificallypointed out in regulatorydecisionwithcorrespondingrequirement of delivery. • STUK’sreviewwork is based on systemdescriptions. Practicalguidance for inspectionmemorandumincluding the keyreviewissueswasprovided. Also Standard ReviewPlanswereutilized as a referencematerialsince the structure of PSAR followed the US practice.

34. STUK activities during CL stage • Review of submitted CL documentation (PSAR, PSA, etc.) • identification of documentation deficiencies (against YVL guides, RG 1.70) • review and assessment of the fulfilment of safety requirements • Outcomes: PSAR and PSA inspection reports, decisions (other documents), memos • Independent calculations to validate accident analysis • in co-operation with expert organisations, also contracted work • Meetings with license applicant and vendor • several meetings weekly on technical issues and quality management • Audits on plant vendor and applicant: design process, project management • STUK inspections on design and manufacturing of reactor vessel and steam generators

35. STUK’s resources spent for Olkiluoto 3 review and inspections Year 2004 of Construction License review : • 23 manyears divided among 60 persons • 2,0 Meuros contracted work (equals about another 23 manyears of work by contracted experts) Previous years 1999-2003: • 8 manyears & 0,6 Meuros contracts, altogether Support to STUK from Finnish expert organisations • VTT: advice and independent analysis of several topics including PSA, water chemistry, postulated accidents, severe accidents and I&C validation; tests including simulation of aircraft crash and of cable fires • Lappeenranta Technical University: tests and assessment of approach to severe accident management

36. Support to STUK from expert organisations • Foreign organisations • DGSRN and IRSN France: exchange of information on assessment of several design topics, in specific I&C systems • GRS Germany: assessment of Break Preclusion concept for primary and secondary systems; independent analysis and assessment of aircraft crash protection approach • ISaR Germany: independent analysis of specific accidents, assessment of the ECCS

37. Goals of the review

38. RegulationsGuidelines Technicalsolutions Verificationand validation Operationalreadiness Buildings Reviews Tech Specs Plantdesign Systems Analyses Commissioning Structures Testing Physicalprotection andemergencypreparedness Safetyanalyses Components Inspections Principaldesign Project and quality management Organization Training Implementationrequirements Preparations for operation Instructions Summary on the stages and goals Preparatoryphase Constructionpermit reviews Oversight duringconstruction Operatinglicense reviews Plant and site selection by utilityConstruction permit application Decision in principle Design bases OK Implementation OK Plant OK

39. Conclusions 1 • Licensing steps in each country has certain differences, but nuclear safety related documentation structure is similar as well as the gradually increasing level of detail in each step • Requirements for licensing documentation in each step should be presented in Regulation, in Finland requirements are presented in legislation level, in the Nuclear Energy Decree and in several regulatory guides (YVL guides) - important elements are: • YVL guides are followed • explicit text and requirements • transparent and traceable documentation

40. Conclusions 2 • What is the level of design that has to be completed and documented in each step? • E.g. in the construction license phase • Clearly defined design basis → Demonstrated by supporting safety analyses → explicit design requirements • In general, the design documentation and design process shall provide evidence that • status of the design is in a phase were design of different technical disciplines (civil, process, electrical, I&C, HVAC etc.) has proceeded to a level in which there are verifiable design requirements originating from the design basis of the plant • requirements have been comprehensively managed from safety point of view, systematically taken into account in the plant layout, systems and component’s design

41. Conclusions 3 • To proceed into the detailed design • Vendor’s design management and Licensee’s activities in the design review and approval need to be able to create confidence on well managed and competent performance • the licensing of detailed design is well planned and progresses logically with the project implementation • Configuration and change management as well as requirement management systems are in place from the beginning of the project and well documented to ensure that design meets safety requirements

42. Conclusions 4 • Regulatory access to Licensee’s licensing document data base would increase the productivity of regulatory review. Paper format documentation still needed. • Licensing plan which indicates the document submissions to the each party in each step of review process.