IAEA International Atomic Energy Agency Content 1 2

IAEA International Atomic Energy Agency

Content 1. 2. 3. 4. 5. Introduction General Principles Key Licensing Aspects Roles and Responsibilities Licensing Stages IAEA Module 2 - Core set on Licensing Process 2016 2

1. Introduction • Authorization is a key function of the regulatory body, resulting with the granting or denial of a licence • Granting authorizations is to establish regulatory control over an activity or facility where safety is concerned • A licence is granted on the basis of the applicant’s demonstration on the safety of the proposed installation against the licensing basis established by the regulatory body • Generally accompanied with conditions and limits bounding the activity authorized Applicant, a legal person who applies to a regulatory body for authorization to undertake specified activities Licensing Basis, a set of requirements, criteria and standards applicable to the facilities and associated activities IAEA Licence, legal document allowing to perform specified activities, synonymous to Permit, Authorization, Approval. Generally accompanied with conditions and limits bounding the activity Holder of a Licence is termed a Licensee Module 2 - Core set on Licensing Process 2016 3

1. Introduction Siting and Site Evaluation Design From a licensing viewpoint, the lifetime of a nuclear installation can be divided into: • 7 major steps Construction Commissioning Operation Decommissioning Release from Regulatory Control IAEA Module 2 - Core set on Licensing Process 2016 4

1. Introduction • Convention on Nuclear Safety International Obligations for Authorization • Article 7: the legislative and regulatory framework in the Contracting Party includes a system of NPP licensing and the prohibition of the operation of a NPP without a licence • Article 19: the initial licence to operate a NPP is based upon an appropriate safety analysis and a commissioning programme demonstrating that the NPP, as constructed, is consistent with design and safety requirements • Article 6: importance of upgrading NPP safety throughout of the operational lifetime of NPP through periodic review of safety or operational experience feedback • The regulatory body is responsible for control of modifications to a NPP and for operating limits and conditions resulting from upgrading. IAEA Module 2 - Core set on Licensing Process 2016 5

1. Introduction To protect people and the environment from harmful effects of ionizing radiation. IAEA Responsibility for safety Protective actions to reduce existing or unregulated radiation risks Role of government Emergency Preparedness and Response Leadership and management for safety Prevention (and mitigation) of accidents Justification of facilities and activities Optimization of protection Limitation of risks to individuals Module 2 - Core set on Licensing Process Protection of present and future generations 2016 6

1. Introduction To protect people and the environment from harmful effects of ionizing radiation. The prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks. Protective actions to reduce existing or unregulated radiation risks 3. 4. Authorization to operate. Responsibility a facility or conduct an for safety activity may be granted to an operating organization or to an individual, known as the Role of government licensee. 3. 5. The licensee retains the prime responsibility for safety Leadership throughout the lifetime of and facilities and activities, and management this responsibility cannot be for safety delegated. IAEA Justification of facilities and activities Emergency Preparedness and Response Prevention (and mitigation) of accidents Optimization of protection Limitation of risks to individuals Module 2 - Core set on Licensing Process Protection of present and future generations 2016 7

1. Introduction IAEA Module 2 - Core set on Licensing Process 2016 8

1. Introduction Req. 23 Authorization of facilities and activities › Regulatory authorization, including specification of the conditions necessary for safety, is a prerequisite for a nuclear installation Req. 24 Demonstration of safety for authorization › Applicant shall submit an adequate demonstration of safety in support of an application for the authorization IAEA Module 2 - Core set on Licensing Process 2016 9

Content 1. 2. 3. 4. 5. Introduction General Principles Roles and Responsibilities Key Licensing Aspects Licensing Stages IAEA Module 2 - Core set on Licensing Process 2016 10

2. General Principles REGULATORY BODY should • Have adequate legal authority, technical and managerial competence, and human and financial resources to fulfil its responsibilities • Be effectively independent of the licensee and of any other body, so that it is free from any undue pressure from interested parties • Consult parties in the vicinity, the public and other interested parties, as appropriate, in an open and inclusive process, well described and balanced • To present their views during certain steps of the licensing process, even • challenge the issuing a license if it appears to jeopardize health or safety If a site is near a Member State’s national border, there should be appropriate cooperation, including public participation, with neighbouring Member State(s) in the vicinity of the nuclear installation IAEA Module 2 - Core set on Licensing Process 2016 11

2. General Principles • The licensing process should be carefully designed and clearly defined • At any time, prime responsibility to safety should be assigned • Contents for a licence application and associated documents to be prepared and submitted to the regulatory body should be regularly defined • The regulatory body should have the authority to request additional relevant information during the licensing and associated review process • The documents submitted to the regulatory body as part of the licensing process should be updated, as appropriate, during the facility lifetime • Licences may be granted for: • Specific time period (e. g. 10 years, 30 years) • Specific stage in the lifetime of the installation (construction, operation…) • Indefinite period of time, under certain conditions and until the licence is officially terminated by the regulatory body • Specific activities or conditions of the nuclear installation IAEA Module 2 - Core set on Licensing Process 2016 12

2. General Principles Embarking country in nuclear power ð Phase 2 • • Action 30 the regulatory body should issue regulations and guides specifying the documentation and procedures necessary in the various steps of the licensing process and inspections to be conducted Action 161 the regulatory body should establish specific safety requirements for site evaluation, including requirements for the process for authorizing the site selected, in compliance with the relevant IAEA safety standards ð Phase 3 • • Action 36 the regulatory body to ensure that a full and comprehensive set of regulations and guides is in place for regulating construction, commissioning and operational activities at the appropriate time” Action 34 the regulatory body should plan and conduct all the required licensing and oversight activities to be conducted during the licensing process, including siting, construction, commissioning and operation, consistent with the regulatory approach that was selected IAEA Module 2 - Core set on Licensing Process 2016 13

Content 1. 2. 3. 4. 5. Introduction General Principles Key Licensing Aspects Roles and Responsibilities Licensing Stages IAEA Module 2 - Core set on Licensing Process 2016 14

3. Key Licensing Aspects • The licensing process should be understood by the parties concerned and should be predictable (i. e. well defined, clear, transparent and traceable). Licensing principles should be established in the regulatory and legal framework, including: × The regulatory framework for dealing with authorization requests should be clear × Expenses associated with the licensing process and the person or organization that will be charged should be clearly specified × The regulatory regime for the licensing process should be explicitly established by the regulatory body × The licensing of a nuclear installation should be based on predefined documents that are submitted to the regulatory body by the person or organization responsible for the nuclear installation and its activities × The analysis approach to safety should be clearly defined (including the use of deterministic and probabilistic methodologies and analytical tools) IAEA Module 2 - Core set on Licensing Process 2016 15

3. Key Licensing Aspects × A facility and activity should be authorized only when the regulatory body is satisfied and has confirmed that the facility or activity is going to be used or conducted in a manner that does not pose an undue risk to workers, the public or the environment × The scope of the license, its validity period any incorporated conditions should be clearly defined by the regulatory body × The means of challenging or appealing against a license or part of a license should be made clear by the regulatory body × A graded approach should be taken into account by the regulatory body when performing regulatory tasks relevant to the licensing/ authorization of nuclear facilities IAEA Module 2 - Core set on Licensing Process 2016 16

Content 1. 2. 3. 4. 5. Introduction General Principles Key Licensing Aspects Roles and Responsibilities Licensing Stages IAEA Module 2 - Core set on Licensing Process 2016 17

4. Roles and Responsibilities APPLICANT/LICENSEE › Action 157 the Operating Organization should, in coordination with the vendor as necessary, prepare all the safety documentation as required in the licensing process for submission to the regulatory body › Action 71 the Operating Organization (and Regulatory Body) should oversee the activities performed by their external support organizations and contractors, and should assess the quality of the services provided, in accordance with their management systems • SITE SURVEY AND EVALUATION - Action 163 the Operating Organization should prepare the site evaluation report and should submit it to the regulatory body, on the basis of a full assessment of the site selected and including the confirmation of site acceptability and the characterization of the site for the definition of the site related design basis parameters IAEA Module 2 - Core set on Licensing Process 2016 18

4. Roles and Responsibilities APPLICANT/LICENSEE • DESIGN SAFETY Action 181 “the Operating Organization should, in coordination with the vendor as necessary, prepare all the safety documentation as required in the licensing process for submission to the regulatory body” and Action 183 “ the Operating Organization should ensure the adequate validation and verification of the design of the nuclear power plant and its structures, systems and components (SSCs) • CONSTRUCTION Action 159 “the Operating Organization should ensure completion of the construction of the nuclear power plant in accordance with the design basis license conditions, and with primary consideration given to safety aspects” • OPERATION Action 158 “the Operating Organization should develop all necessary programmes for operational management (including for operations, maintenance and training) and should submit them to the regulatory body as appropriate. ” IAEA Module 2 - Core set on Licensing Process 2016 19

4. Roles and Responsibilities REGULATORY BODY should • Communicate with interested parties about the licensing process, safety requirements and regulatory oversight (Action 45, TRANSPARENCY AND OPENNESS) • Verify, as part of the licensing process, that the operating organization has • sufficient financial resources (Action 59 FUNDING AND FINANCING) (or the government) Verify that a system for the funding of decommissioning activities, radioactive waste management, and spent fuel management including disposal is in place (Action 30 FUNDING AND FINANCING) IAEA Module 2 - Core set on Licensing Process 2016 20

4. Roles and Responsibilities REGULATORY BODY should review and assess • the operating organization’s programme, including on safety management (Action 38, REGULATORY FRAMEWORK & Action 84, LEADERSHIP AND MANAGEMENT FOR SAFETY) • the operating organization's programme with regard to human resources management (Action 97, HUMAN RESOURCES DEVELOPMENT) • the radiological environmental impact analysis for the site selected, as appropriate (Action 111, RADIATION PROTECTION) • the operating organization’s programmes with regard to radiation protection and relevant environmental protection, and should verify compliance with the regulatory requirements (Action 115, RADIATION PROTECTION) • the site evaluation report, and should make a decision regarding the acceptability of the site selected and the site related design bases (Action 164, SITE SURVEY AND EVALUATION) IAEA Module 2 - Core set on Licensing Process 2016 21

4. Roles and Responsibilities REGULATORY BODY • Should carry out a comprehensive review and an independent verification of the safety analysis reports submitted by the operating organization (Action 120, SAFETY ASSESSMENT) • Should review: • the validation and verification of the design and SSCs (Action 183, DESIGN SAFETY) • the operating organization’s programmes for: waste management, for spent fuel • • management and for decommissioning (Action 129, RADIOACTIVE WASTE, SPENT FUEL AND DECOMMISSIONING) the emergency programme, plans and procedures (Action 144, EMERGENCY PREPAREDNESS AND RESPONSE) the commissioning programme, should verify compliance with requirements and should prepare a programme to oversee the commissioning of systems important to safety in the next Phase (Action 188, PREPARATION FOR COMMISSIONING) IAEA Module 2 - Core set on Licensing Process 2016 22

5. Licensing Stages During the lifetime of a nuclear installation 7 major licensing steps can be identified Siting and Site Evaluation Variants × Early site approval × Design certification Design Construction Commissioning × Several steps may be merged or combined under one authorisation × Each step may be divided into several sub-steps × Overlapping activities IAEA Operation Decommissioning Release from Regulatory Control Module 2 - Core set on Licensing Process 2016 23

5. Licensing Stages Site selection, to select one or more candidates sites Site evaluation • To verify the acceptability of the site, whether the selected site is suitable to host a nuclear installation • To determine site characteristics necessary for analysis and installation design to ensure final design is fit for safety purpose STAGE Ex. AUTHORIZATION Ex. DOCUMENTS TO BE SUBMITTED 1. Siting Site Approval Actions 110, 111, 161 - 166 Site Report (Geography, demography, topography, meteorology, hydrology, geology and seismology…) Report on concept design and, if relevant, reference design Site Evaluation (on a basis of a full assessment of the site selected, including confirmation of site acceptability and characterization for the definition of the site related design basis parameters (Action 163)) Environmental Impact Assessment (EIA) Public enquiring plan and preliminary results… A formal decision should be issued before construction begins. The RB should have the authority site on safety basis (Action 164) IAEA to accept or reject a proposed Module 2 - Core set on Licensing Process 2016 24

5. Licensing Stages Design To verify the proposed nuclear installation has been designed on the relevant design basis, conditions and events explicitly taken into account, and suitable to the selected site STAGE Ex. AUTHORIZATION Ex. DOCUMENTS TO BE SUBMITTED 2. Design approval (may include design certification) Actions 120, 174, 178, 181 – 184 IAEA Safety concept and design approach (safety classification, Defence in Depth, limits for radioactive releases, human–machine interface, etc. ) Safety analyses, including models, initial conditions, responding to postulated events, and extent to which operator can control or accommodate situations during events and fault conditions Predicted limits and conditions for safe operations Preliminary Safety Analysis Report Preliminary plan for decommissioning, including radioactive waste/spent fuel management Detailed systems design and specifications for procurement or manufacture of equipment Detailed design and engineering for site construction, installation, commissioning and operation… Module 2 - Core set on Licensing Process 2016 25

5. Licensing Stages Construction Prerequisites. Site evaluation and demonstration of the selected design meets safety objectives and criteria STAGE Ex. AUTHORIZATION Ex. DOCUMENTS TO BE SUBMITTED Actions 83, 84 3. Construction Permit Specific authorization IAEA Construction descriptive report: facilities, processes, technologies… Project implementation plan and schedule, resources, investments… Procurement programmes, including systems and components to be purchased/manufactured Management system, including quality assurance programme and management of the supply chain… Technical design and construction documents of individual systems and components to be installed Arrangements on site for physical protection, nuclear security, fire protection Programme and reports on EIA Training and qualification programmes/plans for operating staff and others… Module 2 - Core set on Licensing Process 2016 26

5. Licensing Stages Commissioning Usually divided in sub-stages, including: • Non nuclear testing, before introducing nuclear/radioactive material • Nuclear testing after introducing of nuclear or radioactive material To be verified • Test programme is complete and contains a set of well defined operational limits, test • STAGE acceptance criteria, conditions and procedures Tests can be safely conducted as proposed by the licensee or applicant and their justification is appropriate Ex. AUTHORIZATION Ex. DOCUMENTS TO BE SUBMITTED 4. Commissioning Action 181, 182, 185, 188 Authorizations for Cold system tests Authorization of IAEA Loading Fuel Documents and reports on as-built design of the plant Commissioning organization and commissioning programme, including plans for individual tests Test reports on results of non-nuclear commissioning tests and analyses Reports on non-conformances or unexpected results, and actions or corrective actions Technical specifications and procedures for loading fuel in the reactor core, including operating limits and conditions Preliminary operational limits and conditions in commissioning and general Module 2 - Core set on Licensing Process 2016 27 operating rules

5. Licensing Stages Operation › To be verified results of commissioning tests and arrangements in place to: Operate safely; Face an emergency situation; Manage safely wastes and effluents › During operation, considerations on installation modifications, significant or not Long-term shutdown, and [periodic] safety review STAGE Ex. AUTHORIZATION DOCUMENTS TO BE SUBMITTED Authorization of Full Power Testing 5. Operation Actions 157, 158 Operation Licence IAEA Commissioning report, where all tests completed and their results assessed Operational limits and conditions Operating instructions and procedures and shift arrangements Draft Final Safety Analysis Report On-and off-site emergency preparedness and response plans Report on the completion of commissioning tests, including validated operational limits and conditions Operating instructions and procedures for normal, abnormal and accident situations Procedures on testing, maintenance, inspection, surveillance, modifications Procedures on safety performance indicators and OPEX feedback Programmes on radioactive waste and spent fuel management Programmes for ageing management, surveillance, maintenance, and periodic testing Module 2 - Core set on Licensing Process 28 Reports on operational parameters, occurrences or events, 2016 root cause analyses, and action plans

5. Licensing Stages Decommissioning, to be verified • Decommissioning plan, which may comprise several sub-stages STAGE Ex. AUTHORIZATION DOCUMENTS TO BE SUBMITTED 6. Decommissioning Authorization of decommissioning Decommissioning plans and procedures, including final shutdown, sub stages, actions and safety analyses Preliminary programme for management of spent fuel and radioactive waste resulting from decommissioning… Installation remains licensed throughout the decommissioning period IAEA Module 2 - Core set on Licensing Process 2016 29

5. Licensing Stages Release from reg. control • Release from regulatory control, to be verified • Completion of the decontamination and dismantling and/or removal of radioactive material, including waste and contaminated components and structures STAGE Ex. AUTHORIZATION DOCUMENTS TO BE SUBMITTED 7. Release from regulatory control Termination of relevant authorization(s) Demonstration that all responsibilities covered by all authorizations have been satisfactorily discharged and there is no reasonable expectation that the licensee will have further responsibilities with respect to anything remaining on the site Description of any necessary institutional controls, including continuing environmental monitoring in place Radiological history of workers and contractors Final radiological status of the nuclear installation including results of final radiological survey… Before releasing, a radiological survey should be carried out to guarantee regulatory criteria and decommissioning objectives have been fulfilled IAEA Module 2 - Core set on Licensing Process 2016 30

5. Licensing Stages IAEA Module 2 - Core set on Licensing Process 2016 31

5. Licensing Stages M 3 Ready to make a knowledgeable commitment to a nuclear programme Phase 1 Ready to invite bids Ready to commission and operate the first NPP Phase 2 Phase 3 Licensing process implementation Initial site survey Issuance of the nuclear law Feasibility study Environmental Impact Assessment Issuance of requirements needed for bid specification Application for: - Design license - Construction license Fuel delivery Construction phase Issuance of commissioning licence First concrete Site preparation Issuance of construction licence IAEA Assessment by the regulatory body Licensing process design Preparation of safety documentation M 2 Issuance of the Site licence Bid preparation Establishing the basic regulatory framework M 1 Contract

THANK YOU j. jubin@iaea. org IAEA Module 2 - Core set on Licensing Process