Why is Licensing Process important? - To establish a regulatory control over a facility - To establish hold points during a lifetime of a Facility to ensure that for key steps and periodically the demonstration for safety is adequate

Content Introduction General Principles Key Licensing Aspects Roles and Responsibilities Licensing Stages Module 2 - Core set on Licensing Process 2016

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 Licence, legal document allowing to perform specified activities, synonymous to Permit, Authorization, Approval. Generally accompanied with conditions and limits bounding the activity Licensing Basis, a set of requirements, criteria and standards applicable to the facilities and associated activities Holder of a Licence is termed a Licensee Module 2 - Core set on Licensing Process 2016

1. Introduction From a licensing viewpoint, the lifetime of a nuclear installation can be divided into: 7 major steps Siting and Site Evaluation Design Construction Commissioning Operation The licensing process for a nuclear installation normally includes the following steps, depending on national legislation: siting and site evaluation (which may include the environmental impact assessment), construction, design, commissioning, operation, decommissioning and release from regulatory control. Decommissioning Release from Regulatory Control Module 2 - Core set on Licensing Process 2016

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. Module 2 - Core set on Licensing Process 2016

Prevention (and mitigation) Justification of facilities and activities 1. Introduction To protect people and the environment from harmful effects of ionizing radiation. 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 Protection of present and future generations Module 2 - Core set on Licensing Process 2016

Prevention (and mitigation) Justification of facilities and activities 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. Responsibility for safety Protective actions to reduce existing or unregulated radiation risks 3.4. Authorization to operate a facility or conduct an activity may be granted to an operating organization or to an individual, known as the licensee. 3.5. The licensee retains the prime responsibility for safety throughout the lifetime of facilities and activities, and this responsibility cannot be delegated. Role of government Emergency Preparedness and Response Principle 1: Responsibility for safety The prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks. This responsibility cannot be delegated and includes Establishing and maintaining the necessary competences and providing adequate training and information Establishing procedures and arrangements to maintain safety under all conditions Verifying appropriate design and the adequate quality of facilities and activities and of their associated equipment Ensuring the safe control of all radioactive material that is used, produced, stored or transported and the safe management of all generated radioactive waste Principle 2: Role of government An effective legal and governmental framework for safety, including an independent regulatory body, must be established and maintained To adopt legislation, regulations, and other standards and measures that are necessary to fulfil international obligations To ensure that arrangements are made for preparing programmes of actions to reduce radiation risks, including actions in emergencies, for monitoring releases of radioactive substances to the environment and for disposing of radioactive waste. Principle 3: Leadership and management for safety Effective leadership and management for safety must be established and sustained in organizations concerned with, and facilities and activities that give rise to, radiation risks. Leadership in safety to be demonstrated at the highest levels in an organization. Safety has to be achieved and maintained by means of an effective management system. The management system has to ensure the promotion of a safety culture, the regular assessment of safety performance Principle 4: Justification of facilities and activities Facilities and activities that give rise to radiation risks must yield an overall benefit which should outweigh the radiation risks In many cases, decisions relating to benefit and risk are taken at the highest levels of government, such as a decision by a State to embark on a nuclear power programme. Leadership and management for safety Prevention (and mitigation) of accidents Justification of facilities and activities Optimization of protection Limitation of risks to individuals Protection of present and future generations Module 2 - Core set on Licensing Process 2016

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

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 Module 2 - Core set on Licensing Process 2016

Content Introduction General Principles Roles and Responsibilities Key Licensing Aspects Licensing Stages Module 2 - Core set on Licensing Process 2016

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 Module 2 - Core set on Licensing Process 2016

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 Module 2 - Core set on Licensing Process 2016

2. General Principles Embarking country in nuclear power 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 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 Module 2 - Core set on Licensing Process 2016

Content Introduction General Principles Key Licensing Aspects Roles and Responsibilities Licensing Stages Module 2 - Core set on Licensing Process 2016

Module 2 - Core set on Licensing Process 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) If a State has an established nuclear power programme, the costs of the regulatory body could be recovered in whole or in part through fees. The costs of the preparation of a licence, review and assessment, inspection, and the development of regulations and guides could be recovered through fees. Where the regulatory body levies charges for licenses, a direct link between the funds generated and the regulatory body’s budget should be avoided. The government may establish provisions under legislative framework to allow the regulatory body to charge for the costs or its efforts for regulating nuclear power plant such as in the form of licensing fee. However, the legislative or regulatory framework needs to establish mechanism for determining the amount of licensing fee. Module 2 - Core set on Licensing Process 2016

Module 2 - Core set on Licensing Process 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 and 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 Module 2 - Core set on Licensing Process 2016

Content Introduction General Principles Key Licensing Aspects Roles and Responsibilities Licensing Stages Module 2 - Core set on Licensing Process 2016

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 Module 2 - Core set on Licensing Process 2016

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.” Module 2 - Core set on Licensing Process 2016

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) The regulatory body needs to establish its plans for development of a complete set of regulations and guides well in time i.e., regulation and guides related to construction license stage may be developed before initiation of the regulatory process for construction license. Module 2 - Core set on Licensing Process 2016

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) Similarly, in our other reference, which is SSG 16, Action#38 states that the regulatory body ………. Specifically, (Action 84) …………………. The following actions given in the following slides are as a list of the information and documentation that should be reviewed by the regulatory body after their submission by the applicant or licensee. Module 2 - Core set on Licensing Process 2016

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) Module 2 - Core set on Licensing Process 2016

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 Operation The licensing process for a nuclear installation normally includes the following steps, depending on national legislation: siting and site evaluation (which may include the environmental impact assessment), construction, design, commissioning, operation, decommissioning and release from regulatory control. Several steps may be merged or combined under one authorisation Each step may be divided into several sub-steps Overlapping activities Decommissioning Release from Regulatory Control Module 2 - Core set on Licensing Process 2016

5. Licensing Stages Site 1. Siting 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 to accept or reject a proposed site on safety basis (Action 164) Module 2 - Core set on Licensing Process 2016

(may include design certification) 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 Design approval (may include design certification) Actions 120, 174, 178, 181 – 184 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

Specific authorization 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 3. Construction Actions 83, 84 Permit Specific authorization 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

5. Licensing Stages Commissioning 4. 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 acceptance criteria, conditions and procedures Tests can be safely conducted as proposed by the licensee or applicant and their justification is appropriate STAGE Ex. AUTHORIZATION Ex. DOCUMENTS TO BE SUBMITTED Action 181, 182, 185, 188 4. Commissioning Authorizations for Cold system tests 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 Authorization of Loading Fuel 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 operating rules Radiation protection programme and emergency response plan Module 2 - Core set on Licensing Process 2016

Authorization of Full Power Testing 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 5. Operation Actions 157, 158 Authorization of Full Power Testing 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 Operation Licence 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 Reports on operational parameters, occurrences or events, root cause analyses, and action plans Module 2 - Core set on Licensing Process 2016

Installation remains licensed throughout the decommissioning period 5. Licensing Stages Decommissioning 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 Module 2 - Core set on Licensing Process 2016

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 Module 2 - Core set on Licensing Process 2016

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

5. Licensing Stages Licensing process implementation Ready to make a knowledgeable commitment to a nuclear programme Ready to invite bids Ready to commission and operate the first NPP Phase 1 Phase 2 Phase 3 Licensing process implementation Initial site survey Issuance of the nuclear law Contract Issuance of requirements needed for bid specification Application for: - Design license - Construction license Feasibility study Environmental Impact Assessment M1 M2 First concrete Establishing the basic regulatory framework Preparation of safety documentation Bid preparation Issuance of the Site licence Issuance of construction licence Fuel delivery Issuance of commissioning licence Assessment by the regulatory body Site preparation Licensing process design Construction phase

Thank you j.jubin@iaea.org Module 2 - Core set on Licensing Process