Regulatory Control Training Workshop Module 2 “Licensing Process and Authorization in Pakistan” Application Set Regulatory Control Training Workshop ” DISCLAIMER This example was prepared by (individual or organization) for this IAEA workshop. The information contained in this example is based on publicly available information and/or personal knowledge; therefore, it does not necessarily represent the institutional position of the organization referred to in the example.

CONTENTS Overview of PNRA Licensing Basis Steps of the licensing process Roles and responsibilities of the regulatory body and the licensee Licensing stages and Submission requirements Management of the licensing process Interaction with the licensee and its Contractors/Subcontractors Documents prepared by the regulatory body Involvement of the interested parties WS | M2 | Application Set

EVOLUTION OF REGULATORY BODY Creation of PAEC Creation of DNSRP Promulgation of PNSRP Regulations PNRB created as an interim step Creation of PNRA as an independent regulatory body 1965 1984 1990 1994 2001 JOURNEY TOWARDS AN INDEPENDENT REGULATORY BODY WS|M4|Application Set

ORGANIZATIONAL STRUCTURE WS|M4|Application Set

PNRA REGULATED FACILITIES Nuclear Power Plants, Research Reactors and Waste Management Facilities Nuclear Medical Centers & Agriculture Research Centers X-Ray Machines , Diagnostic Radiology & Irradiators used for sterilization of medical equipment Industrial Radiography & Industrial applications of radiation PNRA

FUNCTIONS & RESPONSIBILITIES Regulate all stages of nuclear installations and radiation facilities Formulate and implement rules and regulations Grant license or Authorization Perform regulatory inspections Take enforcement actions in case of violations Ensure that emergency preparedness plans are in place Ensure physical protection of nuclear installations and nuclear materials Fix extent of Civil Liability for an operator in case of various nuclear incidents Establish the extent of insurance against nuclear damage Ensure and coordinate implementation of national program for environmental monitoring

NPPs SITES IN PAKISTAN Chashma Nuclear Power Plants (C-1, C-2, C-3, & C-4) Karachi Nuclear Power Plants (K-1, K-2 and K-3) WS|M4|Application Set

Chashma Nuclear Power Plant C-1 OVERVIEW OF NPPs IN PAKISTAN Karachi Nuclear Power Plant – K-1 Pressurized Heavy Water Reactor Net Electrical Output: 137 MWe Commercially operating since 1972 Design life: 30 years Re-licensed for further operation Chashma Nuclear Power Plant C-1 Pressurized Water Reactor Design Electrical Power 325 MWe Started commercial operation in 2000 Design life: 40 years Granted operating license till 2020 WS|M4|Application Set

OVERVIEW OF NPPs IN PAKISTAN Chashma Nuclear power plant C-2 Pressurized Water Reactor (PWR) Design Electrical Power 325 MWe Commercial operation started in May 2011 Design life: 40 years C-3 – 325 MWe Pressurized Water Reactor (PWR): Construction started March 2011: Operation expected by the end of 2016 C-4 – 325 MWe Pressurized Water Reactor (PWR): Construction started in 2012 K-2 and K-3 − 1100 MWe each Pressurized Water Reactor (PWR): Construction started in 2015 WS|M4|Application Set

LICENSING BASIS PNRA Ordinance Regulations for licensing of nuclear installation(s) other regulations and applicable codes and standards Final Safety Analysis Report WS | M2 | Application Set

STEPS OF LICENSING PROCESS FOR NPPs Site Registration Removal from Regulatory Control Construction License Authorization for Decommissioning/ Closure Permission for Commissioning Licensing Beyond Design Life Permission to Introduce Nuclear Material into the Facility Operating License Revalidation of Operating License WS | M2 | Application Set

STEPS OF LICENSING PROCESS FOR NPPs Review and assessment of licensing submissions Completeness of application Formulation of review queries and responses Review meetings Preparation of Safety Evaluation Report Evaluation of feedback from inspection activities and their integration Preparation of licensing conditions Issuance of License or Authorization WS | M2 | Application Set

ROLES AND RESPONSIBILITIES OF PNRA IN LICENSING PROCESS Grant authorization or issue license for the production, storage and use of any nuclear or radioactive material and disposal of radioactive waste Inspect all nuclear installations, radiation generators, nuclear or radioactive materials to ensure compliance with the regulations Issue directives, warning or show cause notices to the licensee on failure to comply with the provisions of the Ordinance and regulations Suspend or cancel the authorization on consistent contravention of the regulations or the terms and conditions of an authorization Require every operator of a nuclear installation to maintain an insurance or other financial guarantee adequate to cover the civil liability for nuclear damage WS | M2 | Application Set

ROLES AND RESPONSIBILITIES OF APPLICANT/LICENSEE Retain the prime responsibility for safety to ensure utmost priority to safety Execute control on the use and occupation of lands situated within the plant boundary Operate and maintain the nuclear power plant in conformance with the technical specifications prohibit manipulation of the controls for licensed positions by anyone who is not the holder of a valid license Keep the Authority informed of the schedule and progress of its activities during all phases of nuclear installation(s). WS | M2 | Application Set

ROLES AND RESPONSIBILITIES OF APPLICANT/LICENSEE Maintain the plant and carry out its activities as per approved documents and maintain a list of all changes made in the documents Establish the programs and plans for emergency preparedness and response and coordinate with local response organizations for the management of such situations. Acquire permission of the Authority for transporting nuclear/radioactive material to/from a nuclear installation. Maintain insurance or other financial guarantee to cover civil liability for nuclear damage. The licensee shall prepare and implement programs of maintenance, testing, surveillance and inspection of those structures, systems and components, which are important to safety. These programs shall be in place prior to fuel loading. These shall take into account operational limits and conditions as well as any other applicable regulatory requirements and shall be re-evaluated in the light of experience. WS | M2 | Application Set

LICENSING STAGES AND SUBMISSION REQUIREMENTS SITE REGISTRATION The applicant shall submit an application to the Authority (PNRA) for the registration of site for nuclear installation along with the following documents: Site Evaluation Report (SER); No Objection Certificates (NOC) from relevant departments of the federal, provincial and/or local governments; Quality Assurance Program applied during site evaluation On approval of SER, the site will be registered which will allow concrete pouring in the nuclear island WS | M2 | Application Set

LICENSING STAGES AND SUBMISSION REQUIREMENTS CONSTRUCTION LICENCE After site registration, the applicant has to establish design and safety criteria in accordance with the nuclear safety standards and submit the same for approval of the Authority (PNRA) After completion of the preliminary design, the licensee shall submit the following documents to the Authority (PNRA) for issuance of construction licence: Preliminary Safety Analysis Report (PSAR) Design Probabilistic Safety Assessment (PSA) of full power internal initiating events (for NPPs only) Quality Assurance Program for design and construction phases (for reference and record) On approval of these documents the construction licence may be issued by the Authority (PNRA). The applicant shall not begin the construction of nuclear installation on the site until a construction licence has been issued. The pouring of the concrete in the foundation shall be deemed to be the beginning of construction. The construction licence shall normally be valid for a period of 10 years or as specified in the licence. After the expiry of construction licence, the construction activities may only continue/commence after revalidation of the construction licence. The licensee shall submit a request to the Authority (PNRA) for revalidation of the construction licence along with the following documents: Updates of all the documents and reports submitted for the grant of construction licence Reasons for the delay along with justification for continuing/ commencing the construction An evaluation of the impact in design as a result of changes such as changes in the design, nuclear safety standards, industrial standards, experience feedback. In case the licensee is unable to start construction of the nuclear installation within a period of five (05) years after the issuance of construction licence, the same shall be deemed to have been cancelled. In such a case, the applicant shall have to re-submit the case for issuance of construction licence WS | M2 | Application Set

LICENSING STAGES AND SUBMISSION REQUIREMENTS PERMISSION FOR COMMISSIONING At least six months before commissioning of the installation, the licensee shall submit a request for permission of commissioning along with the commissioning program and quality assurance program for the commissioning phase. Upon acceptance of the commissioning program, the Authority (PNRA) may allow commissioning without introducing nuclear material into the system of the installation. WS | M2 | Application Set

LICENSING STAGES AND SUBMISSION REQUIREMENTS PERMISSION TO INTRODUCE NUCLEAR MATERIAL INTO THE INSTALLATION The licensee shall submit the following documents with the application: Final Safety Analysis Report (FSAR) Probabilistic Safety Analysis (PSA) Level-I Physical Protection Program (approval and demonstration required for arrival of nuclear fuel at site) Emergency Preparedness Plans Radiation Protection Program Environmental Monitoring Program Radioactive Waste Management Program Initial Decommissioning Plan WS | M2 | Application Set

LICENSING STAGES AND SUBMISSION REQUIREMENTS PERMISSION TO INTRODUCE NUCLEAR MATERIAL INTO THE INSTALLATION Pre-Service Inspection and In-Service Inspection Programmes Quality Assurance Program for Operation Programs for maintenance, testing and surveillance of structures, systems and components important to safety Fire Protection Program In addition, the licensee has to demonstrate: implementation of Emergency Preparedness Plans in an exercise and availability of required number of licensed/authorized operating personnel, In addition, the following documents shall also be submitted along with the application for reference and record: As the cold and hot commissioning (without introducing nuclear material in the systems) proceeds, the licensee shall regularly submit commissioning reports up to introduction of nuclear material to the Authority (PNRA) for information, reference and record [2]. PNRA regulatory framework requires from licensee to demonstrate implementation of physical security plan three months before arrival of nuclear material at site. WS | M2 | Application Set

LICENSING STAGES AND SUBMISSION REQUIREMENTS OPERATING LICENCE Within six months after completion of the commissioning, the licensee shall apply for the Operating Licence alongwith the following documents: Results of the first start-up, criticality, low power tests, power ascension tests and full power tests; Updates of all documents mentioned in previous slides on which amendments have been carried out. The Operating Licence shall normally be valid for a period up to a maximum of ten (10) years. WS | M2 | Application Set

LICENSING STAGES AND SUBMISSION REQUIREMENTS REVALIDATION OF OPERATING LICENCE During the design life of the nuclear installation and at least one year before the expiry of Operating Licence, the licensee shall apply for revalidation of the licence along with the latest reports of Periodic Safety Review (PSR). On approval of these documents, the Operating Licence may be revalidated by the Authority (PNRA) for another period up to a maximum of ten (10). LICENSING BEYOND DESIGN LIFE At least three (03) years before the end of design life alongwith the following documents: Latest reports of Periodic Safety Review (PSR); Updates of all documents mentioned for fuel load permit. WS | M2 | Application Set

LICENCE FOR DECOMMISSIONING LICENSING STAGES AND SUBMISSION REQUIREMENTS LICENCE FOR DECOMMISSIONING Application shall be submitted at least three years before terminating the operation of the nuclear installation alongwith following documents: Final Decommissioning plan Technical Specifications during decommissioning Quality Assurance Program for decommissioning Emergency Preparedness Plan Physical Protection Program Radiation Protection Program Radioactive Waste Management Program Environmental Monitoring Program Upon approval of these documents, the Authority (PNRA) may terminate the Operating Licence and issue licence for decommissioning/closure of the installation [2]. WS | M2 | Application Set

LICENSING STAGES AND SUBMISSION REQUIREMENTS REMOVAL FROM REGULATORY CONTROL After the completion of all decommissioning activities and restoring the site to condition such that the site can be used for any other purposes, the licensee may apply for removal of the installation from regulatory control alongwith the following submissions: Decommissioning Completion Report Final Radiological Survey Report WS | M2 | Application Set

AMENDMENT IN LICENCE/AUTHORIZATION Amendment in the license is required if the licensee intends to incorporate a modification which may lead to changes in the existing design/licensing basis of the installation, shall submit an application to the Authority (PNRA) for amendment in the licence. The application shall accompany the documents fully describing the desired changes, safety analysis and justification for the modification along with parts of the revised safety analysis report. WS | M2 | Application Set

ORGANIZATIONAL SETUP FOR LICENSING PROCESS MANAGEMENT OF THE LICENSING PROCESS ORGANIZATIONAL SETUP FOR LICENSING PROCESS Regional Office (Chashma Site) Nuclear Safety Transport & Waste Safety Radiation Safety C H A I R M A N Member (Executive) Director General (Technical Support) Member (Corporate) Safety Analysis Centre (Technical) Regional Office (K-1/K-2 Site) (Inspection & Enforcement) Centre for Physical Protection and Security WS | M2 | Application Set

MANAGEMENT OF THE LICENSING PROCESS SIMPLIFIED FLOW DIAGRAM Submission of Safety Case Initial Review for Completeness of Information Case Acceptable Docketing of Application Detailed Review and Assessment Comments Sent/Responses Received Formation of Regulatory Position Conduct of Review Meetings Follow up Responses Received Safety Issues Resolved Issuance of Authorization /License Submission of additional information by the licensee Submission of Further Information/Analysis Actions Identified No Yes WS | M2 | Application Set

INTERACTION WITH THE LICENSEE AND ITS CONTRACTORS/SUB-CONTRACTORS Main Objectives: To develop common understanding on licensing requirements and process so as to reduce uncertainties; To agree on a tentative time frame for licensing activities and milestones To share necessary information with each other; To address and resolve important issues timely to avoid unnecessary delays. Formal liaison is established for communication among different stakeholders e.g., licensee, national and international organizations, etc., involved in licensing process. WS | M2 | Application Set

INTERACTION WITH THE LICENSEE AND ITS CONTRACTORS/SUB-CONTRACTORS INTERFACE WITH LICENSEE Process for establishing formal liaison starts with receiving a letter of intent from applicant regarding installation of a nuclear installation to the Chairman of regulatory body The applicant is requested to inform about its persons/positions to communicate with interfaces identified by PNRA. The Interface arrangements include: Correspondences (letters, memos, reports, etc.) Formal Meetings (regular periodic coordination meetings and review meetings WS | M2 | Application Set

INTERFACE ARRANGEMENTS INTERACTION WITH THE LICENSEE AND ITS CONTRACTORS/SUB-CONTRACTORS INTERFACE ARRANGEMENTS Licensing issues Nuclear Safety Directorate Applicant/ Licensee Regional Nuclear Safety Directorates Inspection issues WS | M2 | Application Set

INTERACTION WITH THE LICENSEE AND ITS CONTRACTORS/SUB-CONTRACTORS INTERACTION WITH LICENSEE’S CONTRACTORS/SUB CONTRACTORS Safety is the responsibility of licensee No direct interface with the contractors and sub-contractors of licensee All interactions are through licensee PNRA performs inspections and audits of licensee’s contractors through licensee However, nuclear safety class equipment manufacturing within Pakistan is regulated by PNRA and thus has direct interface WS | M2 | Application Set

DOCUMENTS PREPARATION BY REGULATORY BODY The documents generated and recorded includes: Review and assessment schedule Approval of review team, core team and advisory committee Review queries & responses Action sheets (Query, response, action and follow up) Safety Evaluation Report License (with licensing conditions) WS | M2 | Application Set

INVOLVEMENT OF INTERESTED PARTIES Public involvement licensing process of EPA while issuing environmental licence for any project Environmental licence is a pre-requisite for initiating formal licensing process with PNRA Stakeholders in the government Kept informed by PNRA on the status and progress through quarterly reports Media involvement PNRA media spokesperson Case to case basis WS | M2 | Application Set

THANK YOU WS | M2 | Application Set