1. 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.

2. 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

3. 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
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4. ORGANIZATIONAL STRUCTURE
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5. 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

6. 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

7. 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)
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8. 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
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9. 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 : 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
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10. LICENSING BASIS PNRA Ordinance
Regulations for licensing of nuclear installation(s)
other regulations and applicable codes and standards
Final Safety Analysis Report
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11. 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
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12. 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
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13. 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
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14. 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).
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15. 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.
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16. 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
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17. 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
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18. 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.
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19. 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
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20. 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.
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21. 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.
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22. 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.
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23. 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].
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24. 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
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25. 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.
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26. 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
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27. 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
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28. 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.
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29. 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
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30. 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
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31. 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
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32. 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)
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33. 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
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34. THANK YOU
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