1. “LICENSING PROCESS FOR NUCLEAR INSTALLATIONS IN PAKISTAN” Application Set

2. LEARNING OBJECTIVES
The key objectives of this lecture are to familiarize the workshop participants with the:
Different stages of the licensing process for nuclear installations
Submissions required during various licensing stages and the contents of major documents
Process of Amendment in Licence / Authorization
Regulatory Oversight during Licensing Process
Interface with licensee and its contractors/sub-contractors

3. INTRODUCTION
Section 19 of the Ordinance empowers PNRA to grant authorization, or issue licence for the
production, storage, disposal, trade in and use of any nuclear substance,
radioactive material or any other substance or equipment used for production or use of nuclear energy
Accordingly, PNRA issued “Regulations for Licensing of Nuclear Installation(s) in Pakistan-PAK/909”.
PAK/909 establishes licensing stages and submission requirements during various stages of the licensing process

4. DIFFERENT LICENSING STAGES
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

5. Submission Requirements for various licensing stages

6. 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 for reference and record.
On approval of SER, the site will be registered which will allow preparation of the site for construction of nuclear installation

7. CONTENTS OF SER Major contents of SER include:
Geography and demography
Man-made hazards (industrial, transportation, military, etc.)
Meteorology
Hydrologic Engineering
Geology
Seismology
Geotechnical Engineering

8. DESIGN AND SAFETY CRITERIA
After registration of the site, the applicant shall establish design and safety criteria comprising of a list of codes and standards to be followed in design such as
Requirements to be followed (regulations, IAEA nuclear safety standards, etc.)
Regulatory and safety guides (PNRA, IAEA, etc.)
Industrial codes and standards
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

9. CONSTRUCTION LICENCE
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)

10. CONTENTS OF SAR Introduction and general description of the plant
Site Characteristics
Design of SSCs
Reactor
Reactor Coolant System
Engineer Safety Features
Instrumentation & Control
Electrical Power
Auxiliary Systems
Steam and Power Conversion System
Radioactive Waste Management
Radiation Protection
Conduct of Operation
Initial Test Program
Accident Analysis
Technical Specifications
Quality Assurance
Human Factors Engineering
Severe Accident Analysis

11. CONTENTS OF PSA REPORT According to PNRA RG-911.01 Summary Report
Overview of the Study
Plant and Site Description
Identification of Radioactive Sources, Accident Initiators and Plant Response
Accident Sequence Modeling
Data assessment and parameter estimation
Accident Sequence Quantification
Display and Interpretation of Results

12. PERMISSION FOR COMMISSIONING
At least six months before the 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 approval of the commissioning program, the Authority (PNRA) may allow commissioning without introducing nuclear material into the system of the installation.

13. PERMISSION TO INTRODUCE NUCLEAR MATERIAL INTO THE INSTALLATION
The permission to introduce nuclear material into the system of the installation is subject to approval of the following documents:
Final Safety Analysis Report (FSAR);
Probabilistic Safety Analysis (PSA) Level-I full scope
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
Pre-Service Inspection/In-Service Inspection Program;
Quality Assurance Program for Operation; ;

14. PERMISSION TO INTRODUCE NUCLEAR MATERIAL INTO THE INSTALLATION
Programs for maintenance, testing, surveillance and inspection of structures, systems and components important to safety (for reference and record);
Fire Protection Program (for reference and record).
On approval of these documents and demonstration of :
implementation of Emergency Preparedness Plans in an exercise and
availability of required number of licensed/authorized operating personnel,
permission to introduce nuclear material into the systems of nuclear installation may be granted by PNRA to complete nuclear commissioning and subsequent operation until the issuance of Operating Licence.
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.

15. OPERATING LICENCE
Within six months after completion of the commissioning, the licensee shall apply for the Operating Licence and shall submit 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.
On acceptance of reports and results the Operating Licence may be issued subject to the availability of required number of licensed operating personnel.
The Operating Licence shall normally be valid for a period up to a maximum of ten (10) years.

16. 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 report 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).

17. LICENSING BEYOND DESIGN LIFE
In case the licensee intends to operate the nuclear installation beyond its design life he shall apply at least three (03) years before the end of design life along with the documents mentioned below:
Latest report of Periodic Safety Review (PSR);
Updates of all documents mentioned for fuel load permit.
On approval of these documents the Authority (PNRA) may grant licence to operate the nuclear installation beyond its design life for the duration requested in the application or as determined by the Authority (PNRA).

18. LICENCE FOR DECOMMISSIONING
Licensee shall apply for decommissioning at least three years before terminating the operation of the nuclear installation. The application shall accompany the 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].

19. 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 along with the following documents:
Decommissioning Completion Report and
Final Radiological Survey Report.
Upon satisfaction that no potential for radiation hazard exists for using the site for any other purposes, the site may be removed from the regulatory control of the Authority

20. AMENDMENT IN LICENCE/AUTHORIZATION
The holder of an authorization or a licence intending to incorporate a modification which may lead to changes in the existing design/licensing basis of the installation, shall submit an application accompanying
the documents fully describing the desired changes,
safety analysis and justification for the modification
parts of the revised safety analysis report.
Upon approval of the submissions, PNRA may amend the authorization/license. .

21. REGULATORY OVERSIGHT DURING LICENSING PROCESS
PNRA has established a well defined Regulatory Oversight Process which is implemented during different phases/stages of nuclear installation.
The documents submitted by licensee during different phases of nuclear installation are subjected to the process of review and assessment and results of these review & assessment are being followed-up, documented and recorded for regulatory compliance .
Similarly, inspection & enforcement are carried out to ensure compliance with the national regulations, licence and licensing conditions, and commitments made by the applicant/licensee for the safety of nuclear power plants.

22. INTERFACE WITH LICENSEE
Interaction between regulatory body and licensee / applicant is essential during licensing process to:
have common understanding on licensing requirements and process so as to reduce uncertainties;
agree on a tentative time frame for licensing activities and milestones (with provision for unforeseen reasons that may stretch the time frame;
sharing necessary information with each other;
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.

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

24. THANK YOU