1. IAEA Safety Guidance on Licensing and Oversight Activities
Luis Lederman
6-10 November, 2017
Morocco

2. Acknowledgement
This presentation was prepared with material kindly provided by the IAEA staff from the departments of Nuclear Energy and Nuclear Safety and Security.

3. Learning objectives In this lecture participants will learn about:
The relevant IAEA safety standards for licensing
The process of licensing for NPPs
The steps of licensing of NPPs
The stages of licensing of NPPs starting with the site license, construction, operation licenses until the installation is released from regulatory control

4. Content Definitions Objectives IAEA Standards
Licensing process principles
Licensing stages
Licensing Process
2016

5. 1. Definitions |1 (from IAEA Safety Glossary)
Authorization
The granting by a regulatory body or other governmental body of written permission for an operator to perform specified activities.
Approval
The granting of consent by a regulatory body. Typically used to represent any form of consent from the regulatory body that does not meet the definition of authorization
License (Permit, Certificate, Authorization…)
Legal document issued by the regulatory body granting authorization to create a nuclear installation or perform specified activities related to a facility or activity
The conditions attached to the licence may require that further, more specific, authorization or approval have to be obtained by the licensee before carrying out particular activities.
Licensing Process
2016

6. 1. Definitions |2 Licensing basis Applicant Licensee/Operator
A set of regulatory requirements applicable to a nuclear installation.
May also include agreements and commitments made between the regulatory body and the licensee (e.g. in the form of letters exchanged or of statements made in technical meetings)
Applicant
person or organization who applies for authorization
Licensee/Operator
The holder of a current license is termed a licensee, person or organization having the overall responsibility for a nuclear installation and its activities
Licensing process
includes all licensing and/or authorization required throughout the lifetime of a nuclear installation from siting to delicensing.
Also covers the preparatory activities by the applicant in order to submit a licensing request, as well as the regulatory activities.
Licensing Process
2016

7. Content Definitions Objectives IAEA Standards
Licensing process principles
Licensing stages
Licensing Process
2016

8. 2. Objectives (of licensing)
To ensure adequate demonstration of safety and compliance with legal and regulatory requirements
Authorization is issued when the RB is satisfied or convinced that there is adequate protection of the people and the environment
To establish regulatory control over all activities and facilities where nuclear safety is concerned
The regulatory authority may attach general and specific licensing conditions to any issued license or authorization
Licensing Process
2016

9. Content Definitions Objectives IAEA Standards
Licensing process principles
Licensing stages
Licensing Process
2016

10. 3. IAEA Standards
Licensing Process
2016

11. 3. IAEA Standards SF-1: Fundamental Safety Principles
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.
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.
GSR part 1: Governmental, Legal and Regulatory Framework for Safety
Requirement 23: Authorization of facilities and activities by the regulatory body
Requirement 24: Demonstration of safety for the authorization of facilities and activities.
Licensing Process
2016

12. 3. IAEA Standards Requirements 23 & 24
Prior to the granting of an authorization, the applicant shall be required to submit a safety assessment, which shall be reviewed and assessed by the regulatory body in accordance with clearly specified procedures
The regulatory body shall issue guidance on the format and content of the documents to be submitted by the applicant in support of an application for an authorization
Requirement 7: Coordination among different authorities
Where different authorities have responsibilities in the regulatory framework for safety, the government shall provide for the effective coordination of their regulatory functions, to avoid any omissions or undue duplication and to avoid conflicting requirements being placed on authorized parties
Licensing Process
2016

13. SSG-12 Licensing Process for Nuclear Installations
Highlights
Licensing principles should be established in the regulatory and legal framework
The regulatory body should develop regulations for the licensing process of nuclear installations and should provide guidelines for applicants in order to provide clarity and transparency in the licensing process
The regulatory framework should empower the regulatory body to conduct reviews, assessments and inspections to access applicant’s compliance to regulatory requirements
The regulatory framework should also empower the regulatory body to make regulatory decisions and to grant, amend, suspend or revoke licences, conditions or authorizations, as appropriate.
Licensing Process
2016

14. Content Definitions Objectives IAEA Standards
Licensing process principles
Licensing stages
Licensing Process
2016

15. Major steps of NPP licensing
Siting and site evaluation
Design
Construction
Commissioning
Operation
sub-steps may be defined
Decommissioning
Release
Licensing Process
2016

16. Role of the Regulatory Body
to establish regulations and guides, carry out review and assessment of the application, perform inspections and issue licenses. License conditions can be attached to any license, ensuring specific safety conditions. These conditions may be temporary or final
to ensure the licensee takes the responsibility for safety “Compliance with regulations and requirements does not relieve the licensee of its prime responsibility for safety”
to have enough competent and experienced staff and external technical support
to establish a mechanism to resolve safety issues with the applicant
Licensing Process
2016

17. Role of the Applicant To apply for a license or authorization:
To be familiar with the safety requirements
To carry out the necessary safety analyses in order to demonstrate the required level of safety of the nuclear installation
To carry out internal reviews and assessments before submitting any request for authorization
To prepare and submit the required documentation
To respond to the Regulatory Body’s requests
To comply with the regulations and licence conditions at any time
To take the prime responsibility for safety
Licensing Process
2016

18. Graded approach Fundamental Safety Principle 5 states that:
“the resource devoted to safety… have to be commensurate with the magnitude of the radiation risks”
Factors to be considered:
occupational doses, radioactive discharges and generation of radioactive waste
potential consequences of accidents
licensee maturity
operating experience
ageing issues
Graded approach also applies to the licensing process
e. g. number of authorizations, scope of the review and assessment, and inspections.
Licensing Process
2016

19. Content Definitions Objectives IAEA Standard
Licensing process principles
Licensing stages
Licensing Process
2016

20. Licensing stages
National licensing process should be tailored, considering:
SSG-12 guidance and other relevant IAEA Safety Standards
Regional requirements (e.g. European requirements)
National experience and background (newcomer or not)
Maturity of the NPP design
National arrangements, including legal and regulatory
International cooperation
Licensing Process

21. Different national approaches for authorization:
Siting
Design
Construction
Commissioning
Operation… BG
Siting permit
Design
permit
Construction
permit
Commission.
permit
Operating
permit
FIN
Construction licence
Operating licence FR
Construction licence
Commissioning authorisation
GER
1st
Partial Cl
2Nd
Partial Cl …
Nth
Partial Cl
1st Partial OL
2nd Partial OL UK
Nuclear Site Licence
USA
Early site permit
Combined Licence
Licensing Process

22. Siting and site evaluation
Licensing stages
Siting and site evaluation
Selection of one or more candidate 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
Before construction begins a formal decision should be issued
The RB should have the authority to accept or reject a proposed site on safety basis
Design
Construction
Commissioning
Operation
Decommissioning
Licensing Process
2016

23. Licensing stages Review and assessment of : Siting and site evaluation
Design
Construction
Commissioning
Operation
Decommissioning
Review and assessment of :
Adequacy of design parameters in relation to site characteristics
Application of defence-in-depth principle
Safety analyses and assumptions
Structures, systems and components important to safety
Limits, conditions and permitted operational states
Anticipated operational occurrences
Postulated initiating events for the safety analyses
List of features, barriers, design requirements, analytical methods and computer codes used in the safety analysis
Radioactive releases and radiation exposures in normal operation and fault conditions
Safety criteria for analyses of operator actions, common cause events, cross-link effects, single failure criterion, redundancy, diversity and separation
Considerations for the decommissioning
Licensing Process
2016

24. Licensing stages
Siting and site evaluation
The management system of the licensee and, as necessary, of the vendors and contractors
Construction in accordance with the relevant site parameters
Planned or unplanned deviations from the approved design
Industrial codes, standards, rules and regulations
Physical protection measures and fire protection in place
Radiological monitoring equipment and devices operational prior to radioactive material being brought to site
Design
Construction
Commissioning
Operation
Decommissioning
Licensing Process
2016

25. Licensing stages
Siting and site evaluation
Design
Construction
Commissioning
Operation
Decommissioning
Before the start of commissioning programme, the RB should conduct reviews, assessments and inspections to determine whether:
The commissioning test programme is complete and well defined operational limits, test acceptance criteria, conditions and procedures
The commissioning tests can be safely conducted as proposed by the licensee
Before allowing nuclear and/or radioactive materials to be brought onto the site, an adequate decommissioning and final disposal plan should be submitted to the RB and should include costs such as spent fuel and waste management and disposal
Licensing Process
2016

26. Licensing stages
Siting and site evaluation
Design
Construction
Commissioning
Operation
Decommissioning
Release
Commissioning tests and arrangements should demonstrate:
Readiness to operate the NPP safely
Preparedness for an emergency situation
Ability to safely manage wastes and effluents
During operation:
Management of installation modifications
Long-term shutdown
Carry on Periodic Safety Reviews
Licensing Process
2016

27. Licensing stages
Siting and site evaluation
Design
Construction
Commissioning
Operation
Decommissioning
Release
Demonstration that decommissioning is properly designed and will be implemented safely
The installation remains licensed throughout the decommissioning period
Release from Regulatory Control – Final stage
The release of a nuclear facility or a site from regulatory control requires, among others, completion of decontamination and dismantling and removal of all radioactive material, radioactive waste and contaminated components and structures
Licensing Process
2016

28. Thank you