Main Requirements on Different Stages of the Licensing Process for New Nuclear Facilities Module 4.1 Steps in the Licensing Process Geoff Vaughan University of Central Lancashire, UK Drafting School, Vienna, December Module 4.1 1

IAEA Safety Standards Specific Safety Guide Licensing Process for Nuclear Installations SSG-12 Drafting School, Vienna, December Module 4.1 2

This Safety Guide supplements and provides recommendations on meeting: IAEA Safety Standards Specific Safety Requirements Governmental, Legal and Regulatory Framework for Safety GSR Part 1 Drafting School, Vienna, December Module 4.5/1 3

In particular Requirement 7: Coordination of different authorities with responsibilities for safety within the regulatory framework for safety Where several authorities have responsibilities for safety … the government shall make provision for … effective coordination … to avoid any omissions or undue duplication and … conflicting requirements … Drafting School, Vienna, December Module 4.1 4

and Requirement 23: Authorization of facilities and activities by the regulatory body Authorization by the regulatory body, including specification of the conditions necessary for safety, shall be a prerequisite for all those facilities and activities that are not either explicitly exempted or approved by means of a notification process. Requirement 24: Demonstration of safety for the authorization of facilities and activities The applicant shall be required to submit an adequate demonstration of safety in support of an application for the authorization of a facility or an activity. Drafting School, Vienna, December Module 4.1 5

The Safety Guide describes the processes needed to meet legal and regulatory requirements for establishing a nuclear installation It identifies several stages in the licensing process over the lifecycle of the installation These stages may overlap Drafting School, Vienna, December Module 4.1 6

FIG. 1. Stages in the lifetime of a nuclear installation; the arrows indicate where hold points may be imposed. Drafting School, Vienna, December Module Siting and site evaluation Design Construction Commissioning Decommissioning Release from Regulatory control Operation These are indicative hold points and should not be taken as defining either the number or timing of actual hold points “Hold points” are where regulatory permission is needed to move to the next activity

Definitions (paragraphs 2.1 – 2.5) A licence is a legal document issued by the regulatory body granting authorization to create a nuclear installation and to perform specified activities. The authorization or licensing process, generally covers a particular stage of the lifetime of a nuclear installation. The terms ‘licence’, ‘authorization’ and ‘permit’ are considered to be synonymous; authorization may take different forms, such as certification, granting of a permit, agreement, consent, regulatory approval or granting of a similar regulatory instrument Drafting School, Vienna, December Module 4.1 8

BASIC LICENSING PRINCIPLES – 1 (paragraphs 2.6 – 2.22) The legal framework of the State should set out the responsibilities for issuing a licence or authorization and, in particular, determine who is empowered to issue licences or other authorizations. Depending on the system different authorizations may be issued by different authorities. The licensing process involves fulfilment of a set of regulatory requirements applicable to a nuclear installation and formal submissions by an applicant. Drafting School, Vienna, December Module 4.1 9

BASIC LICENSING PRINCIPLES – 2 (paragraphs 2.6 – 2.22) The licensing process should be understood by the parties concerned and should be predictable (i.e. well defined, clear, transparent and traceable). The licensing process should be established in a systemic way to facilitate efficient progression of regulatory activities. Procedures for issuing authorizations for each stage of the installation lifecycle should be prepared by the regulatory body, to ensure that all necessary steps have been taken prior to the granting of a licence. Drafting School, Vienna, December Module

BASIC LICENSING PRINCIPLES - 3 (paragraphs 2.6 – 2.22) The objective of granting authorizations in the licensing process is for the regulatory body to establish regulatory control over all activities and facilities in relation to safety. Once the initial licence has been issued, subsequent licensing process activities and arrangements should be undertaken between the licensee and the regulatory body. These will include requests for carrying out further activities, including, in some States, the construction of additional facilities on the site. Drafting School, Vienna, December Module

BASIC LICENSING PRINCIPLES - 4 (paragraphs 2.6 – 2.22) Licences may be granted: (a) For a specific time period or for a specific stage in the lifecycle of the nuclear installation. In such a cases, a mechanism is needed to ensure that the responsible organization remains responsible for safety, even if the licence has expired, unless the site has been removed from regulatory control. (b) For an indefinite period of time (a permanent licence), until the licence is officially terminated by the regulatory body. (c) For a specific activity or a specific condition of the nuclear installation (e.g. temporary storage of spent fuel). Drafting School, Vienna, December Module

BASIC LICENSING PRINCIPLES - 5 (paragraphs 2.6 – 2.22) Multi-installation sites pose particular problems: in developing a licensing process, consideration should be given to issues such as: Potential interactions between installations and whole-site events Installations at different stages of their lifetimes with authorizations or licences possibly having different licensing bases. Where different authorizations and licences are granted a process for keeping all of them consistent should be put in place. How to ensure a site-wide regulatory control process If several licensees share safety related features, arrangements are needed to ensure overall safety is not compromised. Drafting School, Vienna, December Module

BASIC LICENSING PRINCIPLES - 6 (paragraphs 2.6 – 2.22) Licence conditions are additional specific obligations with the force of law, which are specifically attached to a Licence. Licence conditions supplement general requirements or make them more precise, and should cover safety related aspects affecting the whole lifecycle to enable effective regulatory control at all stages. While licence conditions may vary in format, it is essential to ensure that they are consistent such that the fulfilment of one does not conflict with the fulfilment of another or with any other legal requirement. Drafting School, Vienna, December Module

BASIC LICENSING PRINCIPLES - 7 SSG-12 Paragraph 2.19 recommends Licensing Principles are established in the legal and regulatory framework. A list of suggested licensing principles is given: some of these need to have the force of law, others are good practices. Drafting School, Vienna, December Module It is suggested that before drafting licensing regulations and guidance, this list is considered and their position in law determined: if appropriate, additional principles may be added.

OBLIGATIONS, ROLES AND RESPONSIBILITIES OF THE REGULATORY BODY – 1 (paragraphs ) The requirements for application for a new licence should be published. The regulatory body should develop regulations for the licensing process of nuclear installations and should provide guidelines for applicants to provide clarity and transparency in the licensing process. The necessary competence and capability of the applicant should be set out to ensure the applicant will be able to manage the later phases of the project. Drafting School, Vienna, December Module

OBLIGATIONS, ROLES AND RESPONSIBILITIES OF THE REGULATORY BODY - 2 (paragraphs ) The minimum requirements for applying for a new licence include: (a) The name, address and contact information of the applicant; (b) The site for which the application is being made, if required; (c) The nature of the activity that the applicant wishes to undertake; (d) Details of any relevant existing licence; (e) Any environmental assessment report, required by national laws; (f) Information on ownership if by a person from another State or a foreign corporation. Drafting School, Vienna, December Module

OBLIGATIONS, ROLES AND RESPONSIBILITIES OF THE REGULATORY BODY - 3 (paragraphs ) The regulatory framework should empower the regulatory body to conduct reviews, assessments and inspections of: (a) The licensee’s evidence plans to meet regulatory requirements (b) The safety case for the nuclear installation and related activities; (c) The descriptions and claims in the documentation of the licensee; (d) The continued competence and capability of the licensee (and of its contractors and subcontractors) to make regulatory decisions and to grant, amend, suspend or revoke licences, conditions or authorizations, as appropriate. Drafting School, Vienna, December Module

OBLIGATIONS, ROLES AND RESPONSIBILITIES OF THE APPLICANT OR LICENSEE SSG – 12 sets out what the Applicant or Licensee must do in paragraphs 2.38 & 2.39 Providing guidance based on these paragraphs should be considered Drafting School, Vienna, December Module

MAIN CONTENTS OF A LICENCE SSG – 12, paragraph 2.40 sets out what should be considered for inclusion in a licence Internal regulatory guidance should include all these items (unless in other legislation or regulations) to ensure they are covered during the licensing process Consideration should be given as to whether some of these should also be in regulations NB see also paragraph 2.41 Drafting School, Vienna, December Module

PUBLIC PARTICIPATION SSG-12 recommends that the public should be given an opportunity to present their views during the licensing process Paragraphs 2.42 – 2.44 set out the processes should be considered Drafting School, Vienna, December Module A process for consideration and resolution of concerns should be established in national regulations and guides. (Paragraph 2.45)

Graded Approach (paragraphs 2.46 – 2.50) SSG-12 recommends that a graded approach is used by the regulatory body to determine the: scope, extent, level of detail and effort devoted to review, assessment and inspection, and the number of authorizations issued The main factor in applying the graded approach should be the magnitude of the risks associated with the activities performed at the nuclear installation. Drafting School, Vienna, December Module

SSG-12 lists “EXAMPLES OF DOCUMENTS TO BE SUBMITTED TO THE REGULATORY BODY” in an Appendix These will be considered under each specific lifecycle stage Other Safety Guides relevant to the Licensing Process include Drafting School, Vienna, December Module

IAEA Safety Standards Specific Safety Guide Review and Assessment of Nuclear Facilities by the Regulatory Body GS-G-1.2 Drafting School, Vienna, December Module

IAEA Safety Standards Specific Safety Guide Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body GS-G-1.3 Drafting School, Vienna, December Module

IAEA Safety Standards Specific Safety Guide Format and Content of the Safety Analysis Report for Nuclear Power Plants GS-G- 4.1 Drafting School, Vienna, December Module