1. Development of safety regulations and guides for nuclear power plants
Regulatory Control Training Workshop
Regulatory Cooperation Forum
Luis Lederman
7-11 November, 2016
IAEA, Vienna

2. Learning Objective
The aim of the lecture is to familiarize participants with the development of safety regulations and guides, including:
IAEA safety standards
Steps for the development, review and revision process
Involvement of interested parties
Milestones for prioritization
The purpose of this presentation is to introduce one of the main regulatory functions, namely “development of safety regulations and guides”, based on relevant IAEA Safety Standards.
This presentation will provide a background for the following presentations.

3. Process for development, review and revision of regulations and guides
Content
Learning Objective
Introduction
Process for development, review and revision of regulations and guides
Involvement of interested parties
Milestones for the prioritization
The purpose of this presentation is to give an overview of those functions.
Try to avoid detailed questions until these lectures

4. Introduction 1
Purpose of regulations is to establish mandatory safety requirements with which the licensee must comply to achieve the highest level of safety during all phases of the life of a nuclear installation.
Regulations specify the requirements that are considered by the regulatory body to be necessary for achieving and maintaining safety, and should cover all stages of the authorization process.
Regulations form the basis of regulatory decisions and actions and also provide a framework for more detailed conditions and requirements to be incorporated into individual authorizations.
Why we develop/produce regulations as the regulatory body? Because we should define safety requirements with which licensee must comply to achieve the highest level of safety during all phases of nuclear installation, which are mandatory in nature and form the basis of regulatory decisions and actions. And, this is one of our main duty as indicated in the previous slides. We are the only public authority to do that.
Regulations should specify the requirements that are considered by the regulatory body to be necessary for achieving and maintaining safety, and should cover all the major aspects to be dealt with at all stages of the authorization process
Regulations also provide a framework for more detailed conditions and requirements to be incorporated into individual authorizations.

5. Introduction 2
The regulatory body may also establish provisions in the form of guides to advise the licence of ways of meeting more general regulatory requirements. These guides are advisory, not obligatory, and the operator has the flexibility to propose other approaches to reach the intent of the regulations (requirements).
The regulatory body should establish a systematic process for developing the regulatory framework and of involving consultation with interested parties.

6. Introduction 3
Initially regulations may be adopted or adapted based on regulations of other experienced countries including the vendor countries and or IAEA Safety Standards
The regulatory body should establish a process for developing adopting, reviewing, revising or amending regulations and guides. These processes should involve consultation with interested parties in the development of the regulations and guides.
During phase 2, the regulatory body should also take into account prioritization in developing the safety regulations and implementing guides according to the sequence of activities to be carried out in different phases.
The regulatory body may require external technical support if competencies in certain areas are not available in the regulatory body.
In developing the regulations and regulatory guides, account may be taken of International standards, such as the IAEA safety standards which are technology neutral and developed through international consensus. Regulations and Guides developed by regulatory bodies of other advanced countries having experience of operating nuclear installations including the vendor county may also be adopted or adapted.

7. IAEA Safety Requirements
Requirement 32: The regulatory body shall establish or adopt regulations and guides to specify the principles, requirements and associated criteria for safety upon which its regulatory judgements, decisions and actions are based.
Requirement 33: Regulations and guides shall be reviewed and revised as necessary to keep them up to date, with due consideration given to relevant international safety standards, technical standards and of relevant experience.
Requirement 34: The regulatory body shall notify interested parties and the public of the principles and associated criteria for safety established in its regulations and guides, and shall make its regulations and guides available.
Requirement 2 of GSR Part 1 enlist the elements for the establishing a framework of safety within the country. It includes 19 elements in which one is “The authority and responsibility of the regulatory body for promulgating regulations and preparing the guidance for their implementation”.

8. IAEA Safety guidance for newcomers
IAEA Safety Guide SSG-16 recommends that:
Action 30:
The regulatory body should issue regulations and guides
specifying the documentation and procedures necessary in the various steps of the licensing process and inspections to be conducted”.
Action 31:
The regulatory body should specify the safety requirements that should be known for the bidding process or contract negotiations.
Action 36:
The regulatory body should ensure that a full and comprehensive set of regulations and guides is in place for regulating the construction, commissioning and operational activities at the appropriate time.

9. Sources of Information for development of SS
Standards and recommendations prepared by international organizations such as the IAEA, ICRP, ISO etc.
Regulations and guides produced by regulatory bodies of other countries
Industrial standards
Experience in the nuclear industry
Results of research in nuclear safety
First Source of Information:
The regulatory body should base its regulations and guides on national legislation and should utilize existing national regulations or industrial standards in areas relating to or adaptable to nuclear facilities as its initial sources of information.
Other sources of information includes the list mentioned above.
For States embarking on a nuclear power programme should consider adapting the IAEA Safety Standards or regulations developed by other States, or a combination of these. If regulations of other States, usually those of the State supplying a nuclear facility, are to be adapted, particular attention should be paid to the legal framework of that State.

10. Steps of the development process |1
A consistent procedure should be established for developing safety regulations and guides including the following basic steps:
Determining the need for developing a particular set of regulations
Setting the priority for issuing regulations according to activities related to different phases for installation of first nuclear power plant
Determining the scope depending upon the facility type and stage of the authorization process as well as the technical topic
Determining the resources including the available financial, technical, and human resources
The development and review of regulations and guides will require professional legal support which can be provided by staff of the regulatory body or by another governmental body, or it can be obtained by means of a contract.
The regulatory body should develop and follow a consistent procedure for establishing, reviewing, revising, issuing and revoking regulations and guides that details the general format and style of language to be used.
Generally, the procedure for establishing regulations and implementing guides should include the following basic steps:
Determining the need for developing a particular set of regulations which may arise from the regulatory body’s activities in relation to its functions and responsibilities prescribed by the national legislation.
Setting the priority for issuing regulations according to activities related to different phases of development of infrastructure for the first nuclear power plant.
Determining the scope of the proposed regulations including identification of the type of facility and the stage of the authorization process to be covered, as well as the technical topic to be addressed.
Determination of resources including the available financial, technical and human resources depending upon the time-scale for developing and issuing a particular set of regulations.

11. Steps of Development Process |2
Collecting the information necessary to prepare the proposed regulations
Initial drafting of the proposed regulation by the staff of the regulatory body, consultants or advisory committees.
Review of the initial draft by other staff of the regulatory body, including legal staff and special advisory committees or by the licensee, nuclear industry and general public.
Evaluation of comments which should be analysed, evaluated, resolved and finalized for incorporation.
Establishing and issuing the regulations which should be promulgated in a manner which makes them legally binding under the national legal system.
5. Collection of information necessary to prepare the proposed regulations.
6. Initial drafting of the proposed regulation either by the staff of the regulatory body, or by consultants and/or advisory committees.
7. Review of the initial draft by other staff of the regulatory body, including legal staff and special advisory committees or by the licensee, nuclear industry and other interested parties including general public.
8. Evaluation of comments received as the result of the review which should be analysed, evaluated, resolved and finalized for incorporation.
9. Establishing and issuing the regulations which should be promulgated in a manner which makes it legally binding under the national legal system.

12. Steps of Development Process |3
Step 1 - Determination of the need
Need for the establishment of regulations may arise from:
regulatory body’s activities in relation to its sets of responsibilities and functions
as a result of a request or enquiry by an operator or its contractors
as a result of national debates or to meet international obligations
new developments affecting nuclear safety and
introduction of new facilities or activities into the national system
issuance of a new or revisions in existing legislation
Establish advisory committees of experts of different fields to advice on the need of regulations and its technical contents and to ensure that policies and regulations are clear, practicable and complete
It may be useful for the regulatory body to establish advisory committees consist of experts of different fields to advice on the need of regulations and on their technical contents. A well founded committee can provide a valuable service to the regulatory body by helping to ensure that policies and regulations are clear, practicable and complete.
For more details on the composition of advisory committees please see IAEA safety guide GS-G-1.1 on Organization and Staffing of the RB for Nuclear Facilities.

13. Steps of Development Process |4
Step 2 - Setting the priority for development of the regulation
Regulations that could have an impact on the choice of technology should be established early in the process
Factors may be considered for setting the priority of the development of regulations
advantages and disadvantages of the proposed regulation
risks associated with the type of facility
need for improvements in safety
number of licensees to be affected
effect on the efficiency of the authorization process
Regulatory body should also take into consideration information from the feedback of experience and comments from interested parties (SSG16)
The states, those are starting nuclear programme, priority should be given to the establishment of regulations dealing with safety objectives, principles and criteria, in particular those relating to radiation protection (including dose limits). A range of engineering factors and also judgment or probabilistic safety assessments may contribute to setting priorities for topics to be covered by additional and more detailed regulations and guides.

14. Prioritization of site requirements
Action 161 recommends that the regulatory body should establish specific safety requirements for site evaluation, including requirements for the process for authorizing the site selected, in compliance with the relevant IAEA safety standards.
Safety objectives, principles and requirements applicable in the site evaluations are needed early in phase-2.
IAEA Requirements on Site Evaluation for nuclear Installations are contained in (NS-R-3) and the recommendations given in the relevant IAEA Safety Guides.
The licensing process by the regulatory body should be well defined to provide the operating organization with a clear indication of the stages and the requirements of the regulatory body’s intervention (for example, the review and approval process of the site evaluation report, issuance of a site permit).

15. Prioritization of design requirements
Action 174 recommends that the regulatory body should prepare and enact national safety regulations on design that are necessary for bid specification or contract negotiation. In phase 2, decisions that should be made typically include the type of nuclear power plant to be built, its main safety characteristics and the specification of any additional safety features that should be incorporated into the design. Design requirements are contained in the IAEA Requirements on Safety of Nuclear Power Plants Design (SSR-2/1) and the recommendations are given in the relevant IAEA Safety Guides.

16. Steps of Development Process |5
Step 3 - Determination of the scope of proposed regulations The scope of proposed regulations should be clearly defined and include the following factors:
identification of the type of facility to be regulated
stage of the authorization process to be covered and
technical topic to be addressed
Step 4 - Determination of the resources to be employed
Resources available
Time-scale for the preparation and establishment of regulations
These four steps should form the basis for a decision on whether or not to prepare the proposed regulation

17. Steps of Development Process |6
A positive decision should be followed by these additional steps:
Step 5 - Collection of information
The information necessary to prepare the proposed regulation should be collected
Step 6 - Drafting of the proposed regulations
The initial version of the proposed regulation may be drafted either by staff of the regulatory body, or by consultants or advisory committees

18. Steps of Development Process |7
Step 7 - Review of the proposed regulation
A formal procedure should be established to ensure that advice on the proposed regulations is obtained from all parties concerned
Although practices vary widely, the initial version of the proposed regulation is usually reviewed by: - other staff of the regulatory body, including legal staff and special advisory committees - Operators, nuclear industry organizations and other organizations - Public and other interested parties

19. Steps of Development Process |8
Step 8 – Evaluation of comments
Comments received as a result of the review should be analyzed, evaluated and resolved as appropriate
Consideration should also be given to the implications of the regulation for existing facilities
A final decision should be made by the regulatory body (with regard to the advice) before the regulation is finalized
Step 9 - Establishing and Issuing the regulation
Regulation should be established and promulgated in a manner which makes it legally binding under the national legal system
Ensuring that its provisions can be enforced by the regulatory body in a timely manner

20. Process for review and revision of regulations |1
Procedures for review of regulations and regulatory guides
Regulatory body should ensure the development of procedures for the periodic review and update of regulations and guides
Similar steps as followed for the preparation should be followed for the revision of regulations
Consideration should be given to the implications of the revision for existing facilities and activities;
Operators and others who may be affected by the revised regulation should be given adequate time to complete any preparations that may be necessary to enable them to comply with newly established requirements.
The effect of too frequent changes on the stability of the regulatory system should be taken into account
The regulatory body should ensure that regulations and guides are kept up to date, and procedures should be established for their periodic review. Experience in implementing the regulations should be examined, and any problems or difficulties which may have arisen should be duly considered. The status of applicable requirements should also be examined in the light of new developments in relation to nuclear safety. The effect of too frequent changes on the stability of the regulatory system should be taken into account. However, events may occur which necessitate more frequent revisions.

21. Process for review and revision |2
The reasons for revising regulations may include:
changes in legislation
changes in the organization, responsibilities, policies or procedures of the regulatory body
experience gained by the regulatory body in the authorization process
feedback from events, incidents and accidents
major modification or refurbishment of a facility
results from research and development in fields relevant to safety
technological advances
the need to improve or revoke impracticable, misleading, unenforceable or otherwise inadequate regulations

22. Involvement of Interested Parties |1
Interested Parties are those who have specific interest or concern in NPP Project, such as:
customers, owners, operators, employees, suppliers, partners, trade unions; the regulated industry or professionals;
scientific bodies; governmental agencies or regulators (local, regional and national) whose responsibilities may cover nuclear energy;
the public (individuals, community groups and interest groups);
the media; and
other States, especially neighbouring States that have entered into agreements providing for an exchange of information concerning possible transboundary impacts, or States involved in the export or import of certain technologies or materials.

23. Involvement of Interested Parties |2
it is generally acknowledged that involvement of the interested parties can enhance safety as well as the public confidence.
An important aspect of the involvement of Interested parties is to find out their real concerns and act upon them as appropriate.
in many countries, the means for involvement of interested parties in the regulation development process are defined by legislation.
the involvement of the interested parties in the process of the development of safety regulations is an IAEA requirement.

24. Involvement of Interested Parties |3
Requirement 34 of GSR Part-1 states that,
“The regulatory body shall notify interested parties and the public of the principles and associated criteria for safety established in its regulations and guides, and shall make its regulations and guides available”.
The government or the regulatory body shall establish, within the legal framework, processes for establishing or adopting, promoting and amending regulations and guides.
These processes shall involve consultation with interested parties in the development of the regulations and guides, with account taken of internationally agreed standards and the feedback of relevant experience.

25. Milestones for prioritization of regulations
Site evaluation
Radiation Protection
Licensing Process
Management system
WS3 | T4 | Core Set | Rev.0

26. THANK YOU