Nuclear Regulation

2014

The Characteristics of an
Effective Nuclear Regulator

NEA
Nuclear Regulation
NEA/CNRA/R(2014)3

The Characteristics of an Effective

Nuclear Regulator

© OECD 2014
NEA No. 7185

NUCLEAR ENERGY AGENCY

ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
 ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT

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economic, social and environmental challenges of globalisation. The OECD is also at the forefront of efforts
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provides a setting where governments can compare policy experiences, seek answers to common
problems, identify good practice and work to co-ordinate domestic and international policies.

The OECD member countries are: Australia, Austria, Belgium, Canada, Chile, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan,
Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal, the Republic of Korea, the
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This work is published on the responsibility of the Secretary-General of the OECD.

NUCLEAR ENERGY AGENCY

The OECD Nuclear Energy Agency (NEA) was established on 1 February 1958. Current NEA
membership consists of 31 countries: Australia, Austria, Belgium, Canada, the Czech Republic, Denmark,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Mexico, the
Netherlands, Norway, Poland, Portugal, the Republic of Korea, the Russian Federation, the Slovak Republic,
Slovenia, Spain, Sweden, Switzerland, Turkey, the United Kingdom and the United States. The European
Commission also takes part in the work of the Agency.

The mission of the NEA is:

– to assist its member countries in maintaining and further developing, through international
co-operation, the scientific, technological and legal bases required for a safe, environmentally
friendly and economical use of nuclear energy for peaceful purposes, as well as

– to provide authoritative assessments and to forge common understandings on key issues, as

input to government decisions on nuclear energy policy and to broader OECD policy analyses in
areas such as energy and sustainable development.

Specific areas of competence of the NEA include the safety and regulation of nuclear activities,
radioactive waste management, radiological protection, nuclear science, economic and technical analyses
of the nuclear fuel cycle, nuclear law and liability, and public information.

The NEA Data Bank provides nuclear data and computer program services for participating countries.
In these and related tasks, the NEA works in close collaboration with the International Atomic Energy
Agency in Vienna, with which it has a Co-operation Agreement, as well as with other international
organisations in the nuclear field.

This document and any map included herein are without prejudice to the status of or sovereignty over any
territory, to the delimitation of international frontiers and boundaries and to the name of any territory,
city or area.

Corrigenda to OECD publications may be found online at: www.oecd.org/publishing/corrigenda.

© OECD 2014

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Cover photo: Oskarshamn Nuclear Power Plant, Sweden (Jann Lipka)

 FOREWORD

Foreword

The Committee on Nuclear Regulatory Activities (CNRA) of the OECD Nuclear

Energy Agency (NEA) is an international body made up of senior representatives
from nuclear regulatory authorities. The committee guides the NEA programme
concerning the regulation, licensing and inspection of nuclear installations with
respect to safety. It acts as a forum for exchange of information and experience,
and for review of developments which could affect regulatory requirements.
The CNRA has produced a series of regulatory guidance reports, known as
“green booklets”, which are prepared and reviewed by senior regulators and
provide a unique resource on key nuclear regulatory issues. The booklets examine
various regulatory challenges and address the major elements and contemporary
issues of a nuclear safety regime.
Following a special topical discussion held on the characteristics of an effective
regulator at the 27th CNRA meeting on 4-5 June 2012 [1] and subsequent
discussions at the 28th CNRA meeting on 3-4 December 2012 [2], the CNRA decided
that a “green booklet” on The Characteristics of an Effective Nuclear Regulator would be
a timely and appropriate addition to this resource on key contemporary nuclear
regulatory issues. A senior-level task group (STG) was therefore established with
the remit to prepare a regulatory guidance report on the characteristics of an
effective nuclear regulator.
Although the audience for this report is primarily nuclear regulatory bodies,
the information is also expected to be of interest to other stakeholders and to the
nuclear industry. The CNRA believes it should also be of use to countries that are
looking to begin a nuclear energy programme but have yet to develop well-
established regulatory regimes. The CNRA encourages established regulatory
bodies to use this report as a benchmark, and to continually strive to enhance their
effectiveness as they fulfil their mission to protect public health and ensure
nuclear safety.
This report has been prepared by the CNRA STG on the Characteristics of an
Effective Regulator and is based on discussions and input from members of the
group as well as information from a wide array of documents produced by the NEA,
its member countries and other international organisations.
Michael Cheok (United States) chaired the meetings and the work of the
STG. The members of the group were An Wertelaers (Belgium), Robert Lojk
(Canada), Miguel Santini (Canada), Kirsi Alm-Lytz (Finland), Anne-Cécile Rigail
(France), Kai-Jochen Weidenbruck (Germany), Gisela Stoppa (Germany), Roberto
Rainieri (Italy), Masahiro Aoki (Japan), Victor M. Gonzalez-Mercado (Mexico),

THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014 3
FOREWORD

Mikhail Miroshnichenko (Russian Federation), Nikolay Kuznetsov (Russian

Federation), Evgeny Kudryavtsev (Russian Federation), Rafael Cid (Spain), Anna
Franzen (Sweden), Lars Skanberg (Sweden), Steve Gibson (United Kingdom),
Mina Golshan (United Kingdom), Michael Cheok (United States), Adriana Nicic
(International Atomic Energy Agency), Nancy Salgado (OECD Nuclear Energy
Agency) and Len Creswell (OECD/NEA Consultant).

4 THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014
 TABLE OF CONTENTS

Table of contents

Foreword .............................................................................................................................. 3
1. Executive summary........................................................................................................ 7
2. Nuclear regulatory roles and responsibilities ........................................................... 9
Purpose of the regulator ................................................................................................. 9
Regulatory framework and mandate ............................................................................ 9
Regulatory activities and functions ............................................................................ 10
Implementation strategy ............................................................................................. 10
3. Principles for an effective nuclear regulator ............................................................ 13
Safety focus and safety culture ................................................................................... 13
Independence ................................................................................................................ 14
Competence ................................................................................................................... 15
Openness and transparency ........................................................................................ 15
4. Attributes of an effective nuclear regulator ............................................................. 17
Clear and consistent regulation .................................................................................. 17
Consistent and balanced decision making ................................................................ 17
Accountability................................................................................................................ 18
Strong organisational capability ................................................................................. 18
Continuous improvement, peer review and international involvement .............. 19
Efficiency ........................................................................................................................ 20
Credibility, trust and respect ....................................................................................... 20
5. Conclusions and recommendations ......................................................................... 21
6. References ...................................................................................................................... 23
Appendix 1......................................................................................................................... 25
Summary description of regulatory approaches and strategies ............................. 25
Appendix 2......................................................................................................................... 29
Complete list of the CNRA series of regulatory guidance reports (green booklets) .... 29

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 EXECUTIVE SUMMARY

1. Executive summary

Both national and international organisations agree that the fundamental

objective of all nuclear safety regulatory bodies – the regulator’s prime purpose – is
to ensure that nuclear licensees operate their facilities at all times in a safe
manner. In order to effectively achieve this objective, the nuclear safety regulator
requires specific characteristics that will allow it “to do the right thing well and
efficiently”.
Much has been written about ways to improve regulatory processes or to improve
the effectiveness of a regulatory body, including in previous NEA regulatory guidance
booklets [3] or in International Atomic Energy Agency (IAEA) publications [4]. However,
since no report has been dedicated to the topic of the characteristics of an effective
nuclear safety regulator, the CNRA decided that a “green booklet” on the subject
would be a timely and appropriate addition to the series. (See Appendix 2 for a full
list of NEA regulatory guidance booklets.)
Effective organisations are those that have good leadership and are able to
transform strategic direction into operational programmes. Effectiveness is about
how well the organisation is achieving its fundamental purpose – in the case of a
nuclear safety regulator, ensuring that licensees operate their facilities and
discharge their obligations in a safe manner.
This report describes the characteristics of an effective nuclear safety regulator
in terms of roles and responsibilities, principles and attributes. For the purpose of
this report, the following definitions are used:
• Principles
– Fundamental primary and accepted rules or the basis of conduct from
which all actions are derived.
• Attributes
– Qualities that identify or describe an organisation that results from the
actions of the organisation.
Each of the characteristics discussed in this report is a necessary feature of an
effective nuclear safety regulator but no one characteristic is sufficient on its own.
It is the combination of these characteristics – the roles and responsibilities, the
principles and the attributes – that leads to the effectiveness of a nuclear
regulatory body.
In summary, an effective nuclear regulator:
• is clear about its regulatory roles and responsibilities, its purpose, mandate
and functions;

THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014 7
EXECUTIVE SUMMARY

• has public safety as its primary focus;

• has independence in regulatory decision making from any undue influence
on the part of the nuclear industry and those sectors of government that
sponsor this industry;
• has technical competence at its core, with other competencies built upon
this fundamental and essential requirement;
• is open and transparent in its regulations and decisions;
• has a regulatory framework and requirements that are clear and easily
understood by all stakeholders;
• makes clear, balanced and unbiased decisions, and is accountable for those
decisions;
• has a strong organisational capability in terms of adequate resources,
strong leadership and robust management systems;
• performs its regulatory functions in a timely and efficient manner;
• has and encourages a continuous self-improvement and learning culture,
including the willingness to subject itself to independent peer reviews.
A regulator with the above characteristics should be effective in ensuring that
nuclear facilities are operated at all times in a safe manner, in accordance with
international safety principles and with full respect of the environment.
This regulatory guidance booklet on the characteristics of an effective nuclear
regulator provides a unique resource to countries with existing, mature regulators
and can be used for benchmarking as well as training and developing staff. It will
also be useful for new entrant countries in the process of developing and
maintaining an effective nuclear safety regulator.

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 NUCLEAR REGULATORY ROLES AND RESPONSIBILITIES

2. Nuclear regulatory roles and responsibilities

Individuals working within an effective regulatory body need to have clarity of

purpose and a consistent view of what the organisation is focused on achieving
and why.

Purpose of the regulator

The fundamental objective of all national nuclear safety regulatory bodies is to

ensure that, within their countries, activities related to the peaceful use of nuclear
energy are carried out in a safe manner, in accordance with international safety
principles and with full respect of the environment.
This is reflected in the mission statements of regulators around the world,
which generally promote their roles in protecting workers, patients, the public and
the environment against the risks to safety and security related to nuclear
activities and in respecting international accords.
It is important to emphasise that, although the mission of the regulatory body
is to provide oversight on nuclear safety, the prime responsibility for the safety of a
nuclear installation has to remain with the licensee or plant operator.

Regulatory framework and mandate

National parliaments or governments provide the overarching legislation creating

and mandating regulatory bodies to discharge their responsibilities in ensuring
that the health and safety of people and the environment are protected.
The scope and the kind of facilities and activities under the regulator’s
supervision vary from one country to another, according to the mandate given by
the national regulations.
Within this mandate, regulators have key roles in the development of a
regulatory framework, overseeing nuclear safety and radiological protection, and
in emergency management.
Regarding emergency management, regulatory bodies may have the
responsibility for helping to co-ordinate national and international emergency
management programmes, as well as ensuring that licensees/operators have
adequate plans, training, programmes and resources in place to deal with
postulated and potential emergencies and events.

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NUCLEAR REGULATORY ROLES AND RESPONSIBILITIES

Regulatory activities and functions

In order to ensure that the licensees properly discharge their responsibility, the
regulators must carry out the following activities [3]:
• define safety objectives;
• develop or propose and promulgate regulations;
• set standards and issue regulatory guides;
• issue or advise on the issuing of licences and amendments;
• carry out inspections;
• undertake regulatory reviews;
• enforce regulatory requirements;
• review operating experience;
• observe attitudes to safety;
• carry out independent safety analyses;
• sponsor safety research;
• contribute to emergency preparedness and response;
• interact with stakeholders and inform the public on radiation protection
and nuclear safety;
• interact with the international community.
Regulatory bodies should have an integrated management system that ensures
that the above activities are carried out efficiently.

Implementation strategy

The activities of a regulatory body must be carried out in accordance with national
laws and through a robust regulatory framework. In order to ensure that regulatory
activities are commensurate with the importance of the safety issues, a graded
approach should be applied. This should be a consistent, transparent and objective
process which is understood by stakeholders. Such regulatory processes require
the insight from experienced staff who have an understanding of nuclear safety
(including radiological protection). The regulatory body should consider the
opinions of stakeholders and have an understanding of the impact of the
regulatory activities on society.
The regulator may consider the use of various regulatory approaches [5]. These
include prescriptive, case and facility based, outcome based, risk and hazard
informed, process based, self-assessment based and education/influence-based.
Appendix 1 to this document provides a summary description of these approaches.

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 NUCLEAR REGULATORY ROLES AND RESPONSIBILITIES

Regulatory supervision is an iterative and dynamic process that uses

combinations of approaches as tools to address the inherent complexity of the
facilities being regulated. The effectiveness and efficiency of any approach are tied
to its suitability to the specific features of the case. Therefore, the regulator should
consider the appropriate approaches to be used depending on the specific case,
including the safety significance of the issue, characteristics of the industry, the
use of contractors, the level of trust in the licensee/regulator relationship, the type
of communication or interaction between the regulatory body and licensee and the
experience and competence of the licensee and the regulator.

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 PRINCIPLES FOR AN EFFECTIVE NUCLEAR REGULATOR

3. Principles for an effective nuclear regulator

The following principles are the fundamental primary and accepted rules or the
basis of conduct from which all regulatory body actions should be derived.

Safety focus and safety culture

A regulatory body must have public safety as its primary focus. In addition, a
robust and strong safety culture is important for regulatory bodies. This culture
must encompass individual staff members, leaders and the organisation as a
whole [3a]. INSAG-4 [6] was originally written for operators but the concepts apply
equally well to regulatory bodies. It defines safety culture as follows: “Safety
culture is that assembly of characteristics and attitudes in organisations and
individuals which establishes that, as an overriding priority, nuclear plant safety
issues receive the attention warranted by their significance”.
The regulatory body’s safety culture starts at the highest level in the
organisation and includes the following individual and organisational characteristics
(summarised from [3a, 6] and various safety culture charters from existing regulatory
bodies, e.g. [7], and other organisations):
• The expected safety culture within the regulator is clear and promotes the
highest level of safety consciousness in the organisation.
• Leaders demonstrate a commitment to safety in their decisions and
behaviours.
• All individuals take personal responsibility for safety, hold themselves
personally accountable and demonstrate strong values and ethics. Their
personal accountabilities are clear.
• Issues potentially impacting safety are identified, evaluated, and addressed
in a timely manner.
• Continuous learning opportunities to ensure safety are sought out and
implemented.
• Individuals feel free to raise safety concerns without fear of retaliation,
intimidation, harassment, or discrimination.
• Communications are effective and maintain a focus on safety.
• Trust and respect permeate the organisation.
• Individuals have a questioning attitude and avoid complacency with
respect to existing conditions and activities.

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PRINCIPLES FOR AN EFFECTIVE NUCLEAR REGULATOR

Independence

The basic requirements for regulatory body independence are set out in GSR-Part 1
Requirement 4 [8] and in Article 8 of the Convention on Nuclear Safety [9].
According to these texts, the function of the regulatory body shall be effectively
separated from those of any other body or organisation concerned with the
promotion or utilisation of nuclear energy or having other interests. Functional
separation forms the background and the conditions for independent regulatory
decision making without undue influence. This includes making and being seen to
make independent, clear, balanced and unbiased regulatory decisions.
Due to the ultimate responsibility for nuclear safety on the part of the
government in each member country, the regulatory body is not entirely separate
from the government [10, 11]. Based on its constitution and organisation of
government, each country sets up the regulatory and legislative framework
recognising that the regulatory body needs sufficient authority. Within this
framework it is fundamental to ensure that the regulatory body is able to perform its
functions for ensuring safety. Sufficient authority is needed to avoid any conflict of
interests regardless of the regulatory body’s functional separation from government
or parts of the government. Such independence enables a regulator to take, when
appropriate, strong decisions, such as requiring the closure of an unsafe facility. This
independence requires a strong supporting legal framework, including decision
making and enforcement capabilities, as well as transparent and active relations
with government, parliament and stakeholders.
Independence does not mean isolation – the regulator needs to have frequent
open discussions with all of its stakeholders at all times and remain accountable to
them for its actions and its decisions.
In order to ensure that the regulatory body is effectively independent from
undue influence in its decision making, several elements are of utmost importance.
These elements include:
• Political independence
– Authorised and being able to make independent regulatory judgments
and regulatory decisions within their field of competence for routine
work and in crisis situations.
– Ability to take regulatory decisions and enforcement measures founded
on objective safety-related requirements.
– Empowered to give independent advice to government departments and
governmental bodies on matters relating to the safety of facilities and
activities.
• Financial independence
– Provided with sufficient financial resources, reliable funding and staffing
for the proper and timely discharge of its assigned responsibilities.
– Provided with a clearly defined financing mechanism and budget
allocation process within the national framework.

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 PRINCIPLES FOR AN EFFECTIVE NUCLEAR REGULATOR

• Technical independence
– Possess technical and scientific competence and the capacity to make
independent decisions.
– Has access to independent scientific and technical support.

Competence

Core technical competency and experience are the basis of an effective regulatory
body. As discussed in other sections of this report, competence is the foundation of
many of the other characteristics of an effective regulator such as independence,
transparency, credibility and trust.
The organisation’s technical competency is a necessary and fundamental
condition but not sufficient in itself. Other complementary competencies need to
be built upon it. Relevant competencies include knowledge of organisational and
human factors, legal competence and core regulatory competence. The
competency and skills for effectively exercising legal enforcement are also key
elements for the decisions of the regulatory body so that these decisions have the
intended impact on the level of safety.
In order to be an effective, credible and trusted regulatory body, the regulator
must be able to explain its requirements and expectations to the licensees and
other stakeholders in a clear and understandable manner. The regulator must also
be able to independently justify or verify technical, regulatory and legal
information when there is a need to do so.
The regulatory body must have available facilities and the means to maintain
and develop the technical and regulatory skills of both new and present staff. The
training programmes must cover relevant areas so that technical, organisational
and human factors and regulatory competencies can be maintained and improved.

Openness and transparency

Openness and transparency means adopting a policy of disclosure of information

and of stakeholder involvement and ensuring the public are informed about the
regulatory processes.
Appropriate stakeholder involvement within decision-making processes
provides the opportunity to obtain a broader basis for decisions which can also
contribute to the regulatory body’s improved credibility in society. In considering
stakeholder input, the regulatory body should be seen by the public as a competent,
professional and independent body that makes timely decisions ensuring the
required level of safety and protection of the environment.
Key outputs of the policy on disclosure of information are publishing safety
information and the appropriate annual reports and results that would be of
interest to stakeholders. Information concerning incidents and events at nuclear
facilities, their safety relevance and regulatory measures should be made

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PRINCIPLES FOR AN EFFECTIVE NUCLEAR REGULATOR

publically available. Communications should be clear to the public and other

competent authorities.
Availability of information and transparency of regulatory activities and
reporting on regulatory decisions can lead to increased public confidence that
decisions are underpinned by robust criteria and processes.

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 ATTRIBUTES OF AN EFFECTIVE NUCLEAR REGULATOR

4. Attributes of an effective nuclear regulator

Attributes are the qualities that identify or describe an organisation that result
from or are caused by the actions of the organisation.

Clear and consistent regulation

Laws, regulations, guides and licence conditions provide the framework for
regulatory requirements. These requirements need to be kept clear, consistent,
and comprehensive with predictable implications.
Regulations vary among member countries depending on the regulatory
approach and national practices and requirements. However, most regulators
recognise the value and importance of issuing regulatory guides to provide more
detail to explain the regulatory objectives, and thus the expectations for different
facilities, phases of operation, etc. The legal status of such regulatory guides must
be clear and the extent to which they will be used to measure safety achievements
should be made clear to all stakeholders, especially the operators.
Moreover, to maintain the regulations up-to-date, technological advances,
research and development, relevant operational lessons learnt and institutional
knowledge, in addition to well-established standards and endorsed practices, are
valuable in reviewing and revising the regulations and guides.
In summary, regulatory requirements and guides should:
• have a clear legal/legislative basis and status;
• be readily understood, coherent and logical;
• have a clear connection with the regulatory body’s goals and objectives;
• be benchmarked against the state of the art in science and technology, for
example, internationally and regionally recognised expectations and
requirements (e.g. OECD/NEA guidance, IAEA Nuclear Safety Fundamentals
and Standards, WENRA reference levels).

Consistent and balanced decision making

Effective regulatory processes ensure the stability and consistency of regulatory

control and prevent subjectivity in decision making by the individual staff
members of the regulatory body. The regulatory body should strive to ensure that
its regulatory decisions are technically sound, consistent from case to case,
pragmatic and commensurate with the risk, and timely and just. The regulator

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ATTRIBUTES OF AN EFFECTIVE NUCLEAR REGULATOR

should make sure that its decisions are balanced and transparent, have a clear
basis in law and regulations, are based on facts and scientific grounds, and are
viewed by impartial observers as being fair to all parties. It is very important that
the regulatory body be able to justify its decisions.
The regulator should be sensitive to the need to maintain consistency in its
decisions. That is, when faced with similar safety issues and similar circumstances,
the regulator should render similar decisions or clearly explain why a different
decision was made. A good way to promote balanced and consistent decision
making is to have clear criteria and to maintain transparency – that is, being open
in publishing the decisions in terms of how these decisions were arrived at and
their implications.

Accountability

National regulatory bodies are accountable to national parliaments/

governments and the public. The regulatory body must have the capacity, ability
and willingness to make considerate and well-informed decisions that are
supported by evidence. The regulator should be able to explain their decisions and
actions, either to licensees or to other stakeholders, and be able to withstand
challenges to those decisions.

Strong organisational capability

The regulatory body should be structured in a way so that good practices are
employed, and that the managers have appropriate spans of control, with
appropriate authority and responsibility at the various levels of the organisation.
Attributes that characterise a capable and strong organisation include sufficient
financial resources, competence in all areas of importance for nuclear safety and
radiation protection and an effective management system.
Management system
The regulatory body’s management system should [8]:
• ensure that the responsibilities assigned to it are properly discharged;
• maintain and improve its performance;
• foster and support a safety culture in the regulatory body.
The management system should consist of processes and internal guides that
support staff when they execute their regulatory work. These include inspections,
reviews and assessments, licensing, enforcement and developing or proposing
regulations. The internal guides should be followed to ensure a systematic and
consistent approach to regulatory processes while allowing sufficient flexibility for
staff to take the initiative when dealing with new concerns that arise. The
management system should also have provision to monitor and improve the
processes.

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 ATTRIBUTES OF AN EFFECTIVE NUCLEAR REGULATOR

Leadership
A vital role of all regulatory body’s senior leaders is to give the organisation and
the staff clarity of purpose i.e. a clear and consistent view of what the organisation
is trying to achieve and why. That purpose is generally agreed by the international
nuclear safety community to be about ensuring that nuclear activities are carried
out in a safe manner.
All leaders within the regulatory body should serve as role models for the
activities of the regulator, both internally and externally. Leaders should
demonstrate a commitment to safety and safety culture in their decisions and
behaviours and be capable of dealing with issues from the licensees, with
demands from the general public and communicating with media. The leaders are
also responsible for ensuring that activities are conducted effectively, efficiently
and in alignment with the mission and objectives of the regulatory body.
In addition to these aspects, they should be good supervisors who are not only
expected to manage the operations, but to improve them as well. Training
programmes for supervisors should be available so that supervisors can provide
staff with the assistance and support needed to deal with complicated issues.
Staffing
The regulatory body needs sufficient and qualified staff in all areas, and access to
suitable technical and scientific support. A technical support organisation (TSO)
can provide technical and scientific support. The regulator should maintain
supervision over assistance from external experts and be an intelligent customer
capable of properly understanding and independently evaluating the expert advice.

Continuous improvement, peer review and international involvement

The regulatory body should establish appropriate governance within the

management system to monitor performance and effectiveness of regulatory
strategies and to embrace a culture of continuous improvement. Such arrangements
should include processes for self-assessments, management reviews, internal audits
and independent reviews. Data should be evaluated to determine the robustness of
regulatory activities and decisions. Appropriate operational experience feedback
should be used to inform and improve the regulatory strategy. Examples of
frameworks developed for evaluating performance within regulatory bodies can be
found in projects led by the CNRA [3a].
Peer reviews are important to enhance the effectiveness and the independence
of a regulatory body and to promote continuous improvement. These should be
performed at appropriate intervals. In conducting these reviews, the peers accept a
joint mandate for review in order to identify good practices and areas for
improvement, and the hosting country sets up an action plan to respond to the
findings.
A commitment of the NEA member countries to implement peer review
processes of their own activities as well as to engage in international peer reviews

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ATTRIBUTES OF AN EFFECTIVE NUCLEAR REGULATOR

is an important step forward to ensure continuous improvement of nuclear safety

and improvement of the effectiveness of regulatory bodies.
The NEA CNRA acts as a forum for exchange of information and experience,
and for review of developments which could affect regulatory requirements. Closer
global harmonisation of approaches to the application and implementation of
safety requirements through peer evaluations and discussions is a goal that many
organisations are actively pursuing.

Efficiency

Regulatory effectiveness is about ensuring that nuclear facilities are operated

safely. Regulatory efficiency is about doing this work right and with good
governance [3b]. Efficient regulators make sound use of their resources.
Regulatory bodies may use various combinations of regulatory approaches and
strategies to carry out their responsibilities in the most efficient way possible
(Appendix 1).
In general, within the regulatory framework, an efficient and effective
regulator would require the operator to provide justified solutions to safety issues.
The regulator then checks if these proposed solutions are acceptable, thus
ensuring that the prime responsibility for the safety remains with the operator.
As an element of efficiency, regulatory decisions should be made without
unnecessary delays. However, in all cases, expediency must not come at the
expense of safety and striving for efficiency should not harm the effectiveness
objective.

Credibility, trust and respect

Credibility, trust and respect are universally seen to be desirable attributes that a
regulatory body should possess. However, unlike some of the other attributes
discussed above, credibility, trust and respect are more subjective and are
outcomes that can only be achieved if the regulatory body is considered to be
effective and possesses the characteristics described in this report. That is,
credibility, trust and respect are attributes that result from or are caused by the
actions of an effective regulatory body.

20 THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014
 CONCLUSIONS AND RECOMMENDATIONS

5. Conclusions and recommendations

Each of the characteristics discussed in this report is a necessary feature of an

effective regulator but no one characteristic is sufficient on its own. It is the
combination of the characteristics – the roles and responsibilities, the principles
and the attributes – that leads to the effectiveness of a regulatory body.
Much of what is discussed in this booklet represents cultural and behavioural
aspects of a regulatory body as well as those that are statutory and process-driven.
The regulatory body should have an appropriate and deeply established safety
culture that supports all aspects of The Characteristics of an Effective Nuclear Regulator,
a culture that is driven and led from the top of the organisation and reflected and
reinforced at all levels within the regulatory body.
Individuals within an effective regulatory body should have clarity of purpose
and a clear and consistent view of what the organisation is trying to achieve and
why. This purpose is generally agreed by the international nuclear safety
community to be about ensuring that nuclear activities are carried out in a safe
manner, in accordance with international safety principles on the peaceful use of
nuclear energy with full respect of the environment. However, it is important to
underline that the licensee or the operator has the prime responsibility for safety
at all times.
Independence from any undue influence on the part of the nuclear industry
and those sectors of government that sponsor this industry is vital to an effective
regulator. This functional separation forms the background and the conditions for
independent regulatory decision making. It includes making, and being perceived
as making, independent, clear, balanced and unbiased regulatory decisions.
Independence does not mean isolation – the regulator needs to have frequent and
open discussions with all of its stakeholders and remain accountable to them for
its actions and its decisions.
Core technical competency and experience are the basis of an effective
regulatory body. The organisation’s technical competency is a necessary condition
but not sufficient in itself. Other complementary competencies need to be built
upon this technical competency, such as knowledge of organisational and human
factors, as well as legal and core regulatory competencies.
Openness and transparency are seen as fundamental to a regulatory body in
achieving and maintaining credibility, trust and respect.
The organisation should have a regulatory framework and requirements that
are clear and easily understood by all stakeholders. These should be coherent and
logical and have a clear connection with the regulatory body’s goals and objectives.

THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014 21
CONCLUSIONS AND RECOMMENDATIONS

An effective regulatory body should have strong organisational capacity,

demonstrate leadership and have in place management systems, sufficient
resources and extensive staffing, as well as access to scientific and technical
support.
The organisation should use its resources and make its decisions in an efficient
and a timely manner. However, expediency must not come at the expense of
safety and striving for efficiency should not harm the effectiveness objective.
Continuous improvements, international activities, co-operation and peer
review are closely interlinked and are seen as another set of necessary
characteristics of an effective regulator, as is an environment of continuous
learning to maintain competence and credibility.
The above technical, cultural and behavioural competencies are necessary for
effective regulation. These competencies support balanced and unbiased decision
making that is commensurate with the risk and cost to people and to society, and
they enable the safe operations of nuclear facilities. Such competencies are
reflected in people with experience who can formulate and communicate clear
judgments and who can resist any pressure that could compromise safety.
A regulator with the above characteristics should be capable of effectively and
efficiently discharging its prime purpose of ensuring that the nuclear industry
operates its facilities at all times in a safe manner, in accordance with
international safety principles and with full respect of the environment.
The NEA Committee on Nuclear Regulatory Activities (CNRA) considers that
this regulatory guidance booklet on the characteristics of an effective nuclear
regulator provides a unique resource to countries with existing, mature regulators
and can be used for benchmarking as well as training and developing staff. It will
also be useful for new entrant countries in the process of developing and
maintaining an effective nuclear safety regulator.

22 THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014
 REFERENCES

6. References

[1] OECD/NEA (2012), Summary record of the 27th CNRA meeting

NEA/SEN/NRA(2012)3, Paris.
www.oecd-nea.org/documents/2012/nra/sen-nra2012-3.pdf
[2] OECD/NEA (2013), Summary record of the 28th CNRA meeting
NEA/SEN/NRA(2013)1, Paris.
www.oecd-nea.org/documents/2013/nra/sen-nra2013-1.pdf
[3] OECD/NEA, Committee on Nuclear Regulatory Activities, CNRA Regulatory
Guidance Booklets (green booklets).
a. 2005 Nuclear Regulatory Decision Making
www.oecd-nea.org/nsd/reports/2005/nea5356-decision.pdf
b. 1999 The Role of the Nuclear Regulator in Promoting and Evaluating Safety
Culture
www.oecd-nea.org/nsd/reports/nea1547-Murley.pdf
[4] IAEA (2006), Fundamental Safety Principles, No. SF-1 (Principle 2: Role of
Government (3.8-3.11)), Vienna.
[5] Strål Säkerhets Myndighethen (2013), (Swedish Radiation Safety Authority)
(SSM) Regulatory Approaches in Nuclear Power Supervision, SSM Report 2013:29,
Second study report, Stockholm.
[6] IAEA (1991), Safety Series No. 75-INSAG-4, Safety Culture: A report by the
International Nuclear Safety Group (INSAG), Vienna.
[7] Nuclear Regulatory Commission (2011), Final Safety Culture Policy Statement,
NRC–2010–0282, www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-14656.pdf,
Washington.
[8] IAEA (2010), General Safety Requirements Part 1, Governmental, Legal and
Regulatory Framework for Safety, IAEA Safety Standards, Vienna.
[9] IAEA (1994), The Convention on Nuclear Safety, Vienna.
[10] OECD/NEA (1960), The Paris Convention on Nuclear Third Party Liability, and
amending protocols.
[11] IAEA (1963), The Vienna Convention on Civil Liability for Nuclear Damage,
and amending protocols.

THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014 23
 APPENDIX 1

Appendix 1

Summary description
of regulatory approaches and strategies

Context

Regulators take different approaches to creating and enforcing safety requirements

depending on the mandate provided by the national regulations. In addition to
clear and comprehensive regulations and licence conditions, a regulatory body
therefore needs to develop strategies by identifying appropriate approaches or
combination of different approaches for conducting its regulatory supervision. In
order to achieve a regulatory supervision that is effective and appropriate for a
particular purpose, approaches and strategies need to be developed for various
areas of regulatory supervision and be adapted to the nature of the areas and
matters of regulatory supervision, taking into account their importance for safety.
These approaches have an impact on the outcomes for the licensee and other
stakeholders and on regulatory supervision. In considering the overarching
regulatory framework, regulators should take into account the benefits and
difficulties of different approaches for different regulatory functions.
The discussion below is a summary from a study [5] sponsored by the Swedish
Radiation Safety Authority (SSM). These regulatory approaches were discussed at
the OECD/NEA CNRA Workshop on Regulatory Approaches and the Characteristics
of an Effective Regulator which was hosted by SSM in Stockholm, Sweden in
October 2013.

A summary of the pros and cons of various regulatory approaches

Prescriptive approach
A prescriptive approach is used by regulators to establish specific requirements for
licensees and their activities, including proposed technical or other solutions.
A major benefit of a prescriptive approach is the level of clarity for both the
regulator and the licensees. An additional benefit in some situations is that the
approach can be used to exert specific regulatory authority. This approach has
several difficulties, one of which is the appearance that the regulator is assuming
responsibility for plant safety. The approach can also be resource-intensive for
regulators and inflexible for licensees and operators.

THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014 25
APPENDIX 1

Case- and facility-based approaches

A case-based or facility-based approach is used by regulators to determine the
safety requirements for each licensee through individual assessment of its design
and operation, while considering the unique history of each facility.
Case- and facility-based approaches imply benefits of flexibility for the licensees
in adapting to regulatory responses to unique situations. Since regulatory
requirements are different for different licensees or different situations, potential
difficulties of this approach include the regulator being considered arbitrary,
inconsistent and unfair. The approach can also be resource-intensive for regulators.
Outcome-based approach
An outcome-based approach is used by regulators to establish specific
performance goals or outcomes for licensees to attain, but does not specify how
they must be attained. Licensees determine how they will conduct their work
activities.
An outcome-based approach is beneficial because it allows licensees to decide
on optimal methods to meet safety goals. The approach also encourages licensees
to improve plant performance and clearly places the responsibility for safety with
the licensee. Potential difficulties for regulators using this approach include
identification of good outcome measures.
Risk-informed and hazard-informed approaches
Risk-informed and hazard-informed approaches are used by regulators to
determine risk or hazard associated with an issue in order to evaluate the
appropriate level of regulatory attention.
• A risk-informed approach uses a specific methodology including probability
and potential for harm to identify areas of greatest risk.
• A hazard-informed approach uses specific criteria for the identification of
areas of greatest potential for harm.
A major benefit of risk- and hazard-informed approaches includes focusing
regulatory attention by prioritising safety issues and allocating resources. Potential
difficulties for regulators using these approaches include the possibility of
overlooking the limitations of risk and hazard analysis methods, which can
therefore result in some regulatory areas receiving inadequate or too much
attention.
Process-based approach
A process-based approach is used by regulators to identify specific key processes
that lead to safe performance and requires licensees to establish and implement
these processes effectively.
A major benefit of a process-based approach is that it can provide in depth
understanding of the licensees’ performance. A difficulty of process-based
approaches is the complexity of defining and evaluating processes. A major

26 THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014
 APPENDIX 1

drawback of a process-based approach can also be that it is not effective unless the
processes are linked to outcomes.
Self-assessment based approach
A self-assessment based approach is used by regulators to establish requirements
for licensees to develop and implement self-assessment programmes for
identification of good practices as well as problem areas needing improvement,
including internal reviews and follow-ups. The regulator evaluates the licensee
self-assessment programme, reviews the results of the licensee assessments, and
selectively inspects the licensee’s follow-up of self-assessment results.
A self-assessment approach is beneficial because it places the responsibility for
safety on the licensee and it promotes continuous improvement by the licensee.
Major difficulties of this approach are that it should not be used as a stand-alone
approach, that self-assessment programmes need to be closely monitored by the
regulator and that the approach often lacks credibility with the general public.
Education/influence-based approach
An education/influence-based approach is used by regulators to provide
information and training opportunities for the industry (including workshops,
feedback, research results and other information) in order to improve industry
performance.
This approach could potentially be a key tool for regulators when introducing
new programmes such as safety culture and in situations when it is important to
provide information to the licensees and the public. Potential difficulties of this
approach include the requirement of a great deal of regulator experience and the
dependence upon licensee acceptance.

THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014 27
 APPENDIX 2

Appendix 2

Complete list of the CNRA series of regulatory guidance reports

(green booklets)

1 1999 The Role of the Regulator in Promoting and Evaluating Safety Culture

2 2000 Regulatory Response Strategies for Safety Culture Problems

3 2001 Nuclear Regulatory Challenges Arising from Competition in Electricity

Markets

4 2001 Improving Nuclear Regulatory Effectiveness

5 2002 The Nuclear Regulatory Challenges in Judging Safety Backfits

6 2002 Improving versus Maintaining Nuclear Safety

7 2003 The Regulatory Challenges of Decommissioning Nuclear Reactors

8 2003 Nuclear Regulatory Review of Licensee Self-assessment (LSA)

9 2004 Nuclear Regulatory Challenges Related to Human Performance

10 2004 Direct Indicators of Nuclear Regulatory Efficiency and Effectiveness: Pilot

Project Results

11 2005 Nuclear Regulatory Decision Making

12 2006 Regulatory Challenges in Using Nuclear Operating Experience

13 2008 The Regulatory Goal of Assuring Nuclear Safety

14 2011 The Nuclear Regulator’s Role in Assessing the Licensee Oversight of

Vendor and Other Contracted Services

15 2012 Challenges in Long-term Operation of Nuclear Power Plants: Implications

for Regulatory Bodies

THE CHARACTERISTICS OF AN EFFECTIVE NUCLEAR REGULATOR, NEA No. 7185, © OECD 2014 29
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The Characteristics of an Effective
Nuclear Regulator
Both national and international organisations agree that the fundamental objective of
all nuclear safety regulatory bodies – the regulator’s prime purpose – is to ensure that
nuclear licensees operate their facilities at all times in a safe manner. Much has been
written about ways to improve regulatory processes or to improve the effectiveness of a
regulatory body, including in previous OECD/NEA regulatory guidance booklets. But until
now, none have focused on the characteristics of an effective nuclear safety regulator.
Effective organisations are those that have good leadership and are able to transform
strategic direction into operational programmes. Effectiveness is about how well the
organisation is achieving its fundamental purpose – in the case of a nuclear safety
regulator, ensuring that licensees operate their facilities and discharge their obligations
in a safe manner.
This regulatory guidance booklet describes the characteristics of an effective nuclear
safety regulator in terms of roles and responsibilities, principles and attributes. Each of
the characteristics discussed in this report is a necessary feature of an effective nuclear
safety regulator but no one characteristic is sufficient on its own. It is the combination
of these characteristics that leads to the effectiveness of a nuclear regulatory body. The
report provides a unique resource to countries with existing, mature regulators and can
be used for benchmarking as well as training and developing staff. It will also be useful
for new entrant countries in the process of developing and maintaining an effective
nuclear safety regulator.

OECD Nuclear Energy Agency

12, boulevard des Îles
92130 Issy-les-Moulineaux, France
Tel.: +33 (0)1 45 24 10 15
nea@oecd-nea.org  www.oecd-nea.org NEA No. 7185