IAEA GSG-13

IAEA Safety Standards
for protecting people and the environment
Functions and Processes

of the Regulatory Body
for Safety
General Safety Guide

No. GSG-13
IAEA SAFETY STANDARDS AND RELATED PUBLICATIONS
IAEA SAFETY STANDARDS

Under the terms of Article III of its Statute, the IAEA is authorized to establish or adopt
standards of safety for protection of health and minimization of danger to life and property, and
to provide for the application of these standards.
The publications by means of which the IAEA establishes standards are issued in the
IAEA Safety Standards Series. This series covers nuclear safety, radiation safety, transport
safety and waste safety. The publication categories in the series are Safety Fundamentals,
Safety Requirements and Safety Guides.
Information on the IAEA’s safety standards programme is available on the IAEA Internet
site
http://www-ns.iaea.org/standards/
The site provides the texts in English of published and draft safety standards. The texts
of safety standards issued in Arabic, Chinese, French, Russian and Spanish, the IAEA Safety
Glossary and a status report for safety standards under development are also available. For
further information, please contact the IAEA at: Vienna International Centre, PO Box 100,
1400 Vienna, Austria.
All users of IAEA safety standards are invited to inform the IAEA of experience in their
use (e.g. as a basis for national regulations, for safety reviews and for training courses) for the
purpose of ensuring that they continue to meet users’ needs. Information may be provided via
the IAEA Internet site or by post, as above, or by email to Official.Mail@iaea.org.
RELATED PUBLICATIONS
The IAEA provides for the application of the standards and, under the terms of Articles III
and VIII.C of its Statute, makes available and fosters the exchange of information relating
to peaceful nuclear activities and serves as an intermediary among its Member States for this
purpose.
Reports on safety in nuclear activities are issued as Safety Reports, which provide
practical examples and detailed methods that can be used in support of the safety standards.
Other safety related IAEA publications are issued as Emergency Preparedness and
Response publications, Radiological Assessment Reports, the International Nuclear Safety
Group’s INSAG Reports, Technical Reports and TECDOCs. The IAEA also issues reports
on radiological accidents, training manuals and practical manuals, and other special safety
related publications.
Security related publications are issued in the IAEA Nuclear Security Series.
The IAEA Nuclear Energy Series comprises informational publications to encourage
and assist research on, and the development and practical application of, nuclear energy for
peaceful purposes. It includes reports and guides on the status of and advances in technology,
and on experience, good practices and practical examples in the areas of nuclear power, the
nuclear fuel cycle, radioactive waste management and decommissioning.
FUNCTIONS AND PROCESSES
OF THE REGULATORY BODY
FOR SAFETY
The following States are Members of the International Atomic Energy Agency:
AFGHANISTAN GERMANY PALAU

ALBANIA GHANA PANAMA
ALGERIA GREECE PAPUA NEW GUINEA
ANGOLA GRENADA PARAGUAY
ANTIGUA AND BARBUDA GUATEMALA PERU
ARGENTINA GUYANA PHILIPPINES
ARMENIA HAITI POLAND
AUSTRALIA HOLY SEE PORTUGAL
AUSTRIA HONDURAS QATAR
AZERBAIJAN HUNGARY
REPUBLIC OF MOLDOVA
BAHAMAS ICELAND
ROMANIA
BAHRAIN INDIA
INDONESIA RUSSIAN FEDERATION
BANGLADESH
BARBADOS IRAN, ISLAMIC REPUBLIC OF RWANDA
BELARUS IRAQ SAINT VINCENT AND
BELGIUM IRELAND THE GRENADINES
BELIZE ISRAEL SAN MARINO
BENIN ITALY SAUDI ARABIA
BOLIVIA, PLURINATIONAL JAMAICA SENEGAL
STATE OF JAPAN SERBIA
BOSNIA AND HERZEGOVINA JORDAN SEYCHELLES
BOTSWANA KAZAKHSTAN SIERRA LEONE
BRAZIL KENYA SINGAPORE
BRUNEI DARUSSALAM KOREA, REPUBLIC OF SLOVAKIA
BULGARIA KUWAIT SLOVENIA
BURKINA FASO KYRGYZSTAN SOUTH AFRICA
BURUNDI LAO PEOPLE’S DEMOCRATIC SPAIN
CAMBODIA REPUBLIC SRI LANKA
CAMEROON LATVIA SUDAN
CANADA LEBANON
SWEDEN
CENTRAL AFRICAN LESOTHO
SWITZERLAND
REPUBLIC LIBERIA
CHAD LIBYA SYRIAN ARAB REPUBLIC
CHILE LIECHTENSTEIN TAJIKISTAN
CHINA LITHUANIA THAILAND
COLOMBIA LUXEMBOURG THE FORMER YUGOSLAV
CONGO MADAGASCAR REPUBLIC OF MACEDONIA
COSTA RICA MALAWI TOGO
CÔTE D’IVOIRE MALAYSIA TRINIDAD AND TOBAGO
CROATIA MALI TUNISIA
CUBA MALTA TURKEY
CYPRUS MARSHALL ISLANDS TURKMENISTAN
CZECH REPUBLIC MAURITANIA UGANDA
DEMOCRATIC REPUBLIC MAURITIUS UKRAINE
OF THE CONGO MEXICO UNITED ARAB EMIRATES
DENMARK MONACO UNITED KINGDOM OF
DJIBOUTI MONGOLIA GREAT BRITAIN AND
DOMINICA MONTENEGRO NORTHERN IRELAND
DOMINICAN REPUBLIC MOROCCO UNITED REPUBLIC
ECUADOR MOZAMBIQUE
OF TANZANIA
EGYPT MYANMAR
UNITED STATES OF AMERICA
EL SALVADOR NAMIBIA
ERITREA NEPAL URUGUAY
ESTONIA NETHERLANDS UZBEKISTAN
ESWATINI NEW ZEALAND VANUATU
ETHIOPIA NICARAGUA VENEZUELA, BOLIVARIAN
FIJI NIGER REPUBLIC OF
FINLAND NIGERIA VIET NAM
FRANCE NORWAY YEMEN
GABON OMAN ZAMBIA
GEORGIA PAKISTAN ZIMBABWE
The Agency’s Statute was approved on 23 October 1956 by the Conference on the Statute of the
IAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957.
The Headquarters of the Agency are situated in Vienna. Its principal objective is “to accelerate and enlarge
the contribution of atomic energy to peace, health and prosperity throughout the world’’.
IAEA SAFETY STANDARDS SERIES No. GSG-13
FUNCTIONS AND PROCESSES

OF THE REGULATORY BODY
FOR SAFETY
INTERNATIONAL ATOMIC ENERGY AGENCY

VIENNA, 2018
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© IAEA, 2018
Printed by the IAEA in Austria

September 2018
STI/PUB/1804
IAEA Library Cataloguing in Publication Data

Names: International Atomic Energy Agency.
Title: Functions and processes of the regulatory body for safety / International
Atomic Energy Agency.
Description: Vienna : International Atomic Energy Agency, 2018. | Series: IAEA
safety standards series, ISSN 1020–525X ; no. GSG-13 | Includes bibliographical
references.
Identifiers: IAEAL 18-01177 | ISBN 978–92–0–100718–6 (paperback : alk. paper)
Subjects: LCSH: Independent regulatory commissions. | Administrative agencies —
Management. | Nuclear facilities.
Classification: UDC 621.039.58:3.075.6 | STI/PUB/1804
FOREWORD
by Yukiya Amano
Director General
The IAEA’s Statute authorizes the Agency to “establish or adopt…

standards of safety for protection of health and minimization of danger to life and
property” — standards that the IAEA must use in its own operations, and which
States can apply by means of their regulatory provisions for nuclear and radiation
safety. The IAEA does this in consultation with the competent organs of the
United Nations and with the specialized agencies concerned. A comprehensive
set of high quality standards under regular review is a key element of a stable and
sustainable global safety regime, as is the IAEA’s assistance in their application.
The IAEA commenced its safety standards programme in 1958. The
emphasis placed on quality, fitness for purpose and continuous improvement
has led to the widespread use of the IAEA standards throughout the world. The
Safety Standards Series now includes unified Fundamental Safety Principles,
which represent an international consensus on what must constitute a high level
of protection and safety. With the strong support of the Commission on Safety
Standards, the IAEA is working to promote the global acceptance and use of its
standards.
Standards are only effective if they are properly applied in practice.
The IAEA’s safety services encompass design, siting and engineering safety,
operational safety, radiation safety, safe transport of radioactive material and
safe management of radioactive waste, as well as governmental organization,
regulatory matters and safety culture in organizations. These safety services assist
Member States in the application of the standards and enable valuable experience
and insights to be shared.
Regulating safety is a national responsibility, and many States have
decided to adopt the IAEA’s standards for use in their national regulations. For
parties to the various international safety conventions, IAEA standards provide
a consistent, reliable means of ensuring the effective fulfilment of obligations
under the conventions. The standards are also applied by regulatory bodies and
operators around the world to enhance safety in nuclear power generation and in
nuclear applications in medicine, industry, agriculture and research.
Safety is not an end in itself but a prerequisite for the purpose of the
protection of people in all States and of the environment — now and in the
future. The risks associated with ionizing radiation must be assessed and
controlled without unduly limiting the contribution of nuclear energy to equitable
and sustainable development. Governments, regulatory bodies and operators
everywhere must ensure that nuclear material and radiation sources are used
beneficially, safely and ethically. The IAEA safety standards are designed to
facilitate this, and I encourage all Member States to make use of them.
THE IAEA SAFETY STANDARDS
BACKGROUND
Radioactivity is a natural phenomenon and natural sources of radiation are

features of the environment. Radiation and radioactive substances have many
beneficial applications, ranging from power generation to uses in medicine,
industry and agriculture. The radiation risks to workers and the public and to the
environment that may arise from these applications have to be assessed and, if
necessary, controlled.
Activities such as the medical uses of radiation, the operation of nuclear
installations, the production, transport and use of radioactive material, and the
management of radioactive waste must therefore be subject to standards of safety.
Regulating safety is a national responsibility. However, radiation risks may
transcend national borders, and international cooperation serves to promote and
enhance safety globally by exchanging experience and by improving capabilities
to control hazards, to prevent accidents, to respond to emergencies and to mitigate
any harmful consequences.
States have an obligation of diligence and duty of care, and are expected to
fulfil their national and international undertakings and obligations.
International safety standards provide support for States in meeting their
obligations under general principles of international law, such as those relating to
environmental protection. International safety standards also promote and assure
confidence in safety and facilitate international commerce and trade.
A global nuclear safety regime is in place and is being continuously
improved. IAEA safety standards, which support the implementation of binding
international instruments and national safety infrastructures, are a cornerstone
of this global regime. The IAEA safety standards constitute a useful tool
for contracting parties to assess their performance under these international
conventions.
THE IAEA SAFETY STANDARDS
The status of the IAEA safety standards derives from the IAEA’s Statute,
which authorizes the IAEA to establish or adopt, in consultation and, where
appropriate, in collaboration with the competent organs of the United Nations
and with the specialized agencies concerned, standards of safety for protection of
health and minimization of danger to life and property, and to provide for their
application.
With a view to ensuring the protection of people and the environment
from harmful effects of ionizing radiation, the IAEA safety standards establish
fundamental safety principles, requirements and measures to control the radiation
exposure of people and the release of radioactive material to the environment, to
restrict the likelihood of events that might lead to a loss of control over a nuclear
reactor core, nuclear chain reaction, radioactive source or any other source of
radiation, and to mitigate the consequences of such events if they were to occur.
The standards apply to facilities and activities that give rise to radiation risks,
including nuclear installations, the use of radiation and radioactive sources, the
transport of radioactive material and the management of radioactive waste.
Safety measures and security measures1 have in common the aim of
protecting human life and health and the environment. Safety measures and
security measures must be designed and implemented in an integrated manner
so that security measures do not compromise safety and safety measures do not
compromise security.
The IAEA safety standards reflect an international consensus on what
constitutes a high level of safety for protecting people and the environment
from harmful effects of ionizing radiation. They are issued in the IAEA Safety
Standards Series, which has three categories (see Fig. 1).
Safety Fundamentals
Safety Fundamentals present the fundamental safety objective and principles
of protection and safety, and provide the basis for the safety requirements.
Safety Requirements
An integrated and consistent set of Safety Requirements establishes
the requirements that must be met to ensure the protection of people and the
environment, both now and in the future. The requirements are governed by the
objective and principles of the Safety Fundamentals. If the requirements are not
met, measures must be taken to reach or restore the required level of safety. The
format and style of the requirements facilitate their use for the establishment, in a
harmonized manner, of a national regulatory framework. Requirements, including
numbered ‘overarching’ requirements, are expressed as ‘shall’ statements. Many
requirements are not addressed to a specific party, the implication being that the
appropriate parties are responsible for fulfilling them.
1
See also publications issued in the IAEA Nuclear Security Series.
Safety Fundamentals
Fundamental Safety Principles
General Safety Requirements Specific Safety Requirements
Part 1. Governmental, Legal and 1. Site Evaluation for

Regulatory Framework for Safety Nuclear Installations
Part 2. Leadership and Management

2. Safety of Nuclear Power Plants
for Safety
2/1 Design
Part 3. Radiation Protection and 2/2 Commissioning and Operation
Safety of Radiation Sources
Part 4. Safety Assessment for 3. Safety of Research Reactors

Facilities and Activities
Part 5. Predisposal Management 4. Safety of Nuclear Fuel

of Radioactive Waste Cycle Facilities
Part 6. Decommissioning and 5. Safety of Radioactive Waste

Termination of Activities Disposal Facilities
Part 7. Emergency Preparedness 6. Safe Transport of

and Response Radioactive Material
Collection of Safety Guides
FIG. 1. The long term structure of the IAEA Safety Standards Series.
Safety Guides
Safety Guides provide recommendations and guidance on how to comply
with the safety requirements, indicating an international consensus that it
is necessary to take the measures recommended (or equivalent alternative
measures). The Safety Guides present international good practices, and
increasingly they reflect best practices, to help users striving to achieve high
levels of safety. The recommendations provided in Safety Guides are expressed
as ‘should’ statements.
APPLICATION OF THE IAEA SAFETY STANDARDS
The principal users of safety standards in IAEA Member States are

regulatory bodies and other relevant national authorities. The IAEA safety
standards are also used by co-sponsoring organizations and by many organizations
that design, construct and operate nuclear facilities, as well as organizations
involved in the use of radiation and radioactive sources.
The IAEA safety standards are applicable, as relevant, throughout the entire
lifetime of all facilities and activities — existing and new — utilized for peaceful
purposes and to protective actions to reduce existing radiation risks. They can be
used by States as a reference for their national regulations in respect of facilities
and activities.
The IAEA’s Statute makes the safety standards binding on the IAEA in
relation to its own operations and also on States in relation to IAEA assisted
operations.
The IAEA safety standards also form the basis for the IAEA’s safety review
services, and they are used by the IAEA in support of competence building,
including the development of educational curricula and training courses.
International conventions contain requirements similar to those in
the IAEA safety standards and make them binding on contracting parties.
The IAEA safety standards, supplemented by international conventions, industry
standards and detailed national requirements, establish a consistent basis for
protecting people and the environment. There will also be some special aspects
of safety that need to be assessed at the national level. For example, many of
the IAEA safety standards, in particular those addressing aspects of safety in
planning or design, are intended to apply primarily to new facilities and activities.
The requirements established in the IAEA safety standards might not be fully
met at some existing facilities that were built to earlier standards. The way in
which IAEA safety standards are to be applied to such facilities is a decision for
individual States.
The scientific considerations underlying the IAEA safety standards provide
an objective basis for decisions concerning safety; however, decision makers
must also make informed judgements and must determine how best to balance
the benefits of an action or an activity against the associated radiation risks and
any other detrimental impacts to which it gives rise.
DEVELOPMENT PROCESS FOR THE IAEA SAFETY STANDARDS
The preparation and review of the safety standards involves the IAEA
Secretariat and five safety standards committees, for emergency preparedness
and response (EPReSC) (as of 2016), nuclear safety (NUSSC), radiation
safety (RASSC), the safety of radioactive waste (WASSC) and the safe
transport of radioactive material (TRANSSC), and a Commission on Safety
Standards (CSS) which oversees the IAEA safety standards programme
(see Fig. 2).
All IAEA Member States may nominate experts for the safety standards
committees and may provide comments on draft standards. The membership of
Outline and work plan
prepared by the Secretariat;
review by the safety standards
committees and the CSS
Secretariat and
consultants:
drafting of new or revision
of existing safety standard
Draft
Review by Draft
safety standards Member States
committee(s)
Comments
Final draft
Endorsement
by the CSS
FIG. 2. The process for developing a new safety standard or revising an existing standard.
the Commission on Safety Standards is appointed by the Director General and

includes senior governmental officials having responsibility for establishing
national standards.
A management system has been established for the processes of planning,
developing, reviewing, revising and establishing the IAEA safety standards.
It articulates the mandate of the IAEA, the vision for the future application of
the safety standards, policies and strategies, and corresponding functions and
responsibilities.
INTERACTION WITH OTHER INTERNATIONAL ORGANIZATIONS
The findings of the United Nations Scientific Committee on the Effects

of Atomic Radiation (UNSCEAR) and the recommendations of international
expert bodies, notably the International Commission on Radiological Protection
(ICRP), are taken into account in developing the IAEA safety standards. Some
safety standards are developed in cooperation with other bodies in the United
Nations system or other specialized agencies, including the Food and Agriculture
Organization of the United Nations, the United Nations Environment Programme,
the International Labour Organization, the OECD Nuclear Energy Agency, the
Pan American Health Organization and the World Health Organization.
INTERPRETATION OF THE TEXT
Safety related terms are to be understood as defined in the IAEA Safety

Glossary (see http://www-ns.iaea.org/standards/safety-glossary.htm). Otherwise,
words are used with the spellings and meanings assigned to them in the latest
edition of The Concise Oxford Dictionary. For Safety Guides, the English version
of the text is the authoritative version.
The background and context of each standard in the IAEA Safety
Standards Series and its objective, scope and structure are explained in Section 1,
Introduction, of each publication.
Material for which there is no appropriate place in the body text
(e.g. material that is subsidiary to or separate from the body text, is included
in support of statements in the body text, or describes methods of calculation,
procedures or limits and conditions) may be presented in appendices or annexes.
An appendix, if included, is considered to form an integral part of the
safety standard. Material in an appendix has the same status as the body text,
and the IAEA assumes authorship of it. Annexes and footnotes to the main text,
if included, are used to provide practical examples or additional information or
explanation. Annexes and footnotes are not integral parts of the main text. Annex
material published by the IAEA is not necessarily issued under its authorship;
material under other authorship may be presented in annexes to the safety
standards. Extraneous material presented in annexes is excerpted and adapted as
necessary to be generally useful.
CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Background (1.1–1.5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Objective (1.6–1.8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Scope (1.9–1.12) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Structure (1.13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2. GRADED APPROACH TO FUNCTIONS AND

PROCESSES OF THE REGULATORY BODY (2.1–2.10) . . . . . . . . 5
3. CORE REGULATORY FUNCTIONS AND PROCESSES (3.1–3.2) 8
Regulations and guides (3.3–3.9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Objectives of regulations and guides (3.10–3.24) . . . . . . . . . . . 10
Scope and content of regulations and guides (3.25–3.40) . . . . . 14
Regulations and guides for review and assessment (3.41–3.44) 19
Regulations and guides for enforcement (3.45–3.46) . . . . . . . . 19
Exemption and clearance from regulatory requirements
(3.47–3.48) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Regulations and guides on the release criteria for sites
(3.49–3.50) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Process for development, review and revision
of regulations and guides (3.51–3.71) . . . . . . . . . . . . . . . . . . . 21
Internal guidance (3.72) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Notification and authorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
General (3.73–3.90) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Objectives of notification and authorization (3.91–3.95) . . . . . . 30
Information to be provided in the submission of a notification
or application for authorization (3.96–3.102) . . . . . . . . . . . . . 32
Form of notification or authorization for a facility
or activity (3.103–3.106) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Form of authorization for individuals (3.107) . . . . . . . . . . . . . . 40
Form of notification and authorization for objects
(3.108–3.111) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Authorization conditions (3.112–3.114) . . . . . . . . . . . . . . . . . . . 41
Steps in the authorization process (3.115–3.141) . . . . . . . . . . . . 42
Modification or revocation of authorizations (3.142–3.146) . . . 49
Review and assessment of facilities and
activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
General (3.147–3.155) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Objectives of review and assessment (3.156–3.158) . . . . . . . . . 54
Information to be reviewed and assessed (3.159–3.160) . . . . . . 55
Review and assessment process (3.161–3.189) . . . . . . . . . . . . . 56
Specific aspects of review and assessment (3.190–3.207) . . . . . 64
Records of review and assessment (3.208–3.209) . . . . . . . . . . . 70
Inspection of facilities and activities (3.210–3.219) . . . . . . . . . . . . . . 70
Objectives of regulatory inspection (3.220) . . . . . . . . . . . . . . . . 72
Organization of regulatory inspection (3.221–3.235) . . . . . . . . 73
Types of regulatory inspection (3.236–3.251) . . . . . . . . . . . . . . 77
Planning of regulatory inspections (3.252–3.261) . . . . . . . . . . . 81
Performance of regulatory inspection (3.262–3.282) . . . . . . . . . 82
Records of regulatory inspections (3.283–3.293) . . . . . . . . . . . . 88
Follow-up of inspection findings (3.294) . . . . . . . . . . . . . . . . . . 92
Enforcement (3.295–3.299) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Objectives of enforcement (3.300–3.301) . . . . . . . . . . . . . . . . . 93
Methods of enforcement (3.302–3.307) . . . . . . . . . . . . . . . . . . . 93
Factors in determining enforcement actions (3.308) . . . . . . . . . 95
Implementing enforcement (3.309–3.315) . . . . . . . . . . . . . . . . . 95
Records of enforcement (3.316–3.319) . . . . . . . . . . . . . . . . . . . 96
Emergency preparedness and response (3.320–3.326) . . . . . . . . . . . . 97
Ensuring on-site emergency arrangements are in place
(3.327–3.332) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Ensuring coordination with off-site response organizations
(3.333–3.336) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Establishing and maintaining internal emergency
arrangements (3.337–3.340) . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Discharging its assigned responsibilities in emergency
response (3.341–3.344) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Communication and consultation with interested parties
(3.345–3.347) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
APPENDIX I: PROVISION OF CONSUMER PRODUCTS . . . . . . . . . 105
APPENDIX II: AUTHORIZATION CONDITIONS

RELEVANT FOR CERTAIN STEPS OF THE
AUTHORIZATION PROCESS FOR COMPLEX
FACILITIES OR ACTIVITIES . . . . . . . . . . . . . . . . . . . . 107
APPENDIX III: TOPICS TO BE COVERED BY REVIEW
AND ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
APPENDIX IV: REGULATORY INSPECTION AREAS

FOR NUCLEAR FACILITIES . . . . . . . . . . . . . . . . . . . . . 119
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . 137

1. INTRODUCTION
BACKGROUND
1.1. Regulation is essential for ensuring the safety of all facilities and
activities that give rise to radiation risks for people and the environment. The
establishment of a legally based, independent, fully resourced and technically
competent regulatory body is a fundamental element set out in Principle 2 of
IAEA Safety Standards Series No. SF-1, Fundamental Safety Principles [1]. This
principle is reinforced and further elaborated in IAEA Safety Standards Series
Nos GSR Part 1 (Rev. 1), Governmental, Legal and Regulatory Framework
for Safety [2], and GSR Part 3, Radiation Protection and Safety of Radiation
Sources: International Basic Safety Standards [3].
1.2. This Safety Guide provides guidance on the technical aspects of a regulatory
body’s core functions as defined in GSR Part 1 (Rev. 1) [2] and the associated
processes for ensuring the regulatory control of facilities and activities1. This
guidance is particularly important for regulatory bodies having responsibilities
covering a range of facilities and activities that give rise to radiation risks, or
when interfaces are present between various regulatory authorities, which require
effective coordination and cooperation. This guidance promotes a consistent
approach to the regulation of radiation risks.
1.3. Corresponding supporting functions, supported by processes within the

framework of an integrated management system, are necessary to ensure that
the core functions can be performed efficiently and effectively. The regulatory
body should manage its organizational structure and staffing in accordance with
a graded approach, so that the degree of regulatory control is appropriate. These
aspects are covered in the companion Safety Guide, IAEA Safety Standards
Series No. GSG-12, Organization, Management and Staffing of the Regulatory
Body for Safety [4]. It is strongly recommended that this Safety Guide and
GSG-12 [4] be read in conjunction with one another.
1
Facilities and activities is a general term encompassing nuclear facilities, all uses
of all sources of ionizing radiation, all radioactive waste management activities, transport of
radioactive material and any other activity or circumstances in which people may be exposed
to radiation risks arising from naturally occurring or artificial sources. See footnote 3 of GSR
Part 1 (Rev. 1) [2] for a more complete definition.
1
1.4. The recommendations provided in this Safety Guide and GSG-12 [4]
are intended mainly to be used by regulatory bodies, but can be also useful
for governments that are developing a regulatory framework for radiation and
nuclear safety. This Safety Guide will also assist authorized parties and others
dealing with radiation sources in understanding regulatory procedures, processes
and expectations.
1.5. This Safety Guide supersedes IAEA Safety Standards Series Nos GS-G-1.2,
Review and Assessment of Nuclear Facilities by the Regulatory Body2 issued in
2002; GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement
by the Regulatory Body3 issued in 2002; GS-G-1.4, Documentation for Use in
Regulating Nuclear Facilities4 issued in 2002; and GS-G-1.5, Regulatory Control
of Radiation Sources5 issued in 2004. This Safety Guide also supersedes the parts
of IAEA Safety Standards Series No. SSG-12, Licensing Process for Nuclear
Installations [5] relating to the functions and processes of the regulatory body and
the parts of IAEA Safety Standards Series No. WS-G-5.1, Release of Sites from
Regulatory Control on Termination of Practices [6] relating to the regulatory
body.
OBJECTIVE
1.6. The objective of this Safety Guide is to provide recommendations on

meeting the requirements of GSR Part 1 (Rev. 1) [2] on the regulatory body’s
core functions and the associated processes to implement those functions.
The core functions addressed in this Safety Guide are those described in
GSR Part 1 (Rev. 1) [2] and in IAEA Safety Standards Series No. GSR Part 7,
2
INTERNATIONAL ATOMIC ENERGY AGENCY, Review and Assessment of
Nuclear Facilities by the Regulatory Body, IAEA Safety Standards Series No. GS-G-1.2,
IAEA, Vienna (2002).
3
INTERNATIONAL ATOMIC ENERGY AGENCY, Regulatory Inspection of
Nuclear Facilities and Enforcement by the Regulatory Body, IAEA Safety Standards Series
No. GS-G-1.3, IAEA, Vienna (2002).
4
INTERNATIONAL ATOMIC ENERGY AGENCY, Documentation for Use
in Regulating Nuclear Facilities, IAEA Safety Standards Series No. GS-G-1.4, IAEA,
Vienna (2002).
5
FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS,
INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR OFFICE,
PAN AMERICAN HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION,
Regulatory Control of Radiation Sources, IAEA Safety Standards Series No. GS-G-1.5, IAEA,
Vienna (2004).
2
Preparedness and Response for a Nuclear or Radiological Emergency [7] and
comprise:
(a) The development and/or provision of regulations and guides;

(b) Notification and authorization, including registration and licensing;
(c) Regulatory review and assessment;
(d) Regulatory inspection;
(e) Enforcement;
(f) Emergency preparedness and response;
(g) Communication and consultation with interested parties.
1.7. The core functions interact with one another; for example, regulations and
guides set out the regulatory requirements to be used in review and assessment,
in the authorization process, in carrying out inspections, and when determining
enforcement actions. Similarly, the findings of review and assessment guide the
approach to inspection, and inspection provides areas for review and assessment.
Both review and assessment, and inspection may influence the development of
regulations and guides. This Safety Guide addresses these interactions between
the core functions.
1.8. There are several supporting functions that are necessary to ensure that the
core functions can be performed efficiently and effectively. These include:
(a) Administrative support, including human resources, finance, management

of relevant documents and records, equipment purchasing and control;
(b) Legal assistance;
(c) Research and development processes;
(d) Arrangements for contracting external expert support, where needed;
(e) Establishment of advisory committees;
(f) Organization of international links and cooperation.
These supporting functions and the associated processes are described in

GSG-12 [4].
SCOPE
1.9. This Safety Guide covers the core functions of the regulatory body, and
the processes by which they are discharged, for all the stages of the lifetime of
a facility or activity, from initial site evaluation and design through to release
from regulatory control. While this Safety Guide is based on the regulation of
3
authorized facilities and activities, many of the functions and processes also apply
for any pre-authorization stages. However, in line with a graded approach, not all
the regulatory controls and recommendations described will be applicable to all
facilities and activities; even where regulatory controls are applicable, they will
differ and vary in depth and scope in accordance with the facility and activity, as
well as the lifetime stage.
1.10. In this Safety Guide, the terms ‘authorization’ (which is considered to be

synonymous with ‘licence’ or ‘permit’) and ‘notification’ are used. Authorization
may take different forms, such as licensing, certification, granting of a permit,
registration, agreement, consent or granting of another similar regulatory
instrument, depending on the legal and regulatory framework of the particular
State. The term ‘authorized party’ is used in this Safety Guide to indicate the
person or organization responsible for an authorized facility or an authorized
activity that gives rise to radiation risks who has been granted written permission
(i.e. authorized) by a regulatory body or other governmental body to conduct
specified activities; the authorized party may be a licensee, a registrant, an
operator or an operating organization. The term ‘safety’ is used in this Safety
Guide to mean the protection of people and the environment against radiation
risks, and the safety of facilities and activities that give rise to radiation risks.
Safety as used here includes the safety of nuclear installations, radiation safety,
the safety of radioactive waste management and safety in the transport of
radioactive material; it does not include non-radiation-related aspects of safety.
1.11. In this Safety Guide, the expression ‘lifetime of facilities and activities’
is used to cover both the full lifetime of a facility and the duration of an
activity. Site evaluation, design, construction, commissioning, operation and
decommissioning or closure are the stages in the lifetime of a facility, and of the
associated authorization process; while these stages apply for all facilities, they
might not apply for all activities. For complex facilities or activities, each stage
of the authorization process may include one or more steps (also referred to as
‘hold points’) at which additional information is required by the regulatory body.
Further definitions are provided in the IAEA Safety Glossary [8].
1.12. The scope of this Safety Guide is limited to the regulation of safety and
does not extend to nuclear security. However, recommendations are provided
in this Safety Guide on the interfaces between safety and nuclear security. The
regulation of safety and nuclear security should be carried out in such a way that
safety measures and nuclear security measures are designed and implemented in
an integrated manner so that nuclear security measures do not compromise safety
and safety measures do not compromise nuclear security. The essential elements
4
of an effective nuclear security regime are established in the Nuclear Security
Fundamentals [9]. Guidance on addressing nuclear security aspects is provided
in IAEA Nuclear Security Series No. 13, Nuclear Security Recommendations on
Physical Protection of Nuclear Material and Nuclear Facilities (INFCIRC/225/
Revision 5) [10], IAEA Nuclear Security Series No. 14, Nuclear Security
Recommendations on Radioactive Material and Associated Facilities [11] and
IAEA Nuclear Security Series No. 23-G, Security of Nuclear Information [12].
STRUCTURE
1.13. Section 2 of this Safety Guide provides recommendations on the

application of a graded approach to the regulation of nuclear and radiation safety.
Section 3 provides recommendations for each of the core regulatory functions
and processes. Four Appendices provide more detailed guidance on authorization
for the provision of consumer products, authorization conditions for the various
steps of the authorization process, topics to be covered by review and assessment,
and inspection areas for nuclear facilities, respectively.
2. GRADED APPROACH TO FUNCTIONS

AND PROCESSES OF THE
REGULATORY BODY
2.1. Paragraph 3.24 of SF-1 [1] states that:
“The resources devoted to safety by the licensee, and the scope and
stringency of regulations and their application, have to be commensurate
with the magnitude of the radiation risks and their amenability to control.”
2.2. Requirement 1 of GSR Part 1 (Rev. 1) [2] states that:
“The government shall establish a national policy and strategy for

safety, the implementation of which shall be subject to a graded
approach in accordance with national circumstances and with the
radiation risks associated with facilities and activities.”
5
2.3. Paragraph 2.4 of GSR Part 1 (Rev. 1) [2] states that:
“The national policy and strategy for safety shall be implemented in

accordance with a graded approach, depending on national circumstances,
to ensure that the radiation risks associated with facilities and activities,
including activities involving the use of radiation sources, receive
appropriate attention by the government or by the regulatory body.”
2.4. Furthermore, para. 4.3 of GSR Part 1 (Rev. 1) [2] states that:
“The performance of regulatory functions shall be commensurate with the

radiation risks associated with facilities and activities, in accordance with a
graded approach.”
2.5. Specific reference is made to the application of a graded approach in

relation to the core functions of the regulatory body, as follows:
(a) Regulations and guides “shall provide adequate coverage commensurate

with the radiation risks associated with the facilities and activities, in
accordance with a graded approach” (GSR Part 1 (Rev. 1) [2], para. 4.62).
(b) For notification and authorization “[t]he extent of the regulatory control
applied shall be commensurate with the radiation risks associated
with facilities and activities, in accordance with a graded approach”
(GSR Part 1 (Rev. 1) [2], para. 4.33).
(c) “Review and assessment of a facility or an activity shall be
commensurate with the radiation risks associated with the
facility or activity, in accordance with a graded approach”
(GSR Part 1 (Rev. 1) [2], Requirement 26).
(d) “Inspections of facilities and activities shall be commensurate with the
radiation risks associated with the facility or activity, in accordance
with a graded approach” (GSR Part 1 (Rev. 1) [2], Requirement 29).
(e) For enforcement, “[t]he response of the regulatory body to non-compliances
with regulatory requirements or with any conditions specified in
the authorization shall be commensurate with the significance for
safety of the non-compliance, in accordance with a graded approach”
(GSR Part 1 (Rev. 1) [2], para. 4.54).
(f) For communication and consultation with interested parties, “[p]ublic
information activities shall reflect the radiation risks associated with
facilities and activities, in accordance with a graded approach”
(GSR Part 1 (Rev. 1) [2], para. 4.69).
6
2.6. Furthermore, para. 3.36 of SF-1 [1] states that:
“The scope and extent of arrangements for emergency preparedness and

response have to reflect…[t]he likelihood and the possible consequences of
a nuclear or radiation emergency.”
This is further addressed in GSR Part 7 [7], particularly in Requirement 4.
2.7. Thus, all the regulatory core functions (see Section 3) are required to be
subject to a graded approach so that, while the descriptions of these functions are
generic, the degree of application will differ in accordance with the facility or
activity. For example, the degree of review and assessment applied to a nuclear
power plant would clearly not be the same as for a medical X ray unit.
2.8. The main factor to take into consideration in the application of a graded
approach is that the application of the regulatory functions should be consistent
with the magnitude of the possible radiation risks6 arising from the facility or
activity. The approach should take into account any exposures to radiation, and
discharges or releases of radioactive substances in normal operation, anticipated
operational occurrences and accident conditions, as well as the possibility of
events with a very low probability of occurrence, without neglecting very low
probability events with potentially high consequences. An approach to screening
of events based on their probability is included in IAEA Safety Standards Series
No. NS-G-3.1, External Human Induced Events in Site Evaluation for Nuclear
Power Plants [13].
2.9. Other relevant factors, such as the maturity or complexity of the facility or
activity and the knowledge and expertise of the authorized party, should also be
taken into account in a graded approach to regulatory activities. The consideration
of maturity relates to the use of established practices and procedures, established
designs, data on operational performance of similar facilities or activities,
uncertainties in the performance of the facility or activity, and the continuing and
future availability of experienced manufacturers and constructors. Complexity
relates to the extent and difficulty of the effort required to construct and
operate a facility or to implement an activity, the number of related processes
for which control is necessary, the extent to which radioactive material has to
6
The term ‘possible radiation risks’ relates to the maximum possible radiological
consequences that could occur when radioactive material is released from the facility or the
activity, with no credit being taken for the safety systems or protective measures in place to
prevent this.
7
be handled, the half-lives of the radionuclides involved, the reliability and
complexity of systems and components, and their accessibility for maintenance,
inspection, testing and repair. These factors need special consideration during
decommissioning or remediation activities, which will involve new procedures
and processes not applied in other stages of the lifetime (e.g. institutional controls,
including continuing environmental monitoring programmes and controls of the
radiological status of the facility).
2.10. The application of the graded approach should be reassessed as a

better understanding is obtained of the radiation risks arising from the
facility or activity. For example, the extent and frequency of inspections
(see GSR Part 1 (Rev. 1) [2], para. 4.52) in the plan for periodic inspections may
be adapted in accordance with the trend of findings from previous inspections.
In Section 3, more detailed consideration is given to the application of a graded
approach in each of the core functions of the regulatory body.
3. CORE REGULATORY FUNCTIONS

AND PROCESSES
3.1. The core functions of a regulatory body are described in the following
subsections. The first subsection contains guidance on establishing and
maintaining regulations that set out the safety requirements for operating a facility
or conducting an activity and guides that set out the procedures and processes
that should be carried out by the regulatory body and authorized parties. These
include the process for notification or authorization of a facility or activity, which
is expanded on in the next subsection.
3.2. The subsequent subsections cover the responsibilities of the regulatory

body from the initial application to operate a facility or conduct an activity, and
thereafter throughout the entire lifetime of the facility or duration of the activity.
The regulatory body carries out review and assessment of information relevant
to safety, much of which will be submitted by the authorized party as part of the
notification or authorization process, to ensure that all regulatory requirements
are being addressed. The regulatory body also carries out inspections of the
facility or activity to ensure compliance with the safety requirements. Where
non-compliance or violations exist, enforcement is used to identify and document
their nature and require corrective actions to be taken by authorized parties. The
regulatory body in most States also has a role in emergency preparedness and
8
response, although this will differ in accordance with national practices. Finally,
communication and consultation with interested parties are important throughout
the lifetime of the facility or duration of the activity to both inform and obtain the
views of the public and other interested parties.
REGULATIONS AND GUIDES
3.3. The provision of regulations and guides is subject to Requirements 32–34

of GSR Part 1 (Rev. 1) [2]. The system of regulations and guides should be in
accordance with the legal system of the State, and the nature and extent of the
facilities and activities to be regulated. The regulations and guides should specify
the requirements and associated criteria for ensuring the protection of people and
the environment.
3.4. The provision of regulations and guides is a means for the regulatory
body to ensure that regulatory control is stable, unambiguous and consistent; to
emphasize the continuous enhancement of safety as a general objective; and to
build confidence among interested parties [2].
3.5. When regulations are not established directly by the regulatory body,
mechanisms established within the legal and governmental framework should
ensure that such regulations are developed and issued in a timely manner. The
regulatory body should advise the government on the need for regulations on
matters affecting safety to be established or adopted.
3.6. The regulatory body should specify the purposes of the various
documents in the legal framework that are necessary to perform its functions.
The documents may be categorized, for example, as legislation and regulations
(mandatory by law), supporting guides (not mandatory by law) to be used either
by the authorized parties or by the regulatory body (internal guidance) and other
relevant documents.
3.7. A suitable system of guides will help the regulatory body to maintain
consistency in the implementation of the regulatory requirements. However, the
regulatory body should refrain from prescribing specific solutions in its guides.
The advisory status of a guide carries the implication that alternative approaches
would be acceptable provided that the authorized party can demonstrate that the
required level of safety will be achieved.
9
3.8. Internationally recognized standards and recommendations as well as
technical standards developed by organizations working in various technological
fields may be referenced by the regulatory body in its regulations and guides or
in the authorization conditions, or may be proposed by the authorized party in the
authorization process.
3.9. The regulatory body should establish a system to ensure that the
development and implementation of regulations and guides is based on a graded
approach, such that the application of regulatory requirements is commensurate
with the radiation risks associated with the type of facility or activity.
Objectives of regulations and guides
3.10. An important objective of the regulations and guides is to ensure the stability
and consistency of regulatory control and to prevent subjectivity in decision
making by individual staff members of the regulatory body. The regulatory
body is required to be able to justify its decisions if they are challenged [2]. The
provision of regulations and guides also enables the regulatory body to inform
authorized parties and applicants of the objectives, principles and associated
criteria for safety on which its requirements, judgements and decisions, in
connection with its reviews and assessments, inspections and enforcement
actions, are based.
3.11. As part of its integrated management system, the regulatory body should
establish a process for the development of regulations and guides. This process
should ensure that the regulations and guides:
(a) Provide the framework for regulatory requirements and conditions to be

incorporated into individual authorizations or applications for authorization;
(b) Establish principles, requirements and the criteria to be used for assessing
compliance;
(c) Are consistent and comprehensive;
(d) Are commensurate with the radiation risks associated with the facilities and
activities;
(e) Involve consultations with interested parties;
(f) Take into account internationally agreed standards and feedback gained
from related experience;
(g) Are made available to interested parties;
(h) Are reviewed and revised as necessary and are kept up to date.
10
3.12. Regulations have the force of law and may be issued either by the
government, or by the regulatory body on behalf of the government. The principal
purpose of establishing a system of regulations is to codify safety requirements
of general applicability that require mandatory compliance by all authorized
parties. The system of regulations should provide an appropriate balance between
regulatory provisions that are sufficiently detailed to achieve and maintain safety,
and sufficiently flexible to permit their application to developing technologies
and in new circumstances. The degree to which the regulations are performance
based or prescriptive, and the level of detail in the associated guidance, will
depend on the national approach; however, this should not reduce the authorized
party’s prime responsibility for safety.
3.13. The regulatory body may develop safety objectives and requirements
itself or it may adopt objectives and requirements that have been developed and
issued by international organizations or by regulatory bodies in other States. If
safety objectives and regulatory requirements are to be adopted, the regulatory
body should ensure that it obtains a good understanding of their basis, use and
effectiveness in other States by means of appropriate contact with the relevant
bodies. Safety objectives and regulatory requirements should be adopted as
necessary for specific purposes.
3.14. The safety objectives and regulatory requirements should specify the
performance criteria for structures, systems and components, and management
and operational procedures and processes, to be achieved in operating the facility
or conducting the activity. The regulatory body should refrain from prescribing
specific designs, management systems or operational procedures.
3.15. The safety objectives and regulatory requirements should include the
following, as appropriate:
(a) Emphasis on prevention of, rather than mitigation of, accidents;

(b) Application of the concept of defence in depth;
(c) Meeting the single failure criterion for safety systems;
(d) Requirements for redundancy, diversity and separation;
(e) Requirements for adequate safety demonstration of any passive systems
that are used;
(f) Criteria relating to human factors and the human–machine interface;
(g) Dose limits and dose constraints (for both occupational exposure and public
exposure), and limits on discharges to the environment;
(h) Criteria for assessing radiation risks to workers and the public;
11
(i) Minimization of waste and management of the waste generated, including
waste from decommissioning;
(j) Emergency preparedness.
3.16. The regulations should explicitly state the obligations, roles and
responsibilities of the applicant or authorized party. In this respect, the regulatory
body should include provisions in the regulations requiring that the applicant
or authorized party accomplish some or all of the following, depending on the
facility or activity:
(a) Prepare and submit a comprehensive application to the regulatory body that
demonstrates that highest priority is given to safety; this means that the
level of safety is as high as reasonably achievable and that safety will be
maintained for the entire lifetime of the facility or duration of the activity,
until it is released from regulatory control by the regulatory body.
(b) Have the capability within its own organization (either at the facility or
activity or within the organization as a whole) to understand the design basis
and safety analyses for the facility or activity, and the limits and conditions
under which the facility is to be operated or the activity performed.
(c) Exercise control over the work of contractors, understand the safety
significance of their work (an ‘intelligent customer’ capability7) and take
responsibility for the implementation of the work.
(d) Submit a procedure or description of the process for dealing with
modifications that may be subject to approval by the regulatory body.
(e) Have a design capability and a formal and effective external relationship
with the original design organization of the facility or equipment, or an
acceptable alternative arrangement.
(f) Assess safety in a systematic manner and on a regular basis.
(g) Develop a safety assessment and submit it to the regulatory body as part of
the application, depending on the magnitude of the possible radiation risks
associated with the facility or activity (e.g. if there is a possibility for an
exposure to be greater than a level specified by the regulatory body).
(h) Have an appropriate prospective assessment made of radiological
environmental impacts, commensurate with the radiation risks associated
with the facility or activity (see GSR Part 3 [3], para. 3.9(e)).
7
An intelligent customer capability is the capability of the organization to have a clear
understanding and knowledge of the product or service being supplied. The intelligent customer
concept relates mainly to a capability required of organizations when using contractors or
external expert support.
12
(i) For an application for authorization, demonstrate that it has and will
continue to maintain:
(i) Adequate financial resources for construction, operation and
maintenance of the facility or activity as well as for the timely
decommissioning (or closure) of the facility or termination of the
activity and the management of radioactive waste and/or spent
radiation sources, including disposal;
(ii) Adequate human resources to safely construct, maintain, operate and
decommission the facility or activity and deal with any radioactive
material and waste and to ensure that regulatory requirements and
safety standards are met and will continue to be met.
3.17. A system of regulations is no substitute for good technical and

administrative approaches. Unduly detailed formal regulatory requirements can
inhibit engineering innovation and good management initiatives, and may even
be counterproductive if they have the effect of relieving (or tending to relieve)
the authorized party of the responsibility for safety. Only a serious commitment
to safety on the part of all those concerned, not limited to the obligation just to
meet regulatory requirements, will engender a strong safety culture and bring
about lasting resolutions of safety issues.
3.18. Irrespective of the degree to which the government or regulatory body has
developed prescriptive regulations, the regulatory body should give consideration
to supplementing its regulations with supporting guides of a non-mandatory
nature on how to comply with regulations, where appropriate.
3.19. Guides are advisory in nature; they should allow the authorized party
flexibility in applying new technologies and developing new procedures to
enhance safety. The processes for developing guides should also enable the
regulatory body to promote learning and improvement by modifying guides
as necessary to include innovative good practices and to revoke impractical or
unnecessary provisions.
3.20. The overall purpose of guides is to advise authorized parties on how to

comply with laws and regulations, and on how to implement the regulatory
requirements, thus improving effectiveness and efficiency and enhancing safety.
Guides also provide detailed and specific information on acceptable technical
and administrative approaches to satisfying the requirements established in the
regulations. Guides should always be consistent with the law and regulations.
13
3.21. In developing guides, recent operating experience and developments should
be taken into account, including technological advances that have been shown by
experience or by research results to be capable of providing effective and reliable
means of satisfying regulatory requirements.
3.22. The regulatory body should, where appropriate, also support the production
of guidance documents by professional bodies wishing to help their members
in the discharge of their responsibilities regarding safety; the provision of such
support should be such that any undue influence that may compromise regulatory
independence is avoided.
3.23. In determining whether a particular topic should be made mandatory and

thus be addressed in a regulation rather than a guide, consideration should be
given to the regulatory requirements and the extent to which the topic in question
can be considered as essential for implementing these requirements.
3.24. Safety requirements that apply to a particular type of facility or activity

should be established in the regulations. Other safety requirements, such as those
applicable for only a short duration or relating to a particular characteristic of
an individual facility or activity, should be specified in mandatory conditions
attached to the authorization (see para. 3.112). However, the extent to which
detailed provisions are made in authorization conditions will depend upon the
legal system and the approach to authorization of the State concerned.
Scope and content of regulations and guides
3.25. Requirement 3 of GSR Part 3 [3] states that: “The regulatory body shall
establish or adopt regulations and guides for protection and safety and shall
establish a system to ensure their implementation.”
The system is required to cover all exposure situations, namely planned exposure
situations, emergency exposure situations and existing exposure situations (see
para. 2.29 of GSR Part 3 [3]).
3.26. The regulatory body is required to establish a regulatory system for safety
that includes (see GSR Part 3 [3], para. 2.30):
(a) Notification and authorization; the regulations should provide clarity and
transparency in the notification and authorization process.
(b) Review and assessment of facilities and activities; the regulations should
require a demonstration of the safety of the facility or activity that enables
14
the regulatory body to make a decision or a series of decisions on the
acceptability of the facility or activity in terms of safety.
(c) Inspection of facilities and activities; the regulatory body should provide
its inspectors with written guidelines in sufficient detail to ensure that
facilities and activities are inspected to a common standard, based on a
graded approach, and that there is a consistent level of safety.
(d) Enforcement of regulatory requirements; the regulatory body should adopt
clear administrative procedures and guidelines governing the use and
implementation of enforcement actions.
(e) The regulatory functions relevant to emergency exposure situations and
existing exposure situations.
(f) Provision of information to, and consultation with, parties affected by its
decisions and, as appropriate, the public and other interested parties.
3.27. The government or the regulatory body should ensure that the following
technical, administrative and procedural topics and requirements are included
in the regulations, if appropriate, depending on the State’s legal system and
practices:
(a) The name and location of the regulatory body;

(b) The purpose of the regulations, their scope and their date of entry into force;
(c) The powers of the regulatory body, such as powers of authorization,
inspection and enforcement;
(d) The relationship of a given set of regulations to other governmental
regulations in force;
(e) The criteria for exemption from some or all of the regulatory requirements;
(f) Requirements for planned exposure situations, emergency exposure
situations and existing exposure situations;
(g) Requirements for occupational exposure, public exposure and medical
exposure;
(h) Requirements for construction, commissioning, operation and
decommissioning (or closure) of facilities, management of radioactive
waste and transport of radioactive material;
(i) The financial arrangements for dealing with orphan sources and waste
management (including decommissioning and waste disposal);
(j) Acceptance criteria and performance criteria for any manufactured or
constructed source, device, equipment or facility that when in use has
implications for safety;
(k) Criteria and methods for assessing the adequacy of the implementation of
remediation following contamination;
15
(l) Safety criteria and planning for radioactive waste management and
discharge monitoring, as well as aspects of institutional controls at different
stages of the authorized facility or activity’s lifetime, including removal
from regulatory control.
Notification and authorization
3.28. Requirement 7 of GSR Part 3 [3] states that: “Any person or organization
intending to operate a facility or to conduct an activity shall submit to
the regulatory body a notification and, as appropriate, an application for
authorization.”
As part of the regulations, the regulatory body should clarify those facilities and
activities for which only notification is required and those facilities and activities
for which authorization is required, by providing criteria or lists of activities. The
regulations and guides should cover all the major aspects to be dealt with at all
steps of the authorization process.
“The applicant shall be required to submit or to make available to the

regulatory body, in accordance with agreed timelines, all necessary
safety related information as specified in advance or as requested in the
authorization process.”
3.30. The regulatory body should issue detailed guidance for applicants on how
to notify of the intention to conduct an activity or how to apply for authorization.
The guidance for applicants for an authorization may include, as appropriate:
(a) Guidance on the format and content of the documents to be submitted by

the applicant in support of an application for an authorization, including
printed (or electronic) forms to be completed by authorized parties in a
question and answer format, so that all relevant information is gathered.
Guidance for nuclear power plants is provided in IAEA Safety Standards
Series No. GS-G-4.1, Format and Content of the Safety Analysis Report
for Nuclear Power Plants [14]; guidance for research reactors is provided
in IAEA Safety Standards Series No. SSG-20, Safety Assessment for
Research Reactors and Preparation of the Safety Analysis Report [15].
(b) A list clearly stating the regulations and standards to be applied.
(c) Advance information on the requirements for each major stage of
authorization, in order to assist the authorized party in making sound plans
16
and decisions with respect to safety in the siting, design, construction,
commissioning, operation and decommissioning or closure of a facility or
conduct and termination of an activity.
Main contents of an authorization
3.31. The main contents of an authorization, as well as the objectives of possible

authorization conditions, should be specified within regulations and guides.
Detailed recommendations on notification and authorization are provided in
paras 3.73–3.146.
Documentation to be submitted by the authorized party
3.32. The regulations and guides describing the authorization process should
identify the essential documents to be prepared and submitted by the authorized
party. Additional documents may be requested as necessary, depending on the
type of facility or activity, in accordance with a graded approach and at specific
steps in the authorization process.
3.33. The regulations and guides should indicate other documents that should be
submitted to the regulatory body to confirm that the requirements established in
the regulations and in the authorization conditions have been satisfied.
Reporting of events
3.34. The regulations or the authorization conditions should specify the

requirements for reporting to the regulatory body on events that are considered
significant to safety. The regulations or the authorization conditions should
specify the types of event that require reporting and the reporting procedures
including the method of reporting and the time limit for reporting. They should
also specify that an investigation is to be carried out by the authorized party and a
report prepared and submitted to the regulatory body within a specified period of
time, covering details of the event, details of associated doses and environmental
impacts, the findings of the investigation performed and proposals for corrective
actions. The requirements for such reporting should be applied in accordance
with the severity of the event.
Reporting of design changes, modifications and non-conformances
3.35. The regulations and guides should specify the requirements for the reporting
of changes to the design, prior to their implementation, and design deficiencies
17
and non-conformances identified during commissioning or operation. The
requirements for such reporting should be applied in accordance with the safety
significance of the change, modification or non-conformance.
Records to be kept by the authorized party
3.36. The regulations and guides should specify requirements for the authorized
party to keep adequate records relating to the safety of facilities and activities.
Such records, even if not formally requested by the regulatory body for review
and approval, should be capable of being made available, as necessary. The
regulations and/or the authorization conditions should establish the types of
records to be kept and the periods for which they are to be retained. In specifying
the retention period, account should be taken of the possible future need to refer
to these records and of the difficulties of regenerating the information.
Records to be kept by the regulatory body
“The regulatory body shall make provision for establishing,

maintaining and retrieving adequate records relating to the safety of
facilities and activities.”
“The regulatory body shall make provision for establishing and maintaining
the following main registers and inventories:
—— Registers of sealed radioactive sources and radiation generators;10

Records of doses from occupational exposure;
—— Records relating to the safety of facilities and activities;
—— Records that might be necessary for the shutdown and decommissioning
(or closure) of facilities;
—— Records of events, including non-routine releases of radioactive
material to the environment;
—— Inventories of radioactive waste and of spent fuel.
“10
The regulatory body specifies which sources are to be included in the registers and
inventories, with due consideration given to the associated risks.”
18
3.39. The regulatory body should also make provision for the establishment and
maintenance of records by authorized parties of unsealed sources and records of
airborne and liquid releases during normal operation.
3.40. Such registers and inventories may be held by the regulatory body or by the
authorized party. If the regulatory body is not the sole entity responsible for the
maintenance of such registers and inventories, it should ensure that the authorized
party has arrangements for their proper retention and retrieval. The responsibility
of the regulatory body to maintain safety related records at a national level should
not diminish the responsibility of authorized parties to keep their own records.
Regulations and guides for review and assessment
“The regulatory body shall review and assess relevant information…

to determine whether facilities and activities comply with regulatory
requirements…”
3.42. Further, Requirement 26 of GSR Part 1 (Rev. 1) [2] states that:
“Review and assessment of a facility or an activity shall be

commensurate with the radiation risks associated with the facility or
activity, in accordance with a graded approach.”
3.43. In order to fulfil these requirements, the regulatory body should issue
regulations and guides that describe the safety assessments to be performed by
the authorized party for the facility or activity, and how these should be submitted
for review by the regulatory body prior to the granting of the authorization at
each lifetime stage. Further requirements for safety assessment are established in
paras 3.29–3.36 of GSR Part 3 [3] and in IAEA Safety Standards Series No. GSR
Part 4 (Rev. 1), Safety Assessment for Facilities and Activities [16].
3.44. In carrying out its review and assessment, the regulatory body should refer
to the relevant regulatory requirements when deciding on the acceptability of an
authorized party’s submission.
Regulations and guides for enforcement
3.45. The regulations and guides governing the use and implementation of
enforcement actions should include the policy for the use of regulatory and
19
enforcement measures and the associated authority delegated to inspectors and
other regulatory body staff. Depending on national practices, the need to allow
the authorized party to state a point of view on regulatory decisions, to respond
to enforcement actions and to appeal against enforcement decisions should be
recognized and taken into account in regulations and guides. In some States,
the regulations and guides specify that a hearing with the authorized party be
initiated before significant enforcement actions are taken.
3.46. Considering the level of detail of legislation and regulations, guides should
describe the decision making approach of the regulatory body in determining the
type and extent of the enforcement actions to be taken and the way in which
the actions are to be taken, including how the failure of the authorized party
to comply with requirements for regulatory enforcement is dealt with. Guides
should also indicate which other governmental organizations, if any, are to be
informed in the event of enforcement actions.
Exemption and clearance from regulatory requirements
3.47. Requirement 8 of GSR Part 3 [3] states that:
“The government or the regulatory body shall determine which

practices or sources within practices are to be exempted from some or all
of the requirements of [GSR Part 3]. The regulatory body shall approve
which sources, including materials and objects, within notified practices
or authorized practices may be cleared from regulatory control.”
3.48. In this respect, the government or the regulatory body is required to

determine within the regulations:
(a) Which activities and/or radiation sources are to be exempted from some
or all of the legislative requirements, including the requirements for
notification or authorization. The regulatory body is required to use
as a basis for this determination the criteria for exemption specified in
Schedule I of GSR Part 3 [3], or to specify any exemption levels on the
basis of these criteria. The regulations should clearly state that exemption
cannot be granted for activities deemed to be not justified (see paras 3.10
and 3.11 of GSR Part 3 [3]).
(b) Which sources, including materials and objects, within notified or
authorized activities may be cleared from further regulatory control. The
regulatory body is required to use as the basis for this determination the
criteria for clearance specified in Schedule I of GSR Part 3 [3], or to
20
specify any clearance levels on the basis of these criteria. By means of
these arrangements, the regulatory body is required to ensure that sources
that have been cleared from regulatory control do not again become subject
to the requirements for notification or authorization unless the regulatory
body so specifies (see para. 3.12 of GSR Part 3 [3]).
Regulations and guides on the release criteria for sites
3.49. The regulations and guides should specify generic release criteria for
use in the evaluation of potential radiological consequences associated with a
site after its release. In order to derive release criteria (in, for example, Bq/g or
Bq/cm2), all relevant exposure pathways should be considered and dose
assessment involving direct radiation, inhalation and ingestion pathways should
be used.
3.50. Alternatively, the authorized party can derive site specific release criteria,
on the basis of an optimization process, which the regulatory body should review
and assess and then approve, if considered adequate.
Process for development, review and revision of regulations and guides
“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. Moreover, technological advances, research and
development work, relevant operational lessons learned and institutional
knowledge can be valuable and shall be used as appropriate in revising the
regulations and guides.”
Sources of information and general guidance
3.52. The nature of the national legal framework, more than any other single
factor, will determine the form and content of the regulations and guides. As
an initial source of information, the regulatory body should base its regulations
and guides on national legislation and should make use of existing national
regulations or technical standards in areas relating to, or adaptable to, facilities
and activities. The degree to which the regulations are prescriptive will depend on
21
national approaches. In some States, for example, detailed guidance is preferred
to prescriptive regulations.
3.53. While regulations may be established, in whole or in part, by the

government, the regulatory body should be involved in the development
process. The following paragraphs cover the role of the regulatory body in the
development process.
3.54. In developing regulations and guides, consideration should be given to

adopting, either directly or as a reference, the IAEA’s safety standards. IAEA
safety standards are established in the form of specific requirements and
recommendations so as to facilitate their incorporation into regulations. Although
IAEA safety standards may be adopted individually or collectively, adaptation,
rewording and amendment may be necessary, depending on the national legal
system. IAEA safety standards may be adopted into national regulations by
the addition of appropriate specific requirements, or by referencing the safety
standards, or by adapting the safety standards as necessary, or by issuing them as
national guides or incorporating them into guides.
3.55. Consideration should be given to obtaining advice on and support in the

development of regulations and guides from international organizations, such as
the IAEA, and from the regulatory bodies of other States. When the design of
a facility or the performance of an activity originates in another State, it may
be particularly useful to seek advice and support from the regulatory body of
that State. States embarking on a nuclear power programme should consider
regulations developed by the State supplying the facility.
3.56. When regulations, guides and other relevant information issued by a

regulatory body in another State are considered in the development of regulations,
particular attention should be paid to the legal framework of that State. Owing to
differences between States’ legal and governmental infrastructures, and available
resources, it is unlikely that the regulatory body will be able to adopt regulations
issued in another State without revision. In adapting regulations and guides
issued in another State, the regulatory body should ensure that it understands the
regulations in terms of their technical background and significance and the legal
and regulatory framework in the State that issued them.
3.57. The regulatory body, as part of the drafting process, should consider
performing comparisons of its national regulations and guides with international
standards.
22
3.58. Consideration should also be given to other sources of information relevant
to safety. This could include relevant industrial standards (in their entirety or in
part), technical standards developed in other States, experience from the nuclear
industry and from users of radiation sources, and the results of research in nuclear
and radiation safety.
3.59. The regulatory body may find it useful to set up an advisory committee to
advise on the need for regulations and on their technical content. The members
of the advisory committee should be independent of the regulatory body and of
authorized parties to ensure separate and unbiased reviews. Such an advisory
committee can provide a valuable service to the regulatory body by helping to
ensure that policies and regulations are clear, practicable and complete.
3.60. The regulatory body should follow a consistent process for establishing,
reviewing and revising regulations and guides. The process should be well
documented, comprehensive, cover all regulated activities and facilities, and
should ensure a clear allocation of responsibilities. When establishing new
regulations as well as revising existing regulations, careful consideration should
be given to the cumulative effect of changes on safety.
3.61. The process of developing regulations and guides should be described in

procedures and should be sufficiently flexible to permit timely revisions to be
made to take account of changes in technological, legal and practical conditions.
3.62. Owing to variations in the legal systems and practices of States, it is

impossible to provide detailed procedural guidance for establishing regulations
and guides to be used by all States. However, certain basic steps for establishing
regulations and guides can be specified, and are described in the following.
Process for establishing regulations and guides
3.63. The process used by the regulatory body to establish regulations and guides
should include the following steps:
(a) Determining the need for the regulations or guide. This need may arise
from the regulatory body’s activities and from the inventory of facilities
and activities in the State. Alternatively, the need may be identified as a
result of a request or enquiry by an authorized party, or an applicant for a
new facility or activity. Additionally, the need for regulations may arise as a
result of national debates or to meet international obligations.
23
(b) Setting the priority for the development of the regulations or guide. The
regulatory body should consider the advantages and disadvantages of
the proposed regulations or guide, including such matters as: the risks
associated with the facility or activity; the need for, and the costs associated
with, improvements in safety; the number of authorized parties to be
affected; the effects on the efficiency of the authorization process; and
the feedback of information and experience from review and assessments,
inspections, investigations and enforcement activities.
(c) Determining the scope of the regulations or guide. This involves
clear identification of the facilities and activities to which regulatory
requirements or recommendations are to be applied, as well as the stage
of the authorization process to be covered and the technical topic to be
addressed.
(d) Determining the resources necessary to develop the regulations or guide.
The development of regulations and guides requires sufficient suitably
qualified, competent and experienced people to be available, as well as
adequate financial and other resources [4]. The need for the regulations or
guide and the timescale required for its preparation and establishment will
be a factor in determining the resources required.
(e) Collection of information. The information necessary to prepare the
proposed regulations or guide should be collected. In particular, the state of
the art in technology should be taken into account.
(f) Drafting of the regulations or guide. The staff of the regulatory body,
assisted by technical support organizations, consultants, professional
societies or advisory committees, drafts the initial version of the regulations
or guide. Regulations and guides should be written in a style that is clear and
easy to understand. Regulations and guides should be relevant, precise and
unambiguous so as to be readily applicable and enforceable, as appropriate.
(g) Review of the regulations or guide. Although practices differ widely, legal
staff and special advisory committees, as appropriate, usually review
the initial versions of proposed regulations or guides. In some States,
authorized parties, professional societies or other organizations participate
in these reviews. A draft version may also be published provisionally with
an invitation for comment from the interested parties. Comments received
as a result of the review should be analysed, evaluated and resolved, as
appropriate. A review of the final draft for quality control should be carried
out before formal approval. At this stage, consideration should also be given
to the implications of the new regulations or guide for existing facilities and
activities.
(h) Establishing and issuing the regulations or guide. Regulations should be
established and promulgated in a manner that makes them legally binding
24
in accordance with the national legal system, thereby ensuring that their
provisions can be enforced by the regulatory body. The procedure for
issuing guides should follow steps similar to those for regulations, but
a guide can be formally issued with a lower level of approval, since its
contents are only advisory in nature.
3.64. Consideration should be given to grouping the guides, for example:
(a) Detailed or specific recommendations, concerning specific facilities,

activities, equipment, operating procedures and protocols, and the
qualification and training of personnel, that can be adopted by authorized
parties as a means of meeting regulations;
(b) Practical protection and safety manuals covering various activities and
procedures that serve as aids for the training of workers and for management
in setting up local rules;
(c) Procedural guides, such as those pertaining to instrument calibration,
individual monitoring, environmental surveys and radioactive waste
management, for use by authorized parties and/or technical service
providers;
(d) Guidance relating to the safety of persons undergoing medical exposure;
(e) Guidance on developing safety assessments that identifies areas that need
to be evaluated or reviewed for the authorization;
(f) Guidance on the safe transport of radioactive material;
(g) Procedures for the conduct of investigations;
(h) Guidance on the development of emergency plans and emergency
procedures.
Process for review and revision of regulations and guides
3.65. The regulatory body should ensure that the regulations and guides are kept
up to date and should establish procedures, within its integrated management
system, for their periodic review.
3.66. Experience from implementing the regulations should be examined and

any problems or difficulties should be duly considered. The status of relevant
requirements should also be examined in the light of new safety related
developments. The possible effects of frequent changes in regulations and guides
on the stability of the regulatory system should be taken into account. 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
25
of information and experience from events, as well as from relevant national and
international good practices; technological advances; and the need to improve
or eliminate any impractical, misleading, unenforceable or otherwise inadequate
regulations.
3.67. The procedures applicable in the development of regulations may also be

followed for making revisions. Authorized parties and other interested parties
potentially affected by the revised regulations should be given adequate time to
complete any preparations that may be necessary to enable them to comply with
newly established requirements.
3.68. The process and procedures established for the revision of regulations and
guides should not diminish the authority of the regulatory body to take immediate
action if required for reasons of safety.
Impact of the revision of regulations
“The regulatory body shall…recognize the risks associated with making

modifications to well established practices. Prospective changes in
regulatory requirements shall be subject to careful scrutiny, to evaluate the
possible enhancements in safety that are to be achieved. The regulatory
body shall also inform and consult interested parties in relation to the basis
for such proposed changes in regulatory requirements.”
3.70. In revising regulations, special care should be taken to ensure that no

contradictions or inconsistencies arise between the retained parts and the revised
parts of a regulation.
3.71. The extent to which the proposed changes are to be made applicable to
facilities and activities that have already been authorized and the degree of
back-fitting to be required should also be considered.
Internal guidance
3.72. In order to ensure a systematic and consistent approach, the regulatory

body should develop internal guidance on the processes and procedures to be
followed to carry out the regulatory functions in an effective and efficient manner
as well as on the safety objectives to be met. Detailed guidance on specific
topics is provided in the relevant parts of this section. Consideration should be
26
given to the extent to which the regulatory body’s internal guidance may be
made available to authorized parties and the public and other interested parties.
Publication is an important aspect of communication with interested parties and
openness demonstrates that the regulatory body is discharging its responsibilities
in an appropriate manner.
NOTIFICATION AND AUTHORIZATION
General
“Any person or organization intending to operate a facility or to

conduct an activity shall submit to the regulatory body a notification
and, as appropriate, an application for authorization.”
3.74. The notification and, as appropriate, the application for authorization

should be submitted on forms prescribed by the regulatory body with information
that is commensurate with the level of radiation risk associated with operating
the facility or conducting the activity.
“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.”
3.76. The concepts of notification, authorization by registration, and authorization

by licensing broadly represent a graded approach to regulatory control based
upon the levels of risk or the nature of the facility or activity.
3.77. The regulatory body is required to determine which facilities or activities

are to be exempted from the requirements for notification or authorization,
using as the basis for this determination the criteria for exemption specified in
Schedule I of GSR Part 3 [3] or any exemption levels specified by the regulatory
body on the basis of these criteria.
27
3.78. A notification is “[a] document submitted to the regulatory body by a
person or organization to notify an intention to carry out a practice or other use
of a source” [8].
3.79. For some activities that are suitable for exemption, there may be particular
reasons why a notification should be submitted (e.g. to prevent uncontrolled
waste disposal).
3.80. Paragraph 3.7 of GSR Part 3 [3] states that:
“Notification alone is sufficient provided that the exposures expected to

be associated with the practice or action are unlikely to exceed a small
fraction, as specified by the regulatory body, of the relevant limits, and that
the likelihood and magnitude of potential exposures and any other potential
detrimental consequences are negligible.”
3.81. Where notification alone is insufficient (i.e. because the exposures

expected to be associated with the facility or activity have the potential to exceed
the small fraction of the limit specified by the regulatory body) an application
for authorization should be submitted to the regulatory body. An application
for authorization may also serve as notification. Where a notification has been
submitted, but the regulatory body determines that the potential exposures can
exceed the specified limit for notification, an authorization should be required.
3.82. The authorization process is the principal means by which the regulatory
body is able to initially apply the legal and regulatory framework and by which
the responsibilities of the applicant or authorized party are clearly connected to
the legal framework.
3.83. Authorization is required to take the form of either registration or

licensing [3]. Other terms are used for authorization, including certification,
granting of a permit, agreement, consent, approval or granting of another similar
regulatory instrument, depending on the governmental and regulatory framework
of the particular State. For complex facilities or activities and where the radiation
risks are significant, the authorization process is usually referred to as a licensing
process, which results in a licence in the form of a legal document issued by the
regulatory body granting authorization to perform specified activities relating to
operation of a facility or conduct of an activity.
3.84. Registration is “[a] form of authorization for facilities and activities of low
or moderate risks whereby the person or organization responsible for the practice
28
has, as appropriate, prepared and submitted a safety assessment of the facilities
and equipment to the regulatory body” [8]. The regulatory body should determine
which facilities and activities require authorization by registration only and for
which a licensing process is required. In either case, the facility or activity should
be authorized with conditions or limitations as appropriate. The requirements
for safety assessment and the conditions or limitations applied to the facilities
or activities would be less severe for registration than those for issuing a licence.
3.85. With regard to material being transported in accordance with IAEA

Safety Standards Series No. SSR-6 (Rev. 1), Regulations for the Safe Transport
of Radioactive Material [17], the requirements established in GSR Part 3 [3]
for notification and authorization are fulfilled by means of compliance with
SSR-6 (Rev. 1) [17].
3.86. Authorizations should be granted or denied in accordance with the

governmental, legal and regulatory framework and should cover all stages
of the lifetime of a facility or activity. For a nuclear facility, for example, this
encompasses site evaluation, design, manufacturing, construction, installation,
commissioning, operation, decommissioning (or closure) and subsequent release
of the site from regulatory control.
3.87. The legal framework of the State should set out the responsibilities for
issuing an authorization and, in particular, should determine who is empowered
to issue authorizations. Depending on the system used in the particular State,
different authorizations may be issued by different authorities. Requirement 7 of
GSR Part 1 (Rev. 1) [2] states that:
“Where several authorities have responsibilities for safety within the

regulatory framework for safety, the government shall make provision
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.”
3.88. Paragraph 3.9(b) of GSR Part 3 [3] states that:
“Any person or organization applying for authorization…[s]hall refrain

from carrying out any of the actions [covered by the application] until the
registration or the licence has been issued”.
3.89. The authorized party is the legal person or organization that has prime
responsibility for safety and retains this responsibility even if the validity of an
29
authorization expires or lapses, or if the authorization is revoked by the regulatory
body. However, the responsibilities conferred by the authorization may be
transferred to a different authorized party (e.g. upon change of ownership, where
this has been approved by the regulatory body).
3.90. After having determined that the justification principle has been
implemented, the regulatory body should specify the conditions under which
consumer products that contain radioactive material may be made available to
the public, who have no regulatory obligation with respect to the product. In this
context, the presumption is that the consumer product can be used and disposed
of without any special safety measures being required. The provision of consumer
products to the public is subject to authorization by the regulatory body unless
their use has been exempted (see Requirement 33 of GSR Part 3 [3]).
Objectives of notification and authorization
3.91. The objective of notification is to provide initial information to the

regulatory body that a person or organization is intending to operate a facility or
conduct an activity. The regulatory body should use the information received in
the notification process to update the registers of sources, facilities and activities
and to decide on the level of regulatory control to be applied. The notification
should be reviewed and, if necessary, the regulatory body should inform the
person or organization as to what further regulatory interactions will be required.
3.92. The objective of granting authorizations is for the regulatory body to

establish effective regulatory control for safety throughout the lifetime of a
facility or activity. The authorization process should require assurance by the
applicant that it can comply with all safety requirements.
General principles for authorization
3.93. Principles for authorization should be established in the regulatory and

legal framework. Examples of principles for authorization include the following:
(a) A facility or activity should be authorized only when the regulatory body
has confirmed, by review and assessment of the submitted documentation,
that the facility or activity is going to be used or conducted in a manner
that does not pose an unacceptable radiation risk to people or the
environment. This should include confirmation that the applicant has the
organizational capability, the organizational structure, adequate resources,
adequate competence of managers and staff, and appropriate management
30
arrangements to comply with the safety requirements to become an
authorized party.
(b) The regulatory framework for dealing with requests for authorization
should be clear, especially the process for applying for authorization.
(c) The regulatory framework for the authorization process should be explicitly
established by the regulatory body.
(d) The authorization of a facility or activity should be based on a predefined
list of documents that are to be submitted to the regulatory body by the
person or organization responsible for the facility or activity. These
documents should be reviewed by the regulatory body. Expenses associated
with the authorization process and the person or organization that will be
charged these expenses should be clearly specified.
(e) A clear and explicit set of requirements, criteria and standards forming the
basis for authorization should be defined.
(f) A graded approach should be taken by the regulatory body when performing
reviews, assessments or inspections throughout the authorization process.
(g) Clear mechanisms should be established for public participation in the
authorization process.
(h) The authorization process should be transparent to the public, and
authorizations should be published or made available to the public by
other means, with account taken of the need for information security and
protection of proprietary information.
(i) The regulatory body should include conditions in the authorization, as
appropriate.
(j) The scope of the authorization (the site, the facility or activity, or parts
of the facility or activity; or whether the authorization is one of a series
of authorizations), its period of validity and any incorporated conditions
should be clearly defined by the regulatory body.
(k) Responsibility for safety may be transferred to a different authorized party,
depending on national regulations; however, this may be done only with
the agreement of the regulatory body, which may attach provisions and
conditions to the new authorization (see para. 2.14 of GSR Part 1 (Rev. 1) [2]).
(l) The applicant and the regulatory body should take into account good
practices in other States, as appropriate, throughout the authorization
process.
(m) Regulatory review and assessment of reference or generic facilities and
activities, and of similar facilities or activities in the State or other States,
should be taken into account, if this would contribute to the authorization
process.
31
(n) The analysis approach to demonstrating safety should be clearly defined,
including the use of deterministic and probabilistic methodologies and
analytical tools, as appropriate.
(o) Safety reviews should be carried out by the authorized party as required
by the conditions in the authorization, and the results should be submitted
to the regulatory body for review and assessment. Appropriate regulatory
decisions may then follow.
(p) The prime responsibility for safety is assigned to and assumed by the
person or organization responsible for a facility or activity that gives rise to
radiation risks. Compliance with regulations and requirements imposed by
the regulatory body does not relieve the person or organization responsible
for any facility or activity of the prime responsibility for safety (see
Requirement 6 of GSR Part 1 (Rev. 1) [2]). The person or organization
responsible for a facility or activity should demonstrate to the satisfaction
of the regulatory body that this prime responsibility has been and will
continue to be fulfilled.
(q) The means of challenging or appealing against an authorization or part of
an authorization should be made clear by the regulatory body and within
the regulatory framework.
3.94. The legal and regulatory framework should include provisions for
unrestricted access for designated staff of the regulatory body, at any time, to:
the premises of an applicant or authorized party, any facility or activity already
authorized or for which an application for authorization has been submitted, and
any documents relating to safety and considered necessary for the authorization
process.
3.95. The regulatory body should ensure that any interfaces between safety and
nuclear security measures are addressed by the authorized party or applicant and
are appropriately considered in conjunction with the competent authority with
responsibility for nuclear security.
Information to be provided in the submission of a notification or application

for authorization
Notification
3.96. The regulatory body should specify the minimum information to be

submitted in support of notification by a person or organization intending to
operate a facility or conduct an activity that involves the use of radiation sources,
including the following:
32
(a) Clear identification of the applicant submitting the notification;
(b) Information on the provisions for justification of the facility or activity;
(c) The location(s) of the facility and, if applicable, where the radiation
source(s) will be stored and used;
(d) Specification of the management system for the facility or activity;
(e) Clear specification of the equipment to be used in the facility or activity,
including the radiation source(s) and associated equipment.
Authorization
“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.”
3.98. The applicant should provide all relevant information describing the
approach to safety in order to demonstrate that the facility or the activity will
not present unacceptable radiation risks to people and the environment. This
should include proposed objectives, principles, criteria, standards and analyses
in relation to safety for all stages of the authorization process. The aim should be
to provide all the relevant information such that the regulatory body can conduct
its review and assessment process without needing to seek further information or
clarification.
3.99. The documents submitted to the regulatory body in the framework of the
authorization process should be updated, as appropriate, during the lifetime of
the facility or activity, to ensure they cover relevant aspects. The documents
submitted to the regulatory body (which may be divided or combined into
different documents, as appropriate) should be incorporated as part of the
authorization, if required by national regulations and the regulatory approach and
practices.
3.100. For complex facilities or activities, before an applicant submits an

application, the regulatory body should consider implementing a preparatory
phase, in which basic safety requirements to be met and the authorization process
to be followed are made clear to the applicant. This may include specification
of, for example, the language, units, methodology and format of the proposed
application. In this phase, it should be ensured that the staff of the regulatory
body receive suitable training and have sufficient knowledge of the design of the
facility or the proposed activity. Detailed and explicit design requirements for the
33
facility or characteristics of the activity should be developed in the early stages of
the authorization process.
3.101. Early assessment of the competence and capability of the applicant

should be conducted to ensure that the applicant will be able to manage all stages
of the lifetime of the facility or the full duration of the activity. At a very early
stage, the applicant should be encouraged to conduct a study to identify the staff
and competences it will need in the different stages in the lifetime of the facility
or the duration of the activity and should give consideration to how and from
where it will recruit such staff.
3.102. The extent of the information to be submitted to support an application

for authorization should take into account the type of facility or activity. The
scope of the information required should depend on the stage in the lifetime for
which the authorization is being considered. The information should include, as
applicable:
(a) Legal information:

(i) The formal name and address of the applicant and any additional
contact information, such as the name of the individual(s) representing
the applicant;
(ii) Details of any relevant existing authorizations;
(iii) Information on whether the facility or activity is fully or partly
owned or controlled by a person from another State or by a foreign
corporation, and, if so, details of the ownership structure.
(b) Information on organizational matters:
(i) The applicant’s organizational structure;
(ii) Evidence that the applicant has and will continue to maintain adequate
financial resources to cover the necessary costs associated with
safety, such as regulatory fees, liability insurance and funding for
decommissioning or radioactive waste management, as applicable,
depending on national legislation and regulation;
(iii) Evidence that the applicant has adequate human resources to ensure
that regulatory requirements and safety standards are met and will
continue to be met throughout the lifetime of the facility or activity.
(c) Characteristics of the site and the facility or activity:
(i) The nature of the facility or activity that is the subject of the
application;
(ii) A description of the relevant premises, including the layout of the
facility, buildings and equipment;
34
(iii) Where relevant, a description of the site in terms of geography,
demography, topography, meteorology, hydrology, geology and
seismology.
(d) Staff qualification and training:
(i) Identification of the necessary qualifications and training of staff who
will have safety related responsibilities;
(ii) For authorization of certain facilities or activities, the identification
of persons by name may be required to be included in the application
(e.g. the name of radiation protection officers or qualified experts);
(iii) Details of qualifications and training in radiation protection of workers
engaged in activities that involve or could involve occupational
exposure;
(iv) Evidence of trustworthiness of all staff who will be engaged in
responsible or sensitive positions.
(e) The management system:
(i) For relevant safety systems of facilities or activities with significant
risk, the operating procedures and maintenance procedures that will
be followed;
(ii) A description of the system for identification, traceability and
preservation of documents and for control of records;
(iii) The system for the development of procedures;
(iv) Procedures for reporting on and learning from operating experience
including accidents and other incidents;
(v) Procedures for learning from good practices in the State and in other
States;
(vi) A description of the arrangements for establishing and sustaining
leadership and management on the part of organizations and managers
responsible for facilities and activities that give rise to radiation risks;
(vii) A procedure or description of the process for dealing with
modifications of the facility or activity that may be subject to approval
by the regulatory body, depending on national legislation, regulations
and practices if requirements for dealing with modifications are not
established directly in the regulations;
(viii) A description of the quality assurance arrangements established to
ensure that all items to operate the facility or conduct the activity are
designed, manufactured, constructed, assembled, tested, qualified,
operated, maintained and replaced in compliance with the relevant
safety requirements;
(ix) A description of the arrangements for ensuring the technical quality
of information provided to the applicant by external organizations
35
(e.g. contractors) for use during the operation of the facility or the
duration of the activity;
(x) Quality assurance arrangements, including internal and external
audits.
(f) Safety activities:
(i) Applicable safety regulations, guides and industrial standards.
(ii) Safety assessments for exposures in normal operation and for potential
exposures.
(iii) An appropriate prospective assessment of radiological environmental
impacts, commensurate with the radiation risks associated with the
facility or activity, as required by the regulatory body (see para. 3.9(e)
of GSR Part 3 [3]).
(iv) The occupational radiation protection programme, including
arrangements for designation of areas, local rules and procedures,
monitoring of workers and the workplace, the health surveillance
programme, and provision and maintenance of personal protective
equipment.
(v) Safety assessments and other design related documents that address
the optimization of protection and safety, the design criteria and the
design features relating to the assessment of exposure and potential
exposure of members of the public.
(vi) For activities involving medical exposure, information relating to
the radiation protection of patients, including arrangements for the
calibration of sources used for medical exposure and for clinical
dosimetry and the description of the management system.
(vii) For new, unusual or complex activities, or for the provision of
consumer products, a demonstration that the principle of justification
for engaging in the activity is fulfilled.
(viii) Arrangements for ensuring safety, which will be maintained for all
stages of the lifetime of the facility or the duration of the activity.
(ix) The safety concepts and criteria used in the design of the facility or
for carrying out the activity, including the classification of equipment,
systems and components; the application of the concept of defence in
depth; the use of multiple barriers to prevent radioactive releases; and
the approach to issues relating to the human–machine interface.
(x) A description of the items important to safety for operating the facility
or conducting the activity (e.g. the facility’s structures, systems and
components, including their design criteria, the processes involved in
their design, and the modes of operation and testing).
(xi) Arrangements for the management of radioactive waste generated
throughout the lifetime of the facility or activity, including in
36
decommissioning and for the management of disused sources (disused
sources should either be managed in the State concerned or be returned
to the supplier or manufacturer), and information on the financial
arrangements for such activities.
(xii) The results of an analysis of the normal operation of the facilities
and activities, and, for a radioactive waste disposal facility, of the
long term period after closure, to demonstrate the acceptability of the
design, including a demonstration that radiation protection criteria,
radioactive waste management requirements and effluent limits are
met by the design.
(xiii) The results of a safety analysis to demonstrate how the design
and related operational procedures of the facility or activity will
contribute to the prevention of accidents and to the mitigation of
the consequences of accidents if they do occur. The analysis should
describe and evaluate the predicted response of the facility or activity
to events, both internal and external, which could lead to anticipated
operational occurrences and accident conditions. The analysis should
include relevant combinations of such disturbances, malfunctions,
failures, errors and events. Consideration should be given to aspects,
such as the initial conditions assumed, the physical or mathematical
models used and their correlation with experiments, and the method of
presenting the results.
(xiv) A safety analysis that shows the extent to which the authorized party
addresses precursors to events and anticipated operational occurrences
and accident conditions. The limits and conditions for safe operation
should be derived from this analysis. If any part of the analysis has
been independently reviewed, the results of this review should also
be presented. Additional recommendations and guidance on safety
analysis for nuclear power plants are provided in IAEA Safety
Standards Series Nos SSG-2 (Rev. 1), Deterministic Safety Analysis
for Nuclear Power Plants [18]; SSG-3, Development and Application
of Level 1 Probabilistic Safety Assessment for Nuclear Power
Plants [19]; and SSG-4, Development and Application of Level 2
Probabilistic Safety Assessment for Nuclear Power Plants [20].
(xv) Information on other plans and programmes established by the
authorized party in support of its safety activities. This includes areas
such as:
●● The environmental monitoring programme;
●● Fire protection;
●● Research and development in relation to the safe design, operation,
decommissioning or closure of the facility or the activity;
37
●● Feedback of operating experience [21];
●● Thedecommissioning (or closure) strategy.
(g) Emergency arrangements:
(i) Emergency arrangements, including an emergency plan and
financial arrangements for preparedness and response for a nuclear
or radiological emergency, where appropriate, that address the
general, functional and infrastructural requirements established in
GSR Part 7 [7].
(h) Interface with nuclear security:
(i) In accordance with the national regulatory framework, relevant
information on nuclear security needs to be provided to the competent
nuclear security authority [10, 11].
Form of notification or authorization for a facility or activity
Notification for a facility or activity
3.103. The information required for notification (see para. 3.96) may be
described in a notification form. The purpose of the notification form is to enable
an applicant to provide information with respect to the provisions for justification
of the activity and to demonstrate that notification is sufficient to allow operation
of the facility or conduct of the activity. Depending on national requirements, the
regulatory body might prefer to have separate notification forms for facilities,
radioactive material and other radiation sources.
Authorization for a facility or activity
3.104. Authorization is “[t]he granting by a regulatory body or other

governmental body of written permission for a person or organization (the
operator) to conduct specified activities” [8]. Authorization also establishes,
directly or by reference, conditions governing the safe performance of these
activities.
3.105. Authorizations may be granted:
(a) For a specific time period (e.g. 10 years, 40 years) or for a specific stage in
the lifetime of the facility (e.g. construction, operation) or for the duration
of an activity. In such a case, a mechanism should be put in place to ensure
that the authorized party responsible for the facility or activity retains
the prime responsibility for safety and for the implementation of security
38
measures at the facility or for the activity, even if the authorization has
expired, unless the site has been removed from regulatory control.
(b) For an indefinite period of time (a permanent authorization), under certain
conditions and until the authorization is officially terminated by the
regulatory body.
(c) For a specific activity or a specific condition of the facility (e.g. the
temporary storage of spent nuclear fuel).
3.106. The format of an authorization will depend on the type of authorization

and its content and, for complex facilities or activities, on the conditions deemed
necessary by the regulatory body for a given stage of the authorization process in
accordance with national legal procedures. For example, the authorization may
incorporate by reference the underlying documents and only provide explanations
of basic terms not defined elsewhere. Thus, the format of an authorization can
differ not only among States, but also within a State, from stage to stage of the
lifetime of the facility or activity, and from authorization to authorization for a
given stage. However, the authorization should normally contain the following
information:
(a) Statutory authority. The authorization should have a unique identification

and should explicitly refer to the laws and regulations on which it is based.
(b) Issuing authority. The authorization should state the official designations of
those who are empowered by law or regulation to issue the authorization,
whose signature and/or stamp will appear on the authorization, and to
whom the authorized party will be accountable under the terms of the
authorization.
(c) Fulfilment of requirements. The authorization should include a summary
statement that all legal and technical requirements in respect of safety have
been fulfilled and that the facilities can be operated and the activities can be
conducted without unacceptable radiation risk to people or the environment.
(d) Documentary basis. The authorization should identify the documents
provided by the authorized party in support of the application, and those
prepared by staff of the regulatory body in the review and assessment
process, which together form the basis for issuing the authorization.
(e) Relationship to other authorization(s). The authorization should indicate
whether it is contingent upon a prior authorization or is a prerequisite for a
future authorization.
(f) The authorized party. The authorization should contain a precise
identification of both the individual or organization legally responsible
for the authorized facility or activity and the individual or organization
responsible for the day to day control of the facility or the activity.
39
(g) Period of authorization. The authorization should state an effective date of
authorization. It may also include a termination date, which may be based
on a fixed term. Alternatively, a period of validity may be stated over which
the assumptions underlying the authorization decision will remain valid
and at the end of which the basis for authorization will be re-examined.
(h) Authorized activity. The authorization should clearly describe, in sufficient
detail, the location of the facility or activity, including, as appropriate:
(i) A clear depiction and description of the site boundaries;
(ii) The facility design and its mode of operation and/or the conduct of
activities;
(iii) The allowed inventory of radioactive material or radiation sources;
(iv) Other relevant information, as appropriate.
(i) The authorized party’s responsibility for compliance. The authorization
should contain:
(i) An appropriate declaration that the authorized party has the
responsibility for compliance with the legal requirements, regulations
and conditions referenced or contained in the authorization or in other
references, as applicable;
(ii) A statement that establishes that the responsibility for safety may be
transferred to a different authorized party, subject to the approval of
the regulatory body.
Form of authorization for individuals
3.107. In some States, legislation determines that an authorization in terms of

individual qualification is required for a person to perform specific functions. In
that case, the authorization should be the means of verifying the competences of
the personnel to carry out those specific activities.
Form of notification and authorization for objects
3.108. Authorization for objects should be considered where it is effective for

regulatory purposes. An example is the authorization (certificate of approval) of
package design, special form radioactive material or low dispersible radioactive
material as required in SSR-6 (Rev. 1) [17].
“Providers of consumer products shall ensure that consumer products

are not made available to the public unless their use by members of the
40
public has been justified, and either their use has been exempted or
their provision to the public has been authorized.”
3.110. The regulatory body should require the manufacturer of consumer

products to apply to the regulatory body and seek authorization to provide
products to the public to ensure that consumer products meet all the requirements
for design and performance that were taken into account in the safety assessment
conducted by the manufacturer for the type of consumer product (see Appendix I).
3.111. For consumer products, notification is required only with respect to

manufacture, assembly, maintenance, import, distribution and, in some cases,
disposal (GSR Part 3 [3], para. 3.7).
Authorization conditions
3.112. An authorization should state explicitly, or should impose by reference

or attachment, all conditions as determined by the regulatory body, which
are obligations with which the authorized party is required to comply. Laws
and practices relating to authorization differ between States. In some States,
conditions are specified in the law and in regulations, and are merely referenced
in the authorization, while in other States some or all conditions are stated
explicitly in the authorization itself.
3.113. Authorization conditions should cover, as appropriate, safety aspects

affecting the facility or activity throughout its lifetime, encompassing site
evaluation, design, construction, installation, commissioning, operation and
decommissioning of the facility or activity and its subsequent release from
regulatory control. Authorization conditions should cover important aspects,
such as design, radiation protection, the maintenance programme, emergency
plans and procedures, modifications, the management system, operational
limits and conditions, procedures and authorization of personnel. Furthermore,
authorization conditions may refer to, but should not duplicate, regulations to
avoid discrepancies or inconsistencies when the regulations are amended.
3.114. While authorization conditions may differ in format, they should

exhibit certain basic qualities and characteristics to make them understandable
and effective. Each authorization condition should be consistent with all other
authorization conditions in that the fulfilment of one should not conflict with the
fulfilment of another or with any other legal requirement. In the event that it is
necessary to specify several authorization conditions addressing various technical
41
and administrative aspects, it may be useful to group the authorization conditions
into categories, such as:
(a) Authorization conditions that set technical limits and thresholds, such as:
(i) Any limits on operation and use, such as dose constraints or discharge
limits;
(ii) Action levels;
(iii) Limits on the duration of the authorization.
(b) Authorization conditions that specify procedures and modes of operation,
such as:
(i) The obligations of the authorized party in respect of its facility,
equipment, radiation source(s), management and personnel;
(ii) Requirements for minimization of the generation of radioactive waste;
(iii) Criteria for conditioning of radioactive waste for existing or foreseen
radioactive waste management facilities;
(iv) Arrangements for emergency preparedness and response.
(c) Authorization conditions pertaining to administrative matters, such as:
(i) Requirements for notifying the regulatory body of any modifications
in accordance with their safety significance;
(ii) Any additional separate authorizations that the authorized party should
obtain from the regulatory body, if necessary;
(iii) The reports that the authorized party should make to the regulatory
body;
(iv) The means and procedures for changing any information stated in the
authorization;
(v) Procedures for, information about and identification of the legal
framework for challenging the conditions in the authorization or part
of it.
(d) Authorization conditions relating to inspection and enforcement, such as:
(i) The records that the authorized party should retain and the time
periods for which they should be retained.
(e) Authorization conditions pertaining to the response to abnormal conditions,
such as:
(i) The requirements for reporting of events and the procedures for taking
suitable corrective actions.
Steps in the authorization process
3.115. Although national practices differ, the regulatory body should carry
out authorization in several steps for complex facilities or activities, with
an application usually being required for each step (see Appendix II). For
42
nuclear facilities, industrial irradiation installations and facilities for industrial
radiography, nuclear medicine and radiotherapy, the regulatory body may
require a multistep process of authorization (e.g. it might require the submission
of an application to construct the facility before construction can begin). The
regulatory body might also prohibit the procurement of nuclear material or
radiation sources (including their import) until a particular stage of construction
has been completed and the safe and secure storage of the nuclear material or
radiation sources can be ensured.
3.116. The authorization process should be understood by the parties concerned

and should be predictable (i.e. well defined, clear, transparent and traceable).
The authorization process should be such that the efficient conduct of regulatory
activities is facilitated. The authorization process should be subdivided into steps
(which may be based on the stage in the lifetime or be set at specific points within
a particular stage) and the regulatory body should require additional information
from the authorized party before the authorized party is granted an authorization
to move from one step to the next. The steps of the authorization process should
be discrete and should follow a logical order.
3.117. In developing the authorization process, consideration should be given

to adoption or adaptation of pre-authorization processes; for example, steps
that provide for the early approval of sites and the advance certification of
standardized plant designs for authorization for construction and operation of a
complex facility or activity. Such an authorizing process may help to minimize
duplication of effort through the various steps and may allow for some steps to be
conducted in parallel. It will also provide for a clear division of responsibilities at
the various steps between the regulatory body, vendors, suppliers and authorized
parties, will permit opportunities for early participation of the public, and
will ensure that the most important safety issues are dealt with properly in the
pre-authorization step.
3.118. The authorization process, including any processes for renewal

of authorizations, should be carried out in a transparent manner, providing
opportunities for communication and consultation with interested parties such as
the public. The regulatory body should consider holding meetings with interested
parties to provide information on the authorization renewal processes. Further
recommendations on communication and consultation with interested parties are
provided in paras 3.345–3.347.
43
Authorization process for a particular type of facility
3.119. If the national approach allows it, it may be appropriate for an authorized
party or applicant to provide a submission to the regulatory body in terms of a
‘reference facility’ or a ‘generic design’, for example in cases where a particular
type of facility (or parts thereof) is to be constructed many times. In such cases,
the regulatory body should apply the same rigour in its review as for other
submissions. A reference facility is a designated existing authorized facility of a
type that will also be constructed in other locations, whereas the definition of a
generic design is established by the regulatory body (see SSG-12 [5], para. 3.13)
and relates to a type of facility that is to be constructed with relatively minor
modifications in other locations. The review and assessment by the regulatory
body of a submission in terms of a generic design in a pre-authorization
assessment, if completed satisfactorily, means that it may be accepted as the basis
for granting an authorization.
3.120. The use of generic designs or reference facilities will facilitate the
authorization process. Not all the aspects that need to be considered can be dealt
with on the basis of such a submission, and the regulatory body cannot grant an
authorization in the same manner as for a single, specific facility; however, the
authorized party will then generally only have to provide a limited submission
for each particular facility. Such limited submissions should concentrate on those
aspects for which the facility under consideration differs from the reference
facility or the generic design; in particular, on those features that are specific
to the chosen location or site. In providing a limited submission for a particular
facility, the authorized party should clearly indicate which aspects of the limited
submission differ from the earlier submission in terms of a reference facility or
generic design, and should provide an explanation of why the other aspects of
the limited submission are not affected. In addition, the regulatory body, in its
comments on the generic design or reference facility, may identify particular
aspects that should be addressed in the submission for the particular facility. In
particular, authorization of the design of a facility that has been subjected to a
pre-authorization assessment should consider the actual site characteristics and
should ensure whether the site and the design are compatible. When moving
forward from a pre-authorization step the regulatory body should require a
submission by the applicant or authorized party detailing how it will manage and
operate the facility.
44
Different steps of the authorization process for a complex facility or activity
3.121. The authorization process for a complex facility or activity should be

considered to consist of a series of steps, each subject to the need for regulatory
input to allow progress from one step to the next. These steps may depend on
national legislation but are normally as follows:
(a) Siting and site evaluation (which may include the environmental impact
assessment);
(b) Design;
(c) Construction;
(d) Commissioning;
(e) Operation;
(f) Decommissioning (or closure);
(g) Release from regulatory control.
3.122. Each step of the authorization process may be divided into several
substeps or may be merged or combined, as appropriate, to facilitate the regulatory
process. Combining the authorizations (e.g. for construction and operation) may
also give more predictability to the process for the authorized party, but will also
require some information to be submitted earlier in the process.
3.123. In practice, review and assessment at each step of the authorization

process may start at an earlier step and continue into subsequent steps. Also,
depending on the arrangements made at the national level and the nature of the
facility or the activity, review and assessment in some steps may be combined.
The degree to which combination of the certain steps should be considered will
depend on the nature of the facility or the activity and the risks associated with it.
3.124. Once an initial authorization has been issued, subsequent activities and
arrangements should be undertaken by the authorized party and the regulatory
body, as part of the authorization process.
3.125. On a particular site, there may be different facilities and/or activities at

different stages of their lifetimes. Where there are different authorized parties
on the same site, or on neighboring sites, the regulatory body should ensure
cooperation between the authorized parties. The authorizations may have
different licensing bases, depending on the type of regulatory control established
in the State, and therefore a process for ensuring and maintaining consistency
should be put in place. In cases where several authorized parties are permitted to
45
share common safety related items, arrangements should be reviewed to ensure
that overall safety is not compromised.
Site evaluation
3.126. Site evaluation for many facilities or activities is initially determined

by general processes rather than by highly prescriptive technical criteria.
General requirements concerning remoteness, environmental concerns, local
population density and transport arrangements may apply, which might not be
within regulatory control. Geological and hydrogeological considerations should
be major factors in site evaluation, particularly for radioactive waste disposal
facilities. The regulatory body should consider being involved in the formulation
of site selection criteria and in the process of determining the general suitability of
a site. Further recommendations on site evaluation are provided in Refs [22–31].
3.127. For a facility or an activity that is to be operated or conducted at a

permanent site, a decision should be reached on the acceptability of the specific
site from a safety perspective after information on the site itself and preliminary
information on the facility or activity and its interaction with the site have been
reviewed and assessed by the regulatory body.
Design, construction, manufacture and installation
3.128. Construction, manufacture or installation of the facility should not be

authorized until the initial design has been reviewed and assessed, including
verification of the compatibility of the design and the site, as appropriate. The
design requirements for nuclear power plants are established in IAEA Safety
Standards Series No. SSR-2/1 (Rev. 1), Safety of Nuclear Power Plants:
Design [32]. Guidance on the construction of nuclear installations consistent
with the design requirements can be found in IAEA Safety Standards Series
No. SSG-38, Construction for Nuclear Installations [33].
Commissioning
3.129. There is some overlap between the construction and commissioning

stages, in that individual structures, systems and components might be
commissioned before completion of the construction of the entire facility or the
installation of all systems required for the activity. There are several steps in the
commissioning process for which the regulatory body may require the authorized
party to obtain prior approval and at which regulatory decisions may be made.
However, the introduction of fissile material or other radioactive material into
46
the facility or activity marks a significant step within the commissioning stage
and is often considered the main point at which regulatory decisions are made.
The introduction of fissile material or other radioactive material should not be
authorized until the proposed commissioning programme has been reviewed and
assessed, preliminary operational limits and conditions have been established,
the final design has been assessed and conformity of the construction with the
design has been verified. Further recommendations on commissioning for nuclear
power plants and research reactors are provided in IAEA Safety Standards Series
No. SSG-28, Commissioning for Nuclear Power Plants [34] and IAEA Safety
Standards Series No. NS-G-4.1, Commissioning of Research Reactors [35].
Operation
3.130. Commencement of operation should be authorized only once

commissioning tests have been completed and their results assessed, and
operational limits and conditions have been reviewed and assessed by the
regulatory body.
3.131. Over the full operational lifetime of the facility or activity, the regulatory
body should require the authorized party to provide evidence at appropriate
intervals, in the form of a comprehensive safety review, such as a periodic safety
review [36], that the facility or the activity is still fit to continue in operation. In
many States, this reassessment period is around ten years for a complex nuclear
installation such as a nuclear power plant. In such comprehensive safety reviews,
account should be taken of significant changes in the potential nature and
magnitude of the associated hazards, operating experience, significant changes to
safety standards, technical developments and new safety related information from
relevant sources. Depending on national laws and regulations and the outcome of
the comprehensive safety review, the regulatory body may decide to renew the
authorization of the authorized party.
3.132. Before bringing a facility back into operation following a major outage,
the authorized party should be required to demonstrate to the satisfaction of the
regulatory body that the facility will be able to continue to operate in compliance
with the safety requirements until the next outage.
3.133. Throughout the lifetime of the facility or activity, modifications may be

made to equipment, to management arrangements and to operational procedures.
Where these modifications potentially affect safety they should be subjected
to proper consideration by the authorized party. The regulatory body should
ensure that proposed modifications are categorized by the authorized party in
47
accordance with their safety significance. This categorization should follow an
established procedure, which may be subject to agreement or approval by the
regulatory body. Modifications that are categorized as significant to safety should
be submitted to the regulatory body for review and approval or agreement.
The regulatory body should inspect the modifications for compliance with the
established categorization procedure on a regular basis. Further recommendations
on modification control at nuclear power plants are provided in IAEA Safety
Standards Series No. NS-G-2.3, Modifications to Nuclear Power Plants [37].
3.134. Plans for radioactive waste management and decommissioning

(including technical solutions, waste streams, the governmental and regulatory
policies for disposal, and funding) should be reviewed and updated periodically
during operation.
Decommissioning
3.135. Decommissioning or closure should be authorized only once the relevant,

detailed plans and procedures to be used, the conditions to be observed during
decommissioning or closure, and the proposed final state of the facility, including
the radiological status, have been reviewed and assessed by the regulatory body
and site inspections have been undertaken, as necessary.
3.136. The regulatory body should ensure that, before, during and after
decommissioning, relevant documents and records are prepared by the authorized
party, kept for an agreed time and maintained to a specified quality. Requirements
for decommissioning are established in IAEA Safety Standards Series No. GSR
Part 6, Decommissioning of Facilities [38] and further relevant requirements and
recommendations are provided in WS-G-5.1 [6], SSG-47 [39], GSR Part 5 [40],
SSR-5 [41], SSG-40 [42], SSG-41 [43] and SSG-49 [44].
Release from regulatory control
3.137. Before release from regulatory control, the authorized party should be
required to demonstrate to the regulatory body that the site meets the release
criteria. The regulatory body should review the evidence submitted by the
authorized party, should confirm compliance with the criteria and only then
should the site be released from regulatory control. Guidance on the release of
sites from regulatory control is provided in WS-G-5.1 [6].
3.138. The regulatory body should ensure that an effective records system is
put in place for sites to be released from regulatory control and is maintained for
48
future users of such sites. The responsibilities for maintaining site release records
should be clearly assigned; these records could be maintained by a specific
organization.
3.139. If the site does not meet the release criteria, restrictions should be
imposed in relation to future use of the site (the ‘restricted use’ option). If after
further remediation and site surveys it can be demonstrated that the site meets the
release criteria and restrictions are not necessary, the selected option should be
‘unrestricted use’.
3.140. For restricted use, the type, extent and duration of the restrictions and
controls for release of the site can range from monitoring and surveillance
to restriction of access to the site. The restrictions should be proposed by the
authorized party on the basis of a graded approach, and after consideration of
factors such as the type and level of residual contamination after the completion
of remediation, the relevant dose constraints and release criteria, and the human
and financial resources necessary to implement the restrictions and controls.
The restrictions proposed by the authorized party should be submitted to the
regulatory body for its agreement and should be enforceable. It should be clear
which organization will be responsible for ensuring that the restrictions are
maintained. In addition, the way in which the restrictions are to be removed when
they are no longer necessary should be specified in the remediation plan.
Review and assessment of documents prepared by the authorized party in the

authorization process
3.141. Essential documents to be prepared by the authorized party in the

authorization process should be identified in the regulations and their content
should be described in guides issued by the regulatory body. Additional
documents may be requested as necessary, depending on the type of facility or
activity concerned, and on the specific step of the authorization process.
Modification or revocation of authorizations
3.142. The granting of an authorization should not restrict or preclude the

subsequent amendment, suspension or revocation of that authorization by the
regulatory body within the period of its validity. A request for an amendment may
be initiated by the authorized party, or an amendment may be imposed by the
regulatory body in the interest of safety. A modification of the authorization may
be desirable or necessary as a result of proposed changes relating to the facility or
activity, experience from the facility or activity or from elsewhere, technological
49
advances, or as a consequence of research and development relating to nuclear or
radiation safety.
“Any subsequent amendment, renewal, suspension or revocation of the

authorization for a facility or an activity shall be undertaken in accordance
with a clearly specified and established procedure, and shall make provision
for the timely submission of applications for the renewal or amendment of
the authorization.”
3.144. The regulatory body may require the renewal of an authorization after a
set time interval, depending on national legislation. In such cases, a review and
assessment of the safety documentation submitted by the authorized party should
be conducted, which should include the findings of regulatory inspections and
other information on performance. The results should be documented as part of
the renewal process.
3.145. Proposals to change or modify the site, the facility, the activity, the
organizational structure of the authorized party, associated management, and
operational procedures and processes (including plans for future activities such as
decommissioning) may be made. The regulatory body should require notification
by the authorized party of any significant changes affecting safety and that the
authorized party apply, where necessary, for an amendment to the authorization.
Any modification affecting safety should be subject to an assessment by the
authorized party in accordance with the graded approach. In addition, as stated in
GSR Part 1 (Rev. 1) [2], para. 4.44:
“Any proposed modification that might significantly affect the safety of

a facility or activity shall be subject to a review and assessment by the
regulatory body.”
3.146. An authorization for an activity involving the use of radiation sources

may be revoked because the radiation sources are no longer required or because
the regulatory body has taken an enforcement action. The regulatory body
should ensure that the radiation sources are transferred to an authorized party
that possesses the necessary authorization, or are disposed of in an authorized
radioactive waste disposal facility.
50
REVIEW AND ASSESSMENT OF FACILITIES AND ACTIVITIES
General
“The regulatory body shall review and assess relevant information —

whether submitted by the authorized party or the vendor, compiled
by the regulatory body, or obtained from elsewhere — to determine
whether facilities and activities comply with regulatory requirements
and the conditions specified in the authorization. This review and
assessment of information shall be performed prior to authorization
and again over the lifetime of the facility or the duration of the activity,
as specified in regulations promulgated by the regulatory body or in
the authorization.”
3.148. Furthermore, para. 4.45 of GSR Part 1 (Rev. 1) [2], also states that:
“In the process of its review and assessment of the facility or activity, the
regulatory body shall take into account such considerations and factors as:
(1) The regulatory requirements;

(2) The nature and categorization of the associated hazards;
(3) The site conditions and the operating environment;
(4) The basic design of the facility or the conduct of the activity as
relevant to safety;
(5) The records provided by the authorized party or its suppliers;
(6) Best practices;
(7) The applicable management system;
(8) The competence and skills necessary for operating the facility or
conducting the activity;
(9) Arrangements for protection (of workers, the public, patients and the
environment) [see GSR Part 3 [3]];
(10) Arrangements for preparedness for, and response to, emergencies;
(11) Arrangements for nuclear security;
(12) The system of accounting for, and control of, nuclear material;
(13) The relevance of applying the concept of defence in depth to take into
account inherent uncertainties (e.g. in the long term for the disposal
of radioactive waste);
(14) Arrangements for the management of radioactive sources, radioactive
waste and spent fuel;
51
(15) Relevant research and development plans or programmes relating to
the demonstration of safety;
(16) Feedback of operating experience, nationally and internationally, and
especially of relevant operating experience from similar facilities and
activities;
(17) Information compiled in regulatory inspections;
(18) Information from research findings;
(19) Arrangements for the termination of operations.”
3.149. The review and assessment process is a critical appraisal, performed

by the regulatory body, of information submitted by the authorized party or
information that comes from inspection, information on events, feedback on
operating experience at national and international levels or other specified
reports (e.g. records, comprehensive safety reviews, dose records) relevant to the
safety of the facility or activity. Review and assessment are undertaken in order
to enable the regulatory body to make a decision or a series of decisions on the
acceptability of the facility or activity in terms of safety. The process consists of
examining the authorized party’s submissions, and other information as described
above, on all aspects relating to the safety of the facility or activity. One of the
initial tasks of the review and assessment is to confirm the completeness of
submissions. When necessary, the review and assessment process should include
checks on the site to verify the claims made in the submissions.
3.150. Various types of documents will need to be prepared by the authorized

party in discharging its responsibilities with respect to the safety of the facility
or the activity. Some of these documents will also form part of the formal
submission to the regulatory body for review and assessment. Other documents
to keep the regulatory body fully informed of the conditions prevailing at the
facility or for the activity include routine reports periodically submitted to the
regulatory body, and specific reports of events. Another type of documentation
is for internal use by the authorized party, which should be made available
upon request to the regulatory body to ensure its complete understanding of the
design and operation of the facility or the activity, so that it can confirm that
the requirements established in the regulations and authorization conditions have
been fulfilled.
3.151. A fundamental feature of the process of review and assessment is for

the regulatory body to consider the documents submitted by the applicant. For
significant radiation risks or unusual or complex facilities or activities, the
regulatory body should also verify the contents of the submitted documents by
means of inspection of the site where the radiation sources are to be installed
52
or used. Such inspections will also allow the regulatory body to supplement the
information and data necessary for review and assessment. Additionally, such
inspections will enable the regulatory body to extend its practical understanding
of the management, engineering and operational aspects contained within
the application for authorization and to foster links with specialists from the
authorized party.
3.152. The regulatory body should take into account assessments done in the
past as well as assessments by other States for the same or similar facilities.
“In performing its review and assessment of the facility or activity, the
regulatory body shall acquire an understanding of the design of the facility
or equipment, the concepts on which the safety of the design is based and
the operating principles proposed by the applicant, to satisfy itself that,
among other factors:
(a) The available information demonstrates the safety of the facility

or the proposed activity and the optimization of protection
[see SF-1 [1] and GSR Part 3 [3]];
(b) The information provided in the applicant’s submissions is accurate
and is sufficient to permit confirmation of compliance with regulatory
requirements;
(c) Operational and technical provisions, and in particular any novel
provision, have been proved or qualified by experience or testing, or
both, and will enable the required level of safety to be achieved.”
3.154. In addition, the justification for engaging in the activity or the need for
the facility should be evaluated. (In some States justification is considered by
other processes and is not the responsibility of the regulatory body.)
3.155. In undertaking the review and assessment, the regulatory body should
not rely solely on safety assessments conducted by the authorized party, nor
on those that the regulatory body has commissioned from external consultants
or technical support organizations. Instead, the regulatory body should have
sufficient full-time staff capable of either performing regulatory reviews and
assessments, or evaluating assessments performed for it by consultants.
53
Objectives of review and assessment
3.156. The basic objective of regulatory review and assessment is to determine

whether the authorized party’s submissions demonstrate that, throughout the
lifetime of the facility or duration of an activity, it will comply with all safety
requirements stipulated or approved by the regulatory body.
3.157. The specific objectives of the review and assessment will depend on the
stage of the lifetime of the facility or activity. Examples of specific objectives
include the following:
(a) To determine whether the authorized party has in place an appropriate

management system that meets the regulatory body’s requirements;
(b) To determine whether the authorized party has put in place the necessary
arrangements for establishing, sustaining and continuously improving
leadership and management for safety;
(c) To determine whether the operational limits and conditions are consistent
with the regulatory body’s requirements, the operational characteristics of
the facility or activity, and up to date operational procedures and experience;
(d) To determine whether an adequate level of safety is being maintained and
improved;
(e) To determine whether the authorized party’s personnel meet the regulatory
requirements, in terms of number, qualification and competence;
(f) To determine whether, regardless of the stage of the lifetime of a
facility or activity, proposed modifications have been designed and their
implementation planned so that safety is not compromised;
(g) To evaluate safety reviews performed by the authorized party;
(h) To determine whether the authorized party’s plans and commitments in
respect of decommissioning meet the requirements of the regulatory body;
(i) To determine whether the authorized party’s plans and commitments
in respect of the closure and post-closure stages for a radioactive waste
disposal facility meet the requirements of the regulatory body;
(j) To evaluate the final radiological survey documentation;
(k) To determine, if relevant, whether the performance indicators proposed by
the authorized party are appropriate;
(l) To determine whether the programme proposed by the authorized party
for confirmation of performance is acceptable (particularly important for
radioactive waste disposal facilities);
(m) To determine whether any additional requirements (or authorization
conditions) have been fulfilled by the authorized party.
54
3.158. Even if the same or a similar design or a similar facility has been
authorized in another State, the regulatory body should still perform its own
independent review and assessment. The review and assessment performed by
the regulatory body may take into account the review and assessment made by the
other State, and also new experience and knowledge that have been gained since
that review and assessment, and should also take into account the differences
in the legal and regulatory framework of the States concerned. The regulatory
bodies of the States concerned should establish close contact in order to facilitate
the review and assessment process.
Information to be reviewed and assessed
Reporting by the authorized party
3.159. As appropriate (and for complex facilities, as a minimum), the following

reports should be required from the authorized party for review and assessment at
set times or upon the completion of specific activities during various steps in the
authorization of the facility or the activity:
(a) During the authorization steps of siting and construction, reports on:
—— The progress of site studies;
—— The progress of construction activities;
—— Results of the pre-operational environmental monitoring programme;
—— Relevant events occurring during construction and manufacturing.
(b) During the authorization steps of commissioning and operation, reports on:
—— The results of commissioning tests;
—— Data from operation, including data on the facility’s output and
performance;
—— Modifications;
—— Results of the radiation protection programme;
—— Results of the environmental monitoring programme;
—— Radioactive waste management;
—— Relevant operational safety and performance events occurring during
commissioning and during operation.
(c) For the release of any facility or site from regulatory control, or for
institutional controls for the post-closure stage of a radioactive waste
disposal facility, reports on:
—— The types, amounts and destinations of radioactive waste resulting from
the decontamination and dismantling programme;
—— Levels of residual activity in the facility;
55
—— Results of the radiation protection programme and environmental
monitoring programme, including the final radiological survey, and
other relevant confirmatory programmes;
—— Restrictions and institutional controls in the case of restricted release
from regulatory control.
Information collected by the regulatory body
3.160. During its inspection activities, the regulatory body will collect on-site
information, for example when examining records kept by the authorized party.
Such information should be subjected to review and assessment by the regulatory
body, in addition to any information associated with non-compliances with
regulatory requirements or violations of the authorization conditions. Although
this source of information may only represent a small part of the review and
assessment, it is essential as it provides factual insights on how the authorized
party complies with regulatory requirements.
Review and assessment process
3.161. In order to provide assurance that all topics significant to safety will be
covered consistently with submissions for similar facilities or activities, review
and assessment should be carried out by means of a systematic and formalized
process implemented through specific procedures.
3.162. The review and assessment process should include the following steps:
(a) Definition of the scope of the review and assessment process;

(b) Specification of the purpose of and technical bases for the review and
assessment process (these could be considered acceptance criteria for the
review and assessment);
(c) Identification of additional information, if necessary, for the review and
assessment;
(d) Performance of a step by step review and assessment procedure to determine
whether the applicable safety objectives and regulatory requirements have
been met for each aspect or topic;
(e) Decisions8 on the acceptability of the authorized party’s safety arguments
or the need for further submissions;
(f) Reporting and documentation.
8
Follow-up of review and assessment results is conducted through regulatory
compliance activities.
56
Bases for review and assessment
3.163. At all steps of the authorization process, the regulatory body should
have a clear understanding of the safety objectives and regulatory requirements
that will be used in the review and assessment.
3.164. When collecting and structuring the applicable safety objectives and
requirements to be used in its review and assessment process, the regulatory body
should consider a broad range of sources, including the following:
(a) National laws and regulations;

(b) Advice obtained from external experts including consultants, dedicated
support organizations and advisory bodies associated with the regulatory
body;
(c) Standards and guidance on nuclear, radiation, transport and radioactive
waste safety as well as information issued by national and international
organizations;
(d) Requirements applicable in and experience gained in other relevant
industries;
(e) Technical results and experience from research and development;
(f) Expertise and requirements used by others involved in reviewing and
assessing similar facilities or activities in respect of technologies or safety.
3.165. The regulatory body might not have, in advance, detailed requirements
covering all the areas that are subject to review and assessment since, even
with a fairly comprehensive set of safety objectives and requirements, some
aspects of safety might not be covered. The regulatory body should evaluate the
acceptability of the proposals put forward by an authorized party or applicant
on a case by case basis against general principles stated in laws and regulations.
Consideration of the proposals may provide input for the development of
additional regulations and guides or the modification of existing regulations and
guides (see also paras 3.41–3.44).
3.166. In some instances, the authorized party may propose an alternative

approach to that suggested in a guide to achieving a safety objective. In such
cases, the authorized party should be required to demonstrate that its proposed
approach will provide an equivalent level of safety.
3.167. The regulatory body should consider in what circumstances it might

be appropriate to issue an authorization on the basis that a specific model of
equipment has been ‘type approved’ or carries a certificate of compliance, in
57
accordance with industrial standards or other nationally recognized equivalent
standards. In many cases, the safety of the facility or activity will depend on
additional factors, such as the design and manufacture of equipment, qualification
and training of the staff, and management and operational procedures and
processes.
Major areas for review and assessment
3.168. Since this Safety Guide covers a wide range of facilities and activities, it
is not possible to provide details of specific areas that should be subject to review
and assessment at each stage of the lifetime of each type of facility or activity.
A graded approach should be used to determine how the major areas for review
and assessment should be considered, depending on the nature of the facility or
activity and the risks associated with it.
3.169. Paragraphs 3.170–3.184 outline the areas on which review and

assessment should concentrate for complex facilities or activities. It is not
sufficient to review and assess these areas in isolation; all relevant areas from
previous stages in the lifetime of the facility or activity should be considered at
each step in the authorization process in order to ensure that the acceptability of
the authorized party’s submissions has not been compromised. A list of the topics
that should be considered in the review and assessment process throughout the
lifetime of a facility or activity is provided in Appendix III.
Site evaluation
3.170. The review and assessment should consider the potential interaction
between the proposed facility or activity and the site, and assess the suitability
of the site from the point of view of safety. The review and assessment of the
site may be performed in parallel with the review and assessment of the design
or may, as in some States, be performed at an earlier stage. Areas of particular
significance are the possible impacts of the local environment (both natural and
human-made aspects of the local environment) on the safety of the facility or
activity, and the demands that the facility or activity would make on the local
infrastructure. Natural phenomena to be considered should include earthquakes,
high winds, flooding and other phenomena as appropriate for the geographical
location of the facility or activity.
3.171. For radioactive waste disposal facilities, safety depends primarily on

the properties of natural and engineered barriers. The review and assessment
will require a detailed understanding of the features of the facility and its host
58
environment and of the factors that will influence its safety after closure. Such
an understanding is unlikely to exist at this stage and so the outcome of review
and assessment at the site evaluation stage should be reinforced and confirmed
in the construction and operational stages to complete the technical basis and to
gain the public’s confidence. The process of review and assessment of the site
characteristics may take a long time and continue into a period of institutional
control following closure of the facility.
Design, construction, manufacture and installation
3.172. Before authorization of construction, review and assessment will

concentrate on the applicant’s or authorized party’s approach to safety and
to compliance with safety requirements, and how these have been applied in
developing the design of the facility or activity. Features such as the physical
layout and the construction, manufacture and installation of the systems of the
facility or activity and the key elements of the process should be considered
carefully, and their effects on the safety of the facility throughout its lifetime
should be assessed at the design stage [32]. In addition, before authorizing
construction or installation, the regulatory body should review and assess the
authorized party’s arrangements for the control of activities in construction,
manufacture and installation. Once construction and installation has commenced,
many features of the design can be changed only with great difficulty. An initial
plan for decommissioning, covering issues such as the strategies to be used, the
radiation doses to be expected and the amounts of waste expected to be generated,
should be prepared by the applicant or authorized party early in the design stage.
This plan should be subject to review and assessment by the regulatory body.
3.173. Review and assessment of the design should continue during

construction, manufacture and installation as the details become finalized.
Changes to the approved design at this stage should be analysed by the applicant
or authorized party and reported to the regulatory body, which should carry out
the necessary review and assessment.
Commissioning
3.174. Commissioning generally takes place in two stages: inactive

commissioning, before fissile material and other radioactive material is
introduced; and active commissioning, after fissile material and other radioactive
material has been introduced. Radiation risks are present mainly in the second
stage. Commissioning should be carried out in accordance with programmes
that have been reviewed and assessed by the regulatory body. Before authorizing
59
commissioning, the regulatory body should determine whether the as-built
facility meets the design requirements.
3.175. The inactive stage of commissioning is aimed at ensuring that the facility
or systems for an activity have been constructed, manufactured and installed
correctly and in accordance with the design documentation. If deviations from
the approved design documentation have occurred, they should be recorded, and
it should be shown by reconsideration of the safety documentation that safety
has not been compromised. The results of inactive commissioning should also
confirm the operational features and should lead to the finalization of detailed
instructions for operators, which should be confirmed during the active
commissioning stage.
3.176. Active commissioning, which takes place after the introduction of

radioactive material, is a major step in the authorization process. The review and
assessment of active commissioning should take into consideration: the final or
as-built design of the facility or activity systems as a whole; the commissioning
programme and its progress; the organizational structure; the qualifications of
operating personnel; emergency preparedness; the preliminary operational limits
and conditions; and the preliminary operating procedures. Whenever there are
deviations from the design parameters, these should be analysed by the authorized
party and reported to the regulatory body, which should carry out the necessary
review and assessment.
3.177. As the active commissioning processes move closer to completion,

review and assessment should concentrate on how the facility is operated or
the activity is performed, on how the necessary safety systems, procedures and
processes are maintained, and on the procedures for controlling and monitoring
operations and responding to deviations or other occurrences. Before authorizing
operation of the facility or conduct of the activity, the regulatory body should
review and assess the consistency of the results of commissioning tests. If
the regulatory body finds inconsistencies in these results, it should assess any
corrections of non-conformances and modifications to the design and operational
procedures that were made as a result of the commissioning. The regulatory body
should review and assess any proposed changes to the operational limits and
conditions.
Operation
3.178. For normal operation of the facility or conduct of the activity, the
regulatory body should require the authorized party to report regularly on
60
adherence to safety objectives and compliance with specified regulatory
requirements, and on efforts made to enhance safety. The regulatory body
should review and assess the reports and should perform inspections to confirm
compliance with regulatory requirements and to confirm that operation of the
facility or conduct of the activity can continue.
3.179. While a need for reassessment may arise in a number of ways

(see para. 3.189), a comprehensive safety review, such as a periodic safety
review [36], should be carried out by the authorized party at intervals to
assess the cumulative effects of ageing of the facility or activity systems and
of modifications, and the implications of operating experience and technical
developments. The nature of this review and the interval between reviews will
depend on the nature of the facility or activity and the radiation risks associated
with it. The objective of the review should be to assess the facility or activity
against current national and/or international safety standards and operating
practices and to determine whether adequate arrangements are in place to
maintain safety. When the results of a review indicate that the facility or activity
does not meet current standards and operating practices, the significance of the
shortcomings should be assessed and the regulatory body should be notified.
Possible ways of meeting the standards or operating practices should be
considered. The comprehensive safety review should enable the regulatory body
to judge whether it is acceptable for the facility to continue operation until the
next comprehensive safety review is carried out.
3.180. The regulatory body should require the authorized party to provide
evidence that in normal operation the facility is being operated or the activity
is being conducted in accordance with the safety requirements, in particular the
operational limits and conditions. Such evidence may be provided by means
of reporting on operational parameters and occurrences relevant to safety. The
regulatory body should review and assess the reports, and should perform
inspections to ensure that the facility or activity complies with the safety
requirements and is fit to continue operation.
3.181. From time to time, throughout the operation of the facility or the
conduct of the activity, the initial decommissioning plan should be updated
by the authorized party and reviewed by the regulatory body in the light of
operating experience, new or revised regulatory requirements and technological
developments.
61
Decommissioning
3.182. Aspects of decommissioning typically include planning for

decommissioning, conducting decommissioning actions and terminating the
authorization for decommissioning [38]. Decommissioning actions are the
procedures, processes and work activities (e.g. decontamination, dismantling and
removal of structures, systems and components) as described in the approved final
decommissioning plan. Within a period agreed with the regulatory body (typically
within two to five years prior to permanent shutdown of the facility or cessation
of the activity), a detailed plan is required to be prepared by the authorized
party and submitted to the regulatory body for authorization or approval, in
accordance with Requirement 10 of GSR Part 6 [38]. The decommissioning
plan is required to be reviewed and assessed by the regulatory body in order to
ensure that decommissioning can be accomplished safely with a progressive and
systematic reduction in radiological hazards. For all decommissioning strategies,
it is required to be demonstrated that no undue burdens will be imposed on
future generations. The arrangements for the management of waste from
decommissioning should be a significant feature of the decommissioning plan.
Large amounts of waste may be generated over short time periods, and the waste
may differ greatly in type and activity from the waste generated during operation
of the facility. In the review and assessment of the decommissioning plans, it
should be ensured that such waste can be managed safely.
Closure of a radioactive waste disposal facility
3.183. To enable a radioactive waste disposal facility to proceed beyond the

operational stage to closure, surface facilities should be decommissioned and
the facility should be appropriately sealed. The safety case, including detailed
proposals for closure and for assessment of the safety of the disposal facility in
the long term, is required to be reviewed and assessed by the regulatory body.
Further guidance is provided in SSG-29 [29], SSG-14 [30] and SSG-1 [31].
Particular consideration should be given to the provision of detailed information,
including relevant operating records on the radionuclide content and physical
properties of the waste and its packaging; geological and hydrogeological
conditions; the performance of the facility’s design (including backfill materials,
engineered structures and the sealing arrangements); aspects of monitoring,
surveillance and irretrievability; and the migration of radionuclides and potential
exposure pathways.
3.184. If institutional control after closure of a waste disposal facility is

deemed necessary, the arrangements for future control, including continuing
62
environmental monitoring programmes, should be subject to review and
assessment by the regulatory body.
Release from regulatory control
3.185. Before an authorized party can be allowed to relinquish an authorization,

it should be ensured that all responsibilities and liabilities that pertain to the
authorization have been satisfactorily discharged and that there is no reasonable
possibility that any future requirements will be placed on the authorized party.
The authorized party should be required to provide evidence of this and, in
particular, should be required to demonstrate that the site to be released from
regulatory control will not pose unacceptable radiation risks in comparison with
those that prevailed before the facility was built or the activity was started. The
regulatory body should review and assess this evidence and should determine
whether it is sufficient to allow the facility or site to be released from regulatory
control.
Information exchange between the regulatory body and the authorized party
3.186. The process of review and assessment is conducted by means of

exchanges between the regulatory body and the authorized party, which should
be formally recorded. These records will mostly consist of:
(a) Requests for additional information and questions by the regulatory body;
(b) Responses from the authorized party (including responses provided by its
contractors);
(c) Records of meetings between staff of the regulatory body and staff of the
authorized party.
3.187. This information should be kept in an organized way that permits

retrieval in accordance with relevant criteria, such as subject, type, date or
originator.
3.188. The regulatory body should request any necessary additional information
and should be prepared to suspend or terminate its review and assessment if, in
its judgement, such action is justified because of deficiencies in the information
provided. The regulatory body should require that the documentation submitted
for review and assessment be prepared by the authorized party in accordance with
an effective management system, which should include proper quality assurance
arrangements and an appropriate internal review process.
63
Reassessments
3.189. Throughout the lifetime of a facility or an activity, it may be necessary

for the authorized party to make a reassessment of safety (or of an aspect of
it). This reassessment could be at the initiative of the authorized party or at the
request of the regulatory body, and may be prompted by one or more of the
following reasons:
(a) Experience relevant to safety that has been gained from the facility or
activity, at similar facilities or activities or at other relevant nuclear and
non-nuclear facilities or activities;
(b) Information from relevant tests or from research and development
programmes, and new knowledge of technical matters;
(c) Proposed modifications to the facility or activity or to the way in which it is
to be managed and operated;
(d) Changes in the regulatory framework, regulations and guides;
(e) A proposal to extend the lifetime of the facility or activity.
Specific aspects of review and assessment
3.190. To facilitate the review and assessment process for a facility or

activity, the regulatory body should consider developing lists of approved
equipment containing radiation sources, based on the submission of a certificate
confirming compliance with international industry standards (e.g. of the
International Electrotechnical Commission and the International Organization for
Standardization). In such cases, the basis for approval should be documented,
together with a summary of the conditions of use of the equipment and any
appropriate limitations on its use.
Internal guidance
3.191. The regulatory body should provide internal guidance for its own staff
on the procedures to be followed in the review and assessment process and on the
safety objectives to be met. Internal guidance on specific topics for review and
assessment should also be provided, as necessary.
3.192. The regulatory body should develop internal guidance on reporting on its
review and assessment activities and on how it reaches its regulatory decisions.
The regulatory body’s internal guidance on review and assessment should be
made available to other regulatory bodies worldwide.
64
Confirmatory calculations
3.193. The regulatory body may decide to perform confirmatory calculations to

check that the authorized party has properly assessed a particular aspect of safety.
Confirmatory calculations can provide information that can assist in:
(a) Identifying weaknesses, if any, in the safety case;

(b) Estimating safety margins or the degree of conservatism in the safety case;
(c) Performing sensitivity analyses and uncertainty analyses in order to verify
the authorized party’s designation of the risk significance of various
structures, systems and components;
(d) Understanding complex process interactions between engineered features
and natural features (this is particularly important for radioactive waste
disposal facilities);
(e) Verifying that the safety assessment is consistent with current data obtained
from research and monitoring;
(f) Gaining further confidence in its own decision making process;
(g) Developing its in-house capacity for the resolution or further clarification
of safety issues;
(h) Extending the review and assessment process to include a quantitative
evaluation of the design and operation of facilities and activities.
3.194. Where additional analyses are deemed necessary, the regulatory body
should require the applicant or authorized party to perform them.
Verification of the safety analysis
3.195. The review and assessment process by the regulatory body consists of
examination of the submissions from the authorized party on its management
arrangements and operational procedures and verification of the safety analysis.
For complex facilities and activities, additional submissions from the authorized
party on engineered systems should also be examined by the regulatory body.
This safety analysis should cover normal operation, anticipated operational
occurrences and accident conditions in order to demonstrate that the safety of the
facility or activity meets the safety objectives and requirements of the regulatory
body. It is the responsibility of the regulatory body to determine whether these
submissions have provided a sufficiently complete, detailed and accurate
demonstration of this. In carrying out the review and assessment, the regulatory
body may find it useful to perform its own analyses or research. The following
subsections deal with major aspects of such verification; further details of these
aspects are set out in Appendix III.
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3.196. In the verification of the safety analysis for the facility or activity, the
regulatory body should determine whether the authorized party has defined
criteria that meet the safety objectives and requirements relating to:
(a) Engineering design;

(b) Operational and management aspects;
(c) Normal operation, anticipated operational occurrences and accident
conditions.
Structures, systems and components
3.197. For complex facilities and activities, the review and assessment by the
regulatory body should confirm that the authorized party has performed a suitable
and sufficient safety analysis of the structures, systems and components important
to safety and has used the results to demonstrate that the regulatory requirements
are met by the equipment and are reflected in operational procedures. Specific
features that should be subject to review and assessment include the following:
(a) Definition and categorization of the safety functions;

(b) Identification and classification of structures, systems and components;
(c) Ensuring the quality of engineered features as set out in the regulatory
requirements or in terms of good engineering practice;
(d) Demonstration of control of the facility or activity in normal operation,
anticipated operational occurrences and accident conditions, with account
taken of automatic systems, the human–machine interface and operating
instructions;
(e) Adequacy of the management system covering the structures, systems and
components, and operational aspects, such as the training, qualification
and experience of the authorized party’s personnel and quality assurance
procedures.
Operational safety performance
3.198. The regulatory body should review reports submitted periodically by

the authorized party, in compliance with regulatory requirements, to monitor the
operational safety performance of the facility or activity. Additionally, reports on
safety significant events should be thoroughly reviewed by the regulatory body.
3.199. The regulatory body should ensure that an effective system for the
feedback of operating experience, including events, is in place. If the severity
of the event warrants it, the regulatory body may conduct or arrange for an
66
independent investigation, usually by a team with appropriately selected areas of
expertise, to confirm that the event was adequately investigated, the root causes
were correctly identified, and that adequate corrective and remedial actions were
taken. The regulatory body’s review should cover the identification of lessons to
be learned and the sharing of safety related information. Operating experience
feedback should not be restricted to consideration of the facility or activity itself
but should consider a wide range of both radiation and non-radiation related
facilities and activities from which lessons may be learned.
Organization and management
3.200. A well-engineered facility or activity will not achieve the required level
of safety if it is not properly built, operated and managed. Review and assessment
by the regulatory body should therefore include consideration of the authorized
party’s organization, management, procedures and safety culture [45], which
may affect the operation of the facility or conduct of the activity. The authorized
party should be able to demonstrate that there is a documented and effective
management system in place that gives safety the highest priority.
3.201. Specific aspects that should be considered as part of review and

assessment include the following:
(a) Whether the authorized party’s safety policy has been established by and
is promoted by senior management and shows commitment at a high level
to meeting regulatory requirements and states the means by which these
requirements will be met.
(b) Whether the authorized party’s organization is such that it can achieve the
aims and objectives in its safety policy. In particular, the following should
be addressed:
(i) Adequate control of activities at the facility;
(ii) Fostering cooperation between staff members and between staff and
managers;
(iii) A satisfactory system for communication both up and down the
management chain and between managers;
(iv) Systems to ensure that staff are competent for the positions to which
they are assigned.
(c) Whether the authorized party has systems in place to ensure adequate
planning of work and suitable performance standards so that staff and
managers know what is expected of them in order to achieve the aims and
objectives of the safety policy.
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(d) Whether the authorized party has systems in place to review and to audit
periodically all the evidence on its performance, including consideration
of operational events and other matters important to safety, in order to
determine whether it is adequately achieving its aims and objectives, and to
consider and make improvements where necessary.
(e) Whether the authorized party has systems in place to ensure that it acquires
and retains adequate capability within its organization to understand the
nature, substance and detail of the advice given to it by contractors and is
able to judge the soundness of that advice.
3.202. The review and assessment by the regulatory body should cover all
aspects of the authorized party’s management and organizational procedures and
systems that have a bearing on safety, such as:
(a) The development of operational limits and conditions;

(b) The production and revision of safety documentation;
(c) The planning and monitoring of maintenance, inspection and testing;
(d) Control of contractors (see Appendix III for further details);
(e) The procedures for the control and justification of changes to the authorized
party’s management and organizational procedures and systems that could
have an impact on safety;
(f) Feedback of operating experience.
Radiation risks in normal operation
3.203. Assessment and review of radiation risks in normal operation is directed

towards the determination of occupational exposures and radioactive discharges
to the environment [3]. These data will be compared with the safety objectives,
requirements and limits approved by the regulatory body, including application
of the principle of optimization of protection and safety. In the regulatory
review and assessment, it should be determined whether the authorized party’s
submission meets the safety objectives, requirements and limits. In the review and
assessment, particular attention should be devoted to those aspects that influence
the radiological consequences for protection of people and the environment in
normal operation, which include:
(a) The inventory of radiation sources;

(b) The occupational radiation protection programme and other matters relating
to radiation protection of workers;
(c) Radiation protection of the public, with all pathways of exposure taken
into account;
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(d) Radioactive waste management;
(e) Discharge, dilution and dispersion of radioactive effluents.
3.204. In considering these aspects, the regulatory body should satisfy itself
that radiation doses to workers and the public and radioactive releases to the
environment are below relevant limits, and are as low as reasonably achievable.
Specifically, review and assessment should verify that:
(a) The operational limits and conditions and the bases for these have been
determined;
(b) The radiation risks associated with operation at these limits have been
considered;
(c) Arrangements (including operating procedures) are in place to ensure that
protection and safety is optimized.
3.205. The regulatory body should at all times require reasonably achievable
improvements to be made in the design or operating procedures of the facility or
activity with the aim of reducing radiation risks.
Safety analysis for abnormal operation, anticipated operational occurrences and

accident conditions
3.206. A major part of the review and assessment effort should be directed to
the safety analysis for abnormal operation, anticipated operational occurrences
and accident conditions performed by the authorized party. The review and
assessment of the safety analysis should be performed in accordance with the
nature and magnitude of the risks associated with the particular facility or activity.
3.207. For the post-closure assessment of performance for waste disposal

facilities, consideration should be given to all significant features, events and
processes that may affect the performance of the facility. A comprehensive list
of features, events and processes should be developed and criteria (with technical
bases) should be clearly defined for screening to exclude those features, events
and processes from further consideration that would have either a very small
impact on the disposal system or a very low probability of occurrence. Scenarios
to be considered for performance assessment should be determined in accordance
with the features, events and processes selected for consideration.
69
Records of review and assessment
Records of the regulatory body’s review and assessment
3.208. The review and assessment process will invariably involve the
production of reports by the regulatory body and, where appropriate, by external
experts. A document control system should be established for keeping records of
the review and assessment process so that these documents and records can be
readily retrieved. The bases for previous decisions should also be made accessible
so as to achieve consistency and to facilitate any reassessment made necessary by
new information.
Documentation produced by the regulatory body
3.209. Review and assessment should result in a decision on the acceptability

of the safety of the facility or activity, which may be connected to a step in
the authorization process. The basis for the decision should be recorded and
documented in an appropriate form. This documentation should summarize the
review and assessment performed and should present a clear conclusion about
the safety of the authorized facility or activity. Typically, the following topics
should be covered:
(a) Reference to the documentation submitted by the authorized party;

(b) The basis for the evaluation;
(c) The evaluation performed;
(d) Comparison with regulatory requirements, regulations and guides;
(e) Comparison with another similar (reference) facility or activity, where
appropriate;
(f) Independent analysis performed by the regulatory body’s staff, or by
consultants or dedicated support organizations on its behalf;
(g) Conclusions with respect to safety;
(h) Additional requirements to be met by the authorized party.
INSPECTION OF FACILITIES AND ACTIVITIES
“The regulatory body shall carry out inspections of facilities and

activities to verify that the authorized party is in compliance with
70
the regulatory requirements and with the conditions specified in the
authorization.”
3.211. The regulatory body should verify the contents of the documents
submitted by the applicant by means of inspection of the facility or activity
where radiation sources are to be installed or used. Such inspections will also
allow the regulatory body to supplement the information and data necessary for
review and assessment.
3.212. The regulatory body should conduct inspections of manufacturers

authorized to provide consumer products (see Appendix I).
“Regulatory inspection cannot diminish the prime responsibility for safety

of the authorized party, and cannot substitute for the control, supervision
and verification activities conducted under the responsibility of the
authorized party.”
“Regulatory inspections shall cover all areas of responsibility of the

regulatory body, and the regulatory body shall have the authority to carry
out independent inspections. Provision shall be made for free access by
regulatory inspectors to any facility or activity, at any time, within the
constraints of ensuring operational safety at all times and other constraints
associated with the potential for harmful consequences. These inspections
may include, within reason, unannounced inspections.”
“In conducting inspections, the regulatory body shall consider a number of

aspects, including:
—— Structures, systems and components and materials important to safety;

—— Management systems;
—— Operational activities and procedures;
—— Records of operational activities and results of monitoring;
—— Liaison with contractors and other service providers;
—— Competence of staff;
—— Safety culture;
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—— Liaison with the relevant organization for joint inspections,
where necessary.”
3.216. The regulatory body should also consider the following aspects in
inspection, as appropriate:
(a) Radiation risks associated with the facility or activity, including areas of
higher risk;
(b) Unintended or accidental medical exposure;
(c) Arrangements for the control of radioactive material.
“Inspections of facilities and activities shall be commensurate with the

radiation risks associated with the facility or activity, in accordance
with a graded approach.”
3.218. The priority and frequency of inspections should reflect the risk
associated with the radiation source and the complexity of the facility or activity,
as well as the possible consequences of an accident and the type and frequency of
any regulatory non-compliances found by inspections.
3.219. In implementing the inspection programme, the regulatory body should

also apply a graded approach in responding to unforeseen circumstances (see
also paras 3.295–3.319).
Objectives of regulatory inspection
3.220. Regulatory inspection is performed to make an independent check on the

authorized party and the state of the facility or activity, and to provide confidence
that the authorized party is in compliance with the safety objectives prescribed
or approved by the regulatory body. This should be achieved by confirming that:
(a) The authorized party is in compliance with applicable laws, regulations

and authorization conditions and all relevant codes, guides, specifications
and practices;
(b) The authorized party has in place an effective management system, a strong
safety culture, and self-assessment systems for ensuring the safety of the
facility or activity and the protection of people and the environment;
72
(c) The required quality and performance are achieved and maintained in
the items and activities important to safety throughout the lifetime of the
facility or activity;
(d) Persons employed by the authorized party (including contractors) possess
the necessary competence for the effective performance of their functions
throughout the whole lifetime of the facility or activity;
(e) Deficiencies and abnormal conditions are identified and promptly evaluated
and remedied by the authorized party and duly reported to the regulatory
body as required;
(f) Any other safety issue that is neither specified in the authorization nor
addressed in the regulations is identified and appropriately considered;
(g) Any safety lessons learned are identified and disseminated to other
authorized parties and suppliers and to the regulatory body as appropriate.
Organization of regulatory inspection
3.221. Specific responsibilities of the regulatory body with respect to inspection

should include the following:
(a) Conducting planned inspections, at relevant steps of the authorization

process;
(b) Carrying out reactive inspections, as appropriate, in response to events;
(c) Identifying and recommending necessary changes to the requirements
approved by the regulatory body, as specified in the authorization or
contained in the regulations;
(d) Preparing reports to document inspection activities and their findings;
(e) Ensuring that the authorized party has adequate, comprehensive and up to
date information on the status of the facility or activity and information
for demonstrating safety, and a procedure for keeping such information up
to date;
(f) Detecting degraded performance and potential non-compliances;
(g) Tracking recurrent problems and non-compliances;
(h) Verifying that corrective actions have been undertaken by the authorized
party to resolve safety issues identified previously;
(i) Developing procedures and directives as necessary for the effective conduct
and administration of the inspection programme;
(j) Determining and recommending suitable enforcement actions when
non-compliance with regulatory requirements or a violation of the
conditions of an authorization is encountered.
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3.222. The major activities of the inspection programme are related to the steps
of the authorization process. The regulatory body should organize and modify its
inspection activities in accordance with the stage of the lifetime of the facility or
activity. Specifically, as a facility or activity passes from one stage of its lifetime
to another, the regulatory body will normally find it necessary:
(a) To adjust the levels of attention given to particular inspection areas and to
redeploy its human resources accordingly;
(b) To alter the extent to which various inspection techniques and methods are
employed;
(c) To modify the rigour and frequency of the inspections.
Inspection programme
3.223. This Safety Guide focuses on technical aspects of the development of an

inspection programme, while the organization and management of an inspection
programme is addressed in GSG-12 [4].
“The regulatory body shall develop and implement a programme of

inspection of facilities and activities, to confirm compliance with regulatory
requirements and with any conditions specified in the authorization. In this
programme, it shall specify the types of regulatory inspection (including
scheduled inspections and unannounced inspections), and shall stipulate the
frequency of inspections and the areas and programmes to be inspected, in
accordance with a graded approach.”
3.225. The regulatory inspection programme should be comprehensive and

consistent with the overall regulatory strategy. The inspection programme should
be thorough enough to ensure that the regulatory objectives and requirements
are being met, thereby providing the regulatory body with a confidence that the
authorized party is effectively maintaining the safety of the facility or activity.
The inspection programme should also be developed so that the regulatory body
can determine whether the authorized party conducts activities in accordance
with previously established procedures, and has an effective self-assessment
process capable of prompt identification and correction of actual and potential
problems.
3.226. The regulatory body’s inspection programme should include the

following key elements:
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(a) A system of prioritizing inspections based on a graded approach;
(b) On-site inspections9;
(c) The investigation and follow-up of events and deviations from normal
operation;
(d) The submission of information on key operational safety parameters by
authorized parties.
3.227. On-site inspection is the element of the regulatory framework that gets
closest to actual operations, and a significant proportion of the regulatory body’s
resources should be allocated to this task.
3.228. The regulatory inspection programme should give due consideration to

leadership and the management system at the authorized party, and to human,
technological and organizational factors. Accordingly, the inspectors’ training
and qualification programme should be tailored to develop competences in
these areas. Independent external experts (e.g. technical and scientific support
organizations) might also be engaged for inspections, as appropriate and as
allowed by the regulatory system.
3.229. In addition to verifying compliance with regulatory requirements, the

regulatory body’s inspection programme should be able to obtain a general
indication of safety performance at the facility or activity. Common performance
indicators for safety include the following:
(a) Housekeeping;
(b) Financial stability;
(c) Staffing, including turnover of staff;
(d) Record keeping and retrieval systems;
(e) Investigation levels set by the authorized party and the procedures to be
followed in the event that investigation levels are exceeded;
(f) Training, including arrangements for retraining of staff;
(g) Occupational exposures for the type of facility or activity;
(h) Recurring failures of structures, systems and components important to
safety;
(i) Unavailability of structures, systems and components;
(j) Frequency of enforcement actions.
9
‘On-site’ needs to be interpreted appropriately: some activities (e.g. well logging) do
not take place on fixed sites so inspections may need to be carried out in a different location.
75
3.230. These indicators could be used as a basis for informing authorized
parties of the need to make safety improvements, and as a basis for establishing
the frequency of inspections for any particular authorized party. The regulatory
body should require authorized parties to pay attention to indicators of degraded
safety performance. This focus on indicators and the underlying performance
issues should contribute to the enhancement of a strong safety culture in the
authorized party.
3.231. Different methods may be used in establishing or modifying an

inspection programme, and its associated priorities, to achieve the objectives of
regulatory inspections. The regulatory body should consider the following:
(a) The results of previous inspections;

(b) The safety analysis performed by the authorized party and the results of
regulatory review and assessment;
(c) The use of performance indicators or any other systematic method for
assessment of the safety performance of the authorized party;
(d) Operating experience and lessons learned from operating the facility or
conducting the activity, and from similar facilities and activities in the State
and in other States, as well as results of research and development;
(e) Inspection programmes of the regulatory bodies in other States.
3.232. The regulatory body should have the capability to undertake inspection
activities when necessary; in particular, sufficient inspection resources should
be available for reactive inspections. For verification of the overall performance
of the authorized party, inspections of adequate depth should be conducted in a
wide range of subject areas and at appropriate intervals. Each planned inspection
should have objectives that have previously been specified by the regulatory
body to serve to the extent practicable as guidance for inspectors.
3.233. The regulatory body should establish a process of periodically

evaluating the findings of inspections, identifying generic safety issues and
making arrangements to enable inspectors from various locations or projects to
meet to exchange views and discuss the findings and issues.
3.234. The authorized party should be required to keep the regulatory body
informed of its schedules for carrying out activities and tests of regulatory interest
and should submit or make available to the regulatory body, in a timely manner,
the procedures for these activities. To facilitate this process, the regulatory body
should inform the authorized party well in advance as to which activities and
tests it wishes to be kept apprised of and possibly inspect on the site.
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3.235. As part of the inspection programme, on a regular basis the regulatory
body should compile and assess data on the performance of authorized parties,
the results of the regulatory inspection programme (inspection findings,
corrective actions and inspection reports) and trends in these data and results.
This information should be used to identify potential areas for improvement in
the performance of authorized parties and regulatory processes. The reports of
such assessments and analyses should be shared and communicated within the
regulatory body.
Types of regulatory inspection
3.236. Requirement 28 of GSR Part 1 (Rev. 1) [2] states that: “Inspections of

facilities and activities shall include programmed inspections and reactive
inspections, both announced and unannounced.”
3.237. Regulatory inspection should include a range of planned and reactive

inspections over the lifetime of the facility or activity and should include
inspections of relevant parts of the authorized party’s organization and its
contractors’ organizations to ensure compliance with regulatory requirements.
3.238. Inspections may be conducted by individuals or teams and may

be announced or unannounced. Inspections may be made as part of a general
inspection programme, or may have specific objectives.
3.239. The regulatory body should use the authorized party’s reports of safety
related activities or events in preparing for both planned and reactive inspections.
Matters to be included in reports from the authorized party should be clearly
defined so that difficulties in interpretation are avoided.
Planned inspections
3.240. Planned inspections, either announced or unannounced, should be

carried out in fulfilment of a predetermined inspection plan developed by the
regulatory body to provide sufficient confidence that regulatory requirements
are being met (baseline inspection plan). These inspections may be linked to
authorized party schedules for the performance or completion of certain activities
at the various steps of the authorization process. Planned inspections differ from
reactive inspections in that they are scheduled in advance by the regulatory body
and are not initiated because of unusual or unexpected circumstances. Planned
inspections provide an opportunity for the examination of the authorized party’s
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activities in order to confirm the authorized party’s performance and to identify
potential problems at an early stage.
3.241. In planned inspections, emphasis should be given to the observation and

assessment of ongoing safety activities in order to assess the effectiveness of the
authorized party’s performance.
3.242. The regulatory body should consider conducting special inspections

addressing specific issues that are of interest to the regulatory body, such
as refurbishment, new findings from research and development work, and
experience from other facilities or activities. Special inspections are usually
planned inspections, since they are scheduled in advance; however, in certain
circumstances they may be reactive inspections. Special inspections may range
from a single inspector reviewing a specific work area or activity, to a team of
inspectors reviewing different areas.
Reactive inspections
3.243. In addition to routine inspection activities, the regulatory body should

carry out inspections at short notice if an abnormal occurrence warrants
immediate investigation. Such reactive regulatory inspection does not diminish
the responsibility of the authorized party itself to investigate any such occurrence
immediately.
3.244. Reactive inspections, by individuals or teams, are usually initiated by

the regulatory body in response to an unexpected, unplanned situation or incident
in order to assess its significance, the implications for safety and the adequacy of
corrective actions. A reactive inspection may be prompted by an isolated incident
or a series of less significant events occurring at the particular facility or during
the particular activity under consideration. Similarly, a reactive inspection may
be made in response to a generic problem encountered at another facility or
activity or identified by the review and assessment staff of the regulatory body.
Unlike planned inspections, which are scheduled, reactive inspections are only
partly subject to planning by the regulatory body and may disrupt regulatory
programmes and schedules. The regulatory body should assume that there will
be a need for reactive inspections and should plan to meet its needs for staff
and external experts accordingly. All available resources may be necessary
in responding to a serious event, whereas in simple cases only one inspector
may be necessary. A pre-established, graded approach to responding to special
circumstances will assist in determining the appropriate level of resources for use
in reactive inspections.
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3.245. For a more serious event (or a potentially serious event), or when
operational parameters (e.g. doses) exceed regulatory limits or are significantly
elevated, an independent investigation should be conducted by the regulatory
body and in some cases by other governmental bodies, in addition to the
investigation to be conducted by the authorized party. There are usually two main
objectives in an investigation of a serious event by the authorities, which are not
completely separable but which need to be distinguished:
(a) Determination of the reasons why the event occurred so as to take measures
to prevent its recurrence;
(b) Consideration of the legal aspects concerning liability for the event.
3.246. Determining why the event happened is of central interest with regard to
safety. Investigations should be carried out by, or in consultation with, a person
with appropriate knowledge and experience of the facility or activity, the type of
event and of investigation techniques. With regard to the regulatory investigation
of the event, the following should be included:
(a) The determination of the root causes, the sequence of events and the
contributory factors;
(b) The assessment of the consequences;
(c) The identification of preventive and corrective actions;
(d) The identification and documentation of lessons to be learned;
(e) The recommendations for measures to be taken for the prevention of similar
events in the future, including changes in the regulatory programme, as
well as any adjustments to the authorized party’s arrangements for safety;
(f) The dissemination of the findings, lessons to be learned and
recommendations to relevant authorized parties, manufacturers and
suppliers, and other interested parties both in the State and in other States.
Announced and unannounced inspections
3.247. An announced inspection is an inspection of which the authorized party

has been informed in advance by the regulatory body. The regulatory body should
consider the timing of the announcement of the inspection, which may differ in
accordance with the circumstances of the inspection to be performed. Inspections
may be announced, for example, when the regulatory body wishes to observe a
specific test or activity, to review a specific self-assessment by the authorized
party while it is in progress or to interview a specific member of the authorized
party’s staff.
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3.248. The main advantage of announced inspections is that the inspector
is able to discuss plans and needs with the authorized party’s personnel in
advance in order to secure assurances that documentation will be available
for inspection, personnel will be available for interview and activities can be
inspected as scheduled. Hence, the announcement of inspections may enhance
their effectiveness.
3.249. Unannounced inspections might not always be feasible, but they have
benefits. The advantage of unannounced inspections is that the actual state of the
facility and the way in which it is being operated can be observed. Inspections
may be carried out at any time of the day or night so as to provide a more
complete picture of the situation at the facility or activity. However, unannounced
inspections need to take account of ongoing activities at the site.
Team inspections
3.250. Team inspections, which may require a multidisciplinary approach,

provide an in-depth, independent and balanced assessment of the authorized
party’s performance. Team inspections may vary in both scope and complexity.
Team inspections are of particular value once safety problems have been
identified, since other inspections may cover only small samples of the authorized
party’s activities in any particular area. Team inspections should identify
underlying causes of problems in order to determine whether a safety concern
represents an isolated case or may signify a broader, more serious problem.
3.251. Different approaches may be used in planning team inspections.

Some team inspections may be broad in focus and cover a wide subject area
(a horizontal slice) in the programme or area of interest. For example, a team of
inspectors may assess the performance of operations at a facility or the conduct
of all relevant activities on a site, or a team of inspectors with maintenance and
engineering competences may assess outage activities at a nuclear power plant.
Other team inspections may be narrow in focus and cover a smaller subject area
(a vertical slice). For example, a number of specialist inspectors may review,
in depth, a single safety system in order to confirm that the system is in full
compliance with the regulatory requirements or a team may inspect the same
safety aspect at similar facilities or activities in the State.
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Planning of regulatory inspections
3.252. The organization and management of planning for inspection and the
allocation of resources for inspection are described in GSG-12 [4]; this Safety
Guide focuses on technical aspects of the inspection plan.
3.253. The regulatory body should have an overall plan for the programme of
inspection that it intends to undertake at a facility or during an activity.
3.254. For each technical area to be inspected, the intervals between inspections
and the level of effort to be applied to the inspection will depend on the following
factors:
(a) The type of facility or activity;

(b) The safety significance of the technical area to be inspected;
(c) The inspection methods and approaches used (e.g. the use of resident
inspectors may influence the intervals and the scope and depth of
inspections);
(d) The performance record of the authorized party and the facility; for
example, the number of non-compliances with regulatory requirements,
violations of conditions in the authorization, deficiencies, events and the
number of reactive inspections;
(e) The results of regulatory review and assessment;
(f) The personnel and other resources available to the regulatory body;
(g) The results of previous inspections.
3.255. To manage the allocation of resources for inspections, the regulatory

body should develop specific inspection plans in which the factors listed in
para. 3.254 are taken into account. The inspection plans should be recorded in
such a way that they can be modified to take new activities or changes to ongoing
activities into account. They should be reviewed periodically and modified as
necessary.
3.256. The inspection plan for a specific facility or activity should be flexible
enough to allow inspectors to respond to particular needs and situations. On
major facilities, many States allow for 25% of the inspection time to be available
for reactive inspections.
3.257. The planning of the programme of inspection will also be influenced by

the locations of the regulatory body’s offices and of the facility or activity to be
inspected.
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3.258. Arrangements should be made to ensure that all relevant staff of
the regulatory body can fully contribute to the planning of inspections and, in
particular, if the offices of the regulatory body are distributed over a wide area,
that inspectors are involved in the planning process. This will ensure the best use
of the skills and knowledge of the staff of the regulatory body.
Selection of inspection areas
3.259. This Safety Guide covers a wide range of types of facility and activity,
and it is not possible to provide details of specific areas that would be subject to
inspection at each lifetime stage for each type of facility and activity. The degree
to which the areas should be considered will depend on the nature of the facility
or activity and the risks associated with it. Major inspection areas for nuclear
facilities are listed in Appendix IV.
3.260. Inspection should not be limited to the facility or activity itself and
should cover any safety related services that may be provided at an authorized
party’s headquarters or other offices, such as activities relating to the development
of safety assessments, outage planning or training.
3.261. Whenever the authorized party makes use of the safety related services
or products of a contractor, the regulatory body should include the contractor’s
supervision by the authorized party and the contractor’s activities in its inspection
programme in all steps of the authorization process. This may comprise
inspection of the design and manufacturing of components, including, where
appropriate, activities performed in other States. Inspection of the authorized
party’s contractors should only be performed in conjunction with inspection of
the authorized party, so that the authorized party is not relieved of the prime
responsibility for safety.
Performance of regulatory inspection
Internal guidance
3.262. The regulatory body should issue internal guidance for its inspectors
on performing regulatory inspections in order to ensure a consistent approach to
inspection while allowing sufficient flexibility for inspectors to take the initiative
in dealing with new concerns that arise. Each inspector should be given adequate
training in following this guidance.
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3.263. The guidance for inspectors should include the following:
(a) Policies of the regulatory body regarding inspections.

(b) The legal basis for regulatory inspection and the scope of the inspector’s
authority.
(c) The use of regulatory requirements, regulations, guides and standards.
(d) The development of an inspection programme.
(e) The implementation of the inspection programme, including:
(i) Facilities (or areas of the facility) or activities to be subject to
inspection;
(ii) Method of inspection to be used;
(iii) Methods for selection of inspection samples;
(iv) Use of relevant technical information;
(v) Use of inspection questionnaires;
(vi) Follow-up on inspection findings.
(f) Reporting requirements and practices for inspectors.
(g) Standards of conduct of inspectors.
(h) The enforcement policy, procedures and practices.
3.264. The regulatory body should stress in the guidance the importance of
objectivity and fairness on the part of inspectors, together with the need to respect
the rules of the facility or activity as established by the authorized party provided
these rules do not prevent inspectors from fulfilling their duty.
3.265. The authority vested in inspectors should oblige them to conduct

themselves in a manner that inspires confidence in and respect for their
competence and integrity. They should, for example, make adequate preparation
by gathering and reviewing all relevant information and data before proceeding
on assignment and should be knowledgeable about the area that they are required
to inspect.
Preparation for an inspection
3.266. Before an inspection is carried out, inspectors should be thoroughly

prepared for the task. The type of preparation will depend on the type (planned
or reactive, announced or unannounced, individual or team) and method
(see para. 3.268) of inspection. Preparation may include a review of the following:
(a) Regulatory requirements relating to the authorized facility or activity, and

conditions in the authorization issued to the authorized party;
(b) Experience feedback relating to the inspection area;
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(c) Findings of previous inspections and enforcement actions relating to the
inspection area, and any unresolved issues from previous inspections;
(d) The analysis of accidents and other events in the past;
(e) Past correspondence between the regulatory body and the authorized party
relating to the inspection area;
(f) The safety documentation and operational limits and conditions;
(g) Documentation on operation and design for the facility or activity;
(h) The authorized party’s management system.
3.267. Preparations should be made by the individual or team (including any

external experts) who will be conducting the inspection. It is generally useful
to establish a specific plan for the inspection by compiling a questionnaire and
a list of the documents to be reviewed with the authorized party. Preparation
includes the identification of the necessary documentation and equipment for
the inspection. Depending on the particular circumstances and the nature of the
facility or activity these may include:
(a) Relevant inspection procedures, questionnaires and checklists as well as

other relevant documents;
(b) The accreditation of the inspector;
(c) Personal dosimeters;
(d) Appropriate survey meters or other necessary measuring equipment;
(e) Safety equipment, such as high visibility clothing, safety shoes and hard
hats;
(f) A camera for documentation.
Methods of inspection
3.268. The inspection procedures of the regulatory body should incorporate

and use a variety of methods, as follows:
(a) Monitoring and direct observation (such as of working practices and

equipment);
(b) Discussions and interviews with personnel of the authorized party and of
the contractor, if necessary;
(c) Examination of procedures, records and documentation;
(d) Confirmatory tests and measurements.
In individual inspections, one or more of these methods should be employed,

depending on the specific issues being considered.
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Monitoring and direct observation
3.269. The inspection methods should include provision for direct observation
of elements, such as human factors significant to safety (performance of
personnel, attitudes of managers), tests and other safety related activities carried
out by the authorized party.
3.270. The regulatory body may prescribe certain categories of structures,

systems and components, tests and activities that should be directly observed
by its inspectors in whole or in part. In some cases, the regulatory body may
require regulatory monitoring of a specific structure, system, component, test
or activity as a condition for the authorized party to be permitted to proceed to
subsequent stages of work or operation. Monitoring is particularly useful during
the commissioning stage, or as a means of verifying corrective action at any stage
over the lifetime of the facility or activity as required by the regulatory body after
an abnormal occurrence or a serious non-compliance.
3.271. The regulatory inspection programme should provide time for general
surveillance of the facility or activity by regulatory inspectors. Such surveillance
is aimed at gaining an overall impression of the authorized party’s capabilities
and performance and is not restricted to specifically designated components and
systems or designated scheduled activities and tests. Examples of where such
surveillance may be useful include the following:
(a) Workplaces;
(b) Transfer of jobs between persons;
(c) Radiation protection arrangements including boundaries of controlled
areas;
(d) Items important to safety for the facility or activity;
(e) Fire barriers;
(f) Housekeeping;
(g) The presence of management;
(h) Internal and external interfaces and communications;
(i) Arrangements for emergency preparedness and response.
Discussion and interviews with authorized party personnel
3.272. Regulatory inspectors should, as appropriate, communicate directly with

the authorized party’s personnel responsible for supervising and performing the
activities being inspected. This is especially important in follow-up investigations
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in which inspectors are involved in reconstructing events and assessing the
authorized party’s response.
3.273. The authorized party’s personnel should be kept appropriately informed

of inspection activities. These considerations can be partly satisfied by means
of discussions and interviews. Interviews with workers, the facility or activity
manager and, as appropriate, with other senior managers should be standard
features of most inspection visits. In interacting with the authorized party’s staff,
the inspector should exercise mature judgement concerning the prerogatives and
responsibilities of the facility’s management. Generally, the focus of interviews
should be to gain insights about technical, human or organizational topics and
processes.
Examination of procedures, records and documentation
3.274. Examination of the authorized party’s documentation contributes to

the regulatory body’s verification of the authorized party’s compliance without
unduly disrupting work schedules or interfering with the authorized party’s prime
responsibility for safety. Documentation examined by regulatory inspectors may
include the following:
(a) Procedures and schedules for maintenance and testing;

(b) Quality assurance records;
(c) Test results and data;
(d) Operational and maintenance records, and results of workplace monitoring;
(e) Records of deficiencies and incidents;
(f) Modification records, including records of modifications to management
and operating procedures;
(g) Training records;
(h) Shift schedules;
(i) Dose records.
3.275. The regulatory body should examine the authorized party’s

documentation in a manner sufficient to satisfy itself that the authorized party is
fulfilling the requirements for authorization and is operating in accordance with
the practices proposed by the authorized party and approved by the regulatory
body and that any deviations or deficiencies that have been detected have been
adequately addressed.
3.276. The examination of documentation by regulatory inspectors may in

some cases take place, in part, off the site — for example, at the regulatory
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body’s headquarters or the authorized party’s headquarters — and can contribute
towards the preparation for the inspection of the facility or activity.
Tests and measurements
3.277. The regulatory body should have the authority and resources [4] to be
able to carry out confirmatory tests and measurements as necessary, at fixed
points or in places of special interest, as applicable, using its own equipment.
3.278. The extent to which the regulatory body conducts its own confirmatory
tests and measurements independently of the authorized party differs greatly
between States, depending upon factors such as the qualifications of personnel
available to the regulatory body, its regulatory approach, and the experience and
demonstrated performance of authorized parties. The regulatory body should
not engage in the conduct of confirmatory tests or measurements that would
necessitate its assuming direct operational control of the facility or activity or any
of its systems.
3.279. Tests of components and systems of the facility should only be

undertaken after consultation with the facility’s management. In most instances,
confirmatory tests and measurements replicate and serve as an independent
verification of tests and measurements performed by the authorized party. The
conduct of such confirmatory tests and measurements by the regulatory body
does not relieve the authorized party of the prime responsibility for safety. The
confirmatory tests undertaken by the regulatory body should not place the facility
in an unsafe condition nor contribute to risks of any kind.
3.280. Since the regulatory body itself conducts only limited testing, a detailed
review should be carried out of a sample of the authorized party’s procedures
for tests and its interpretation of their results. If external experts are used by the
regulatory body to monitor the confirmatory tests and measurements undertaken
by the authorized party, their reports should also be reviewed. Where further
confirmatory tests or measurements are necessary, the regulatory body should
request that they be performed by the authorized party.
Conduct of inspections
3.281. Inspections should be conducted in accordance with an approved

inspection programme, plan, guidelines, procedures and checklists. The
techniques utilized for the inspections should be commensurate with the
inspection requirements and the activity or area being inspected. Certain activities
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may require the inspectors to avoid immediate discussions with the personnel
performing the activity, and some inspections may not provide the opportunity
for direct observations.
3.282. Inspectors should write down their observations while conducting the
inspections. Upon completion of the inspection, the inspectors should conduct an
exit briefing with the authorized party’s senior management and should share the
details about the inspection activities, observations, good practices, deficiencies
and deviations with the inspected organization. Inspectors should also seek
feedback from the authorized party about the conduct of inspections.
Records of regulatory inspections
“The regulatory body shall record the results of inspections and shall take
appropriate action (including enforcement actions as necessary). Results of
inspections shall be used as feedback information for the regulatory process
and shall be provided to the authorized party.”
Inspection reports and findings
3.284. A report of each regulatory inspection should be prepared by the

inspector(s) who performed the inspection. The report should be reviewed and
approved in accordance with established internal procedures of the regulatory
body. The scope, layout, content, timing and distribution of inspection reports
may differ in accordance with:
(a) The general administrative and legal structure in the State and the
requirements established by the regulatory body;
(b) The type of facility or activity and its steps of authorization;
(c) The location of the inspection;
(d) The type of inspection, whether planned or reactive, announced or
unannounced, individual or team;
(e) The purpose of the inspection (e.g. team inspection, special inspection, site
visit by non-resident site inspectors, weekly inspection activities carried out
by resident inspectors).
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3.285. The purposes of inspection reports are:
(a) To record the results of all inspection activities relating to safety or of

regulatory significance;
(b) To document and record an assessment of the authorized party’s activities
in relation to safety;
(c) To record discussions held with authorized party’s staff, management and
other concerned persons;
(d) To provide a basis for informing the authorized party of the findings of the
inspection and of any non-compliance with regulatory requirements, and to
provide a record of any enforcement actions taken;
(e) To record any findings or conclusions reached by inspectors;
(f) To record any recommendations by inspectors for future actions by
the authorized party or the regulatory body and to record progress on
recommendations from previous inspections;
(g) To inform other staff of the regulatory body of inspection results;
(h) To contribute to maintaining an organizational memory.
Content of inspection reports
3.286. Inspection reports should typically contain:
(a) Details of the authorized party inspected, the purpose and date of the
inspection and the inspectors’ names;
(b) The methods used in the inspection (interviews, observations, review of
documents);
(c) Reference to applicable requirements;
(d) Criteria used in the assessment of safety performance;
(e) Details of areas, activities, documents, processes, items, and qualification
and training of personnel that have been inspected, assessed or reviewed;
(f) A record of actual or potential problems relating to safety;
(g) A record of the results of any checks for compliance with regulatory
requirements and the conditions of the authorization;
(h) A record of any deficiency or non-compliance with regulatory requirements
or violation of conditions of the authorization found in regulatory
inspections, including a record of which requirements or authorization
conditions have been contravened;
(i) A record of discussions held with the authorized party’s staff, managers and
other persons, including a record of discussions with the authorized party’s
managers about points of concern;
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(j) A record of the inspectors’ opinion about the response of the authorized
party’s management to any matter of concern to which their attention was
drawn after a regulatory inspection;
(k) A record of any regulatory action taken by inspectors and any consequent
action taken by the authorized party in the period covered by the report;
(l) A record of the findings or conclusions of the inspectors, including
corrective actions that should be taken;
(m) A record of recommendations made by inspectors for future action, such
as a need to advise other inspectors or authorized parties about particular
problems, proposals for further inspections or proposals for enforcement
actions.
Distribution and use of inspection reports
3.287. Inspection reports should be distributed, or made available electronically,

in accordance with established procedures in order to provide the following:
(a) A basis for future regulatory action;

(b) A contribution to maintenance of the regulatory history by providing a
record of inspections, discussions and associated findings and conclusions;
(c) A basis for identifying major or generic issues that necessitate special
inspections, changes to inspection plans or generic regulatory action;
(d) Information to other staff of the regulatory body, for example those staff
responsible for the development of regulations and guides, for review and
assessment, and for the development of requirements for authorization;
(e) A means of sharing information with other inspectors;
(f) Information to regulatory staff responsible for the analysis of reportable
events;
(g) A basis for periodic reviews of inspection findings, including trends and
root causes;
(h) A means of passing information to interested parties or governmental
bodies;
(i) Self-assessment activities.
3.288. Inspection findings should be discussed at regular meetings attended

by groups of inspectors. It is also a good practice in many States to include
those regulatory body staff involved in review and assessment activities or
authorization activities in such meetings.
3.289. Inspection findings should be forwarded to the authorized party for its
information and records, as well as for necessary corrective actions. Whenever
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corrective action is necessary, a formal communication including the findings
from inspection reports should be sent to the authorized party. In some States,
the full inspection report is forwarded to the authorized party. In communications
with the authorized party, caution should be exercised in identifying individuals
by their name or their post because of the possible implications (including those
of a legal nature) for the individuals concerned.
3.290. Documents that are made available to the inspector by the authorized
party during an inspection should be referenced in the inspection report.
Inspection reports and copies of relevant documents received in connection with
the inspection should be stored in a manner that permits ready retrieval and that
follows applicable document classification procedures.
3.291. From time to time the regulatory body may find it useful to produce
a composite report covering a type of facility, activity or a specific aspect of
inspection, drawing together findings from a number of relevant inspection
reports.
Publication of inspection findings
3.292. In order to inform the public of the safety of facilities and activities
and of the effectiveness of the regulatory body, findings of inspections and the
associated regulatory decisions may be made publicly available. The extent
to which such information is made publicly available will depend on the legal
provisions in the State concerned. Although it may be the practice in some States
to publish individual inspection reports or inspection follow-up letters sent to the
authorized party, such reports and letters may contain confidential information,
such as nuclear security information, information that the regulatory body may
wish to use in connection with future regulatory actions, proprietary information,
or personal or medical information relating to individuals. Such information
should be processed in accordance with the relevant national requirements.
3.293. All information exchanged between the regulatory body, other

governmental bodies, the authorized party, its contractors, advisory committees
and the regulatory body’s consultants and, as appropriate, members of the public
should be formally recorded upon receipt by the regulatory body and should be
stored in a manner that permits ready retrieval.
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Follow-up of inspection findings
3.294. A programme to systematically analyse and follow-up on inspection

findings should also be established. The programme should include provisions
for periodic review and surveillance of the follow-up actions to verify that the
authorized party is taking the necessary actions in response to inspection findings.
Upon satisfactory completion of the actions, the inspection findings should be
formally closed and necessary documents and records should be maintained.
ENFORCEMENT
3.295. Paragraph 2.5 of GSR Part 1 (Rev. 1) [2] requires that the government
promulgate laws and statutes to make provision for an effective governmental,
legal and regulatory framework for safety, including provision for the
enforcement of regulations, in accordance with a graded approach.
“The regulatory body shall establish and implement an enforcement

policy within the legal framework for responding to non-compliance by
authorized parties with regulatory requirements or with any conditions
specified in the authorization.”
“Enforcement actions by the regulatory body may include recorded

verbal notification, written notification, imposition of additional
regulatory requirements and conditions, written warnings, penalties and,
ultimately, revocation of the authorization. Regulatory enforcement may
also entail prosecution, especially in cases where the authorized party
does not cooperate satisfactorily in the remediation or resolution of the
non-compliance.”
3.298. The authorization process itself is a form of enforcement as refusal of

an application for an authorization effectively means that operation of the facility
or conduct of the activity is prohibited and legal sanctions can be used if the
prohibition is not complied with. However, in most States the term ‘enforcement
process’ refers to the actions taken by the regulatory body in response to
non-compliances with regulatory requirements and violations of authorization
conditions that occur during the operation of a facility or conduct of an activity.
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3.299. Regulatory enforcement activities should cover all areas of regulatory
responsibility. Enforcement actions should be applied as necessary by the
regulatory body using a graded approach appropriate to the legal system and the
authorization practices of the State.
Objectives of enforcement
3.300. The principal objectives of enforcement should be to provide a high

level of assurance that the authorized party complies with all safety requirements
at all steps of the authorization process and all stages of the lifetime of the facility
or duration of the activity meet the safety objectives and authorization conditions,
and that the authorized party promptly identifies and corrects non-compliances
with safety requirements.
3.301. Regulatory enforcement actions are taken by the regulatory body to

address non-compliance by the authorized party with specified conditions and
requirements. Such actions should be taken to ensure that the authorized party
modifies or corrects aspects of its procedures and practices, or of a facility or
activity’s structures, systems and components important to safety.
Methods of enforcement
3.302. The main purpose of enforcement is to ensure safety by deterring

non-compliance, encouraging prompt identification of non-compliances, and
ensuring that appropriate corrective actions are taken. Enforcement actions
should be chosen to achieve this end. However, the method chosen should also be
appropriate to the severity of the non-compliance with regulatory requirements
or the violation of authorization conditions, and the regulatory body’s policy on
this should be documented. Paragraphs 3.303–3.307 describe some of the main
enforcement methods; para. 3.308 describes the factors affecting the choice of
method.
Verbal or written notification of non-compliance
3.303. In many cases it may be possible to resolve unsatisfactory situations

with minor safety significance by means of discussion with the authorized
party. If necessary, such a verbal notification should be formalized in a written
notification, in accordance with the legal system of the State.
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Written warnings or directives
3.304. Deviations from, or non-compliance with, the regulatory requirements

as set out in regulations, or unsatisfactory situations that have more than minor
safety significance, may be identified at facilities or in the conduct of activities.
In such circumstances, the regulatory body should issue a written warning or
directive to the authorized party, which should specify the nature and regulatory
basis for each case and the period of time permitted for taking remedial action,
and may provide guidance on the required corrective action(s). This is the most
common form of enforcement action and will, in most cases, be sufficient to
remedy the safety issue.
Penalties
3.305. The regulatory body should have the authority to impose or to recommend
penalties; for example, fines on the authorized party, whether a corporate body or
an individual; or to institute prosecution through the legal process, depending on
the legal system and the authorization practices of the State. The use of penalties
is usually reserved for serious non-compliances with regulatory requirements and
for repeated violations of the authorization conditions of a less serious nature.
Experience in some States suggests that imposing penalties on the authorized
party rather than on individual workers is preferable as it is more likely to lead to
improved safety performance.
Restriction or suspension of activities
3.306. If there is evidence of a deterioration in the level of safety, or in the

event of a serious violation of the authorization conditions that, in the judgement
of the regulatory body, poses an imminent radiological hazard to people or the
environment, the regulatory body should require the authorized party to restrict
or suspend the operation of specified facilities or activities and to take any further
action necessary to restore an adequate level of safety.
Modification, suspension or revocation of the authorization
3.307. In the event of a persistent or extremely serious or willful

non-compliance with regulatory requirements or violation of the authorization
conditions, or a significant release of radioactive material to the environment
due to serious malfunctioning of equipment, damage to structures, systems and
components or incorrect operation of a facility or conduct of an activity, the
regulatory body should direct the authorized party to cease the operation of a
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facility or the conduct of an activity and may suspend or revoke the authorization.
The authorized party should be directed to eliminate any unsafe conditions.
In considering the withdrawal of an authorization, the regulatory body should
ensure that operations or activities important to maintain safety continue to be
performed by the authorized party.
Factors in determining enforcement actions
3.308. The factors to be taken into account by the regulatory body in deciding
which type of enforcement action is appropriate in each case include the
following:
(a) The safety significance of the non-compliance or of the violation and the
complexity of the corrective action necessary;
(b) Whether the non-compliance or violation is repeated;
(c) Whether there has been a willful violation or a willful non-compliance;
(d) Whether or not the authorized party identified and/or reported the
non-compliance or the violation;
(e) Whether the non-compliance or violation impacted the ability of the
regulatory body to perform its regulatory oversight function;
(f) The past safety performance of the authorized party and the
performance trend;
(g) The need for consistency and openness in the treatment of authorized parties.
Implementing enforcement
The inspector’s authority in relation to enforcement
3.309. The extent of the authority of regulatory inspectors to take immediate

enforcement actions should be determined by the regulatory body, in accordance
with the national legal framework and regulations. The authority given to
an inspector may depend on the structure of the regulatory body and on the
inspector’s duties and experience.
3.310. In many States, inspectors are empowered to implement immediate

enforcement actions for non-compliances with regulatory requirements or
violations of authorization conditions, to enable a more rapid response and
improvement in safety. Where immediate enforcement authority is not granted
to individual inspectors, the transmission of information to the regulatory body
should be commensurate with the urgency of the situation so that necessary
actions are taken in a timely manner. Information should be transmitted
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immediately if an inspector judges that the health and safety of workers or the
public are at risk, or that the environment is endangered.
3.311. Significant enforcement actions, particularly those involving penalties,

the curtailment of activities or the suspension of the authorization, are not taken
immediately by regulatory inspectors except in unusual situations. Normally,
decisions concerning these types of enforcement action should be taken by the
regulatory body in accordance with its established procedures.
Use of the enforcement process
3.312. The regulatory body should adopt clear administrative procedures

governing the taking of enforcement actions, which should be documented in
internal guidance. All inspectors and other staff of the regulatory body should be
trained in, and knowledgeable about, the procedures.
3.313. If there is no immediate risk to safety, the regulatory body should allow
the authorized party a reasonable period of time in which to complete a corrective
action. The time period should reflect the safety significance of the issue and
the complexity of the corrective action required as well as other relevant factors
(e.g. the proximity to a maintenance outage). However, in an integrated approach
to safety, the contribution to the total risk of each non-compliance requiring a
corrective action should be considered.
3.314. Procedures should stipulate which other governmental bodies, if any,

should be informed in the event of enforcement actions being taken.
3.315. Regulatory procedures should state the circumstances under which it

is appropriate to carry out further inspections to check whether the authorized
party has responded to regulatory enforcement measures. The purpose of such
inspections should be to confirm that the authorized party has complied with the
enforcement measures within the periods of time specified.
Records of enforcement
“At each significant step in the enforcement process, the regulatory body
shall identify and document the nature of non-compliances and the period of
time allowed for correcting them, and shall communicate this information
in writing to the authorized party.”
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3.317. All enforcement actions should be recorded in accordance with an
established procedure and with legal and regulatory practices. Whenever an
enforcement action has to be taken urgently to ensure the protection of people and
the environment, the action should be confirmed in writing as soon as possible.
3.318. Internal records of decisions relating to enforcement actions and any

supporting documentation should be kept by the regulatory body in such a way
that they are easily accessible and retrievable when required.
3.319. Moreover, para. 4.65 of GSR Part 1 (Rev. 1) [2] requires that the
regulatory body use such internal records in support of its regulatory functions
and to support the enforcement of regulatory requirements.
EMERGENCY PREPAREDNESS AND RESPONSE
3.320. The responsibilities of the government in the area of emergency

preparedness and response are set out in Requirement 8 of GSR Part 1
(Rev. 1) [2] and Requirement 43 of GSR Part 3 [3]. Furthermore, Requirement 2
of GSR Part 7 [7] states that:
“The government shall make provisions to ensure that roles and

responsibilities for preparedness and response for a nuclear or
radiological emergency are clearly specified and clearly assigned.”
“The regulatory body shall require that arrangements for preparedness and
response for a nuclear or radiological emergency be in place for the on-site
area for any regulated facility or activity that could necessitate emergency
response actions.”
3.322. The above roles, responsibilities and arrangements should address

coordination and integration of on-site emergency arrangements with other
relevant plans (e.g. those of other response organizations and the nuclear security
plans of the authorized party).
3.323. The government may assign the regulatory body other roles and
responsibilities in emergency preparedness and response; the precise nature
of these roles and responsibilities will depend on the specific legal and
organizational structures in the State. Consequently, in the following text it is only
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possible to describe in a generic manner the necessary functions and processes
that the regulatory body should perform in relation to emergency preparedness
and response.
3.324. The functions and processes in which the regulatory body will have a
role can be considered under the following four general headings:
(a) Ensuring that on-site emergency arrangements are in place;

(b) Ensuring coordination with off-site response organizations;
(c) Establishing and maintaining internal arrangements for emergency
preparedness and response;
(d) Discharging its assigned responsibilities in emergency response.
3.325. Many of the roles and responsibilities of the regulatory body in

respect of emergency preparedness and response will be conducted through the
functions and processes described in earlier sections of this Safety Guide, but
additional processes within the integrated management system may also need to
be considered [4].
3.326. While much of the effort by the regulatory body and the authorized party
in emergency preparedness and response for a nuclear or radiological emergency
will be devoted to incidents including accidents occurring at a facility or activity
within the State, a nuclear or radiological emergency in another State may have
an impact on the State concerned. Such impacts should be considered in the
hazard assessment carried out for the facility or activity by the authorized party
and should be addressed, as appropriate, in the emergency arrangements.
Ensuring on-site emergency arrangements are in place
Regulations and guides
“[The] regulations and guides shall include principles, requirements

and associated criteria for emergency preparedness and response for the
operating organization.”
The regulations and guides should include requirements for the following:
(a) Performing a hazard assessment;
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(b) Provisions for establishing and maintaining adequate infrastructure to
support the performance of emergency response actions (e.g. plans,
procedures, training and exercise programmes, staffing, equipment, tools,
facilities, quality management programme and record keeping);
(c) The timely notification of a nuclear or radiation emergency to the
appropriate authorities;
(d) The timely activation of the necessary emergency response actions on-site
and, as relevant, off-site;
(e) Provisions for obtaining off-site support and coordination with
off-site authorities;
(f) Provisions for protecting emergency workers (including health
surveillance, medical follow-up, monitoring and control of exposure during
the response);
(g) Provisions for terminating the emergency;
(h) Conducting a subsequent analysis of the emergency and the
emergency response.
Review and assessment
3.328. The regulatory body should review and assess the on-site emergency
arrangements developed by the authorized party, to verify compliance with
regulatory requirements. This review and assessment should ensure that the
on-site emergency arrangements provide, to the extent practicable, assurance
of an effective response to the full range of postulated nuclear or radiological
emergencies, including those of very low probability [7].
3.329. The review and assessment should consider whether the on-site
emergency arrangements:
(a) Are based on a hazard assessment that identifies all postulated nuclear
or radiological emergencies that might occur in relation to the facility or
activity, including those of very low probability;
(b) Include arrangements for managing the on-site emergency response and for
coordination with off-site response;
(c) Address, as applicable, the operability and habitability of emergency
response facilities (e.g. the emergency centre, technical support centre,
operational support centre) under the range of postulated emergency
conditions identified in the hazard assessment;
(d) Include emergency procedures covering all postulated nuclear or
radiological emergencies, including, where necessary, severe accident
management guidelines [46], and which satisfactorily cover the necessary
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operator actions and functions in emergency response (including procedures
for notification and activation of off-site emergency response);
(e) Identify tools, instruments, supplies, equipment and communication
systems necessary for response to a nuclear or radiological emergency that
are adequate for the usage expected;
(f) Include a specific training programme (which includes drills) and
instructions for all staff of the authorized party on how to respond to a
nuclear or radiological emergency and on the discharge of their expected
duties;
(g) Include sufficient suitably qualified staff to be available at all times to
implement the emergency plans and procedures;
(h) Include arrangements for obtaining support from off-site response
organizations;
(i) Describe the coordination with other plans, such as plans for nuclear
security and plans for firefighting;
(j) Include an exercise programme to ensure that all the emergency
arrangements are tested satisfactorily within a specific period.
Inspection
3.330. As part of its inspection plan, the regulatory body should inspect and
evaluate the on-site emergency arrangements against predetermined criteria and
checklists. In addition, it is required that the regulatory body evaluate some of
the emergency exercises carried out by the authorized party (see GSR Part 7,
para. 6.30 [7]). To do so, the regulatory body should develop necessary evaluation
guidelines and checklists. As appropriate, this evaluation should assess the
adequacy of coordination and integration of the on-site emergency arrangements
with those off-site.
3.331. The regulatory body should ensure that the authorized party demonstrates
the effectiveness of the on-site emergency arrangements as a prerequisite to
issuing the authorization to bring nuclear and radioactive material onto the site
and that this is completed before the start of commissioning or operation of a
facility or commencement of the activity.
Enforcement
3.332. Enforcement, as described in paras 3.295–3.319, should also be applied

with regard to the on-site emergency arrangements.
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Ensuring coordination with off-site response organizations
3.333. The regulatory body is part of the coordinating mechanism that is

required to be established by the government in accordance with para. 4.10
of GSR Part 7 [7]. The coordinating mechanism ensures that emergency
arrangements are coordinated, consistent and are in place for all postulated
nuclear or radiological emergencies, including those beyond State borders. The
regulatory body should ensure that the authorized party provides the information
necessary for establishing and maintaining adequate and coordinated off-site
emergency arrangements at all levels, as appropriate.
3.334. The regulatory body will usually be either a source of advice during
the preparation of the national radiation emergency response plan or a lead
organization for its preparation. In many States, the regulatory body may be
assigned the responsibility to provide advice in an emergency to the government
and other response organizations. In some States, the regulatory body may
also provide expert services (e.g. services for radiation monitoring and risk
assessment for actual and expected future radiation risks) in accordance with
the responsibilities assigned to it. Irrespective of its assigned responsibility in
emergency response, the regulatory body should develop and maintain necessary
arrangements (e.g. plans, procedures, tools, equipment, training, exercises) to
effectively discharge this responsibility.
3.335. The regulatory body should take part in the regular exercises for
emergency response, including national exercises, and should evaluate its
own performance against pre-established objectives associated with its duties
in emergency response. The results of this self-evaluation should be used to
identify where and what further improvements are necessary in its emergency
arrangements.
3.336. As an important aspect of the regulatory body’s evaluation of the

national exercises, the regulatory body should assess the interface between the
authorized party, off-site response organizations and itself.
Establishing and maintaining internal emergency arrangements
3.337. The regulatory body should set up internal processes and procedures to
ensure that it will fulfil the duties set out in previous paragraphs, both at the
preparedness stage and during an emergency response.
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3.338. The regulatory body, within its sphere of responsibility, should
coordinate its emergency arrangements with those of authorized parties,
with emergency arrangements at national and local levels and with its related
international agreements and obligations.
3.339. GSG-12 [4] describes the management provisions and organizational and
training provisions necessary for regulatory body staff with appropriate training
to carry out their responsibilities in emergency preparedness and response. The
regulatory body should, as applicable, put mechanisms in place to:
(a) Send staff to appropriate locations during a nuclear or radiological

emergency;
(b) Collect data on the progress of the emergency either directly or remotely,
which may require having access to the authorized party’s systems;
(c) Analyse and draw conclusions on the likely progression of the emergency;
(d) Advise the appropriate response organizations, which includes the
authorized party, of its findings;
(e) Ensure secure and reliable communication between its staff and
other organizations.
3.340. The regulatory body should develop and implement internal training and
exercise programmes to ensure that the emergency arrangements are tested and
that staff are familiar with the roles they will be expected to undertake in the
event of a nuclear or radiological emergency.
Discharging its assigned responsibilities in emergency response
On-site responsibilities
3.341. The prime responsibility for safety remains with the authorized party
during a nuclear or radiological emergency confined to the site of the facility or
where the activity is taking place. The role of the regulatory body should be to
observe the actions the authorized party takes; the regulatory body should not
impede the authorized party from taking the necessary pre-planned emergency
response actions on the site in a timely manner (see paras 4.15 and 5.23 of
GSR Part 7 [7]).
3.342. The regulatory body should collect information, analyse the situation
and compare its findings with that of the authorized party. In addition, without
interfering with the authorized party’s responsibilities for safety, the regulatory
body should consider the actions that the authorized party takes. To do this
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effectively, the regulatory body may assign staff to a position on the site or to
other locations. These staff should record how decisions regarding on-site
emergency response actions are taken and implemented by the authorized party.
Off-site responsibilities
3.343. The regulatory body’s responsibilities should be clearly described in the

government’s provisions for dealing with a nuclear or radiological emergency.
In preparing an emergency plan and in the event of an emergency, the regulatory
body is required to advise the government and response organizations and to
provide expert services in accordance with the responsibilities assigned to it
(see GSR Part 1 (Rev. 1), para. 2.24 [2]).
3.344. Where applicable, the regulatory body should make information on

incidents, including accidents, available to authorized parties, governmental
bodies and international organizations, and the public, as appropriate, in
accordance with the pre-planned arrangements.
COMMUNICATION AND CONSULTATION WITH

INTERESTED PARTIES
3.345. Paragraph 3.10 of SF-1 [1] states that:
“The regulatory body must: …[s]et up appropriate means of informing

parties in the vicinity, the public and other interested parties, and the
information media about the safety aspects (including health and
environmental aspects) of facilities and activities and about regulatory
processes; [and] [c]onsult parties in the vicinity, the public and other
interested parties, as appropriate, in an open and inclusive process.”
“The regulatory body shall promote the establishment of appropriate

means of informing and consulting interested parties and the public
about the possible radiation risks associated with facilities and
activities, and about the processes and decisions of the regulatory body.”
3.347. The regulatory body should develop and implement a communication

and consultation strategy and should be committed to a high level of
transparency and openness, while ensuring an adequate level of protection of
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sensitive information, in order to address the legitimate concerns of interested
parties in nuclear and radiation safety matters, to enable the regulatory body to
make informed decisions and to contribute to ensuring its freedom from undue
influences that might adversely affect safety. Recommendations and guidance
covering the communication and consultation with interested parties are provided
in IAEA Safety Standards Series No. GSG-6, Communication and Consultation
with Interested Parties by the Regulatory Body [47].
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Appendix I
PROVISION OF CONSUMER PRODUCTS
AUTHORIZATION FOR THE PROVISION OF CONSUMER PRODUCTS
I.1. Requirement 33 of GSR Part 3 [3] states that:
“Providers of consumer products shall ensure that consumer products

are not made available to the public unless their use by members of the
public has been justified, and either their use has been exempted or
their provision to the public has been authorized.”
I.2. The aim of authorization is to ensure that consumer products meet all
the requirements for design and performance that were taken into account in
the generic safety assessment conducted by the manufacturer for the type of
consumer product. The manufacturer should provide the regulatory body with
sufficient documentation and certification to enable it to review and assess the
proposed consumer product. The documentation should include the following:
(a) A description of the consumer product, its intended uses and benefits, the
radionuclide(s) incorporated and the function served by the radionuclide(s).
Documentary evidence that the radioactive substance fulfils its function
should also be provided.
(b) The activity of the radionuclide(s) to be used in the consumer product.
I.3. The following additional information should be provided, as may be

appropriate or as required by the regulatory body. See IAEA Safety Standards
Series No. SSG-36, Radiation Safety for Consumer Products [48]:
(a) Justification of the choice of radionuclide(s), particularly in relation to other

radionuclide(s) that could be of lower risk to the public (e.g. radionuclides
that emit less penetrating radiation and/or have a shorter half-life).
The reason for choosing the radioactive substance in preference to a
non-radioactive alternative should also be provided.
(b) The chemical and physical forms of the radionuclide(s) contained in the
consumer product.
(c) Details of the construction and design of the consumer product, particularly
with regard to the containment and shielding of the radionuclide in normal
105
and abnormal conditions of use and disposal, and the degree of access to
the radionuclide(s).
(d) The quality assurance and verification procedures to be applied to
radioactive sources, components and finished products to ensure that the
maximum specified quantities of radionuclides or the maximum specified
radiation levels are not exceeded, and to ensure that the consumer product
is constructed in accordance with the design specifications.
(e) A description of the prototype tests for demonstrating the integrity of the
consumer product in normal use and in the event of possible misuse and
accidental damage, and the results of these tests.
(f) External radiation levels arising from the consumer product and the method
of measurement.
(g) Safety assessments, including estimates of individual doses and, if
appropriate, collective doses arising from normal use, possible misuse and
accidental damage and disposal and, if applicable, servicing, maintenance
and repair.
(h) The anticipated useful lifetime of the consumer product and the total
numbers expected to be distributed and/or made available annually.
(i) Information about any advice to be provided on the correct use, installation,
maintenance, servicing and repair of the consumer product.
(j) An analysis to demonstrate that the consumer product is inherently safe
(i.e. it will not give rise to significant doses to individuals in the event of
foreseeable accidents).
(k) Information on how the consumer product is intended to be labelled.
(l) The provisions foreseen for recycling or disposal of the consumer product
at the end of its useful lifetime.
REGULATORY INSPECTION FOR THE PROVISION

OF CONSUMER PRODUCTS
I.4. Periodic inspections of the facilities authorized to manufacture consumer

products should be undertaken to confirm that the consumer products are being
manufactured and distributed in accordance with the product specifications,
regulatory requirements and conditions of the authorization. The regulatory body
should also conduct investigations, or review the results of investigations, of any
accidents or instances of misuse. If the regulatory body receives new information
that casts doubt on part or all of the original safety assessment, then appropriate
enforcement actions should be taken.
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Appendix II
AUTHORIZATION CONDITIONS RELEVANT FOR

CERTAIN STEPS OF THE AUTHORIZATION PROCESS FOR
COMPLEX FACILITIES OR ACTIVITIES
II.1. In addition to general authorization conditions that are applicable to all

authorizations, there are some specific conditions that are relevant only at
certain steps of the authorization process. The following list of conditions is not
all-inclusive, nor is it the only possible arrangement, but it may be helpful in
determining which conditions are relevant.
SITE PREPARATION
II.2. The regulatory body should specify the controls that the authorized party is
required to exercise over the use of the site and the degree to which the authorized
party may prepare the site without conducting activities which, under the laws
and regulations of the State, require an authorization for construction.
CONSTRUCTION
II.3. In authorizing construction, the regulatory body should ensure that certain
conditions are fulfilled so that this step can proceed in a manner that ensures safe
operation of the facility. These conditions include the following:
(a) The facility should be designed and constructed in accordance with the
relevant site parameters approved by the regulatory body.
(b) The facility should be constructed in accordance with the design that has
been justified in a safety case. The authorized party should not deviate
from this design in any way that might affect safety without following
a modification process that requires categorization of the modification
according to safety significance. This modification process may require
approval or agreement from the regulatory body depending upon the safety
significance of the modification.
(c) The authorized party should initiate a radiological study of the region,
including an appropriate baseline survey, prior to the start of operation.
(d) The authorized party should prepare reports during the stages of site
evaluation and construction to keep the regulatory body informed of the
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progress of the project, covering the progress of site studies, the progress
of construction and results of the pre-operational environmental monitoring
programme.
(e) The authorized party should keep records of site evaluation and construction
of the facility (as appropriate), such as the results of site evaluation studies
(geological, meteorological and hydrological data, as well as results of the
pre-operational environmental monitoring programme), design records,
manufacturing records (including results from quality control activities)
and erection records (including quality control results and as-built design
records). Such records may be useful later in the investigation of events or
generic problems and in decommissioning.
II.4. Furthermore, at the time of authorizing construction, conditions may be

imposed on the authorized party requiring that it obtain from the regulatory body
additional approvals relating to the design of certain parts of the facility.
COMMISSIONING
II.5. In authorizing the commissioning of a facility, the regulatory body should

specify a number of conditions, including the following:
(a) Commissioning should be carried out in accordance with a programme

approved by the regulatory body.
(b) Completed structures, systems and components important to safety should
be put into service only once they have been inspected, tested and approved
as being in accordance with the terms of the authorization.
(c) Commissioning records, including records of equipment and system
tests, test procedures and test results should be kept to demonstrate to
the regulatory body the continuing safety of the facility. Commissioning
records should cover the following:
—— The results of the commissioning tests and their evaluations;
—— Operational data, including data on the facility’s output and
performance;
—— Modifications performed;
—— Results of the radiation protection programme;
—— Results of the environmental monitoring programme;
—— Radioactive waste management.
(d) The authorized party should provide approved storage facilities for nuclear
or radioactive materials. The competent authority responsible for nuclear
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security may require that appropriate nuclear security measures be in effect
before nuclear or other radioactive material is brought into the facility.
(e) Fissile material or other radioactive material should not be brought onto the
site without a regulatory authorization.
(f) From the introduction of radioactive material into the facility, the authorized
party should operate the facility only under the control and supervision
of authorized personnel using written procedures, in accordance with the
operational limits and conditions approved by the regulatory body. Any
changes made to the operational limits and conditions should be approved
by the regulatory body prior to their implementation.
(g) The authorized party should have an approved emergency plan, coordinated
with the other authorities involved in emergency preparedness and response.
OPERATION
II.6. In authorizing operation, the conditions imposed for commissioning should

be amended appropriately in the light of commissioning results. The regulatory
body should add conditions to the authorization, as necessary, such as the
following:
(a) The authorized party should not operate the facility or conduct the activity
outside the limits authorized by the regulatory body.
(b) The authorized party should have a procedure for modifications to be
approved by the regulatory body in order to ensure that no part of the
approved facility that is important to safety will be modified without the
prior approval of the regulatory body.
(c) The authorized party should ensure that the facility is subjected to in-service
inspection and testing, to be carried out as specified for structures, systems
and components important to safety, in accordance with a schedule
(d) The authorized party should keep operational records to be used in the
regulatory oversight for possible examination by the regulatory body.
Operational records should cover:
—— Operational data and performance records of the facility or activity;
—— Operating log books;
—— Inventories of fissile material and other radioactive material;
—— Periodic calibration of equipment;
—— Periodic testing of equipment and systems;
—— Internal reviews or inspections;
—— Preventive maintenance and repairs;
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—— Personnel training;
—— Monitoring of occupational exposures;
—— Records of workplace monitoring for the facility or activity;
—— Radioactive waste management;
—— Effluent discharges and the environmental monitoring programme;
—— Anticipated operational occurrences and accidents.
(e) The authorized party should ensure that the maintenance of equipment and
systems important to safety is carried out in accordance with a schedule
(f) Only changes given prior approval by the regulatory body should be made
to the approved arrangements, schedules, procedures and rules.
(g) The authorized party should ensure that the facility is operated or the
activity is carried out only under the control and supervision of authorized
personnel in adequate numbers that are acceptable to the regulatory body.
II.7. Authorization conditions relating to liability of the authorized party in the

event of an accident are outside the scope of this Safety Guide.
DECOMMISSIONING
II.8. In authorizing the decommissioning of a facility, the regulatory body should

take particular care in specifying conditions, since the sanctions of shutting
down the facility or revoking the authorization are unlikely to be effective at this
stage. The regulatory body should examine the results of the final radiological
survey conducted by the authorized party. The final radiological survey should
be conducted after the completion of decommissioning activities to ensure that
regulatory requirements are met prior to release of the facility from regulatory
control.
CLOSURE
II.9. Following the closure of a radioactive waste disposal facility, continuing

institutional control, including environmental monitoring, may be necessary.
Depending on national legislation, conditions may be specified in a post-closure
authorization held by the authorized party or responsibilities may be taken by a
relevant national authority prior to agreeing to closure of the facility.
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Appendix III
TOPICS TO BE COVERED BY REVIEW AND ASSESSMENT
III.1. This appendix provides a generic list of topics that should be considered in
the review and assessment process by the regulatory body throughout the lifetime
of a facility or activity, from site selection to decommissioning or closure. Each
topic has been itemized; however, addressing all items does not necessarily mean
that every aspect of safety has been fully addressed. Also, depending on the
facility or activity and on the particular stage of the lifetime, some topics will
be more important than others and the degree of detail necessary in the review
and assessment may differ. This Appendix focuses on complex facilities and
activities. For less complex facilities and activities, the review and assessment
process should follow a graded approach.
THE PHYSICAL NATURE OF THE FACILITY OR ACTIVITY

AND ITS ENVIRONMENT
III.2. The following information on the facility or activity and on the processes
conducted should be provided by the authorized party at various stages and used
as a basis for review and assessment:
(a) A detailed description of the facility or activity, supported by drawings of

the layout, the systems and the equipment;
(b) Information on the functional capability of the facility and the nature of
the activity, its systems and major items of equipment (including radiation
protection equipment and waste management systems and equipment);
(c) The findings of tests that validate the functional capability of equipment
and systems;
(d) The results of inspections of components;
(e) Maintenance records;
(f) A description of the physical condition of structures, systems and
components on the basis of inspections or tests;
(g) A description of the support facilities available both on and off the site,
including maintenance and repair workshops;
(h) Geological, hydrogeological and meteorological conditions at the site;
(i) A description of off-site characteristics, including population densities, land
use, industrial structures and facilities (including pipelines) and transport
arrangements (such as airports, roads and railways).
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INFRASTRUCTURAL ASPECTS
III.3. Throughout the lifetime of a facility or activity, the authorized party will
have to propose and implement arrangements for radioactive waste management.
The regulatory body should review and assess any proposals in the safety case
for on-site processing (i.e. pretreatment, treatment and conditioning) and storage
of radioactive waste, to ensure that the characteristics of the processed waste and
the waste packages are compatible with the national strategy for radioactive waste
management, any subsequent waste acceptance requirements and regulatory
requirements. Specifically, the regulatory body should satisfy itself that the
radioactive waste and waste packages:
(a) Are properly characterized and compatible with the anticipated nature and
duration of storage pending disposal;
(b) Can be subjected to regular surveillance;
(c) Can be retrieved for further steps in radioactive waste management.
III.4. Adequate arrangements should be made for the transport of radioactive

material, waste and equipment both on and off the site. The regulatory body
should review and assess these arrangements and should satisfy itself that all
national and regulatory requirements have been met.
SAFETY ANALYSIS
III.5. Throughout the lifetime of the facility or activity, the regulatory body
should review and assess the information on the facility or activity provided by
the authorized party to determine whether the facility or activity is in compliance
with the relevant safety and regulatory requirements, and, in particular,
information covering the following:
(a) Specification of the safety standards and design codes used.

(b) A compilation of the safety analyses and their assumptions.
(c) Structures, systems and components important to safety.
(d) Limits and permitted operational states.
(e) Anticipated operational occurrences.
(f) Postulated initiating events for the safety analyses:
—— External hazards (e.g. external floods, earthquakes, aircraft
crashes, transportation accidents, explosions, external fires and
meteorological hazards);
—— Internal failures (e.g. mechanical and electrical failures);
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—— Internal hazards (e.g. internal fires, internal floods and internally
generated missiles).
(g) Features, events and processes:
—— A list of barriers with their relative contributions;
—— A description of how requirements for defence in depth are met;
—— Anticipated activities for confirmation of performance.
(h) Analytical methods and computer codes used in the safety analyses and the
verification and validation of such codes.
(i) Radioactive releases and radiation exposures in normal operation,
anticipated operational occurrences and accident conditions.
(j) The authorized party’s safety criteria for analyses of authorized party
actions, common cause failures, cross-link effects, the single failure
criterion, redundancy, diversity and separation.
III.6. The impacts of the facility or activity on its surroundings should be

assessed. Societal and economic issues, land use issues, technical issues such
as detailed considerations of geology and hydrogeology, transport routes for the
facility and protection of the environment should be taken into account in such
an assessment. Both the anticipated impacts and the consequences of anticipated
operational occurrences and accident conditions, which are the subject of safety
analysis, should be considered.
THE AUTHORIZED PARTY AND THE MANAGEMENT SYSTEM
III.7. At all stages of the facility’s lifetime, the authorized party should be
required to demonstrate that:
(a) It will be in control of the facility or activity;

(b) It has resources available to meet its obligations and liabilities in connection
with an authorization.
III.8. The authorized party should be required to demonstrate that it has a

management system in place, whereby all activities are controlled, so as
to provide an assurance that requirements for quality assurance, safety and
protection of people and the environment will be met. This will include having
operational procedures in place.
III.9. For some facilities (notably waste disposal facilities) this demonstration
may need to apply for an extended period, perhaps covering several generations,
over which control will need to be maintained.
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III.10. The information to be provided by the authorized party to the regulatory
body for review and assessment should include:
(a) Details of the organizational structure of the authorized party, showing that
it has adequate control over the activities of its own staff and its contractors;
(b) A demonstration of the adequacy of resources in terms of sufficient and
appropriately trained and experienced staff, ensuring in-house expertise;
(c) A demonstration of the adequacy of the procedures for controlling changes
to the organizational structure and resources;
(d) The specification and documentation of the duties of staff, demonstrating
the integration of responsibilities for safety into their duties;
(e) A demonstration of the provision of, or access to, a high level of expertise
in safety to carry out safety and engineering analyses and to perform
associated audit and review functions;
(f) A demonstration of the adequacy of the provisions for financing of
continuing liabilities for nuclear damage and of decommissioning;
(g) Provisions for the use of contractors.
III.11. The authorized party should be required to demonstrate that it has

in place:
(a) A mechanism for setting operating targets and safety targets;

(b) A policy that states that the demands of safety take precedence over those
of production;
(c) Documented roles and responsibilities for individuals and groups;
(d) Procedures for the control of modifications to the facility;
(e) Procedures for the feedback of operating experience to staff, including
experience relating to organizational and management aspects;
(f) Mechanisms for maintaining the configuration of the facility and
its documentation;
(g) Formal arrangements for employing and controlling contractors;
(h) Staff training facilities and programmes for initial, refresher and upgrade
training, including the use of simulators, where appropriate;
(i) A quality assurance programme and regular quality assurance audits with
independent assessors;
(j) A system for ensuring compliance with regulatory requirements;
(k) Comprehensive, readily retrievable and auditable records of baseline
information and operational and maintenance history;
(l) Staffing levels for the operation of the facility or conduct of the activity that
take account of absences, shift working and overtime restrictions;
(m) Sufficient and qualified staff available and on duty at all times;
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(n) Systematic and validated methods for the selection of staff, including
testing for aptitude, knowledge and skills;
(o) A systematic approach to fostering leadership and management for safety,
including training in safety culture, particularly for managers;
(p) Guidelines on fitness for duty in relation to hours of work, health and use
of drugs or alcohol;
(q) Competence requirements for operating, maintenance and technical staff
and managers;
(r) A system for consideration of the human–machine interface and its design
and for the analysis of information needs and task workload for operators in
the control room and at other workstations.
OPERATIONAL PROCEDURES
III.12. The authorized party should be required to demonstrate that the operation
of the facility or conduct of the activity is in accordance with the relevant safety
objectives and safety and regulatory requirements, and that it has developed or
obtained the following:
(a) Formal approval and documentation where required by regulatory body;

(b) A formal system for modification of a procedure;
(c) Understanding and acceptance of the procedures by management and staff;
(d) Verification that the procedures are being followed;
(e) Procedures that are adequate in comparison with international good
practices;
(f) Arrangements for regular review and, if necessary, revision of
the procedures;
(g) Clear procedures in which principles relating to human factors have been
taken into account;
(h) Procedures that comply with the assumptions and findings of the safety
analysis and with experience from design and operation;
(i) Adequate emergency operating procedures.
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EQUIPMENT QUALIFICATION
III.13. The authorized party should be required to maintain:
(a) A list of equipment covered by the equipment qualification programme,

including documentation of the analyses used to derive this list of
equipment, and a list of control procedures;
(b) A qualification report and other supporting documents (such as equipment
qualification specifications and a qualification plan);
(c) Verification that the installed equipment matches the qualification
requirements;
(d) Documentation of procedures to maintain qualification over the lifetime of
the installed equipment;
(e) Information on mechanisms for ensuring compliance with these procedures;
(f) Documentation of a maintenance, testing and inspection programme and
a procedure for providing feedback to ensure that ageing degradation of
qualified equipment remains insignificant;
(g) A list of appropriate corrective actions to maintain equipment qualification;
(h) Information on the physical integrity and functionality of qualified
equipment;
(i) Records of all qualification measures taken over the installed lifetime
of equipment.
III.14. In the selection of equipment for measurements, the minimum detection

limit should be commensurate with the compliance level such that the minimum
detection limit is around 10% of the level to be measured for demonstration of
compliance.
MANAGEMENT OF AGEING
III.15. The authorized party should be required to establish and maintain

a programme for the management of ageing of equipment that includes
the following:
(a) Documented methods and criteria for identifying structures, systems and
components covered by the ageing management programme;
(b) A list of structures, systems and components covered by the ageing
management programme and records that provide information for use in
the management of ageing;
116
(c) An evaluation of and documentation of potential ageing related degradation
that may affect the safety functions of structures, systems and components;
(d) Details of the extent of understanding of the dominant mechanisms of
ageing for structures, systems and components;
(e) Details of the programme for the timely detection and mitigation of ageing
processes and/or ageing effects;
(f) Acceptance criteria and required safety margins for structures, systems
and components;
(g) Awareness of the physical condition of structures, systems and components,
including actual safety margins.
AUTHORIZED PARTY’S SAFETY PERFORMANCE
III.16. The authorized party should be required to provide details of:
(a) The system used for identifying and classifying safety related events.
(b) The arrangements made for root cause analysis of events, the results and
lessons learned and the follow-up measures taken.
(c) Methods for selecting and recording safety related operational data,
including data for maintenance, testing and inspection.
(d) Trend analyses of safety related operational data.
(e) Feedback of safety related operational data, including records and reports
of incidents including accidents.
(f) Records of radiation doses to persons on the site.
(g) Records of off-site contamination and data from radiation monitoring on
the site.
(h) Records of quantities and relevant characteristics of radioactive waste
generated and stored at the facility.
(i) Records of the quantities of radioactive effluents discharged.
(j) Analyses of safety performance indicators, such as:
—— Frequency of unplanned shutdowns of operation;
—— Frequency of selected safety system actuations and demands;
—— Frequency of safety system failures;
—— Unavailability of safety systems;
—— Annual individual and collective occupational radiation doses;
—— Trends in causes of failures (operator errors, equipment failures,
administrative matters, control matters);
—— Backlog of outstanding maintenance tasks;
—— Extent of repeat maintenance;
—— Extent of corrective maintenance, including repair and replacement;
117
—— Frequency of unplanned operator actions in relation to safety and their
success rate;
—— Amounts of radioactive waste generated;
—— Quantities of radioactive waste in storage.
EXPERIENCE FROM OTHER FACILITIES AND

RESEARCH FINDINGS
III.17. The authorized party should be required to provide information to the

regulatory body on its arrangements for:
(a) Obtaining and assessing feedback of experience relevant to safety from

similar facilities and activities and from other nuclear and non-nuclear
facilities and activities, and taking action on the basis of this feedback;
(b) Determining the need for research and development;
(c) Obtaining and assessing the findings of relevant research programmes, and
taking action on the basis of these findings.
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Appendix IV
REGULATORY INSPECTION AREAS FOR NUCLEAR FACILITIES
IV.1. This appendix sets out the areas of nuclear facilities that may be of
particular interest for regulatory inspection at different steps of the authorization
process. Depending on the facility or activity and on the particular stage of the
lifetime, some topics will be more important than others, and the degree of their
applicability may differ.
SITE EVALUATION
IV.2. Before the construction of a nuclear facility is to begin, the regulatory

body should monitor, as appropriate, by means of its inspection programme, site
preparation activities undertaken by the applicant or authorized party, including
verification of site characteristics and authorized excavations and earthworks.
IV.3. The specific objectives of regulatory inspection in these areas include

verification that the authorized party is undertaking siting activities in full
compliance with existing regulatory requirements, and assurance that the site
preparation work does not proceed beyond that permitted by any authorization
in force. During site preparation, the regulatory body should also confirm that
the site characteristics remain consistent with the description presented by the
authorized party in its authorization application and in the subsequent supporting
documentation submitted to the regulatory body. This is vital for disposal sites,
for which the action of a major barrier to the movement of radionuclides is
dependent on the characteristics of the site. In addition, inspectors should be alert
to any new conditions or information revealed as a result of activities for site
preparation, which should then be considered by the regulatory body in making
subsequent decisions on authorization.
DESIGN AND CONSTRUCTION
IV.4. The chief objectives of the regulatory inspection programme in the design
and construction of the facility should be to verify that:
(a) Materials and structures, systems and components important to safety

meet the requirements established by the regulatory body and conform to
good practices;
119
(b) Construction activities associated with manufacturing and installing
structures, systems and components are conducted in accordance with
regulatory requirements and in conformity with general safety objectives;
(c) The as-built configuration of structures, systems and components is in
conformity with the assumptions made in the regulatory review and
assessment, any deviation is analysed and justified and the documentation
is updated accordingly;
(d) The authorized party’s system and procedures for quality assurance and
inspection are adequate to ensure the conformance of equipment to the
technical specifications.
IV.5. The regulatory body should inspect design and construction activities in
a number of areas in order to meet these objectives. In particular, the following
areas should receive close attention in the construction stage, primarily because
of the difficulty of detecting and correcting deficiencies in these areas once fissile
material or other radioactive material has been brought to the site and the facility
enters the active commissioning stage:
(a) Mixing and placement of concrete and its reinforcement, especially in:
—— Foundations;
—— Structures important to safety, particularly containment structures.
(b) Construction of cooling intakes and discharge systems.
(c) Installation of components important to safety, particularly:
—— Containment and shielding boundaries;
—— Internals of vessels that will contain fissile material and other
radioactive material;
—— Equipment to be used in radiation areas.
(d) Installation of control, protection and power systems important to safety.
(e) Areas of the facility that are inaccessible after construction is completed,
particularly systems and components embedded in the foundations or the
building structure.
(f) Housekeeping in respect of structures, systems and components important
to safety.
(g) The management systems of the designer, manufacturer and constructor.
COMMISSIONING
IV.6. Activities associated with commissioning will normally begin before

construction is completed. Accordingly, the regulatory body should be prepared
to inspect areas of commissioning activity in parallel with activities of the
120
construction stage. In some States the commissioning programme is subject to
approval by the regulatory body and the agreement of the regulatory body should
be obtained before advancing beyond certain hold points.
IV.7. Inspection by the regulatory body during the commissioning stage should
focus on four broad areas of the authorized party’s activity:
(a) Testing before the introduction of fissile material and other radioactive
material;
(b) Initial introduction of fissile material and other radioactive material;
(c) Testing of operations involving fissile material and other radioactive
material;
(d) Other commissioning activities.
Testing before the introduction of fissile material and other radioactive

material
IV.8. The inspection area of testing before the introduction of fissile material and
other radioactive material encompasses those activities and tests performed before
the introduction of such material by the authorized party in order to demonstrate
that structures, systems and components function properly and conform to design
requirements. It also covers the inspection and acceptance criteria for the receipt
at the facility of fissile material and other radioactive material. The regulatory
inspection programme should include:
(a) Examination of documented procedures to verify that they are in accordance

with the conclusions of the regulatory review and assessment;
(b) Review of the implementation of these procedures;
(c) Direct observation of the performance of certain key pre-operational tests;
(d) Examination of the results of selected tests;
(e) Confirmation of the integrity of any engineered barriers.
IV.9. The number of tests and the key tests that are to be examined and directly
witnessed by the regulatory body will differ depending on factors such as the
importance of the test for safety and whether the facility to be commissioned
is the first of its kind or one of several similar facilities. The regulatory body
should, however, place particular emphasis on inspection by the examination of
documentation and by the direct observation of some of the tests performed on:
121
(a) Structures, systems and components that prevent unsafe conditions or
that mitigate the consequences of anticipated operational occurrences and
accident conditions;
(b) Structures, systems and components whose failure to operate properly
will require action from one or more safety related structures, systems
and components.
IV.10. As such, the regulatory body may inspect the following tests:
(a) Tests of safety systems (such as instrumentation and control systems,

shutdown systems and standby systems);
(b) Tests of the integrity of the containment and shielding boundaries (such as
hydraulic tests of pressurized structures), as appropriate;
(c) Tests of the susceptibility of structures, systems and components to
vibration or to other design loads;
(d) Tests for secondary containment integrity (such as overpressure and leak
rate tests), as appropriate;
(e) Tests of emergency power systems, as appropriate;
(f) Tests of communication capabilities;
(g) Tests of ventilation systems;
(h) Integrated cold and hot functional tests.
Initial introduction of fissile material and other radioactive material
IV.11. In the regulatory inspection programme, close attention should be paid to

authorized party activities relating to the preparation for and actual introduction
of fissile material and other radioactive material. Inspectors should be present at
the facility site to observe some of these activities directly.
IV.12. Although some of these tests may be performed at times other than the
time when fissile material and other radioactive material is first introduced, the
regulatory body should inspect the following:
(a) Tests of the main control room;

(b) Access control and implementation of the radiation protection programme;
(c) Arrangements for emergency preparedness and response and demonstration
of the emergency plan;
(d) Systems for monitoring radioactive releases and meteorological
monitoring systems;
122
(e) The distribution of fissile material and other radioactive material (such
as the fuel loading pattern in a reactor) and process calculations and/or
criticality calculations, as appropriate;
(f) Systems involved in the handling or movement of radioactive or
fissile material.
Testing of operations involving fissile material and other radioactive

material
IV.13. Tests during this stage, which should be subject to regulatory review and
inspection, will depend on the type of facility being commissioned. They include
tests to demonstrate as far as possible that:
(a) The facility is being operated in accordance with the descriptions given in
the safety analysis report;
(b) Systems respond to malfunctions in accordance with the claims made in the
safety analysis report.
IV.14. The inspection area of testing of operations involving fissile material

and other radioactive material encompasses activities of the authorized party
performed in conditions gradually progressing towards nominal operating
conditions. At this point, structures, systems and components are tested in
an operational environment to ensure that they have been constructed and
installed properly and are capable of functioning in compliance with the design
requirements. Consideration should be given to the performance of radiation
surveys of facility shielding (such as concrete walls) during startup of the facility.
This will help to identify any voids or faulty joints in the shielding or any radiation
penetrating through joints. In the event of such an occurrence, alterations should
be made prior to further operation. During this period, the authorized party carries
out tests at increasing operational levels. This testing includes the recording and
analysis of data relating to temperatures, pressures, radiation levels, flows and
variations in process parameters as well as other relevant parameters.
IV.15. Inspectors should examine and assess the safety aspects of a sample of
the authorized party’s procedures for conducting operational tests. In addition,
as the tests are completed, a sample of the test documentation and the results
of the inspection should be examined by regulatory personnel to verify that the
tests have been completed in accordance with the test instructions and that the
results are acceptable. Regulatory inspection should also include the monitoring
and direct observation of several tests.
123
Other commissioning activities
IV.16. In addition to the examination of documentation and the surveillance

of tests, there are a number of other areas necessitating inspection by the
regulatory body at the commissioning stage. The ability of the authorized party’s
management to progress from supervising construction to supervising operation
and its arrangements for doing so should also be inspected. This inspection should
cover the management’s provisions for putting the emergency plan into effect and
for the training and qualification of operating personnel. Hold points during the
pre-operational tests, fuel loading and subcritical tests, initial criticality and low
power tests, power ascension tests stage and into the full operational stage should
be closely monitored. These areas overlap, necessitating continuing attention in
inspections during the operation stage.
OPERATION
IV.17. Once the facility has reached the authorized operation stage, the
regulatory body shall implement an inspection programme to systematically
verify the authorized party’s compliance with regulatory requirements and
achievement of general safety objectives, and to detect potential safety problems.
This verification should consist of: a balanced approach to monitoring and
direct observation of activities; interviews with personnel, including managers;
a review of the qualifications of the authorized party’s personnel; and sampling
of documentation. For waste management facilities and particularly for waste
disposal facilities, the structure of the inspection programme and the tests to be
carried out will primarily relate to conformance to the relevant design criteria
and waste acceptance criteria for the facility and will constitute an element in
providing confidence in the long term safety of the facility. For all facilities,
these inspections should cover the aspects detailed in paras IV.18–IV.41.
Operations
IV.18. Inspections in the area of operations should focus on the control and
execution of activities directly relating to operating a facility to the operational
limits and conditions established by regulatory requirements and authorizations
or by procedures or specifications. Inspectors should perform safety verification
of: operating procedures; the operating configuration of systems important to
safety; control room activities; and the abilities of the operations staff to perform
their duties. Simulator training and the responses of operating staff to abnormal
events and emergency conditions, as well as the adequacy of the management’s
124
actions, should also be assessed. In performing this safety verification, the
reviews described in paras IV.19–IV.22 should be carried out.
Operating procedures
IV.19. A sampling review of operating procedures should be performed,

including all the procedures for normal operations, anticipated operational
occurrences and accident conditions. Inspections should be focused on the
operating personnel’s adherence to procedures, including operational limits
and conditions. The usability and adequacy of the procedures should also be
evaluated. The inspection programme in this area may necessitate sustained
observations (e.g. in the control room) to cover 24 hour operation as necessary,
and in particular shift turnovers. The inspectors should check the availability of
safety systems and the presence of alarm systems, and the way in which they are
handled by the operations staff.
Authorized party’s training programme
IV.20. The adequacy of the authorized party’s training programme for staff
should be assessed routinely to ensure that the training reflects actual conditions
in the facility.
Safety systems
IV.21. A sampling review of safety systems should be performed to evaluate

the following:
(a) Any identified degraded equipment;

(b) Discrepancies between installed components and/or system hardware and
the facility drawings;
(c) Controls for performing maintenance on equipment;
(d) The quality of performance of the operations staff in log keeping and record
keeping and in routine monitoring of equipment.
Note should be taken of the effectiveness of the operations staff in getting

degraded equipment repaired by maintenance staff or its prompt evaluation to
ensure operability. Inspection of the facility should also include observations of
non-safety-related areas to ensure that they have no adverse effects on the safety
related areas of the facility. The adequacy of the fire protection and prevention
programme, including the management’s attention to this area, should be noted in
these inspections.
125
Management
IV.22. The management’s involvement in the facility and its effectiveness

in paying appropriate attention to operational issues, including abnormal
events, should be evaluated. In inspections it should be considered: whether
the organizational structure is suitable; whether there are adequate numbers of
staff; how well management and staff communicate; and how the management
emphasizes the importance of safety and fosters a strong safety culture.
Outages
IV.23. Inspections should cover outage activities. In addition to providing

opportunities to observe modifications being made to the facility, outages provide
opportunities to observe activities in areas that are not always accessible during
normal operation. Certain activities, such as inspections in highly radioactive
areas or the maintenance and repair of highly contaminated systems, present a
challenge to the authorized party’s organization. Outages can provide valuable
insights into the management’s ability to perform tasks outside the normal
operational mode. Furthermore, movements of fissile and other radioactive
material need to be well controlled and special checks may be necessary before
returning the facility to normal operation to ensure that it is still within its safety
justification. Before returning the facility to normal operation, it is usual for the
regulatory body to perform a special inspection.
Radiation protection and radioactive waste management
IV.24. The area of radiation protection should cover all related activities at
the facility, including radiation protection of staff and contractor personnel
and of the public [49, 50]. The area of radioactive waste management should
cover processing (i.e. pretreatment, treatment and conditioning), storage and
transport of waste, the release of effluents and the environmental monitoring
programme [42].
Organizational structure for radiation protection
IV.25. The structure of the organization responsible for the implementation of

the radiation protection programme, the procedures necessary for implementation
of the programme, the effectiveness of the management and its commitment with
respect to radiation protection, including application of the optimization principle,
should all be assessed during inspections. Indicators of the effectiveness of the
management are the levels of exposure of personnel, levels of contamination in
126
working areas, levels of releases of effluents, and the level of understanding on the
part of management and workers of their responsibilities in the implementation
of the radiation protection programme. Any self-assessments performed by the
authorized party under this programme should be reviewed.
Records of occupational radiation doses
IV.26. Inspectors should selectively review records of individual occupational

doses, including internal and external doses. Activities should be observed to
ensure that procedural and management controls are effective. This includes
controls for radiation areas and contamination areas as well as inspection of
activities for internal and external dosimetry. Exposures of personnel that result
in the authorized party’s reference levels for effective doses or intakes being
exceeded should be noted. Records of radiation protection training and retraining
should be assessed.
Effluents
IV.27. The inspection programme should include verification that any releases
of effluents are within the authorized discharge limits. This should include the
review of systems for the treatment of radioactive waste and for the monitoring
of effluents. Training and qualifications for technicians and workers employed in
the areas concerned should also be reviewed.
Environmental monitoring
IV.28. The environmental monitoring programme should be reviewed to ensure

that all environmental monitoring is performed in accordance with established
procedures. Independent measurements may be performed to verify the accuracy
of the authorized party’s monitoring equipment and the results of measurements.
Radioactive waste management
IV.29. The implementation of arrangements for on-site waste treatment,

conditioning and storage should be reviewed and records should be inspected.
In particular, the waste characterization process, the compliance with any
requirements for waste storage or disposal, and the records for these processes
should be subject to inspection.
IV.30. Whenever unpackaged waste is stored or waste packages are stored, or

have been placed in a waste disposal facility pending a decision on closure of the
127
facility, degradation of the waste may occur over time. The storage conditions
for the waste and the waste packages should be inspected at appropriate intervals
to provide confidence that the waste remains suitable for treatment and/or
conditioning or that the waste packages will be suitable for retrieval, transport
and further steps in radioactive waste management, as necessary.
IV.31. Transport arrangements for radioactive material on the site should be

examined. Receipt and dispatch arrangements should be inspected and attention
should be paid to the integrity of packages, residual levels of contamination and
associated records.
Maintenance and testing
IV.32. Inspection in the area of maintenance and testing should comprise

assessments of the implementation of the maintenance and testing programme.
These should cover:
(a) All types of maintenance performed on structures, systems and components

and maintenance of the physical condition of the facility;
(b) Testing, including the conduct of all surveillance testing activities, all
in-service inspection and testing, calibration of instruments, equipment
operability tests and other special tests.
IV.33. Direct observation by the regulatory body should include a sampling of

the authorized party’s inspection and testing activities, including such tests as:
(a) Calibration of nuclear instrumentation systems;

(b) Verification of containment integrity;
(c) Testing of local leak rates for the containment;
(d) Testing of piping support and restraint systems;
(e) Tests for safety pumps, valve capacity and stroke timing;
(f) Surveillance tests for breakers and transformers.
Inspectors should note the capability of the individuals performing the tests
and, for complex surveillance activities, should assess the interface between
the surveillance personnel and the operations staff involved in the performance
of the test. The adequacy and usability of the procedures should be assessed
and the control and calibration of the test equipment should be observed. The
inspectors should observe the involvement of management in these programmes
to ensure that the programmes are effective and that safety equipment is
properly maintained, with few recurring problems. Maintenance backlogs, the
128
intervals at which repetitive equipment repairs are carried out and the amount
of maintenance work actually being performed should be noted, as these may
be early indicators of declining performance in the maintenance programme.
A large backlog of repairs, a high number of equipment failures and a low level
of maintenance activity may also be indicative of a maintenance programme that
is difficult to manage and requires a disproportionate amount of documentation.
Self-assessment activities in these programmes should be observed and their
findings should be routinely reviewed.
IV.34. As part of the inspection area, a sample of maintenance activities

should be observed to assess the adequacy of programmes and procedures and
the capability of the maintenance technicians to perform their assigned tasks.
The planning and scheduling of maintenance should be assessed to ensure
that maintenance activities are performed by competent staff and are properly
coordinated, and that repairs to equipment are handled in accordance with
appropriate priorities. All types of maintenance activities should be observed.
Before initiating maintenance work, special attention should be paid to the
isolation and tagging of safety systems that are out of service. Inspectors should
observe compliance with procedures for such isolation and tagging controls in
order to evaluate their adequacy and should evaluate the procedures for ensuring
that systems are returned correctly to their operational state. The in-service
inspection programme and the in-service testing programme should be reviewed
to ensure that their purpose, which is to ensure the early detection of degradation
of equipment and components, is being served. Programmes, procedures and
data should be reviewed and evaluated, particularly for those maintenance
tasks that can be performed only during outages. Data that may indicate that
a high number of component systems need repair may necessitate an in-depth
review of the maintenance programmes. Repairs to piping systems, pumps,
valves, electrical systems and instrumentation and control systems should all be
selectively sampled for review. Welding on systems of safety significance should
be observed, including examination by non-destructive means.
Engineering support
IV.35. The engineering support group usually provides necessary support to

the operations or maintenance staff anywhere in the facility at any time. The
engineering support group usually assists operations staff with the evaluation
of non-conforming or degraded conditions and assists maintenance staff in the
performance of activities in the course of which problems may arise. Inspectors
should review a sample of the evaluations for non-conforming or degraded
129
conditions for both adequacy and quality, and should observe the interface
between the maintenance groups and engineering support groups.
IV.36. Inspectors should walk down part of a system to assess how well systems
are being maintained and should note any non-conformance. Any problems
identified by inspectors but not known to the facility’s management would call
into question the adequacy of the support programme for system engineering.
Modifications
IV.37. Modifications may be simple or complex and may involve changes to

engineering, operating procedures and/or the organizational structure. For major
modifications to the structures, systems and components of a facility, most of
the planning, design and manufacture will be performed prior to outages. The
regulatory body should inspect the authorized party’s record to determine
whether its modification process has been effective in controlling modifications
in a manner that is appropriate for their safety significance. Where required, the
regulatory body should also inspect submissions by the authorized party to the
regulatory body concerning a modification. The details of the process should be
checked in the inspections by sampling specific modifications and reviewing
their execution and their implications for documentation, such as the need for
changes to safety related documentation, for updating of maintenance schedules
and engineering drawings, and for changes to operational procedures and training
modules. These checks may involve other parts of the regulatory body in addition
to the inspection unit. The regulatory body should also determine whether the
qualifications of the authorized party’s staff who perform the modifications are
suitable for the function they are performing.
Emergency preparedness and response
IV.38. Inspection in the area of emergency preparedness and response should

include a review of emergency response plans and procedures in order to verify
that the arrangements for dealing with an emergency are adequate. Procedures
for the detection and classification of an emergency and for decision making
in an emergency should be assessed. Procedures for notification of a nuclear or
radiological emergency, communication, shift staffing, shift augmentation, dose
calculation and dose assessment should also be evaluated. Emergency exercises
should be witnessed to ensure that the emergency planning is adequate and that
its implementation is effective.
130
Management system
IV.39. Inspection of the effectiveness of the management system should include

inspection of those indicators that demonstrate that the management system is
focused on safe operation and on the identification and remediation of problems
and weaknesses within the programme. This includes the management’s
involvement in day to day operations and its routine presence in the facility.
What is most important is whether the management demonstrates a willingness
to listen to problems and then to ensure that problems are promptly evaluated and
solved. The management’s ability to create an environment in which problems are
openly identified and discussed and self-assessment programmes are effectively
supported helps to foster a strong safety culture.
IV.40. The authorized party’s quality assurance programme should be reviewed

to ensure that it is comprehensive and adequately implemented. The review
should cover, in addition to the activities described earlier, activities such as:
procurement, receipt, storage and handling of equipment; document control;
and operating experience. In particular, the adequacy and effectiveness of the
authorized party’s performance of corrective actions should be assessed.
DECOMMISSIONING
IV.41. During the decommissioning stage of a nuclear facility, inspection

activities should concentrate on:
(a) The adequacy of the authorized party’s procedure for the control of each
stage of decommissioning;
(b) The removal of radioactive material;
(c) The strategy for management of radioactive material;
(d) The drainage of any residual fluids;
(e) Decontamination and dismantling activities;
(f) The waste management strategy for the treatment, conditioning, storage
and disposal of all radioactive waste;
(g) The physical condition of the facility, especially surveillance of the integrity
and/or the availability of relevant structures, systems and components,
including protective barriers, and the appropriateness of the procedures at
each stage of decommissioning;
(h) Characterization of the residual radioactivity;
131
(i) Accounting for and control of nuclear material and access control;
environmental monitoring, radiological monitoring and surveillance,
including plans for radiation protection of workers and the public;
(j) The adequacy and maintenance of instrumentation and control systems for
long term safety;
(k) Decommissioning records.
IV.42. After a long period of safe enclosure, some of these regulatory inspection
activities may be reduced in thoroughness and frequency.
Closure of waste disposal facilities
IV.43. Before the regulatory body considers the release of any waste disposal
facility from further regulatory control, inspection activities should concentrate on:
(a) Conformance with the overall radioactive waste inventory;

(b) Sealing arrangements for the facility including any measures to prevent
human intrusion;
(c) Arrangements for any environmental monitoring after closure.
The release of a facility and/or site from regulatory control
IV.44. Before releasing a site from any further control, the regulatory body
should carry out an inspection to confirm that any residual radioactivity has
been reduced to acceptable levels. This will include review of the remediation
and monitoring procedures, review of the management system, independent
monitoring and analysis of compliance with the release criteria for the site
or review of the implementation of restrictions at the site. For waste disposal
facilities, the release from control will be related to the long term safety of the
facility as set out in the post-closure safety case.
132
REFERENCES
[1] EUROPEAN ATOMIC ENERGY COMMUNITY, FOOD AND AGRICULTURE

ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC
ENERGY AGENCY, INTERNATIONAL LABOUR ORGANIZATION,
INTERNATIONAL MARITIME ORGANIZATION, OECD NUCLEAR ENERGY
AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS
ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION,
Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, IAEA,
Vienna (2006).
[2] INTERNATIONAL ATOMIC ENERGY AGENCY, Governmental, Legal and
Regulatory Framework for Safety, IAEA Safety Standards Series No. GSR Part 1
(Rev. 1), IAEA, Vienna (2016).
[3] EUROPEAN COMMISSION, FOOD AND AGRICULTURE ORGANIZATION OF
THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY,
INTERNATIONAL LABOUR ORGANIZATION, OECD NUCLEAR ENERGY
AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS
ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Radiation
Protection and Safety of Radiation Sources: International Basic Safety Standards, IAEA
Safety Standards Series No. GSR Part 3, IAEA, Vienna (2014).
[4] INTERNATIONAL ATOMIC ENERGY AGENCY, Organization, Management and
Staffing of the Regulatory Body for Safety, IAEA Safety Standards Series No. GSG-12,
[5] INTERNATIONAL ATOMIC ENERGY AGENCY, Licensing Process for Nuclear
Installations, IAEA Safety Standards Series No. SSG-12, IAEA, Vienna (2010).
[6] INTERNATIONAL ATOMIC ENERGY AGENCY, Release of Sites from Regulatory
Control on Termination of Practices, IAEA Safety Standards Series No. WS-G-5.1,
[7] FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS,
INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL CIVIL
AVIATION ORGANIZATION, INTERNATIONAL LABOUR ORGANIZATION,
INTERNATIONAL MARITIME ORGANIZATION, INTERPOL, OECD NUCLEAR
ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, PREPARATORY
COMMISSION FOR THE COMPREHENSIVE NUCLEAR-TEST-BAN TREATY
ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, UNITED
NATIONS OFFICE FOR THE COORDINATION OF HUMANITARIAN AFFAIRS,
WORLD HEALTH ORGANIZATION, WORLD METEOROLOGICAL
ORGANIZATION, Preparedness and Response for a Nuclear or Radiological
Emergency, IAEA Safety Standards Series No. GSR Part 7, IAEA, Vienna (2015).
[8] INTERNATIONAL ATOMIC ENERGY AGENCY, IAEA Safety Glossary:
Terminology Used in Nuclear Safety and Radiation Protection, 2018 Edition, IAEA,
Vienna (in preparation).
133
[9] INTERNATIONAL ATOMIC ENERGY AGENCY, Objective and Essential Elements
of a State’s Nuclear Security Regime, IAEA Nuclear Security Series No. 20, IAEA,
Vienna (2013).
[10] INTERNATIONAL ATOMIC ENERGY AGENCY, Nuclear Security Recommendations
on Physical Protection of Nuclear Material and Nuclear Facilities (INFCIRC/225/
Revision 5), IAEA Nuclear Security Series No. 13, IAEA, Vienna (2011).
[11] INTERNATIONAL ATOMIC ENERGY AGENCY, Nuclear Security Recommendations
on Radioactive Material and Associated Facilities, IAEA Nuclear Security Series
No. 14, IAEA, Vienna (2011).
[12] INTERNATIONAL ATOMIC ENERGY AGENCY, Security of Nuclear Information,
IAEA Nuclear Security Series No. 23-G, IAEA, Vienna (2015).
[13] INTERNATIONAL ATOMIC ENERGY AGENCY, External Human Induced Events in
Site Evaluation for Nuclear Power Plants, IAEA Safety Standards Series No. NS-G-3.1,
[14] INTERNATIONAL ATOMIC ENERGY AGENCY, Format and Content of the Safety
Analysis Report for Nuclear Power Plants, IAEA Safety Standards Series No. GS-G-4.1,
[15] INTERNATIONAL ATOMIC ENERGY AGENCY, Safety Assessment for Research
Reactors and Preparation of the Safety Analysis Report, IAEA Safety Standards Series
No. SSG-20, IAEA, Vienna (2012).
[16] INTERNATIONAL ATOMIC ENERGY AGENCY, Safety Assessment for Facilities
and Activities, IAEA Safety Standards Series No. GSR Part 4 (Rev. 1), IAEA,
Vienna (2016).
[17] INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport
of Radioactive Material, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA,
Vienna (2018).
[18] INTERNATIONAL ATOMIC ENERGY AGENCY, Deterministic Safety Analysis for
Nuclear Power Plants, IAEA Safety Standards Series No. SSG-2 (Rev. 1), IAEA, Vienna
(in preparation).
[19] INTERNATIONAL ATOMIC ENERGY AGENCY, Development and Application of
Level 1 Probabilistic Safety Assessment for Nuclear Power Plants, IAEA Safety
Standards Series No. SSG-3, IAEA, Vienna (2010).
[20] INTERNATIONAL ATOMIC ENERGY AGENCY, Development and Application of
Level 2 Probabilistic Safety Assessment for Nuclear Power Plants, IAEA Safety
[21] INTERNATIONAL ATOMIC ENERGY AGENCY, Operating Experience Feedback for
Nuclear Installations, IAEA Safety Standards Series No. SSG-50, IAEA, Vienna (2018).
[22] INTERNATIONAL ATOMIC ENERGY AGENCY, Site Evaluation for Nuclear
Installations, IAEA Safety Standards Series No. NS-R-3 (Rev. 1), IAEA, Vienna (2016).
(A revision of this publication is in preparation.)
[23] INTERNATIONAL ATOMIC ENERGY AGENCY, UNITED NATIONS
ENVIRONMENT PROGRAMME, Prospective Radiological Environmental Impact
Assessment for Facilities and Activities, IAEA Safety Standards Series No. GSG-10,
IAEA, Vienna (in preparation).
134
[24] INTERNATIONAL ATOMIC ENERGY AGENCY, Seismic Hazards in Site Evaluation
for Nuclear Installations, IAEA Safety Standards Series No. SSG-9, IAEA,
Vienna (2010).
[25] INTERNATIONAL ATOMIC ENERGY AGENCY, WORLD METEOROLOGICAL
ORGANIZATION, Meteorological and Hydrological Hazards in Site Evaluation for
[26] INTERNATIONAL ATOMIC ENERGY AGENCY, Volcanic Hazards in Site Evaluation
for Nuclear Installations, IAEA Safety Standards Series No. SSG-21, IAEA,
Vienna (2012).
[27] INTERNATIONAL ATOMIC ENERGY AGENCY, Geotechnical Aspects of Site
Evaluation and Foundations for Nuclear Power Plants, IAEA Safety Standards Series
No. NS-G-3.6, IAEA, Vienna (2004).
[28] INTERNATIONAL ATOMIC ENERGY AGENCY, Site Survey and Site Selection for
[29] INTERNATIONAL ATOMIC ENERGY AGENCY, Near Surface Disposal Facilities for
Radioactive Waste, IAEA Safety Standards Series No. SSG-29, IAEA, Vienna (2014).
[30] INTERNATIONAL ATOMIC ENERGY AGENCY, Geological Disposal Facilities for
[31] INTERNATIONAL ATOMIC ENERGY AGENCY, Borehole Disposal Facilities for
[32] INTERNATIONAL ATOMIC ENERGY AGENCY, Safety of Nuclear Power Plants:
Design, IAEA Safety Standards Series No. SSR-2/1 (Rev. 1), IAEA, Vienna (2016).
[33] INTERNATIONAL ATOMIC ENERGY AGENCY, Construction for Nuclear
Installations, IAEA Safety Standards Series No. SSG-38, IAEA, Vienna (2015).
[34] INTERNATIONAL ATOMIC ENERGY AGENCY, Commissioning for Nuclear Power
Plants, IAEA Safety Standards Series No. SSG-28, IAEA, Vienna (2014).
[35] INTERNATIONAL ATOMIC ENERGY AGENCY, Commissioning of Research
Reactors, IAEA Safety Standards Series No. NS-G-4.1, IAEA, Vienna (2006).
[36] INTERNATIONAL ATOMIC ENERGY AGENCY, Periodic Safety Review for Nuclear
Power Plants, IAEA Safety Standards Series No. SSG-25, IAEA, Vienna (2013).
[37] INTERNATIONAL ATOMIC ENERGY AGENCY, Modifications to Nuclear Power
Plants, IAEA Safety Standards Series No. NS-G-2.3, IAEA, Vienna (2001).
[38] INTERNATIONAL ATOMIC ENERGY AGENCY, Decommissioning of Facilities,
IAEA Safety Standards Series No. GSR Part 6, IAEA, Vienna (2014).
[39] INTERNATIONAL ATOMIC ENERGY AGENCY, Decommissioning of Nuclear
Power Plants, Research Reactors and Other Nuclear Fuel Cycle Facilities, IAEA Safety
Standards Series No. SSG-47, IAEA, Vienna (in preparation).
[40] INTERNATIONAL ATOMIC ENERGY AGENCY, Predisposal Management of
Radioactive Waste, IAEA Safety Standards Series No. GSR Part 5, IAEA, Vienna (2009).
[41] INTERNATIONAL ATOMIC ENERGY AGENCY, Disposal of Radioactive Waste,
IAEA Safety Standards Series No. SSR-5, IAEA, Vienna (2011).
Radioactive Waste from Nuclear Power Plants and Research Reactors, IAEA Safety
135
Radioactive Waste from Nuclear Fuel Cycle Facilities, IAEA Safety Standards Series
No. SSG-41, IAEA, Vienna (2016).
[44] INTERNATIONAL ATOMIC ENERGY AGENCY, Decommissioning of Medical,
Industrial and Research Facilities, IAEA Safety Standards Series No. SSG-49, IAEA,
Vienna (in preparation).
[45] INTERNATIONAL ATOMIC ENERGY AGENCY, Leadership and Management for
Safety, IAEA Safety Standards Series No. GSR Part 2, IAEA, Vienna (2016).
[46] INTERNATIONAL ATOMIC ENERGY AGENCY, Severe Accident Management
Programmes for Nuclear Power Plants, IAEA Safety Standards Series No. NS-G-2.15,
IAEA, Vienna (2009). (A revision of this publication is in preparation.)
[47] INTERNATIONAL ATOMIC ENERGY AGENCY, Communication and Consultation
with Interested Parties by the Regulatory Body, IAEA Safety Standards Series No.
GSG-6, IAEA, Vienna (2017).
[48] INTERNATIONAL ATOMIC ENERGY AGENCY, OECD NUCLEAR ENERGY
AGENCY, Radiation Safety for Consumer Products, IAEA Safety Standards Series No.
SSG-36, IAEA, Vienna (2016).
[49] INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR
ORGANIZATION, Occupational Radiation Protection, IAEA Safety Standards Series
No. GSG-7, IAEA, Vienna (in preparation).
[50] INTERNATIONAL ATOMIC ENERGY AGENCY, UNITED NATIONS
ENVIRONMENT PROGRAMME, Radiation Protection of the Public and the
Environment, IAEA Safety Standards Series No. GSG-8, IAEA, Vienna (2018).
136
CONTRIBUTORS TO DRAFTING AND REVIEW
Asfaw, K. International Atomic Energy Agency
Bosnjak, J. International Atomic Energy Agency
Jones, G. International Atomic Energy Agency
Kamenopoulou, V. Greek Atomic Energy Commission, Greece
Lungu, S. International Atomic Energy Agency
Mansoor, F. Pakistan Nuclear Regulatory Authority, Pakistan
Mansoux, H. International Atomic Energy Agency
Nicic, A. International Atomic Energy Agency
Pacheco Jimenez, R. International Atomic Energy Agency
Parlange, J. International Atomic Energy Agency
Shaw, P. International Atomic Energy Agency
Suman, H. International Atomic Energy Agency
Trivelloni, S. National Institute for Environmental Protection and

Research, Italy
Vaughan, G. Consultant, United Kingdom
Westermeier, E. Federal Office for Radiation Protection (BfS), Germany
Wrona, D. United States Nuclear Regulatory Commission, United

States of America
137
@ No. 25
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18-03361
R E L AT ED PUBL ICAT IONS
Atoms for Peace
FUNDAMENTAL SAFETY PRINCIPLES

IAEA Safety Standards Series No. SF-1
STI/PUB/1273 (21 pp.; 2006)
ISBN 92–0–110706–4 Price: €25.00
GOVERNMENTAL, LEGAL AND REGULATORY FRAMEWORK
FOR SAFETY
IAEA Safety Standards Series No. GSR Part 1 (Rev. 1)
STI/PUB/1713 (42 pp.; 2016)
ISBN 978–92–0–108815–4 Price: €48.00
LEADERSHIP AND MANAGEMENT FOR SAFETY
IAEA Safety Standards Series No. GSR Part 2
STI/PUB/1750 (26 pp.; 2016)
ISBN 978–92–0–104516–4 Price: €30.00
RADIATION PROTECTION AND SAFETY OF RADIATION SOURCES:
INTERNATIONAL BASIC SAFETY STANDARDS
STI/PUB/1578 (436 pp.; 2014)
ISBN 978–92–0–135310–8 Price: €68.00
SAFETY ASSESSMENT FOR FACILITIES AND ACTIVITIES
IAEA Safety Standards Series No. GSR Part 4 (Rev. 1)
STI/PUB/1714 (38 pp.; 2016)
ISBN 978–92–0–109115–4 Price: €49.00
PREDISPOSAL MANAGEMENT OF RADIOACTIVE WASTE
STI/PUB/1368 (38 pp.; 2009)
ISBN 978–92–0–111508–9 Price: €45.00
DECOMMISSIONING OF FACILITIES
STI/PUB/1652 (23 pp.; 2014)
ISBN 978–92–0–102614–9 Price: €25.00
PREPAREDNESS AND RESPONSE FOR A NUCLEAR OR
RADIOLOGICAL EMERGENCY
STI/PUB/1708 (102 pp.; 2015)
ISBN 978–92–0–105715–0 Price: €45.00
REGULATIONS FOR THE SAFE TRANSPORT OF RADIOACTIVE
MATERIAL, 2018 EDITION
IAEA Safety Standards Series No. SSR-6 (Rev. 1)
STI/PUB/1798 (165 pp.; 2018)
ISBN 978–92–0–107917–6 Price: €49.00
www.iaea.org/books
Safety through international standards
“Governments, regulatory bodies and operators everywhere must

ensure that nuclear material and radiation sources are used
beneficially, safely and ethically. The IAEA safety standards are
designed to facilitate this, and I encourage all Member States to
make use of them.”
Yukiya Amano
Director General
INTERNATIONAL ATOMIC ENERGY AGENCY

VIENNA
ISBN 978–92–0–100718–6
ISSN 1020–525X

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IAEA Safety Standards

for protecting people and the environment

Functions and Processes

General Safety Guide

IAEA SAFETY STANDARDS

AFGHANISTAN GERMANY PALAU

FUNCTIONS AND PROCESSES

INTERNATIONAL ATOMIC ENERGY AGENCY

Marketing and Sales Unit, Publishing Section

Printed by the IAEA in Austria

IAEA Library Cataloguing in Publication Data

The IAEA’s Statute authorizes the Agency to “establish or adopt…

Radioactivity is a natural phenomenon and natural sources of radiation are

THE IAEA SAFETY STANDARDS

General Safety Requirements Specific Safety Requirements

Part 1. Governmental, Legal and 1. Site Evaluation for

Part 2. Leadership and Management

Part 4. Safety Assessment for 3. Safety of Research Reactors

Part 5. Predisposal Management 4. Safety of Nuclear Fuel

Part 6. Decommissioning and 5. Safety of Radioactive Waste

Part 7. Emergency Preparedness 6. Safe Transport of

Collection of Safety Guides

APPLICATION OF THE IAEA SAFETY STANDARDS

The principal users of safety standards in IAEA Member States are

DEVELOPMENT PROCESS FOR THE IAEA SAFETY STANDARDS

the Commission on Safety Standards is appointed by the Director General and

INTERACTION WITH OTHER INTERNATIONAL ORGANIZATIONS

The findings of the United Nations Scientific Committee on the Effects

INTERPRETATION OF THE TEXT

Safety related terms are to be understood as defined in the IAEA Safety

2. GRADED APPROACH TO FUNCTIONS AND

3. CORE REGULATORY FUNCTIONS AND PROCESSES (3.1–3.2) 8

Regulations and guides (3.3–3.9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

APPENDIX I: PROVISION OF CONSUMER PRODUCTS . . . . . . . . . 105

APPENDIX II: AUTHORIZATION CONDITIONS

APPENDIX IV: REGULATORY INSPECTION AREAS

CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . 137

1.3. Corresponding supporting functions, supported by processes within the

1.6. The objective of this Safety Guide is to provide recommendations on

(a) The development and/or provision of regulations and guides;

(a) Administrative support, including human resources, finance, management

These supporting functions and the associated processes are described in

1.10. In this Safety Guide, the terms ‘authorization’ (which is considered to be

1.13. Section 2 of this Safety Guide provides recommendations on the

2. GRADED APPROACH TO FUNCTIONS

2.1. Paragraph 3.24 of SF-1 [1] states that:

2.2. Requirement 1 of GSR Part 1 (Rev. 1) [2] states that:

“The government shall establish a national policy and strategy for

“The national policy and strategy for safety shall be implemented in

“The performance of regulatory functions shall be commensurate with the

2.5. Specific reference is made to the application of a graded approach in

(a) Regulations and guides “shall provide adequate coverage commensurate

“The scope and extent of arrangements for emergency preparedness and

This is further addressed in GSR Part 7 [7], particularly in Requirement 4.

2.10. The application of the graded approach should be reassessed as a

3. CORE REGULATORY FUNCTIONS

3.2. The subsequent subsections cover the responsibilities of the regulatory

REGULATIONS AND GUIDES

3.3. The provision of regulations and guides is subject to Requirements 32–34

Objectives of regulations and guides