IAEA

SAFETY
STANDARDS
SERIES

Review and Assessment

of Nuclear Facilities
by the Regulatory Body

SAFETY GUIDE
No. GS-G-1.2
INTERNATIONAL
ATOMIC ENERGY AGENCY
VIENNA
 IAEA SAFETY RELATED PUBLICATIONS

IAEA SAFETY STANDARDS

Under the terms of Article III of its Statute, the IAEA is authorized to establish standards
of safety for protection against ionizing radiation and to provide for the application of these
standards to peaceful nuclear activities.
The regulatory related publications by means of which the IAEA establishes safety
standards and measures are issued in the IAEA Safety Standards Series. This series covers
nuclear safety, radiation safety, transport safety and waste safety, and also general safety (that
is, of relevance in two or more of the four areas), and the categories within it are Safety
Fundamentals, Safety Requirements and Safety Guides.
Safety Fundamentals (blue lettering) present basic objectives, concepts and principles of
safety and protection in the development and application of nuclear energy for peaceful
purposes.
Safety Requirements (red lettering) establish the requirements that must be met to ensure
safety. These requirements, which are expressed as shall statements, are governed by
the objectives and principles presented in the Safety Fundamentals.
Safety Guides (green lettering) recommend actions, conditions or procedures for meeting
safety requirements. Recommendations in Safety Guides are expressed as should state-
ments, with the implication that it is necessary to take the measures recommended or
equivalent alternative measures to comply with the requirements.
The IAEAs safety standards are not legally binding on Member States but may be
adopted by them, at their own discretion, for use in national regulations in respect of their own
activities. The standards are binding on the IAEA in relation to its own operations and on States
in relation to operations assisted by the IAEA.
Information on the IAEAs safety standards programme (including editions in languages
other than English) is available at the IAEA Internet site
www.iaea.org/ns/coordinet
or on request to the Safety Co-ordination Section, IAEA, P.O. Box 100, A-1400 Vienna, Austria.

OTHER SAFETY RELATED PUBLICATIONS

Under the terms of Articles III and VIII.C of its Statute, the IAEA makes available and
fosters the exchange of information relating to peaceful nuclear activities and serves as an inter-
mediary among its Member States for this purpose.
Reports on safety and protection in nuclear activities are issued in other series, in
particular the IAEA Safety Reports Series, as informational publications. Safety Reports may
describe good practices and give practical examples and detailed methods that can be used to
meet safety requirements. They do not establish requirements or make recommendations.
Other IAEA series that include safety related sales publications are the Technical
Reports Series, the Radiological Assessment Reports Series and the INSAG Series. The
IAEA also issues reports on radiological accidents and other special sales publications.
Unpriced safety related publications are issued in the TECDOC Series, the Provisional Safety
Standards Series, the Training Course Series, the IAEA Services Series and the Computer
Manual Series, and as Practical Radiation Safety Manuals and Practical Radiation
Technical Manuals.
REVIEW AND ASSESSMENT
OF NUCLEAR FACILITIES
BY THE REGULATORY BODY
 The following States are Members of the International Atomic Energy Agency:
AFGHANISTAN GHANA PANAMA
ALBANIA GREECE PARAGUAY
ALGERIA GUATEMALA PERU
ANGOLA HAITI PHILIPPINES
ARGENTINA HOLY SEE POLAND
ARMENIA HUNGARY PORTUGAL
AUSTRALIA ICELAND QATAR
AUSTRIA INDIA REPUBLIC OF MOLDOVA
AZERBAIJAN INDONESIA ROMANIA
BANGLADESH IRAN, ISLAMIC REPUBLIC OF RUSSIAN FEDERATION
BELARUS IRAQ SAUDI ARABIA
BELGIUM IRELAND SENEGAL
BENIN ISRAEL SIERRA LEONE
BOLIVIA ITALY SINGAPORE
BOSNIA AND HERZEGOVINA JAMAICA SLOVAKIA
BOTSWANA JAPAN SLOVENIA
BRAZIL JORDAN SOUTH AFRICA
BULGARIA KAZAKHSTAN SPAIN
BURKINA FASO KENYA SRI LANKA
CAMBODIA KOREA, REPUBLIC OF SUDAN
CAMEROON KUWAIT SWEDEN
CANADA LATVIA SWITZERLAND
CENTRAL AFRICAN LEBANON SYRIAN ARAB REPUBLIC
REPUBLIC LIBERIA TAJIKISTAN
CHILE LIBYAN ARAB JAMAHIRIYA THAILAND
CHINA LIECHTENSTEIN THE FORMER YUGOSLAV
COLOMBIA LITHUANIA REPUBLIC OF MACEDONIA
COSTA RICA LUXEMBOURG TUNISIA
CTE DIVOIRE MADAGASCAR TURKEY
CROATIA MALAYSIA UGANDA
CUBA MALI UKRAINE
CYPRUS MALTA UNITED ARAB EMIRATES
CZECH REPUBLIC MARSHALL ISLANDS UNITED KINGDOM OF
DEMOCRATIC REPUBLIC MAURITIUS GREAT BRITAIN AND
OF THE CONGO MEXICO NORTHERN IRELAND
DENMARK MONACO UNITED REPUBLIC
DOMINICAN REPUBLIC MONGOLIA OF TANZANIA
ECUADOR MOROCCO UNITED STATES OF AMERICA
EGYPT MYANMAR URUGUAY
EL SALVADOR NAMIBIA
UZBEKISTAN
ESTONIA NETHERLANDS
VENEZUELA
ETHIOPIA NEW ZEALAND
VIET NAM
FINLAND NICARAGUA
YEMEN
FRANCE NIGER
YUGOSLAVIA,
GABON NIGERIA
FEDERAL REPUBLIC OF
GEORGIA NORWAY
ZAMBIA
GERMANY PAKISTAN
ZIMBABWE
The Agencys 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, 2002
Permission to reproduce or translate the information contained in this publication may be
obtained by writing to the International Atomic Energy Agency, Wagramer Strasse 5, P.O. Box 100,
A-1400 Vienna, Austria.
Printed by the IAEA in Austria
August 2002
STI/PUB/1128
 SAFETY STANDARDS SERIES No. GS-G-1.2

REVIEW AND ASSESSMENT

OF NUCLEAR FACILITIES
BY THE REGULATORY BODY
SAFETY GUIDE

INTERNATIONAL ATOMIC ENERGY AGENCY

VIENNA, 2002
VIC Library Cataloguing in Publication Data
Review and assessment of nuclear facilities by the regulatory body: safety
guide. Vienna : International Atomic Energy Agency, 2002.
p. ; 24 cm. (Safety standards series, ISSN 1020525X ; no. GS-G-1.2)
STI/PUB/1128
ISBN 9201117027
Includes bibliographical references.
1. Nuclear facilities Safety measures. I. International Atomic Energy
Agency. II. Series.
VICL 0200287
 FOREWORD

by Mohamed ElBaradei
Director General

One of the statutory functions of the IAEA is to establish or adopt standards of

safety for the protection of health, life and property in the development and application
of nuclear energy for peaceful purposes, and to provide for the application of these
standards to its own operations as well as to assisted operations and, at the request of
the parties, to operations under any bilateral or multilateral arrangement, or, at the
request of a State, to any of that States activities in the field of nuclear energy.
The following bodies oversee the development of safety standards: the
Commission on Safety Standards (CSS); the Nuclear Safety Standards Committee
(NUSSC); the Radiation Safety Standards Committee (RASSC); the Transport Safety
Standards Committee (TRANSSC); and the Waste Safety Standards Committee
(WASSC). Member States are widely represented on these committees.
In order to ensure the broadest international consensus, safety standards are
also submitted to all Member States for comment before approval by the IAEA Board
of Governors (for Safety Fundamentals and Safety Requirements) or, on behalf of the
Director General, by the Publications Committee (for Safety Guides).
The IAEAs safety standards are not legally binding on Member States but may
be adopted by them, at their own discretion, for use in national regulations in respect
of their own activities. The standards are binding on the IAEA in relation to its own
operations and on States in relation to operations assisted by the IAEA. Any State
wishing to enter into an agreement with the IAEA for its assistance in connection with
the siting, design, construction, commissioning, operation or decommissioning of a
nuclear facility or any other activities will be required to follow those parts of the
safety standards that pertain to the activities to be covered by the agreement.
However, it should be recalled that the final decisions and legal responsibilities in any
licensing procedures rest with the States.
Although the safety standards establish an essential basis for safety, the
incorporation of more detailed requirements, in accordance with national practice,
may also be necessary. Moreover, there will generally be special aspects that need to
be assessed on a case by case basis.
The physical protection of fissile and radioactive materials and of nuclear
power plants as a whole is mentioned where appropriate but is not treated in detail;
obligations of States in this respect should be addressed on the basis of the relevant
instruments and publications developed under the auspices of the IAEA. Non-
radiological aspects of industrial safety and environmental protection are also not
explicitly considered; it is recognized that States should fulfil their international
undertakings and obligations in relation to these.
 The requirements and recommendations set forth in the IAEA safety standards
might not be fully satisfied by some facilities built to earlier standards. Decisions on
the way in which the safety standards are applied to such facilities will be taken by
individual States.
The attention of States is drawn to the fact that the safety standards of the
IAEA, while not legally binding, are developed with the aim of ensuring that the
peaceful uses of nuclear energy and of radioactive materials are undertaken in a
manner that enables States to meet their obligations under generally accepted
principles of international law and rules such as those relating to environmental
protection. According to one such general principle, the territory of a State must not
be used in such a way as to cause damage in another State. States thus have an
obligation of diligence and standard of care.
Civil nuclear activities conducted within the jurisdiction of States are, as any
other activities, subject to obligations to which States may subscribe under
international conventions, in addition to generally accepted principles of international
law. States are expected to adopt within their national legal systems such legislation
(including regulations) and other standards and measures as may be necessary to
fulfil all of their international obligations effectively.

EDITORIAL NOTE

An appendix, when included, is considered to form an integral part of the standard and
to have the same status as the main text. Annexes, footnotes and bibliographies, if included, are
used to provide additional information or practical examples that might be helpful to the user.
The safety standards use the form shall in making statements about requirements,
responsibilities and obligations. Use of the form should denotes recommendations of a
desired option.
The English version of the text is the authoritative version.
 CONTENTS

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Background (1.11.3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Objective (1.4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Scope (1.5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Structure (1.6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2. REVIEW AND ASSESSMENT PROCESS . . . . . . . . . . . . . . . . . . . . . . . 2

Objectives of review and assessment (2.12.2) . . . . . . . . . . . . . . . . . . . . . 2

Management of review and assessment (2.32.5) . . . . . . . . . . . . . . . . . . . 3
Scheduling of submissions (2.6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Different stages of the authorization process (2.72.25) . . . . . . . . . . . . . . 5
Organization and technical resources for review
and assessment (2.262.29) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
External relationships (2.302.39) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3. PERFORMANCE OF THE REVIEW AND ASSESSMENT

PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

General (3.1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Internal guidance (3.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Review and assessment plan (3.33.8) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Documentation to be submitted by the operator (3.93.14) . . . . . . . . . . . 17
Bases for decisions (3.153.20) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Bases for review and assessment (3.213.39) . . . . . . . . . . . . . . . . . . . . . . 19
Verification of the safety analysis (3.403.62) . . . . . . . . . . . . . . . . . . . . . 24
Regulatory inspection for review and assessment (3.633.64) . . . . . . . . . 32
Records of the regulatory bodys review and assessment (3.65) . . . . . . . . 32
Documentation produced by the regulatory body (3.66) . . . . . . . . . . . . . . 33
Research and development initiated by the regulatory body (3.673.68) . 33

4. MONITORING OF THE REVIEW AND ASSESSMENT

PROCESS (4.14.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

APPENDIX: TOPICS TO BE COVERED BY REVIEW AND

ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . . . . . 45
BODIES FOR THE ENDORSEMENT OF SAFETY STANDARDS . . . . . . . . 46
 1. INTRODUCTION

BACKGROUND

1.1. The achievement and maintenance of a high level of safety in the siting, design,
construction, commissioning, operation and decommissioning of nuclear facilities,
and in the closure of waste disposal facilities, requires a sound legal and govern-
mental infrastructure, including a regulatory body with well defined responsibilities
and functions. Review and assessment of submissions on safety from the operator of
a nuclear facility are among the principal functions of such a regulatory body.

1.2. The IAEA Safety Requirements publication on Legal and Governmental

Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety [1] sets
out the requirements for such an infrastructure. These include requirements in respect
of the establishment of an independent regulatory body for nuclear facilities and the
responsibilities and functions to be assigned to it.

1.3. Four interrelated IAEA Safety Guides provide recommendations for satisfying
the requirements concerning particular responsibilities and functions of the regulatory
body in the regulation of nuclear facilities. The present Safety Guide addresses
regulatory review and assessment; three related Safety Guides cover, respectively, the
organization and staffing of the regulatory body [2], regulatory inspection and
enforcement [3], and documentation relating to the regulatory process [4].

OBJECTIVE

1.4. The purpose of this Safety Guide is to provide recommendations for regulatory
bodies on reviewing and assessing the various safety related submissions made by the
operator of a nuclear facility at different stages (siting, design, construction,
commissioning, operation and decommissioning or closure) in the facilitys lifetime
to determine whether the facility complies with the applicable safety objectives and
requirements1.

1 Throughout this publication, the term safety objectives is used to mean safety

objectives, safety principles and safety criteria.

1
SCOPE

1.5. This Safety Guide covers the review and assessment of submissions in relation
to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants;
nuclear power plants; other reactors such as research reactors and critical assemblies;
spent fuel reprocessing plants; and facilities for radioactive waste management, such
as treatment, storage and disposal facilities. This Safety Guide also covers issues
relating to the decommissioning of nuclear facilities, the closure of waste disposal
facilities and site rehabilitation.

STRUCTURE

1.6. Objectives, management, planning and organizational matters relating to the

review and assessment process are presented in Section 2. Section 3 deals with the
bases for decision making and conduct of the review and assessment process. Section
4 covers aspects relating to the assessment of this process. The Appendix provides a
generic list of topics to be covered in the review and assessment process.

2. REVIEW AND ASSESSMENT PROCESS

OBJECTIVES OF REVIEW AND ASSESSMENT

2.1. The basic objective of review and assessment is to determine whether the
operators submissions demonstrate that the facility complies throughout its lifetime
with the safety objectives stipulated or approved by the regulatory body.

2.2. The specific objectives of the review and assessment will depend on the stage of
the lifetime of the facility. Examples of these specific objectives include the following:

(a) To determine whether an operator has the ability and resources (in particular, the
funding arrangements for decommissioning) to discharge its obligations associated
with any authorization granted for any stage of the lifetime of the facility.
(b) To determine whether the site chosen is suitable for the proposed facility,
account being taken of the interaction between the site and the facility and of
anticipated changes to the environment of the site during the proposed period
of commissioning and operation; and to recommend to the appropriate
authorities requirements in respect of the site surroundings that may be
considered necessary by the regulatory body.

2
(c) Before manufacture, construction, installation, commissioning, operation and
decommissioning or closure: to determine whether proposals and commitments
of the operator in respect of design, operation and decommissioning or post-
closure meet the regulatory bodys requirements, and to apply any further
conditions or requirements that may be considered necessary by the regulatory
body.
(d) To determine whether the commissioning test programme is complete and
contains a well defined set of operational limits, test acceptance criteria,
conditions and procedures; whether the commissioning tests can be safely
conducted; and whether the test results are adequate for confirming the
adequacy of all safety related features of the facility.
(e) To determine whether the operator uses an appropriate safety management
system that meets the regulatory bodys requirements.
(f) To determine whether the operational limits and conditions are consistent with
the regulatory bodys requirements, the operational characteristics of the
facility, and the state of knowledge and operational experience; and to
determine whether an adequate level of safety is being maintained.
(g) To determine whether the operators personnel meet the regulatory
requirements, in terms of both number and competence.
(h) To determine whether proposed modifications to the facility, at whichever stage
in its lifetime, have been conceived and their implementation planned so that
safety is not compromised.
(i) To evaluate safety reviews performed by the operator.
(j) To determine whether the operators plans and commitments in respect of
decommissioning meet the requirements of the regulatory body.
(k) To determine whether the operators plans and commitments in respect of the
closure and post-closure stages for a disposal facility meet the requirements of
the regulatory body.
(l) To determine, if relevant, whether the performance indicators proposed by the
operator are appropriate.
(m) To determine whether the programme proposed by the operator for
confirmation of performance is acceptable (this is particularly important for
waste disposal facilities).
(n) To determine whether any additional requirements (or licence conditions) have
been fulfilled by the operator.

MANAGEMENT OF REVIEW AND ASSESSMENT

2.3. Management within the regulatory body of the review and assessment process
is an important part of the process. Consideration should be given to assigning

3
managerial responsibility to a single individual or organizational unit. The
management of review and assessment should include responsibility for:

(a) Planning and directing the review and assessment process;

(b) Preparing the procedures to be followed in accordance with the overall quality
management programme;
(c) Co-ordinating all information exchange between the regulatory body and the
operator;
(d) For all documents sent or received, keeping a log to record the name of the
sender and that of the recipient, the follow-up action necessary and the outcome
of this action;
(e) Monitoring the progress of documents submitted by the operator and the
progress of the review and assessment process against the tentative
programme agreed by the operator and the regulatory body (if there is such a
programme);
(f) Making the necessary arrangements whenever different parts of the regulatory
body need to combine their expertise to make a decision in a timely manner;
(g) Making arrangements for co-ordination between review and assessment
activities and inspection activities, as appropriate;
(h) Making arrangements for liaison with consultants, advisory committees or any
other relevant organizations as appropriate, whenever these are called upon;
(i) Facilitating consultation nationally with other regulatory bodies and
governmental departments, where appropriate;
(j) Collating and disseminating the overall findings of the regulatory body
following the completion of the review and assessment process;
(k) Planning for public consultation during the review process, as appropriate;
(l) Planning for any hearing process at the end of the review and assessment
process, as appropriate;
(m) Qualification and training of the personnel engaged in the review and
assessment process.

2.4. The IAEA Safety Requirements publication on Legal and Governmental

Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety [1]
establishes the following requirements. A primary basis for review and assessment
is the information submitted by the operator. A thorough review and assessment of the
operators technical submission shall be performed by the regulatory body in order to
determine whether the facility or activity complies with the relevant safety objectives,
principles and criteria. In doing this, the regulatory body shall acquire an
understanding of the design of the facility or equipment, the safety concepts on which
the design is based and the operating principles proposed by the operator, to satisfy
itself that:

4
(1) The available information demonstrates the safety of the facility or proposed
activity;
(2) The information contained in the operators submissions is accurate and sufficient
to enable confirmation of compliance with regulatory requirements; and
(3) The technical solutions, and in particular any novel ones, have been proven or
qualified by experience or testing or both, and are capable of achieving the
required level of safety (Ref. [1], para. 5.9.)

2.5. The review and assessment of nuclear facilities necessitate considerable amounts
of work and resources, and appropriate plans should be made for these. The regulatory
body should develop a programme to review and assess information provided by the
operator (see Ref. [4], paras 4.24.8) or collected during its own inspections [3]. The
co-operation of the operator should be obtained to ensure that review and assessment
can be carried out in an effective and informed manner. In addition, information from
other sources (such as incident reports from other States) which have a bearing on the
safety of facilities should be reviewed and assessed.

SCHEDULING OF SUBMISSIONS

2.6. The regulatory body should indicate to the operator the period of time that is
considered necessary for the review and assessment process so as to facilitate the
process and to minimize delays in the granting of any necessary authorizations. It is
appropriate to reach agreement on an indicative schedule. In scheduling a review and
assessment programme, the regulatory body should allow for the fact that the
information initially submitted by the operator may be incomplete. In such cases, it
will take time to obtain adequate information so that review and assessment in full
can be initiated. In addition, important issues may arise, necessitating additional
studies and leading to delays. Such factors may lead to large variations in the time
necessary for review and assessment in a given stage of the lifetime of the facility.
The operator should submit any additional information sought by the regulatory
body within the stipulated time. The regulatory body should expend its best efforts
to complete its review and assessment process in accordance with the agreed
schedule, but this objective should in no way compromise the regulatory bodys
responsibilities.

DIFFERENT STAGES OF THE AUTHORIZATION PROCESS

2.7. The authorization process (see Ref. [4], Appendix) is a continuing process
which may start before the planning and feasibility study for the site and continue

5
through decommissioning or closure of the nuclear facilities until release from
regulatory control. This section outlines the areas in which review and assessment
should be concentrated. It is not sufficient to review and assess these areas in
isolation; all relevant areas from previous decision points should be considered at
each stage in the authorization process in order to ensure that the acceptability of the
operators submissions has not been compromised. A listing of the topics that should
be considered in the review and assessment process throughout the lifetime of a
facility is given in the Appendix.

2.8. As a practical matter, review and assessment of each area may start at an earlier
stage and continue into subsequent stages. Also, depending on the arrangements made
at the national level and the nature of the facility, review and assessment of some
areas may be combined. Since this Safety Guide covers a wide range of types of
facility, 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 facilities of each type.
However, this section provides a general overview of major areas for review and
assessment; the degree to which the respective areas should be considered will
depend on the nature of the facility and the risks associated with it.

Site evaluation

2.9. In considering an application for siting, the regulatory body will tend to
concentrate on the characteristics of the site and, as appropriate, the interaction between
the proposed facility and the site. Site evaluation for many facilities is initially
determined by processes not greatly influenced by highly prescriptive criteria.
However, general requirements concerning remoteness, local population density and
transport arrangements will apply. For waste disposal sites, geological and
hydrogeological considerations will be major factors in site evaluation. It is likely that
for such sites the regulatory body may be involved in the formulation of site selection
criteria and in the process of determining the suitability of a site (see Refs [57]).

2.10. In all cases, the site of the facility should be qualified by review and assessment
to determine the potential interaction between the proposed facility and the site and
to assess the suitability of the site from the point of view of safety. This site review
and assessment may be performed in parallel with the design review and assessment
or may, as in some States, be performed at an earlier stage. Areas of review and
assessment which are of particular significance are the implications of the local
environment, natural and human made, for the facilitys safety and the demands that
the facility would make on the local infrastructure.

6
2.11. For waste disposal facilities, the geological barrier is an important element of
the very long term assurance necessary. The arguments to be made will depend on an
understanding of the natural environment. Such an understanding is unlikely to be
complete at this stage and should be reinforced and confirmed in the construction and
operational stages to provide the technical basis and gain the public confidence
necessary. The process of review and assessment of the site qualification could take
many decades and indeed may last into a period of institutional control following
closure of the facility.

Design, construction, manufacture and installation

2.12. Before authorization of construction of the facility, review and assessment will
be concentrated on the operators approach to safety and safety standards, and how
these have been applied in developing the design. Features such as the physical layout
and the construction of the facility and the key process elements should be carefully
considered, and their effects on the safety of the facility throughout its lifetime should
be assessed at the design stage. In addition, before authorizing construction, the
regulatory body should review and assess the operators arrangements for the control
of activities in construction, manufacture and installation. Once construction has
started, many features of the design can be changed only with great difficulty. An
outline plan for decommissioning, covering issues such as strategies to be used,
radiation doses to be expected and amounts of waste to be produced, should be
prepared by the operator at the design stage. The plan should be subject to review and
assessment by the regulatory body.

2.13. Review and assessment of the design should continue during construction,
manufacture and installation as the details become finalized. Changes to the
authorized design at this stage should be analysed by the operator and reported to the
regulatory body, which should carry out the necessary review and assessment.

Commissioning

2.14. Commissioning can be considered in two stages: inactive, before fissile and
radioactive material is introduced, and active, after fissile and radioactive material
has been introduced. Clearly, radiological risks arise only after the second stage has
been started. Commissioning should be carried out in accordance with programmes
which have been reviewed and assessed by the regulatory body, which should
determine whether the as-built facility meets its requirements.

2.15. The inactive stage of commissioning is aimed at ensuring that the facility has
been constructed, manufactured and installed correctly and in accordance with the

7
design documentation. If deviations from this documentation have occurred, they
should be recorded, and it should be shown that the safety analysis has not been
compromised. The results of inactive commissioning should also confirm the
operational features of the facility and should lead to the development of detailed
instructions for operators, which should be confirmed during the active stage.

2.16. Active commissioning with the introduction of fissile and radioactive material
is a major step in the authorization process. The review and assessment should take
into consideration: the final or as-built design of the facility 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 operator and reported to the regulatory body, which should carry out the
necessary review and assessment.

2.17. As the active commissioning processes move closer to completion, review

and assessment should be concentrated on how the facility is operated and
maintained, and on the procedures for controlling and monitoring operation and
responding to deviations or other occurrences. Before authorizing routine
operation, 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 limits and conditions.

Operation

2.18. For routine operation the regulatory body should require that the operator report
regularly on 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 the facility is able to continue in
operation.

2.19. While the need for reassessment may arise in a number of ways (see para. 2.25),
systematic safety reassessments, termed periodic safety reviews (PSRs), should be
carried out by the operator at intervals to review the cumulative effects of ageing of
the facility and of modifications, and the implications of operating experience and

8
technical developments. The nature of this review and the interval between reviews
will depend on the nature of the facility and the potential magnitudes of the risks it
presents. The objective of the reviews should be to assess the facility against current
regulatory requirements and practices and to determine whether adequate arrangements
are in place to maintain its safety. When a review shows that the facility does not meet
current regulatory requirements, the significance of the shortcomings should be
assessed and possible ways of meeting the requirements should be considered. The PSR
should enable the regulatory body to judge whether it is acceptable for the facility to
continue to be operated until the next PSR is carried out.

2.20. During the operation of the facility, the outline plan for decommissioning
should be updated by the operator from time to time and reviewed by the regulatory
body in the light of operational experience, new or revised regulatory requirements
and technological developments.

Decommissioning

2.21. Decommissioning of a nuclear facility, such that regulatory controls may be

removed, includes decontamination and the dismantling and/or removal of
radioactive materials, radioactive waste, components and structures.
Decommissioning comprises: the preparation and approval of a detailed
decommissioning plan; the actual decommissioning activities; and the management
of waste arising from these activities. Just before the permanent shutdown of the
facility, a detailed plan should be prepared for authorization or approval by the
regulatory body. The decommissioning plan should be reviewed and assessed in order
to ensure that decommissioning can be accomplished safely with a progressive and
systematic reduction in radiological hazards. In those cases for which it is proposed
to defer decommissioning in whole or in part, it should be shown that there will be
no undue burden on future generations. The management of waste from
decommissioning should be a significant feature of decommissioning plans. Large
amounts of waste may be generated over short time periods, and the waste may vary
greatly in type and activity. In the review and assessment of the decommissioning
plans, it should be ensured that such waste can be managed safely.

Closure of a waste disposal facility

2.22. To enable a disposal facility to proceed beyond the operational stage to

closure, ancillary facilities should be decommissioned and the facility should be
appropriately sealed. Detailed proposals for closure and for assessment of the

9
safety of the facility in the long term should be reviewed and assessed by the
regulatory body. Particular consideration should be given to 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 facilitys design (including backfill materials,
engineered structures and the sealing arrangements); aspects of monitoring and
retrievability; and the migration of radionuclides and potential pathways.

2.23. If institutional control after closure of a waste disposal facility is deemed

necessary, the arrangements for future control, including continuing environmental
monitoring programmes, should be subject to review and assessment by the regulatory
body.

Release from regulatory control

2.24. Before an operator can be allowed to relinquish the authorization, it should be

ensured that all responsibilities and liabilities that pertain under the authorization
have been satisfactorily discharged and that there is no reasonable possibility that
any future requirement will be made on the operator. The operator should provide
evidence of this and, in particular, should demonstrate that the rehabilitated site
will not pose unacceptable radiological risks in comparison with radiological
conditions that prevailed before the facility was built. The regulatory body should
review and assess this evidence and should determine whether it adequately closes
the issues.

Reassessments

2.25. Throughout the lifetime of a facility, it may be necessary for the operator to
make a reassessment of its safety (or of an aspect of it). This reassessment could be
at the initiative of the operator or at the request of the regulatory body. The need for
reassessment may arise owing to:

Experience relevant to safety that has been gained at the facility, at similar
facilities and at other relevant nuclear and non-nuclear facilities;
Information from relevant tests and from research and development
programmes, and new knowledge of technical matters;
Proposed modifications to the facility or to the way in which it is to be managed
and operated; and
Changes in the regulatory framework, regulations and guides.

10
ORGANIZATION AND TECHNICAL RESOURCES FOR REVIEW
AND ASSESSMENT

Organization

2.26. Review and assessment are principal functions of the regulatory body. The size
and composition of the regulatory body, the number of consultants used and the use
of advisory committees should reflect the number and the size, nature and stage in the
lifetime of the facilities that it regulates. The Safety Guide on Organization and
Staffing of the Regulatory Body for Nuclear Facilities [2] gives recommendations on
the general approach to the organization of review and assessment, and the
qualifications, abilities and training necessary for personnel engaged in these
functions.

Consultants

2.27. Paragraph 4.3 of Ref. [1] establishes requirements in respect of the use of
consultants to assist the regulatory body in, among other things, the review and
assessment process. Additional considerations in relation to consultants are presented
in Ref. [2], paras 3.283.29.

2.28. In using consultants, the regulatory body should carefully define the terms of
reference for the review and assessment. The regulatory body should ensure that
consultants have a clear understanding of its safety objectives. The regulatory body
should have permanent staff with the competence to manage the work of consultants
and to evaluate the quality and results of their work. The use of consultants shall not
relieve the regulatory body of any of its responsibilities. In particular, the regulatory
bodys responsibility for making decisions and recommendations shall not be
delegated. (Ref. [1], para. 4.4.)

Advisory bodies

2.29. The functions and organization of advisory bodies are discussed in para. 4.9 of
Ref. [1] and paras 3.303.32 of Ref. [2]. Careful consideration should be given to the
establishment of one or more such bodies to provide assistance in the review and
assessment process of the regulatory body.

11
EXTERNAL RELATIONSHIPS

Relationship with the operator

2.30. The regulatory body and the operator should establish formal relations based on
independence and mutual respect. Proper channels of communication between the
operator and the regulatory body should be established. The operator, with its
responsibility for the safety of the facility, may be the only organization among those
involved in the manufacture, construction, installation, operation and safety analysis
of the facility that will have direct relations with the regulatory body. In this case, the
operator should represent all its contractors in formal dealings with the regulatory
body, including the submission of documents and attendance at meetings.

2.31. The operator should submit its documentation early enough to allow the
regulatory body to proceed in a timely manner with its review and assessment. The
regulatory body may issue general guidance on meeting requirements for
documentation. The regulatory body should have regular contacts with the operator
in order to provide detailed guidance, including guidance on the type and content of,
and timing for, documentation to be presented by the operator.

2.32. In all stages of the authorization process, the operator and the regulatory body
should continue to hold meetings to discuss topics such as the bases for proposed
changes, in advance of making formal submissions, or to discuss matters already
under consideration. A formal programme of meetings at different levels of
management may be established between the regulatory body and the operator, in
order to promote good relations and to afford the possibility of announcing possible
changes or initiatives, thus facilitating future planning. Written records should be kept
of such meetings, and of any decisions or agreements reached.

Relationship with the operators contractors

2.33 Much of the information needed by the regulatory body to perform its review
and assessment may be prepared for the operator by its contractors. These contractors
may be involved in design, manufacture, construction, installation, maintenance or
safety analysis, and may themselves have subcontractors. It should be the
responsibility of the operator to make arrangements with its contractors to ensure the
availability of all necessary information and to keep the regulatory body fully
apprised of new information and of any revisions to information submitted previously
that may be relevant to the review and assessment process. The regulatory body may
seek or may permit the participation of contractors in meetings between the
regulatory body and the operator in order to clarify issues concerning safety and to

12
facilitate the exchange of information. As review and assessment progress, it may be
necessary for the regulatory body, with the knowledge of the operator, to have direct
contact with a contractor. These contacts should not diminish the responsibility of the
operator for the safety of the facility.

Relationship with other governmental bodies

2.34. In addition to the regulatory body, other governmental bodies may participate
in the regulatory process in accordance with national legislation, regulations and
practices. The regulatory body should establish and maintain liaison throughout the
lifetime of the facility with other governmental bodies as appropriate; and it should
develop and, where practicable, formalize working procedures with such bodies,
whether at the national, regional or local level. Areas of the review and assessment in
which such bodies might participate should be identified. These bodies may include:

Environmental protection authorities;

Authorities responsible for public liability issues;
Authorities for physical protection and/or safeguards;
Authorities for planning the use of water resources and land;
Authorities responsible for public and occupational health and safety;
Fire protection authorities;
Transport authorities;
Law enforcement bodies;
Bodies with responsibilities for civil engineering structures and buildings, and
electrical and mechanical equipment;
Other bodies with responsibilities for emergency preparedness;
Other bodies with responsibilities for limits on releases of radioactive effluents.
Other regulatory authorities, particularly those performing similar functions.

2.35. The nature of the relation between the operator and other governmental bodies
should be determined by national laws, regulations and practices.

Relationship with regulatory bodies of other States and international bodies

2.36. The safety of facilities and activities is of international concern. Several

international conventions relating to various aspects of safety are in force. National
authorities, with the assistance of the regulatory body, as appropriate, shall establish
arrangements for the exchange of safety related information, bilaterally or regionally,
with neighbouring States and other interested States, and with relevant
intergovernmental organizations, both to fulfil safety obligations and to promote
co-operation. (Ref. [1], para. 4.11.)

13
2.37. There may be specific technical areas in which the regulatory body can obtain
information for use in the review and assessment process. Exchange of information
will be particularly useful whenever regulatory bodies of other States have experience
in authorizing similar facilities; it should be considered whether to set up a group of
such regulatory bodies. Sources of information and expertise include international
bodies such as the IAEA.

2.38. Specific reasons for a regulatory body to seek information include:

(1) Gaining knowledge of a novel facility to be introduced of which other States

have experience;
(2) Adding to the database of operating experience with specific facilities;
(3) Gaining knowledge of different methods of analysis, such as methods using
computer codes;
(4) Gaining knowledge of different approaches to review and assessment;
(5) Gaining knowledge of the management of the review and assessment process;
(6) Gaining knowledge of the operators contractors in another State;
(7) Obtaining information on facilities in other States which, owing to their
proximity, may have an influence on neighbouring States.

2.39. Information may be exchanged by means of meetings, transfer of documents

and visits by experts, but none of these should in any way relieve the national
regulatory body of its responsibilities for making decisions and recommendations.

3. PERFORMANCE OF THE REVIEW

AND ASSESSMENT PROCESS

GENERAL

3.1. The review and assessment process is a critical appraisal, performed by the
regulatory body, of information submitted by the operator to demonstrate the safety
of the facility. Review and assessment are undertaken in order to enable the
regulatory body to make a decision or series of decisions on the acceptability of the
facility in terms of safety. The process consists of examining the operators
submissions on all aspects relating to the safety of the facility. It should include
consideration of both normal operation and failures, and events, including human
errors, that have the potential for causing the exposure of workers or the public or
radiological hazards to the environment. This safety analysis should be as complete

14
as possible, and one of the initial tasks of the review and assessment is to confirm its
completeness. The review and assessment process should include checks on the site
and elsewhere to validate the claims made in the submissions. Operators often have
external peer reviews conducted at their facilities by national or international
organizations. The results of such reviews could provide the regulatory body with
additional insights into the activities of the operator.

INTERNAL GUIDANCE

3.2. The regulatory body should provide internal guidance on the procedures to be
followed in the review and assessment process and guidance on the safety objectives
to be met. Detailed guidance on specific topics for review and assessment should also
be provided, as necessary. Consideration should be given to the extent to which the
regulatory bodys internal guidance may be made available to operators and the
public.

REVIEW AND ASSESSMENT PLAN

3.3. The regulatory body shall prepare its own programme of review and
assessment of the facilities and activities under scrutiny. The regulatory body shall
follow the development of a facility or activity, as applicable, from initial selection of
the site, through design, construction, commissioning and operation, to
decommissioning, closure or closeout. (Ref. [1], para. 5.10.)

3.4. For regulatory efficiency, the findings of the preliminary review should be
prioritized on the basis of their potential implication for the overall safety assessment
of the facility and associated hold points in the authorization process. For regulatory
effectiveness, the review and assessment efforts should usually be focused more on
those aspects of site evaluation, design or operation which involve untested
(innovative) features.

3.5. For more important submissions by the operator (such as the safety analysis
report) it may be useful for the regulatory body to perform an acceptance review of
the documentation. As a result of this acceptance review, an application or submission
that is grossly deficient in certain areas may be returned to the operator for correction
and resubmittal.

3.6. In carrying out a review and assessment of an operators submission, the

regulatory body should employ a systematic plan to provide assurance that all topics

15
significant to safety will be covered and that operators of similar facilities will be
treated equally. This plan should include a series of procedures that the regulatory
body will follow for all aspects and topics covered by the submission in order to
identify those items for which applicable safety objectives and requirements have
been met and those for which they have not. An outline for such a plan might be as
follows:

(1) Definition of the scope of the review and assessment process;

(2) Specification of the purpose and technical bases for the review and assessment
process (these could be considered acceptance criteria);
(3) Identification of the additional information necessary for the review and
assessment;
(4) 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;
(5) Decisions on the acceptability of the operators safety arguments or the need for
further submissions.

3.7. In practice, the scope and depth of the review and assessment will depend on
several factors such as novelty, complexity, previous history, the experience of the
operator and the associated risk2. The areas on which regulatory review and
assessment should be concentrated at different stages can be considered in broad
terms. For example, while the site qualification stage is a significant stage for all
facilities, it is particularly important for waste disposal facilities.

3.8. A major feature of the operators submission will be its analysis of normal and
fault conditions3. However, the importance of the other aspects of the safety
submission should be recognized: the safety of a facility is based on sound
engineering and good management, and safety analysis is a confirmation of the
adequacy of these and not a substitute for them. The value of safety analysis is in
extending knowledge and understanding of the facility and its behaviour and in
identifying shortcomings in areas in which safety can be improved.

2 Note that for the purposes of this publication the term risk is used in the general
sense of a qualitative combination of the frequency and the consequences of a type of event.
3 Throughout this publication the term fault conditions is used to denote all situations

in which there is a deviation from the normal operational envelope or from reference conditions
resulting from postulated initiating events.

16
DOCUMENTATION TO BE SUBMITTED BY THE OPERATOR

Responsibilities of the operator

3.9. The operator should be responsible for submitting documentation in support of

its application for authorization. At each stage of the authorization process the
operator should be required to demonstrate to the satisfaction of the regulatory body
that the facility can be sited, designed, constructed, commissioned, operated,
decommissioned or closed without giving rise to undue radiological risks to workers,
the public or the environment. The nature of this information and the types of
documents containing the information will depend on the nature of the facility and the
risks it presents as well as on the applicable national requirements.

3.10. At all stages the operator should be able to demonstrate that it is in control of
the facility and has adequate organization, management, procedures and resources to
discharge its obligations and, as appropriate, its liabilities. The totality of the
documentation which the operator uses in making this demonstration, some of which
may not be in the initial formal submission, should cover all appropriate topics (see
Appendix), depending on the stage of the authorization process and the nature of the
facility.

3.11. Any modification to safety related aspects of a facility or activity (or having
an indirect but significant influence on safety related aspects) shall be subject to
review and assessment, with the potential magnitude and nature of the associated
hazard being taken into account. (Ref. [1], para. 5.11.)

Records of the operators submissions

3.12. The formal exchange of information through agreed channels of

communication is a fundamental element of the review and assessment process.
Information exchanges that may occur between the regulatory body and other
concerned parties (including other governmental bodies, the operator and its
contractors, advisory committees, consultants and, as appropriate, members of the
public) should be in written form and should be formally recorded upon receipt and
stored in a manner that allows easy retrieval. Certain formal documentation will be
required by the laws and regulations of the State or by the requirements of the
regulatory body. This documentation should be provided in a timely manner by the
operator.

3.13. Other formal submissions will be made in response to specific requests from
the regulatory body or at the initiative of the operator. The records of official meetings

17
and hearings may also constitute means for formal exchanges of information and
should also be suitably recorded and stored.

Proprietary information and confidentiality

3.14. Certain information provided by the operator or its contractors should be

considered confidential because of its proprietary nature, for security reasons or
because of the right of individuals to privacy, in accordance with national law and
regulations. Such confidential information should be made available as necessary
without restriction, to the regulatory body; that is, to its staff, consultants and
advisory committees as well as to any other governmental bodies involved in the
review and assessment process. Those to whom such information is entrusted should
be advised of its confidential nature and should be obliged, consistently with national
law and regulations, to protect its confidentiality.

BASES FOR DECISIONS

3.15. The regulatory review and assessment will lead to a series of regulatory
decisions. At a certain stage in the authorization process, the regulatory body shall
take formal actions which will result in either:

(1) The granting of an authorization which, if appropriate, imposes conditions or

limitations on the operators subsequent activities; or
(2) The refusal of such an authorization.

The regulatory body shall formally record the basis for these decisions. (Ref. [1],
para 5.5.)

3.16. The purpose of the review and assessment of the documented information
submitted by the operator is to enable the regulatory body to make a decision or a
series of decisions on the safety of the facility and its associated activities.

3.17. Decisions relating to safety should be made on the basis of the review and
assessment of the operators submissions, the studies and evaluations performed
independently by the regulatory body itself, and the safety objectives and specific
requirements established by the regulatory body. These safety objectives (see footnote
1) and regulatory requirements will themselves be founded on current knowledge as
represented by technological developments in all pertinent fields. Decisions of the
regulatory body should reflect professional judgement by technically competent

18
persons on the basis of regulatory requirements and operational experience
throughout the review and assessment process.

3.18. 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 subject to a proper and effective quality assurance
system and should be appropriately reviewed.

3.19. At many stages during the review and assessment process, decisions will be
taken on the acceptability of various aspects of the facility. The nature of these
decisions will vary during the lifetime of the facility, and some will be directly
associated with stages of the regulatory authorization process. The regulatory body
should recognize the basis for such decisions, in which a number of factors should be
taken into account. Important among these are:

(a) The extent to which the safety objectives and regulatory requirements have
been met;
(b) The acceptability of the depth and detail of the operators submission, in view
of the nature of the facility and the magnitudes of the risks it presents;
(c) The state of knowledge concerning particular processes or effects;
(d) The confidence in the conclusions reached on the basis of the analysis.

3.20. These factors are an integral part of the review and assessment process and
should be given special consideration in the documentation produced by the
regulatory body. The decisions on acceptability are taken against a background of
safety objectives, precedents and judgements, the basis for which should be clearly
understood. The decision on the safety of the facility, for example, will always be
taken in the light of a requirement to meet certain obligations. These will include, for
example, operational limits and conditions and obligations in respect of the
maintenance programme and the frequency of in-service inspection or acceptance
criteria for radioactive waste.

BASES FOR REVIEW AND ASSESSMENT

Safety objectives and requirements

3.21. At all stages of the authorization process, the regulatory body should have a
clear understanding of the safety objectives and regulatory requirements that will be

19
used in the review and assessment. The safety objectives and regulatory requirements
should be communicated to the operator for guidance in preparing its documentation.

3.22. Safety objectives and regulatory requirements should specify safety goals for
levels of performance in the protection to be achieved at the facility. The regulatory
body should refrain from prescribing specific designs, safety management systems or
operational procedures.

3.23. 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 these
objectives and requirements are to be adopted, a good understanding of their basis,
use and effectiveness in other States should be acquired by means of appropriate
contact with the relevant bodies. They should be adopted as necessary for specific
purposes.

3.24. In formulating the content and structure of the safety objectives and
requirements to be used in its review and assessment process, the regulatory body
should consider a broad range of sources, including:

(a) National laws and regulations;

(b) Advice obtained from 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 and experience 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 in respect of technologies or safety.

Public consultation is a part of the process for the establishment of safety objectives
and regulatory requirements in some States.

3.25. The safety objectives and regulatory requirements should cover, among other
things:

Prevention of faults rather than mitigation of their consequences;

Application of the principle of defence in depth;
Meeting the single failure criterion for safety related systems;
Requirements for redundancy, diversity and separation;

20
 Preference for a passive system over an active or operator based system for
prevention and protection;
Criteria relating to human factors and the humanmachine interface;
Dose limits and dose constraints (both occupational and public), amount of
discharges to the environment and ALARA considerations;
Criteria for assessing radiological risks to workers and the public;
Minimization and management of waste generated, including the future
decommissioning stage;
Emergency preparedness.

Regulations and guides

3.26. The system of regulations and guides shall be chosen so as to suit the legal
system of the State, and the nature and extent of the facilities and activities to be
regulated. Where regulations are not issued by the regulatory body, the legislative and
governmental mechanisms shall ensure that such regulations are developed and
approved in accordance with appropriate time-scales. (Ref. [1], para. 5.25.) In
developing regulations and guides, recommendations issued by international bodies
such as the IAEA and those used in other States will provide a useful reference source
and should be considered.

3.27. Regulations (mandatory) should be developed on a generic basis or on the basis

of facility type and should provide for more detailed requirements to be incorporated
into individual authorizations. In some States such mandatory requirements are
incorporated into conditions attached to the licence (Ref. [4], paras 5.115.21).

3.28. Guides, of a non-mandatory nature, on how to comply with the regulations shall
be prepared, as necessary. These guides may also provide information on data and
methods to be used in assessing the adequacy of the design and on analyses and docu-
mentation to be submitted to the regulatory body by the operator. (Ref. [1], para. 5.27.)

3.29. The regulatory body should require at all times reasonably practicable
improvements in the safety of facilities and to this end should periodically review its
regulations and guides against scientific and technological advances. The extent to
which regulations and guides should be revised will depend on their level of detail. If
safety goals and general guidance only are given, less frequent revision will be
necessary. If legal requirements are changed, this may necessitate changes to
regulations and guides.

3.30. The regulatory body might not have, in advance, detailed safety objectives and
requirements covering all the areas that are subject to review and assessment since,

21
even with a fairly comprehensive set of safety objectives and requirements, some
aspects of safety may not be covered. The regulatory body should evaluate the
acceptability of the proposals put forward by an operator case by case against general
principles. Consideration of the proposals may lead to the production of additional
regulations and guides or in the modification of existing ones.

3.31. In some instances, the operator may propose an alternative approach to that
suggested in a guide to achieving a safety objective. In such a case, the operator
should be required to demonstrate that its proposed approach will provide an
equivalent level of safety. Further details on regulations, guides and licence
conditions are provided in Ref. [4].

Comparison with regulations, guides and industrial standards

3.32. The regulatory body should establish which requirements, regulations, guides
and industrial standards are applicable to the facility in question and should determine
the requirements to be placed on the operator. Where no such requirements,
regulations, guides and industrial standards exist, the regulatory body should consider
developing them. In carrying out its review and assessment, the regulatory body
should use the applicable requirements as a reference in deciding on the acceptability
of an operators submissions.

3.33. In many cases, the applicable regulations, guides and industrial standards may
not adequately cover the full range of facilities or may not have the level of detail that
should be considered in making a decision on acceptability. The regulatory body
should produce non-mandatory guidelines. These guidelines should be made
available to the operator so that it is aware of the requirements and guides against
which it will be judged. The guidelines should cover, among other things, the
applicable requirements in terms of engineering principles and operational and
managerial aspects.

Reference (generic) submissions

3.34. Whenever submissions for a particular type of facility (or parts thereof) may be
repeated many times, it may be appropriate for an operator (or in some cases a
contractor, which may be in another State) to provide a submission for a reference
facility or a generic facility. A reference facility is a designated existing facility of
a type that is to be constructed in various other locations as well, whereas a generic
facility is a type of facility which is to be constructed with relatively minor
modifications in various locations. If the national approach provides for reference or
generic submissions to be considered, the regulatory body should apply the same

22
rigour in its review as for other submissions. However, since not all the aspects that
should necessarily be considered in the process (as discussed previously) can be dealt
with on the basis of such a submission, the regulatory body cannot grant an
authorization in the same manner as for a single, specific facility.

3.35. It would be inappropriate to give full authorization on the basis of the reference
facility or generic facility, since safety depends on such factors as siting related,
managerial and operational aspects which will only become apparent when a specific
operator requests authorization in respect of a specific site. The authorization should
be limited to the generic design, the submission of which should be followed by
supplementary submissions by the operator in respect of the specific facility.

3.36. Provided that the review and assessment by the regulatory body have been
completed satisfactorily and the regulatory body has authorized the generic facility,
the reference facility or the design, the operator should then have to make only a
limited submission for each particular facility. This limited submission should be
concentrated on those aspects in which the particular facility under consideration
differs from the reference facility or the generic facility, and in particular on those
features that are particular to the chosen location or site. In providing a limited
submission for a particular facility, the operator should clearly indicate which aspects
of the reference submission or generic submission will differ for the particular facility
and should provide an explanation of why the other aspects of this submission will
not be affected. In addition, the regulatory body, in its comments on the generic
facility or reference facility, may identify particular aspects that should be addressed
in the specific submission.

3.37. Even if 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.
It 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. It should also take into account the differences in safety objectives and
requirements between the States. The regulatory bodies of the States concerned should
establish close contact in order to facilitate the review and assessment process.

Audit calculations

3.38. The regulatory body may decide to perform a limited number of audit
calculations to check that the operator has justified a particular aspect of safety
correctly, for specific purposes such as:

(a) Identifying weaknesses, if any, in the operators safety case;

23
(b) Estimating safety margins or the degree of conservatism in the operators safety
case;
(c) Performing sensitivity analyses and uncertainty analyses in order to verify the
operators designation of the risk significance of various structures, systems
and components (SSCs);
(d) Understanding complex process couplings between engineered and natural
systems (this is particularly important for waste facilities);
(e) Verifying that the safety assessment has been maintained 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; and
(h) Extending, on a quantitative basis, the task of reviewing and assessing the
design and operation of facilities.

3.39. However, it is neither cost effective nor appropriate for the regulatory body to
conduct a complete set of calculations for every submission in the licensing process.
Performing audit calculations is very resource intensive and, if routinely practised,
could lead to an abrogation of responsibility by the operator.

VERIFICATION OF THE SAFETY ANALYSIS

General

3.40. Much effort that the regulatory body will need to expend in the review and
assessment process will be concentrated on the performance of a step by step review
and assessment procedure to determine whether the applicable safety objectives and
requirements for each aspect or topic have been met. This stage of the process
consists in examining the submissions from the operator on its managerial
arrangements, engineered systems and operational procedures and on the safety
analysis for the facilities. This safety analysis should cover both normal and fault
conditions in order to demonstrate that the safety of the facility meets the safety
objectives and requirements of the regulatory body. It should be 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. Any input of this nature by the regulatory body should in no way
compromise or diminish the operators responsibility for the safety of the facility. The
following sections deal with major aspects of such verification; further details of
topics for these aspects are set out in the Appendix.

24
3.41. In carrying out its review and assessment, the regulatory body should determine
whether the operator has defined criteria which meet the safety objectives and
requirements relating to:

(1) Engineering design;

(2) Operational and managerial aspects; and
(3) Normal operation and fault conditions.

3.42. The general aim of the regulatory review of the safety analysis report, whether
deterministic or probabilistic, is to verify that for each identified barrier to the release
of radioactive material the safety measures are sufficient to provide adequate
assurance at the following levels:

Prevention of failure of the barrier itself and prevention of failure of related

systems in normal operation and in fault conditions;
Monitoring of any parameter significant to the integrity of the barrier, to allow
the initiation of either manual or automatic actions in order to prevent any
evolution towards an unsafe condition;
Safety action to prevent or limit the release of radioactive material if the barrier
has failed;
For certain applications and depending on the associated risk, the mitigation of
consequences.

Structures, systems and components

3.43. From this analysis, the requirements on the SSCs and operations can be derived
and compared with the provisions made by the operator. The review and assessment
by the regulatory body should ensure that the operator has used the safety analysis to
determine the requirements on the SSCs and that the requirements will be met by the
equipment and in operational procedures. Specific features that should be subject to
review and assessment include:

(a) Safety functions and classification of SSCs;

(b) Quality of engineered features in terms of good engineering practice or as set
out in the regulatory requirements;
(c) Control of the facility in normal operation and in fault conditions, with account
taken of automatic systems, the humanmachine interface and operating
instructions;
(d) Quality assurance covering SSCs and operational aspects such as the training,
qualification and experience of the operators personnel and the safety
management system.

25
Organization and management

3.44. A well engineered facility may not achieve the required level of safety if it is
not managed well. Review and assessment by the regulatory body should therefore
include consideration of the operators organization, management, procedures and
safety culture, which affect nuclear, radiation, transport and radioactive waste safety
and the operation of the facility. The operator should demonstrate by documentary
means that there is an effective safety management system in place which gives
nuclear safety the highest priority.

3.45. Specific aspects which should be subject to review and assessment include the
following:

(1) Whether the operators safety policy emanates from senior management and
shows commitment at a high level to regulatory requirements and states the
means by which these will be met.
(2) Whether the operators organization is such that it can achieve the aims and
objectives in its safety policy. In particular, the following should be addressed:
Adequate control of activities at the facility
Fostering co-operation between staff members and between staff and
managers,
A satisfactory system for communication both up and down the managerial
chain and between the managers,
Systems to ensure that the staff are competent for the positions assigned to
them.
(3) Whether the operator 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.
(4) Whether the operator 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.
(5) Whether the operator 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.

3.46. The review and assessment by the regulatory body should cover all aspects of
the operators managerial and organizational procedures and systems which have a

26
bearing on nuclear safety, such as: feedback of operational safety experience; the
development of operational limits and conditions; the planning and monitoring of
maintenance, inspection and testing; the production and revision of safety
documentation; and the control of contractors (see the Appendix for further details).
The regulatory body should also review and assess the operators procedures for the
control and justification of changes to the operators managerial and organizational
procedures and systems which could have an impact on nuclear safety.

Operational safety performance

3.47. The regulatory body should review reports submitted periodically by the
operating organization, in compliance with established requirements, so as to monitor
the operational safety performance of the facility. Additionally, reports on safety
significant events should be thoroughly reviewed by the regulatory body. The
regulatory body should ensure that an effective system for the feedback of operational
safety experience is in place, that no safety related event will go undetected and that
corrective measures will be adopted to prevent the recurrence of safety related events.
If the severity of the event warrants it, the regulatory body may conduct or arrange
for an 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 the corrective and remedial actions taken were
adequate. The regulatory bodys review should cover the identification of lessons to
be learned and the sharing of safety related information.

Radiological consequences in normal conditions

3.48. The assessment of routine operation is directed towards the determination of

occupational radiation doses and radioactive discharges. These consequences will be
compared with those safety objectives, requirements and limits approved by the
regulatory body, including applying the as low as reasonably achievable (ALARA)
principle. In the regulatory review and assessment of the operators submission, it
should be determined whether the submission meets these objectives and
requirements. In the review and assessment, particular attention should be devoted to
a number of factors that influence the potential radiological consequences for
workers, the public and the environment in routine operation, which include:

(1) Sources and inventory;

(2) The occupational radiation protection programme and other matters relating to
radiation protection;
(3) Radiation protection of the public, with all pathways of exposure taken into
account;

27
(4) Radioactive waste management;
(5) Discharge, dilution and dispersion of radioactive effluents.

3.49. In considering these items, the regulatory body should satisfy itself that
radiation doses to workers and the public and radioactive releases to the environment
are acceptable. Specifically, review and assessment should ensure that:

(1) The operational limits and conditions and the bases for these have been
determined;
(2) The potential radiological consequences at the upper limits of this range have
been considered;
(3) It has been demonstrated that arrangements (including operating procedures)
which apply the ALARA principle are in place.

3.50. The regulatory body should at all times require reasonably achievable
improvements to be made in the design or operating procedures of the facility with
the aim of reducing potential radiological consequences.

Safety analysis of fault conditions

3.51. The consideration of fault conditions strongly influences the design limits for
the safety systems and for most SSCs needed for the operation of the facility [8]. It
will also strongly influence the operational instructions and procedures that operating
personnel should follow. In addition, the potential radiological consequences for
workers, the public and the environment of fault conditions may be much more severe
than those in routine operation. For this reason, the major part of the review and
assessment effort should be directed to the safety analysis of fault conditions
provided by the operator. It should be performed in accordance with the potential
magnitude and nature of the risks associated with the particular facility. Safety
analysis can be considered to consist of two major steps:

(1) Identification of postulated initiating events (PIEs) and their frequencies;

(2) Evaluation of how these PIEs develop and their consequences.

3.52. For post-closure performance assessment of the waste disposal facilities,

consideration should be given to all significant features, events and processes that
may affect the performance of the facility. A complete list of features, events and
processes should be developed and criteria (with technical bases) for screening the
features, events and processes should be clearly defined. Scenarios to be considered
for performance assessment should logically follow from the features, events and
processes selected for consideration.

28
Identification of PIEs

3.53. The identification of the PIEs which should be taken into account in the safety
analysis is the first step in the review and assessment process. The method used
should be systematic and auditable. Moreover, as complete as possible a listing of
PIEs should be provided. An important feature of the review and assessment process
should be considering whether the operators method of identification meets these
requirements and whether the operators list of PIEs is acceptable as the basis for the
safety analysis.

3.54. PIEs can be grouped in various ways. One commonly used method is to
separate them into:

(a) External hazards, which are outside the control of the operator and may result
from natural or human made causes such as a seismic event, an aircraft crash
or an explosion of flammable liquid gas in transport.
(b) Internal faults that result from inherent failures of the facility, such as
mechanical or electrical failures or loss of services.
(c) Internal hazards such as fire or spillage of corrosive material resulting from
failures of systems that are within the operators control but are not directly
considered in the review and assessment process.

Consideration should also be given to human errors, which may be initiators in their
own right or may exacerbate a fault.

3.55. It is usual to classify the PIEs relating to internal faults according to the
initiating frequencies of the PIEs and their potential consequences. The purpose of
such a classification is to help decide on the type and level of analysis that should be
undertaken. The regulatory body should decide on which type of classification of
PIEs it requires the operator to provide information so that it can decide whether its
safety objectives and requirements have been met. The nature of the facility and the
potential magnitudes of the risks it presents will influence these requirements, as well
as the depth and level of detail of the subsequent analysis.

3.56. A typical PIE classification, based on initiating frequency, would be used to

determine the following:

(a) PIEs that are of high likelihood, which should be analysed to show that the facility
has a robust tolerance for them owing to the provision of safety systems or an
inherent behaviour tending (i) to restore a safe state, (ii) to prevent the release of
radioactive material or (iii) to limit any such release to an acceptably low level.

29
(b) PIEs that are of low likelihood but that have severe potential consequences such
that the facility should have safety systems in place to prevent the release of
radioactive material or to limit any release to an acceptable level.

PIEs which do not fall into these two groups should also be analysed to determine
whether in totality they make an unacceptable contribution to the total risk, whether the
PIEs in the classes defined are at a threshold for the rapid escalation of consequences
(cliff edge effects), and whether the emergency arrangements are adequate.

Analysis of PIEs

3.57. The regulatory body should determine the type of analytical considerations and
assumptions that will apply in its review and assessment of the operators analysis,
and should check whether these have been taken into account. For those PIEs that
may affect the design and provision of safety systems, or may affect the requirements
for engineering SSCs, sufficient safety margins may be required in the analysis to
meet the requirement of demonstrating that the safety of the facility is robust. This
part of the safety analysis should be coupled with consideration of the engineering
and operational practices. The regulatory body, as part of its review and assessment,
should ensure that all claims made in the safety analysis for the performance of such
systems are met in practice. Similarly, the engineering systems should be qualified to
meet the functional requirements for which they were designed: for all situations and
at all times, with ageing and environmental conditions taken into account.

3.58. The analyses of fault conditions and long term safety should usually be
performed by using computer codes. Regulatory review and assessment should
include a check that any data, modelling or computer codes used in making
calculations in relation to either the performance of equipment under the conditions
indicated by the analysis or any radiological consequences are based on sufficiently
well founded knowledge and understanding, and that an adequate degree of
conservatism has been included. As part of its review and assessment, the regulatory
body should ensure that the computer codes are based on well understood principles.
Computer codes should be validated against experience or experiment to confirm that
the coding has been done accurately and the input data have been correctly assigned.
In many cases the codes will already have been used widely both nationally and
internationally, and thus it will be possible to consider their verification and validity
on a generic basis. However, checks should be made to ensure that the code has not
been corrupted by modifications and is being used in an appropriate manner.

3.59. As a complement to the deterministic approach, the regulatory body should

require an evaluation of the risks arising from the facility. A common method of

30
providing such an evaluation is for the operator to perform a probabilistic safety
assessment4 (PSA). Probabilistic safety assessment provides a comprehensive,
structured approach to identifying failure scenarios and the corresponding damages
to the facility, and, as a last step, to deriving numerical estimates of the risks to
workers, the public and the environment. Likewise, PSA offers a systematic approach
to determining whether the reliability and independence of safety systems are
adequate for checking defence in depth provisions [9] and assessing whether the risks
are ALARA. It is usual in such analyses to make less conservative assumptions and
to consider best estimate values.

3.60. The regulatory body should review and assess the PSA in order to gain
confidence that it has been carried out according to an acceptable standard so that the
results can be used as input to the regulatory decision making process. For additional
details on the capabilities and limitations of the methods of PSA, see Ref. [10]. In the
review and assessment, it should be considered: whether the data used in estimating
frequencies and probabilities are sufficiently well founded; whether the treatment of
supporting systems, dependent failures and human intervention is appropriate;
whether the bounding of PIEs into groups for analysis, if used, is sound; whether the
identification of failure scenarios is comprehensive; and whether the analyses of the
facilitys response and consequences are acceptable. In some circumstances it may be
appropriate to estimate the risk in a more qualitative manner using principles based
on good operational or engineering practices, and for disposal facilities on the
consideration of long term natural phenomena. The PSA should include a
consideration of the sensitivity of the results to uncertainties in data and modelling
and of the importance of individual events in the progression of the failure scenarios.

3.61. The insights gained from PSA should be considered together with those from
other analyses in making a decision on the acceptability of the safety of a facility. An
important aspect of PSA is that, apart from giving an estimate of risks, it also provides
information on whether the design is balanced, on the interaction between design
features of the facility, and on where there are weaknesses. These additional aspects
should be given due consideration by a regulatory body reviewing a PSA.

3.62. It has been emphasized previously that in the regulatory review and assessment
it should be verified that the claims made in the operators submissions are accurate.
In the consideration of the safety analysis, these checks should cover the manner in

4 For waste disposal facilities, probabilistic risk assessment (PRA) is a more commonly

used term.

31
which operations are carried out, the range of normal operational modes, the
availability of standby equipment and personnel, and the performance of major items
of equipment. These checks should also ensure that the identification of faults and
hazards has been accurate, since some possibilities of common mode effects or causes
those due to internal hazards, for example may not be apparent until the
physical layout is observed. The layout may also limit the degree of operator
intervention if systems are difficult to access owing to their position. In considering
this aspect, the fact that access by the operator may be necessary because of another
fault condition should be taken into account.

REGULATORY INSPECTION FOR REVIEW AND ASSESSMENT

3.63. Although a fundamental feature of the review and assessment process is the
consideration by the regulatory body of the documentation provided by the operator,
the regulatory body should also verify claims made in the documentation, as a
necessary part of the process, by means of and inspections of the facility. Such
verification should be carried out by specialists at all stages of the authorization
process. These inspections will also allow the regulatory body to supplement the
information and data needed for review and assessment. Additionally, the regulatory
body will be able to extend its practical understanding of managerial, engineering and
operational aspects involved and foster links with specialists in the operating
organization. Where the operator fulfils some central functions away from the facility,
the regulatory body should also visit the relevant parts of the operating organization.
The staff of the regulatory body who carry out review and assessment shall have the
right to visit, or to designate others to visit on their behalf, the operators site and, if
necessary, to visit contractors establishments with the knowledge of the operator.
Such visits may provide a good opportunity to access the adequacy and effectiveness
of the quality assurance systems of the operator, the manufacturers and the suppliers.

3.64. It may be useful for the operator to arrange for those preparing, or involved in,
complex submissions to make presentation(s) to key regulatory assessors highlighting
the main technical issues raised and the analytical techniques used in the submissions.

RECORDS OF THE REGULATORY BODYS REVIEW AND ASSESSMENT

3.65. The review and assessment process will invariably involve the production of
reports by various experts in the regulatory body and by any consultants employed.
A document control system should be set up for keeping records of the process so as
to allow such documents and records to be readily retrieved. It should be possible to

32
access the bases for previous decisions so as to achieve consistency and to facilitate
any reassessment made necessary by new information.

DOCUMENTATION PRODUCED BY THE REGULATORY BODY

3.66. Review and assessment should result in a decision on the acceptability of the
safety of the facility which may be connected to a stage 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 activity authorized (Ref. [4],
paras 5.35.5). Typically, the following topics should be covered:

Reference to the documentation submitted by the operator;

The basis for the evaluation;
The evaluation performed;
Comparison with regulatory requirements, regulations and guides;
Comparison with another similar (reference) facility where appropriate;
Independent analysis performed by the regulatory bodys staff, or by
consultants or dedicated support organizations on its behalf;
Conclusions with respect to safety;
Additional requirements to be fulfilled by the operator.

RESEARCH AND DEVELOPMENT INITIATED

BY THE REGULATORY BODY

3.67. The regulatory body may find that there are aspects of regulated facilities which
are insufficiently understood. This may apply to existing or to future facilities. These
aspects may involve, among other things, modelling techniques, processes or fault
progression. The regulatory body should encourage the operator (or operators, if
similar facilities exist or are planned) to carry out the necessary research and
development work to extend understanding of safety related issues. The regulatory
body should not accept a safety submission which is not supported by sufficient
technical arguments and, if necessary, it should require from the operator a
justification of the assumptions made and data used by means of additional studies.

3.68. The regulatory body may decide to initiate research and development work
where it considers that there is a need for additional studies beyond those undertaken
by the operator. There may also be situations in which the regulatory body requires
independent research and development work so that it can apply suitable critical
considerations in its review and assessment. For example, if the operator offers a

33
novel solution to a technical problem, in the form of either hardware or analysis, the
regulatory body may conduct or contract independent research, or produce an
independent interpretation of research findings, to validate and verify the approach.
To ensure that the research and development work is carried out independently of the
operator, the regulatory body should consider taking steps to ensure that sources of
technical support are maintained which do not have direct contacts with the operator,
in view of the fact that the operator itself may also be using outside organizations.

4. MONITORING OF THE REVIEW AND ASSESSMENT

PROCESS

4.1. The regulatory body should ensure that the findings and decisions of the review
and assessment process are subjected to a suitable process of peer review conforming
to the national practices of the State and the overall quality assurance system of the
regulatory body. The regulatory body should document the findings of its review and
assessment and should make them available to the operator and others in accordance
with national practice. Further information is provided in Ref. [4].

4.2. The regulatory body should have a system to audit, review and monitor all
aspects of its review and assessment process so as to ensure that it is being carried out
in a suitable and efficient manner and that any changes to the process necessitated by
advances in knowledge or improvements in methods or for similar reasons are
implemented. This system should cover, among other things:

(a) Regulations and guides;

(b) Procedures for assessment within the regulatory body;
(c) Procedures for contact with the operator;
(d) Availability of suitable staff for review and assessment;
(e) Procedures for using consultants and advisory committees in the process;
(f) Procedures for commissioning and evaluating research initiated by the
regulatory body;
(g) Records of documentation;
(h) Production, recording and dissemination of the results of reviews and
assessments.

34
 Appendix

TOPICS TO BE COVERED BY REVIEW AND ASSESSMENT

A.1. This appendix provides a generic list of topics that should be considered in the
review and assessment process throughout the lifetime of the facility, 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 covered. Also, depending on the facility and on the particular stage of the
facilitys lifetime, some topics will be more important than others, and the degree of
detail necessary in the review and assessment may vary.

THE PHYSICAL NATURE OF THE FACILITY AND ITS ENVIRONMENT

A.2. The following information on the facility and on the processes conducted
should be provided by the operator at various stages and used as a basis for review
and assessment:

(a) A detailed description of the facility, supported by drawings of the layout, the
systems and the equipment;
(b) Information on the functional capability of the facility, its systems and major
items of equipment (including waste management systems and radiation
protection systems and equipment);
(c) The findings of tests which validate the functional capability;
(d) The results of inspections of components;
(e) Maintenance records;
(f) A description of the present physical condition of SSCs 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 shops;
(h) Geological, hydrogeological and meteorological conditions; and
(i) A description of off-site characteristics, including population densities, land
use, industrial developments (including pipelines) and transport arrangements
(such as airports, roads and railways).

INFRASTRUCTURAL ASPECTS

A.3. Throughout the lifetime of any facility, the operator will have to propose and
implement arrangements for waste management. The regulatory body should review

35
and assess proposals for on-site treatment 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, the applicable waste acceptance
requirements for subsequent steps in waste management and regulatory requirements.
Specifically, the regulatory body should satisfy itself that the waste or waste
packages:

Are properly characterized and compatible with the anticipated nature and
duration of storage pending disposal;
Can be subjected to regular surveillance; and
Can be retrieved for further steps in predisposal waste management.

A.4. Adequate arrangements should be made for the transport of radioactive material
and 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

A.5. Throughout the lifetime of the facility, the regulatory body should review and
assess the information on the facility provided by the operator, and in particular
information covering:

(a) A compilation of the safety analysis and its assumptions;

(b) SSCs important to safety;
(c) Limits and permitted operational states;
(d) Anticipated operational occurrences;
(e) PIEs for the safety analyses:
External hazards (floods, seismic events, aircraft crashes, explosions of gas
or liquid)
Internal faults (mechanical or electrical failures)
Internal hazards (fires, spillages of corrosive material);
(f) List of features, events and processes:
List of barriers with their relative contributions
A description of how requirements for defence in depth are met
Anticipated activities for confirmation of performance;
(g) Analytical methods and computer codes used in the safety analysis and the
verification and validation of such codes;
(h) Radioactive releases and radiation exposures in normal operation and fault
conditions;

36
(i) The operators safety criteria for analyses of operator actions, common cause
events, cross-link effects, the single failure criterion, redundancy, diversity and
separation.

A.6. The impacts of the facility on its surroundings should be assessed. Social 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 fault conditions, which are the subject of safety
analysis, should be considered.

THE OPERATING ORGANIZATION AND THE MANAGEMENT SYSTEM

A.7. At all stages of the facilitys lifetime, the operator should demonstrate that:

(a) It will be in control of the facility;

(b) It has an adequate safety management system to be able to manage and control
the facility;
(c) It has resources available to meet its obligations and liabilities in connection
with an authorization.

It should be noted that for some facilities (notably waste disposal facilities) this
demonstration may need to apply to an extended period, perhaps covering several
generations, over which control should be maintained.

A.8. The information that the operators should provide to the regulatory body for
review and assessment should include:

(1) Details of the structure of the operating organization, showing that it has
adequate control over the activities of its own staff and its contractors;
(2) A demonstration of the adequacy of resources in terms of appropriately trained
and experienced staff, ensuring in-house expertise;
(3) A demonstration of the adequacy of the procedures for controlling changes to
the organizational structure and resources;
(4) The specification and documentation of the duties of staff, demonstrating the
integration of responsibilities for safety into their duties;
(5) A demonstration of the provision of, or access to, a high level of expertise in
safety to carry out safety and engineering analysis and to perform associated
audit and review functions;

37
(6) A demonstration of the adequacy of the provisions for financing continuing
liabilities and decommissioning; and
(7) Any proposals for the use of contractors.

A.9. The operator should demonstrate an overall system for the management of
safety whereby all activities are controlled so as to provide an assurance that
requirements for quality assurance, safety and protection of the environment will be
met. This will include having operational procedures in place.

A.10. The operator should demonstrate that it has:

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

(b) A policy which states that demands of safety takes 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 operational experience to the staff, including
experience relating to organizational and management failures;
(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;
(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 that take account of absences,
shift working and overtime restrictions;
(m) Qualified staff available and on duty at all times;
(n) Systematic and validated methods for the selection of staff, including testing
for aptitude, knowledge and skills;
(o) Programmes for initial, refresher and upgrade training, including the use of
simulators;
(p) Training in safety culture, particularly for managers;
(q) Programmes for the feedback of operational experience relating to failures in
human performance;
(r) Guidelines on fitness for duty in relation to hours of work, health and substance
abuse;
(s) Competence requirements for operating, maintenance, and technical and
managerial staff;

38
(t) A system for consideration of the humanmachine interface and its design and
for the analysis of human information needs and task workload for the control
room and other work stations.

OPERATIONAL PROCEDURES

A.11. The operator should demonstrate that it has produced or obtained:

(1) Formal approval and documentation for all safety related procedures;
(2) A formal system for modification of a procedure;
(3) Understanding and acceptance of the procedures by management and on-site staff;
(4) Verification that the procedures are followed;
(5) Procedures that are adequate in comparison with international good practice;
(6) Arrangements for regular review and if necessary revision of the procedures;
(7) Clear procedures in which principles relating to human factors have been taken
into account;
(8) Procedures which comply with the assumptions and findings of the safety
analysis and with experience from design and operation; and
(9) Adequate emergency operating procedures.

EQUIPMENT QUALIFICATION

A.12. The operator should provide:

(a) A list of equipment covered by the equipment qualification programme 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 from it to ensure that ageing degradation of
qualified equipment remains insignificant;
(g) Documentation of an analysis of the effects of equipment failure on the
qualification of equipment not covered by the equipment qualification
programme;

39
(h) A list of appropriate corrective actions to maintain equipment qualification;
(i) Information on means of protection of qualified equipment from adverse
environmental conditions;
(j) Information on the physical integrity and functionality of qualified
equipment;
(k) Records of all qualification measures taken over the installed lifetime of
equipment.

MANAGEMENT OF AGEING

A.13. The operator should provide a programme for the management of ageing of
equipment that covers:

(1) Documented methods and criteria for identifying SSCs covered by the ageing
management programme;
(2) A list of SSCs covered by the ageing management programme and records
which provide information for use in the management of ageing;
(3) An evaluation and documentation of potential ageing related degradation that
may affect the safety functions of SSCs;
(4) Details of the extent of understanding of the dominant mechanisms of ageing
for SSCs;
(5) Details of the programme for the timely detection and mitigation of ageing
processes and/or ageing effects;
(6) Acceptance criteria and required safety margins for SSCs;
(7) Awareness of the physical condition of SSCs, including actual safety margins.

OPERATORS SAFETY PERFORMANCE

A.14. The operating organization should provide details of:

(1) The system used for identifying and classifying safety related incidents;
(2) The arrangements made for root cause analysis of incidents, the lessons learned
and the follow-up measures taken;
(3) Methods for selecting and recording safety related operational data, including
those for maintenance, testing and inspection;
(4) Trend analyses of safety related operational data;
(5) Feedback of safety related operational data into the operating regime, including
records and reports of incidents and accidents;
(6) Analyses of safety performance indicators such as:

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 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 faults, administrative
matters, control matters)
Backlog of outstanding maintenance
Extent of repeat maintenance
Extent of corrective maintenance including repair and replacement
Frequency of unplanned operator actions in relation to safety and their
success rate
Amounts of radioactive waste generated
Quantities of radioactive waste in storage;
(7) Records of radiation doses to persons on the site;
(8) Records of off-site contamination and data from radiation monitoring for the
site;
(9) Records of quantities and relevant characteristics of radioactive waste
generated and stored in the facility;
(10) Records of the quantities of radioactive effluents discharged.

EXPERIENCE FROM OTHER FACILITIES AND RESEARCH FINDINGS

A.15. The operator should provide information on its arrangements for:

(a) Feedback of experience relevant to safety from similar facilities and from other
nuclear and non-nuclear facilities;
(b) Assessing this experience and taking action on the basis of it;
(c) Determining the need for research and development;
(d) Obtaining information on the findings of relevant research programmes;
(e) Assessing research information and taking action on the basis of it.

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 REFERENCES
[1] INTERNATIONAL ATOMIC ENERGY AGENCY, Legal and Governmental
Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety
Standards Series No. GS-R-1, IAEA, Vienna (2000).
[2] INTERNATIONAL ATOMIC ENERGY AGENCY, Organization and Staffing of the
Regulatory Body for Nuclear Facilities, Safety Standards Series No. GS-G-1.1, IAEA,
Vienna (2002).
[3] INTERNATIONAL ATOMIC ENERGY AGENCY, Regulatory Inspection of
Nuclear Facilities and Enforcement by the Regulatory Body, Safety Standards Series
No. GS-G-1.3, IAEA, Vienna (2002).
[4] INTERNATIONAL ATOMIC ENERGY AGENCY, Documentation for Use in
Regulating Nuclear Facilities, Safety Standards Series No. GS-G-1.4, IAEA, Vienna
(2002).
[5] INTERNATIONAL ATOMIC ENERGY AGENCY, Site Evaluation for Nuclear
Facilities, Safety Standards Series No. NS-R-3, IAEA, Vienna (to be published).
[6] INTERNATIONAL ATOMIC ENERGY AGENCY, External Human Induced Events in
Site Evaluation for Nuclear Power Plants, Safety Standards Series No. NS-G-3.1, IAEA,
Vienna (2002).
[7] INTERNATIONAL ATOMIC ENERGY AGENCY, Dispersion of Radioactive Material
in Air and Water and Consideration of Population Distribution in Site Evaluation for
Nuclear Power Plants, Safety Standards Series No. NS-G-3.2, IAEA, Vienna (2002).
[8] INTERNATIONAL ATOMIC ENERGY AGENCY, Safety Assessment and Verification
for Nuclear Power Plants, Safety Standards Series No. NS-G-1.2, IAEA, Vienna (2001).
[9] INTERNATIONAL NUCLEAR SAFETY ADVISORY GROUP, Defence in Depth in
Nuclear Safety, INSAG Series No. 10, IAEA, Vienna (1996).
[10] INTERNATIONAL NUCLEAR SAFETY ADVISORY GROUP, Probabilistic Safety
Assessment, Safety Series No. 75-INSAG-6, IAEA, Vienna (1992).

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 GLOSSARY

assessment. The process, and the result, of analysing systematically the hazards
associated with sources and practices, and associated protection and safety
measures, aimed at quantifying performance measures for comparison with
criteria.

authorization. The granting by a regulatory body or other governmental body of

written permission for an operator to perform specified activities. Authorization
could include, for example, licensing, certification, registration, etc.

closure. Administrative and technical actions directed at a repository at the end of its
operating lifetime e.g. covering of the disposed waste (for a near surface
repository) or backfilling and/or sealing (for a geological repository and the
passages leading to it) and termination and completion of activities in any
associated structures.

commissioning. The process during which systems and components of facilities,

having been constructed, are made operational and verified to be in accordance
with the design and to have met the required performance criteria.

decommissioning. Administrative and technical actions taken to allow the removal

of some or all of the regulatory controls from a facility (except for a repository
which is closed and not decommissioned).

inspection. An examination, observation, measurement or test undertaken to assess

structures, systems, components and materials, as well as operational activities,
processes, procedures and personnel competence.

licence. A legal document issued by the regulatory body granting authorization to

perform specified activities related to a facility or activity.

operational limits and conditions. A set of rules setting forth parameter limits, the
functional capability and the performance levels of equipment and personnel
approved by the regulatory body for safe operation of an authorized facility.

operator (operating organization). Any organization or person applying for

authorization or authorized and/or responsible for nuclear, radiation, radioactive
waste or transport safety when undertaking activities or in relation to any
nuclear facilities or sources of ionizing radiation. This includes, inter alia,

43
 private individuals, governmental bodies, consignors or carriers, licensees,
hospitals, self-employed persons, etc.

postulated initiating event (PIE). An event identified during design as capable of

leading to anticipated operational occurrences or accident conditions. The
primary causes of postulated initiating events may be credible equipment
failures and operator errors (both within and external to the facility), human-
induced or natural events.

regulatory body. An authority or a system of authorities designated by the

government of a State as having legal authority for conducting the regulatory
process, including issuing authorizations, and thereby regulating nuclear,
radiation, radioactive waste and transport safety.

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 CONTRIBUTORS TO DRAFTING AND REVIEW

Almeida, C. Comisso Nacional de Energia Nuclear, Brazil

Kim, Jin-Hong International Atomic Energy Agency

Karbassioun, A. International Atomic Energy Agency

Ranguelova, V. International Atomic Energy Agency

Vaughan, G.J. Health and Safety Executive, United Kingdom

Weedon, C.J. Environment Agency, United Kingdom

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 BODIES FOR THE ENDORSEMENT
OF SAFETY STANDARDS

Nuclear Safety Standards Committee

Argentina: Sajaroff, P.; Belgium: Govaerts, P. (Chair); Brazil: Salati de Almeida, I.P.;
Canada: Malek, I.; China: Zhao, Y.; Finland: Reiman, L.; France: Saint Raymond,
P.; Germany: Wendling, R.D.; India: Venkat Raj, V.; Italy: Del Nero, G.; Japan:
Hirano, M.; Republic of Korea: Lee, J.-I.; Mexico: Delgado Guardado, J.L.;
Netherlands: de Munk, P.; Pakistan: Hashimi, J.A.; Russian Federation: Baklushin,
R.P.; Spain: Mellado, I.; Sweden: Jende, E.; Switzerland: Aberli, W.; Ukraine:
Mikolaichuk, O.; United Kingdom: Hall, A.; United States of America: Murphy, J.;
European Commission: Gmez-Gmez, J.A.; IAEA: Hughes, P. (Co-ordinator);
International Organization for Standardization: dArdenne, W.; OECD Nuclear
Energy Agency: Royen, J.

Waste Safety Standards Committee

Argentina: Siraky, G.; Australia: Williams, G.; Belgium: Baekelandt, L. (Chair);

Brazil: Schirmer, H.P.; Canada: Ferch, R.; China: Xianhua, F.; Finland: Rukola, E.;
France: Averous, J.; Germany: von Dobschtz, P.; India: Gandhi, P.M.; Israel:
Stern, E.; Japan: Irie, K.; Republic of Korea: Suk, T.; Netherlands: Selling, H.;
Russian Federation: Poluehktov, P.P.; South Africa: Pather, T.; Spain: Gil Lpez, E.;
Sweden: Wingefors, S.; Ukraine: Bogdan, L.; United Kingdom: Wilson, C.; United
States of America: Wallo, A.; IAEA: Hioki, K., (Co-ordinator); International
Commission on Radiological Protection: Valentin, J.; International Organization for
Standardization: Hutson, G.; OECD Nuclear Energy Agency: Riotte, H.

Commission on Safety Standards

Argentina: DAmato, E.; Brazil: Caubit da Silva, A.; Canada: Bishop, A., Duncan,
R.M.; China: Zhao, C.; France: Lacoste, A.-C., Gauvain, J.; Germany: Renneberg,
W., Wendling, R.D.; India: Sukhatme, S.P.; Japan: Suda, N.; Republic of Korea: Kim,
S.-J.; Russian Federation: Vishnevskij, Yu.G.; Spain: Martin Marqunez, A.; Sweden:
Holm, L.-E.; Switzerland: Jeschki, W.; Ukraine: Smyshlayaev, O.Y.; United
Kingdom: Williams, L.G. (Chair), Pape, R.; United States of America: Travers, W.D.;
IAEA: Karbassioun, A. (Co-ordinator); International Commission on Radiological
Protection: Clarke, R.H.; OECD Nuclear Energy Agency: Shimomura, K. (Co-ordi-
nator); International Commission on Radiological Protection: Clarke, R.H.; OECD
Nuclear Energy Agency: Shimomura, K.

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