IAEA

SAFETY
STANDARDS
SERIES

Documentation for
Use in Regulating
Nuclear Facilities

SAFETY GUIDE
No. GS-G-1.4
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 IAEA’s 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 IAEA’s 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.
DOCUMENTATION FOR
USE IN REGULATING
NUCLEAR FACILITIES
 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
CÔTE D’IVOIRE 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 Agency’s Statute was approved on 23 October 1956 by the Conference on the Statute of the
IAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957. The
Headquarters of the Agency are situated in Vienna. Its principal objective is “to accelerate and enlarge the
contribution of atomic energy to peace, health and prosperity throughout the world’’.
© IAEA, 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/1132
SAFETY STANDARDS SERIES No. GS-G-1.4

DOCUMENTATION FOR
USE IN REGULATING
NUCLEAR FACILITIES
SAFETY GUIDE

INTERNATIONAL ATOMIC ENERGY AGENCY

VIENNA, 2002
VIC Library Cataloguing in Publication Data
Documentation for use in regulating nuclear facilities : safety guide. — Vienna
: International Atomic Energy Agency, 2002.
p. ; 24 cm. — (Safety standards series, ISSN 1020–525X ; no. GS-G-1.4)
STI/PUB/1132
ISBN 92–0–113702–8
Includes bibliographical references.
1. Nuclear facilities — Law and legislation. 2. Nuclear facilities —
Safety regulations. I. International Atomic Energy Agency. II. Series.
VICL 02–00290
 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 State’s 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 IAEA’s 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
site evaluation for or the 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 (1.1–1.3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Objective (1.4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Scope (1.5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Structure (1.6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2. OVERVIEW OF DOCUMENTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

General (2.1–2.5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Legal framework (2.6–2.8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
System of regulations and guides (2.9–2.22) . . . . . . . . . . . . . . . . . . . . . . 4
Industrial standards (2.23–2.24) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Documents produced by the operator (2.25–2.26) . . . . . . . . . . . . . . . . . . 7
Internal guidance and procedures of the
regulatory body (2.27–2.29) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3. REGULATIONS AND GUIDES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

General (3.1–3.16) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Process for developing regulations and guides (3.17–3.27) . . . . . . . . . . . 12
Review and revision of regulations and guides (3.28–3.31) . . . . . . . . . . 16

4. DOCUMENTS TO BE PRODUCED BY THE OPERATOR . . . . . . . . . . 17

General (4.1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Documents to be submitted for the authorization process (4.2–4.8) . . . . 17
Reporting by the operator (4.9–4.16) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Records to be kept by the operator (4.17–4.23) . . . . . . . . . . . . . . . . . . . . 21

5. DOCUMENTS PRODUCED FOR A PARTICULAR FACILITY

BY THE REGULATORY BODY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

General (5.1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Results of review and assessment (5.2–5.5) . . . . . . . . . . . . . . . . . . . . . . . 23
Records of inspection activities (5.6–5.7) . . . . . . . . . . . . . . . . . . . . . . . . 24
Records of enforcement actions (5.8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Licence document (5.9–5.21) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
 Document control (5.22–5.23) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Review of the documentation system (5.24–5.26) . . . . . . . . . . . . . . . . . . 30

APPENDIX: THE AUTHORIZATION PROCESS . . . . . . . . . . . . . . . . . . . . . . 33

General (A.1–A.4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Significant regulatory decisions (A.5–A.6) . . . . . . . . . . . . . . . . . . . . . . . . 33
Approval of the site (A.7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Authorizing construction, manufacture and installation (A.8) . . . . . . . . . 34
Authorizing commissioning (A.9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Authorizing operation (A.10–A.13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Authorizing modifications (A.14) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Authorizing decommissioning or closure (A.15–A.16) . . . . . . . . . . . . . . . 36

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . . . . 41
BODIES FOR THE ENDORSEMENT OF SAFETY STANDARDS . . . . . . . 42
 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 governmen-
tal infrastructure, including a regulatory body with clearly defined responsibilities
and functions. The process of regulating a nuclear facility entails the preparation of a
large amount of documentation, both by the operator of the facility and by the regu-
latory 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 a regulatory infrastructure for nuclear facilities.
These include requirements in respect of documentation to be produced by the
operator or by the regulatory body at the various stages of the authorization
process.

1.3. Four interrelated IAEA Safety Guides provide recommendations on satisfying

the requirements concerning particular responsibilities and functions of the regula-
tory body in the regulation of nuclear facilities. The present Safety Guide addresses
documentation relating to the regulatory process; three related Safety Guides cover,
respectively, the organization and staffing of the regulatory body [2], regulatory
review and assessment [3], and regulatory inspection and enforcement [4].

OBJECTIVE

1.4. The purpose of this Safety Guide is to provide recommendations for regulatory
bodies and operators on the documentation to be prepared for regulatory processes for
nuclear facilities, and on how to ensure that such documentation is of sufficient
quality and provides correct information in an appropriate way to serve its intended
purpose.

SCOPE

1.5. This Safety Guide covers the documentation required in the regulatory process
for nuclear facilities such as enrichment plants and fuel manufacturing plants, nuclear

1
power plants, other reactors such as research reactors and critical assemblies, spent
fuel reprocessing plants, and radioactive waste management facilities such as
treatment, storage and disposal facilities. This Safety Guide also covers issues
relating to the decommissioning (or closure) of nuclear facilities.

STRUCTURE

1.6. Section 2 presents an overview of documentation and Section 3 covers aspects

of regulations and guides. Sections 4 and 5 cover documents to be produced by the
operator and by the regulatory body, respectively. The appendix provides an outline
of the authorization process.

2. OVERVIEW OF DOCUMENTATION

GENERAL

2.1. Certain formal documents will be required for the regulatory process by the
laws and regulations of the State or by the rules of the regulatory body. Other
formal documentation will be provided in response to specific requests from the
regulatory body or at the initiative of the operator or other parties involved.
The regulatory body itself will also produce and disseminate many documents,
some of which will form the basis for its decisions. The records of official
meetings and hearings could also constitute a means of formally exchanging
information.

2.2. The regulatory body should maintain a record of all documents received or
sent out, which should indicate from whom the documents were received or to whom
they were sent, and should state what action was required and the result of that
action.

2.3. The regulatory body should specify the purposes of the various regulatory
documents necessary for it to perform its functions. The documents may be categor-
ized as comprising:

— legislation;
— regulations, licences and other mandatory documents;
— guides and other advisory documents.

2
2.4. The regulatory body should also identify other documents that are required to
be developed both by the regulatory body itself (see paras 2.27–2.29 and Section 5)
and by the operator (see paras 2.25–2.26 and Section 4). In addition, industrial
standards (see paras 2.23–2.24) developed by organizations working in various
technological fields may be proposed by the operator in the authorization process, or
may be referenced by the regulatory body in regulations and guides or in licence
conditions (see paras 2.20–2.22).

2.5. The number of documents and their designations will vary substantially among
States, depending on the legal system and on regulatory and industrial practices. This
Safety Guide provides general guidance on the basis of a proposed system as
described in this section, but it is recognized that other systems may also be effective
in providing adequate control over nuclear safety. All documents prepared should be
covered by the quality management system of the regulatory body.

LEGAL FRAMEWORK

2.6. “In order to fulfil its statutory obligations, the regulatory body shall define
policies, safety principles and associated criteria as a basis for its regulatory actions.”
(Ref. [1], para. 3.l)

2.7. In accordance with para. 3.2 of Ref. [1], in fulfilling its statutory obligations the
regulatory body is required to perform the following functions relating to documen-
tation:

— developing or adopting regulations and guides upon which its regulatory

actions are based;
— reviewing and assessing submissions relating to safety from the operators,
both prior to authorization and in all phases of the facility’s life-
time;
— issuing, amending, suspending, revoking or terminating authorizations or
licences, as appropriate, and setting licence conditions which have the force of
law and thus function in a similar way to regulations;
— carrying out regulatory inspections;
— taking necessary enforcement action in the event of a violation of safety
requirements.

2.8. It is assumed in this Safety Guide that legislation is in force under which the
regulatory body is granted sufficient authority and resources to carry out the author-
ization process (see the appendix). Depending on the legal system, the regulatory

3
body itself may participate in the preparation of additional legislation, or in the
review and amendment of existing legislation.

SYSTEM OF REGULATIONS AND GUIDES

2.9. “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)

Regulations

2.10. “The main purpose of regulations is to establish requirements with which all
operators must comply. Such regulations shall provide a framework for more detailed
conditions and requirements to be incorporated into individual authorizations.”
(Ref. [1], para. 5.26)

2.11. Regulations which have the force of law are issued either by the govern-
ment or by the regulatory body on behalf of the government. The principal purpose
of establishing a system of regulations is to codify safety requirements of general
applicability. The regulations should specify the requirements for authorization of
nuclear facilities and for ensuring the protection of workers, the public and the
environment. They should establish at least those requirements considered by
the regulatory body to be necessary for achieving and maintaining safety, and
should cover all the major aspects to be dealt with at all stages of the authorization
process.

2.12. By providing orderly procedures and clear statements of safety requirements, a

system of regulations serves as a basis for the authorization process. It helps the
regulatory body to establish, maintain and enforce an acceptable level of safety and
assists it in carrying out its regulatory functions in a consistent and orderly
manner.

2.13. The system of regulations should provide advance information to the operator
on the requirements for each major stage of authorization. This will assist the opera-
tor to make sound plans and decisions with respect to safety in the siting, design,
construction, commissioning, operation and decommissioning or closure of a nuclear
facility.

4
2.14. It should be recognized that a system of regulations is no substitute for good
engineering and good management practices. Unduly detailed formal regulatory
requirements can inhibit engineering innovation and good management initiatives,
and may even be counterproductive if they have the effect of relieving or tending to
relieve the operator of the responsibility for safety. Only a serious concern for safety
on the part of all those concerned, not limited to the obligation to meet regulatory
requirements, will engender a true safety culture and bring about lasting resolutions
of safety issues.

2.15. The system of regulations adopted should provide an appropriate balance

between regulatory provisions that are:

(a) numerous and detailed enough to achieve and maintain safety, and
(b) flexible enough to permit their application to developing technologies and in
new circumstances.

The extent to which detailed provisions are made in licence conditions (see paras
5.11–5.21) will depend upon the legal system and the licensing philosophy of the
State concerned.

2.16. “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
documentation to be submitted to the regulatory body by the operator.” (Ref. [1],
para. 5.27)

2.17. Guides, which are advisory in nature, should be established by or under the
authority of the regulatory body. Their purpose is to provide detailed and specific
information on acceptable technical and administrative approaches to satisfying the
regulatory requirements established in the regulations. In issuing guides, recent
developments should be taken into account, including technological advances that
have been proved by experience or shown by research results to be capable of pro-
viding effective and reliable means of satisfying regulatory requirements.

2.18. A system of guides will help the regulatory body to maintain consistent prac-
tices in implementing its requirements. However, the regulatory body should refrain
from prescribing specific solutions. The advisory status of a guide carries the impli-
cation that alternative approaches would be acceptable provided that the operator can
demonstrate that the required level of safety will be achieved.

2.19. Guides can assist the operator:

5
 — by clarifying the regulatory body’s interpretation of regulations;
— by explaining the basis or rationale for regulations, and their applica-
bility;
— by providing guidelines for procedures, or approaches for implementing regu-
lations;
— by providing information on data and methods to be used in assessing the
adequacy of the design of a nuclear facility, and on results of analyses and
documentation to be submitted to the regulatory body by the operator.

Relationships between regulations, licence conditions and guides

2.20. Safety requirements that are common to a particular type of nuclear facility
should be established in the regulations. Other requirements, such as those applicable
for only a short duration or relating to particular site characteristics, should be speci-
fied in the licence conditions.

2.21. In determining whether a particular topic should be made mandatory and thus
be addressed in a regulation rather than a guide, consideration should be given to the
regulatory requirements and the extent to which the topic in question can be consid-
ered as essential for implementing these requirements. Alternatively, a subject can be
made mandatory by its inclusion in the licence conditions.

2.22. The regulatory body may facilitate its task if, instead of attempting to issue
many detailed regulations, it establishes some of the provisions in the form of guides
to advise the operators of ways of meeting more general regulatory requirements.
Since guides are advisory, they allow the operator more flexibility in applying new
technologies and developing new procedures which, in some cases, may enhance
safety. They also allow the regulatory body to promote learning by modifying its
guides to include innovative good practices and to revoke impractical or unnecessary
features.

INDUSTRIAL STANDARDS

2.23. Industrial standards are developed by organizations working in various

technological fields, generally independently of the regulatory body, although the
regulatory body may be represented. Industrial standards describe technical solutions,
products and services to a high level of detail. They may also be developed by
specific operators and their suppliers. The industrial standards to be used by the
operator and/or designer of a nuclear facility may require the approval or consent of
the regulatory body.

6
2.24. Regulations and guides may incorporate, by reference, relevant industrial
standards (in their entirety or in part) so as to provide an effective and reliable means
of meeting the safety requirements. Compliance with industrial standards may also be
made mandatory by specific references in the licence conditions. In all these cases the
edition of the industrial standard to be used should be specified and consideration
should be given to the question of whether to change the relevant regulations, licence
conditions or guides if the standards are revised.

DOCUMENTS PRODUCED BY THE OPERATOR

2.25. Essential documents to be prepared by the operator in the authorization process

should be identified in the regulations and guides issued by the regulatory body.
Additional documents may be requested as needed, depending on the type of facility
concerned as well as on the specific stage of the authorization process.

2.26. Documents of different types are required to be prepared by the operator in

discharging its responsibilities with respect to the safety of the facility. Some of these
documents are required to be submitted formally to the regulatory body for review
and assessment in the course of the authorization process. Other documents are
reports that should be submitted to the regulatory body periodically, or event, incident
or accident reports to keep the regulatory body fully informed of the conditions
prevailing at the facility. A third type of document is for internal use by the operator
but should be made available upon request to the regulatory body to ensure its
complete understanding of the design and operation of the facility, so that it can
confirm that the requirements established in the regulations and licensing conditions
have been fulfilled.

INTERNAL GUIDANCE AND PROCEDURES OF THE REGULATORY BODY

2.27. The regulatory body should establish its own set of internal guidance docu-
ments which describe its functions and the methods of performing them. For a
regulatory body with responsibilities covering several facilities of the same type, it
may be useful to develop written procedures that will make the authorization process
consistent among its several technical groups, and among similar facilities. The inter-
nal guidance documents prepared should be covered by the regulatory body’s quality
assurance programme. This should include, among other things:

— review and assessment procedures;

— inspection procedures;

7
 — general procedures for the development of regulations and guides;
— procedures for issuing, amending, suspending, revoking and terminating
licences;
— enforcement procedures;
— procedures for issuing public information, with account taken of the confiden-
tial nature of some information and the security of the facility.

Documents produced by the regulatory body for a specific facility

2.28. A programme for the production of documents for specific facilities should be
established by the regulatory body. This programme should include the development
of:

— procedures describing the review and assessment process, documents to be

generated in the course of this process, and the corresponding level of internal
review and approval;
— procedures describing steps to be taken in the preparation of an inspection, the
conduct of inspections, and the preparation of inspection reports as well as their
review, approval and distribution;
— a system to control the status of identified deficiencies in order to ensure that
corrective actions are taken in a timely manner, commensurate with the poten-
tial impact on the safety of the facility.

2.29. The licence is the principal document produced by the regulatory body
that relates the legal framework of the regulatory system, (that is, laws and
regulations) to the responsibilities of the operator of a facility at each stage of the
authorization process. Licence conditions are incorporated into the licence, as
necessary, in order to impose additional specific obligations with the force of law.
Procedures for preparing a licence for each phase and type of facility should be
prepared, in order to ensure that all necessary steps have been taken prior to the
issue of a licence.

3. REGULATIONS AND GUIDES

GENERAL

3.1. A systematic approach should be adopted for the production of regulations and
guides, and the regulatory body’s quality management should cover these activities.

8
Procedures should be developed which establish the general method for the
development and review of regulations and guides, in accordance with the State’s
legal system. These procedures should cover the composition of working groups and
the drafting and review procedure, including the required legal support. The proce-
dure for formal approval and promulgation of the regulations and guides should be
established in accordance with the legal system of the State concerned.

3.2. The establishment and periodic review of a system of regulations and guides
tailored to the specific needs of a State entail a continuing effort. They constitute an
integral part of the activities of the regulatory body prior to the authorization process
and in the preparation of a periodic safety review. The scope and content of a system
of regulations and guides that is sufficient to fulfil the needs of the regulatory body
and the operators will emerge gradually and will change over time.

3.3. “In developing regulations and guides, the regulatory body shall take into
consideration comments from interested parties and the feedback of experience. Due
account shall also be taken of internationally recognized standards and recommenda-
tions, such as IAEA safety standards.” (Ref. [1], para. 5.28)

Extent and timing

3.4. The extent and detail of the system of regulations and guides established or
adopted by the regulatory body will depend on several factors, including:

— the regulatory philosophy and the level of detail with which regulatory controls
will be applied;
— the nature of the nuclear programme, including the types of facilities and the
number of operators, and the extent of regulatory experience with the tech-
nologies utilized;
— the risks posed by the facilities.

3.5. Although the development effort may be lengthy, basic regulations should be
established at an early stage. A range of engineering factors and also judgement or
probabilistic safety assessments may contribute to setting priorities for topics to be
covered by additional and more detailed regulations and guides. These should be
sufficiently comprehensive and should be kept up to date to ensure that all essential
safety requirements can be considered in a systematic and orderly manner in the
authorization process.

3.6. Information to be included in the regulations needed for a nuclear programme,

which may comprise different types of facility, may be divided into three categories:

9
 Category 1: safety objectives, principles and criteria;
Category 2: requirements for structuring and conducting the authorization
process;
Category 3: technical and managerial requirements relating to the stages of
the authorization process.

3.7. In initiating a State’s nuclear programme, priority should be given to the estab-
lishment of regulations dealing with safety objectives, principles and criteria, in
particular those relating to radiation protection (including dose limits) (para. 3.6,
Category 1).

3.8. The requirements covering applications for authorization and the related docu-
ments (para. 3.6, Category 2) should be clearly defined from the outset. Initially these
requirements may be limited to a single design of facility and may be expressed in a
letter to an operator, possibly with reference to international requirements or regula-
tions of other States. As a nuclear programme matures, however, a more standard and
uniform procedure will be beneficial and should be used.

3.9. As regards technical and managerial requirements (para. 3.6, Category 3), at an
early stage the safety considerations relating to site evaluation have priority, and for
the purposes of design these considerations should include interactions between the
facility and the site.

3.10. Regulations establishing general design criteria such as defence in depth, use of
multiple barriers, redundancy and diversity should be developed first (para. 3.6,
Category 2). Later, more detailed regulations or guides should be developed which
cover the details of design requirements for systems, components and equipment,
their functional and testing requirements, and the requirements for the analysis of
normal operation and fault conditions1 (para. 3.6, Category 3).

3.11. Requirements relating to quality assurance should also be covered by regula-

tions and guides and should be applied early enough to ensure that adequate quality
assurance systems are put in place by the operator for all phases of a facility’s life-
time.

1 Throughout this publication, the term ‘fault condition’ is used to cover all situations
in which there is a deviation from operational states or reference conditions that results from
postulated initiating events.

10
3.12. Requirements for operation, decommissioning or closure will have an impact
on the design and construction of a facility. For this reason, safety objectives, prin-
ciples and criteria covering these stages should also be established at an early stage.
At a later stage, detailed regulations and guides should be developed to cover aspects
such as the conduct of operations, training of staff, reporting requirements and emer-
gency preparedness.

Prescriptive versus performance based regulations

3.13. The principal purpose in establishing a system of regulations is to codify safety

requirements of general applicability. The development of any particular regulation
will involve a balance between the need for flexibility (to permit easy adaptation of
the regulation to developing circumstances and technology) and the need to include
detailed requirements (to facilitate determination of whether the requirements have
been met).

3.14. Performance based regulations specify primarily the overall safety objectives.
Performance based regulations can be comparatively easy to develop and are focused
on what is to be achieved in terms of protection and safety. By setting objectives
rather than prescribing specific requirements, performance based regulations have the
advantage that they will not need to be changed so frequently to reflect changing
technology or new knowledge. In addition, the use of objectives will tend to promote
continual safety related improvements and the search for better approaches by the
operator. Performance based regulations need greater involvement by the operator in
determining how objectives are to be met. The regulatory body should assess whether
the intent of the regulations has been fulfilled by judging how the operator has
interpreted these regulations in each specific situation. The preparation of regulatory
guides that set out acceptable ways of meeting performance based regulations should
be considered.

3.15. A prescriptive regulation is more specific than a performance based one and
states how to achieve safety. Prescriptive regulations have the advantage of providing
both the regulatory body and the operator with clearly defined provisions for a
particular activity or situation. They prescribe the means and methods to be used in
order to comply with regulatory requirements for achieving an adequate level of
protection and safety. Prescriptive regulations reduce the time and skills necessary to
perform a licensing review or conduct an inspection. They enable the authorization
and inspection process to focus on verification of compliance. However, they are
more difficult to prepare, needing more detailed and expert knowledge of the specific
practice in question on the part of the regulatory body. They are narrowly applicable
to a specific activity or situation and need to be regularly reviewed and amended, as

11
necessary, to keep pace with technological changes. One difficulty with prescriptive
regulations is that they tend to limit the flexibility of the operator in achieving safety;
in addition, they may not be of help in the development of a safety culture.

3.16. A regulatory system should include both types of regulations, striking an

appropriate balance between performance based and prescriptive regulations (or
guides) to match the anticipated workload and the skills of the regulatory body’s
staff.

PROCESS FOR DEVELOPING REGULATIONS AND GUIDES

3.17. In order to develop regulations and guides, the regulatory body should have two
basic resources: qualified staff and information. The staffing requirements, the
organization, the resources and the necessary liaison with other organizations for the
development of regulations and guides are covered in Ref. [2].

Sources of information

3.18. The regulatory body should base its regulations and guides on national legis-
lation and should utilize existing national regulations or industrial standards in areas
relating to or adaptable to nuclear facilities as its initial sources of information. Other
sources of information that should be considered in the development of regulations
include:

— standards and recommendations prepared by international organizations such

as the IAEA, the International Commission on Radiological Protection (ICRP),
the International Organization for Standardization (ISO) and the International
Electrotechnical Commission (IEC);
— regulations, guides and other relevant information produced by regulatory
bodies in other States;
— industrial standards developed in other States;
— experience in the nuclear industry;
— results of research in nuclear safety.

3.19. States embarking on a nuclear programme should consider adapting the IAEA’s
safety standards or regulations developed by other States, or a combination of these.
The IAEA’s safety standards are issued in the form of specific requirements and
recommendations so as to facilitate their incorporation into regulations. The IAEA
standards may be adopted individually or collectively. However, adaptation and
rewording may be necessary, depending on the national legal system. IAEA safety

12
standards that are expressed in a general way may be implemented in a State by
introducing appropriate requirements into regulations or by adapting the standards as
national guides.

3.20. If regulations of other States, usually those of the State supplying a nuclear
facility, are to be adapted, particular attention should be paid to the legal framework
of that State. Owing to differences between States in legal and governmental
infrastructures, and in the structure of industry and available resources, it is unlikely
that the regulatory body will be able to adopt without revision regulations issued in
another State. In adapting regulations and guides issued in other States, the regu-
latory body should ensure that it understands the regulations in terms of their
technical background and significance, and the legal and regulatory framework in the
State that issued them.

3.21. In adapting IAEA safety standards or regulations of other States, the regu-
latory body should:

— make its regulations compatible with its national legal and regulatory frame-
work;
— include appropriate requirements specific to national conditions such as special
site characteristics and electrical grid conditions;
— promptly evaluate amendments made to the reference regulations or standards
and issue amendments to its own regulations as appropriate.

3.22. It should be noted that the nature of the national legal framework, more than
any other single factor, will determine the form and content of the regulations and
guides. Advice and support may be obtained from the IAEA and from other States.
When the design of a nuclear facility originates in another State, it may be particu-
larly useful to seek advice and support from the regulatory body of that State. The
IAEA can, as appropriate, provide assistance to States on request.

3.23. The regulatory body may find it useful to set up advisory committees to advise
on the need for regulations and on their technical content. A well founded committee
can provide a valuable service to the regulatory body by helping to ensure that
policies and regulations are clear, practicable and complete. For more details on the
composition of advisory committees see Ref. [2], paras 3.30–3.32.

Legal support

3.24. The development and review of regulations and guides will, by its very nature,
require professional legal support. This legal support can be provided by staff of the

13
regulatory body or by another governmental body, or it can be obtained by means of
a contract. The regulatory body should be structured in such a way as to facilitate the
interaction between legal functions and its technical and management functions.
Functions that typically require professional legal assistance include:

— development of the basic nuclear legislation;

— development and review of regulations;
— checking of the compatibility of regulations;
— review of drafts of legislative documents.

3.25. The purpose of the review by legal staff is to ensure that regulations do not
contain provisions that are beyond the jurisdiction and authority of the regulatory
body, prohibited by or inconsistent with laws or other regulations, unclear or ambigu-
ous, or otherwise unenforceable.

Procedures for the development of regulations and guides

3.26. The regulatory body should follow a consistent procedure for establishing,
revising and revoking regulations and guides.2 A general procedure should be
prepared that details the general format and style of language to be used in develop-
ing the regulations and guides. This procedure should be distributed to members of
drafting working groups and should be adhered to by all parties involved. Procedures
should be efficient and flexible enough to permit revisions to be made so as to
adapt to changing conditions or as justified by technological advances. Because of
differences between States’ legal systems and practices, it is impossible to provide
detailed procedural guidance for establishing regulations that can be followed by all
States. However, certain basic steps for establishing regulations can be specified. The
procedure followed by the regulatory body for establishing regulations should include
the following steps:

(1) Determination of the need for the regulation. The need for a regulation may
arise from the regulatory body’s activities in relation to its sets of responsi-
bilties and functions as specified in Ref. [1]. Alternatively, the need may be
identified as a result of a request or enquiry by an operator or its contractors.
Additionally, regulations may be needed as a result of national debates or to
meet international obligations.

2
In some States a cost–benefit analysis is performed in connection with the develop-
ment of regulations and guides.

14
(2) Setting the priority for development of the regulation. The regulatory body
should consider the advantages and disadvantages of the proposed regulation,
including such matters as risks associated with the type of facility, the need for
improvements in safety, the number of operators to be affected, and the effect
on the efficiency of the authorization process.
(3) Determination of the scope of the proposed regulation. This includes identifi-
cation of the type of facility and the stage of the authorization process to be
covered, as well as the technical topic to be addressed.
(4) Determination of the resources to be employed. This will depend on the
resources available and on the time-scale for the preparation and establishment
of the regulation.

These four steps should form the basis for a decision on whether or not to prepare the
proposed regulation, including adoption or adaptation of regulations issued by others.
A positive decision should be followed by these additional steps:

(5) Collection of information. The information necessary to prepare the proposed

regulation should be collected.
(6) Drafting of the proposed regulation. The initial version of the proposed regula-
tion may be drafted either by staff of the regulatory body, or by consultants or
advisory committees.
(7) Review of the proposed regulation. Although practices vary widely, the initial
version of the proposed regulation is usually reviewed by other staff of the
regulatory body, including legal staff and special advisory committees, as
appropriate. In some States, operators, nuclear industry organizations and other
organizations participate in such reviews. The draft version may also be
published with an invitation for comment from the public. Comments received as
a result of the review should be analysed, evaluated and resolved as appropriate.
Which-ever review process is adopted, a formal procedure should be established
to ensure that advice on the proposed regulations is obtained from all parties
concerned. A final decision with regard to the advice obtained should be made by
the regulatory body before the regulation is finalized. At this stage, consideration
should also be given to the implications of the regulation for existing facilities.
(8) Establishing and issuing the regulation. The regulation should be established
and promulgated in a manner which makes it legally binding under the
national legal system, thereby ensuring that its provisions can be enforced by
the regulatory body.

3.27. The procedures for issuing safety guides should follow steps similar to those for
regulations. However, a guide can be formally issued with a lower level of approval,
since its contents are only advisory in nature.

15
REVIEW AND REVISION OF REGULATIONS AND GUIDES

Review procedures for regulations and guides

3.28. The regulatory body should ensure that regulations and guides are kept up to
date, and procedures should be established for their periodic review. Experience in
implementing the regulations should be examined, and any problems or difficulties
which may have arisen should be duly considered. The status of applicable require-
ments should also be examined in the light of new developments in relation to nuclear
safety. The effect of too frequent changes on the stability of the regulatory system
should be taken into account. However, events may occur which necessitate more
frequent revisions. The reasons for revising regulations may include:

— changes in legislation;
— changes in the organization, responsibilities, policies or procedures of the regu-
latory body;
— experience gained by the regulatory body in the authorization process;
— feedback from events, incidents and accidents;
— major modification or refurbishment of a facility;
— results from research and development in fields relevant to safety;
— technological advances;
— the need to improve or revoke impracticable, misleading, unenforceable or
otherwise inadequate regulations.

Procedures for the revision of regulations and guides

3.29. The procedures applicable in the establishment of regulations may also be

followed for making any necessary revisions. Advice should be obtained from all
parties concerned. Operators and others who may be affected by the revised
regulation should be given adequate time to complete any preparations that may be
necessary to enable them to comply with newly established requirements. A general
procedure should be prepared that details the general format and style of language to
be used in revising regulations and guides. This procedure should be distributed to
members of drafting working groups and should be adhered to by all parties involved.
A review of the final draft for quality control should be carried out before formal
approval. One way in which the regulatory body can do this is to publish the regula-
tion in its revised form for comment in advance of the effective date.

3.30. The process and procedures established for the revision of regulations and
guides should not diminish the authority of the regulatory body to take immediate
action if required for reasons of safety.

16
Impact of the revision of regulations

3.31. In revising regulations, special care should be taken to ensure that no contra-
dictions or inconsistencies arise between the retained and the revised parts of a regu-
lation. The extent to which the proposed changes should be applicable to nuclear
facilities that have already been authorized and the degree of backfitting to be
required should also be considered.

4. DOCUMENTS TO BE PRODUCED BY THE OPERATOR

GENERAL

4.1. As discussed in paras 2.25–2.26, documents of different types have to be

prepared by the operator in carrying out its responsibilities in respect of the safety of
a facility. Where a contractor is used to prepare these documents, the operator is still
responsible for their content and for ensuring that they are adequate and are covered
by the quality assurance system. There are three categories of documents:

— documents required to be submitted to the regulatory body for formal approval

at the various stages of the authorization process (paras 4.2–4.8);
— reports which should be submitted to the regulatory body periodically or, for
events, incidents or accidents, should be specified in the regulations (paras
4.9–4.16);
— documents which should be prepared for the conduct of activities relating to the
facility and which should be made available to the regulatory body upon
request (paras 4.17–4.23).

DOCUMENTS TO BE SUBMITTED FOR THE AUTHORIZATION PROCESS

4.2. In applying for a licence, the operator should provide all relevant information
describing the approach to safety in order to demonstrate that the facility will not
present undue radiological risks to workers, the public and the environment. This
should include proposed objectives, principles, criteria, standards and analyses in
relation to nuclear safety for all stages of the authorization process. The aim should
be to present the relevant information in such a way that the regulatory body can
conduct the review and assessment process without needing to seek further informa-
tion or clarification [3].

17
4.3. The basic information to be provided should cover each stage of the authoriza-
tion process, including:

— a description of the site in terms of geography, demography, topography,

meteorology, hydrology, geology and seismology;
— a description of the facility, including the layout of buildings and equipment;
— applicable safety regulations, guides and industrial standards;
— the safety concepts and criteria used in the design of the facility, including the
classification of equipment, systems and components, the application of the
defence in depth principle, the use of multiple barriers to prevent radioactive
releases and the approach to issues relating to the human–machine interface;
— a description of the facility’s systems and components, including their design
criteria, the processes involved in their design, and the modes of operation and
testing.

4.4. The results of an analysis of the normal operation of the facility and, for a waste
disposal facility, of the long term period after closure should be provided to demonstrate
the acceptability of the design, including a demonstration that radiation protection
criteria, waste management requirements and effluent limits are met by the design.

4.5. The results of a safety analysis should be provided to demonstrate how the
design of the facility and related operational procedures will contribute to the
prevention of accidents and to the mitigation of the consequences of accidents if they
do occur. The analysis should describe and evaluate the predicted response of the
facility to postulated initiating events, both internal and external, which could lead
to fault conditions. The analysis should be extended to relevant combinations of
such disturbances, malfunctions, failures, errors and events. Consideration should
be given to aspects such as the initial conditions assumed, the physical or mathe-
matical models used and their correlation with experiments, and the method of
presenting the results.

4.6. Such analyses should show the extent to which the operator can control or
accommodate situations at the facility relating to various events and fault conditions.
The limits and conditions for safe operation should be defined. If any part of the
analysis has been independently reviewed by another organization, the results of this
review should also be presented to the regulatory body. Additional recommendations
and guidance on safety analysis are provided in Ref. [5].

4.7. Information regarding organizational matters should be formally presented for

review and assessment by the regulatory body. It should include a description of the
quality assurance system established to ensure that all items are designed, manufactured,

18
constructed, assembled, tested, qualified, operated, maintained and replaced in compli-
ance with the relevant safety requirements. The information should cover topics such as:

— management structure and resources;

— quality assurance arrangements, including internal and external audits;
— the organizational structure for each stage of authorization;
— qualification and training of personnel;
— development of procedures;
— documents and records control.

4.8. Information on other plans and programmes that are established by the opera-
tor in support of its safety activities should also be submitted to the regulatory body
for review and assessment. This includes areas such as:

— the radiation protection programme (including how to apply the ‘as low as
reasonably achievable’ (ALARA) principle);
— the environmental monitoring programme;
— emergency preparedness;
— physical protection;
— fire protection;
— radioactive waste management;
— research and development in relation to the safe design, operation, decommis-
sioning or closure of the facility;
— feedback of operating experience;
— the decommissioning (or closure) strategy.

REPORTING BY THE OPERATOR

4.9. The requirements for periodic reporting and progress reporting and the general
criteria for notifying the regulatory body of events, incidents or accidents should be
specified in regulations or licence conditions.

Periodic reporting and progress reporting

4.10. Reports should be required from the operator at set times or upon the comple-
tion of specific activities over the lifetime of the facility.

4.11. During the stage of site evaluation and construction, reports should be prepared
to keep the regulatory body informed of the progress of the project. The reports
should cover:

19
 — the progress of site studies;
— the progress of construction;
— results of the pre-operational environmental monitoring programme.

4.12. During commissioning and operation, reports should be prepared to

demonstrate to the regulatory body the continuing safety of the facility. The reports
should cover:

— the results of commissioning tests;

— operational data, including data on the facility’s output and performance;
— modifications;
— results of the radiation protection programme;
— results of the environmental monitoring programme;
— radioactive waste management.

4.13. In order to enable the regulatory body to consider the release of any facility
from regulatory control, or to require institutional controls for the post-closure phase,
reports should include details of:

— the amounts and destinations of radioactive waste resulting from the deconta-
mination and dismantling programme;
— levels of residual activity in the facility;
— results of environmental monitoring and other performance confirmation
programmes.

Where necessary owing to the nature of the facility (for example, for a waste disposal
site), reports should also include details of:

— the overall waste inventory;

— the sealing arrangements;
— any institutional controls intended for the post-closure phase.

Notification and reporting of events, incidents and accidents

4.14. The operator should notify the regulatory body of any event considered
significant to safety. The time limit for and type of notification should be established
in regulations and should be commensurate with the severity of the event. Events that
require notification may be specified in regulations or licence conditions.

4.15. Depending on the severity of the event or fault, an investigation should be

carried out by the operator and a report prepared and submitted to the regulatory body

20
within a specified period of time. The report should cover details of the event, the
findings of the investigation and proposals for corrective action.

Reporting of changes and modifications

4.16. During site evaluation and construction, any changes in the design or major
non-conformances that may affect safety should be reported to the regulatory body
prior to their implementation. Any major design deficiencies identified during
commissioning or operation should also be analysed and reported.

RECORDS TO BE KEPT BY THE OPERATOR

4.17. The operator, having responsibility for the safety of the facility, should be
required to keep records of all activities that are considered to be safety related. These
records, although not formally submitted to the regulatory body for review and
approval, should be made available upon request. Regulations or licence conditions
should establish the types of records that should be kept and the periods for which
they should be retained. In specifying the retention period, account should be taken
of the possible future need to refer to these records and of the difficulties of regener-
ating the information.

Records of site evaluation and construction

4.18. The results of site evaluation studies (geological, meteorological and hydrolog-
ical data, as well as results of the pre-operational environmental monitoring
programme), construction design records, manufacturing records (including shop
quality control results) and erection records (including quality control results and as-
built design records) should be kept in accordance with established regulations or
licence conditions. They may be useful later in the investigation of events or generic
problems and in decommissioning.

Commissioning records

4.19. Records made during commissioning should include records of equipment and
system tests, test procedures and test results. The results should be thoroughly
evaluated by the operator, and the results of this evaluation should also be retained
together with the test results. It is common practice for the regulatory body, which
would normally closely monitor the commissioning of a facility, to review commis-
sioning test results at each phase of the commissioning process before proceeding to

21
the next phase. The retention of documentation relating to commissioning tests
should also be required by regulations.

Operational records

4.20. Operational records form the main documentation to be used in the

routine monitoring of nuclear safety by the regulatory body. This monitoring is
conducted through the system of regulatory inspections [4]. The documents to be
retained by the operator for possible examination by the regulatory body should
include:

— output and performance records of the facility;

— operating log books;
— inventories of fissile and radioactive materials;
— records of periodic calibration of equipment;
— records of periodic testing of equipment and systems;
— records of in-service inspections;
— records of preventive maintenance and repairs;
— records of personnel training;
— records of personnel radiation monitoring;
— records of radiation monitoring and contamination records for the facility;
— records of radioactive waste management;
— records of effluent discharges and of the environmental monitoring programme;
— records of fault conditions.

Records of modifications to the facility

4.21. All modifications relevant to safety and their evaluations should be recorded
for possible re-examination. The regulatory body should periodically examine the
complete set of modifications made to the facility in order to evaluate the effec-
tiveness of the operator’s control process and to ensure that all modifications
relevant to safety have been submitted for approval, in accordance with applicable
regulations.

Records and evaluation of events

4.22. The event evaluation process and its results should be recorded for all events
above an established threshold of significance. Recorded events should be period-
ically reviewed by the operator to identify trends and possible deterioration of safety
levels. The regulatory body should periodically examine the complete set of events
in order to evaluate the effectiveness of the evaluation process, to ensure that

22
procedures for notification have been properly followed, and to review trends in the
events recorded at the facility.

Decommissioning and licence termination records

4.23. The operator should maintain, for an agreed period of time, records of decom-
missioning actions and licence termination to provide a basis for examining safety
related issues. These records should include records of any decisions taken with
regard to the release of parts of the site before the initial site licence is terminated.

5. DOCUMENTS PRODUCED FOR A

PARTICULAR FACILITY BY THE REGULATORY BODY

GENERAL

5.1. The regulatory body should treat the authorization process for each facility as
a specific task which should generate specific documentation. This documentation
may be similar to the documentation for similar facilities, but it should remain
specific to the facility concerned. The documentation may be categorized according
to the main continuous functions of the regulatory body, including review and
assessment, inspection and enforcement.

RESULTS OF REVIEW AND ASSESSMENT

5.2. The review and assessment performed by the regulatory body are discussed in
Ref. [3]. The documentation submitted by the operator as described in paras 4.2–4.8
should be evaluated for the review and assessment.

Records of information exchange between the regulatory body

and the operator

5.3. The process of review and assessment is conducted by means of exchanges

between the regulatory body and the operator, which should be formally recorded.
The records will concern mainly:

— requests for additional information by the regulatory body;

— questions formulated by the regulatory body;

23
 — responses by the operator (including those provided by its contractors);
— records of meetings between regulatory body staff and operator per-
sonnel.

5.4. These records should be kept in an organized way that permits retrieval accord-
ing to different criteria such as subject, type, date or originator.

Documentation of review and assessment

5.5. At several stages of the authorization process a decision will have to be made
on whether a licence should be granted. The regulatory body should record in the
form of a report the basis for such a decision. This report should summarize the
review and assessment performed by or for the regulatory body and should provide a
clear conclusion about the safety of the authorized activity. Typically, the report
should cover the following points:

— reference to the documentation submitted by the operator;

— the basis for the evaluation;
— the evaluations performed;
— conformance with regulatory requirements and guides;
— comparison with similar (reference) facilities;
— independent analysis performed by the staff of the regulatory body or by
consultants on its behalf;
— conclusions with respect to nuclear safety;
— reasons for the decisions made;
— any additional conditions to be fulfilled by the operator.

RECORDS OF INSPECTION ACTIVITIES

5.6. The primary purpose of inspection reports is to record the results of all inspec-
tion activities in order to provide the basis for notification of the inspection findings
to the operator. The format, content and distribution of inspection reports are
discussed in Ref. [4], paras 4.29–4.39. Inspection findings should be forwarded to the
operator so that the necessary corrective actions can be taken. In some States, the full
inspection report is forwarded to the operator. Care should be taken not to identify
individuals by their name or their post.

5.7. From time to time the regulatory body may find it useful to produce a com-
posite report covering a type of facility or a specific aspect of inspection, drawing
together findings from a number of relevant inspection reports.

24
RECORDS OF ENFORCEMENT ACTIONS

5.8. Enforcement actions should be taken in the event of non-compliance with the
regulations. All enforcement actions should be recorded in accordance with an estab-
lished procedure and with legal and regulatory practices. Whenever an enforcement
action has to be taken urgently to ensure the protection of workers, the public and the
environment, the action should be confirmed in writing as soon as possible (see Ref.
[4], Section 5).

LICENCE DOCUMENT

5.9. The authorization process (see the appendix) is the principal mechanism
connecting the legal framework of the regulatory system (laws and regulations) with
the responsibilities of the principal parties concerned with the regulatory system (the
regulatory body and the operator). As already mentioned, the principal purpose of
regulation for a nuclear facility is to establish requirements, both technical and
administrative, that apply to persons, activities and facilities involved in a nuclear
power programme. Such regulations provide a basis for the more detailed require-
ments incorporated into licences. The licence may also refer to non-mandatory
technical guides or industrial standards, in their entirety or in part, thus making them
mandatory. The licence establishes, directly or by reference, conditions governing the
safe performance of activities.

Format of licences

5.10. The format of a licence will depend upon the content of the authorization and
the conditions deemed necessary by the regulatory body for a given stage of the
authorization process in accordance with national legal procedures. For example, the
licence may incorporate by reference the underlying documents and provide only the
material necessary to define the basic terms not previously defined elsewhere. Thus,
the format of a licence will vary not only among States, but also within a State, from
stage to stage, and from licence to licence for a given stage. Consequently, this Safety
Guide provides only general considerations for use by a State in determining which
licence formats best meet its needs. However, the licence should contain information
such as:

— Statutory authority. The licence should explicitly refer to the laws and regula-
tions on which it is based.
— Issuing authority. The licence should identify the official designations of those
who are empowered by law or regulation to issue the licence, whose signature

25
 and stamp will appear on the licence, and to whom the operator will be account-
able under the terms of the licence.
— Fulfilment of requirements. The licence should include a summary statement
that all legal and technical requirements in respect of safety have been fulfilled
and that the proposed activities can be carried out without undue radiological
risk to workers, the public or the environment.
— Documentary basis. The licence should identify the documents provided by the
operator in support of the application and those prepared by staff of the regula-
tory body in the review and assessment process, which together form the basis
for issuing the licence.
— Relationship to other licences. The licence should indicate whether it is
contingent upon a prior authorization or is a prerequisite for a future authori-
zation.
— The operator. The licence should contain a precise identification of the
individual or organization both legally responsible for the licensed activity and
in day to day control of the facility.
— Period of authorization. The licence should state an effective date of authoriza-
tion. It may also include a termination date, which may be based on a fixed term
such as one or two years. Alternatively a period may be stated over which the
assumptions underlying the licensing decision will remain valid and at the end
of which the basis for licensing will be re-examined.
— Licensed activity. The licence should clearly describe in sufficient detail the
nuclear facility, its location and the activities authorized.
— The operator’s responsibility for compliance. The licence should contain an
appropriate declaration that the operator has the responsibility for compliance
with the legal requirements, regulations and conditions referenced or contained
in the licence or in other references, if applicable. The licence should also state
that this responsibility is not transferable.

Licence conditions

5.11. Licences should state explicitly, or should impose by reference or attachment,

all conditions as determined by the regulatory body, which are obligations with which
the operator is required to comply. Laws and practices relating to licensing vary
between States. In some States, conditions are specified in the law and in regulations
of the regulatory body, and are merely referenced in the licence, while in other States
some or all conditions are stated explicitly in the licence.

5.12. Licence conditions should cover as appropriate all safety related requirements
affecting the siting, construction, commissioning, operation and decommissioning or
closure of the nuclear facility, so as to enable effective regulatory control. These

26
requirements should cover such important aspects as design, radiological protection,
emergency procedures, modifications, quality assurance, operational limits and
conditions, procedures, and authorization of operating personnel.

5.13. While the conditions may vary in format, there are certain basic qualities
that should characterize the set of conditions so as to make them understandable
and effective. Each condition should be consistent with all other conditions in
that the fulfilment of one should not conflict with the fulfilment of another or
with any other legal requirement. It may be useful to group the conditions into
logical types, such as conditions which set technical limits and thresholds,
conditions which specify procedures and modes of operation, conditions pertaining
to administrative matters, conditions relating to inspection and enforcement
requirements, and conditions pertaining to the response to abnormal circum-
stances.

General licence conditions

5.14. General licence conditions should include the following provisions:

(a) The operator shall provide the authorized representatives of the regulatory body
with full access to personnel, facilities and records that are under the operator’s
control, when such access is deemed necessary by the regulatory body to verify
compliance and to assess safety.
(b) The operator shall keep the regulatory body fully and continuously informed of
any significant or potentially significant events or changes in the consider-
ations, information, assumptions and expectations upon which the issue of the
licence was based.
(c) The operator shall take such corrective actions or measures as the regulatory
body may require in the interests of safety.
(d) The operator shall not extend its activities beyond those specifically authorized
in the licence without the prior approval of the regulatory body.
(e) The operator shall develop, preserve, update and maintain a complete set of
records relating to the safety of the facility, including those referenced in the
applications and those required by law, regulations and the licence, and shall
dispose of them only as authorized by the regulatory body.
(f) The operator shall carry out its activities in accordance with an approved
quality assurance programme covering all stages of the authorization process,
so as to provide a basic framework for ensuring that all activities are carried out
with due regard for safety.
(g) The operator shall report on modifications to the facility in accordance with the
requirements established by the regulatory body.

27
(h) The operator shall report on all accidents, incidents and events relating to
safety as required by the regulatory body.

Licence conditions relevant to certain stages of the authorization process

5.15. In addition to those general licence conditions which are applicable to all
licences, there are some conditions that are relevant only to licences issued at certain
stages of the authorization process. The following listing is not all-inclusive, nor is it
the only possible arrangement of such conditions, but it may be helpful in determin-
ing which conditions are relevant.

5.16. Site preparation. The regulatory body should specify the controls that the
operator is required to exercise over the use of the site and the degree to which the
operator may prepare the site without conducting activities which, under the laws and
regulations of the State, require a construction licence.

5.17. Construction. When authorizing construction, there are several conditions

which should be fulfilled to ensure that this stage can proceed in a manner that ensures
safe operation of the nuclear facility. These conditions should include the following:

— The nuclear facility shall be designed and constructed in accordance with the
relevant site parameters approved by the regulatory body.
— The nuclear facility shall be constructed in accordance with the design that has
been approved by the regulatory body. The operator shall not deviate from the
approved design in any way that might affect safety without the prior approval
of the regulatory body.
— The operator shall initiate a radiological study of the region, including an
appropriate baseline survey, prior to the start of operation.

Furthermore, at the time of authorizing construction, conditions may be imposed on

the operator requiring that it obtain from the regulatory body additional approvals
relating to the design of certain parts of the facility.

5.18. Commissioning. In authorizing the commissioning of a nuclear facility, the

regulatory body should specify a number of conditions, including the following:

— Commissioning shall be carried out in accordance with a programme approved

by the regulatory body.
— Completed structures, systems and components important to safety shall only
be put into service once they have been inspected, tested and approved as being
in accordance with the terms of the licence.

28
 — The operator shall provide approved storage facilities for nuclear materials. The
regulatory body may require that appropriate physical security measures be in
effect before nuclear material is brought into the facility.
— Fissile or radioactive material shall only be brought onto the site with regula-
tory authorization.
— Beginning with the introduction of fissile and radioactive material into the
facility, the operator shall operate the facility only under the control and super-
vision of authorized personnel using written procedures, in accordance with the
operational limits and conditions approved by the regulatory body. Any
changes made to these limits and conditions shall be approved by the regu-
latory body prior to their implementation.
— The operator shall have an approved emergency plan, co-ordinated with the
other authorities involved in emergency preparedness.

5.19. Operation. In authorizing routine operation, the conditions imposed for

commissioning (para. 5.18) should be appropriately amended in the light of commis-
sioning results. The regulatory body should add conditions such as the following to
the licence, as necessary:

— The operator shall not operate the facility outside the design limits authorized
by the regulatory body.
— The operator shall have a procedure for modifications to be approved by the
regulatory body in order to ensure that no part of the approved facility that is
important to safety will be modified without the prior approval of the regu-
latory body.
— The operator shall ensure that the facility is subjected to in-service inspection
and testing, to be carried out as specified for structures, systems and
components important to safety, to a time schedule approved by the regulatory
body.
— The operator shall ensure that the maintenance of safety related equipment and
systems is carried out in accordance with a schedule approved by the regula-
tory body.
— Only changes given prior approval by the regulatory body shall be made to the
approved arrangements, schedules, procedures and rules.
— The operator shall ensure that the facility is operated only under the control and
supervision of authorized personnel in adequate numbers, that are acceptable to
the regulatory body.

Other possible licence conditions relating to such matters as the liability of the oper-
ator in the event of accidents are not covered in this Safety Guide.

29
5.20. Decommissioning. In authorizing decommissioning of a facility, the regulatory
body should take particular care in specifying requirements to ensure compliance,
since the sanction of shutting down the facility or revoking the licence is unlikely to
be effective at this stage. The regulatory body should examine a final radiological
survey conducted by the operator. The radiological survey should be conducted after
the completion of decommissioning activities to ensure that regulatory requirements
are met prior to terminating the licence and releasing the site.

5.21. Closure. Following the closure of a waste disposal facility, continuing control,
including environmental monitoring, may be necessary. Depending on national
legislation, requirements may be specified in a post-closure licence held by the
operator or responsibilities may be taken by a relevant national authority prior to
agreeing to closure of the facility.

DOCUMENT CONTROL

5.22. The regulatory body should establish a system to control the preparation,
review, approval, issuance, revision, distribution and storage of documents.

5.23. The document control system should be such as to ensure that regulatory staff
are provided with up to date regulatory requirements and policies and are issued with
the appropriate revisions of documents for use in their work. External documents that
are products of the regulatory staff’s work, such as regulations and guides or reports,
should also be controlled and should be kept available. For further details, see
Ref. [6].

REVIEW OF THE DOCUMENTATION SYSTEM

5.24 The effectiveness of the regulatory body’s activities in relation to the docu-
mentation system should be assessed regularly by different methods such as manage-
ment overview, internal audits and the use of quality indicators. Management should
ensure that a suitable document approval process is established and adhered to.

5.25. Internal audits should be conducted to review the use of up to date versions of
internal procedures and regulations as well as the use of controlled copies of docu-
ments that have been submitted to the regulatory body by the operator.

5.26. The effectiveness of the document control system should be evaluated on the
basis of the capability of retrieving documentation under different conditions and for

30
different search criteria (such as by date, source, type or subject). Numerical
indicators relating to the time necessary for retrieving the documentation may be
established and monitored, and deviations may be recorded and corrected. Systems
and conditions for the storage of records should also be reviewed periodically.
Guidance on quality assurance for document control and records is provided in
Ref. [6].

31
 Appendix

THE AUTHORIZATION PROCESS

GENERAL

A.1. Authorization is the principal mechanism connecting the legal framework of

the regulatory system (the laws and regulations) with the responsibilities of the prin-
cipal parties that are affected by the regulatory system (the regulatory body and the
operator).

A.2. An authorization is a written permission for an operator to perform a specified

activity or a set of activities dealing with the siting, design, construction, commission-
ing, operation, decommissioning or closure of a facility. It also establishes, directly or
by reference, conditions governing the safe performance of these activities.
Authorization could consist of, for example, a licence, certification or registration.

A.3. An important task of the regulatory body is the approval or rejection of

applications for authorization on the basis of its review and assessment. To obtain an
authorization for a facility, the operator submits adequate information to the
regulatory body for its review and assessment. Approval of an application by the
regulatory body is formalized by granting an authorization to the operator in accord-
ance with the laws and regulations of the State concerned.

A.4. The granting of an authorization does not restrict or preclude subsequent

amendment, suspension or revocation of that authorization by the regulatory body
within the period of its validity. Once it has been issued, however, the terms of the
authorization, including any conditions attached thereto, are binding on the operator
unless and until amended, suspended or revoked by the regulatory body. A request for
an amendment may be initiated by the operator, or an amendment may be imposed by
the regulatory body in the interest of safety. A modification of the authorization may
be desirable or necessary as a result of proposed changes relating to the facility,
experience from the facility itself or elsewhere, or technological advances, or as a
consequence of research and development relating to nuclear safety.

SIGNIFICANT REGULATORY DECISIONS

A.5. Review and assessment by the regulatory body give rise to a series of decisions
in the authorization process. Not all of these decisions necessarily result in the

33
granting of a formal authorization to the operator. However, at the conclusion of one
or more stages, the regulatory body takes an official action which may result in the
granting of an authorization.

A.6. The types and number of authorizations to be issued in connection with a

particular facility vary between States. Some States, for example, issue only one
authorization, followed by various amendments, additions and modifications, while
others issue several authorizations at a number of intermediate points from site
evaluation to decommissioning. Practices vary widely in terms of the number of
authorizations issued and the points in time at which they are issued. Despite these
differences in practice, several points can be identified, corresponding to the major
stages of the authorization process, at which significant regulatory decisions are
usually made and documents issued. It should be noted that some of these stages may
be combined, depending on the nature of the facility and the laws and regulations of
the State concerned.

APPROVAL OF THE SITE

A.7. For a facility that is to be installed at a permanent site, at some point a decision
has to be reached on the acceptability of the site from the safety point of view, after
information on the site itself and preliminary information on the facility and its inter-
action with the site has been reviewed and assessed.

AUTHORIZING CONSTRUCTION, MANUFACTURE AND INSTALLATION

A.8. Construction, manufacture or installation of the facility shall not be authorized

until the basic design has been reviewed and assessed, including verification of the
compatibility of the design with the site, as appropriate.

AUTHORIZING COMMISSIONING

A.9. There is some overlap between the construction and commissioning stages in
that individual structures, systems and components may be commissioned before
completion of the entire facility. There are several steps in the commissioning process
for which the regulatory body may require the operator to obtain prior approval and
at which regulatory decisions may be made. However, the introduction of fissile and
radioactive material into the facility marks a significant step in the commissioning
procedure and is often considered the main point at which regulatory decisions are

34
made at this stage. Introduction of fissile and radioactive material shall not be author-
ized until the proposed commissioning programme has been reviewed and assessed,
preliminary operational limits and conditions have been established, the final design
has been assessed and conformity of the construction with the design of related
systems has been verified.

AUTHORIZING OPERATION

Initial routine operation

A.10. Commencement of routine operation shall only be authorized once commis-

sioning tests have been completed and their results assessed, and operational limits
and conditions have been reviewed and assessed by the regulatory body.

Routine operation

A.11. The regulatory body shall require the operator to provide evidence that in
routine operation the facility is being operated in accordance with the safety require-
ments, in particular the operational limits and conditions. This evidence may be
provided by means of reporting on operational parameters and occurrences relevant
to safety. The regulatory body shall review and assess the reports, and shall perform
inspections to ensure that the facility complies with the safety requirements and is fit
to continue in operation.

Return to operation after an outage

A.12. Before bringing a facility back into operation following a major outage, the
operator should demonstrate to the satisfaction of the regulatory body that the facility
will be able to continue to operate in compliance with the safety requirements.

Periodic safety review

A.13. Over the full operational lifetime of a nuclear facility, the regulatory body shall
require the operator to provide evidence at appropriate intervals, in the form of a
safety reassessment termed a periodic safety review, that the facility is still fit to
continue in operation. In many States, this reassessment period is around ten years for
nuclear power plants. In the periodic safety review, account should be taken of the
potential nature and magnitude of the associated hazards, operating experience,
significant changes to safety standards, technical developments, and new safety
related information from relevant sources. Depending on the national laws and

35
regulations and the outcome of the periodic safety review, the regulatory body may
renew the authorization of the operator at this stage.

AUTHORIZING MODIFICATIONS

A.14. In any phase of the lifetime of a facility, the operator may wish to modify the
existing design and operations. Any modification proposed that may have a signifi-
cant effect on safety related aspects should be implemented only if it has been
authorized. The proposal shall be subject to appropriate regulatory review and
assessment.

AUTHORIZING DECOMMISSIONING OR CLOSURE

A.15. Decommissioning or closure shall only be authorized once the detailed plans
and procedures to be used, the conditions to be observed during decommissioning or
closure, and the proposed final state of the facility, including the radiological status,
have been inspected, reviewed and assessed by the regulatory body.

A.16. Before the release of a facility from regulatory control, the regulatory body
should review and assess the evidence for the following:

— that all responsibilities and liabilities have been discharged, particularly for
waste disposal facilities;
— that any necessary institutional controls, including continuing environmental
monitoring programmes, are in place;
— that the final radiological status of the facility is fully documented;
— that such documentation is made publicly available.

36
 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, Review and Assessment of Nuclear
Facilities by the Regulatory Body, Safety Standards Series No. GS-G-1.2, IAEA, Vienna
(2002).
[4] 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).
[5] INTERNATIONAL ATOMIC ENERGY AGENCY, Safety Assessment and Verification
for Nuclear Power Plants, Safety Standards Series No. NS-G-1.2, IAEA, Vienna (2001).
[6] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance for Safety in
Nuclear Power Plants and Other Nuclear Installations, Safety Guide Q3, Safety Series
No. 50-C/SG-Q, IAEA, Vienna (1996).

37
 GLOSSARY

assessment. The process, and the result, of analysing systematically the hazards asso-
ciated 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 and registration.

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 and
activities, 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).

enforcement. The application by a regulatory body of sanctions against an operator

intended to correct and, as appropriate, penalize non-compliance with condi-
tions of an authorization.

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.

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

rization 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,

39
 private individuals, governmental bodies, consignors or carriers, licensees,
hospitals, self-employed persons, etc.

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

ment 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.

repository. A nuclear facility where waste is emplaced for disposal.

40
 CONTRIBUTORS TO DRAFTING AND REVIEW

Almeida, C. Comissão Nacional de Energia Nuclear, Brazil

Ito, H. International Atomic Energy Agency

Karbassioun, A. International Atomic Energy Agency

Kim, Jin-Hong International Atomic Energy Agency

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

Weedon, C.J. Environment Agency, United Kingdom

41
 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: Gómez-Gómez, J.A.; IAEA: Hughes, P. (Co-ordinator);
International Organization for Standardization: d’Ardenne, 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 Dobschütz, 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 López, 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: D’Amato, E.; Brazil: Caubit da Silva, A.; Canada: Taylor, 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: Azuara, J.A., Santoma, L.; 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.

42