Iaea Enforsman
Iaea Enforsman
Iaea Enforsman
IAEA
SAFETY
STANDARDS
SERIES
Regulatory Inspection
of Nuclear Facilities
and Enforcement
by the Regulatory Body
SAFETY GUIDE
No. GS-G-1.3
INTERNATIONAL
ATOMIC ENERGY AGENCY
VIENNA
This publication has been superseded by GSG-13.
REGULATORY INSPECTION
OF NUCLEAR FACILITIES
AND ENFORCEMENT
BY THE REGULATORY BODY
This publication has been superseded by GSG-13.
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/1130
This publication has been superseded by GSG-13.
REGULATORY INSPECTION
OF NUCLEAR FACILITIES
AND ENFORCEMENT
BY THE REGULATORY BODY
SAFETY GUIDE
FOREWORD
by Mohamed ElBaradei
Director General
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.
This publication has been superseded by GSG-13.
CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Background (1.1–1.3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Objective (1.4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Scope (1.5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Structure (1.6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5. REGULATORY ENFORCEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . . . . . 45
BODIES FOR THE ENDORSEMENT OF SAFETY STANDARDS . . . . . . . . 46
This publication has been superseded by GSG-13.
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 governmental
infrastructure, including a regulatory body with well defined responsibilities and
functions. One of the key functions of the regulatory body is inspection for
monitoring compliance with regulatory requirements and, in the event of non-
compliance, taking enforcement action to bring about compliance.
1.3. Four interrelated IAEA Safety Guides provide recommendations for satisfying
the requirements concerning particular responsibilities and functions of the
regulatory body in the regulation of nuclear facilities. The present Safety Guide
addresses regulatory inspection and enforcement; three related Safety Guides cover,
respectively, the organization and staffing of the regulatory body [2], regulatory
review and assessment [3], and documentation relating to the regulatory process [4].
OBJECTIVE
1.4. The purpose of this Safety Guide is to provide recommendations for regulatory
bodies on the inspection of nuclear facilities, regulatory enforcement and related
matters. The objective is to provide the regulatory body with a high level of
confidence that operators have the processes in place to ensure compliance and
that they do comply with legal requirements, including meeting the safety objectives
and requirements of the regulatory body. However, in the event of non-compliance,
the regulatory body should take appropriate enforcement action.
SCOPE
1.5. This Safety Guide covers regulatory inspection and enforcement in relation to
nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power
plants; other reactors such as research reactors and critical assemblies; spent fuel
reprocessing plants; and facilities for radioactive waste management, such as
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treatment, storage and disposal facilities. This Safety Guide also covers issues
relating to the decommissioning of nuclear facilities, the closure of waste disposal
facilities and site rehabilitation.
STRUCTURE
1.6. Section 2 sets out the objectives of regulatory inspection and enforcement.
Section 3 covers the management of regulatory inspections. Section 4 covers the
performance of regulatory inspections, including internal guidance, planning and
preparation, methods of inspection and reports of inspections. Section 5 deals with
regulatory enforcement actions. Section 6 covers the assessment of regulatory
inspections and enforcement activities. The Appendix provides further details on
inspection areas for nuclear facilities.
2.1. “Regulatory inspection and enforcement activities shall cover all areas of
regulatory responsibility. The regulatory body shall conduct inspections to satisfy
itself that the operator is in compliance with the conditions set out, for example, in
the authorization or regulations. In addition, the regulatory body shall take into
account, as necessary, the activities of suppliers of services and products to the
operator. Enforcement actions shall be applied as necessary by the regulatory body in
the event of deviations from, or non-compliance with, conditions and requirements.”
(Ref. [1], para. 5.12.) Inspection by the regulatory body shall not relieve the operator
of its responsibility for ensuring nuclear safety.
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(a) All applicable laws, regulations and licence conditions and all relevant codes,
guides, specifications and practices are complied with;
(b) The operator has a strong and effective management, good safety culture and
self-assessment systems for ensuring the safety of the facility and the protection
of workers, the public and the environment;
(c) The required quality and performance are achieved and maintained in the safety
related activities of the operator and in the structures, systems and components
(SSCs) of the facility throughout its lifetime;
(d) Sufficient numbers of personnel, who have the necessary competences for the
efficient and safe performance of their duties, are available at all times and
throughout all stages of the facility’s lifetime;
(e) Deficiencies and abnormal conditions are identified and promptly evaluated and
remedied by the operator and duly reported to the regulatory body as required;
(f) Any other safety issue that is neither specified in the authorization nor
addressed in the regulation is identified and appropriately considered.
2.5. Regulatory enforcement actions are actions taken to deal with non-compliance
by the operator with specified conditions and requirements. These actions are
intended to modify or correct any aspect of an operator’s procedures and practices or
of a facility’s SSCs as necessary to ensure safety. Enforcement actions may also
include the imposition or recommendation of civil penalties and other sanctions.
LEGAL AUTHORITY
2.6. In accordance with Ref. [1], the regulatory body shall be granted legal authority
for conducting and co-ordinating inspection and enforcement actions during site
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2.7. With regard to regulatory inspection, the regulatory body shall have the
authority to:
— Establish regulations and issue guidance which, among other things, will serve
as the basis for inspection;
— Enter the premises of any facility that is subject to any stage of the regulatory
process or any related establishment at any time for the purposes of inspection;
— Require the preparation of, access to and submission of reports and documents
from operators and their contractors when necessary;
— Seek the co-operation and support of other governmental bodies and consultants
with competences or qualifications relevant to regulatory inspections;
— Communicate information, findings, recommendations and conclusions from
regulatory inspections to other governmental bodies or interested parties,
including high level officials, as appropriate in view of the significance of the
issue.
2.8. The regulatory body shall have the authority and powers necessary to carry out
its inspections. However, the co-operation of the operator should be forthcoming to
ensure that the regulatory inspection can be carried out in an effective, informed and
unhindered manner. The operator shall give inspection personnel free and prompt
access to any area of the facility and its site for the purposes of regulatory inspection.
The only necessary limitation to this requirement may arise when the operator can
demonstrate that such access would give rise to a hazard. The operator should also
provide regulatory inspectors with free and prompt access to all personnel at the
nuclear facility and to all relevant documentation. The operator should additionally
make appropriate arrangements to provide personnel conducting a regulatory
inspection with access to its contractors and consultants where such access is
deemed necessary by the regulatory body for the discharge of its responsibilities for
inspection. Any findings from an inspection should be formally communicated to the
operator.
2.9. With regard to enforcement, the regulatory body shall have the authority:
— to require the operator to take action to remedy deficiencies and prevent their
recurrence, to curtail activities or to shut down the facility when the results of
a regulatory inspection or another regulatory assessment indicate that the
protection of workers, the public and the environment might be
inadequate;
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2.10. The regulatory body shall be given adequate powers and authority to enforce
compliance with its requirements and licence conditions, and should have available a
number of methods of enforcement to provide the flexibility to use the method best
suited to the seriousness of the violation and the urgency of corrective actions. The
degree of authority of the regulatory inspectors should be clearly specified and clear
administrative procedures should be adopted and implemented.
3. MANAGEMENT OF INSPECTION
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3.3. “Inspection by the regulatory body, both announced and unannounced, shall be
a continuing activity.” (Ref. [1], para. 5.15.) The major activities of the inspection
process are related to the stages of the authorization process. The regulatory body
should organize and modify its inspection activities to conform to the stage of the
facility’s lifetime in order to make the most effective and efficient use of resources
for inspections. Specifically, as a facility passes from one stage to another, the
regulatory body will normally find it necessary:
TYPES OF INSPECTION
3.4. The regulatory body should conduct two general types of inspection,
namely planned inspections (including special inspections) and reactive
inspections. Inspections may be conducted by individuals or teams and may be
announced or unannounced, as part of a general programme or with specific
aims.
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Planned inspections
3.5. Planned inspections are carried out in fulfilment of, and in conformity with, a
structured and largely prearranged or ‘baseline’ inspection programme developed by
the regulatory body. They may be linked to operator schedules for the performance or
completion of certain activities at all stages of the authorization process. Planned
inspections differ from reactive inspections in that they are scheduled in advance by
the regulatory body and are not initiated because of unusual or unexpected
circumstances. Planned inspections provide an opportunity for the examination of the
operator’s activities in order to confirm the operator’s performance and to identify
potential problems at an early stage. Considerations in relation to performing planned
inspections should include:
3.7. Special inspections may be carried out to consider specific issues which may be
of interest to the regulatory body, such as refurbishment, new findings from research
and development work and experience from other facilities. Special inspections are
usually in the category of planned inspections, since they are scheduled in advance;
however, in certain circumstances they may be reactive inspections. This type of
inspection may range from a single inspector reviewing a specific inspection area to
a team of inspectors reviewing different inspection areas.
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3.9. Different approaches may be used in planning team inspections, some of which
may be broad in focus and cover a wide subject area (‘horizontal slice’) in the
programme area of interest. For example, during operation a team of inspectors may
assess the performance of facility operations, or a team of maintenance and
engineering inspectors may assess activities during an outage of the facility. Other
team inspections may be narrow in focus and cover a smaller subject area (‘vertical
slice’). For example, a number of specialist inspectors may review in depth a single
safety system in order to confirm that the system is in full compliance with the
regulatory requirements or a team may inspect the same aspect at similar nuclear
facilities in the State.
Reactive inspections
3.11. The regulatory body should use the operator’s reports of safety related
activities or events for assistance in preparing for both planned and reactive
inspections. Matters to be included in reports from the operator should be clearly
defined so that difficulties in interpretation can be avoided. This information should
include, for example, notification of:
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3.13. The main advantage of announced inspections is that the regulatory inspector
is able to discuss plans and needs with the operator’s personnel in advance in order
to secure assurances that documentation will be available for inspection, personnel
will be available for interview and activities can be inspected as scheduled. Hence,
the announcement of inspections may enhance their effectiveness. The advantage of
unannounced inspections is that the actual state of the facility and the way in which
it is being operated can be observed. Inspections may be carried out at any time of
the day or night so as to provide a more complete picture of the situation at the
facility.
3.15. The regulatory body’s attention to major inspection areas does not begin and
end in a single stage but continues with varying degrees of emphasis throughout
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the lifetime of the facility. This Safety Guide covers a wide range of types of
facility, and it is not possible to provide for each type details of specific areas that
would be subject to inspection at each stage of its lifetime. The degree to which
the areas should be considered will depend on the nature of the facility and the
risks associated with it. Major inspection areas for nuclear facilities are listed in
the Appendix.
3.16. Whenever the operator makes use of the services or products of a contractor,
the regulatory body should include the contractor’s activities in its inspection
programme in all stages of the authorization process. This may comprise inspection
and surveillance of the design and manufacturing of components, including, where
appropriate, activities performed in other States.
3.18. It is neither necessary nor practicable for the regulatory body to be entirely
self-sufficient in all technical areas relating to inspection. It may therefore be
necessary for it to use consultants in specialized areas. It may occasionally be
necessary owing to a heavy short term workload to augment the regulatory body’s
inspection staff with consultants having as much knowledge and experience as the
regulatory body’s inspection staff. Such consultants may be any of the following:
When consultants are engaged, arrangements should be made for them to have access
to the facility and to any information necessary to perform their tasks. “The use of
consultants shall not relieve the regulatory body of any of its responsibilities. In
particular, the regulatory body’s responsibility for making decisions and
recommendations shall not be delegated.” (Ref. [1], para. 4.4.)
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EXTERNAL RELATIONSHIPS
3.19. The regulatory body should establish requirements and guidelines for the
operator that govern notification and reporting periods and the formats in which the
notices and reports should be submitted.
3.20. The operator should, at all times, provide personnel conducting regulatory
inspections with such equipment, assistance and support as may be necessary for
discharging their responsibilities. This may include:
3.21. In addition to the regulatory body, other governmental bodies may participate
in the regulatory process according to national practices. The regulatory body should
establish and maintain liaison throughout the lifetime of the facility with other
relevant governmental bodies, and should develop and, where practicable, formalize
working procedures with such bodies, whether at the national, regional or local level.
Such bodies may undertake their own inspections of the facility, and it may be
appropriate for the regulatory body to conduct joint inspections with one or more of
them. In planning an inspection programme and determining a specific inspection
plan, the regulatory body should consider whether inspectors from these bodies
should participate in the inspection.
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3.23. The areas which may be inspected by other governmental bodies should be
identified. The latter could include but are not limited to:
3.24. The regulatory body should be aware of the relationships between the operator
and other governmental bodies such as may be determined by national legislation,
regulations and practices.
3.26. There may be specific technical areas in which a regulatory body can obtain
useful information for the inspection activities. It would be particularly useful to
obtain information from regulatory bodies in other States with experience in
inspecting similar facilities and it should be considered whether to set up an
international grouping of such regulatory bodies. The IAEA and other international
bodies are also sources of information and expertise.
3.27. A regulatory body may seek information internationally for such reasons as:
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INTERNAL GUIDANCE
4.1. To ensure that all nuclear facilities in a State are inspected to a common
standard and that their level of safety is consistent, the regulatory body should
provide its inspectors with written guidelines in sufficient detail. The guidelines
should be followed to ensure a systematic and consistent approach to inspection while
allowing sufficient flexibility for inspectors to take the initiative in dealing with new
concerns that arise. Appropriate information and guidance should be provided to the
inspectors and each inspector should be given adequate training in following this
guidance. Consideration should be given to the extent to which this guidance should
be made available to the operator or to the public. Appropriate subjects for guidance
and instructions for inspectors could include:
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4.2. The authority vested in inspectors should oblige them to conduct themselves on
the site in a manner that inspires confidence in and respect for their competence and
integrity. They should, for example, make adequate preparation by gathering and
reviewing all relevant information and data before proceeding on assignment and
should be knowledgeable about the area which they are required to inspect. The
importance of objectivity and fairness on the part of inspectors should also be stressed
by the regulatory body in its guidance, together with the need to respect the rules for
the facility as established by the operator.
INSPECTION PROGRAMME
4.3. “The regulatory body shall establish a planned and systematic inspection
programme. The extent to which inspection is performed in the regulatory process
will depend on the potential magnitude and nature of the hazard associated with the
facility or activity.” (Ref. [1], para. 5.14.)
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4.6. The regulatory body should have the capability to undertake inspection
activities at any time as necessitated by the normal operation of a facility or by any
fault conditions or operator activities at a facility. For verification of the overall
performance of the operator, inspections of adequate depth should be conducted in a
wide range of subject areas and at appropriate intervals. Each planned inspection
should have objectives which have previously been specified by the regulatory body
to serve to the extent practicable as guidance for inspection personnel.
4.7. The planning of the programme of inspections will also be influenced by the
locations of the regulatory body’s offices and of the facility to be inspected. In
particular, it will depend on whether inspectors are permanently at the facility site
(resident inspectors) during one or more stages of the facility’s lifetime. The general
advantages and disadvantages of relying on resident inspectors, as opposed to non-
resident inspectors, are considered in paras 3.20–3.22 of Ref. [2]. The use of resident
inspectors may be more beneficial at certain stages than at others: for example, the
use of resident inspectors may be particularly beneficial during commissioning to
permit direct observation of commissioning tests.
4.8. Arrangements should be made to ensure that all relevant staff of the regulatory
body can fully contribute to the planning of inspections and in particular, if the offices
of the regulatory body are distributed over a wide area, that resident inspectors are
involved in the planning process. This will ensure the best use of the skills and
knowledge of its staff.
4.9. The regulatory body should have an overall plan for the programme of
inspections that it is to undertake at a facility. In determining the intervals between
inspections and the level of effort to be applied, the regulatory body should take into
account the relative significance for the safety of the facility of each authorization
stage and each inspection area.
4.10. The particular aspects that should be considered in determining the intervals
between inspections in the various areas and the level of effort to be applied in the
inspection include:
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— the performance record of the operator and the facility, for example, the number
of violations, deficiencies, incidents and problems and the number of reactive
inspections;
— the results of the regulatory review and assessment;
— the type of facility;
— the personnel and other resources available to the regulatory body;
— the results of previous inspections.
4.12. The inspection plan should be flexible enough to permit inspectors to respond
to particular needs and situations. In a number of States it is the practice to allocate
about three quarters of the resources of the overall inspection programme for planned
inspections and to keep the remaining quarter available for reactive inspections. The
regulatory body should establish a process of periodically evaluating the findings of
inspections, identifying generic issues and making arrangements to enable inspectors
from various plants, locations or projects to meet to exchange views and discuss the
findings and issues.
4.13. The operator should notify the regulatory body of its schedules for carrying out
activities and tests of regulatory interest and should submit or make available to the
regulatory body in a timely manner the procedures for these activities. To facilitate
this process, the regulatory body should specify well in advance to the operator the
activities and tests of which it wishes to be informed. Notification to the regulatory
body by the operator should be as prompt as is warranted by the situation according
to established procedures.
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METHODS OF INSPECTION
4.16. The inspection programme of the regulatory body should incorporate and use
a variety of methods:
4.17. The inspection programme of the regulatory body should include provision for
direct monitoring of SSCs, human factors significant to safety (performance of
operating personnel, managerial attitudes), tests and other safety related activities
carried out by the operator.
4.18. The regulatory body may prescribe certain categories of SSCs, tests and
activities which should be directly observed by its inspectors in whole or in part. In
some cases, the regulatory body may require regulatory monitoring of a specific
structure, system, component, test or activity as a condition for the operator to be
permitted to proceed to subsequent stages of work or operation. Monitoring is most
likely to be of benefit during the commissioning stage, or as a means of verifying
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corrective action at any stage over the lifetime of the facility as required by the
regulatory body after an abnormal occurrence or a finding of serious non-compliance.
4.19. The regulatory inspection programme should provide time for general
surveillance of the facility site by regulatory inspectors. Such surveillance is aimed at
gaining an overall impression of the operator’s capabilities and performance and is
not restricted to specifically designated components and systems or designated
scheduled activities and tests. Examples of areas for observation include:
4.22. The operator should be required to record all activities, results and
considerations important to safety in the siting, design, construction, commissioning,
operation and decommissioning or closure of the facility.
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schedules or interfering with the operator’s primary responsibility for the safe siting,
design, construction, commissioning, operation and decommissioning of the facility.
Documentation examined by regulatory inspectors may include:
4.24. The regulatory body should examine samples of the operator’s documentation
sufficient to satisfy itself that the operator is fulfilling the requirements for
authorization and is operating in accordance with the practices proposed by the
operator and approved by the regulatory body.
4.26. The extent to which the regulatory body does its own testing and measurement
work independently of the operator varies greatly between States, depending upon
such factors as the qualifications of personnel available to the regulatory body, its
regulatory philosophy, and the experience and demonstrated performance of operators.
However, the regulatory body should not engage in the conduct of tests or
measurements which would necessitate its assuming direct operational control of the
facility or any of its systems. In some States, the inspection staff of the regulatory body
conduct physical tests and measurements as part of the inspection programme. Tests
of components and systems of the facility should only be undertaken after consultation
with the facility’s management. In most instances, these tests and measurements
replicate and serve as an independent verification of tests and measurements
performed by the operator. The conduct of these tests and measurements by the
regulatory body shall not relieve the operator of its prime responsibility for safety.
4.27. Since the regulatory body itself conducts only limited testing, a detailed review
should be carried out of a sample of the operator’s procedures for tests and its
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interpretation of their results. If external experts are used to monitor the tests and
measurements, their reports also should be reviewed.
4.28. Whatever its inspection programme may be, the regulatory body should be able
to carry out tests and measurements as necessary or should obtain the capability by
using consultants.
— general administrative and legal structure in the State and the requirements
established by the regulatory body;
— type of facility and its stage of authorization;
— location of the inspection, whether on or off the site;
— type of the inspection, whether planned or reactive.
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— identification of the facility inspected, the purpose and date of the inspection
and the inspectors’ names;
— the methods used in the inspection (interviews, observations, review of
documents);
— reference to applicable requirements;
— criteria used in the assessment;
— details of facility areas, activities, documents, processes, systems or
components which have been inspected, assessed or reviewed;
— a record of actual or potential problems relating to safety;
— a record of the results of any checks for compliance with the terms and conditions
of the authorization for the facility and applicable national regulations;
— a record of any deficiency or violation found in regulatory inspections,
including a record of which requirements or regulations have been contravened;
— a record of any regulatory action taken by inspectors and any consequent action
taken by the operator in the period covered by the report;
— a record of discussions held with the facility’s staff, the operator’s managers
and other persons, including a record of discussions with facility managers
about points of concern;
— a record of the inspectors’ opinion about the operator’s or relevant facility
manager’s response to any matter of concern to which their attention was drawn
after a regulatory inspection;
— a record of the findings or conclusions of the inspectors, including corrective or
enforcement actions that should be taken;
— a record of recommendations made by inspectors for future action, such as
a need to advise other inspectors or operators about particular problems,
proposals for further inspections or proposals for enforcement actions.
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4.36. Documents that are made available to the inspector by the operator during an
inspection should be referenced in the inspector’s report of the inspection. Inspection
reports and copies of documents received should be stored in a manner that permits
ready retrieval.
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4.37. In order to inform the public of the safety of nuclear installations and of the
effectiveness of the regulatory body, findings of inspections and regulatory
decisions may be made publicly available. The extent to which such information
is made publicly available will depend on the legal provisions in the State
concerned.
4.38. Although it may be the practice in some States to publish individual inspection
reports, some inspection reports may contain confidential information, such as
security information, information which the regulatory body may wish to use in
connection with future regulatory actions, personal or medical information relating to
individuals and proprietary information. Such information should be withheld.
However, in the interests of confidentiality it may be undesirable to show which
information has been withheld. In such cases, therefore, only the general findings of
the inspection and regulatory decisions should be made available to the general
public.
4.39. All information exchanged between the regulatory body, other govern-
mental bodies, the operator, its contractors, advisory committees and the
regulatory body’s consultants and, as appropriate, members of the public should be
formally recorded upon receipt and stored in a manner that permits ready
retrieval.
5. REGULATORY ENFORCEMENT
5.1. The organizational structure of the regulatory body should enable enforcement
actions to be taken at an appropriate level. The managerial responsibilities for
enforcement actions include:
— applying the policy of the regulatory body with regard to enforcement actions;
— determining the level of an inspector’s authority to carry out enforcement
actions;
— ensuring that enforcement actions are carried out properly and in accordance
with due legal process in the State concerned and that corrective actions are
performed.
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5.2. The regulatory body shall have statutory powers to enforce compliance with its
requirements as specified in the applicable regulations and in licence conditions,
including the authority to require an operator to modify, correct or curtail any aspect
of a facility’s operation, procedures, practices or SSCs, as necessary, to ensure that
the required level of safety is achieved. Within the legal framework in which it is
established, the regulatory body may develop and issue enabling regulations detailing
procedures for determining and exercising enforcement actions as well as the rights
and obligations of the operator.
5.4. “The extent of the authority of the regulatory inspectors to take on the
spot enforcement actions shall be determined by the regulatory body.” (Ref. [1],
para. 5.23.) The degree of authority given to an inspector may depend on
the structure of the regulatory body and on the inspector’s role and experience.
5.6. Enforcement actions taken on the spot by regulatory inspectors are appropriate
only in abnormal situations. In normal situations, decisions concerning enforcement
actions, particularly those involving fines, curtailment of activity or suspension of
authorization, should be approved by the regulatory body in accordance with the
procedures established in the State concerned.
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5.7. A range of enforcement actions should be available to the regulatory body, such as
the issuing of written requirements, warnings or directives or orders to curtail activities,
the modification or revocation of licences or authorizations and the imposition of
penalties. The enforcement should depend on consideration of the factors listed in para.
5.8, but in many cases it may be possible to resolve the non-compliance by means of
discussion with the operator. Whenever such a process is inappropriate or has been
unsuccessful it may be necessary to invoke one of the formal measures; however, caution
should be exercised in considering the imposition of penalties. In determining the
enforcement measure to be applied, it should be noted that for some facilities or at
some stages of a facility’s lifetime the option to curtail activities may not be available.
5.8. The factors to be taken into account by the regulatory body in deciding which
enforcement action is appropriate in each case should include:
— the safety significance of the deficiency and the complexity of the correction
that is needed;
— the seriousness of the violation;
— whether a violation of a less serious nature has been repeated;
— whether there has been a deliberate or wilful violation of the limits and
conditions specified in the authorization or in regulations;
— who identified and reported the non-conformance;
— the past performance of the operator and the trend in performance;
— the need for consistency and transparency in the treatment of operators.
METHODS OF ENFORCEMENT
5.10. Any written requirement, warning or directive should specify the nature of and
the regulatory basis for each violation, deviation or unsatisfactory situation; it should
also specify a period of time for taking corrective action and may provide guidance
on the nature of the corrective action. This is the most common form of enforcement
action and should, in most cases, suffice to remedy the safety issue.
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5.11. The regulatory body should require the operator to curtail specific activities in
the event of serious non-compliance in the construction stage, apparent deterioration
of the facility’s SSCs or serious violations which in the judgement of the regulatory
body pose an imminent radiation hazard to workers, the public or the environment.
In the operational stage, for example, this could mean requiring reductions in power,
pressure, temperature or other parameters, including, if necessary, temporary
shutdown of the facility.
Penalties
5.13. The regulatory body should have the authority to impose or recommend
penalties, such as fines on the operator as a corporate body or on individuals, or
to institute prosecution through the legal process, depending upon the legal
system and authorization practices in the State concerned. The use of penalties
is usually reserved for serious violations, for repeated violations of a less
serious nature or for deliberate and wilful non-compliance. Experience in some
States shows that imposing penalties on the organization rather than on
individuals is preferable and is more likely to lead to improvements in safety
performance.
5.14. The regulatory body should adopt clear administrative procedures and
guidelines governing the use and implementation of enforcement actions. All
inspectors and other staff of the regulatory body should be trained in and should be
knowledgeable about the procedures and guidelines. The procedures and guidelines
should state the policy of the regulatory body for the use of regulatory and
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enforcement measures and the associated authority delegated to inspectors and other
regulatory body staff. Depending on national practices, the need to allow the operator
to state a point of view on regulatory decisions, to respond to enforcement
notifications and to appeal against enforcement decisions should be recognized and
taken into account in the procedures and guidelines. The procedures and guidelines
should cover in detail the decision making approach of the regulatory body in
determining the level of actions to be taken and the way in which the actions should
be taken, including dealing with failure of the operator to comply with requirements
for regulatory enforcement.
5.15. Provided that there is no immediate threat to safety, the regulatory body should
allow reasonable periods of time for the operator to complete corrective actions.
These time periods should depend on the seriousness of the issues and the complexity
of the corrective actions required. However, in an integrated approach to safety, the
contribution of each deficiency for which corrective action is required to the total risk
for the facility should be considered.
5.17. The circumstances under which it is appropriate to carry out further inspections
to determine whether the operator has responded to regulatory and enforcement
measures should be stated in the regulatory procedures. The purpose of these
inspections should be:
— to confirm that the operator has complied with the enforcement measures
within the period of time specified;
— to check that the enforcement measures intended to protect the workers, the
public and the environment from potential radiological consequences have
been taken by the operator even though the operator may intend to appeal
against the notification of the regulatory body.
RECORDS OF ENFORCEMENT
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6. ASSESSMENT OF INSPECTION
AND ENFORCEMENT ACTIVITIES
6.1. The regulatory body should have a system to audit, review and monitor all
aspects of its inspection and enforcement activities to ensure that they are being
carried out in a suitable and effective manner. It should be ensured by means of this
system that any changes necessary in inspection and enforcement activities owing to
improvements in methods are implemented. The following points should be
considered in this system:
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Appendix
A.1. This appendix sets out areas of nuclear facilities that may be of particular
interest for inspection at different stages of the authorization process.
A.2. Before the construction of a nuclear facility is begun, the regulatory body
should monitor as appropriate, by means of its inspection programme, site
preparation activities undertaken by the operator, including verification of site
characteristics and authorized excavation and earthwork.
A.4. The chief objectives of the regulatory inspection programme in the design and
construction of the facility are to verify that:
— Safety related materials and SSCs meet the requirements established by the
regulatory body and conform to good practices;
— Construction activities associated with manufacturing and installing SSCs and
items are conducted in accordance with regulatory requirements and in
conformity with general safety objectives;
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A.5. The regulatory body should inspect design and construction activities in a
number of areas in order to attain these objectives. In particular, the following areas
should receive close attention in the construction stage, primarily because of the
difficulty of detecting and correcting deficiencies in these areas once fissile and
radioactive material has been brought to the site and the facility enters the active
commissioning stage:
(a) mixing and placement of concrete and its reinforcement, especially in:
— foundations,
— safety related structures, particularly containment structures;
(b) construction of cooling intakes and discharge systems;
(c) installation of safety related components, particularly:
— containment and shielding boundaries,
— internals of vessels which will contain fissile and radioactive material,
— equipment to be used in radiation areas;
(d) installation of safety related control, protection and power systems;
(e) areas of the facility that are inaccessible after construction is completed,
particularly systems and components embedded in the foundations or the
building structure;
(f) housekeeping in respect of safety related SSCs;
(g) the quality assurance systems of the designer, manufacturer and constructor.
COMMISSIONING STAGE
A.7. Inspection by the regulatory body during the commissioning stage should focus
on four broad areas of the operator’s activity:
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A.8. The inspection area of testing before the introduction of fissile and radioactive
material encompasses those activities and tests performed before the introduction of
such material by the operator in order to demonstrate that SSCs function properly and
conform to design requirements. It also covers the inspection and acceptance criteria
for the receipt at the facility of fissile and radioactive material. The regulatory
inspection programme should include:
A.9. The number of tests and the key tests that are to be examined and directly
witnessed by the regulatory body will vary depending on such factors as the
importance of the test for safety and whether the facility to be commissioned is the
first of its kind or one of several similar facilities. The regulatory body should,
however, place particular emphasis on inspection by the examination of
documentation and by the direct observation of some of the tests performed on:
A.10. This may involve the regulatory body in inspecting tests of:
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A.12. Although some of these tests may be performed at times other than the time
when fissile and radioactive material is first introduced, the regulatory body should
inspect the following:
A.13. The inspection area of testing of operations involving fissile and radioactive
material encompasses activities of the operator performed in conditions up to nominal
operating conditions. At this point, SSCs are tested in an operational environment to
ensure that they have been constructed and installed properly and are capable of
functioning in compliance with the design requirements. Consideration should be
given to the performance of radiation surveys of facility shielding (such as concrete
walls) during starting up of the facility. This will help to identify any voids or faulty
joints in the shielding or any radiation penetrating through joints. In the event of such
an occurrence, alterations should be made prior to further operation. During this
period the operator carries out tests at increasing operational levels; this testing
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A.14. Regulatory inspection personnel shall examine and assess the safety aspects of
a sample of the operator’s procedures for conducting operational tests. In addition, as
the tests are completed, a sample of the test documentation and the results of the
inspection should be examined by regulatory personnel to verify that the tests have
been completed in accordance with the test instructions and that the results are
acceptable. Regulatory inspection should also include the monitoring and direct
observation of several tests.
A.15. Tests during this stage, which should be subject to regulatory review and
inspection, will depend on the type of facility being commissioned. They include tests
to demonstrate as far as possible that:
— the facility is being operated in accordance with the descriptions given in the
safety analysis report;
— systems respond to malfunctions in accordance with the claims made in the
safety analysis report.
OPERATION STAGE
A.17. Once the facility has attained the authorized operation stage, the regulatory
body shall implement an inspection programme to verify systematically the
operator’s compliance with regulatory requirements and achievement of general
safety objectives, and to detect potential safety problems. This verification should
consist of: a balanced approach to monitoring and direct observation of activities;
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Operations
A.18. The area of operations should include the control and execution of activities
directly relating to operating a facility to the operational limits and conditions
established by regulatory requirements or by procedures or specifications. Inspection
personnel should perform safety verification of: operating procedures; the operating
configuration of safety related systems; control room activities; and the abilities of
the operations staff to perform their duties. Simulator training and the responses of
operating staff to abnormal events and emergency conditions, as well as the
adequacy of the management’s actions, should also be assessed. In performing this
safety verification, the reviews described in paras A.19–A.22 should be carried out.
A.20. Operator’s training programme. The adequacy of the operator’s staff training
programme should be assessed routinely to ensure that the training reflects actual
conditions in the facility.
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the degraded equipment repaired by the maintenance staff or its prompt evaluation to
ensure operability. Inspection of the facility should also include observations of non-
safety-related areas to ensure that they have no adverse effects on the safety related
areas of the facility. The adequacy of the fire protection and prevention programme,
including the management’s attention to this area, should be noted in these
inspections.
Outages
A.24. The area of radiation protection should cover all related activities at the facility,
including radiation protection of staff and contractor personnel and of the public
[5–7]. The area of radioactive waste management should cover treatment,
conditioning, storage and transport of waste, the release of effluents and the
environmental monitoring programme [8].
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in the inspection. Indicators of the effectiveness of the management are the levels of
exposure of personnel, levels of contamination in working areas, levels of releases of
effluents, and the understanding on the part of management and workers of their
responsibilities in the implementation of the radiation protection programme. Any
self-assessments performed by the operator under this programme should be
reviewed.
A.27. Effluents. The inspection programme should include verification that any
releases of effluents are within the authorized discharge limits. This should include
the review of systems for the treatment of radioactive waste and for the monitoring
of effluents. Training and qualifications for technicians and workers employed in the
areas concerned should also be reviewed.
A.30. Whenever unpackaged waste is stored or waste packages are stored or have
been placed in a waste repository pending a decision on closure of the facility,
degradation of the waste with time may occur. The storage conditions for the waste
and the waste packages should be inspected at appropriate intervals to provide
confidence that the waste remains suitable for treatment or that the waste packages
will be suitable for retrieval, transport and further steps in radioactive waste
management, as necessary.
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A.32. Inspection in the area of maintenance and testing should comprise assessments
of the implementation of the maintenance and testing programme. These should
cover:
A.33. Direct observation by the regulatory body should include a sampling of the
operator’s inspection and testing activities, including such tests as: calibration of
nuclear instrumentation systems; verification of containment integrity; testing of
local leak rates for the containment; testing of piping support and restraint systems;
tests for safety pumps, valve capacity and stroke timing; and surveillance tests for
breakers and transformers. Inspectors should note the capability of the individuals
performing the tests and, for complex surveillances, should assess the interface
between the surveillance personnel and the operations staff involved in the
performance of the test. The adequacy and usability of the procedures should be
assessed and the control and calibration of the test equipment should be observed.
The inspection personnel should observe the manager’s involvement in these
programmes to ensure that the programmes are effective and that safety equipment is
properly maintained, with few recurring problems. Maintenance backlogs, the
intervals at which repetitive equipment repairs are carried out and the amount of
maintenance work actually being performed should be routinely noted, as these may
be early indicators of declining performance in the maintenance programme. In this
connection, a large backlog of repairs, a high number of equipment failures and a low
level of maintenance activity may be indicative of a maintenance programme that is
difficult to manage and requires a disproportionate amount of documentation. Self-
assessment activities in these programmes should be observed and their findings
should be routinely reviewed.
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Engineering
A.36. The inspector should walk down part of a system to assess how well systems
are being maintained and should note any non-conformance. Any problems identified
by the inspector but not known to the facility’s management would call into question
the adequacy of the support programme for system engineering.
Modifications
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record to determine whether its modification process has been effective in controlling
modifications in a manner which is appropriate for their safety significance. Where
required, the regulatory body should also inspect submissions by the operator to the
regulatory body concerning a modification. The details of the process should be
checked in the inspections by sampling specific modifications and reviewing their
execution and their implications for documentation, such as the need for changes to
safety related documentation, for updating of maintenance schedules and engineering
drawings and for changes to operational procedures and training modules. These
checks may involve other parts of the regulatory body in addition to the inspection
unit. The regulatory body should also determine whether the qualifications of the
operator’s staff who perform the modifications are suitable for the function they are
performing.
Emergency preparedness
A.38. Inspection of the area of emergency preparedness and response should include
a review of emergency response plans and procedures in order to verify that the
means of coping with an emergency are adequate. Procedures for the detection and
classification of an emergency and for decision making in an emergency should be
assessed. Procedures for notification, communication, shift staffing, shift
augmentation, dose calculation and dose assessment should also be evaluated.
Emergency exercises should be witnessed to ensure that the emergency planning is
adequate and that its implementation is effective.
Physical protection
A.39. Inspection of the area of security should include a review of all activities
relating to access control, the physical protection of equipment in safety related areas
and fitness for duty programmes, as applicable. Inspection personnel should routinely
monitor the controls on access to the facility. The effects of the hardware for physical
protection on accessibility and the ability of the operator to operate the facility safely
should be routinely assessed. Inspection personnel should also review the fitness for
duty programme and assess its effectiveness.
A.40. The operator’s quality assurance programme should be reviewed to ensure that
it is comprehensive and adequately implemented. The review should cover, in
addition to the activities discussed earlier, such activities as: procurement, receipt,
storage and handling of equipment; document control; and operational experience. In
particular, the adequacy and effectiveness of the operator’s performance of a
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DECOMMISSIONING STAGE
— the adequacy of the operator’s procedure for the control of each stage of
decommissioning;
— the removal of radioactive material;
— the strategy for management of radioactive material;
— the drainage of any fluid;
— decontamination and dismantling activities;
— the waste management strategy for the treatment, conditioning, storage and
disposal of all radioactive waste;
— the physical condition of the facility, especially surveillance of the integrity
and/or the availability of relevant SSCs, including protective barriers, and the
appropriateness of the procedures at each stage of decommissioning;
— characterization of the residual activity;
— physical protection, safeguards and access control;
environmental monitoring, radiological monitoring and surveillance, including
plans for radiation protection for workers and the public;
— the adequacy and maintenance of instrumentation and control systems for long
term safety;
— decommissioning records.
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A.43. After a long period of safe enclosure, some of these regulatory inspection
activities may be reduced in thoroughness and frequency.
A.44. Before the regulatory body considers the release of any waste disposal facility
from further regulatory control, inspection activities should be concentrated on:
Areas of interest relating to the release of a facility and/or site from regulatory
control
A.45. Before releasing a site from any further control, the regulatory body should
carry out an inspection to confirm that any residual activity has been reduced to
acceptable levels. For waste disposal facilities, the release from control will be related
to the long term safety of the facility as set out in the post-closure safety case.
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REFERENCES
42
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GLOSSARY
assessment. The process, and the result, of analysing systematically the hazards
associated with sources and practices, and associated protection and safety
measures, aimed at quantifying performance measures for comparison with
criteria.
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.
43
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44
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45
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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.
Argentina: D’Amato, E.; Brazil: Caubit da Silva, A.; Canada: Bishop, A., Duncan,
R.M.; China: Zhao, C.; France: Lacoste, A.-C., Gauvain, J.; Germany: Renneberg,
W., Wendling, R.D.; India: Sukhatme, S.P.; Japan: Suda, N.; Republic of Korea: Kim,
S.-J.; Russian Federation: Vishnevskij, Yu.G.; Spain: Martin Marquínez, A.; Sweden:
Holm, L.-E.; Switzerland: Jeschki, W.; Ukraine: Smyshlayaev, O.Y.; United
Kingdom: Williams, L.G. (Chair), Pape, R.; United States of America: Travers, W.D.;
IAEA: Karbassioun, A. (Co-ordinator); International Commission on Radiological
Protection: Clarke, R.H.; OECD Nuclear Energy Agency: Shimomura, K.(Co-ordi-
nator); International Commission on Radiological Protection: Clarke, R.H.; OECD
Nuclear Energy Agency: Shimomura, K.
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