Legal, Institutional and Regulatory Infrastructure
Introduction
The government establishes national policy for safety by means of different
instruments, statutes and laws. Typically, the regulatory body, as designated by the
government, is charged with the implementation of policies by means of a regulatory
programme and a strategy set forth in its regulations or in national standards. The
government determines the specific functions of the regulatory body and the allocation
of responsibilities. For example, the government establishes laws and adopts policies
pertaining to safety, whereas the regulatory body develops strategies and promulgates
regulations in implementation of such laws and policies. In addition, the government
establishes laws and adopts policies specifying the responsibilities and functions of
different governmental entities in respect of safety and emergency preparedness and
response, whereas the regulatory body establishes a system to provide effective
coordination.
Scope
The objective of this lecture is to introduce the main elements of a national radioactive
waste management infrastructure, the basic requirements for legal and governmental
responsibilities, and other actions needed to achieve effective regulatory control of
radioactive waste management.
The present lecture will address the following issues:
•
Framework for Radioactive Waste Management
•
Legislative arrangements
•
The Regulatory Authority & the Regulatory Control System
•
Responsibilities of implementers
•
Other Infrastructure elements
Definitions
The terms used in this publication have the meanings ascribed to them in the IAEA
Safety Glossary, 2007 Edition [2], where applicable.
Summary of the Lesson
Framework for Radioactive Waste Management
The waste management framework may be described as follows: At the highest level
are found international commitments, agreements, and treaties – in the field of
radioactive waste management, this includes the Joint Convention, regional
agreements (such as the Euratom treaty) and bilateral agreements.
Whether there are international agreements in place or not, a national Policy and
Strategy form the necessary framework for establishing a legal framework.
This legal framework that implements the policy and strategy can be described in a
triangle, with laws at the top, subordinate legislation such as regulations issued under
the authority of the primary legislation, and guidance (non-mandatory) on what are
considered to be satisfactory ways of meeting the legislative requirements. The triangle
schematic represents the relative sizes of these components. The laws at the top are
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changed only rarely, by an act of the legislative assembly. Subordinate legislation is
larger in volume, and can be issued by the government following legislative
requirements for the issuing of this kind of legislation. Guidance is the largest
component, and can usually be issued by the regulatory body without the need for
government approval, although the regulatory body may have policies requiring its
policies and guidance to be subject to a public consultation process. Consultation with
affected parties and other stakeholders is an important step in putting effective
requirements and guidance into place.
In order for any safety regulation system to function effectively, it must have a strong
legal basis in compliance with internationally agreed safety standards and
recommendations. The system for radioactive waste management will often be a
component of the overall legislative system for controlling uses of radiation including,
as appropriate, nuclear safety and radiation protection.
Legislative arrangements
There are certain general and more specific requirements of a legislative system that
are needed in respect of radioactive waste management, as described in Safety
Requirements GSR Part 1, GSR Part 3 and GSR Part 5.
Radioactive waste must be managed in a way that provides adequate protection for
humans and the environment now and in the future. Since a part of the radioactive
waste is long-lived this presents special problems in ensuring that the safety objectives
are met for as long as the waste remains hazardous.
To accomplish this, several elements are necessary: technical operational capability
(obviously); regulatory oversight; and a framework within which both of these operate
(national policy and direction).
Each country in which there is radioactive waste must have a national policy and
strategy for radioactive waste management. The policy sets out the objectives and
principles of radioactive waste management that are to be achieved. The strategy
determines how those objectives are to be met, expressing decisions as to such items
as the final disposition of various types of waste, the interim measures that are to be
taken, and expected time scales for the completion of the steps in the strategy. In order
to carry out a strategy to meet national policy objectives, organizations must be put in
place with the necessary mandates and resources. These organizations should be
divided into two separate domains:
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The operational domain, comprising the facilities and operators where waste is
treated, conditioned, managed and disposed; and
The regulatory domain, comprising the independent means by which oversight
is implemented over the operators.
In the national policy and strategy, account shall be taken of the following:
(a) The fundamental safety objective and the fundamental safety principles established
in the Fundamental Safety Principles;
(b) Binding international legal instruments, such as conventions and other relevant
international instruments;
(c) The specification of the scope of the governmental, legal and regulatory framework
for safety;
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(d) The need and provision for human and financial resources;
(e) The provision and framework for research and development;
(f) Adequate mechanisms for taking account of social and economic developments;
(g) The promotion of leadership and management for safety, including safety culture.
The national policy on radioactive waste management has to set out the preferred
options for radioactive waste management. It has to reflect national priorities and
available resources and has to be based on knowledge of the waste to be managed
(e.g. knowledge of the inventory and of waste streams) now and in the future. It has to
assign responsibilities for various aspects of radioactive waste management, including
regulatory overview.
The national strategy for radioactive waste management has to outline arrangements
for ensuring the implementation of the national policy. It has to provide for the
coordination of responsibilities. It has to be compatible with other related strategies
such as strategies for nuclear safety and for radiation protection.
The government shall promulgate laws and statutes to make provision for an effective
governmental, legal and regulatory framework for safety. This framework for safety
shall set out the following:
(1) The safety principles for protecting people — individually and collectively — society
and the environment from radiation risks, both at present and in the future;
(2) The types of facilities and activities that are included within the scope of the
framework for safety;
(3) The type of authorization that is required for the operation of facilities and for the
conduct of activities, in accordance with a graded approach;
(4) The rationale for the authorization of new facilities and activities, as well as the
applicable decision making process;
(5) Provision for the involvement of interested parties and for their input to decision
making;
(6) Provision for assigning legal responsibility for safety to the persons or organizations
responsible for the facilities and activities, and for ensuring the continuity of
responsibility where activities are carried out by several persons or organizations
successively;
(7) The establishment of a regulatory body, as addressed in Requirements 3 and 4;
(8) Provision for the review and assessment of facilities and activities, in accordance
with a graded approach;
(9) The authority and responsibility of the regulatory body for promulgating (or
preparing for the enactment of) regulations and preparing guidance for their
implementation;
(10) Provision for the inspection of facilities and activities, and for the enforcement of
regulations, in accordance with a graded approach;
(11) Provision for appeals against decisions of the regulatory body;
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(12) Provision for preparedness for, and response to, a nuclear or radiological
emergency;
(13) Provision for an interface with nuclear security;
(14) Provision for an interface with the system of accounting for, and control of, nuclear
material;
(15) Provision for acquiring and maintaining the necessary competence nationally for
ensuring safety;
(16) Responsibilities and obligations in respect of financial provision for the
management of radioactive waste and of spent fuel, and for decommissioning of
facilities and termination of activities;
(17) The criteria for release from regulatory control;
(18) The specification of offences and the corresponding penalties;
(19) Provision for controls on the import and export of nuclear material and radioactive
material, as well as for their tracking within, and to the extent possible outside, national
boundaries, such as tracking of the authorizedexport of radioactive sources.
The Regulatory Authority & the Regulatory Control System
As described in GSR Part 1, the following requirements for the legislative and
governmental mechanisms of States are prerequisites to the safe management of
radioactive waste:
(1) A legislative and statutory framework shall be established to regulate the safety of
facilities and activities.
(2) A regulatory body shall be established and maintained which shall be effectively
independent of organizations or bodies charged with the promotion of nuclear
technologies or responsible for facilities or activities. This is so that regulatory
judgments can be made, and enforcement actions taken, without pressure from
interests that may conflict with safety.
(3) Responsibility shall be assigned to the regulatory body for authorization, regulatory
review and assessment, inspection and enforcement, and for establishing safety
principles, criteria, regulations and guides.
(4) The regulatory body shall be provided with adequate authority and power, and it
shall be ensured that it has adequate staffing and financial resources to discharge its
assigned responsibilities.
(5) No other responsibility shall be assigned to the regulatory body which may
jeopardize, or conflict with, its responsibility for regulating safety.
Government must ensure that there is a legal framework within which waste
management will be carried out. This includes any legal steps necessary to ensure that
the operating organization(s) have the legal status and authority necessary to carry out
waste management, and a regulatory control system for independent oversight. The
regulatory system:
•
establishes requirements and guidance on how to meet those requirements;
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authorizes operations that meet the requirements, subject to any conditions or
limitations necessary to ensure that the operations will stay within authorized
limits;
•
performs reviews, assessments and inspections to confirm that requirements
are met; and
•
where necessary, carries out enforcement actions to ensure that deficiencies
are corrected.
These regulatory functions do not necessarily have to reside in one organization, but a
comprehensive coordinated system must be in place. An independent regulatory body
will not be entirely separate from other governmental bodies. The government has the
ultimate responsibility for involving those with legitimate and recognized interests in its
decision making. However, the government shall ensure that the regulatory body is
able to make decisions under its statutory obligation for the regulatory control of
facilities and activities, and that it is able to perform its functions without undue
pressure or constraint.
To be effectively independent, the regulatory body shall have sufficient authority and
sufficient staffing and shall have access to sufficient financial resources for the proper
discharge of its assigned responsibilities. The regulatory body shall be able to make
independent regulatory judgements and decisions, free from any undue influences that
might compromise safety, such as pressures associated with changing political
circumstances or economic conditions, or pressures from government departments or
from other organizations. Furthermore, the regulatory body shall be able to give
independent advice to government departments and governmental bodies on matters
relating to the safety of facilities and activities.
No responsibilities shall be assigned to the regulatory body that might compromise or
conflict with its discharging of its responsibility for regulating the safety of facilities and
activities.
The legal framework for safety shall be established in such a way that the authorized
party retains the prime responsibility for safety throughout the lifetime of facilities and
the duration of activities, and shall not delegate this prime responsibility. Responsibility
for safety may be transferred to a different authorized party when there has been a
declared change, approved by the regulatory body, of general responsibility for a
facility or activity. In addition, responsibility for safety may extend to other groups
associated with the authorized party, such as designers, suppliers, manufacturers and
constructors, employers, contractors, and consignors and carriers, in so far as their
activities or products may be of significance for safety. However, in no case may this
extension of responsibility relieve the authorized party of the prime responsibility for
safety. The authorized party has the responsibility for verifying that radioactive waste
meet its expectations and that they comply with regulatory requirements.
The prime responsibility for safety shall extend to all stages in the lifetime of facilities
and the duration of activities, until their release from regulatory control; i.e. to site
evaluation, design, construction, commissioning, operation, shutdown and
decommissioning (or closure in the case of disposal facilities for radioactive waste) of
facilities. This prime responsibility for safety includes, as appropriate, responsibility for
the management of radioactive waste and the management of spent fuel, and
responsibility for the remediation of contaminated areas. It also includes responsibility
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for activities in which radioactive material and radioactive sources are produced, used,
stored, transported or handled.
Persons or organizations that are responsible for facilities or activities in which
radioactive waste is generated shall have responsibility for safety in the management
of the radioactive waste, including waste characterization and storage of the waste.
Decommissioning of facilities and the safe management and disposal of radioactive
waste shall constitute essential elements of the governmental policy and the
corresponding strategy over the lifetime of facilities and the duration of activities. The
strategy shall include appropriate interim targets and end states. Radioactive waste
generated in facilities and activities necessitates special consideration because of the
various organizations concerned and the long timescales that may be involved. The
government shall enforce continuity of responsibility between successive authorized
parties.
If institutional control after the closure of a disposal facility for radioactive waste is
deemed to be necessary, the responsibility for maintaining institutional control shall be
clearly assigned.
The government shall make provision for appropriate research and development
programmes in relation to the disposal of radioactive waste, in particular programmes
for verifying safety in the long term.
Appropriate financial provision shall be made for:
(a) Decommissioning of facilities;
(b) Management of radioactive waste, including its storage and disposal;
(c) Management of disused radioactive sources and radiation generators;
(d) Management of spent fuel.
Government must ensure that there is a legal framework within which waste
management will be carried out. This includes any legal steps necessary to ensure that
the operating organization(s) have the legal status and authority necessary to carry out
waste management, and a regulatory control system for independent oversight. The
regulatory system:
•
establishes requirements and guidance on how to meet those requirements;
•
authorizes operations that meet the requirements, subject to any conditions or
limitations necessary to ensure that the operations will stay within authorized
limits;
•
performs reviews, assessments and inspections to confirm that requirements
are met; and
•
where necessary, carries out enforcement actions to ensure that deficiencies
are corrected.
The objective of regulatory functions is the verification and assessment of safety in
compliance with regulatory requirements. The performance of regulatory functions shall
be commensurate with the radiation risks associated with radioactive waste
management facilities and activities, in accordance with a graded approach. The
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regulatory process shall provide a high degree of confidence, until the release of
facilities and activities from regulatory control, that:
(a) Safety is optimized, the balance between operational benefits and potential
consequences for people and the environment being taken into account.
(b) Safety assessments carried out for facilities and activities demonstrate that an
adequate level of safety has been achieved, and that the objectives and criteria for
safety established by the designer, the authorized party and the regulatory body have
been met.
(c) Site evaluation confirms the consistency of the site conditions with the design
requirements, and the adequacy of the local civil infrastructure to support safe
operation of facilities and conduct of activities.
(d) Facilities are designed and constructed to meet the relevant regulatory
requirements.
(e) Facilities are operated and activities are conducted within the limits and conditions
specified in the safety assessment and established in the authorization, and operations
are carried out safely under a proper management system.
(f) Authorized parties have the human, organizational, financial and technical
capabilities to operate facilities safely or to conduct activities safely under all
circumstances until their release from regulatory control.
(g) The shutdown and decommissioning (or closure with the continuation of institutional
control) of facilities and termination of activities comply with the regulatory
requirements.
The system of regulations and guides has to suit the legal system of the State, and the
nature and extent of the facilities and activities to be regulated. The main purpose of
regulations is to establish requirements with which all operators must comply. Such
regulations provide a framework for more detailed conditions and requirements, which
are usually incorporated into individual authorizations.
In developing regulations and guides, the regulatory body should take into
consideration comments from interested parties and the feedback of experience. Due
account should also be taken of internationally recognized standards and
recommendations, particularly IAEA safety standards.
The main purposes of regulatory inspection and enforcement are to ensure that:
(1) facilities, equipment and work performance meet all necessary requirements;
(2) relevant documents and instructions are valid and are being complied with;
(3) persons employed by the operator (including contractors) possess the necessary
competence for the effective performance of their functions;
(4) deficiencies and deviations are identified and are corrected or justified without
undue delay;
(5) any lessons learned are identified and propagated to other operators and suppliers
and to the regulatory body as appropriate; and
(6) the operator is managing safety in a proper manner.
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Regulatory inspections shall not diminish the operator’s prime responsibility for safety,
nor substitute for the control, supervision and verification activities that the operator
must carry out.
The regulatory body has to establish regulatory requirements specific to the
predisposal management of radioactive waste, on the basis of national policy and
legislation and with due regard to the safety objectives and principles. To facilitate
compliance with regulatory requirements, the regulatory body has to do the following:
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Provide necessary guidance on the interpretation of national standards and
regulatory requirements that takes into consideration the complexity of the
operations and the magnitude of the hazards associated with the facility and
operations;
Encourage dialogue between and participate in dialogues with the operator and
other interested parties;
Establish an appropriate definition and/or classification of radioactive waste;
Establish criteria for the clearance of material from regulatory control, in
accordance with national policy;
Establish and clarify to the operator the processes used to evaluate safety and
to review applications;
Document the procedures that operators are expected to follow in the licensing
process;
Document the procedures that apply to the mechanisms for compliance
verification and enforcement;
Establish a mechanism by means of which information on incidents significant
to safety is disseminated to interested parties;
Enter into agreement, where appropriate, with other governmental bodies
responsible for regulation in related fields to delineate areas of responsibility or
of cooperation;
Ensure that due consideration is given to non-radiological hazards throughout
the entire predisposal management of radioactive waste.
The regulatory body has to carry out activities that are necessary to verify that
requirements for safety and environmental protection are being met by the operator.
These activities are required to be supported by an effective management system,
including the establishment and maintenance of a strong safety culture.
To fulfil its regulatory functions, the regulatory body, where appropriate, may undertake
research, acquire independent assessment capabilities and participate in activities for
international cooperation.
Responsibilities of implementers
The prime responsibility for safe management of radioactive waste rests with the
producers of the waste and the operators of the facilities where waste is managed and
stored. Responsibilities of the various organizations shall be delineated and assigned
to ensure that any transfer of responsibility for waste between organizations is
adequately managed.
Depending on the complexity of the operations and the magnitude of the hazards
associated with the facility or the activities concerned, the operator has to ensure an
adequate level of protection and safety by various means, including:
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Demonstration of safety by means of the safety case, and for an existing facility
or activity by means of periodic safety reviews;
Demonstration of environmental protection by means of an assessment of
environmental impacts;
Derivation of operational limits, conditions and controls, including waste
acceptance criteria, to assist with ensuring that the predisposal radioactive
waste management facility is operated in accordance with the safety case;
Preparation and implementation of appropriate operating procedures, including
monitoring;
Application of good engineering practice;
Ensuring that staff are trained, qualified and competent, and, where applicable,
licensed by the regulatory body;
Establishment and implementation of a management system ;
Maintenance of records and reporting as required by the regulatory body,
including those records and reports necessary to guarantee the accountability
for and traceability of radioactive waste throughout the different processes of
radioactive waste management;
Establishment and maintenance of a mechanism to provide and ensure
adequate financial resources to discharge its responsibilities;
Development of an emergency preparedness and response plan;
Consideration of non-radiological hazards and conventional health and safety
issues.
Where appropriate, the operator may delegate work associated with the
aforementioned responsibilities to other organizations, but the operator has to retain
overall responsibility and control.
The operator is responsible for implementing measures to ensure an appropriate level
of security.
The operator, in cooperation with suppliers, in applying for an authorization for
discharges, as appropriate:
(a) Shall determine the characteristics and activity of the material to be discharged, and
the possible points and methods of discharge;
(b) Shall determine by an appropriate pre-operational study all significant exposure
pathways by which discharged radionuclides could give rise to exposure of members of
the public;
(c) Shall assess the doses to the representative person due to the planned discharges;
(d) Shall consider the radiological environmental impacts in an integrated manner with
features of the system of protection and safety, as required by the regulatory body;
(e) Shall submit to the regulatory body the findings of (a) to (d) above as an input to the
establishment by the regulatory body of authorized limits on discharges and conditions
for their implementation.
The operator shall review and modify their discharge control measures, as appropriate
and in agreement with the regulatory body, taking into account:
(a) Operating experience;
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(b) Any changes in exposure pathways or in the characteristics of the representative
person that could affect the assessment of doses due to the discharges.
There are several other infrastructure aspects that are necessary components of an
overall waste management framework. These include such items as infrastructures for
emergency preparedness and for intervention in remediation situations, infrastructure
for supporting services, as well as infrastructure related to waste management
activities, as described on the following slides.
Despite all the precautions that are taken in the design and operation of facilities, there
remains a possibility that an accident may occur. This may be contained within the
facility or it may give rise to a release of radioactive materials onto a site or into the
public environment. The latter will normally initiate emergency response arrangements.
The operator is required to establish and maintain emergency preparedness and
response plans commensurate with the hazards associated with the radioactive waste
facilities and activities, and to report incidents significant to safety in a timely manner to
the regulatory body and other interested parties, as appropriate. The arrangements for
emergency response actions both within and outside facilities, if applicable, or
elsewhere under the control of the operator, are dealt with through the regulatory
process. Government has to ensure that competent authorities have the necessary
resources and that they make preparations and arrangements to deal with any
consequences of accidents in the public domain, whether the accident occurs within or
beyond national boundaries. These preparations include the actions to be taken both
during and after an emergency.
The emergency arrangements must include a clear allocation of responsibility for
notification and decision-making. They need to ensure an effective interface between
the operator and the competent authorities and to provide for effective means of
communication.
In planning for, and in the event of, emergencies, the regulatory body normally acts as
an adviser to the government and competent authorities in respect of nuclear safety
and radiation protection.
In addition to setting policy and deciding on strategy and establishing a regulatory body
and regulatory framework, governments must also provide for the infrastructure
necessary to support the implementation of the strategy.
An item of special importance, however, is ensuring that appropriate storage and
disposal destinations exist for small users of radioactive material, including medical and
industrial users. The requirement for users to identify an acceptable destination for its
waste can only be met if such a destination exists, and it is the responsibility of
government as part of the overall national strategy for radioactive waste management
to ensure that there is such a destination available.
Government shall also ensure that appropriate research and development programmes
for radioactive waste disposal are implemented, in particular for long term safety.
A national inventory of existing and anticipated waste is an important component of a
national strategy, and is also required of signatories of the Joint Convention.
Government is responsible for ensuring that such an inventory is compiled and
maintained up to date.
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Although operators and waste generators are responsible for the safe management of
their waste, if an operator becomes insolvent it will be impossible for them to carry out
that responsibility. In order to avoid this situation, government must ensure that funding
is secured so that the financial resources necessary to manage the waste will be
available even in the event of insolvency or dissolution of the operating organization.
This funding must not be used for any purpose other than the intended waste
management. Government shall specify how such funding is to be set aside, managed,
and protected from unauthorized access. In many cases, government also specifies
how the money for such funding is to be obtained (e.g. in the form of a levy on
electricity rates).
In cases where contamination exists as a result of past activities, whether they are
accidents or simply activities that were carried out at a time when regulatory
requirements were weaker than at present or non-existent, decisions have to be taken
on whether to take action to clean up the contamination. An organization, usually
governmental, must be assigned the responsibility and authority for deciding whether
the benefits of an intervention justify the costs (in terms of occupational and public
doses as well as economic and social costs). This decision-making shall be subject to
the applicable environmental and public consultation requirements. The responsible
organization must plan the remediation work, arrange for a qualified operator to carry it
out and obtain any necessary regulatory approvals. It must also be assigned the
resources, financial and human, necessary to fulfil this responsibility.
The regulatory body must have regulations and authorization processes in place to
cater for any remediation that may be submitted to it requiring approval.
Other Infrastructure elements
In order to ensure that the national strategy can be carried out, government must also
arrange for the existence and provision of supporting services and infrastructure.
Government and, as appropriate, concerned organizations shall pay attention to, and
provide for, among other things, the following:
(1) training and education;
(2) dosimetry services;
(3) calibration and radioanalytical services;
(4) special emergency equipment;
(5) appropriate medical resources; and
(6) international co-operation.
Questions and Answers
1. Please mention 5 aspects that need to be considered in the governmental, legal and
regulatory framework for safety. (Answer: see page 3).
2. Could the operator delegate work associated with his responsibilities to other
organizations? If yes, does the operator retain overall responsibility and control for
safety? (Answer: Yes he can but retain overall responsibility for safety).
3. Is a national inventory of existing and anticipated waste an important component of
a national strategy, and is also required of signatories of the Joint Convention? Who
is responsible for ensuring that such an inventory is compiled and maintained up to
date? (Answer: Yes it is. The responsible for doing this is the Government).
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[2]
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[4]
[5]
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AGENCY,
INTERNATIONAL
LABOUR
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INTERNATIONAL MARITIME ORGANIZATION, OECD NUCLEAR ENERGY
AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS
ENVIRONMENT
PROGRAMME,
WORLD
HEALTH
ORGANIZATION,
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