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Topic 3:
Licensing, Inspection &
Enforcement
 Licensing Legislation (1)
 A license is a legal document issued by the regulatory
body granting authorization to create a nuclear
installation and to perform specified activities.
 A license is a product of the authorization process,
generally covering a particular stage of the lifetime of
a nuclear installation. The term ‘licensing process’ is
often used for nuclear installations; it includes all
licensing and authorization processes for a nuclear
installation and its activities.
 The holder of a current and valid license is termed a
licensee. The licensee is the person or organization
having overall responsibility for a nuclear installation
and its activities and possessing all necessary
licenses for the installation and its activities.
 Licensing Legislation (2)
 The person or organization having overall
responsibility for a nuclear installation needs to apply
to the regulatory body for permission to begin or
continue to carry out certain activities, as specified by
the regulatory body.
 A licensee may lose its license for operation, for
instance, but should not be released from its prime
responsibility for safety and security unless so
specified by the regulatory body.
 An applicant is a person or organization who applies
to a regulatory body for authorization to establish a
nuclear installation, or parts of a nuclear installation,
or to undertake specified activities.
 Licensing Legislation (3)
 Licenses and authorizations, as defined earlier,
should be granted or denied in accordance with the
national legal and governmental framework and
should cover all stages of the lifetime of the nuclear
installation:
- site evaluation
- design
- construction
- commissioning
- operation
- decommissioning
- subsequent release of the site from regulatory
control
 Documentation for Licensing (1)
(1) A descriptive construction report (including a quality
manual), which consists of a description of the fundamental
elements including basic information on the nuclear
installation, the process and technologies used, justification
of related activities and provisions for decommissioning;
(2) References to and benchmarks against other relevant
nuclear installations, including those in other States, if any,
and a summary of the most significant differences between
the installations;
(3) A draft plan for the project, including phases and
anticipated schedule (including technical research and
development, if necessary), a prior economic study
regarding the necessary financial investments and the
expected costs;
 Documentation for Licensing (2)
(4) A site evaluation report, which may include a report on
the environmental radiation monitoring program and all or
some of the elements described previously dealing with the
site evaluation;
(5) Reports on the use of cooling sources and discharges
into the environment, and a report on the environmental
impact assessment;
(6) Public inquiry strategy plans and reports according to
each State’s framework and practices;
(7) A report on the management and organization of the
design and construction project, including responsibilities
and a list of contractors;
(8) A report on the acquisition program, including a list of the
structures;
 Documentation for Licensing (3)
(9) The strategic plan for the licensing process, including
the set of requirements, guides, codes and standards to
comply with, which may be partly adopted from the
vendor State (if any);
(10) A preliminary safety analysis report before
authorization to begin construction, which may include
information on site evaluation, the design basis, nuclear
and radiation safety, deterministic analyses and
complementary probabilistic safety assessment;
(11) Plans relating to the operating organization and its
management system for all licensing steps;
(12) Technical design documents;
 Documentation for Licensing (4)
(13) Physical protection plans prepared using design
related threat analyses, and especially interfaces with
safety measures;
(14) Fire protection plans;
(15) Plans for accounting for and control of nuclear
material;
(17) Proof of trustworthiness of all staff who will be engaged
in responsible or sensitive positions;
(18) Commissioning program and reports, including the
elements described earlier dealing with the commissioning
stage;
(19) Final safety analysis report, which may include all or
parts of the elements described in earlier on the site
evaluation, design, construction, commissioning and
operation stages and on provisions for decommissioning;
 Documentation for Licensing (5)
(20) Ageing management plans;
(21) General operating rules, including details of all
elements described earlier dealing with the operation
stage, and operating procedures;
(22) Technical specifications, including all operational
limits and conditions (may be included in the general
operating rules);
(23) A plan for collecting and applying feedback on
operating procedures;
(25) Operating procedures for accident management;
(26) Emergency preparedness and response plans;
(27) Reports and manuals on the radiation protection
program;
 Documentation for Licensing (6)
(28) Reports on radioactive waste and spent fuel
management, including a description of the system for the
classification and characterization of waste, and rules and
criteria to release waste;
(29) Modification rules (may be included in the general
operating rules);
(30) Details of the maintenance program and the periodic
testing program;
(31) Reports of periodic safety reviews or other safety
reviews;
(32) Decommissioning plans and reports, including
details of final shutdown, and decommissioning sub
stages, actions and safety analyses.
 Inspection & Enforcement Legislation (1)

• Nuclear law itself need not and typically does not

contain detailed technical requirements.
• These are usually promulgated by the regulatory body in
the form of regulations or licence conditions.
• A State’s nuclear law should set forth the regulatory
functions essential for protecting public health, safety
and the environment.
• It will be essential for States to have laws, regulations,
guidance and organizations that can license or permit
nuclear power plants and support nuclear facilities,
ensure compliance by inspection, and enforce nuclear
regulations.
 Inspection & Enforcement Legislation (2)
• The viability of nuclear power worldwide depends on
an extremely high level of safety everywhere, and
compliance with a number of international treaties is
required before supplier nations will provide the
material, both hardware and software, to build and
operate nuclear power plants.
• While infrastructure support can be obtained from the
IAEA and other countries, an essential core of
expertise must exist in the country seeking to
establish domestic nuclear power generation.
 Inspection & Enforcement Legislation (3)
• National arrangements are also needed for emergency
preparedness, environmental protection, fuel
transportation and the storage, transportation and
disposal of radioactive waste. If foreign contractors and
consultants are engaged to perform much of the
technical work for the regulatory body(s) that has to be
performed by the importing nation, that nation must
have a core cadre of technically knowledgeable
regulators and an organization to provide management
and oversight of the contractors and consultants.
• Consistency in national nuclear regulations, the
deployment of standardized nuclear power plant
designs and standardized supporting material
infrastructure can promote the safe and secure
worldwide growth in nuclear power.
 Scope and Objectives of Inspection &
Enforcement (1)

• Regulatory inspection and enforcement activities cover

all areas of regulatory responsibility.
• Inspections allow the regulatory body 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 are applied as necessary by the
regulatory body in the event of deviations or non-
compliance with conditions and requirements.
 Scope and Objectives of Inspection &
Enforcement (2)
• Principal objectives of regulatory inspection and
enforcement are to provide a high level of assurance
that all activities performed by the operator during all
the stages of the authorization process and during all
stages of the lifetime of a nuclear facility (siting, design,
construction, commissioning, operation and
decommissioning or closure) are executed safely and
meet the safety objectives and license conditions.
• Inspection is performed to check independently the
operator and the state of the facility, and to provide a
high level of confidence that operators are complying
with the safety objectives prescribed or approved by the
regulatory body.
 Inspection & Enforcement (1)
• Regulatory inspection includes a range of planned and
reactive inspections over the lifetime of a nuclear facility
and inspections of relevant parts of the operator’s
organization and contractors to ensure compliance with
regulatory requirements.
• Regulatory enforcement actions are actions 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
structures, systems or components as necessary to ensure
safety.
• Enforcement actions may also include the imposition or
recommendation of civil penalties and other sanctions.
 Inspection & Enforcement (2)
• With regard to inspection, the regulatory body shall has
the authority:
• To establish regulations and issue guidance which, among
other things, serve as the basis for inspection;
• To enter the premises of any facility subject to the regulatory
process at any time for the purposes of inspections;
• To require preparation of, access to, and submission of reports
and documents from operators and their contractors when
necessary;
• To seek the co-operation and support of other governmental
bodies and consultants with inspection related competence or
qualifications; and
• To communicate information, findings, recommendations and
conclusions from inspections to other governmental bodies or
interested parties, including high level officials, as deemed
appropriate in view of the significance of the issue.
 Inspection & Enforcement (3)
• With regard to enforcement, the regulatory body has the
authority:
• To require the operator to take action to remedy deficiencies
and prevent recurrence to curtail activities or to shut down the
facility when the results of inspection or another regulatory
assessments indicate that the protection of workers, the public
and the environment might be inadequate; and
• To impose or recommend civil penalties and other sanctions for
non-compliance with specified requirements.
• The regulatory body has adequate powers and authority
to enforce compliance with its requirements and license
conditions, and has available a number of enforcement
methods to provide sufficient flexibility to implement the
method best suited to the seriousness of the violation
and the urgency of corrective actions.
 Inspection & Enforcement (4)
• The degree of authority of the regulatory inspectors is
clearly defined, and clear administrative procedures are
adopted and implemented.
• The regulatory body establishes a planned and
systematic inspection program.
• The extent to which inspection is performed in the
regulatory process will depend upon the potential
magnitude and nature of the hazard associated with the
facility or activity.
• It may occasionally be necessary owing to a heavy
short term workload to augment the regulatory body’s
inspection staff with consultants having knowledge and
experience equivalent to that of the regulatory body’s
inspection staff.
 Inspection & Enforcement (5)
• Specific responsibilities of the regulatory body include:

• Conducting planned inspections in all stages of the

authorization process;
• Carrying out reactive inspections, if appropriate, in response to
events, incidents or accidents;
• Identifying and recommending necessary changes to the safety
requirements approved by the regulatory body, specified in the
authorization or contained in the regulations;
• Preparing reports to document its inspection activities and
findings;
• Verifying the operator’s compliance with regulatory
requirements and otherwise confirming continuous adherence
to safety objectives;
 Inspection & Enforcement (5)

• Specific responsibilities of the regulatory (continuation):

• Ensuring that the operator has adequate, comprehensive and

up-to-date information on the status of the facility and for the
demonstrating its safety, and a procedure to maintain this
information;
• Verifying that corrective actions have been undertaken by the
operator to resolve safety issues identified previously;
• Tracking recurrent problems and non-compliance;
• Developing such procedures and directives as may be
necessary for the effective conduct and administration of the
inspection program; and
• Determining and recommending suitable enforcement actions
when non-conformance with requirements is identified.
 Inspection & Enforcement (6)
• The regulatory body has statutory powers to enforce
compliance with its requirements as specified in the
applicable regulations and in license conditions,
including the authority to require an operator to modify,
correct or curtail any aspect of a facility's operation,
procedures, practices, systems, structures or
components as necessary to ensure the required level
of safety.
• A range of enforcement measures are available to the
regulatory body, such as the issuing of written warnings
or directives, or orders to curtail activities, the
modification or revocation of licenses or authorizations,
and the imposition of penalties.
 Inspection & Enforcement (7)
• The factors to be taken into account by the regulatory
body in deciding which enforcement action is
appropriate in each case 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 willful 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 its related trend;
• The need for consistency and transparency in the treatment of
operators.
 Conclusion

• The regulatory authorities have a wide scope for

discretion in the practical implementation of
inspection and enforcement.
• Safety law holds licensees responsible for safety of
nuclear related activities.
• IAEA provides guidelines of safety goals and the aim
is for licensees to set out on how to meet them.
• Enforcement action will be taken by the regulatory
authorities to ensure safety goals are met by
licensees.