IAEA
International Atomic Energy Agency
Outline
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Learning objectives
Introduction
Functions of Regulatory Body (RB) on EPR
Appraisal guidance:
• Part 1: Appraisal of RB’s EPR regulations and regulatory
processes
• Part 2: Appraisal of RB’s response capabilities
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Learning objectives
After finishing this lecture the
trainee will:
• Understand IRRS Module 10
(EPR)
• Know what is included in the
review of the regulatory aspects
of Emergency Preparedness and
Response (EPR)
• Be familiar with the questions
and issues to be considered for
interviews and discussions with
the RB representatives
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Introduction
Basis for review - IAEA Safety Standards:
• GSR Part 1 (Requirement 8)
• Governmental, Legal and Regulatory
Framework for Safety (2010) (referenced 7
times during missions in the period 20062011)
• GSR Part 3
• Radiation Protection and Safety of
Radiation Sources: International Basic
Safety Standards - INTERIM EDITION
(2011)
• GS-R-2
• Preparedness and Response for a Nuclear
or Radiological Emergency (2002)
(referenced 63 times during missions in the
period 2006-2011)
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Introduction (cont’d)
Regulatory bodies have a dual role
• REGULATOR
• To regulate, authorize and control
facilities and activities in the
nuclear field
• RESPONSE ORGANIZATION
• To provide advice and expert
services on EPR at national level
• To coordinate with the National
EPR system
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As an EPR regulator:
• Establish regulations
• EPR requirements for the licensees
• The RB does not usually have jurisdiction on nonlicensees
• But “The RB shall ensure that [..] emergency arrangements are integrated with
those of other response organizations [and..] that the co-ordinated arrangements
are implemented adequately by the operators [..]” (GS-R-2)
• Authorize
• Establish an authorization system
• Provide reasonable assurance that adequate EPR
arrangements are in place for all licensees
• Verify
• Establish an inspection system
• Check the compliance of EPR arrangements with legal
requirements for all licensees
• Including the systematic evaluation of some exercises
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As a response organization:
• Preparedness
• Provide support to and coordinate with other competent
authorities in the preparedness and planning phase
• Response
• Advise the government and competent authorities
• Provide expert services
• As stipulated in the national emergency response framework
• This role may vary from MS to MS
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APPRAISAL OF EPR REGULATIONS
AND REGULATORY PROCESS
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Regulatory framework
• The RB
• Develops regulations
• Authorizes licensee’s EPR arrangements
• Verifies
• The RB’s mandate is usually limited to licensees
• Other authorities usually set and maintain requirements for the
national emergency response framework
• The RB is not usually the national co-ordinating authority for EPR
• Therefore, co-ordination with those other authorities on EPR
regulatory or legislative matters is required
• Regulatory responsibilities of the RB on EPR matters must be clear
• Coordination mechanisms and processes to ensure comprehensive
coverage of all EPR requirements and consistent approaches in
areas of overlapping jurisdiction
• For example on the protection of emergency workers
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The RB develops EPR regulations
• The EPR regulations issued by the RB should be
complete and consistent with GS-R-2
• Within the scope of the RB’s jurisdiction
• Unless otherwise stated in the legal framework, this normally covers the
responsibility of the operator for on-site and off-site areas under its
direct control and the interface with other competent authorities
• The regulatory body should coordinate with other competent
authorities in regulatory areas not under its direct jurisdiction
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Recommendation
Recommendation of
of Experienced
Experienced Reviewers
Reviewers
GS-R-2:
Generalattention
requirements
Give
particular
to:
For each GS-R-2 general, functional and infrastructure
requirement:
 Does the RB have regulatory responsibility for that
requirement?
 If yes, is there a regulatory requirement or guide on this,
and is it consistent with GS-R-2 and associated
guidance?
 If no, who is responsible for that requirement and how
does the RB coordinate with them?
 If overlapping jurisdiction for that requirement, how is
coordination effected and final regulatory decisions
made?
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Recommendation of Experienced Reviewers
Give particular attention to:
Requirement
Regulatory jurisdiction
of the RB
National
Reference
Consistent with int’l
requirements?
Remarks
Basic responsibilities
Assessment of threat
Emergency management and operations
Identifying, notifying and activating
Urgent protective actions
Information and instructions
Protecting emergency workers
Assessing initial phase
Medical response
Agricultural and longer term
countermeasures
Non-radiological impacts
Recovery
Authority
Note that not all these
areas apply to operating
organizations to the same
extent. For example, the
RB is not usually
responsible for establishing
the responsibilities of other
governments organizations
involved in EPR; the RB is
also often not the
organization responsible
for establishing
requirements for informing
the public.
Organization
Coordination
Plans and procedures
Logistics
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Training, drills and exercises
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The RB authorizes EPR
arrangements
• The applicant normally submits its Emergency
Preparedness and Response Plan
• As part of the application for the authorization
• Documents should cover preparedness processes (sustainability)
and response arrangements (actions)
• “Preparedness” and “Response” are not always in the same
document
• The RB evaluation should be systematic, complete and
consistent
• This suggests the need for an evaluation methodology and standard
• Graded approach
• The extent and depth of the regulatory evaluation should be
commensurate with the radiation risks
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Recommendation of Experienced Reviewers
Give particular attention to:
 How are EPR arrangements evaluated?
• Those documented in the licensee’s EPR plan
• Those documented in the other plans?
• Note that the RB does not necessarily have jurisdiction over
those
• Against what regulatory guide or standard?
• Is there a systematic methodology?
• How is the interface between the licensee and other authorities for
EPR evaluated?
 How does the RB coordinate with other competent
authorities for the evaluation of common areas?
• For example, readiness of emergency services that may support the
operator during an emergency?
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The RB verifies
• Verification is normally through:
• Inspections (plans, equipment, systems, facilities)
• Audits (of the EPR preparedness process, training programme and
records, etc.)
• Exercises
• There should be a process in place
• Procedures and standards
• Regulatory guides
• Etc.
• Graded approach
• The extent of the regulatory control should be commensurate with
the radiation risks
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Recommendation of Experienced Reviewers
Give particular attention to:
 What is the verification process? Look for:
• EPR inspection and audit schedule, methodology, procedures and
records
• Past inspection and audit reports
• Periodic review of the hazard assessment
 Check if the inspections and audits cover all relevant
regulatory areas
• Refer to the section/Table on regulations
• Note that the verification method might vary between EPR
requirements
• For example, equipment “inspection” vs training programme “audit”
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Recommendation of Experienced Reviewers
Give particular attention to:
 How are exercises evaluated?
• Is there a standard methodology?
• Is it consistent with EPR Exercises 2005?
• Check exercise reports, corrective actions and trends
• If an operator has an exercise, evaluate how the RB
evaluates it
• How often are exercise evaluated by the regulator?
 How does the RB ensure the continued harmonization
of licensee EPR arrangements with those of local
response organizations?
 How does the RB monitor continuous improvement in
EPR?
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Recommendation of Experienced Reviewers
Give particular attention to:
 Note: big difference between Hazard Categories (I to
III), and IV
• I to III have a “site operator” and off-site authorities
• IV do not
• Response by local emergency services may NOT be
within the RB’s jurisdiction
• But emergency plans by source owners are
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APPRAISAL OF RB’s
RESPONSE CAPABILITY
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Legislative framework
• Legislative framework defines the role of the RB
• Roles and responsibilities of the RB in preparedness
and response should be clearly defined
• As a minimum, the RB provides advice and expert
services
• Additional roles possible depending on Member State
• The RB must have the capabilities and meet the
infrastructure requirements that apply to these roles
• The RB coordinates
• Coordination focused on preparedness and response of
the national system
• Within the “limited” jurisdiction of the RB
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Examples of possible response roles
• Notification point
• Consequence assessment
• Advice on:
• Facility status, evolution and prognosis
• Protective actions for workers and public
• Public information
• Radiation monitoring
• On-scene response (hazard category IV)
• In many MS, the RB does not actively respond at the scene
• In some, they do
• Again, the response role varies between various MS
• The IRRS review of the response capabilities of the RB must reflect
the MS-specific roles
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Recommendation of Experienced Reviewers
Give particular attention to:
 What is the extent of the RB role during response?
 Does the RB have the tools, systems, capabilities and training to
fulfill this role?
 Does the RB exercise this role on a regular basis?
 Do exercises cover all interfaces, with other response and
operating organizations?
 Check training and exercise records
• Check records and reports
• Look for corrective action plans and continuous improvement
• If they have an exercise, review the way they evaluate themselves
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Summary (Module 10 EPR)
• Module 10 is based on GSR Part 1, GSR Part 3 and
GS-R-2
• The RB is both a regulator and a response organization
• Module 10 (EPR) focuses on:
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Completeness of the EPR regulations
Effectiveness of the regulatory approval process for EPR
Effectiveness of the regulatory verification process for EPR
Coordination with other authorities in setting EPR requirements
Ability of RP to perform its assigned response functions
• Graded approach: regulatory control in EPR
commensurate with radiation risk
• IRRS module 10 (EPR) must recognize the limits of the
RB’s jurisdiction in EPR
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THANK YOU FOR YOUR
ATTENTION
This activity is conducted by the IAEA, with funding by the
European Union. The views expressed in this presentation do not
necessarily reflect the views of the European Commission
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Discussion
• Since the RB does not have jurisdiction over all
EPR aspects, how do we establish which EPR
requirements from GS-R-2 apply, and to what
extent?
• Is it the RB’s responsibility to verify that off-site
emergency preparedness and response
arrangements are adequate?
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