IAEA Introduction to the in-house regulatory system (September 2013) - 1 -
IAEA International Atomic Energy Agency
Introduction to the in-house regulatory system
Eugenio GIL LOPEZ Radiation Safety Regulator
September 2013
IAEA Introduction to the in-house regulatory system (September 2013) - 2 -
• The statutory mandate
• Radiation practices and activities
• Regulatory System
• Roles and responsibilities
• Directors in Charge
• Radiation Protection Officers
• Occupationally Exposed Workers
• Addresses and links
• Final thoughts
Index
IAEA Introduction to the in-house regulatory system (September 2013) - 4 -
DG-IAEA
NS SG MT
NSNS
MTGS SGTS
NSRW
NSNI
NS-IEC
NE NA TC
MTBF
MTHR
MTPI
MTCD
NAFA
NAHU
NAPC
SGAS
TCAF
TCAP
TCEU
TCLA
SGOA
SGOB
SGOC
SGCP
MTIT
SGIM
TCPC
NENP
NEFW
Radiation activities
Use of Radiation Sources
Service Provision
DGO
NAEL
The Agency practices and activities
PACT
IAEA Introduction to the in-house regulatory system (September 2013) - 5 -
The Agency Regulatory System
• The Agency has a statutory obligation to provide for the
application of its safety standards to its own operations
• The Agency is responsible for the protection of his workers (staff, experts, fellows, trainees, visitors…) from ionizing
radiation arising from practices and activities conducted by the Agency or under its supervision or control
• The in-house regulatory system has been created to supervise
radiation safety in the Agency practices and activities,
• The Radiation Safety Regulations are based on the IAEA
Safety Standards and Security Recommendations, and take into account relevant safety conventions and codes of conduct.
IAEA Introduction to the in-house regulatory system (September 2013) - 6 -
Objectives
To protect individuals (workers and public) against ionizing radiation arising from the Agency operations by implementation of adequate safety and security provisions
To protect the Agency from future reclamations, by strict compliance with the international safety and security standards
To serve as an example for the Member States on the application of the
international safety and security standards
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Regulatory framework
• Practice Description • Safety Analysis • Rad. Prot. Programme • Emergency Plan • Security Plan • …
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Radiation Safety Regulations (RSR)
• Set for the in-house regulatory regime
− Implementing the IAEA Statute, Article III.A.6
− Based on the IAEA Radiation Safety Standards
− Approved by IAEA DG in Dec 2006
− Issued as the Administrative Manual, Part X
• Content
− General provisions
− Occupational exposure
− Public exposure
− Safety of sources
− Radiation emergency response at Agency premises
− Protection of workers undertaking interventions
• Manual of Guidelines and Procedures
• RSR are now under revision
IAEA RADIATION SAFETY
REGULATION
VIENNA, AUSTRIA
AUGUST 2007
IAEA Introduction to the in-house regulatory system (September 2013) - 9 -
Procedures and Guidelines Manual
Regulatory Process Procedure and Guideline
Notification Practices RSR-NOT.01-06.2007
Act. outside Agency RSR-NOT.02-06.2007
Authorization Practices RSR-AUT.01-06.2007
Service providing RSR-AUT.02-06.2007
Inspection RSR-INS.01-06.2007
Enforcement RSR-ENF.01-06.2007
RSR role in emergency situation RSR-EME.01-06.2007
Radiation Protection Officer RSR-RPO.01-06.2007
Qualified Expert RSR-QE.01-06.2007
Safety Assessment RSR-SA.01-06.2007
RS Inventory RSR-INV.01-06.2007
Optimization RSR-OPT.01-06.2007
PROCEDURES AND GUIDELINES
FOR THE INTERNAL REGULATION
OF RADIATION SAFETY
MANUAL
INTERNATIONAL ATOMIC ENERGY AGENCY
VIENNA, AUSTRIA
AUGUST 2007
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IAEA Regulatory System Vs. National Regulatory System
Director General (DG) National Authority
Radiation Safety Regulator (RSR) Regulatory Body
Director in Charge (DCh) Licensee
Radiation Protection Officer (RPO) Radiation Protection Officer
Qualified Expert (QE) Qualified Expert
RP Tech. Services Off. (RPTSO) RP Services (own or external)
Staff, Experts, Trainees (OEP) Occupational Exposed Workers
Medical Director (MD) Specialized Health Services
Incident & Emergency Center (IEC) Emergency Response Agency
Rest of the Agency Members of the public
Actors
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Obligatory nature
Standards &
Regulations
Director General
Radiation Safety
Regulator
Directors in
Charge
Radiation Protection
Officer Workers
IAEA Safety Standards
Binding Binding Binding Binding Binding
Radiation Safety
Regulations Approval
Binding May exempt as regulated
Binding Binding Binding
Authorization Certificate
Granting
Binding May temporarily
exempt with notification to the
Regulator
Binding Binding
Operational Procedures
Approval
Binding May temporarily
exempt with notification to the
Director
Binding
IAEA Introduction to the in-house regulatory system (September 2013) - 12 -
Radiation Safety Technical Services Officer
(provision of technical support services and advice)
Radiation Safety Regulator (regulatory control)
Res
pon
sib
ilit
y
for
rad
iati
on
safe
ty
Rep
ort
s on
sta
tus
of
rad
iati
on
safe
ty
Responsibility for regulating
radiation safety
Reports on regulatory compliance
NB: The functions of the Medical Director are not represented on this chart
Request for advice and services
Provision of advice and services
Approval of services
Application for approval of services
Authorization, inspection and
enforcement
Notification, application for authorization,
reports
Resp
on
sibility
for p
rovisio
n o
f
techn
ical se
rvices
Rep
ort
on
sta
tus
an
d n
eed
s
for
serv
ices
Roles and responsibilities
Director General (overall responsibility or health and safety)
Director in Charge (compliance with radiation
safety requirements)
NS -DDG (providing tech. support)
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Director in Charge (DCh)
• Director of the relevant division
• Licensee for:
− Owning practices and radioactive sources
− Performing radiation activities
− Providing technical services
• Main responsible for nuclear and radiation safety of practices and activities
• Shall appoint a Radiation Protection Officer (RPO) who assist him to fulfil its responsibilities.
• Notifying to RSR possession or use of RS and applying for authorization
• Ensuring compliance with regulatory requirements and license conditions on safety and security
• Establishing an operation RP program and RP procedures
• Providing protective equipment, radiation monitoring and keeping dose records
• Ensuring health surveillance of OEW and remove worker unfitted to work with IR
• Requesting technical support services fro RTSO
• Maintaining inventory of RS
• Notifying incidents to RSR and leading response
The DCh is: The DCh shall :
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Radiation Protection Officer (RPO)
• Appointed by DCh
• A staff from the relevant division, but not necessarily
• Responsible for daily implementation of radiological protection provisions in Agency practices and activities
• Guidelines RSR-RPO.01-06.2007 establish responsibilities and competences of the
• Supervise that work with radiation is carried out according to RSR and License Cond.
• Implement the RPP
• Carry out, or supervise, the arrangements for technical support services
• Keep records (source inventory, and dose record)
• Ensure verification of new facilities and procedures and maintenance of equipment and safety systems
• Implement emergency plans
• Supervise radiation safety of personnel
• Supervise safe handling radioactive sources
• Instruct to staff, visitor, etc. on radiation safety s and safety regulation matters
• Set up barriers around and supervise access to controlled areas.
The RPO is: The RPO shall :
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Occupationally Exposed Workers (OEW)
• Staff, experts, fellows, trainees and visitors involved in radiation practices or activities performed by the Agency or under its responsibility
• Designated by the DCh
• Protected with the annual dose limits for workers
• Every OEW have to:
− Receive appropriate training in RP matters
− Be covered by a radiation monitoring program
− Be declared fit to work with ionizing radiation
• Comply with the IAEA Regulations, Procedures and Guidelines
• Work safely and carefully and keep radiation exposure to the minimum
• Safe custody and proper use of sources and protective equipment
• Monitor workplace, body, clothes and personal effects (particularly, when handling open radioactive sources)
• Devote enough attention to radiation safety training
• Report on any unusual condition
• Report on any accident/incident
• Report any significant disorder or disturbing jobs
• Women should notify becoming pregnant
The OEW is: The OEW shall:
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Regulatory requirements
• General requirements
• Occupational exposure
• Public exposure
• Safety of Sources
• Radiation emergency response
at Agency premises
• Protection of workers
undertaking intervention
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Basic obligations
Not
Yes
Practices, services, or activities
involving potential exposure above exemption levels
Potential exposure >
Dose limit for public?
Category [RS] = I, II, III or IV?
Not
Yes
Activities outside the
Agency
Service Provision
Use of Radioactive
Sources
Review of compliance with
Regulations
RSR
Authorization
RSR
RSR
Notification
DiCh
License
RSR
Registration
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Radiation protection and safety
• Justification of practices “… only justified practices are
authorized”
• Optimization of radiation protection and safety “… registrants and licensees shall ensure that protection and safety is optimized”
• Dose limits “… registrants and licensees shall apply the dose limits”
• Dose limits for workers:
− An effective dose of 20 mSv/y averaged over 5 consecutive years
− An effective dose of 50 mSv/y in any single year
− An equivalent dose to the lens of eyes of 20 mSv/y
− An equivalent dose to the extremities or the skin of 500 mSv/y
• Dose limits for the public:
− An effective dose of 1 mSv in a year
− An equivalent dose to the lens of the eye of 15 mSv a year
− An equivalent dose to the skin of 50 mSv in a year
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• Inspections
− The Regulator conducts inspection to verify compliance with RSR and Authorization conditions
− The Regulator report findings to the DCh.
• Enforcement actions may be proposed by the Regulator
− Disciplinary measures may be imposed in case of misconduct
− The Agency may bar access to the premises in case of gross negligence or wilfulness
− The Regulator can suspend Authorization
• Appeal to the DG:
− Refusal of a regulatory authorization
− Conditions imposed in the Authorization Certificate
− Enforcement actions
Regulatory control
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Occupational protection
• Responsibilities
• Classification and delineation of areas
• Personal Protective Equipment
• Individual monitoring
• Monitoring at workplaces
• Dose records/information
• Health surveillance
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• Categorization of persons who can be involved in emergency response
• Just OEW may participate in planned recovery actions
• Dose limits for workers apply for interventions
• Special limit to prevent catastrophic situations or life saving:
− Effective dose 100 mSv
− Dose to the skin: 1 Sv
− Dose to lens of eyes: 300 mSv
• Intervention people are clearly informed about risk associated to the
intervention
• Dose incurred in interventions are recorded separately
• Medical advise has to be requested for preparing special intervention
Workers undertaking interventions
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Addresses
RSR GIL LOPEZ, Eugenio
Radiation Safety Regulator
B0701, Phone. 22814
Radiation Monitoring CRUZ SUAREZ, Rodolfo
Head of Dosimetry Lab
F-333B, Phone. 22713
RPTSO PINAK, Miroslav
NSRW/RSM Section Head
B0778 Phone: 22721, 22720
Occupational Safety Sagi, Lazlo
Radiation Safety Technical Services Unit
B0778 Phone: 22508
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Links
• IAEA Statute http://www.iaea.org/About/statute.html
• International Conventions and Codes of Conduct http://www.iaea.org/Publications/Documents/Conventions/index.html
• IAEA Safety Standards http://www-ns.iaea.org/standards/
http://www-ns.iaea.org/downloads/standards/status.pdf
• IAEA Radiation Safety Regulations http://oasis.iaea.org/OASIS/OASIS/NS/References/Radiation.htm
• IAEA RSR Procedures and Guidelines Manual http://oasis.iaea.org/OASIS/OASIS/NS/Documents/Manual.pdf
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Final thoughts
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Thanks for your attention