Health Physics
563-613B
Regulatory Aspects and Licensing
(or who’s who)
Lecture # 2 ( Sep. 17, 2004)
Michael Evans
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Historical
Discovery of X-Ray:
W. Röentgen Nov. 8, 1895
Prof. J. Cox (Physics - McGill ) and
Dr. R. Kirkpatrick (MGH).
Feb. 7, 1896 - 45 minute
radiograph of the tibia showing the
location of a bullet.
First radiograph to be accepted as
evidence in a court of law.
McGill University Health Centre
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563-613B L#2 MDCE Sep”04
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Legal Jurisdiction
International Bodies
(Advisory)
National Bodies
(Advisory and Binding)
Provincial
(Generally Binding)
Municipal
(Binding and Soliciting)
Institutional
(Soliciting)
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Centre de Santé de l’Université McGill
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Legal Jurisdiction
Radiation Oncology
(Federal)
Nuclear Medicine
(Federal)
Diagnostic
Imaging
(Provincial)
Health Physics
(Fed / Prov / Municipal)
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563-613B L#2 MDCE Sep”04
International Commission on Radiological Protection
ICRP
The International Commission on Radiological Protection, ICRP,
is an independent Registered Charity, established to advance for
the public benefit the science of radiological protection, in
particular by providing recommendations and guidance on all
aspects of protection against ionising radiation.
An advisory body providing recommendations and guidance on
radiation protection;
Founded in 1928 by the International Society of Radiology (ISR),
then called the ‘International X-ray and Radium Protection
Committee
Was restructured to better take account of uses of radiation
outside the medical area, and given its present name, in
1950; Based in the United Kingdom with a small scientific
secretariat in Sweden.
McGill University Health Centre
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563-613B L#2 MDCE Sep”04
International Commission on Radiological Protection
ICRP
ICRP published its recommendations and advice as
papers in various scientific journals in the fields of
medicine and physics. Since 1959, ICRP has its own
series of publications, since 1977 in the shape of a
scientific journal, the Annals of the ICRP
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ICRP Publications
ICRP Publication 23: Reference Man: Anatomical,
Physiological and Metabolic Characteristics
…
ICRP Publication 28: The Principles and General Procedures
for Handling
Emergency and Accidental Exposure of Workers
…
ICRP Publication 44: Protection of the Patient in Radiation
Therapy
…
ICRP Publication 84: Pregnancy and Medical Radiation
…
ICRP Publication 92: Relative Biological Effectiveness
(RBE), Quality Factor (Q), and Radiation Weighting Factor
(wR)
www.icrp.org
$$
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International Commission on Radiation Units
ICRU
The International Commission on Radiation Units and
Measurements (ICRU) was established in 1925 by the
International Congress of Radiology. Since its inception, it
has had as its principal objective the development of
internationally acceptable recommendations regarding (1)
quantities and units of radiation and radioactivity; (2)
procedures suitable for the measurement and application
of these quantities in diagnostic radiology, radiation
therapy, radiation biology, and industrial operations; and
(3) physical data needed in the application of these
procedures, the use of which tends to assure uniformity in
reporting
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International Commission on Radiation Units
ICRU
The ICRU endeavors to collect and evaluate the
latest data and information pertinent to the problems
of radiation measurement and dosimetry, and to
recommend in its publications the most acceptable
values and techniques for current use
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ICRU Publications
71: Prescribing, Recording, and Reporting Electron Beam Therapy(2004),
Journal of the ICRU, vol.4 no.1, available only from OUP
62 : Prescribing, Recording and Reporting Photon Beam Therapy
(Supplement to ICRU Report 50) ( 1999 ) US$ 65.00
50 : Prescribing, Recording and Reporting Photon Beam Therapy ( 1993 )
US$ 60.00
23 : Measurement of Absorbed Dose in a Phantom Irradiated by a Single
Beam of X or Gamma Rays ( 1973 ) US$ 40.00
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International Radiation Protection Association
IRPA
Primary purpose of IRPA is to provide a medium whereby those engaged in
radiation protection activities in all countries may communicate more readily
with each other and through this process advance radiation protection in many
parts of the world. Further objectives of IRPA are:
encourage the establishment of radiation protection societies throughout
the world as a means of achieving international cooperation,
provide for and support international meetings for the discussions of all
aspects of radiation protection• encourage international publications dedicated to
radiation protection,
encourage research and educational opportunities in those scientific and
related disciplines which support radiation protection• encourage the
establishment and continuous review of universally acceptable radiation
protection standards or recommendations through the international bodies
concerned.
McGill University Health Centre
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National Council on Radiation Protection
and Measurements (NCRP)
The NCRP has been active in the areas of radiation protection and
measurements since its inception as “The Advisory Committee on
X-Ray and Radium Protection” in 1929. It was originally established
to represent all of the national radiological organizations in the
United States on a collective, scientific basis and to serve, in
essence, as the United States national analog of the ICRP. The
NCRP originally operated as an informal association of scientists
seeking to make available information and recommendations on
radiation protection and measurements. More than 30 major reports
were produced during the early period of the NCRP's history
including the first recommendation specifying a maximum
permissible level of exposure.The NCRP was reorganized and
chartered by the U.S. Congress in 1964 as the National Council on
Radiation Protection and Measurements.
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National Council on Radiation Protection
and Measurements (NCRP) Objectives:
1. collect, analyze, develop and disseminate in the public interest
information and recommendations about (a) protection against
radiation (referred to herein as radiation protection) and (b)
radiation measurements, quantities and units, particularly
those concerned with radiation protection;
2. provide a means by which organizations concerned with the
scientific and related aspects of radiation protection and of
radiation quantities, units and measurements may cooperate
for effective utilization of their combined resources, and to
stimulate the work of such organizations;
3. develop basic concepts about radiation quantities, units and
measurements, about the application of these concepts, and
about radiation protection;
4. cooperate with the ICRP, the Federal Radiation Council, the
ICRU, and other national and international organizations,
governmental and private, concerned with radiation quantities,
units and measurements and with radiation protection.”
McGill University Health Centre
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NCRP Publications
NCRP 49: Structural Shielding Design and Evaluation
for Medical Use of X Rays and Gamma Rays of
Energies up to 10 MeV (1976)…
NCRP 94: Exposure of the Population in the United
States and Canada from Natural Background
Radiation (1988)
NCRP 90: Neptunium: Radiation Protection Guidelines
(1987)
NCRP 127: Operational Radiation Safety Program
(1998)
NCRP 144:Radiation Protection for Particle
Accelerator Facilities (2003)
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Biological Effects of Ionizing radiation
BEIR
Reports are produced by a sub-committee of the
National Academy of Science for the National
Research Council which reports to the US Congress
– (BEIR) III : "The Effects on Populations of
Exposure to Low Levels of ionizing
Radiation”(1980)
– (BEIR) V : "The Health Effects of Exposure to Low
Levels of ionizing Radiation”(1988)
– (BEIR) VI : "Health Effects of Exposure to Indoor
Radon”(1999)
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U N Scientific Cmmt’e on the Effects of Atomic Radiation
UNSCEAR
UNSCEAR was established by the General Assembly of
the United Nations in 1955. Its mandate in the United
Nations system is to assess and report levels and effects
of exposure to ionizing radiation. Governments and
organizations throughout the world rely on the
Committee's estimates as the scientific basis for
evaluating radiation risk, establishing radiation protection
and safety standards, and regulating radiation sources.

Exposures from the Chernobyl accident"
(74 pages) of the UNSCEAR 1988
Report. Acute radiation effects in victims
of the Chernobyl accident
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Int’l Atomic Energy Agency
IAEA
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Millions of Cancer Victims in Developing Countries Lack
Access to Life-Saving Radiotherapy 2003 | The number
of cancer patients in the developing world will double to
10 million new cases annually by 2015 (World Cancer
Report, World Health Organization, 2003), most of whom
will have no access to the radiation therapy that could
save or prolong their lives, and decrease their pain and
suffering.
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Int’l Atomic Energy Agency
IAEA
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Int’l Atomic Energy Agency
IAEA
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Int’l Atomic Energy Agency
IAEA
IAEA is often a “first responder” in cases of
radiation accidents in various settings including the
medical community.
IAEA can offer help and support to communities
with insufficient medical physics support, and help
with dose estimates.
Spain - Linac accident
Panama - Cobalt mistreatment
Brazil - Ruptured/stolen Cesium source
……
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Some international web sites
www.irpa.net
www.icru.org
www.icrp.org
www.ncrp.com
www.nationalacademies.org (BEIR)
www.nap.edu/catalog (BEIR)
www.unscear.org
www.iaea.org
www-naweb.iaea.org/iaea.org/nahu/dmrp
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Other Organizations
Bureau International de Métrologie Légale
Bureau International des Poids et Mesures
Council for International Organizations of Medical Sciences
European Commission
EC Research on Radiation Protection
EC Regulatory Aspects of Radiation Protection
Food and Agriculture Organization of the United Nations
FAO World Agricultural Information Centre
International Committee of Photobiology
International Council for Science ICSU
International Electrotechnical Commission
International Labour Office
International Labour Organization
International Organization for Medical Physics
International Organization for Standardization
International Society of Radiology
International Union of Pure and Applied Physics
Radiation Research Society
The American Society for Therapeutic Radiology and Oncology, Inc.
The American Association of Physicists in Medicine
United Nations Educational, Scientific and Cultural Organization
World Health Organization
World Standards Services Network WSSN
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Canadian Nuclear Safety Commission
CNSC
– The mission of the Canadian Nuclear Safety
Commission (CNSC) is to regulate the use of
nuclear energy and materials to protect health,
safety, security and the environment and to
respect Canada's international commitments on
the peaceful use of nuclear energy.On May 31,
2000, when the former Atomic Energy Control
Board became the CNSC, it was provided with
a stronger mandate to carry out its job.
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Canadian Nuclear Safety Commission
CNSC
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Canadian Nuclear Safety Commission
CNSC
Under the Nuclear Safety and Control Act, the CNSC's mandate involves four
major areas:
regulation of the development, production and use of nuclear
energy in Canada;
regulation of the production, possession, use and transport of
nuclear substances, and the production, possession and use of prescribed
equipment and prescribed information;
implementation of measures respecting international control of
the development, productions, transport and use of nuclear energy and
substances, including measures respecting the non-proliferation of nuclear
weapons and nuclear explosive devices;
dissemination of scientific, technical and regulatory information
concerning the activities of the CNSC, and the effects on the environment, on
the health and safety of persons, of the development, production, possession,
transport and use of nuclear substances.
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563-613B L#2 MDCE Sep”04
CNSC jurisdiction
CNSC regulations apply to:
Power reactors
Non-power reactors
Nuclear research and test establishments
Uranium mines and mills
Processing and fuel fabrication facilities
Heavy water production plants
Nuclear substance processing facilities
Particle accelerators
Waste management facilities
Packaging and transportation of nuclear substances
Nuclear substances and radiation devices
Lands under evaluation
Irradiators
Imports and exports of nuclear items
Exports of nuclear-related dual-use items
Dosimetry service providers
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CNSC Regulations
Canadian Nuclear Safety Commission Rules of Procedure
General Nuclear Safety and Control Regulations
Office Consolidation
Radiation Protection Regulations
Class I Nuclear Facilities Regulations
Class II Nuclear Facilities and Prescribed Equipment Regulations
Uranium Mines and Mills Regulations
Nuclear Substances and Radiation Devices Regulations
Packaging and Transport of Nuclear Substances Regulations
Office Consolidation
Nuclear Security Regulations
Nuclear Non-Proliferation Import and Export Control
Regulations
CNSC Cost Recovery Fees Regulations

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563-613B L#2 MDCE Sep”04
CNSC Regulations
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
CNSC Class Structures
and Licensing
Class I and II and all radioactive substances below exemption
quantities
Risk types : Low, Medium and High
Controlled Areas
Class A ; alpha and high gamma: 3 Bq/cm2
Class B ; beta and medium gamma: 30 Bq/cm2
Class C ; pure beta and low gamma: 300 Bq/cm2
McGill University Health Centre
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563-613B L#2 MDCE Sep”04
CNSC Class Structures
and Licensing
Class I
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CNSC Class Structures
and Licensing
Class II
1015 Bq = 27 000 Ci
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CNSC for Radiation Oncology
Regulation of all radioactive material
Regulation of all Class II prescribed equipment
Regulation of linear accelerators above 10 MV due
to photo-activation
Mandate is acquired through “The Act”:
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CNSC Radiation Therapy Licensing
Prescribed Equipment Licensing
Brachytherapy, Linacs. Teletherapy
i Construction
ii Operate to commission
iii Operate
iv Decommission
Therapy Servicing License
Survey Meter Calibration
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CNSC Construction License
McGill University Health Centre
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CNSC Operating License

Operating License
» Operating to commission
–
–
–
–
Safety Tests
Acceptance Tests
Commissioning
Safety Report
» Operating to treat
–
–
–
–
Scheduled safety procedures
Annual Compliance Reports
Renewals
Inspections/audits
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CNSC Operating License
McGill University Health Centre
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CNSC Class II Prescribed Equipment
48 Class II licenses
121 Class II PE Units
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Teletherapy Irradiator - Cobalt - 60
Also irradiators (GammaCell/ Cesium…)
Linear Accelerators
Photons (6 & 18 MV)
Electrons ( 4 to 25 MeV)
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High dose rate
brachytherapy units
( Ir - 192) @ 370 GBq
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CNSC Class II Facilities
Shielding
dose limits,workload,
Safety Systems
mechanical, radiation, emergencies
Training
mandatory, safety, service
Compliance Records
previous history
Dosimetry Systems
personnel monitoring program
McGill University Health Centre
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563-613B L#2 MDCE Sep”04
CNSC Class II Prescribed Equipment
Linacs
Co-60
Gamma
HDR
LDR Knife
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CNSC Enforcement
CNSC - Inspections ~ 1/year or so
(no fun)
CNSC - Audits @ as required
(even less fun)
CNSC surprise visits ~ rare but allowed
(the most fun)
Sanctions are on a sliding scale from infractions to warnings
to fines to license revocation to legal action
McGill University Health Centre
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National
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Provincial
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Provincial
a. 147
147. When there is an alteration made in the shielding, in the x-ray
machine or in the latter's use, the shielding and the machine must be
inspected by a physicist before operating such machine.
R.R.Q., 1981, c. P-35, r. 1, s. 147
SCHEDULE 8
(ss. 143, 150, 174, 183, 185 and 190)
MAXIMUM PERMISSIBLE DOSE (MPD) EQUIVALENTS
[L-0.2r1#09, see R.R.Q., 1981, 8-383]
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Provincial
L-0.2, r.1
Regulation respecting the application of the Public Health Protection
Act
(Updated to November, 26 2002)
An Act respecting medical laboratories, organ, tissue, gamete and
embryo
conservation, ambulance services and the disposal of human bodies
(R.S.Q., c. L-0.2, s. 69)
This Act was formerly entitled :"Public Health Protection Act". The
title
of the Act was replaced by section 149 of chapter 60 of the statutes of
2001.
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Provincial
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National - Provincial - Territorial
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Health Canada
Radiation Protection Bureau
To investigate, communicate and reduce health risks to
Canadians from exposure to ionizing and non-ionizing
radiation.
General
•
Radiation Protection in Health Canada
•
Federal Provincial Territorial Radiation
Protection Committee
Emergency Preparedness
•
Nuclear Emergency Preparedness and
Response Division
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Health Canada
Radiation Protection Bureau
Environmental
•
•
•
•
•
Arctic
Canadian Radiological Monitoring Network
Cosmic Radiation Exposure and Air Travel
Radon
Radiological Impact
Worker Related
•
Bioassay Laboratory
•
Human Monitoring Laboratory
•
National Calibration Reference Centre for
Bioassay and In VivoMonitoring
•
National Dose Registry
•
National Dosimetry Services
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National Dosimetry Service
Thermoluminescent Dosimeters
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National Dose Registry
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US Nuclear Regulatory Commission
NRC
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US Nuclear Regulatory Commission
NRC
The Atomic Energy Act (AEA) permits NRC to make
agreements with the governors of states to turn
over regulatory authority for AEA materials to
the State if certain conditions are met. States
that meet the conditions and agree to regulate
AEA materials are called "Agreement States."
Agreement States usually regulate all sources of
radiation in the State, except reactors and large
quantities of special nuclear material. Currently,
32 States have Agreements.Non-Agreement States,
and Areas of Exclusive Federal Jurisdiction within
Agreement
StatesNRC
exercises
regulatory
authority over AEA materials in those States that
do not have Agreements. In addition, certain
locations within the Agreement States may be
subject to "exclusive federal jurisdiction."
Protected areas of nuclear reactors, most
American Indian Reservations, and certain areas
on military bases are examples. NRC retains
regulatory authority over AEA materials in areas
of exclusive federal jurisdiction.
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Canadian Food Inspection Agency
(CFIA)
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Canadian Food Inspection Agency
(CFIA)
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Canadian Food Inspection Agency
(CFIA)
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Transport Canada
Transportation of Dangerous Goods (TDG)

The transportation of such products by air, marine, rail
and road is regulated under the federal Transportation
of Dangerous Goods Act, 1992. The transportation of
Dangerous Goods Regulations, adopted by all
provinces and territories, establishes the safety
requirements for the transportation of dangerous
goods.

Federal and provincial legislation provide for the
regulation of an extensive list of products, substances
or organisms classified as dangerous. The products
fall into one of nine classes:
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Transport Canada
Transportation of Dangerous Goods (TDG)
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Explosives
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Gases
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Flammable
Liquids
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oxidizing substances and
organic peroxides
flammable solids, spontaneously
combustibles and substances that, on
contact with water, emit flammable
gases
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poisonous (toxic) and
corrosives
infectious substances
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miscellaneous
products or
substances
Transport Canada
Transportation of Dangerous Goods (TDG)
Labels
Qu i ck Ti me ™a nd a
TIF F (Un co mpre ss ed )d ec omp res so r
a re ne ed ed to s ee th i s pi c tu re.
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Fissile materials with
Criticality Index
Class 7
Radioactive
Qu i ck Ti me ™a nd a
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a re ne ed ed to s ee th i s pi c tu re.
Packing Groups I,II or III
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Placards
Transport Canada
Transportation of Dangerous Goods (TDG)
Content
Activity (Bq)
Transport Index
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Transport Index
mR/hr at 1 m from the external surface
OR
(mSv /hr x 100) at 1 m from the external surface
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Transport Canada
Transportation of Dangerous Goods (TDG)
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Transport Canada
Transportation of Dangerous Goods (TDG)
Shipping Name (Proper):
Hazard:
ID (UN#):
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Package Type:
Consignor and Consignee:
Air Eligibility Labels:
Handling Labels:
RQ designation:
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Transport Canada
Transportation of Dangerous Goods (TDG)
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Transport Canada
Transportation of Dangerous Goods (TDG)
Eg:Iridium- 192 high dose rate afterloading source
Bucket to be returned by Fed-Ex
UN# 3332
Proper Shipping Name: RADIOACTIVE MATERIAL, TYPE
A PACKAGE, SPECIAL FORM non fissile or fissileexcepted
TI 0.7 and max. surface exposure rate 10 mR/hr :
Category II Yellow
(Using calibrated Survey Meter)
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Transport Canada
Transportation of Dangerous Goods (TDG)
Label: Ir-192, 300 GBq
Air Eligible, and shippers declaration consignee/consignor signature
With 24 hr telephone #(CANUTEC) and Emergency
Response Assistance Plan #
Be ready for questions regarding packing procedures -
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Transport Canada
CANUTEC
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Transport Canada
CANUTEC
EMERGENCIES
1 613 996-6666 (collect)
•666
Information
1 613 992 4624
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Acquisition of high technology equipment in
Quebec
The process is extremely complicated and
bureaucratic, run through three layers of
bureaucracy:
Regional Councils
Ministry of Health, and
Treasury Board.
Example: Purchasing of Imaging and Cancer
Therapy equipment.
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Acquisition of high technology equipment
in Quebec
Health Canada
Lasers, RF for Magnetic Resonnance,…
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
What to do when
things go wrong
Surprise: “Oh no!”
Concern: “Is any body hurt?”
Deny: “I don’t know anything”
Say Nothing: “Ask my boss”
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04
Labarynths - and regulators
QuickTime™ and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
QuickTime™ and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
Regulators tell you what’s wrong ;
you have to determine what’s right
McGill University Health Centre
Centre de Santé de l’Université McGill
563-613B L#2 MDCE Sep”04