Regulatory Aspects and Licensing

McGill University Health CentreCentre de Santé de l’Université McGill563-613B L#2 MDCE Sep”04

Health Physics

563-613B Regulatory Aspects and Licensing

(or who’s who)

Lecture # 2 ( Sep. 17, 2004)Michael Evans


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.

QuickTime™ and aTIFF (Uncompressed) decompressor

are needed to see this picture.




Legal Jurisdiction

International Bodies (Advisory)

National Bodies (Advisory and Binding)

Provincial (Generally Binding)

Municipal (Binding and Soliciting)

Institutional (Soliciting)


Legal Jurisdiction

Radiation Oncology (Federal)

Nuclear Medicine (Federal)

Diagnostic

Imaging (Provincial)

Health Physics (Fed / Prov / Municipal)


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 CommitteeWas 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.


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

QuickTime™ and aTIFF (Uncompressed) decompressorare needed to see this picture.

http://www.icrp.org/products.asp


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 $$

http://www.icrp.org/


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


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




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


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.


National Council on Radiation Protectionand 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.


National Council on Radiation Protectionand 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.”


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)


Biological Effects of Ionizing radiationBEIR

– (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)

Reports are produced by a sub-committee of the National Academy of Science for the National Research Council which reports to the US Congress


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


http://www.unscear.org/pdffiles/1988annexd.pdf

http://www.unscear.org/pdffiles/1988annexgappx.pdf

http://www.unscear.org/pdffiles/1988annexgappx.pdf


Int’l Atomic Energy AgencyIAEA




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.







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 accidentPanama - Cobalt mistreatmentBrazil - Ruptured/stolen Cesium source ……


Some international web sites

www.irpa.netwww.icru.orgwww.icrp.orgwww.ncrp.comwww.nationalacademies.org (BEIR)www.nap.edu/catalog (BEIR)www.unscear.orgwww.iaea.orgwww-naweb.iaea.org/iaea.org/nahu/dmrp

http://www.ncrp.com/

http://www.nationalacademies.org/

http://www.nap.edu/catalog

http://www.unscear.org/

http://www.iaea.org/


Other Organizations

Bureau International de Métrologie LégaleBureau International des Poids et MesuresCouncil for International Organizations of Medical Sciences European CommissionEC Research on Radiation ProtectionEC Regulatory Aspects of Radiation ProtectionFood and Agriculture Organization of the United NationsFAO World Agricultural Information Centre International Committee of PhotobiologyInternational Council for Science ICSUInternational Electrotechnical CommissionInternational Labour OfficeInternational Labour OrganizationInternational Organization for Medical PhysicsInternational Organization for Standardization International Society of RadiologyInternational Union of Pure and Applied PhysicsRadiation Research Society The American Society for Therapeutic Radiology and Oncology, Inc.The American Association of Physicists in MedicineUnited Nations Educational, Scientific and Cultural OrganizationWorld Health Organization World Standards Services Network WSSN


Canadian Nuclear Safety CommissionCNSC

– 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.





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.


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 itemsExports of nuclear-related dual-use items Dosimetry service providers


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 RegulationsUranium 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 RegulationsCNSC Cost Recovery Fees Regulations


CNSC Regulations


CNSC Class Structuresand Licensing

Class I and II and all radioactive substances below exemption quantities

Risk types : Low, Medium and High

Controlled AreasClass 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



Class I



Class II

1015 Bq = 27 000 Ci


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”:


CNSC Radiation Therapy Licensing

Prescribed Equipment LicensingBrachytherapy, Linacs. Teletherapyi Constructionii Operate to commissioniii Operateiv Decommission

Therapy Servicing License

Survey Meter Calibration


CNSC Construction License


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


CNSC Operating License


CNSC Class II Prescribed Equipment

48 Class II licenses121 Class II PE Units





Teletherapy Irradiator - Cobalt - 60Also irradiators (GammaCell/ Cesium…)

High dose rate brachytherapy units( Ir - 192) @ 370 GBq

Linear AcceleratorsPhotons (6 & 18 MV)Electrons ( 4 to 25 MeV)


CNSC Class II Facilities

Shieldingdose limits,workload,

Safety Systemsmechanical, radiation, emergencies

Trainingmandatory, safety, service

Compliance Recordsprevious history

Dosimetry Systemspersonnel monitoring program


CNSC Class II Prescribed Equipment



LinacsLinacs



Co-60Co-60



HDRHDR



LDRLDR



Gamma KnifeGamma Knife


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


National


Provincial


Provincial

a. 147147. When there is an alteration made in the shielding, in the x-raymachine or in the latter's use, the shielding and the machine must beinspected by a physicist before operating such machine.R.R.Q., 1981, c. P-35, r. 1, s. 147SCHEDULE 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]


Provincial

L-0.2, r.1Regulation respecting the application of the Public Health Protection

Act(Updated to November, 26 2002)An Act respecting medical laboratories, organ, tissue, gamete and

embryoconservation, 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 of2001.


Provincial


National - Provincial - Territorial


Health CanadaRadiation 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


Health CanadaRadiation 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


National Dosimetry Service



Thermoluminescent Dosimeters


National Dose Registry


US Nuclear Regulatory CommissionNRC


US Nuclear Regulatory CommissionNRC

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.

http://www.nrc.gov/who-we-are/governing-laws.html#aea-1954

http://www.nrc.gov/reading-rm/basic-ref/glossary/agreement-state.html

http://www.hsrd.ornl.gov/nrc/rulemaking.htm


Canadian Food Inspection Agency (CFIA)






Transport CanadaTransportation 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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Explosives Gases FlammableLiquids

flammable solids, spontaneously combustibles and substances

that, on contact with water, emit

flammable gases

oxidizing substances and organic peroxides

poisonous (toxic) and infectious

substances corrosives

miscellaneous products or substances



Class 7Radioactive

Packing Groups I,II or III

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Fissile materials withCriticality Index

Placards





Transport IndexmR/hr at 1 m from the external surface

OR(mSv /hr x 100) at 1 m from the external surface

ContentActivity (Bq)

Transport Index









Shipping Name (Proper):

Hazard:

ID (UN#):

Package Type:

Consignor and Consignee:

Air Eligibility Labels:

Handling Labels:

RQ designation:







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 fissile-excepted

TI 0.7 and max. surface exposure rate 10 mR/hr :Category II Yellow

(Using calibrated Survey Meter)



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 -


Transport CanadaCANUTEC


Transport CanadaCANUTEC

EMERGENCIES1 613 996-6666 (collect)

•666

Information1 613 992 4624


Acquisition of high technology equipment in

Quebec

The process is extremely complicated and bureaucratic, run through three layers of bureaucracy:

Regional CouncilsMinistry of Health, and Treasury Board.

Example: Purchasing of Imaging and Cancer Therapy equipment.

Acquisition of high technology equipment

in Quebec


Health CanadaLasers, RF for Magnetic Resonnance,…


What to do whenthings go wrong

Surprise: “Oh no!”

Concern: “Is any body hurt?”

Deny: “I don’t know anything”

Say Nothing: “Ask my boss”


Labarynths - and regulators

Regulators tell you what’s wrong ;

you have to determine what’s right





Documents

Regulatory Aspects and Licensing