ORGIMP Block 1-2 Need for a Regulatory Program_2012.ppt

Organization and Implementation of a National Regulatory
Program for the Control of Radiation Sources
Module 1.2
2
Objective
• To understand the role of regulatory program in
providing adequate safety in the use of radiation
sources in various practices (e.g. medical, industrial,
agriculture, research etc).

Module 1.2
3
Contents
• Beneficial uses of ionizing radiation.
• Harmful effects due to the lack of and / or effectiveness
of an adequate and appropriate radiation safety
Program.
• Consequences of radiological accidents and lessons
learned.

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4
• science;
Uses of Radiation
Radiation sources have been used to benefit society in:
• research;
• industry;
• medicine;
• environmental protection; and
• a number of academic and commercial fields.

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• Regardless of the beneficial uses, many people are
afraid of radiation and the potentially harmful effects.
• The public is concerned about accidents that could
affect their health and everyday lives.
Uses of Radiation (cont)

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6
• “Governments, regulatory bodies and
operators everywhere must ensure
that nuclear material and radiation
sources are used beneficially, safely
and ethically”
Basic Safety Standards (GSR Part 3)
Risk control

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7
The Main Uses of Radiation Sources

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The primary purpose of a regulatory program is to provide
an appropriate standard of protection and safety for
humans without unduly limiting the benefits of the practice
giving rise to the exposure.
Purpose of a Regulatory System

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• prevent the occurrence of deterministic effects in
individuals by ensuring doses are kept below the
relevant threshold;
Purpose of a Regulatory System (cont)
Effective defences against radiological hazards from
sources should be established and maintained to:
• ensure that all reasonable steps are taken to minimize
the occurrence of stochastic effects in the population.

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Deterministic effects
• There is a threshold dose below which no short term
effect is observed.
• Above this threshold the severity of the effect
increases with dose e.g. burns, nausea.
Deterministic and Stochastic Effects
Stochastic effects
• There is no established threshold dose.
• The probability of a long term effect increases with dose
e.g. the induction of cancer.

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Early Observed Effects of Ionizing Radiation

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Balance benefits / costs and detriments through:
• justification;
Basic Principles
Implement the regulatory requirements through:
• optimization;
• limitation.
• prevention;
Proper organization and management
• mitigation.

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• The justification of a practice implies doing more good
than harm.
Basic Principles (cont)
• The optimization of protection implies maximizing the
margin of good over harm (ALARA).
• The use of recognized dose limits implies an adequate
standard of protection even for the most highly
exposed individuals.

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The Standards are intended:
• to place requirements on persons or organizations
authorized to conduct practices causing radiation
exposure, and
• to provide for intervention in order to reduce existing
exposures.
Restriction of Risks
The risks associated with radiation exposure must be
minimized and workers and the public protected by
applying basic radiation safety standards.

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• The implementation of the Standards requires that a
Regulatory Body be established by the Government to
regulate the introduction and conduct of any practice
involving sources of radiation.
Implementation of the Standards
• The Regulatory Body should implement a national
regulatory program for the control of radiation sources.

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• in industrial irradiators;
Lessons to be Learned
Accidents resulting in fatalities and injuries have been
reported:
• industrial radiography;
• radiotherapy; and
• as the result of lost or abandoned sources, etc.

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Reports on Lessons from Major Accidents

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Individual Accident Reports

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An inadequate regulatory framework in respect of:
• authorizations;
• inspections;
• enforcement.
Causes of Accidents
Poor user safety culture in areas such as:
• management;
• quality control;
• training and qualifications of personnel.

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Accidents with Irradiators

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Accidents with Irradiators (accelerators)
Date Place Outcome
1965 Illinois, USA 1 person; amputation of a leg
and arm
1967 Pittsburgh, USA 3 persons irradiated; amputation
of the arms of 1 person
1991 Hanoi, Vietnam Amputation of 1 hand and the
fingers of the other hand
1991 Maryland, USA Amputation of 4 fingers of each
hand
1977 New Jersey, USA 1 person; acute radiation
syndrome

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Accidents with Irradiators (gamma)
Date Place Outcome
1974 New Jersey, USA 1 person; acute radiation
syndrome
1975 Stimos, Italy 1 death
1982 Kjeller, Norway 1 death
1989 San Salvador, El Salvador 1 death
1990 Soreq, Israel 1 death
1991 Nesvizh, Belarus 1 death

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Accidents with Radiotherapy Patients

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Number of Patients involved in Radiotherapy Accidents

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• Generally involve the
public; and
• workers who are not
involved with the normal
use of the sources.
Accidents due to loss of control of sources

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Deaths due to loss of control of sources

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Deterministic Effects in Diagnostic Radiology
Skin damage 18-21 months after
this 40 year old patient
underwent 2 coronary
angiograms and a coronary
angioplasty in the one day.
Estimated skin dose > 20 Gy.
Source: Radiation Induced Skin Injuries from Fluoroscopy
Thomas B Shope 1995
USFDA Center for Devices and Radiological Health

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Deterministic skin injuries reported to USFDA 1992-94

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• There was an excessive and / or inappropriate use of
the high dose rate mode.
• The filtration of the x-ray beam was inadequate.
• A fixed beam geometry was used (radiation entering
through the same skin surface all the time).
• There was an undetected malfunction of the automatic
exposure control system.
Diagnostic Radiology Incidents - Summary of Lessons
• The x-ray tube was too close to the patient.

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• Severe deterministic effects e.g.
death, loss of limbs, erythema, acute radiation syndrome.
General Consequences of Accidents
• Contamination of the environment.
• Social impact.
• Economic impact.

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• maintenance;
• control.
Safe operation requires:
• training;
Safe use of Radiation Sources
Radiation Sources:
• are widely used;
SAFETY CULTURE
}
• provide substantial benefits; but
• can cause harmful effects (injury or death).

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the
RISKS
BENEFITS
should outweigh
Safe use of Radiation Sources

Module 1.2
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• Radiation Protection and Safety of Radiation Sources: International Basic
Safety Standards. Generic Safety Requirements. GSR Part 3 (Interim) Vienna
(2011).
• Handbook on Nuclear Law: Volume 1 & 2 (2010).
• Model Regulations for the use of radiation sources and for the management of
the associated radioactive waste. Draft: 2012-04-04.
• Regulatory Control of Radioactive Sources, Safety Standards Series No. GS-G-
1.5, IAEA, Vienna (2004).
• Notification and Authorization for the Use of Radiation Sources
(Supplement to IAEA Safety Standards Series No. GS-G-1.5) IAEA TECDOC
1525, Vienna (2007).
• Inspection of Radiation Sources and Regulatory Enforcement (Supplement to
IAEA Safety Standards Series No. GS-G-1.5) IAEA TECDOC 1526.
• Lessons Learned from Accidents in Radiotherapy, Industrial Irradiation
Facilities and Industrial Radiography, (reports in) IAEA Safety Reports Series.
• Safety of Radiation Generators and Sealed Radioactive Sources, Safety
Standard Series No. RS-G-1.10, IAEA, Vienna (2006). IAEA, Accident reports
(various).
References

ORGIMP Block 1-2 Need for a Regulatory Program_2012.ppt

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