Ga. Comp. R. & Regs. R. 391-3-17-.09 - Licensing and Radiation Safety Requirements for Irradiators
(1)
Purpose and scope.
(a) This
Rule, 391-3-17-.09,
contains requirements for the issuance of a license authorizing the use of
sealed sources containing radioactive materials in irradiators used to
irradiate objects or materials using gamma radiation. This Rule also contains
radiation safety requirements for operating irradiators. The requirements of
this Rule are in addition to other requirements of this Chapter. In particular,
the provisions of Rules
391-3-17-.02,
.03, and
.07 apply to applications and
licenses subject to this Rule. Nothing in this Rule relieves the licensee from
complying with other applicable Federal, State, and local regulations governing
the siting, zoning, land use, and building code requirements for industrial
facilities.
(b) The Regulations in
this Rule apply to panoramic irradiators that have either dry or wet storage of
the radioactive sealed sources and to underwater irradiators in which both the
source and the product being irradiated are under water. Irradiators whose dose
rates exceed 500 rads (5 Grays) per hour at one meter from the radioactive
sealed sources in air or in water, as applicable for the irradiator type, are
covered by this Rule.
(c) This Rule
does not apply to self-contained dry-source-storage irradiators (those in which
both the source and the areas subject to irradiation are contained within a
device and are not accessible by personnel), medical radiology or teletherapy,
radiography (the irradiation of materials for nondestructive testing purposes),
gauging, or open-field (agricultural) irradiations.
(d) Any sealed source licensed pursuant to
this Rule shall have a solubility equal to or less than the solubility of
cobalt-60 metal in water.
(2)
Definitions.
(a) "Annually" means once every 12 calendar
months or no later than the last day of the same calendar month of the
following year.
(b) "Doubly
encapsulated sealed source" means a sealed source in which the radioactive
material is sealed within a capsule and that capsule is sealed within another
capsule.
(c) "Irradiator" means a
facility that uses radioactive sealed sources for the irradiation of objects or
materials.
(d) "Irradiator
operator" means an individual who has successfully completed the training and
testing described in (5)(a) of this Rule and is authorized by the terms of the
license to operate the irradiator without a supervisor present.
(e) "Large irradiator" means an irradiator
where radiation dose rates exceeding 500 rads (5 Grays) per hour exist at one
meter from the sealed radioactive sources in air or in water, as applicable for
the irradiator type, but does not include irradiators in which both the sealed
source and the area subject to irradiation are contained within a device and
are not accessible to personnel.
(f) "Panoramic dry-source-storage irradiator"
means an irradiator in which the irradiations occur in air in areas potentially
accessible to personnel and in which the sources are stored in shields made of
solid materials. The term includes beam-type dry-source-storage irradiators in
which only a narrow beam of radiation is produced for performing
irradiations.
(g) "Panoramic
irradiator" means an irradiator in which the irradiations are done in air in
areas potentially accessible to personnel. The term includes beam-type
irradiators.
(h) "Panoramic
wet-source-storage irradiator" means an irradiator in which the irradiations
occur in air in areas potentially accessible to personnel and in which the
sources are stored under water in a storage pool.
(i) "Pool irradiator" means any irradiator at
which the sources are stored or used in a pool of water including panoramic
wet-source-storage irradiators and underwater irradiators.
(j) "Product conveyor system" means a system
for moving the product to be irradiated to, from, and within the area where
irradiation takes place.
(k)
"Radiation room" means a shielded room in which irradiations take place.
Underwater irradiators do not have radiation rooms.
(l) "Radiation Safety Officer" means an
individual with responsibility for the overall Radiation Safety Program at the
facility.
(m) "Sealed source" means
any byproduct material that is used as a source of radiation and is encased in
a capsule designed to prevent leakage or escape of the byproduct
material.
(n) "Seismic area" means
any area where the probability of a horizontal acceleration in rock of more
than 0.3 times the acceleration of gravity in 250 years is greater than ten
percent, as designated by the U.S. Geological Survey.
(o) "Solubility of one liquid or solid in
another" means the mass of a substance contained in the solution which is in
equilibrium with an excess of the substance.
(p) "Underwater irradiator" means an
irradiator in which the sources always remain shielded under water and humans
do not have access to the sealed sources or the space subject to irradiation
without entering the pool.
(3)
Specific Licensing
Requirements.
(a) Application for a
specific license.
1. A person, as defined in
Rule 391-3-17-.01
may file an application for a specific license authorizing the use of sealed
sources in large irradiators in accordance with Rule
.02 of this Chapter.
2. A separate license is required for each
large irradiator, radiation room, or underwater irradiator.
(b) Specific licenses for large irradiators.
The Director will approve an application for a specific license for the use of
licensed material in an irradiator if the applicant meets the requirements
contained in this section.
1. The applicant
shall satisfy the general requirements specified in Rule
391-3-17-.02 and the requirements
contained in this Rule.
2. The
applicant shall describe its training for irradiator operators that shall
include, at a minimum, the following:
(i) A
minimum of 40 hours of classroom training;
(ii) A minimum of 160 hours of on-the-job
training;
(iii) Safety
reviews;
(iv) The means the
applicant will use to test each operator's understanding of and ability to
comply with the Division's Rules and licensing requirements and the irradiator
operating and emergency procedures; and
(v) Minimum training and experience of
personnel who may provide training.
3. The applicant shall submit an outline or
summary of the written operating and emergency procedures listed in this Rule
that describes the radiation safety aspects of the procedures.
4. The application shall describe the
organizational structure for managing the irradiator, specifically the
radiation safety responsibilities or authorities. In particular, the
application must specify who, within the management structure, has the
authority to stop unsafe operations. The applicant shall also describe the
training and experience required for the position of Radiation Safety
Officer.
5. The application must
include a description of the access control system required by (4)(b) of this
Rule, the radiation monitors required by (4)(e) of this Rule, the method of
detecting leaking sources required by (5)(e) of this Rule including the
sensitivity of the method, and a diagram of the facility that shows the
locations of all required interlocks and radiation monitors.
6. The applicant shall provide assurance that
any radioactive source not used in the irradiation process shall be removed
from the irradiator pool and disposed of or returned to the
manufacturer.
7. If the applicant
intends to perform leak testing of dry-source-storage sealed sources, the
applicant shall establish procedures for leak testing and submit a description
of these procedures to the Division for approval. The procedures must include
the following:
(i) Instruments to be
used;
(ii) Methods of performing
the analysis; and
(iii) Pertinent
experience of the individual who analyzes the samples.
8. If licensee personnel are to load or
unload sources, the applicant shall describe the qualifications and training of
the personnel and the procedures to be used. If the applicant intends to
contract for source loading or unloading at his facility, the loading or
unloading must be done by an organization specifically licensed by the
Director, an Agreement State, or the U.S. Nuclear Regulatory Commission to load
or unload irradiator sources.
9.
The applicant shall perform the following operational tests to ensure proper
functioning of all equipment and safety devices before the irradiator is loaded
with sources:
(i) Interlock and radiation
safety systems;
(ii) Pool integrity
and plumbing;
(iii) Source rack
mechanical positioning system;
(iv)
Source rack movement and position sensing systems;
(v) Source rack electrical control
system;
(vi) Uninterruptible
electrical power supply for radiation monitoring warning systems;
(vii) Fire protection system;
(viii) Emergency systems for returning a
stuck source rack into the pool;
(ix) Systems used for transferring sources to
and from transport vehicles; and
(x) Product conveyor
system.
10. The applicant
shall describe the operational inspection and maintenance program, including
the frequency of the checks required by (5)(f) of this Rule.
11. The roof plug opening or removable
shielding providing access for the loading and removal of sources shall be
large enough to accommodate the largest applicable transportation
cask.
(c) The applicant
shall not begin construction of a new irradiator facility prior to the issuance
of a license by the Director. As used in this section, the term "construction"
includes the construction of any portion of the permanent irradiator structure
on the site but does not include: engineering and design work, purchase of
site, site surveys or soil testing, site preparation, site excavation, and
other similar tasks. Any activities undertaken prior to the issuance of license
with respect to the requirements of this Chapter shall be at the risk of the
applicant and have no bearing on the issuance of a license in accordance with
this Chapter.
(d) Applications for
exemptions.
1. The Director may, upon
application of any interested person or upon its own initiative, grant any
exemptions from the requirements in this Rule that it determines are authorized
by law and will not endanger public health, safety, or property.
2. Any application for a license or for an
amendment of a license authorizing use of a teletherapy-type unit for
irradiation of materials or objects may include proposed alternatives for the
requirements of this Rule. The Division will approve the proposed alternatives
if the applicant provides adequate rationale for the proposed alternatives and
demonstrates that they are likely to provide an adequate level of safety for
workers and the public.
(e) Request for written statements.
1. After the filing of the original
application, the Division may request further information necessary to enable
the Director to determine whether the application should be granted or
denied.
2. Each license is issued
with the condition that the licensee will, at any time before expiration of the
license, upon the Division's request, submit written statements or other
sufficient information to enable the Director to determine whether the license
should be modified, suspended, or revoked.
(4)
Design and Performance Requirements
for Irradiators.
(a) Performance
criteria for sealed sources.
1. Requirements.
Sealed sources installed after January 1, 1994:
(i) Must have a certificate of registration
issued under 10 CFR
32.210;
(ii) Must be doubly incapsulated;
(iii) Must use radioactive material that is
as nondispersible as practical and that is as insoluble as practical if the
source is used in a wet-source-storage or wet-source-change
irradiator;
(iv) Must be
encapsulated in a material resistant to general corrosion and to localized
corrosion, such as 316L stainless steel or other material with equivalent
resistance if the sources are for use in irradiator pools; and
(v) In prototype testing of the sealed
source, must have been leak tested and found leak-free after each of the
following tests:
2.
Temperature. The test source must be held at 40°C for 20 minutes, 600°C
for 1 hour, and then be subjected to a thermal shock test with a temperature
drop from 600°C to 20°C within 15 seconds.
3. Pressure. The test source must be twice
subjected for at least 5 minutes to an external pressure (absolute) of 2
million newtons per square meter.
4. Impact. A 2-kilogram steel weight, 2.5
centimeters in diameter, must be dropped from height of 1 meter onto the test
source.
5. Vibration. The test
source must be subjected 3 times for 10 minutes each to vibrations sweeping
from 25 hertz to 500 hertz with a peak amplitude of 5 times the acceleration of
gravity. In addition, each test source must be vibrated for 30 minutes at each
resonant frequency found.
6.
Puncture. A 50-gram weight and pin, 0.3 centimeter pin diameter, must be
dropped from a height of 1 meter onto the test source.
7. Bend. If the length of the source is more
than 15 times larger than the minimum cross-sectional dimension, the test
source must be subjected to a force of 2000 newtons at its center equidistant
from two support cylinders, the distance between which is 10 times the minimum
cross-sectional dimension of the source.
(b) Access control.
1. Each entrance to a radiation room at a
panoramic irradiator must have a door or other physical barrier to prevent
inadvertent entry of personnel if the sources are not in the shielded position.
Product conveyor systems may serve as barriers as long as they are reliable and
consistently function as a barrier. It must not be possible to move the sources
out of their shielded position if the door or barrier is open. Opening the door
or barrier while the sources are exposed must cause the sources to return
promptly to their shielded position. The personnel entrance door or barrier
must have a lock that is operated by the same key used to move the sources. The
doors and barriers must not prevent any individual in the radiation room from
leaving.
2. Each entrance to a
radiation room at a panoramic irradiator must have an independent backup access
control to detect personnel entry while the sources are exposed. Detection of
entry while the sources are exposed must cause the sources to return to their
full shielded position and must also activate a visible and audible alarm to
make the individual entering the room aware of the hazard. The alarm must also
alert at least one other individual who is onsite of the entry. That individual
shall be trained in how to respond to the alarm and prepared to promptly render
or summon assistance.
3. A
radiation monitor must be provided to detect the presence of high radiation
levels in the radiation room of a panoramic irradiator before personnel entry.
The monitor must be integrated with personnel access door locks to prevent room
access when radiation levels are high. Attempted personnel entry while the
monitor measures high radiation levels must activate the alarm described in
(4)(b)2. of this Rule. The monitor may be located in the entrance (normally
referred to as the maze) but not in the direct radiation beam.
4. Before the sources move from their
shielded position in a panoramic irradiator, the source control must
automatically activate conspicuous visible and audible alarms to alert people
in the radiation room that the sources will be moved from their shielded
position. The alarms must give individuals enough time to leave the room before
the sources leave the shielded position.
5. Each radiation room at a panoramic
irradiator must have a clearly visible and readily accessible control that
would allow an individual in the room to make the sources return to their fully
shielded position.
6. Each
radiation room of a panoramic irradiator must contain a control that prevents
the sources from moving from the shielded position unless the control has been
activated and the door or barrier to the radiation room has been closed with a
present time after activation of the control.
7. Each entrance to the radiation room of a
panoramic irradiator and each entrance to the area within the personnel access
barrier of an underwater irradiator must have a sign bearing the radiation
symbol and the words, "Caution (or danger) radioactive material." Panoramic
irradiators must also have a sign stating "Very High radiation area," but the
sign may be removed, covered, or otherwise made inoperable when the sources are
fully shielded.
8. If the radiation
room of a panoramic irradiator has roof plugs or other movable shielding, it
must not be possible to operate the irradiator unless the shielding is in its
proper location. This requirement may be met by interlocks that prevent
operation if the shield is not placed properly or by an operating procedure
requiring inspection including documentation of inspection, of shielding before
operation.
9. Panoramic irradiators
shall not operate if the requirements in (4)(b) of this Rule are not
met.
10. Underwater irradiators
must have a personnel access barrier around the pool, which must be locked to
prevent access when the irradiator is not attended. Only operators and facility
management may have access to keys to the personnel access barrier. There must
be an intrusion alarm to detect unauthorized entry when the personnel access
barrier is locked. Activation of the intrusion alarm must alert an individual
(not necessarily onsite) who is prepared to respond or summon
assistance.
(c)
Shielding.
1. The radiation dose rate in
areas that are normally occupied during operation of a panoramic irradiator may
not exceed 2 millirems (0.02 millisievert) per hour at any location 30
centimeters or more from the wall of the room when the sources are exposed. The
dose rate must be averaged over an area not to exceed 100 square centimeters
having no linear dimension greater than 20 cm. Areas where the radiation dose
rate exceeds 2 millirems (0.02 millisievert) per hour must be locked, roped
off, or posted and not entered without written approval or in the physical
presence of the Radiation Safety Officer.
2. The radiation dose at 30 centimeters over
the edge of the pool of a pool irradiator may not exceed 2 millirems (0.02
millisievert) per hour when the sources are in the fully shielded
position.
3. The radiation dose
rate at 1 meter from the shield of a dry-source-storage panoramic irradiator
when the source is shielded may not exceed 2 millirems (0.02 millisievert) per
hour and at 5 centimeters from the shield must not exceed 20 millirems (0.02
millisievert) per hour.
(d) Fire protection.
1. The radiation room at a panoramic
irradiator must have heat and smoke detectors. The detectors must activate an
audible alarm. The alarm must be capable of alerting a person who is prepared
to summon assistance promptly. The sources must automatically become fully
shielded if a fire is detected.
2.
The radiation room at a panoramic irradiator must be equipped with a fire
extinguishing system capable of extinguishing a fire without the entry of
personnel into the room. The system for the radiation room must have a shut-off
valve to control flooding into unrestricted areas.
(e) Radiation monitors.
1. Irradiators with automatic product
conveyor systems must have a radiation monitor with an audible alarm located to
detect loose radioactive sources that are carried toward the product exit. If
the monitor detects a source, an alarm must sound and product conveyors must
stop automatically. The alarm must be capable of alerting an individual in the
facility who is prepared to summon assistance. Underwater irradiators in which
the product moves within an enclosed stationary tube are exempt from the
requirements of this paragraph.
2.
For pool irradiators, the licensee shall provide a means to detect radioactive
contamination in pool water each day the irradiator operates. The means may be
either an on-line radiation monitor on the pool water purification system or an
analysis of pool water. If the licensee uses an on-line radiation monitor, the
detection of above normal background radiation levels must activate the alarm.
The alarm set-point must be set as low as practical, but high enough to avoid
false alarms. If a false alarm due to background radiation occurs, the alarm
set-point must be increased. Activation of the alarm must automatically cause
the water purification system to shut off. However, the licensee may reset the
alarm set-point to a higher level if necessary to operate the pool purification
system to clean up contamination in the pool as specifically provided in
written emergency procedures.
3.
Underwater irradiators that are not in a shielded radiation room must have a
radiation monitor over the pool to detect abnormal radiation levels. The
monitor must have an audible alarm and a visible indicator at entrances to the
personnel access barrier around the pool. The audible alarm may have a manual
shut-off. The alarm must be capable of alerting an individual who is prepared
to respond promptly.
(f)
Control of source movement.
1. The mechanism
that moves the sources of a panoramic irradiator must require a key to actuate.
Actuation of the mechanism must cause an audible signal to indicate that the
sources are leaving the shielded position. Only one key may be in use at any
time, and only operators or facility management may possess it. The key must be
attached to a portable radiation survey meter by a chain or cable. The lock for
source control must be designed so that the key may not be removed if the
sources are in an unshielded position. The door to the radiation room must
require the same key.
2. The
console of a panoramic irradiator must have a source position indicator that
indicates when the sources are in the fully shielded position, when they are in
transit, and when the sources are exposed.
3. The control console of a panoramic
irradiator must have an emergency control that promptly returns the sources to
the shielded position.
4. Each
control for a panoramic irradiator must be clearly marked as to its
function.
(g) Irradiator
pools.
1. For licenses initially issued after
January 1, 1994, irradiator pools must either:
(i) Have a water-tight stainless steel liner
or a liner metallurgically compatible with other components in the pool;
or
(ii) Be constructed so that
there is a low likelihood of substantial leakage and have a surface designed to
facilitate decontamination. In either case, the licensee shall have a method to
safely store the sources during repairs of the pool.
2. For licenses initially issued after
January 1, 1994, irradiator pools must have no outlets more than 0.5 meter
below the normal low water level that could allow water to drain out of the
pool. Pipes that have intakes more than 0.5 meter below the normal low water
level and that could act as siphons must have siphon breakers to prevent the
siphoning of pool water.
3. A means
must be provided to replenish water losses from the pool.
4. A visible indicator must be provided in a
clearly visible location to indicate the pool water level is below the normal
low water level or above the normal high water level.
5. Irradiator pools must be equipped with a
purification system designed to be capable of maintaining the water during
normal operation at a conductivity of 20 micromhos per centimeter or less and
with a clarity so that the sources can be seen clearly.
6. A physical barrier, such as a railing or
cover, must be used around or over irradiator pools during normal operation to
prevent personnel from accidentally falling into the pool. The barrier may be
removed during maintenance, inspection, and service operations.
7. If long-handled tools or poles are used in
irradiator pools, the radiation dose rate on the handling areas of the tools
may not exceed 2 millirems (0.02 millisievert) per hour.
(h) Source rack protection.
If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.
(i) Power failures.
1. If electrical power at a panoramic
irradiator is lost for longer than 10 seconds, the sources must automatically
return to the shielded position.
2.
The lock on the door of the radiation room of a panoramic irradiator shall not
be deactivated by a power failure.
3. During a power failure, the area of any
irradiator where sources are located may be entered only when using an operable
and calibrated radiation survey meter.
(j) Design requirements.
Irradiators whose construction begins after January 1, 1994, must meet the design requirements of this section.
1. Shielding. For panoramic irradiators, the
licensee shall design shielding walls to meet generally accepted building code
requirements for reinforced concrete and design the walls, wall penetrations,
and entranceways to meet the radiation shielding requirements of (4)(c) of this
Rule. If the irradiator will use more than 5 million Curies (1.85 x 1017
becquerels) of activity, the licensee shall evaluate the effects of heating of
the shielding walls by the irradiator sources.
2. Foundations. For panoramic irradiators,
the licensee shall design the foundation, with consideration given to soil
characteristics, to ensure that it is adequate to support the weight of the
facility shield walls.
3. Pool
integrity. For pool irradiators, the licensee shall design the pool to assure
that it is leak resistant, that it is strong enough to bear the weight of the
pool water and shipping casks, that a dropped cask would not fall on sealed
sources, that all outlets or pipes meet the requirements of (4)(c)2. of this
Rule, and that metal components are metallurgically compatible with other
components in the pool.
4. Water
handling system. For pool irradiators, the licensee shall verify that the
design of the water purification system is adequate to meet the requirements of
(4)(g) of this Rule. The system must be designed so that water leading from the
system does not drain to unrestricted areas without being monitored.
5. Radiation monitors. For all irradiators,
the licensee shall evaluate the location and sensitivity of the monitor to
detect sources carried by the product conveyor system as required by (4)(e)1.
of this Rule. The licensee shall verify that the product conveyor is designed
to stop before a source on the product conveyor would cause a radiation
overexposure to any person. For pool irradiators, if the licensee uses
radiation monitors to detect contamination under (5)(e)2. of this Rule, the
licensee shall verify that the design of radiation monitoring systems to detect
pool contamination includes sensitive detectors located close to where
contamination is likely to concentrate.
6. Source rack. For pool irradiators, the
licensee shall verify that there are no crevices on the source or between the
source and source holder that would promote corrosion on a critical area of the
source. For panoramic irradiators, the licensee shall determine that source
rack drops due to loss of power will not damage the source rack and that source
rack drops due to failure of cables (or alternate means of support) will not
cause loss of integrity of sealed sources. For panoramic irradiators, the
licensee shall review the design of the mechanism that moves the sources to
assure that the likelihood of a stuck source is low and that, if the rack
sticks, a means exists to free it with minimal risk to personnel.
7. Access control. For panoramic irradiators,
the licensee shall verify from the design and logic diagram that the access
control system will meet the requirements of (4)(b) of this Rule.
8. Fire protection. For panoramic
irradiators, the licensee shall verify that the number, location, and spacing
of the smoke and heat detectors are appropriate to detect fires and that the
detectors are protected from mechanical and radiation damage. The licensee
shall verify that the design of the fire extinguishing system provides the
necessary discharge patterns, densities, and flow characteristics for complete
coverage of the radiation room and that the system is protected from mechanical
and radiation damage.
9. Source
return. For panoramic irradiators, the licensee shall verify that the source
rack will automatically return to the fully shielded position if offsite power
is lost for more than 10 seconds.
10. Seismic. For panoramic irradiators to be
built in seismic areas, the licensee shall design the reinforced concrete
radiation shields to retain their integrity in the event of an earthquake by
designing to the seismic requirements of an appropriate source such as American
Concrete Institute Standard ACI 318-89, "Building Code Requirements for
Reinforced Concrete," Chapter 21, "Special Provisions for Seismic Design," or
local building codes, if current.
11. Wiring. For panoramic irradiators, the
licensee shall verify that electrical wiring and electrical equipment in the
radiation room are selected to minimize failures due to prolonged exposure to
radiation.
12. Product carriers.
For irradiators utilizing product carriers, the basic design of the carrier
shall prevent the carrier from opening or coming into contact with the source
rack or protective barrier. The basic design shall be submitted to the Division
for approval.
13. Floor
penetrations. All floor penetrations, including expansion joints, floor joints,
and drains, shall not allow the uncontrolled release of water, which has not
been analyzed for its radioactive content, from the radiation room.
14. Lift mechanisms. The lift mechanisms for
the source rack and source transport cask must be designed for working and
breaking strength to safely lift a source transport cask and sources into and
out of the irradiator pool.
15.
Ventilation. All radiation rooms in a panoramic irradiator shall be maintained
under negative pressure. Any exhaust from radiation rooms shall be through a
high-efficiency nuclear air cleaning system. This system shall consist of
standard roughing and absolute (HEPA) filters that have been tested in line in
accordance with and has met the requirements of ANSI N510.
(k) Construction monitoring and acceptance
testing.
The requirements of (4)(k) of this Rule must be met for irradiators whose construction begins after January 1, 1994. Additionally, the requirements for shielding, (4)(k)1., foundations, (4)(k)2., pool integrity, (4)(k)3., and wiring, (4)(k)11. of this Rule must be certified by a registered professional engineer. The requirements must be met prior to loading sources.
1. Shielding. For panoramic
irradiators, the licensee shall monitor the construction of the shielding to
verify that its construction meets design specifications and generally accepted
building code requirements for reinforced concrete.
2. Foundations. For panoramic irradiators,
the licensee shall monitor the construction of the foundations to verify that
their construction meets design specifications.
3. Pool integrity. For pool irradiators, the
licensee shall verify that the pool meets design specifications and shall test
the integrity of the pool. The licensee shall verify that outlets and pipes
meet the requirements of (4)(f)2. of this Rule.
4. Water handling system. For pool
irradiators, the licensee shall verify that the water purification system, the
conductivity meter, and the water level indicators operate properly.
5. Radiation monitors. For all irradiators,
the licensee shall verify the proper operation of the monitor to detect sources
carried on the product conveyor system and the related alarms and interlocks
required by (4)(e)1. of this Rule. For pool irradiators, the licensee shall
verify the proper operation of the radiation monitors and the related alarm, if
used, to meet (4)(e)2. of this Rule. For underwater irradiators, the licensee
shall verify the proper operation of the over-the-pool monitor, alarms, and
interlocks required by (4)(e)2. of this Rule.
6. Source racks. For panoramic irradiators,
the licensee shall test the movement of the source racks for proper operation
prior to source loading; testing must include source rack lowering due to
simulated loss of power. For all irradiators with product conveyor systems, the
licensee shall observe and test the operation of the conveyor system to assure
that the requirements in (4)(h) of this Rule are met for protection of the
source rack and the mechanism that moves the rack; testing must include tests
of any limit switches and interlocks used to protect the source rack and
mechanism that moves the rack from moving product carriers.
7. Access control. For panoramic irradiators,
the licensee shall test the completed access control system to assure that it
functions as designed and that all alarms, controls, and interlocks work
properly.
8. Fire protection. For
panoramic irradiators, the licensee shall test the ability of the heat and
smoke detectors to detect a fire, to activate alarms, and to cause the source
rack to automatically become fully shielded. The licensee shall test the
operability of the fire extinguishing system.
9. Source return. For panoramic irradiators,
the licensee shall demonstrate that the source racks can be returned to their
fully shielded positions without offsite power.
10. Computer systems. For panoramic
irradiators that use a computer system to control the access control system,
the licensee shall verify that the access control system will operate properly
if offsite power is lost and shall verify that the computer has security
features that prevent an irradiator operator from commanding the computer to
override the access control system when it is required to be
operable.
11. Wiring. For panoramic
irradiators, the licensee shall verify that the electrical wiring and
electrical equipment that were installed meet the design
specifications.
(5)
Operation of Irradiators.
(a) Training.
1. Before an individual is permitted to
operate an irradiator without a supervisor present, the individual must be
instructed in the following:
(i) The
fundamentals of radiation protection applied to irradiators (including the
differences between external radiation and radioactive contamination, units of
radiation dose, Division's dose limits, why large radiation doses must be
avoided, how shielding and access controls prevent large doses, how an
irradiator is designed to prevent contamination, the proper use of survey
meters and personnel dosimeters, other radiation safety features of an
irradiator, and the basic function of the irradiator);
(ii) The requirements of this Rule and Rule
391-3-17-.07 that are applicable to
the irradiator;
(iii) The operation
of the irradiator;
(iv) Those
operating and emergency procedures listed in (5)(b) of this Rule that the
individual is responsible for performing; and
(v) Case histories of accidents or problems
involving irradiators.
2.
Before an individual is permitted to operate an irradiator without a supervisor
present, the individual shall pass a written test on the instruction received,
consisting primarily of questions based on the licensee's operating and
emergency procedures that the individual is responsible for performing and
other operations necessary to safely operate the irradiator without
supervision.
3. Before an
individual is permitted to operate an irradiator without a supervisor present,
the individual must have received on-the-job training or simulator training in
the use of the irradiator as described in the license application. The
individual shall also demonstrate the ability to perform those portions of the
operating and emergency procedures that he or she is to perform.
4. The licensee shall conduct safety reviews
for irradiator operators at least annually. The licensee shall give each
operator a brief written test on the information. Each safety review must
include, to the extent appropriate, each of the following:
(i) Changes in operating and emergency
procedures since the last review, if any;
(ii) Changes in Regulations and license
conditions since the last review, if any;
(iii) Reports on recent accidents, mistakes,
or problems that have occurred at irradiators, if any;
(iv) Relevant results of inspections of
operator safety performance;
(v)
Relevant results of the facility's inspection and maintenance checks;
and
(vi) A drill to practice an
emergency or abnormal event procedure.
5. The licensee shall evaluate the safety
performance of each irradiator operator at least annually to ensure that the
Regulations, license conditions, and operating and emergency procedures are
followed. The licensee shall discuss the results of the evaluation with the
operator and shall instruct the operator on how to correct any mistakes or
deficiencies observed.
6.
Individuals who will be permitted unescorted access to the radiation room of
the irradiator or the area around the pool of an underwater irradiator, but who
have not received the training required for operators and the Radiation Safety
Officer, shall be instructed and tested in any precautions they should take to
avoid radiation exposure, and procedures or parts of procedures listed in (5)8.
of this Rule that they are expected to perform or comply with, and their proper
response to alarms required in this Rule. Tests may be oral.
7. Individual who must be prepared to respond
to alarms required by (4)(b)2., (4)(b)10., (4)(d)1., (4)(e)1., and (5)(e)2. of
this Rule shall be trained and tested on how to respond. Each individual shall
be retested at least once a year. Tests may be oral.
(b) Operating and emergency procedures.
1. The licensee shall have and follow written
operating procedures for the following:
(i)
Operation of the irradiator, including entering and leaving the radiation
room;
(ii) Use of personnel
dosimeters;
(iii) Surveying the
shielding of panoramic irradiators;
(iv) Monitoring pool water for contamination
while the water is in the pool and before release of pool water to unrestricted
areas;
(v) Leak testing of
sources;
(vi) Inspection and
maintenance checks required by (5)(f) of this Rule;
(vii) Loading, unloading, and repositioning
sources, if the operations will be performed by the licensee; and
(viii) Inspection of movable shielding
required by (4)(b)8. of this Rule, if applicable.
2. The licensee shall have and follow
emergency or abnormal event procedures, appropriate to the irradiator type, for
the following:
(i) Source stuck in the
unshielded position;
(ii) Personnel
overexposures;
(iii) A radiation
alarm from the product exit portal monitor or pool monitor;
(iv) Detection of leaking sources, pool
contamination, or alarm cause by contamination of pool water;
(v) A low or high water level indicator, an
abnormal water loss, or leakage from the source storage pool;
(vi) A prolonged loss of electrical
power;
(vii) A fire alarm or
explosion in the radiation room;
(viii) An alarm indicating unauthorized entry
into the radiation room, area around the pool, or another alarm area;
(ix) Natural phenomena, including an
earthquake, tornado, flooding, or other phenomena as appropriate for the
geographical location of the facility; and
(x) The jamming of the automatic conveyor
system.
3. The licensee
may revise operating and emergency procedures without Division approval only if
all of the following conditions are met:
(i)
The revisions do not reduce the safety of the facility,
(ii) The revisions are consistent with the
outline or summary of procedures submitted with the license
application,
(iii) The revisions
have been reviewed and approved by the Radiation Safety Officer, and
(iv) The users or operators are instructed
and tested on the revised procedures before they are put into use.
(c) Personnel
monitoring.
1. Irradiator operators shall
wear a personnel monitoring device while operating a panoramic irradiator or
while in the area around the pool of an underwater irradiator. The personnel
monitoring device processor must be capable of detecting high energy photons in
the normal and accident dose ranges. Each personnel monitoring device must be
assigned to and worn only by one individual. Film Badges must be replaced at
least monthly and all other personnel monitoring devices must be processed at
least quarterly. All personnel dosimeters must be evaluated at least quarterly
or promptly after replacement, whichever is more frequent.
2. Other individuals who enter the radiation
room of a panoramic irradiator shall wear a dosimeter, which may be a pocket
dosimeter. For groups of visitors, only two people who enter the radiation room
are required to wear dosimeters. If pocket dosimeters are used to meet the
requirements of this paragraph, a check of their response to radiation must be
done at least annually. Acceptable dosimeters must read within plus or minus 30
percent of the true radiation dose.
(d) Radiation surveys.
1. A radiation survey of the area outside the
shielding of the radiation room of a panoramic irradiator must be conducted
with the sources in the exposed position before the facility starts to operate.
A radiation survey of the area above the pool of pool irradiators must be
conducted after the sources are loaded but before the facility starts to
operate. Additional radiation surveys of the shielding must be performed at
intervals not to exceed 3 years and before resuming operations after addition
of new sources or any modification to the radiation room shielding or structure
that might increase dose rate.
2.
If the radiation levels specified in (4)(c) of this Rule are exceeded, the
facility must be modified to comply with the requirements of (4)(c) of this
Rule.
3. Portable radiation survey
meters must be calibrated at least annually to an accuracy of ±20
percent of the gamma energy of the sources in use. The calibration must be done
at two points on each scale or, for digital instruments, at one point per
decade over the range that will be used. Portable radiation survey meters must
be of a type that does not saturate and read zero at high radiation dose
rates.
4. Water from the irradiator
pool, other potentially contaminated liquids, and sediments from pool vacuuming
must be monitored for radioactive contamination before release to unrestricted
areas. Radioactive concentrations must not exceed those specified in 10 CFR
Part 20, Table 2, Column 2 or Table 3 of Appendix B, "Annual Limits on Intake
(ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational
Exposure; Effluent Concentrations; Concentrations for Release to
Sewerage".
5. Before releasing
resins for unrestricted use, they must be monitored before release in an area
with a background level of less than 0.5 millirem (0.005 millisievert) per
hour. The resins may be released only if the survey does not detect radiation
levels above background radiation levels. The survey meter used must be capable
of detecting radiation levels of 0.5 millirem (0.005 millisievert) per
hour.
(e) Detection of
leaking sources.
1. Each dry-source-storage
sealed source must be tested for leakage at intervals not to exceed six months
using a leak test kit or method approved by the Division, an Agreement State,
or the U.S. Nuclear Regulatory Commission. In the absence of a certificate from
a transferor that a test has been made within the six months before the
transfer, the sealed source may not be used until tested. The test must be
capable of detecting the presence of 0.005 microcurie (200 becquerels) of
radioactive material and must be performed by a person approved by the
Division, an Agreement State, or the U.S. Nuclear Regulatory Commission to
perform the test.
2. For pool
irradiators, sources may not be put into the pool unless the licensee tests the
sources for leaks or has a certificate from a transferor that a leak test has
been done within the six months before the transfer. Water from the pool must
be checked for contamination each day the irradiator operates. The check may be
done either by using a radiation monitor on a pool water circulating system or
by analysis of a sample of pool water. If a check for contamination is done by
analysis of a sample of pool water, the results of the analysis must be
available within 24 hours. If the licensee uses a radiation monitor on a pool
water circulating system, the detection of above normal radiation levels must
activate an alarm. The alarm set-point must be set as low as practical, but
high enough to avoid false alarms. The licensee may reset the alarm set-point
to a higher level if necessary to operate the pool water purification system to
clean up contamination in the pool if specifically provided for in written
emergency procedures.
3. If a
leaking source is detected, the licensee shall arrange to remove the leaking
source from service and have it decontaminated, repaired, or disposed of by the
Division, Agreement State, or U.S. Nuclear Regulatory Commission licensee that
is authorized to perform these functions. The licensee shall promptly check its
personnel, equipment, facilities, and irradiated product for radioactive
contamination. No product may be shipped until the product has been checked and
found free of contamination. If a product has been shipped that may have been
inadvertently contaminated, the licensee shall arrange to locate and survey
that product for contamination. If any personnel are found to be contaminated,
decontamination must be performed promptly. If contaminated equipment,
facilities, or products are found, the licensee shall arrange to have them
decontaminated or disposed of by the Division, U.S. Nuclear Regulatory
Commission, or Agreement State licensee that is authorized to perform these
functions. If a pool is contaminated, the licensee shall arrange to clean the
pool until the contamination levels do not exceed the appropriate concentration
in Table 2, Column 2, Appendix B to 20.1001 to 20.2401 of 10 CFR
20.
(f) Inspection and
maintenance.
1. The licensee shall perform
inspection and maintenance checks that include, as a minimum, each of the
following at the frequency specified in the license or license application:
(i) Operability of each aspect of the access
control system required by (4)(b) of this Rule.
(ii) Functioning of the source position
indicator required by (4)(f) of this Rule.
(iii) Operability of the radiation monitor
for radioactive contamination in pool water required by (5)(e)2. of this Rule
using a radiation check source, if applicable.
(iv) Operability of the over-the-pool
radiation monitor at underwater irradiators as required by (4)(e)3. of this
Rule.
(v) Operability of the
product exit monitor required by (4)(e)1. of this Rule.
(vi) Operability of the emergency source
return control required by (4)(e)3. of this Rule.
(vii) Leak-tightness of systems through which
pool water circulates (visual inspection).
(viii) Operability of the heat and smoke
detectors and extinguisher system required by (4)(d) of this Rule (but without
turning extinguishers on).
(ix)
Operability of the means of pool water replenishment required by (4)(g)3. of
this Rule.
(x) Operability of the
indicators of high and low pool water levels required by (4)(g)4. of this
Rule.
(xi) Operability of the
intrusion alarm required by (4)(b)10. of this Rule, if applicable.
(xii) Functioning and wear of the system,
mechanism, and cables used to raise and lower sources.
(xiii) Condition of the barrier to prevent
products from hitting the sources or source mechanism as required by (4)(h) of
this Rule.
(xiv) Amount of water
added to the pool to determine if the pool is leaking.
(xv) Electrical wiring on required safety
systems for radiation damage.
(xvi)
Pool water conductivity measurements and analysis as required by (5)(g)2. of
this Rule.
2.
Malfunctions and defects found during inspection and maintenance checks must be
repaired without undue delay.
(g) Pool water purity.
1. The pool water purification system must be
run sufficiently to maintain the conductivity of the pool water below 20
micromhos per centimeter under normal circumstances. If pool water conductivity
rises above 20 micromhos per centimeter, the licensee shall take prompt actions
to lower the pool water conductivity, and shall take corrective actions to
prevent future recurrences.
2. The
licensee shall measure the pool water conductivity frequently enough, but not
less than weekly, to assure that the conductivity remains below 20 micromhos
per centimeter. Conductivity meters must be calibrated at least
annually.
(h) Attendance
during operation.
1. Both an irradiator
operator and at least one other individual, who is trained on how to respond
and prepared to promptly render or summon assistance if the access control
alarm sounds, shall be present onsite:
(i)
Whenever the irradiator is operated using an automatic product conveyor system;
and
(ii) Whenever the product is
moved into or out of the radiation room when the irradiator is operated in a
batch mode.
2. At a
panoramic irradiator at which static irradiations (no movement of the product)
are occurring, a person who has received the training on how to respond to
alarms described in (5)(a)7. of this Rule must be onsite.
3. At an underwater irradiator, an irradiator
operator must be present at the facility whenever the product is moved into or
out of the pool. Individuals who move the product into or out of the pool of an
underwater irradiator need not be qualified as irradiator operators; however,
they must have received the training described in (5)(a)6. and 7. of this Rule.
Static irradiations may be performed without a person present at the
facility.
4. Irradiator operators
shall not be on duty more than 12 hours in any 24-hour period without at least
8 hours uninterrupted rest, unless an emergency exists and prior authorization
has been given by the Division.
(i) Entering and leaving the radiation room.
1. Upon first entering the radiation room of
a panoramic irradiator after an irradiation, the irradiator operator shall use
a survey meter to determine that the source has returned to its fully shielded
position. The operator shall check the functioning of the survey meter with a
radiation check source while entering the radiation room. The survey meter must
be of a type that does not saturate and read zero at high radiation dose
rates.
2. Before exiting from and
locking the door to the radiation room of a panoramic irradiator prior to a
planned irradiation, the irradiator operator shall:
(i) Visually inspect the entire radiation
room to verify that no one else is in it; and
(ii) Activate a control in the radiation room
that permits the sources to be moved from the shielded position only if the
door to the radiation room is locked within a preset time after setting the
control.
3. During a
power failure, the area around the pool of an underwater irradiator may not be
entered without using an operable and calibrated radiation survey meter unless
the over-the-pool monitor required by (4)(e)3. of this Rule is operating with
backup power.
(j)
Irradiation of explosive or flammable materials.
1. Irradiation of explosive material is
prohibited unless the licensee has received prior written authorization from
the Division. Authorization will not be granted unless the licensee can
demonstrate that detonation of the explosive would not rupture the sealed
sources, injure personnel, damage safety systems, or cause radiation
overexposures of personnel.
2.
Irradiation of more than small quantities of flammable material (flash point
below 140°F) is prohibited in panoramic irradiators unless the licensee has
received prior written authorization from the Division. Authorization will not
be granted unless the licensee can demonstrate that a fire in the radiation
room could be controlled without damage to sealed sources or safety systems and
without radiation overexposures of personnel.
(6)
Records.
(a) Records and retention periods.
The licensee shall maintain the following records at the irradiator for the periods specified:
1. A copy of the license, license conditions,
documents incorporated into a license by reference, and amendments thereto
until superseded by new documents or until the Director terminates the license
for documents not superseded.
2.
Records of each individual's training, tests, and safety reviews provided to
meet the requirements of (5)(a)1., 2., 3., 4., 5., and 7. of this Rule for 3
years after the evaluation.
3.
Records of the annual evaluations of the safety performance of irradiator
operators required by (5)(a)5. of this Rule for 3 years after the
evaluation.
4. A copy of the
current operating and emergency procedures required by (5)(b) of this Rule
until superseded or the Director terminates the license. Records of the
Radiation Safety Officer's review and approval of changes in procedures as
required by (5)(b)3.iii of this Rule are to be retained for 3 years from the
date of the change.
5. Personnel
monitoring results required by (5)(c) of this Rule shall be retained until the
Director terminates each pertinent license requiring the record. Upon
termination of the license, the licensee shall permanently store records on
Division Form, "Occupational Radiation Exposure History", or equivalent, or
shall make provisions with the Division for transfer to the Division.
6. Records of radiation surveys required by
(5)(d) of this Rule for three years from the date of the survey.
7. Records of radiation survey meter
calibrations required by (5)(d) of this Rule and pool water conductivity meter
calibrations required by (5)(g)2. of this Rule until three years from the date
of calibration.
8. Records of the
results of leak tests required by (5)(e)1. of this Rule and the results of
contamination checks required by (5)(e)2. of this Rule for three years from the
date of each test.
9. Records of
inspection and maintenance checks required by (5)(f) of this Rule for three
years.
10. Records of major
malfunctions, significant defects, operating difficulties or irregularities,
and major operating problems that involve required radiation safety equipment
for three years after repairs are completed.
11. Records of the receipt, transfer, and
disposal of all licensed sealed sources for three years after the transfer or
disposal of the sealed source.
12.
Records of the design checks required by (4)(j) of this Rule and the
construction control checks as required by (4)(k) of this Rule until the
license is terminated. The records must be signed and dated. The title or
qualification of the person signing must be included.
13. Records related to decommissioning of the
irradiator as required by Rule
391-3-17-.02(8)(g)8.
(b) Reports.
1. In addition to the reporting requirements
in other Rules of this Chapter, the licensee shall report the following events
if not reported under other Rules of this Chapter:
(i) Source stuck in an unshielded
position.
(ii) Any fire or
explosion in a radiation room.
(iii) Damage to the source racks.
(iv) Failure of the cable or drive mechanism
used to move the source racks.
(v)
Inoperability of the access control system.
(vi) Detection of a radiation source by the
product exit monitor.
(vii)
Detection of radioactive contamination attributable to licensed radioactive
material.
(viii) Structural damage
to the pool liner or walls.
(ix)
Abnormal water loss or leakage from the source storage pool.
(x) Pool water conductivity exceeding 100
micromhos (100 µS) per centimeter.
2. The report must include a telephone report
within 24 hours and a written report within 30 days as described in Rule
391-3-17-.03(14)(b).
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.