Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS 211.842-211.852,
211.990(4)
NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human
Resources is authorized by
KRS
211.844 to provide by administrative
regulation for the registration and licensing of the possession or use of
sources of ionizing or electronic product radiation and the handling and
disposal of radioactive waste. The purpose of this administrative regulation is
to provide radiation safety requirements for particle accelerator
operations.
Section 1. Applicability.
The requirements in this administrative regulation apply to the use of particle
accelerators by persons registering the machines under the provisions of these
administrative regulations. The requirements of this administrative regulation
are in addition to, and not in substitution for, other applicable provisions of
these administrative regulations.
Section
2. Equipment.
(1) A label bearing
essentially the words "CAUTION - RADIATION - THIS MACHINE PRODUCES RADIATION
WHEN ENERGIZED" shall be placed near switches which energize portions of the
machine. Labels shall use the conventional colors (magenta or purple on yellow
background) and bear the conventional radiation symbol.
(2) Apparatus utilized in beam alignment
procedures shall be designed in a way that radiation greater than limits
prescribed in 902 KAR 100:020 shall not strike the operator.
(3) A switch or device which may cause the
radiation machine to produce radiation if actuated shall be located on a
control panel or console, and shall cause a warning light immediately adjacent
to the switch or device to light; this light shall remain lit if, and only if,
the associated control circuit is energized.
(4) Locations designated as high radiation
areas, and entrances to the locations shall be equipped with easily observable
flashing or rotating red or magenta warning lights that operate automatically
if, and only if, radiation is being produced or may be produced.
(5) Each entrance into a target room or other
high radiation area shall be provided with a safety interlock designed to
terminate radiation production for the possible modes of machine operation
under conditions of barrier penetration.
(6) Only a device on the accelerator control
console shall be used to turn the accelerator beam on and off. The safety
interlock system shall not be used to turn off the accelerator beam, except in
an emergency. If the interlock system does turn off the accelerator, it shall
not be possible to resume operation without resetting the accelerator "ON"
device at the control console.
(7)
Safety interlocks shall not be dependent upon the operation of a single
circuit; i.e., they shall be of redundant or fail-safe design. Each safety
interlock shall be on a circuit which shall allow it to operate independently
of other safety interlocks.
(8) A
scram button or other emergency power cutoff switch shall be located and easily
identifiable in high radiation areas. The cutoff switch shall include a manual
reset, so that the accelerator cannot be restarted from the accelerator console
without resetting the cutoff switch.
(9) Circuit diagrams of the accelerator and
the associated interlock systems shall be kept current and maintained for
inspection by the cabinet and shall be available to the operator.
(10) A lock shall be provided on the control
panel or console.
(11)
Instrumentation, readouts, and controls on the particle accelerator control
console shall be clearly identified and easily discernible.
(12) Safety interlocks shall be designed so
that a defect or component failure in the safety interlock system prevents
operation of the accelerator.
Section
3. Administrative Responsibilities.
(1) A person at each facility shall be
appointed as the radiation safety officer, and shall be delegated
responsibility for ensuring the following:
(a)
Establishing and maintaining operational procedures so that the radiation dose
received by a person is as low as reasonably achievable and below the maximum
permissible dose as is practical;
(b) Instructing personnel who work with or
near radiation producing machines, in radiation safety practices;
(c) Maintaining a system of personnel
monitoring;
(d) Arranging for
establishment of radiation control areas, including placement of appropriate
radiation warning signs and devices;
(e) Providing for radiation safety inspection
of radiation producing machines on a routine basis;
(f) Reviewing modifications to apparatus,
shielding, and safety interlocks;
(g) Investigating and reporting to proper
authorities excessive exposure to personnel and taking remedial
action;
(h) Being familiar with
applicable administrative regulations for the control of ionizing radiation;
(i) Terminating operations at the
facility because of radiation safety considerations; and
(j) Maintaining records of these actions to
document compliance with these administrative regulations.
(2) No individual shall be permitted to act
as an operator of an accelerator until the person has:
(a) Received training in radiation safety and
has been approved by the radiation safety officer; and
(b) Demonstrated competence to use the
accelerator, related equipment, and radiation survey instruments to be
employed.
(3) The
registrant shall ensure that each operator shall:
(a) Keep radiation exposure to himself and to
others as low as practical;
(b) Be
familiar with safety procedures as they apply to each machine;
(c) Wear personnel monitoring devices, if
applicable; and
(d) Notify the
radiation safety officer of conditions or situations which may have resulted
in, or threatens to result in, unnecessary radiation exposure.
(4) The registrant shall establish
a radiation safety committee to approve in advance, proposals for uses of
particle accelerators, if deemed necessary by the cabinet.
(5) A registrant authorized to use a particle
accelerator in the healing arts shall:
(a)
Appoint a medical committee of at least three (3) members to evaluate proposals
for research, diagnostic, and therapeutic use of a particle accelerator if
deemed necessary by the cabinet. Membership of the committee shall include
physicians expert in internal medicine, hematology, therapeutic radiology, and
a person experienced in depth dose calculations and protection against
radiation;
(b) The individuals
designated as users have substantial training and experience in deep therapy
technique, or in the use of particle accelerators to treat humans;
and
(c) An individual designated as
a user is a physician.
(6) The radiation safety committee or the
radiation safety officer shall have the authority to terminate the operations
at a particle accelerator facility if this action is deemed necessary to
minimize danger to public health and safety or property.
Section 4. Operating Procedures.
(1) Written operating procedures pertaining
to radiation safety shall be established for each accelerator
facility.
(2) Written emergency
procedures pertaining to radiation safety shall be established and posted in a
conspicuous location. These shall list the telephone number(s) of the radiation
safety officer and shall include the following actions to be taken if a known,
or suspected, accident involving radiation exposure occurs:
(a) Notifying radiation safety officer;
and
(b) Arrange for medical
examination.
(3) The
registrant shall assure that operators and other appropriate personnel are
familiar with and have been given a copy of the written operating and emergency
procedures pertaining to radiation safety. Each operator shall demonstrate an
understanding of these procedures and the applicable requirements of 902 KAR
100:020 and
902 KAR
100:165. These procedures shall be maintained at the
accelerator control panel.
(4)
Particle accelerators shall be secured if not in operation to prevent
unauthorized use.
(5) The
registrants shall assure that personnel do not expose a part of their body to
the radiation beam.
(6) If it is
necessary to intentionally alter safety devices, e.g., bypassing interlocks or
removing shielding action shall be:
(a)
Specified in writing and posted on the control console and at each entrance
requiring a safety interlock as required by this administrative regulation so
that other persons know the existing status of the machine;
(b) Terminated as soon as possible;
and
(c) Authorized by the radiation
safety committee or radiation safety officer.
(7) Accelerators shall not be left unattended
while energized.
(8) Safety devices
shall be tested for proper operation at intervals not to exceed three (3)
months.
(9) Records of personnel
monitoring results and safety device tests shall be maintained for inspection
by the cabinet.
(10) Appropriate,
portable radiation monitoring equipment shall be available at the accelerator
facility, properly maintained and calibrated, and sensitive to those radiations
being monitored. The monitoring equipment shall be tested for proper operation
and calibrated at intervals not to exceed one (1) year and after each servicing
and repair.
(11) Radiation levels
in high radiation areas shall be continuously monitored. The monitoring devices
shall be electrically independent of the accelerator control and safety
interlock systems and capable of providing a readout at the control panel. Area
monitors shall be calibrated at intervals not to exceed one (1) year and after
each servicing and repair.
(12)
Personal radiation dosimeters that measure the expected radiations and are of
sufficient range to be useful under normal and accident conditions shall be
worn by persons designated by the radiation safety officer.
(13) Before a new installation is placed in
routine operation, a radiation protection survey shall be made by a qualified
expert.
(14) A radiation protection
survey shall be performed by a qualified expert if changes have been made in
shielding, operation, equipment, or occupancy of adjacent areas, and
periodically to check for unknown changes and malfunctioning
equipment.
(15) Records of
radiation protection surveys, inspections, and maintenance performed on the
accelerator and related components shall be kept current and on file at each
accelerator facility, and maintained for inspection by the cabinet.
STATUTORY AUTHORITY:
KRS 194.050,
211.090,
211.844