| (B) A radiation survey shall be conducted when the
accelerator is registered and is capable of producing radiation to
determine compliance with §289.231(m) and (o) of this title.
(C) Initial surveys shall be performed as follows.
(i) All new and existing facilities not previously
surveyed shall have a survey made by, or under the direction of, the
registrant.
(ii) A survey report shall be made and shall include,
but not be limited to, the following:
(I) a diagram of the facility that details building
structures and the position of the accelerator, control panel, and
associated equipment;
(II) a description of the accelerator including the
manufacturer, model and serial number, beam type, and beam energy;
(III) a description of the instrumentation used to
determine radiation measurements, including the date and source of
the most recent calibration for each instrument used;
(IV) conditions under which radiation measurements
were taken; and
(V) survey data including:
(-a-) projected annual total effective dose equivalent
(TEDE) in areas adjacent to the accelerator; and
(-b-) a description of workload, use, and occupancy
factors employed in determining the projected annual TEDE.
(iii) The registrant shall maintain a copy of the initial
survey report for inspection by the agency in accordance with subsection
(l) of this section.
(iv) The survey report shall include documentation
of all instances where the facility is in violation of applicable
requirements of this chapter. Any deficiencies detected during the
survey shall be corrected prior to using the accelerator.
(3) Safety requirements.
(A) Interlock systems shall comply with the following
requirements.
(i) Instrumentation, readouts, and controls in the
accelerator console shall be clearly identified.
(ii) Each entrance into a target room or other high
radiation area shall be provided with a safety interlock that shuts
down the machine under conditions of barrier penetration.
(iii) When the production of radiation has been interrupted,
it shall only be possible to resume operation of the accelerator by
manually resetting the console.
(iv) Each safety interlock shall be on an electrical
circuit that allows the interlock to operate independently of all
other safety interlocks.
(v) All safety interlocks shall be designed so that
any defect or component failure in the interlock system prevents operation
of the accelerator.
(vi) A scram button or other emergency power cut-off
switches shall be labeled. The scram button or cut-off switches shall
include a manual reset so that the accelerator cannot be restarted
from the accelerator console without resetting the cut-off switch.
(vii) The safety interlock system shall have a visible
or audible alarm that will indicate when any interlock has been activated.
(viii) All interlocks and visible or audible alarms
shall be tested for proper operation at intervals not to exceed three
months.
(ix) If an interlock or alarm is operating improperly,
it shall be immediately labeled as defective and repaired within 7
calendar days.
(x) Records of tests and repairs required by this paragraph
shall be made and maintained in accordance with subsection (l) of
this section for inspection by the agency.
(B) Each registrant shall develop and implement written
operating and safety procedures. The procedures may be documented
in an electronic reporting system and shall include, but not be limited
to, the following:
(i) methods used to secure the accelerator from unauthorized
use;
(ii) methods of testing and training operators in accordance
with paragraph (4) of this subsection;
(iii) procedures for notifying the proper personnel
in the event of an accident;
(iv) posting requirements;
(v) procedures for testing interlocks, entrance controls,
and alarm systems;
(vi) personnel monitoring;
(vii) maintenance of records; and
(viii) procedures for necessary area surveys and time
intervals.
(C) The registrant shall ensure that radiation measurements
are performed with a calibrated dosimetry system. The dosimetry system
calibration shall be traceable to a national standard. The calibration
interval shall not exceed 24 months. There shall be available at each
accelerator facility, appropriate portable monitoring equipment that
is operable and has been calibrated for the appropriate radiations
being produced at the facility.
(D) A radiation protection survey shall be performed
and the results recorded when changes have been made in shielding,
operation, equipment, or occupancy of adjacent areas.
(E) For portable or mobile accelerators, such as neutron
generators that are used at temporary job sites where permanent shielding
is not available, radiation protection shall be provided by temporary
shielding or by providing an adequate exclusion area around the accelerator
while it is in use.
(F) Records of calibration and survey results made
in accordance with subparagraphs (C) and (D) of this paragraph shall
be maintained in accordance with subsection (l) of this section.
(G) The registrant shall perform radiation surveys
and contamination smears prior to the transfer or disposal of an accelerator
operating at or above 10 MeV. Such survey(s) shall be documented and
maintained by the registrant for inspection by the agency in accordance
with subsection (l) of this section.
(H) The registrant shall retain records of receipt,
transfer, and disposal of all radiation machines specific to each
authorized use location. The records shall include the date, manufacturer
name, model and serial number from the control panel or console of
the radiation machine and identification of the person making the
record.
(4) Training requirements for operators.
(A) No person shall be permitted to operate an accelerator
unless such person has received instruction in and demonstrated competence
with the following:
(i) operating and safety procedures in accordance with
paragraph (3)(B) of this subsection;
(ii) radiation warning and safety devices incorporated
into the equipment and in the room;
(iii) identification of radiation hazards associated
with the use of the equipment; and
(iv) procedures for reporting an actual or suspected
exposure.
(B) Records of the training specified in subparagraph
(A) of this paragraph shall be made and maintained for agency inspection
in accordance with subsection (l) of this section.
(g) Requirements for accelerator(s) used in industrial
radiography. In addition to the requirements in subsections (f)(1),
(2), and (3)(C) - (H) of this section, accelerators used for industrial
radiography shall meet the applicable requirements of §289.255
of this title.
(h) Therapeutic radiation machines, simulators used
in the healing arts, veterinary medicine, and electronic brachytherapy
devices.
(1) General requirements.
(A) Each person possessing a therapeutic radiation
machine capable of operating at or above 1 million electron volts
(MeV) shall apply for and receive a certificate of registration from
the agency before using the accelerator for human use. A person may
energize the accelerator for purposes of installation and acceptance
testing before receiving a certificate of registration from the agency.
(B) Each person possessing a simulator, a therapeutic
radiation machine capable of operating below 1 MeV, and/or an electronic
brachytherapy device, shall apply for a certificate of registration
within 30 days after energizing the equipment.
(C) Individuals who operate radiation machines for
human use shall meet the appropriate credentialing requirements issued
in accordance with the Medical Radiologic Technologist Certification
Act, Texas Occupations Code, Chapter 601. Copies of the credentialing
document shall be maintained at the locations(s) where the individual
is working.
(D) The electronic brachytherapy registrant shall require
the physician to be:
(i) licensed by the Texas Medical Board; and
(ii) certified in:
(I) radiation oncology or therapeutic radiology by
the American Board of Radiology; or
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