W. Va. Code R. § 64-23-10 - Radiation Safety Requirements for Particle Accelerators
Current through Register Vol. XXXVIII, No. 51, December 23, 2021
10.1. Purpose and Scope
10.1.a. This Section establishes procedures
for the registration and use of particle accelerators.
10.1.b. In addition to the requirements of
this Section, all registrants are subject to the requirements of Sections 1, 5,
6, 11 and 13 Subsections 13.5., 13.6. and 13.7. of this rule. Registrants
engaged in industrial radiographic operations are subject to the requirements
of Subsection 8.16. of this rule and registrants engaged in the healing arts
are subject to the requirements of Sections 7. and 12. Subsection 11.7. and
11.8. of this rule. Registrants whose operations result in the production of
radioactive material are subject to the requirements of Section 11. of this
rule.
10.2. Registration
Procedure
10.2.a. Registration Requirements -
No person shall receive, possess, use, transfer, own or acquire a particle
accelerator unless such is in compliance with the registration requirements in
Section 5. of this rule.
10.3. General Requirements for the Use of
Particle Accelerators. In addition to the requirements set forth in Sections 5.
or 11. Subsection 3., a registration for the use of a particle accelerator will
not be issued unless the agency determines that:
10.3.a. The applicant is qualified by reason
of training and experience to use the accelerator in question for the purpose
intended in accordance with this Section and Sections 6. and 13. of this rule
in such a manner as to minimize danger to public health and safety or
property;
10.3.b. The applicant's
proposed equipment, facilities, and operating and emergency procedures are
adequate to protect health and minimize danger to public health and safety or
property;
10.3.c. The issuance of
the registration will not be inimical to the health and safety of the public,
and the applicant satisfies any applicable special requirement in Subsection
11.4. of this rule;
10.3.d. The
applicant has appointed a radiation safety officer;
10.3.e. The applicant or his staff has
substantial experience in the use of particle accelerators for the intended
use;
10.3.f. The applicant has
established a radiation safety committee to approve, in advance, proposals for
use of particle accelerators, whenever deemed necessary by the agency;
and
10.3.g. The applicant has an
adequate training program for particle accelerator operators.
10.4. Human Use of Particle
Accelerators. In addition to the requirements set forth in Section 5., a
registration for use of a particle accelerator in the healing arts will be
issued only if:
10.4.a. Whenever deemed
necessary by the agency, the registrant has appointed a medical committee of at
least three (3) members to evaluate all proposals for research, diagnostic, and
therapeutic use of a particle accelerator. 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;
10.4.b. The
individuals designated on the application as the users have substantial
training and experience in deep therapy techniques or in the use of particle
accelerators to treat humans; and
10.4.c. The individual designated on the
application as the user must be a physician.
10.5. Radiation Safety Requirements for the
Use of Particle Accelerators
10.5.a. General
Provisions
10.5.a.1. This Subsection
establishes radiation safety requirements for the use of particle accelerators
which are in addition to, and not in substitution for, other applicable
provisions of this rule.
10.5.a.2.
The registrant shall be responsible for assuring that all requirements of this
Section are met.
10.6. Limitations
10.6.a. No registrant shall permit any person
to act as a particle accelerator operator until such person:
10.6.a.1. Has been instructed in radiation
safety and shall have demonstrated an understanding thereof:
10.6.a.2. Has received copies of and
instruction in this part and the applicable requirements of Sections 6. and
13., pertinent registration conditions and the registrants's operating and
emergency procedures, and
10.6.a.3.
Has demonstrated competence to use the particle accelerator, related equipment,
and survey instruments which will be employed in his assignment.
10.6.b. Either the radiation
safety committee or the radiation safety officer shall have the authority to
terminate the operations at a particle accelerator facility if such action is
deemed necessary to protect health and minimize danger to public health and
safety or property.
10.7. Shielding and Safety Design
Requirements
10.7.a. A qualified expert
specifically accepted by the agency shall be consulted in the design of the
particle accelerator installation and called upon to perform a radiation survey
when the accelerator is first capable of producing radiation.
10.7.b. Each particle accelerator
installation shall be provided with such primary and or secondary barriers as
are necessary to assure compliance with Subsections 6.2. and 6.3.
10.8. Particle Accelerator
Controls and Interlock Systems
10.8.a.
Instrumentation, readouts, and controls on the particle accelerator control
console shall be clearly identified and easily discernible.
10.8.b. All entrances into a target room or
other high radiation area shall be provided with interlocks that shut down the
machine under conditions of barrier penetration.
10.8.c. When an interlock system has been
tripped, it shall only be possible to resume operation of the accelerator by
manually resetting controls at the position where the interlock has been
tripped, and lastly at the main control console.
10.8.d. Each safety interlock shall be on a
circuit which shall allow its operation independently of all other safety
interlocks.
10.8.e. All safety
interlocks shall be fail safe, i.e., designed so that any defect or component
failure in the interlock system prevents operation of the
accelerator.
10.8.f. A scram button
or other emergency power cutoff switch shall be located and easily identifiable
in all high radiation areas. Such a cutoff switch shall include a manual reset
so that the accelerator cannot be restarted from the accelerator control
console without resetting the cutoff switch.
10.9. Warning Devices
10.9.a. All locations designated as high
radiation areas, and entrances to such locations shall be equipped with easily
observable flashing or rotating warning lights that operate when, and only
when, radiation is being produced.
10.9.b. Except in facilities designed for
human exposure, each high radiation area shall have any audible warning device
which shall be activated for fifteen (15) seconds prior to the possible
creation of such high radiation area. Such warning device shall be clearly
discernible in all high radiation areas and all radiation areas.
10.9.c. Barriers, temporary or otherwise, and
pathways leading to high radiation areas shall be identified in accordance with
Subsection 6.6.
10.10.
Operating Procedures
10.10.a. Particle
accelerators, when not in use, shall be secured to prevent unauthorized
use.
10.10.b. Only a switch on the
accelerator control console shall be routinely 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.
10.10.c. All safety and warning devices,
including interlocks, shall be checked for proper operability at intervals not
to exceed three (3) months. Results of such test shall be maintained for
inspection by the agency at the accelerator facility.
10.10.d. Electrical circuit diagrams of the
accelerator, and the associated interlock systems, shall be kept current and
maintained for inspection by the agency and available to the operator at each
accelerator facility.
10.10.e. If,
for any reason, it is necessary to intentionally bypass a safety interlock or
interlocks, such action shall be:
10.10.e.1.
Authorized by the radiation safety committee and/or the radiation safety
officer;
10.10.e.2. Recorded in a
permanent log and a notice posted at the accelerator control console;
and
10.10.e.3. Terminated as soon
as possible.
10.10.f. A
copy of the current operating and emergency procedures shall be maintained at
the accelerator control panel.
10.11. Radiation Monitoring Requirements
10.11.a. There shall be available at each
particle accelerator facility, appropriate portable monitoring equipment which
is operable and has been calibrated for the appropriate radiations being
produced at the facility. Such equipment shall be tested for proper operation
daily and calibrated at intervals not to exceed one year, and after servicing
and repair.
10.11.b. A radiation
protection survey shall be performed and documented by a qualified expert
specifically approved by the agency when changes have been made in shielding,
operation, equipment, or occupancy of adjacent areas.
10.11.c. Radiation levels in all high
radiation areas shall be continuously monitored. The monitoring devices shall
be electrically independent of the accelerator control and interlock systems
and capable of providing a remote and local readout with visual and/or audible
alarms at both the control panel and at the entrance to high radiation areas,
and other appropriate locations so that people entering or present become aware
of the existence of the hazard.
10.11.d. All area monitors shall be
calibrated quarterly.
10.11.e.
Whenever applicable, periodic surveys shall be made to determine the amount of
airborne particulate radioactivity present in areas of airborne
hazards.
10.11.f. Whenever
applicable, periodic smear surveys shall be made to determine the degree of
contamination in target and other pertinent areas.
10.11.g. All area surveys shall be made in
accordance with the written procedures established by a qualified expert or the
radiation safety officer of the particulate accelerator facility.
10.11.h. Records of all radiation protection
surveys, calibration results, instrumentation tests, and smear results shall be
kept current and on file at each accelerator facility.
10.12. Ventilation Systems
10.12.a. Adequate ventilation shall be
provided in areas where airborne radioactivity may be produced.
10.12.b. A registrant, as required by
Subsection 6.6., shall not vent, release or otherwise discharge airborne
radioactive material to an unrestricted area which exceeds the limits in
Section 6., Table 64-23 E, Table II, except as authorized pursuant to
Subsection 6.14. or Subdivision 6.6.b. For purposes of this Paragraph,
concentrations may be averaged over a period not greater than one year. Every
reasonable effort should be made to maintain releases of radioactive material
to unrestricted areas as far below these limits as practicable.
Notes
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