Statutes, codes, and regulations
West Virginia Administrative Code
Agency 64 - HealthTitle 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Series 64-23 - Radiological Health Rule
Section 64-23-10 - Radiation Safety Requirements for Particle Accelerators

W. Va. Code R. § 64-23-10

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Current through Register Vol. XLI, No. 45, November 8, 2024
Section 64-23-10 - Radiation Safety Requirements for Particle Accelerators
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.

W. Va. Code R. § 64-23-10