R12-1-901. Purpose and Scope

1. This Article establishes procedures and requirements for the registration and the use of particle accelerators.

2. In addition to the requirements of this Article, all registrants are subject to the requirements of Articles 1, 2, 4, and 10. Registrants engaged in industrial radiographic operations are subject to the requirements of Article 5, and registrants engaged in the healing arts are subject to the requirements of Article 6 of these rules. Registrants engaged in the use or production of radioactive material are subject to the requirements of Article 3.

Historical Note

Former Rule Section I.1; Former Section R12-1-901 repealed, new Section R12-1-901 adopted effective June 30, 1977 (Supp. 77-3). Amended effective June 13, 1997 (Supp. 97-2). R12-1-902. Repealed

Historical Note

Former Rule Section I.2; Former Section R12-1-902 repealed, new Section R12-1-902 adopted effective June 30, 1977 (Supp. 77-3). Amended effective June 13, 1997 (Supp. 97-2). Section repealed by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). R12-1-903. General Requirements for the Issuance of a Registration for Particle Accelerators

1. The requirements in this section supplement the registration requirements in 12 A.A.C. 1, Article 2.

2. The Agency shall approve a registration application for use of a particle accelerator only if the Agency determines that:
   1. The applicant is qualified by training and experience to use the accelerator for the purpose requested according to this Article, and Articles 4 and 10, of these rules to minimize danger to public health or property;

   2. The applicant's proposed equipment, facilities, operating, and emergency procedures are adequate to protect health and minimize danger to public health and safety or property;

   3. 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 R12-1-904;

   4. The applicant has appointed a radiation safety officer;

   5. The applicant's staff has substantial experience in the use of particle accelerators for the intended uses; and

   6. The applicant has an adequate training program for particle accelerator operators.

Former Rule Section I.3; Former Section R12-1-903 repealed, new Section R12-1-903 adopted effective June 30, 1977 (Supp. 77-3). Amended effective Aug. 8, 1986 (Supp. 86-4). Amended effective June 13, 1997 (Supp. 97-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). R12-1-904. Special Registration Requirements for Medical Use of Particle Accelerators

1. The requirements in this Section supplement the registration requirements in R12-1-903.

2. An applicant that is a "medical institution", as defined in 12 A.A.C. 1, Article 7, and performing human research shall appoint a radiation safety committee, meeting the requirements in R12-1-706.

3. The applicant shall ensure that an individual designated as an authorized user on the application is an Arizona licensed physician; approved by the radiation safety committee, if applicable; and is:
   1. Certified in:
      1. Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or

      2. Radiation oncology by the American Osteopathic Board of Radiology; or

      3. Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

      4. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

   2. Engaged in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic techniques applicable to the use of a particle accelerator, 500 hours of supervised work experience, and a minimum of 3 years of supervised clinical experience.
      1. To satisfy the requirement for instruction, the classroom and laboratory training shall include all of the following subjects.
         1. Radiation physics and instrumentation;

         2. Radiation protection;

         3. Mathematics pertaining to the use and measurement of radiotherapy; and

         4. Radiation biology.

      2. To satisfy the requirement for supervised work experience, training shall occur under the supervision of an authorized user at a medical institution and shall include:
         1. Reviewing full calibration measurements and periodic spot checks;

         2. Preparing treatment plans and calculating treatment times;

         3. Using administrative controls to prevent misadministration;

         4. Implementing emergency procedures to be followed in the event of the abnormal operation of a particle accelerator; and

         5. Checking and using survey meters.

      3. To satisfy the requirement for a period of supervised clinical experience, training shall include 1 year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional 2 years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience shall include:
         1. Examining individuals and reviewing their case histories to determine their suitability for treatment, noting any limitations or contraindications;

         2. Selecting the proper dose and how it is to be administered;

         3. Calculating the therapy doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses, as warranted by patients' or human research subjects' reaction to radiation; and

         4. Post-administration follow up and review of case histories.

      4. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

4. With the application the applicant shall provide the name of each authorized user, and the training and experience that satisfies the requirements in subsection (C).

5. Each licensee shall establish and maintain a written quality management program to provide high confidence the radiation produced by the particle accelerator will be administered as directed by an authorized user. The quality management program shall include written policies and procedures to meet the specific patient safety objectives established by the Radiation Safety Officer or Radiation Safety Committee, if applicable.

6. Each particle accelerator shall be calibrated by an expert meeting the training and experience qualifications in R12-1-716(G).

7. The Agency shall inspect a particle accelerator before it is used to treat a human.

Historical Note

Former Rule Section I.4; Former Section R12-1-904 repealed, new Section R12-1-904 adopted effective June 30, 1977 (Supp. 77-3). Amended effective Aug. 8, 1986 (Supp. 86-4). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). R12-1-905. Repealed

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Repealed effective August 8, 1986 (Supp. 86-4). R12-1-906. Limitations

1. No registrant shall permit any person to act as a particle accelerator operator until such person:
   1. Has been instructed in radiation safety and shall have demonstrated an understanding thereof;

   2. Has received copies of and instruction in this Article and the applicable requirements of Articles 4 and 10, pertinent registration conditions and the registrant's operating and emergency procedures, and shall have demonstrated understanding thereof; and

   3. Has demonstrated competence to use the particle accelerator, related equipment, and survey instruments which will be employed in his assignment.

2. Both the Radiation Safety Committee and 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/or minimize danger to public health and safety or property.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). R12-1-907. Shielding and Safety Design Requirements

1. A person experienced in the principles of radiation protection and installation design shall be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is 1st capable of producing radiation.

2. The registrant shall provide each particle accelerator installation with the primary and secondary barriers that are necessary to assure compliance with R12-1-408 and R12-1-416.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended subsection (A) effective Aug. 8, 1986 (Supp. 86-4). Amended effective June 13, 1997 (Supp. 97-2). R12-1-908. Particle accelerator controls and interlock systems

1. Instrumentation, readouts and controls on the particle accelerator control console shall be clearly identified and easily discernible.

2. 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.

3. 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.

4. Each safety interlock shall be on a circuit which shall allow its operation independently of all other safety interlocks.

5. 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.

6. 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.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). R12-1-909. Warning Devices

1. All areas, except those in medical facilities, designated as high radiation areas, and entrances to the areas shall be equipped with easily observable flashing or rotating warning light system that operates when, and only when, radiation is being produced. Medical facilities shall be equipped with a continuously operating warning light system.

2. Except in facilities designed for human exposure, each high radiation area shall have an audible warning device which shall be activated for 15 seconds prior to the creation of the high radiation area. The warning device shall be clearly discernible in all high radiation areas and all radiation areas.

3. Barriers, temporary or otherwise, and pathways leading to high radiation areas shall be identified in accordance with R12-1-428 and R12-1-429.

Historical Note Adopted effective June 30, 1977 (Supp. 77-3). Amended effective June 13, 1997 (Supp. 97-2). R12-1-910. Operating procedures

1. Particle accelerators, when not in operation, shall be secured to prevent unauthorized use.

2. 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.

3. All safety and warning devices, including interlocks, shall be checked for proper operability at intervals not to exceed 3 months. Results of such tests shall be maintained for inspection at the accelerator facility.

4. 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.

5. If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action shall be:
   1. Authorized in writing by the Radiation Safety Committee and/or Radiation Safety Officer;

   2. Recorded in a permanent log and a notice posted at the interlock(s) so bypassed and at the accelerator control console; and

   3. Terminated as soon as possible.

6. A copy of the current operating and emergency procedures shall be maintained at the accelerator control panel.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended subsection (D) effective Aug. 8, 1986 (Supp. 86-4). R12-1-911. Radiation Survey Requirements

1. The registrant shall ensure that a portable survey instrument is available at all times in a particle accelerator facility.

2. A person experienced in the principles of radiation protection and installation design shall:
   1. Check operation of the portable survey instrument using a known radiation source prior to its use;

   2. Perform and document a radiation protection survey when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas;

   3. Perform surveys to determine the amount of airborne particulate radioactivity present in areas of airborne hazards in particle accelerator facilities of greater than 30 Mev;

   4. Perform periodic smear surveys to determine the degree of contamination in target and adjoining areas when the conditions described in subsection (B)(3) exist;

   5. Perform surveys as prescribed in the written procedures established by the Radiation Safety Officer of the particle accelerator facility.

3. The registrant shall retain the following records:
   1. Records of any radiation protection survey required in subsection (B), and an associated facility description, required in R12-1-202(E), until the registration is terminated.

   2. Records of particle accelerator calibration, spot checks, personnel radiation safety system tests, and periodic radiation protection surveys until the registration is terminated.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective Aug. 8, 1986 (Supp. 86-4). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). R12-1-912. Ventilation Systems

1. A registrant or licensee shall provide the means to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of those limits specified in Article 4, Appendix B, Table II of this Chapter.

2. A registrant or licensee shall not vent, release, or otherwise discharge airborne radioactive material to an uncontrolled area which exceed the limits specified in Article 4, Appendix B, Table II of this Chapter, except as authorized pursuant to R12-1-435. For purposes of this Section, concentrations may be averaged over a period not greater than 1 year. Every reasonable effort should be made to maintain releases of radioactive material to uncontrolled areas as far below the limits in Appendix B, Table II of this Chapter, as practicable.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective Aug. 8, 1986 (Supp. 86-4). Amended effective June 13, 1997 (Supp. 97-2).