Oregon Secretary of State

Oregon Health Authority

Public Health Division - Chapter 333

Division 109
RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL AND MANUFACTURING USE OF PARTICLE ACCELERATORS

333-109-0001
Purpose and Scope

(1) This division establishes procedures for the registration and the use of particle accelerators.

(2) In addition to the requirements of this division, all registrants are subject to the requirements of divisions 100, 101, 120 and 111 of these rules. Registrants engaged in industrial radiographic operations are also subject to the requirements of divisions 105 and 108 of these rules, and registrants engaged in the healing arts are also subject to the requirements of division 106 of these rules. Registrants whose operations result in the production of radioactive material are also subject to the requirements of division 102 of these rules.

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1995, f. & cert. ef. 4-26-95
HD 1-1991, f. & cert. ef. 1-8-91
HD 4-1985, f. & ef. 3-20-85

333-109-0002
Registration Requirements

No person may receive, possess, use, transfer, own, or acquire a particle accelerator unless they apply for, and are granted, a registration issued pursuant to division 333-101.

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06

333-109-0003
General Requirements for the Issuance of a Registration for Particle Accelerators

In addition to the requirements of division 101 of these rules, a registration application for use of a particle accelerator will be approved only if the Authority determines that:

(1) The applicant is qualified by reason of training and experience to use the accelerator in question for the purpose requested in accordance with this division and divisions 120 and 111 of these rules in such a manner as to minimize danger to public health and safety or property;

(2) The applicant's 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 harmful to the health and safety of the public;

(4) The applicant has appointed a qualified radiation safety officer;

(5) The applicant and/or the applicant's staff has substantial experience in the use of particle accelerators and training sufficient for application to its intended uses;

(6) The applicant has established a radiation safety committee to approve, in advance, proposals for uses of particle accelerators, whenever deemed necessary by the Authority;

(7) The applicant has an adequate training program for operators of particle accelerators;

(8) A shielding design, by a qualified expert licensed to do shielding design in Oregon, must be submitted with the registration application;

(9) For all new accelerators, a record indicating that a radiation safety survey has been conducted prior to the use of the accelerator, must be sent to the Authority as soon as practical after the registration application is submitted; and

(10) Copies of the facility's operating and emergency procedures must be submitted with the registration application.

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1995, f. & cert. ef. 4-26-95
HD 1-1991, f. & cert. ef. 1-8-91

333-109-0005
Equipment

(1) A label bearing essentially the words CAUTION — RADIATION — THIS MACHINE PRODUCES RADIATION WHEN ENERGIZED must be placed near any switch which energizes any portion of the machine. All labels must be the conventional colors (magenta or purple on yellow background) and bear the conventional radiation symbol.

(2) Any apparatus used in beam alignment procedures must be designed in such a way that excessive radiation will not strike the operator.

(3) Any switch or device which may cause the radiation machine to produce radiation when actuated must be located on a control panel or console, and must cause a warning light immediately adjacent to such switch or device to light; this light must remain lit when, and only when, the associated control circuit is energized.

(4) A lock must be provided on the control panel or console that prevents unauthorized operation of the accelerator.

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1991, f. & cert. ef. 1-8-91
HD 4-1985, f. & ef. 3-20-85

333-109-0010
Administrative Responsibilities

(1) A person at each facility must be designated to be responsible for maintaining radiation safety. This person, designated the radiation safety officer, must be responsible for the following:

(a) Establishing and maintaining operational procedures so that the radiation exposure of each worker is kept as far below the maximum permissible dose as is practical;

(b) Instructing all personnel who work with or near radiation producing machines, in 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/or devices;

(e) Providing for radiation safety inspection of radiation producing machines, including operation of all safety devices on a routine basis;

(f) Reviewing modifications to apparatus, shielding and safety interlocks;

(g) Investigating and reporting to proper authorities any case of excessive exposure to personnel and taking remedial action;

(h) Being familiar with all applicable rules for the control of ionizing radiation; and

(i) Terminating operations at the facility because of radiation safety considerations.

(2) No individual must be permitted to act as an operator of an accelerator until such person has:

(a) Received an acceptable amount of training in radiation safety as approved by the radiation safety officer;

(b) Has received copies of and instruction in this division, the applicable requirements of divisions 120 and 111 of these rules and:

(A) Pertinent registration conditions; and

(B) Operating and emergency procedures; and

(C) Must have demonstrated understanding of documents and information required in this rule;

(c) Demonstrated competence to in the use of the accelerator, related equipment and radiation survey instruments which will be employed; and

(d) Been approved by the radiation safety officer. Each operator must be responsible for:

(A) Keeping radiation exposure to all individuals as low as is practical;

(B) Being familiar with safety procedures as they apply to each machine;

(C) Wearing of personnel monitoring devices, if applicable; and

(D) Notifying the radiation safety officer of known or suspected excessive radiation exposures to any individual.

(3) The radiation safety committee or the radiation safety officer must have the authority to terminate the operations at a particle accelerator facility if such action is deemed necessary to minimize danger to public health and safety or property.

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1991, f. & cert. ef. 1-8-91
HD 4-1985, f. & ef. 3-20-85

333-109-0015
Operating Procedures

(1) Particle accelerators, when not in operation must be secured to prevent unauthorized use.

(2) Written operating procedures pertaining to radiation safety must be established for each accelerator facility by the radiation safety officer.

(3) Written emergency procedures pertaining to radiation safety must be established by the radiation safety officer. These must list the telephone number(s) of the radiation safety officer and must include the following actions to be taken in case of a known, or suspected, accident involving radiation exposures:

(a) Notifying the radiation safety officer; and

(b) Arranging for medical examination.

(4) Personnel must not expose any part of their body to the radiation beam.

(5) Accelerator must not be left unattended while energized unless access to radiation areas or high radiation areas is physically prevented.

(6) All safety and warning devices, including interlocks, must be checked for proper operation at intervals not to exceed three months. Results of such tests must be maintained at the accelerator facility for inspection by the Authority.

(7) Records of personnel monitoring results and safety device tests must be maintained for inspection by the Authority.

(8) An appropriate radiation monitor must be used within an accelerator target room and other high radiation areas. This may be:

(a) An area monitor with an easily observable indicator that warns of radiation levels above a predetermined limit in accessible areas; and/or

(b) A personal radiation monitor of the "chirpie" type carried into the room; and/or

(c) A portable survey instrument carried into the room.

(9) 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 all persons designated by the radiation safety officer.

(10) Records of all radiation protection surveys, inspections and maintenance performed on the accelerator and related components must be kept current and on file at each accelerator facility, and maintained for inspection by the Authority.

(11) The safety interlock system must not be used to turn off the accelerator beam except in an emergency.

(12) Electrical circuit diagrams of the accelerator and the associated safety interlock systems must be kept current and maintained for inspection by the Authority and must be available to the operator at each accelerator facility.

(13) If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action must be:

(a) Authorized by the radiation safety committee or radiation safety officer;

(b) Recorded in a permanent log and a notice posted at the accelerator control console; and

(c) Terminated as soon as possible.

(14) A copy of the current operating and the emergency procedures must be maintained at the accelerator control panel.

Statutory/Other Authority: ORS 453.605 - 453.807
Statutes/Other Implemented: ORS 453.605 - 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1991, f. & cert. ef. 1-8-91
HD 4-1985, f. & ef. 3-20-85

333-109-0025
Shielding and Safety Design Requirements

(1) A qualified expert, acceptable to the Authority, must be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation.

(2) Each particle accelerator installation must be provided with such primary and/or secondary barriers as are necessary to assure compliance with OAR 333-120-0100 and 333-109-0030.

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1995, f. & cert. ef. 4-26-95
HD 1-1991, f. & cert. ef. 1-8-91

333-109-0030
Particle Accelerator Controls and Interlock Systems

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

(2) Each entrance into a target room or other high radiation area must be provided with a safety interlock that shuts down the machine under conditions of barrier penetration.

(3) Each safety interlock must be on a circuit which must allow it to operate independently of all other safety interlocks.

(4) All safety interlocks must be designed so that any defect or component failure in the safety interlock system prevents operation of the accelerator.

(5) When a safety interlock system has been tripped, it must only be possible to resume operation of the accelerator by manually resetting controls at the position where the safety interlock has been tripped and, lastly, at the main control console.

(6) A scram button or other emergency power cutoff switch must be located and easily identifiable in all high radiation areas. Such a cutoff switch must include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.

(7) All safety interlocks must not be dependent upon the operation of a single circuit; i.e., they must be of redundant or fail-safe design.

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1991, f. & cert. ef. 1-8-91

333-109-0035
Warning Devices

(1) Each location designated as a high radiation area, and each entrance to such location, must be equipped with easily observable warning lights that operate when, and only when, radiation is being produced.

(2) Except in facilities designed for human exposure, each high radiation area must have an audible warning device which must be activated for 15 seconds prior to the possible creation of such high radiation area. Such warning device must be clearly discernible in all high radiation areas.

(3) Barriers, temporary or otherwise and pathways leading to high radiation areas must be posted in accordance with OAR 333-120-0400.

Statutory/Other Authority: ORS 453.605 - 453.807
Statutes/Other Implemented: ORS 453.605 - 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1995, f. & cert. ef. 4-26-95
HD 1-1991, f. & cert. ef. 1-8-91

333-109-0040
Radiation Monitoring Requirements

(1) There must be available at each particle accelerator facility appropriate portable monitoring equipment which is operable and has been appropriately calibrated for the radiations being produced at the facility. Such equipment must be tested for proper operation daily and calibrated at intervals not to exceed one year and after each servicing and repair.

(2) A radiation protection survey must be performed and documented by a qualified expert, acceptable to the Authority, when changes have been made in shielding, operation, equipment or occupancy of adjacent areas.

(3) Radiation levels in all high radiation areas must be continuously monitored. The monitoring devices must be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel.

(4) All area monitors must be calibrated at intervals not to exceed one year and after each servicing and repair.

(5) Whenever applicable, periodic surveys must be made to determine the amount of airborne particulate radioactivity present.

(6) Whenever applicable, periodic smear surveys must be made to determine the degree of contamination.

(7) All surveys must be made in accordance with the written procedures established by a qualified expert, acceptable to the Authority or the radiation safety officer.

(8) Records of all radiation protection surveys, calibrations and instrumentation tests must be maintained at the accelerator facility for inspection by the Authority.

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1991, f. & cert. ef. 1-8-91

333-109-0045
Ventilation Systems

(1) Ventilation systems must be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive materials in excess of those limits specified in 10 CFR Part 20 Table 1 of Appendix B to 20.1001 to 20.2401.

(2) A registrant, as required by OAR 333-120-0190, must not vent, release or otherwise discharge airborne radioactive material to an unrestricted area which exceed the limits specified in 10 CFR Part 20 Table 2 Appendix B to 20.1001 to 20.2401, except as authorized pursuant to OAR 333-104-0035. For purposes of this rule concentrations may be averaged over a period not greater than one year. Every effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as is reasonably achievable.

[ED. NOTE: Tables referenced are available from the agency.]

Statutory/Other Authority: ORS 453.605 – 453.807
Statutes/Other Implemented: ORS 453.605 – 453.807
History:
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1995, f. & cert. ef. 4-26-95
HD 1-1991, f. & cert. ef. 1-8-91