[27 Pa.B. 5703]
[Continued from previous Web Page] (1) The leakage radiation from the [diagnostic source assembly] tube housing assembly with a beam-limiting device attached measured at a distance of 1 meter in any direction from the source may not exceed 100 milliroentgens (25.8 µC/kg) in 1 hour when the [X-ray] X-ray tube is operated at its [leakage] maximum technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
(2) The radiation emitted by a component other than the tube housing assembly with a beam-limiting device attached may not exceed 2 milliroentgens (0.516 µC/kg) in 1 hour at 5 centimeters from an accessible surface of the component when it is operated in an assembled X-ray system under conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
(b) [Collimators capable of restricting the useful beam to the area of clinical interest shall be provided and shall provide the same degree of protection as is required in subsection (a).] X-ray beam restriction.
(1) The primary X-ray beam shall be restricted to the area of clinical interest and equal to or smaller than the image receptor.
(2) Collimating devices capable of limiting the primary beam to the appropriate image receptor to within 2% of the source to image distance shall be provided and used. They shall provide the same degree of protection as is required in subsection (a)(1) for a diagnostic source assembly.
(3) A means shall be provided to align the center of the X-ray field to the center of the image receptor to within 2% of the source to image distance.
(c) X-ray beam filtration. * * *
(d) [A device shall be provided to terminate the exposure after a preset time or exposure.] Exposure control devices.
(1) An exposure control device shall be provided to terminate the exposure after a preset time interval, preset product of current and time, a preset number of pulses or a preset radiation exposure to the image receptor. Termination of an exposure shall cause automatic resetting of the timer to its initial setting or to zero. It may not be possible to initiate an exposure with the exposure control device in the zero or off position, if either position is available, unless equipped for current adjustment.
(2) A means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator such as the depression of a switch. The switch shall be of the dead man type.
(e) [An x-ray control shall have a dead-man type exposure switch and shall be located behind a protective barrier or arranged so that the operator may stand at least 2 meters from the animal and from the tube head.] The coefficient of variation for exposure may not exceed 0.10 when all technique factors are held constant. This requirement shall be deemed to have been met if, when 4 exposures are made at identical technique factors, the value of the average exposure (A) is greater than or equal to 5 times the maximum exposure (E(MAX)) minus the minimum exposure (E(MIN)).
(f) [Portable] Veterinary portable [x-ray] tube heads] X-ray units shall be supported by a tube stand when the technique permits unless the unit is designed to be hand held during X-ray procedures.
(g) [Fluoroscopic equipment shall satisfy the requirements of §§ 221.31--221.40 (relating to fluoroscopic x-ray systems).] The x-ray control shall provide indication of the production of x-rays that is observable from the operator's position. The technique factors that are set prior to the exposure shall be indicated on the x-ray control and shall be visible to the operator from the operator's position.
[(h) Equipment used for therapeutic purposes shall satisfy the requirements of §§ 221.71--221.76 and 221.81--221.102 (relating to therapeutic x-ray systems with energies less than 1 meV; and therapeutic x-ray and electron beam systems with energies of 1 meV and above).]
§ 223.12. [Structural shielding] (Reserved).
[Facilities regularly used for veterinary x-ray procedures shall have protective barriers sufficient to assure compliance with § 219.21 (relating to radiation protection programs).]
§ 223.12a. Fluoroscopic equipment.
(a) The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the primary beam at the maximum source to image receptor distance.
(b) The X-ray tube used for fluoroscopy may not produce X-rays unless the primary barrier is in position to intercept the entire primary beam.
(c) X-ray production in the fluoroscopic mode shall be controlled by a dead-man switch for the duration of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the X-ray exposures at any time. A means may be provided to permit completion of a single exposure of the series in process.
(d) The protective barrier may not transmit more than 2 milliroentgens (.516 µC/kg) per hour at 10 centimeters from an accessible surface of the fluoroscopic imaging assembly for each roentgen per minute of entrance exposure rate.
(e) During fluoroscopy and cinefluorography, the voltage and the current shall be continuously indicated.
(f) A cumulative timing device activated by the fluoroscope switch shall be provided. It shall indicate the passage of a predetermined period of irradiation either by an audible signal or by temporary or permanent interruption of the irradiation when the increment of exposure time exceeds a predetermined limit not exceeding 5 minutes.
(g) Fluoroscopic table designs when combined with normal operating procedures shall be of a type that no unprotected part of the staff or an ancillary individual's whole body is exposed to unattenuated scattered radiation which originates from under the table. The attenuation required may be not less than 0.25 millimeter lead equivalent.
(h) Equipment configuration when combined with normal operating procedures shall be of a type that no portion of the staff or an ancillary individual's whole body, except the extremities, is exposed to the unattenuated scattered radiation emanating from above the tabletop unless one of the following criteria is met:
(1) The individual is at least 120 centimeters from the center of the primary beam.
(2) The radiation has passed through not less than 0.25 millimeter of lead equivalent material--for example, drapes, bucky-slot cover, sliding or folding panel or self-supporting curtains--in addition to the lead equivalency provided by the protective apron referred to in § 223.8(b)(1) (relating to operating procedures).
(i) In addition to the other requirements of this section, mobile fluoroscopes shall have image intensification.
§ 223.13. [Operating procedures] (Reserved).
[(a) The operator shall stand well away from the useful beam and the animal during radiographic exposures.
(b) Individuals, other than those whose presence is necessary to conduct the x-ray procedures, shall be outside the x-ray room or, for field procedures, shall stand at least 5 meters away from the x-ray tube and from the animal.
(c) In an application in which the operator and other assisting individual are not located behind a protective barrier, a protective apron having a lead equivalent of at least .5 millimeter shall be worn by individuals during exposures.
(d) Whenever possible, restraining, supporting or positioning devices for the animal or film shall be used for radiation exposures.
(e) No individual may be regularly employed to hold or support animals or hold film or the x-ray tube head during radiation exposures. Occupationally exposed individuals may not perform this service except in cases in which no other method is available. An individual holding or supporting an animal or film during radiation exposure shall wear protective gloves and apron having a lead equivalent of not less than .5 millimeter and shall be positioned so that no part of that individual's body will be struck by the useful beam. The exposure of an occupationally exposed individual used for this purpose shall be monitored.]
§ 223.13a. Therapeutic systems.
(a) When the tube is operated at its maximum technique factors, the leakage radiation may not exceed any of the following:
(1) One hundred milliroentgens (25.8 µC/kg) per hour at 5 centimeters from the surface of the tube housing assembly for contact therapy systems.
(2) One roentgen (.258 mC/kg) per hour at 1 meter from the source for 0-500 kVp systems.
(3) One-tenth percent of the exposure rate of the primary beam at 1 meter from the source for 501-999 kVp systems.
(b) Beam limiting devices used for limiting the primary beam shall provide at least the same protection as required by the tube housing assembly.
(c) Therapeutic X-ray systems shall be secured to prevent unauthorized use whenever the system is unattended.
(d) Interlocks shall be provided so that, when a door of the treatment room is opened, either the machine will shut off automatically or the radiation level within the room will be reduced to an average of not more than 2 milliroentgens (0.16 µC/kg) per hour and a maximum of 10 milliroentgens (2.58 µC/kg) per hour at a distance of 1 meter in any direction from the target; or interlocks will energize a conspicuous visible or audible alarm signal so that the individual entering and the operator are made aware of the entry. After a shut-off or reduction in output, it shall be possible to restore the machine to full operation only from the control panel.
(e) Interlocks, on-off beam control mechanisms, and safety and warning devices shall be checked and appropriately serviced at least once in a calendar year.
(f) Treatment room entrances shall be provided with warning lights, which will indicate when the primary beam is on, in a readily observable position near the outside of access doors.
(g) All exposure factors shall be displayed on the control panel.
(h) Provision shall be made to permit continuous observation of the animal patient from the control panel during irradiation.
(i) A registrant may not permit an individual to operate a therapeutic X-ray system until the individual has received a copy of, and instruction in, the operating procedures for the system and has demonstrated understanding of the operating procedures and competence in the use of the system.
CHAPTER 227. RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT, X-RAY GAUGING EQUIPMENT AND ELECTRON MICROSCOPES
ANALYTICAL X-RAY EQUIPMENT § 227.11. [Warnings] (Reserved).
[(a) An analytical X-ray machine shall be labeled with a readily discernible sign bearing the radiation symbol and one of the following groups of words:
(1) ''Caution--High Intensity X-Ray Beam,'' or words containing a similar warning, on the X-ray source housing and ''Caution Radiation--This Equipment Produces Radiation when Energized,'' or words containing a similar warning, near any switch that energizes an X-ray tube if the radiation source is an X-ray tube.
(2) ''Caution--Radioactive Material,'' or words containing a similar warning, on the source housing if the radiation source is a radionuclide.
(b) An easily visible warning light, located immediately adjacent to the tube head or port and labeled with the words ''X-Ray On,'' or words containing a similar warning, shall be provided and shall be one of the following:
(1) Illuminated only when the X-ray tube is energized.
(2) Illuminated only when the shutter is open, in the case of a radioactive source.
(c) Open beam configurations shall have easily identified devices located near one of the following:
(1) The radiation source housing that gives a clear, visible indication of the X-ray tube status (on-off) if the primary beam is controlled in this manner.
(2) Each port on the radiation source housing that gives a clear indication of the shutter status (open-closed) if the primary beam is controlled in this manner.
(d) Warning lights and devices on equipment manufactured and installed after December 19, 1987, shall have fail-safe characteristics.]
§ 227.11a Equipment requirements.
(a) Open-beam configurations shall have a device which either prevents the entry of any portion of an individual's body into the primary X-ray beam path, or causes the beam to be terminated or interrupted upon entry into the path. A registrant may apply to the Department for an exemption from the requirement of a safety device. The application for an exemption shall include the following:
(1) A description of the various safety devices that have been evaluated.
(2) The reason each of these devices cannot be used.
(3) A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.
(b) Open-beam configurations shall be provided with a readily discernible indication of one or both of the following:
(1) X-ray tube status (on-off) located near the radiation source housing, if the primary beam is controlled in this manner.
(2) Shutter status (open-closed) located near each port on the radiation source housing, if the primary beam is controlled in this manner.
(c) Warning devices shall be labeled so that their purpose is easily identified. In addition, equipment manufactured after December 17, 1987, shall have fail-safe characteristics.
(d) An easily visible warning light located immediately adjacent to the tube head or port and labeled with the words ''X-ray on,'' or words containing a similar warning, shall be provided and shall be illuminated when:
(1) The X-ray tube is energized.
(2) In the case of a radioactive source, the shutter is open.
(e) Unused ports on radiation source housings shall be secured in the closed position in a manner which will prevent casual opening.
(f) All analytical X-ray equipment shall be labeled with a readily discernible sign bearing the radiation symbol and one of the following:
(1) ''Caution--High Intensity X-ray Beam'' or words having a similar intent on the X-ray source housing; and ''Caution Radiation--This Equipment Produces Radiation When Energized,'' or words having a similar intent, near any switch that energizes an X-ray tube if the radiation source is an X-ray tube.
(2) ''Caution--Radioactive Material,'' or words having a similar intent, on the source housing if the radiation source is a radionuclide.
(g) On equipment with an open-beam configuration manufactured and installed after December 19, 1987, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or coupling has been connected to the port.
(h) Equipment exclusively designed and exclusively used for vacuum spectroscopy where the tube housing and sample chamber is located behind all external surfaces of the unit shall be exempt from the requirements of this section, §§ 227.12a and 227.13a (relating to area requirements; and operating requirements), but shall meet the requirements of § 227.14 (relating to personnel procedures) and the following:
(1) The unit shall be designed so that when the unit is operating at the maximum kilovoltage and current ratings, the leakage radiation will not be in excess of 0.5 milliroentgens (.129 µC/kg) per hour at a distance of 4 centimeters from any external surface.
(2) Radiation surveys using appropriate radiation survey equipment shall be performed on the analytical X-ray unit upon installation, after moving the unit to a new location, and after maintenance or repair requiring the disassembly or removal of a local component or radiation shielding.
(3) Safety and warning devices shall be tested for proper operation at least annually. If the test reveals that a safety or warning device is not working properly, the unit may not be operated until the warning device is repaired or replaced.
(4) Records of all tests and surveys sufficient to show compliance with subsection (h) shall be maintained and kept available for inspection by the Department for 5 years.
(5) A sign bearing the radiation symbol and the words ''Caution Radiation--This Equipment Produces Radiation When Energized,'' or words of similar intent shall be placed next to any switch or device that activates the X-ray tube.
(6) A sign bearing the radiation symbol and the words ''Caution--Radiation,'' or words of similar intent shall be placed next to the opening of the sample chamber.
§ 227.12. [Safety devices and requirements] (Reserved).
[(a) Unused ports on radiation source housings shall be secured in the closed position in a manner which will prevent accidental opening.
(b) On equipment with an open-beam configuration manufactured and installed after December 19, 1987, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or coupling has been connected to the port.
(c) Open-beam configurations shall have a device which either prevents the entry of any portion of an individual's body into the primary X-ray beam path, or causes the beam to be terminated or interrupted upon entry into the path. A registrant may apply to the Department for an exemption from the requirement of a safety device. The application shall include the following:
(1) A description of the various safety devices that have been evaluated.
(2) The reason each of these devices cannot be used.
(3) A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.]
§ 227.12a. Area requirements.
(a) The source housing construction shall be of a type that when all the shutters are closed and the source is in any possible operating mode, the leakage radiation will not be in excess of 2.5 milliroentgens (.645 µC/kg) per hour at a distance of 5 centimeters from the housing surface.
(b) The X-ray generator shall have a protective cabinet constructed so that the leakage radiation will not be in excess of 0.5 milliroentgen (.129 µC/kg) per hour at a distance of 5 centimeters from the housing surface.
(c) The local components of an analytical X-ray system shall be located and arranged and shall include sufficient shielding or access control so that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the limits given in § 219.51 (relating to dose limits for individual members of the public). For systems utilizing X-ray tubes, these requirements shall be met at any specified tube rating.
(d) To show compliance with subsections (a)--(c), the registrant or licensee shall perform radiation surveys:
(1) Upon installation of the equipment and at least every 12 months thereafter.
(2) Following any change in the initial arrangement, number or type of local components in the system.
(3) Following any maintenance requiring the disassembly or removal of a local component in the system.
(4) During the performance of maintenance and alignment procedures if the procedures require the presence of a primary X-ray beam when any local component in the system is disassembled or removed.
(5) At any time a visual inspection of the local components in the system reveals an abnormal condition.
(6) Whenever personnel monitoring devices show a significant increase in radiation exposure over the previous monitoring period or the readings are approaching the radiation dose limits.
(7) Whenever the machine is operated in a manner other than the routine manner specified in § 227.13a (relating to operating requirements).
(e) The registrant or licensee shall test and inspect all safety and warning devices at least annually to insure their proper operation. If a safety or warning device is found to be malfunctioning, the machine shall be removed from service until repairs to the malfunctioning device are completed.
(f) Records of surveys and tests sufficient to show compliance with this chapter shall be maintained for 5 years and kept available for inspection by the Department.
(g) The equipment used to conduct the surveys and tests required in this chapter shall be adequate to measure the radiation produced by the radiation source.
§ 227.13. [Radiation levels, surveys and tests] (Reserved).
[(a) The source housing construction shall be such that when all the shutters are closed and the source is in any possible operating mode, the leakage radiation will not be in excess of 2.5 milliroentgens (0.645 µC/kg) per hour at a distance of 5 centimeters from the housing surface.
(b) The X-ray generator shall have a protective cabinet constructed so that the leakage radiation will not be in excess of .5 milliroentgen (129 nC/kg) per hour at a distance of 5 cm. from the cabinet surface.
(c) The analytical X-ray system shall have its local components and shielding or access control arranged so that in the area surrounding the local component group, the radiation dose to an individual will not be in excess of the limits given in § 219.51 (relating to dose limits to individual members of the public). For systems utilizing X-ray tubes, these requirements shall be satisfied for the maximum tube rating.
(d) To show compliance with subsections (a)--(c), the registrant or licensee shall perform radiation surveys upon installation of the equipment, and at least once every 12 months thereafter. In addition, to show compliance with subsection (c), the registrant or licensee shall perform radiation surveys:
(1) Following a change in the initial arrangement, number or type of local components in the system.
(2) Following maintenance requiring the disassembly or removal of a local component in the system.
(3) During the performance of maintenance and alignment procedures if the procedures require the presence of a primary X-ray beam when a local component in the system is disassembled or removed.
(4) When a visual inspection of the local components in the system reveals an abnormal condition.
(5) When the machine is operated in a manner other than the routine manner specified § 227.15(a) (relating to operating requirements).
(e) The registrant or licensee shall test and inspect all safety and warning devices at least annually to insure their proper operation. If a safety or warning device is found to be nonfunctional, the machine shall be removed from service until repairs to the nonfunctioning device are completed.
(f) Records of surveys and tests sufficient to show compliance with this chapter shall be maintained and kept available for inspection by the Department.
(g) The equipment used to conduct the surveys and tests required in this chapter shall be adequate to measure the radiation produced by the radiation source.]
§ 227.13a. Operating requirements.
(a) Operating procedures shall be written and available to all analytical X-ray equipment operators. These procedures shall include instructions for sample insertion and manipulation, equipment alignment, routine maintenance and data recording procedures which are related to radiation safety. An individual may not operate analytical X-ray equipment in a manner other than that specified in the operating procedures unless the individual has obtained written approval from the radiation safety officer.
(b) An individual may not bypass or otherwise circumvent a safety device unless the individual has obtained the prior written approval of the radiation safety officer. The radiation safety officer may grant the permission only if the following exist:
(1) The radiation safety officer establishes administrative controls and procedures to assure the radiation safety of individuals working around the system.
(2) The period for the bypass of the safety device is not more than 30 days unless written permission is obtained from the Department for a longer period.
(3) A readily discernible sign bearing the words ''Safety Device Not Working,'' or words containing a similar warning, is placed on the radiation source housing.
(c) Except as specified in subsection (b), an operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators or beam stops may not be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.
(d) Radioactive source housings shall be opened for source replacement, leak testing or other maintenance or repair procedures only by individuals authorized to specifically conduct the procedures under a license issued by the NRC, the Department or an agreement state.
§ 227.14. Personnel requirements.
(a) [The registrant or licensee may not permit an individual to] An individual may not operate or maintain analytical X-ray equipment unless the individual has received instruction in and demonstrated competence as to:
* * * * * (2) Significance of the various radiation warning and safety devices incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment, and the extra precautions necessary if the devices are absent or bypassed.
* * * * * (4) Symptoms of acute localized radiation [injury] exposure.
* * * * * § 227.15. [Operating requirements] (Reserved).
[(a) Written operating procedures shall be available to analytical x-ray equipment operators. These procedures shall include instructions for sample insertion and manipulation, equipment alignment, routine maintenance and data recording procedures which are related to radiation safety. No individual may operate analytical x-ray equipment in a manner other than that specified in the procedures unless the individual has obtained written approval from the radiation safety officer.
(b) No individual may bypass or otherwise circumvent a safety device unless the individual has obtained the written approval of the radiation safety officer. The radiation safety officer shall grant the permission only if the following exist:
(1) The radiation safety officer establishes administrative controls and procedures to assure the radiation safety of individuals working around the system.
(2) The period for the bypass of the safety device is no more than 30 days unless permission is obtained from the Department for a longer period.
(3) A readily discernible sign bearing the words ''Safety Device Not Working'' or words containing a similar warning, is placed on the radiation source housing.]
ELECTRON MICROSCOPES § 227.33. Personnel requirements.
[No] A registrant [shall] may not permit an individual to operate or conduct maintenance upon any electron microscope until the individual has received a copy of [and], instruction in, and demonstrated an understanding of, the operating procedures necessary to insure radiation safety.
CHAPTER 228. RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS
GENERAL PROVISIONS § 228.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise.
* * * * * Applicator--A structure which determines the extent of the treatment field at a given distance from the virtual source.
Beam-limiting device--A device providing a means to restrict the dimensions of the X-ray field.
Beam scattering filter--A filter used to scatter a beam of electrons.
Central axis of the beam--A line passing through the virtual source and the center of the plane figure formed by the edge of the first beam limiting device.
Dose monitoring system--A system of devices for the detection, measurement and display of quantities of radiation.
Dose monitor unit--A unit response from the dose monitoring system from which the absorbed dose can be calculated.
Existing equipment--Systems manufactured on or before the effective date of adoption of this proposal.
Field flattening filter--A filter used to provide dose uniformity over the area of a useful beam of X-rays at a specified depth.
Field size--The configuration of the radiation field along the major axes of an area in a plane perpendicular to the specified direction of the beam of incident radiation at the normal treatment distance and defined by the intersection of the major axes and the 50% isodose line.
Filter--Material placed in the useful beam to absorb the less penetrating radiation.
Isocenter--A fixed point in space located at the center of the smallest sphere through which the central axes of the beams pass.
Leakage radiation--Radiation emanating from the source assembly except for the following:
(i) The useful beam.
(ii) Radiation produced when the exposure switch or timer is not activated.
Moving beam therapy--Radiation therapy with relative displacement of the useful beam and the patient during irradiation.
New equipment--Systems manufactured after January 1, 1985.
Normal treatment distance--For isocentric equipment, the isocenter; for nonisocentric equipment, the target to patient skin distance along the central axis as specified by the manufacturer.
Phantom--A volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation.
Primary dose monitoring system--A system which will monitor the useful beam during irradiation and which will terminate irradiation when a preselected number of dose monitor units have been attained.
Qualified expert--An individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques and to advise regarding radiation protection needs. For example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual having, in addition to the preceding qualifications, training and experience in the clinical applications of radiation physics to radiation therapy, for example, individuals certified in therapeutic radiological physics or X-ray and radium physics by the American Board of Radiology, or radiation oncology physics by the American Board of Medical Physics, or those having equivalent qualifications.
Radiation detector--A device which provides a signal or other indication suitable for measuring one or more quantities of incident radiation.
Radiation head--The structure from which the useful beam emerges.
Secondary dose monitoring system--A system which will terminate irradiation in the event of failure of the primary dose monitoring system.
Shadow tray--A device attached to the radiation head to support auxiliary beam limiting material.
Spot check--A procedure to assure that a previous calibration continues to be valid.
Stationary beam therapy--Radiation therapy without relative displacement of the useful beam and the patient during irradiation.
Subsystem--A combination of two or more components of an accelerator.
Target--The part of a radiation source which intercepts a beam of accelerated particles with subsequent emission of other radiation.
Tube housing assembly--The term includes high-voltage or filament transformers, or both, and other appropriate elements when contained within the tube housing.
Useful beam--The radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated.
Wedge filter--An added filter effecting continuous progressive attenuation on all or part of the useful beam.
§ 228.3. Sale and installation.
A person may not sell or install an accelerator that does not meet the provisions of this article.
[NOTIFICATION PROCEDURES] ADMINISTRATIVE CONTROLS § 228.11. [Notification requirements] (Reserved).
[(a) A person who intends to purchase, construct or acquire an accelerator shall notify the Department of this intent within 30 days after the initial order is issued to obtain any or all parts of the accelerator.
(b) In addition to the notification in subsection (a), a person who intends to install an accelerator shall notify the Department within 30 days after the initial construction or installation begins.]
§ 228.11a. Registrant responsibilities.
(a) A person may not operate or permit the operation of an accelerator unless the accelerator and installation meet the applicable requirements of this article.
(b) Written safety procedures and rules shall be available at a facility, including restrictions of the operating technique required for the safe operation of the particular accelerator. The operator shall be able to demonstrate familiarity with the rules.
(c) An individual may not be exposed to the useful beam except for healing arts purposes. An exposure shall be authorized by a licensed practitioner of the healing arts.
(d) Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.
§ 228.12. Information and maintenance record and associated information.
The registrant or licensee shall maintain records of surveys, calibrations, maintenance, machine malfunctions and modifications performed on the accelerators, including the names of persons who performed the services. The registrant or licensee shall keep these records for inspection by the Department for 5 years.
[GENERAL RADIATION SAFETY REQUIREMENTS] NOTIFICATION AND LICENSING PROCEDURES § 228.21. [Limitations] (Reserved).
[(a) No registrant may permit an individual to act as an operator of an accelerator until the individual:
(1) Has been instructed in radiation safety and shall have demonstrated an understanding thereof.
(2) Has received copies of and instruction in this chapter and Chapters 219 and 220 (relating to standards for protection against radiation; and notices, instructions and reports to workers; inspections), pertinent registration conditions and the registrant's operating and emergency procedures and shall have demonstrated understanding thereof.
(3) Has demonstrated competence to use the accelerator, related equipment and survey instruments which will be employed in that individual's assignment.
(b) The radiation safety officer shall have the authority to terminate operations at an accelerator facility if the action is deemed necessary to minimize danger to health and safety or property.]
§ 228.21a. Notification and license requirements.
(a) A person who intends to purchase, construct or acquire an accelerator shall notify the Department of this intent by filing an application for a specific license within 30 days after the initial order is issued to obtain any or all parts of the accelerator. The application shall be filed in duplicate on a form prescribed by the Department. The application shall contain pertinent information to permit the Department to evaluate the requirements specified in this chapter.
(b) In addition to the notification in subsection (a), a person who intends to install an accelerator shall notify the Department within 30 days after the initial construction or installation begins.
(c) Except as provided in subsection (d), no person may operate a particle accelerator after____ (Editor's Note: Blank refers to effective date of adoption of the proposed rulemaking.), without having obtained a license from the Department.
(d) A registrant possessing an accelerator before ____(Editor's Note: Blank refers to effective date of adoption of the proposed rulemaking.), may continue to operate the accelerator provided in application for a license is filed in duplicate with the Department within 90 days of the adoption of the proposed rulemaking.
(e) The Department may, after the filing of an original application, and before the expiration of the license, require further information to enable the Department to determine whether the application will be granted or denied or whether a license will be modified or revoked.
(f) The application shall be signed by the applicant or licensee or an individual authorized by the applicant or licensee.
§ 228.22. [Shielding and safety design requirements] (Reserved).
[(a) The registrant shall consult a qualified expert for the design of accelerator installation and shall have the expert perform a radiation survey prior to the first use of the accelerator and when changes are made in shielding operations, equipment or occupancy of adjacent areas. The expert shall report the findings of these surveys in writing to the registrant and a copy of this report shall be available for inspection by the Department. The registrant shall comply with limitations indicated by the survey.
(b) An accelerator facility shall have primary and secondary protective barriers that are necessary to assure compliance with § 219.51 (relating to dose limits for individual members of the public).]
§ 228.22a. Issuance of specific licenses.
(a) Upon determination that an application meets the requirements of the act and this article, the Department will issue a specific license authorizing the proposed activity and containing conditions and limitations as it deems appropriate or necessary.
(b) After the issuance of the license, the Department may, by appropriate regulations or order, incorporate additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of the accelerator subject to this chapter as it deems appropriate or necessary in order to:
(1) Minimize danger to public health and safety or property.
(2) Prevent loss or theft of material subject to this chapter.
§ 228.23. [Particle accelerator controls and interlock systems] (Reserved).
[(a) Instrumentation, readouts and controls on the accelerator control console shall be clearly identified and easily discernible.
(b) Entrances into a target room or high radiation areas shall have interlocks that meet the requirements of §§ 219.91 and 219.154 (relating control of access to high radiation areas; and posting of high radiation areas).
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