Subchapter D. OPEN-BEAM RADIATION-PRODUCING DEVICES
Sec.
227a.40. Safety device.
227a.41. X-ray on status.
227a.42. Labeling.
227a.43. Beam ports.
227a.44. Shutters.
227a.45. Radiation emission limits.
227a.46. Primary beam attenuation.
227a.47. Operator attendance.
227a.48. Control of access.
227a.49. Instruction and training.
227a.50. Handheld radiation-producing devices.
227a.51. Bomb detection radiation-producing devices.
227a.52. Radiation-producing devices used in individual security screening.
227a.53. Radiation-producing devices used in vehicle security screening.
227a.54. Permanent radiographic installations.
227a.55. Shielded room radiation-producing devices.§ 227a.40. Safety device.
(a) Documentation. The registrant shall document its justification of the use of an open-beam instead of closed-beam radiation-producing device.
(b) Open-beam considerations. If the registrant needs to use an open-beam radiation-producing device, the registrant shall consider a safety device which minimizes the chance of entry of any portion of the operator’s body into the path of the primary beam or which causes the primary beam to be shut off upon entry into its path.
(c) Records. If the registrant’s use of an open-beam radiation-producing device does not permit the use of a safety device to minimize the chance of direct body exposure, the registrant shall maintain a written record of the justification required in subsection (a) and a description of the various safety devices that have been evaluated and reasons the devices cannot be used. These records shall be available onsite for inspection as long as this method is used, plus an additional 5 years.
(d) Alternative methods. If the registrant’s use of the open-beam radiation-producing device does not permit the use of a safety device to minimize the chance of direct body exposure, the registrant shall use alternative methods, such as policies and procedures, to minimize the possibility of unnecessary exposure. The registrant shall document the alternative methods used. The documentation must include information about the absence of safety devices. This documentation shall be available for inspection as long as the methods are used plus an additional 5 years.
(e) Compliance. For a portable open-beam radiation-producing device without a safety device described under subsection (b) that is manufactured to be used or potentially used as a handheld device, the safety device requirements under subsections (b)—(d) shall be met by complying with § 227a.50 (relating to handheld radiation-producing devices) prior to use.
Cross References
This section cited in 25 Pa. Code § 227a.49 (relating to instruction and training).
§ 227a.41. X-ray on status.
Open-beam radiation-producing devices must have a conspicuous and active indication of the following, as applicable:
(1) X-ray tube ‘‘on-off’’ status indicator located near the radiation source housing. The warning lights required under § 227a.11(b) (relating to warning devices), meet this requirement if the warning lights are conspicuous and viewable by anyone near the primary beam.
(2) Shutter ‘‘open-closed’’ status indicator located at the control panel and near each beam port on the radiation source housing, if the primary beam is controlled with a shutter. The shutter status device must be clearly labeled to indicate whether the shutter is open or closed. The status light at the control panel meets the requirement for the status light at the beam port if the status light at the control panel is conspicuous and viewable by anyone near the primary beam.
(3) The X-ray tube ‘‘on-off’’ status indicator and the shutter ‘‘open-closed’’ status indicators must be of a fail-safe design.
§ 227a.42. Labeling.
Each unit must be labeled at or near the X-ray exit beam port to identify the location of the beam with the words, ‘‘CAUTION—X-RAY BEAM,’’ ‘‘CAUTION—HIGH INTENSITY X-RAY BEAM,’’ or words having a similar intent.
§ 227a.43. Beam ports.
Unused beam ports on radiation source housings shall be secured in the closed position in a manner which will prevent inadvertent opening.
§ 227a.44. Shutters.
On open-beam radiation-producing device configurations that are designed to accommodate interchangeable components, each beam port on the radiation source housing must be equipped with a shutter that cannot be opened unless a collimator or a component coupling has been connected to the beam port.
§ 227a.45. Radiation emission limits.
Radiation emissions limits, exclusive of the primary beam, must be met at any specified tube rating established by the manufacturer. The local components of an open-beam radiation-producing device must be located, and be arranged and include sufficient shielding or access control to prevent either of the following from occurring:
(1) Radiation emissions in any area surrounding the local component group which could result in an occupational dose in excess of 10 CFR Part 20 Subpart C (relating to occupational dose limits).
(2) A dose to an individual in an area surrounding the local component group in excess of the dose limits outlined under § 219.51 (relating to dose limits for individual members of the public).
§ 227a.46. Primary beam attenuation.
In cases where the primary beam is not intercepted by the detector device under all conditions of operation, protective measures, such as auxiliary shielding or administrative procedures, shall be provided to avoid exposure to any individual from the transmitted primary beam.
Cross References This section cited in 25 Pa. Code § 227a.50 (relating to handheld radiation-producing devices).
§ 227a.47. Operator attendance.
The operator shall be present at all times when the equipment is in operation except when the area is locked, or the equipment is secured to protect against unauthorized or accidental entry.
§ 227a.48. Control of access.
If the radiation-producing device is not in a restricted area as defined in 10 CFR 20.1003 (relating to definitions), the operator shall control access to the radiation-producing device at all times during operation. The following apply:
(1) Radiation areas must be conspicuously identified. The following apply:
(i) The radiation source must be within a conspicuous perimeter, for instance, a rope, tape or other barrier, that identifies the area in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in 1 hour.
(ii) The area described in subparagraph (i) must be suitably posted with ‘‘CAUTION—RADIATION AREA’’ signs.
(iii) The operator shall ensure that no one is inside and that no one enters the radiation area during operation of the radiation-producing device.
(2) High radiation areas must be conspicuously identified. The following apply:
(i) The radiation source must be within a conspicuous perimeter, for instance, a rope, tape or other barrier, that identifies the area in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 mSv) in 1 hour.
(ii) The area described in subparagraph (i) must be suitably posted with ‘‘CAUTION—HIGH RADIATION AREA’’ signs.
(iii) The operator shall ensure that no one is inside or enters the high radiation area during operation of the radiation-producing device.
(3) The operator shall perform a visual check of the controlled area to ensure that it is free of unauthorized personnel immediately prior to activating or exposing the radiation source.
§ 227a.49. Instruction and training.
In addition to meeting the requirements of § 227a.21 (relating to instruction and training), an individual may not operate or maintain an open-beam radiation-producing device unless the individual has received training applicable to the procedures to be performed and the specific equipment used. This training may include more specific and detailed instruction in, and demonstrated competence as to, the following:
(1) Sources and magnitude of common radiation exposure.
(2) Units of radiation measurement.
(3) Radiation protection concepts of time, distance, shielding and ALARA.
(4) Procedures and rights of a declared pregnancy.
(5) Regulatory requirements and area postings.
(6) Worker, embryo/fetus and public dose limits.
(7) Proper use of survey instruments and dosimetry.
(8) Policies and procedures required under § 227a.40 (relating to safety device).
Cross References This section cited in 25 Pa. Code § 227a.50 (relating to handheld radiation-producing devices).
§ 227a.50. Handheld radiation-producing devices.
In addition to the requirements in Subchapter B and this subchapter (relating to general technical requirements; and open-beam radiation-producing devices), the following requirements apply to open-beam, hand-held radiation-producing devices.
(1) Procedures. A registrant possessing an open-beam, hand-held radiation-producing device shall have available for review operating policies and procedures that contain measures to ensure that the following are met:
(i) Radiation protection is provided equivalent to that afforded under § 219.51 (relating to dose limits for individual members of the public).
(ii) Radiation protection is provided equivalent to that afforded under § 227a.46 (relating to primary beam attenuation).
(iii) The operator will not hold the sample during operation of the radiation-producing device and that the operator’s hands will not approach the primary beam.
(iv) The operator will not aim the primary beam at any individual, including the operator, during the operation of the radiation-producing device.
(v) Operator radiation exposure is as low as reasonably achievable by use of means such as ancillary equipment that will reduce exposure.
(2) Training. In addition to the training requirements under § § 227a.21 and 227a.49 (relating to instruction and training), the registrant shall provide training for all users and operators on the subjects specified under this section. Records shall be maintained for all user and operator training and be made available for review by the Department for 5 years.
(3) Radiation emission limit. For hand-held radiation-producing devices, the limits of § § 227a.13(b) and 227a.14 (relating to radiation source housing; and generating cabinet or high voltage radiation emission limits), excluding the primary beam, shall be met if the radiation emission at any accessible surface of the radiation-producing device does not exceed 2.5 mrem (0.025 mSv) per hour at 5 centimeters.
Cross References This section cited in 25 Pa. Code § 227a.14 (relating to generating cabinet or high voltage source radiation emission limits); and 25 Pa. Code § 227a.40 (relating to safety device).
§ 227a.51. Bomb detection radiation-producing devices.
In addition to the requirements in Subchapter B (relating to general technical requirements), except § 227a.16 (relating to posting), the following requirements apply to bomb detection radiation-producing devices:
(1) Control panel security. In addition to the requirements in § 227a.17 (relating to security), bomb detection radiation-producing devices shall be locked to prevent unauthorized use when not in use.
(2) Use log. The registrant shall maintain a use log for each bomb detection radiation-producing device. This log must record the description of the unit, the date removed from storage, the date returned to storage, the identity and signature of the person to whom the device is assigned, the dates of use and the site or sites of use. This use log shall be maintained for 5 years.
(3) Area control. The registrant shall provide security to prevent entry by individuals to the area in which the device is energized.
§ 227a.52. Radiation-producing devices used in individual security screening.
In addition to the requirements in Subchapter B (relating to general technical requirements), the following requirements apply to radiation-producing devices used in individual security screening. A person requesting Department approval for a radiation-producing device to be used for individual security screening with intended human exposure to the primary beam for public protection shall submit the following information to the Department for evaluation and approval. The applicant shall state how the dose limits in this section will be met. The applicant shall receive Department approval prior to use.
(1) Efficacy evaluation. An evaluation of all known alternate methods that could achieve the goals of the individual security screening program and an explanation of why these methods will not be used in preference to the applicant’s proposed approach using ionizing radiation.
(2) Equipment evaluation. A device used for individual security screening of humans shall be evaluated by a qualified expert at the following times for optimization of image quality and radiation dose per manufacturer’s recommendations and this section:
(i) Upon installation of the device.
(ii) After maintenance that affects the radiation shielding, shutter mechanism or X-ray production components.
(iii) Upon damage to the system.
(iv) Every 12 months.
(3) Dose limits for general-use systems. An effective dose for a single complete screening must be limited to 25 µrem (0.25 µSv) when the system is used without regard to the number of individuals scanned or number of scans per individual in a year.
(4) Dose limits for limited-use systems. The effective dose per screening must be less than or equal to 1 mrem (0.01mSv) when equipment is capable of operation greater than 25 µrem (0.25 µSv) per screening. The number of scans per individual must be tracked to ensure the dose does not exceed the limits referenced in paragraph (5) and § 227a.53(c) (relating to radiation-producing devices used in vehicle security screening).
(5) Dose limits for repeat security screenings. An individual subject to repeat individual security screenings at a single venue may not receive an effective dose greater than 25 mrem (0.25 mSv) in a 12-month period at the registrant’s or licensee’s facility.
(6) Information available to screening subjects. At a minimum, the registrant shall make the following information available to screening subjects prior to scanning:
(i) The estimated effective dose from one screening.
(ii) Examples comparing the effective dose with commonly known sources of radiation exposure.
(7) Training. Training must include the following:
(i) The RSO shall have 8 hours of training in radiation safety which must include X-ray physics, biological effects, units of measure, safety standards, and protection regulations.
(ii) In addition to X-ray scanner operation training by the manufacturer, an operator shall receive at least 2 hours of radiation safety training.
(iii) Operators and the RSO shall receive annual radiation safety refresher training. Training must include the applicable topics under Chapter 221, Appendix A (relating to determination of competence).
(8) Scanning of minors and pregnant individuals. The scanning of an individual under 18 years of age or an individual known or declared pregnant is prohibited without prior departmental approval.
(9) Preventative maintenance. The registrant shall follow the manufacturer’s recommended preventative maintenance schedule.
(10) Radiation protection program. A written radiation safety program must be based on accepted radiation protection principles, including keeping an exposure ALARA. The registrant is responsible to have the program developed, documented and implemented. The RSO shall review the radiation protection program at least annually.
(11) Records retention. The registrant shall maintain all records relative to the use of the radiation-producing device for at least 5 years.
Cross References This section cited in 25 Pa. Code § 227a.53 (relating to radiation-producing devices used in vehicle security screening).
§ 227a.53. Radiation-producing devices used in vehicle security screening.
(a) Procedure for human exposure. When the procedures for operation of a mobile or transportable radiation-producing device used for security screening of vehicles includes knowingly exposing human occupants to the primary beam when screening vehicles, structures or containers, the system is subject to the same requirements as provided in § 227a.52(1)—(5) (relating to radiation-producing devices used in individual security screening).
(b) Minimizing human exposure. If vehicle occupants are knowingly exposed to the primary beam of a security screening device and the requirements in § 227a.52(3)—(5) cannot be met, then there shall be means to ensure the occupied portion of the vehicle is outside of the scan area while the primary beam is emitted or procedures shall be established and implemented to ensure that no occupants are present in the vehicle during screening.
(c) Dosage limits. The effective dose to an individual for a single inadvertent exposure to the primary beam must not exceed 500 mrem (5 mSv). The reliability of the procedure used to ensure that a vehicle to be scanned is unoccupied must be commensurate with the potential severity of an inadvertent exposure. A pre-screening with a mode or system that can meet the limits under § 227a.52(3)—(5) shall be used to verify that the vehicle being examined is unoccupied if the 500 mrem (5 mSv) limit cannot be ensured.
§ 227a.54. Permanent radiographic installations.
(a) Entrance controls. Permanent radiographic installations having high radiation area entrance controls of the types described in 10 CFR 20.1601 and 20.1902 (relating to control of access to high radiation areas; and posting requirements) must also meet the following requirements:
(1) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have both visible and audible warning signals to warn of the presence of radiation. The visible signal shall be activated by radiation whenever the X-ray source is energized. The audible signal shall be activated when an attempt is made to enter the installation while the X-ray source is energized.
(2) The entrance control device or alarm system shall be tested for proper function prior to beginning operations on each day of use.
(3) The industrial radiographic system may not be used if an entrance control device or alarm system is not operating properly. If an entrance control device or alarm system is not functioning properly, it shall be removed from service and repaired or replaced immediately. If no replacement is available, the facility may continue to be used if the registrant implements the continuous surveillance under 10 CFR 34.51 and 34.53 (relating to surveillance; and posting), § 225.85 (relating to surveys and survey records) and uses an alarming ratemeter. Before the entrance control device or alarm system is returned to service, the RSO or an individual designated by the RSO shall validate the repair.
(b) Records. Records of the tests performed under subsection (a) shall be maintained for inspection by the Department for 5 years.
§ 227a.55. Shielded room radiation-producing devices.
(a) Control of access. A room used for shielded room X-ray radiography must be shielded so that every location on the exterior meets conditions for an unrestricted area. Access to the room may only be through openings that are interlocked. The openings must be interlocked so that the radiation source cannot operate unless all openings are securely closed and meet the requirement of 10 CFR 20.1601 (relating to control of access to high radiation areas).
(b) Physical radiation survey. The operator shall conduct a physical radiation survey to determine that the radiation source is deenergized prior to each entry into the radiographic exposure area.
(c) Radiation monitoring system. The operator may use an independent radiation monitoring system that displays the radiation intensity or displays when radiation levels have returned to their pre-irradiation levels as an alternative to subsection (b).
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