TITLE 25. HEALTH SERVICES

(F) backscatter devices;

(H) flash x-ray;

(I) whole-body scanners for security purposes;

(J) devices used in educational, forensic, or research facilities, including post mortem examinations and work with non-human species; and

(2) Requirements for industrial radiography are specified in §289.255 of this chapter (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography).

(1) This section applies to a person who receives, possesses, uses, acquires, or transfers an RGD used for operations other than healing arts purposes. The registrant is responsible for the administrative control and directing the use of the RGD.

(c) Prohibitions.

(1) Except for whole-body scanners for security purposes, exposing an individual to the primary beam is prohibited. This provision specifically prohibits the deliberate exposure of an individual for:

(A) training;

(B) demonstration;

(C) healing arts; or

(D) other non-healing arts purposes.

(2) Holding a sample during the operation of any RGD is prohibited.

(d) Exemptions.

(1) Excluding training operations, RGDs meeting the definition of "bomb detection equipment," as defined in subsection (e)(5) of this section, are exempt from the requirements of subsection (h) of this section.

(2) The following are exempt from the requirements of this section:

(A) domestic television receivers, with exposure rates less than 0.005 millisieverts (mSv) (0.5 millirem (mrem)) per hour at 5 centimeters (cm) from any outer surface; and

(B) cold-cathode gas discharge tubes, with exposure rates less than 0.1 mSv (10 mrem) per hour at 30 cm from any point on the external surface of the tube.

(3) Equipment described in this subsection is not exempt if used or handled so that any individual might receive a dose of radiation exceeding the limits specified in §289.231 of this subchapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation).

(4) Certified and certifiable cabinet x-ray systems are exempt from the requirements of subsection (h) of this section. This exemption applies only to RGDs that, by design, cannot expose an individual or any body part to the primary beam.

(1) Accessible surface--The external or outside surface of the enclosure or housing provided by the manufacturer. This includes:

(A) the high-voltage generator;

(B) doors;

(C) access panels;

(D) latches;

(E) control knobs; and

(F) other permanently mounted hardware, as well as the plane across the exterior edge of any opening.

(2) Administrative controls--Workplace policies, procedures, and training regimens designed to reduce personnel exposure to radiation hazards.

(3) Analytical x-ray equipment--Machines that electronically generate and use ionizing radiation to examine the microstructure of materials, such as diffraction, spectroscopy, and fluorescence.

(4) Beam port--An opening on the x-ray housing designed to emit a primary beam. This does not include openings on package x-ray systems.

(5) Bomb detection equipment--RGDs used solely to detect explosive devices.

(6) Cabinet x-ray system--An RGD with the x-ray tube installed in an enclosure which is independent of existing architectural structures, except the floor on which it is placed. An x-ray tube used within a shielded part of a building, or x-ray equipment which may temporarily or occasionally incorporate portable shielding, is not a cabinet x-ray system. The cabinet x-ray system is intended to:

(A) contain at least the portion of a material being irradiated;

(B) provide radiation attenuation; and

(C) exclude personnel from its interior during the generation of radiation.

(7) Certifiable cabinet x-ray system--An existing uncertified x-ray system that has been modified to meet the certification requirements as required by 21 Code of Federal Regulations (CFR) §1020.40.

(8) Certified cabinet x-ray system--An x-ray system that has been certified under 21 CFR §1010.2 as being manufactured and assembled on or after April 10, 1975, as required by 21 CFR §1020.40.

(9) Closed-beam RGD--A system in which the beam path cannot be entered by any part of the body when operated under normal conditions.

(10) Cold-cathode gas discharge tube--An electronic device in which electron flow is produced and sustained by ionization of contained gas atoms and ion bombardment of the cathode.

(11) Collimator--A device for restricting the useful x-ray beam in one or more directions.

(12) Control panel--The part of the RGD that includes the switches, knobs, push buttons, and other hardware necessary for initiating and operating the device.

(13) Emergency procedure--The written, pre-planned steps to be taken in the event of actual or suspected exposure of an individual above the administrative or regulatory limits.

(14) Fail-safe design--A design where any likely failure of indicators or safety components prevents the primary beam, ensuring individuals remain protected from radiation even if a safety device fails.

(15) Hand-held RGD--See "radiation generating device" in paragraph (26) of this subsection.

(16) Industrial radiation machine--See "radiation generating device" in paragraph (26) of this subsection.

(17) Industrial radiography--A non-destructive testing method using ionizing radiation, such as gamma rays or x-rays, to make radiographic images for the purpose of detecting flaws in objects without destroying it.

(18) Interlock--A device preventing the start or continued operation of an RGD unless certain predetermined conditions are met.

(19) Leakage radiation--All ionizing radiation emanating from the source housing, except the primary beam.

(22) Package x-ray system--A non-human use, closed-beam RGD or cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, or packages.

(23) Personal protective equipment (PPE)--Device used to mitigate hazards associated with RGD use, including eye protection, protective clothing, or gloves.

(24) Portable RGD--See "radiation generating device" in paragraph (26) of this subsection.

(26) Radiation generating device (RGD)--Any system that generates x-rays or particle radiation up to 1 MeV and is not intended for healing arts as defined in §289.227 of this subchapter (relating to Use of Radiation Machines in the Healing Arts), or veterinary use as defined in §289.233 of this subchapter (Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine), including:

(A) industrial radiation machine--a radiation machine not intended for healing arts or veterinary use;

(B) portable RGD--equipment designed to be hand-carried or mounted on a permanent base with wheels or casters for moving while completely assembled;

(C) hand-held RGD--a portable instrument that is designed to operate when held in the hand; or

(D) stationary RGD--equipment that is installed or placed in a fixed location.

(27) Radiation safety officer (RSO)--An individual meeting the qualification requirements of §289.226 of this subchapter (relating to Registration of Radiation Machine Use and Services) and designated on the certificate of registration.

(28) Radiation source housing--The portion of an x-ray system that contains the x-ray tube or secondary target and contains radiation shielding material or inherently provides shielding.

(30) Scattered radiation--Radiation that has been deviated in direction or energy by interaction with matter.

(31) Shielded room--A room housing an RGD where, with the RGD at maximum output, the exterior of the room meets the dose limits for individual members of the public as specified in §289.231 of this subchapter.

(32) Shutter--A movable device used to block the useful, or primary, beam emitted from an x-ray tube assembly.

(33) Source--The focal spot of the x-ray tube.

(34) Stationary RGD--See "radiation generating device" in paragraph (26) of this subsection.

(35) Warning device--A visible or audible signal that warns individuals when radiation is being produced.

(36) Whole-body scanner for security purposes--A scanner for security using ionizing radiation to screen individuals for concealed items, including weapons, drugs, or explosives.

(37) X-ray generator--The portion of an x-ray system that provides the accelerating high voltage and current for the x-ray tube.

(f) Registration.

(1) Each person possessing a whole-body scanner or occupied vehicle scanner for security purposes, or an accelerator for non-human use, must apply and receive a certificate of registration from the department, as specified in §289.226 of this subchapter, before beginning use.

(2) Each person possessing an RGD for non-human use must apply and receive a certificate of registration from the department, as specified in §289.226 of this subchapter, within 30 days of beginning use of the RGD.

(g) Personnel requirements.

(1) Instructions. An individual is not permitted to operate an RGD unless the individual has received documented training and demonstrated competence in the following areas.

(A) Radiation safety fundamentals.

(i) Understanding the properties of ionizing radiation, the types of radiation emitted by the machine, and the biological effects associated with exposure.

(ii) Identifying potential radiation hazards specific to the RGD and the environment.

(iii) The documentation specified in this subparagraph must include:

(I) record of RGD-specific training;

(II) log of demonstration of competency; and

(III) date and signature of trainer or RSO.

(B) Operating and safety procedures (OSP).

(i) The registrant must document that each individual operating an RGD has read the OSP at least annually.

(ii) The documentation specified in clause (i) of this subparagraph must include:

(I) name and signature of individual;

(II) date individual read the operating and safety procedures; and

(III) initials of the RSO.

(C) Radiation protection principles.

(i) Adhering to "as low as reasonably achievable" (ALARA) principles, as defined in §289.231 of this subchapter, including the use of time, distance, and shielding to minimize exposure.

(ii) Proper use of PPE and individual monitoring devices, including routine monitoring and understanding of dose reports.

(D) Reporting exposures and radiation levels exceeding the limits.

(i) Recognizing and responding to radiation-related emergencies, including suspected overexposures, RGD malfunctions, or breaches of shielding.

(ii) Reporting procedures for actual or suspected exposures exceeding regulatory limits, as specified in §289.231 of this subchapter, including the required documentation and notification protocols.

(E) Machine-specific training.

(i) Familiarity with the manufacturer's operating manual, specific safety features, and maintenance requirements for the RGD being used.

(ii) Performing pre-use inspections and identifying conditions that require immediate shutdown or maintenance.

(2) Instructions for bomb detection RGDs. Personnel operating bomb detection RGDs must be trained in the setup and operation of the RGD, and in establishing a restricted area.

(3) Individual monitoring of occupational dose. In addition to the requirements of §289.231 of this subchapter, each registrant must supply and require the use of an extremity dosimetry device by:

(A) radiation workers using systems with an open-beam configuration without a safety device; and

(B) personnel maintaining radiation machines if the maintenance procedures require the presence of a primary x-ray beam when any local component in the x-ray system is disassembled or removed.

(4) Instruction and training as specified in paragraphs (1) and (2) of this subsection must be documented, maintained, and available for inspection by the department as specified in subsection (q) of this section.

(h) Area monitoring of dose limits for individual members of the public.

(1) Radiation levels. The local components of the RGD must include sufficient shielding or access control so that the dose to an individual present in the area does not exceed the dose limits for individual members of the public specified in §289.231 of this subchapter.

(2) Posting. Each area or room containing an RGD must be conspicuously posted with a sign or signs bearing the radiation symbol and stating, "CAUTION - X-RAY EQUIPMENT" or "CAUTION - RADIATION GENERATING DEVICE" or words with a similar intent.

(i) General operating requirements.

(1) Procedures.

(A) Each registrant must develop, implement, and maintain written OSP. The OSP must be maintained and available for inspection by the department as specified in subsection (q) of this section. The OSP must include:

(i) proper start-up, operation, and shutdown procedures for each RGD, including emergency shutdown procedures;

(ii) use of radiation warning and safety devices, such as shields, beam stops, and alarms, and knowledge of its purpose, function, and limitations;

(iii) procedures for preventing unauthorized access to radiation areas and maintaining compliance with radiation protection standards; and

(iv) emergency procedures in the event of an actual or suspected exposure of an individual above the dose limit specified in §289.231 of this subchapter.

(I) Emergency procedures must include the:

(-a-) names and telephone numbers of individuals to be contacted; and

(-b-) instructions for processing individual monitoring devices.

(II) Documentation of an actual or suspected exposure of an individual above the dose limits must be maintained and available for inspection by the department as specified in subsection (q) of this section.

(B) Operating a radiation machine in any manner other than those specified in the OSP is prohibited unless the operator has obtained written approval from the RSO. Written approval must be documented, maintained, and available for inspection by the department as specified in subsection (q) of this section.

(2) Bypassing safety devices.

(A) Bypassing a safety device is prohibited without the written approval from the radiation safety officer.

(B) If a safety device has been bypassed, a visible sign stating, "SAFETY DEVICE NOT WORKING" or words with a similar intent, must be placed on the radiation source housing and at the control switch.

(C) Documentation of bypassing a safety device or interlock must be maintained and available for inspection by the department as specified in subsection (q) of this section. Documentation must include the:

(i) RGD information, including the;

(I) manufacturer;

(II) model; and

(III) serial number of the RGD;

(ii) date the alteration was made;

(iii) type of alteration;

(iv) name of the individual who made the alteration;

(v) name of the individual who restored the RGD to normal operating condition;

(vi) date the RGD was restored to normal operating condition; and

(vii) result of an area survey, conducted after the RGD is restored to normal operating condition, signed by the RSO.

(3) Installation, assembly, repair, or modification of RGDs.

(A) Only registered service providers are permitted to install, assemble, repair, or modify the RGD.

(B) Except as specified in paragraph (2) of this subsection, the removal of covers, shielding materials, tube housing, or modifications to shutters, collimators, or beam stops is prohibited without:

(i) verifying the tube is de-energized before beginning work and will remain de-energized until safe conditions are restored;

(ii) ensuring the main switch is used for routine shutdown in preparation for repairs; and

(iii) implementing lockout/tagout procedures, as specified by the manufacturer's operating manual, to secure the RGD and prevent accidental re-energization.

(C) Documentation of installation, assembly, repair, or modification of RGDs must be maintained and available for inspection by the department as specified in subsection (q) of this section. Documentation must include:

(i) RGD information, including the;

(I) manufacturer;

(II) model; and

(III) serial number of the RGD;

(ii) the date of service;

(iii) the name of the individual performing the service;

(iv) findings; and

(v) corrective actions.

(4) Control panel.

(A) Activation of the RGD must only be possible from the control panel.

(B) All indicators and controls that operate the primary beam must be clearly labeled with its function.

(5) Interlocks.

(A) De-energizing the x-ray tube or RGD using an interlock is prohibited except in an emergency or during testing of the interlock system.

(B) When an interlock is activated, restoring the RGD to normal operation must require manually resetting it from the control panel.

(C) All interlocks must be of a fail-safe design.

(6) Multiple sources.

(A) If more than one x-ray tube assembly or focal spot can be operated sequentially or simultaneously from a control panel, visual indicators must show which tube assembly or focal spot is selected.

(B) The selector must be clearly labeled with its function.

(C) Symbols must be identified by a reference on the control panel.

(7) Testing safety devices.

(A) Interlocks, shutters, warning lights, and required emergency shut-off switches must be tested within 30 days of receipt or installation, then annually, not to exceed 14 months from the date of the previous test on all operable RGDs.

(B) If any safety device fails during testing, the:

(i) RGD must be removed from service;

(ii) safety device failure must be corrected before returning to normal operation; and

(iii) corrective actions taken for each safety device must be documented and signed by the RSO.

(C) Documentation of testing must be completed and include:

(i) RGD information, including the;

(I) manufacturer;

(II) model; and

(III) serial number of the RGD;

(ii) survey instrument information, as applicable;

(I) manufacturer;

(II) model;

(III) serial number; and

(IV) calibration date, calibrated within the previous 24 months and after any service that may have affected the system calibration;

(iii) the date of the test;

(iv) a list of the safety devices tested;

(v) indication of a pass or fail for each test; and

(vi) the name of the individual performing the tests.

(D) Testing of safety devices may be deferred if the RGD is out of service and visibly marked. Testing must be performed before returning the RGD to normal operation.

(E) Safety device testing is exempt if it cannot be performed due to the manufacturer's design. The registrant must document the exemption in writing and maintain the record as specified in subsection (q) of this section for inspection by the department.

(F) Documentation of the safety device testing must be maintained and available for inspection by the department as specified in subsection (q) of this section.

(A) All RGDs must be labeled with the radiation symbol and the words: "CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED" or words with a similar intent, near any switch that energizes an x-ray tube.

(B) For package x-ray systems, the following must be posted at or near each opening: "CAUTION- X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED" or words with a similar intent.

(B) When the x-ray tube housing is the primary shielding for the x-ray tube and is intended to be opened for normal use or maintenance, the housing must be equipped with an interlock that de-energizes high voltage to the x-ray tube if the housing is opened.

(5) Radiation emission limit. With all shutters closed, the leakage radiation from the x-ray tube housing, measured at 5 cm from the housing surface, must not exceed 0.025 mSv (2.5 mrem) per hour. This limit must be met at the maximum output.

(k) Additional requirements for closed-beam RGDs. In addition to the requirements in subsection (i) of this section, the following requirements apply to all closed-beam RGDs not addressed in this section.

(1) Certified and certifiable cabinet x-ray systems, as defined in this subsection, must also meet the requirements of 21 CFR §1020.40.

(2) The registrant must perform a survey to ensure that radiation emitted 5 cm from any accessible surface of the closed-beam RGD does not exceed 0.005 mSv (0.5 mrem) in any one hour.

(A) Equipment survey frequency. RGDs must be evaluated:

(i) within 30 days of receipt or installation;

(ii) annually, not to exceed 14 months from the date of the previous evaluation;

(iii) after any maintenance that affects the radiation shielding or x-ray production components; and

(iv) after any incident that may have damaged the radiation shielding or x-ray production components.

(B) Equipment survey report must include:

(i) RGD information, including the;

(I) manufacturer;

(II) model; and

(III) serial number of the RGD;

(ii) survey instrument information, as applicable, including the;

(I) manufacturer;

(II) model;

(III) serial number; and

(IV) calibration date, calibrated within the previous 24 months and after any service that may have affected the system calibration;

(iii) the date of the test;

(iv) indication of a pass or fail for each test;

(v) the name of the individual performing the tests;

(vi) the registration number of the service provider, if the survey is performed by a third party;

(vii) numerical data;

(viii) diagram of the location of measurements; and

(ix) any other parameter required by the manufacturer.

(C) Documentation of the equipment survey must be maintained and available for inspection by the department as specified in subsection (q) of this section. Documentation must include the:

(i) date; and

(ii) initials of the individual performing these functions.

(3) System enclosure. The radiation source, sample or object, detector, and analyzing crystal must be enclosed in a chamber or coupled chambers that cannot be entered by any part of the body during normal operation.

(4) Interlocks.

(A) Interlocks must be provided as specified in subsection (i)(5) of this section. All doors and panels accessing the RGDs must be interlocked.

(B) Interlock functions. The sample chamber door or other enclosure must have a fail-safe interlock on the x-ray tube high-voltage supply or a shutter in the primary beam so that the x-ray beam cannot enter the sample chamber while it is open.

(5) Radiation emission limit. The radiation emission for all closed-beam RGDs must not exceed a dose rate of 0.005 mSv (0.5 mrem) in one hour at 5 cm outside any accessible surface.

(6) Package x-ray systems. Package x-ray systems must have an operator present at the controls so that the operator can clearly view the ports and doors at all times during x-ray generation.

(A) During an exposure or preset succession of exposures of one-half second or greater duration, the means provided must allow the operator to terminate the exposure or preset succession of exposures at any time.

(B) During an exposure or preset succession of exposures of less than one-half second duration, the means provided may allow completion of the exposure in progress but must allow the operator to prevent additional exposures.

(l) Additional requirements for open-beam RGDs. In addition to the requirements in subsection (i) of this section, the following requirements apply to all open-beam RGDs not addressed in this section.

(1) Shutters. Each port on the radiation source housing must be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port and provided with a visible indication of:

(A) x-ray tube status (ON-OFF) located near the radiation source housing; or

(B) shutter status (OPEN-CLOSED) located near each port on the radiation source housing.

(2) Beam ports. Unused beam ports on a radiation source housing must be secured in the closed position to prevent inadvertent opening.

(3) Radiation emission limits. The local components of an open-beam RGD must include sufficient shielding or access control to meet dose limits for individual members of the public as specified in §289.231 of this subchapter. These emissions must be met at the maximum output.

(4) Primary beam attenuation. If the primary beam is not intercepted by its detector under all operating conditions, protective measures must be provided to prevent exposure of an individual to the primary beam.

(5) Operator position. The operator must be physically present when the RGD is in operation to prevent unauthorized or accidental entry.

(6) Control of access. If the RGD is not in a restricted area as defined in §289.231 of this subchapter, the operator must be able to control access to the RGD at all times during operation.

(7) Personnel monitoring. In addition to the personnel monitoring requirements specified in §289.231 of this subchapter, individual monitoring devices used to measure the dose to an extremity must be provided to and used by:

(A) personnel with potential for extremity exposure to the primary beam of an open-beam RGD;

(B) personnel maintaining RGDs if the maintenance procedures require the presence of a primary radiation beam when any local component in the RGD is disassembled or removed; and

(C) personnel operating hand-held RGDs.

(m) Shielded room RGDs. For RGDs that do not meet the dose limits of individual members of the public as specified in §289.231 of this subchapter, the RGD must be maintained inside a shielded room. In addition to the requirements in subsection (i) of this section, the following requirements apply to shielded room RGDs not addressed in this section.

(1) Room warning signals.

(A) The interior of the shielded room must be provided with at least one flashing or rotating warning light that only operates when radiation is being produced.

(B) An audible warning signal within the room must be activated for at least 10 seconds immediately before the initiation of radiation.

(C) A sign must be posted to indicate "DANGER- RADIATION AREA- X-RAY IN USE WHEN SIGNAL IS ON" or words with a similar intent.

(D) The sign must be readable and easily accessible for viewing.

(2) Emergency shut-off.

(A) If dose rates exceed the high radiation area limits, as defined in §289.231 of this subchapter, an emergency shut-off switch must be located within the high radiation areas.

(B) The switch must include a manual reset so the RGD cannot be restarted from the console without resetting the shut-off switch.

(C) The switch must be labeled "EMERGENCY SHUT-OFF."

(3) Separate electrical systems. The interlock and emergency shut-off systems must be separate, either electrically or mechanically.

(4) Control panel security. The RGD control panel must not be left unattended unless secured by a locking device or a computerized password system, preventing unauthorized use.

(5) Malfunctions. If a safety or warning device malfunctions, the RGD must not be used until the device is functioning properly.

(n) Additional requirements for bomb detection RGDs. In addition to the requirements in subsection (i) of this section, the following requirements apply to bomb detection RGDs not addressed in this section.

(1) Control panel security. When not in use, each bomb detection RGD must be locked to prevent unauthorized use. This is in addition to the requirements of §289.231 of this subchapter, relating to security and control of radiation machines.

(2) Utilization log. The registrant must maintain a utilization log for each bomb detection RGD.

(A) This log must include the:

(i) RGD information, including the:

(I) manufacturer;

(II) model; and

(III) serial number of the RGD;

(ii) date removed from storage;

(iii) date returned to storage;

(iv) name and signature of the individual using the RGD; and

(v) date and location of use.

(B) Documentation must be maintained and available for inspection by the department as specified in subsection (q) of this section.

(3) Area control. The registrant must establish boundaries to prevent unauthorized entry into the restricted area when the machine is energized.

(o) RGDs used for whole-body scanning for security.

(1) Whole-body scanning for security purposes. Each applicant must apply for and receive a certificate of registration before use.

(A) The OSP must be submitted to the department with the application for evaluation and approval.

(B) In addition to the requirements of subsection (i)(1) of this section, the OSP must address the following requirements:

(i) scans are prohibited on individuals 17 years of age or younger;

(ii) scans are prohibited on pregnant individuals;

(iii) scans are only permitted on inmates, detainees, employees, or contractors;

(iv) dose limits specified in paragraph (3) of this subsection must be met;

(v) effective dose must not exceed 0.0025 mSv (0.25 mrem) per scan; and

(vi) specific controls that limit the number of individuals scanned or the number of scans per individual in 365 calendar days.

(2) Additional requirements for whole-body scanning for security purposes. In addition to the requirements in subsection (i) of this section, the following requirements apply to whole-body scanning for security purposes.

(A) Posting requirements. The registrant must post a sign stating: "If you are pregnant or think you might be pregnant, tell the operator before the scan" or words with a similar intent, in each radiation area.

(B) Equipment evaluation.

(i) RGDs used for whole-body scanning of humans must be evaluated by a registered service provider:

(I) within 30 days of receipt or installation;

(II) annually, not to exceed 14 months from the date of the previous evaluation;

(III) after any maintenance that affects the radiation shielding or x-ray production components; and

(IV) after any incident that may have damaged the system in a way that x-ray leakage may occur.

(ii) Equipment evaluation must include:

(I) effective dose to the individual;

(II) radiation leakage;

(III) inspection zone; and

(IV) any other parameter required by the manufacturer.

(iii) Documentation of the equipment evaluation must include the:

(I) date;

(II) registration number of the registered service provider performing the evaluation; and

(III) initials of the individual performing these functions.

(iv) Records of the equipment evaluation must be maintained as specified in subsection (q) of this section for inspection by the department.

(3) Dose limits for whole-body scanners. For whole-body scanning, an effective dose for a single complete screening must be limited to 0.0025 mSv (0.25 mrem).

(4) Dose limits for repeat security screenings. Individuals subject to repeat security screening must not receive an effective dose greater than 0.25 mSv (25 mrem) annually.

(p) Occupied vehicle screening for security.

(1) Occupied vehicle screening for security purposes. Each applicant must apply and receive a certificate of registration before use.

(A) The OSP must be submitted to the department with the application for evaluation and approval.

(B) The OSP must include the requirements of subsection (i)(1) of this section and address the following:

(i) scans are prohibited on individuals 17 years of age or younger;

(ii) scans are prohibited on pregnant individuals;

(iii) the use of x-ray-based occupied vehicle screening must be used as a secondary screening measure, used only after standard, non-radiological screening procedures indicate further evaluation;

(iv) dose limits specified in paragraph (2)(C) of this subsection must be met; and

(v) exposure from the primary beam must not exceed 0.0025 mSv (0.25 mrem) per scan.

(2) Additional requirements for occupied vehicle screening for security purposes. In addition to the requirements of subsection (i) of this section, the following requirements apply to occupied vehicle screening for security purposes.

(A) Posting requirements. The registrant must post a sign stating: "If you are pregnant or think you might be pregnant, tell the operator before the scan" or words with a similar intent, in each radiation area.

(B) Equipment evaluation.

(i) RGDs used for occupied vehicle screening must be evaluated by a registered service provider:

(I) upon installation;

(II) annually, not to exceed 14 months from the date of the previous evaluation;

(III) after any maintenance that affects the radiation shielding or x-ray production components; and

(IV) after any incident that may have damaged the system in a way that x-ray leakage may occur.

(ii) Equipment evaluation must include:

(I) effective dose to an individual;

(II) radiation leakage;

(III) inspection zone; and

(IV) any other parameter required by the manufacturer.

(iii) Documentation of the equipment evaluation must be maintained and available for inspection by the department as specified in subsection (q) of this section. Documentation must include the:

(I) date;

(II) registration number of the registered service provider performing the evaluation; and

(III) initials of the individual performing these functions.

(C) Dose limits. The effective dose to an individual for a single inadvertent exposure to the primary beam must not exceed 5 mSv (500 mrem). A pre-screening mode or system that meets the limits in subsection (o)(3) - (4) of this section must be used to verify that there are no occupants in the vehicle being examined if the 5 mSv (500 mrem) limit cannot be met.

(q) Records for department inspection. The registrant must maintain the following records at the time intervals specified, for inspection by the department. The records must be available for review at the time of the inspection and may be maintained in electronic format.

Figure: 25 TAC §289.228(q) (.pdf)