| (a) Purpose. This section establishes requirements for the use of industrial radiation machines not otherwise covered by this chapter. For purposes of this section, industrial radiation machines include, but are not limited to, portable/handheld fluorescence x-ray (open beam), fluoroscopy hand held intensified, fluoroscopy x-ray, industrial accelerator, spectrography x-ray, flash x-ray, flash x-ray for bomb detection, educational facility (x-ray for non-human or not live animal use), diffraction x-ray, uncertified cabinet x-ray, and minimal threat radiation machines. (b) Scope. (1) The requirements of this section are in addition to and not in substitution for other applicable requirements of this chapter. (2) In addition to the requirements of this section, all registrants, unless otherwise specified, are subject to the requirements of §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.226 of this title (relating to Registration of Radiation Machine Use and Services), and §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). (3) Radiation safety requirements and registration procedures for industrial radiography are specified in §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography). (c) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) Fail-safe characteristics--Design features that cause beam port shutters to close, or otherwise prevent emergence of the primary beam, upon the failure of a safety or warning device. (2) Local components--Parts of an x-ray system that include areas that are struck by x rays, such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels. (3) Minimal threat radiation machines--Minimal threat radiation machines include, but are not limited to, fluorescence x-ray (closed beam), gauges x-ray, certified cabinet x-ray, package x-ray, electron beam welding, particle size analyzer, ion-implant, and cathodoluminescence. In addition, minimal threat radiation machines are those radiation machines capable of generating or emitting fields of radiation that, during the operation of which: (A) no deliberate exposure of an individual occurs; (B) the radiation is not emitted in an open beam configuration; and (C) no known physical injury to an individual has occurred. (4) Open-beam configuration--A radiation machine in which an individual could accidently place some part of his/her body in the primary beam path during normal operation. (5) Primary beam--Ionizing radiation that passes through an aperture of the source housing by a direct path from the x-ray tube located in the radiation source housing. (6) Safety device--A device that prevents the entry of any portion of an individual's body into the primary x-ray beam path or that causes the beam to be shut off upon entry into its path. (7) X-ray system--A group of components utilizing x rays to determine the elemental composition or to examine the microstructure of materials. (d) Exemptions. (1) Uses of minimal threat radiation machines as specified in §289.231(ll)(3) of this title, are exempt from the requirements of subsections (e)(2)(B) and (C), (f)(3), and (g)(1) of this section. (2) Uses of certified and certifiable cabinet x-ray systems are exempt from the requirements of subsection (f)(1) and (2) of this section. This exemption will apply only to those radiation machines that do not allow a person or body part to be exposed to the radiation beam. (3) Uses of portable/handheld fluorescence x-ray (open beam) devices that are manufactured without safety devices are exempt from the requirements of subsection (e)(1)(A) of this section. (e) Equipment requirements. (1) Safety devices. (A) A safety device shall be provided on all open-beam configurations. (B) A registrant may apply to the agency for an exemption from the requirement of a safety device in accordance with §289.231 of this title. Any such request shall include: (i) a description of the various safety devices that have been evaluated; (ii) the reason each of these devices cannot be used; and (iii) 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. (2) Warning devices. (A) Open-beam configurations shall be provided with a visible indication of: (i) x-ray tube status (ON-OFF) located near the radiation source housing, if the primary beam is controlled in this manner; and/or (ii) shutter status (OPEN-CLOSED) located near each port on the radiation source housing, if the primary beam is controlled in this manner. (B) The x-ray control shall provide visual indication whenever x rays are produced. (C) Warning devices shall be labeled so that their purpose is easily identified and shall have fail-safe characteristics. (3) Ports. Unused ports on radiation machine source housings shall be secured in the closed position in a manner that will prevent inadvertent opening. (4) Labeling. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner to caution individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit. If the radiation machine is not visible from the control unit, the radiation machine shall have a visible indication that it is energized. (5) Shutters. On open-beam configurations, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port. (6) Radiation source housing. Each x-ray tube housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled. (7) Generator cabinet. Each x-ray generator shall be supplied with a protective cabinet that limits leakage radiation measured at a distance of 5 centimeters from its surface such that it is not capable of producing a dose in excess of 0.5 millirem (5.0 microsieverts (µSv)) in any one hour. (8) Certified and certifiable cabinet x-ray systems. Certified and certifiable cabinet x-ray systems, including those designed to allow admittance of individuals, shall: (A) be maintained in compliance with Title 21, Code of Federal Regulations (CFR), §1020.40 and no modification shall be made to the system unless prior agency approval has been granted in accordance with §289.231(d) of this title; and (B) comply with the following requirements. (i) No registrant shall permit any individual to operate a cabinet x-ray system until the individual has received a copy of and instruction in the operating procedures for the unit. (ii) Tests for proper operation of interlocks shall be conducted and recorded at intervals not to exceed 12 months. (iii) The registrant shall perform an evaluation to determinate compliance with §289.231(o)(1) - (3) of this title and Title 21, CFR, §1020.40 at intervals not to exceed one year. The registrant shall ensure that radiation emitted 5 centimeters from the external surface of the cabinet x-ray system does not exceed 0.5 millirem (5.0 µSv) in any one hour. (iv) Documentation of the requirements in clauses (i) - (iii) of this subparagraph shall be maintained by the registrant for 10 years for inspection by the agency. (9) Package x-ray systems. (A) The registrant shall perform an annual evaluation to ensure radiation emitted 5 centimeters from the external surface of the package x-ray system does not exceed 0.5 millirem (5.0 µSv) in any one hour. (B) Tests for proper operation of interlocks shall be conducted and recorded at intervals not to exceed 12 months. Cont'd... |
