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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER FLICENSE REGULATIONS
RULE §289.258Licensing and Radiation Safety Requirements for Irradiators

(a) Purpose. This section contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive material in irradiators that irradiate objects or materials using gamma radiation. This section also contains radiation safety requirements for operating irradiators.

(b) Scope.

  (1) In addition to the requirements of this section, all licensees, unless otherwise specified, are subject to the requirements of §289.201 of this title (relating to General Provisions for Radioactive Material), §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Material), §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), §289.252 of this title (relating to Licensing of Radioactive Material), and §289.257 of this title (relating to Packaging and Transportation of Radioactive Material). Nothing in this section relieves the licensee from complying with other applicable federal, state and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities.

  (2) The requirements in this section apply to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rates exceed 500 rads (5 grays) per hour at 1 meter (m) from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this section.

  (3) The requirements in this section do not apply to self-contained, dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiations.

(c) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

  (1) Annually--At intervals not to exceed 390 days.

  (2) Doubly encapsulated sealed source--A sealed source in which the radioactive material is sealed within a capsule and that capsule is sealed within another capsule.

  (3) Category I self-contained, dry-source irradiator--An irradiator in which the sealed source is completely contained in a dry container constructed of solid materials and is shielded at all times, and in which human access to the sealed source and the volume undergoing irradiation is not physically possible in its designed configuration.

  (4) Irradiator--A facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding 500 rads (5 grays) per hour exist at 1 m from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

  (5) Irradiator operator--An individual who has successfully completed the training and testing described in subsection (s) of this section and is authorized by the terms of the license to operate the irradiator without the presence of a supervisor who has completed the requirements of subsection (s)(1) - (3) of this section.

  (6) Onsite--A physical presence within the building housing the irradiator or on property controlled by the licensee that is contiguous with the building housing the irradiator.

  (7) Panoramic dry-source-storage irradiator--An irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations.

  (8) Panoramic irradiator--An irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.

  (9) Panoramic wet-source-storage irradiator--An irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.

  (10) Pool irradiator--Any irradiator in which the sources are stored or used in a pool of water, including panoramic wet-source-storage irradiators and underwater irradiators.

  (11) Product conveyor system--A system for moving the product to be irradiated to, from, and within the area where irradiation takes place.

  (12) Radiation room--A shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.

  (13) Seismic area--Any area where the probability of horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10%, as designated by the United States Geological Survey.

  (14) Underwater irradiator--An irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.

(d) Application for a specific license. Applications for specific licenses shall be filed in accordance with §289.252(d) of this title.

(e) Specific licenses for irradiators.

  (1) The agency will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this section.

  (2) The applicant shall satisfy the general requirements specified in §289.252 of this title and the requirements contained in this section.

  (3) The application shall describe the training provided to irradiator operators including:

    (A) classroom training;

    (B) on-the-job or simulator training;

    (C) safety reviews;

    (D) means employed by the applicant to test each operator's understanding of the agency's rules and licensing requirements and the irradiator operating, safety, and emergency procedures; and

    (E) minimum training and experience of personnel who may provide training.

  (4) The application shall include a copy of the written operating, safety, and emergency procedures as outlined in subsection (t) of this section that describes the radiation safety aspects of the procedures.

  (5) The application shall describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer (RSO) and those management personnel who have radiation safety responsibilities or authorities. In particular, the application shall specify who, within the management structure, has the authority to stop unsafe operations. The application shall also describe the training and experience required for the position of RSO.

  (6) The application shall include a description of the access control systems required by subsection (i) of this section, the radiation monitors required by subsection (l) of this section, the method of detecting leaking sources required by subsection (w) of this section, including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.

  (7) If the applicant intends to perform and analyze leak tests of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the agency. The description shall include at least the following:

    (A) instruments to be used;

    (B) methods of performing the analysis; and

    (C) pertinent experience of the individual who analyzes the samples.

  (8) If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading shall be done by a person specifically authorized by the agency, the United States Nuclear Regulatory Commission (NRC), an agreement state, or a licensing state to load or unload irradiator sources.

  (9) The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by subsection (x) of this section.

(f) Start of construction. The applicant may not begin construction of a new irradiator prior to the submission to the agency of both an application for a license for the irradiator and the fee required by §289.204 of this title. As used in this section, the term "construction" includes the construction of any portion of the permanent irradiator structure on the site but does not include: engineering and design work; purchase of a site; site surveys or soil testing; site preparation; site excavation; construction of warehouse or auxiliary structures; and other similar tasks. Any construction activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license with respect to the requirements of the Texas Radiation Control Act (Act), rules, and orders issued in accordance with the Act.

(g) Applications for exemptions. Any applications for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this section. The agency will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that they are likely to provide an adequate level of safety for workers and the public.

(h) Performance criteria for sealed sources.

  (1) Cesium-137 shall not be used in any irradiator other than a Category I self-contained, dry-source irradiator as defined in subsection (c) of this section.

  (2) Sealed sources. Sealed sources installed after August 1, 1996, shall meet the following requirements:

    (A) have been evaluated in accordance with §289.252(v) of this title;

    (B) be doubly encapsulated;

    (C) use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator;

    (D) be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the sources are for use in irradiator pools; and

    (E) have been leak tested and found leak-free in prototype testing of the sealed source after each of the tests described in paragraphs (3) - (8) of this subsection.

  (3) Temperature. The test source shall be held at -40 degrees Celsius for 20 minutes, 600 degrees Celsius for one hour, and then be subjected to thermal shock test with a temperature drop from 600 degrees Celsius to 20 degrees Celsius within 15 seconds.

  (4) Pressure. The test source shall be twice subjected for at least five minutes to an external pressure (absolute) of 2 million newtons per square meter.

  (5) Impact. A 2-kilogram steel weight, 2.5 centimeters in diameter, shall be dropped from a height of 1 m onto the test source.

  (6) Vibration. The test source shall be subjected three times for ten minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of five times the acceleration of gravity. In addition, each test source shall be vibrated for 30 minutes at each resonant frequency found.

  (7) Puncture. A 50-gram weight and pin, 0.3-centimeter pin diameter, shall be dropped from a height of 1 m onto the test source.

  (8) Bend. If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source shall be subjected to a force of 2,000 newtons at its center equidistant from two support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source.

(i) Access control requirements in addition to the requirements of §289.202(u) of this title.

  (1) Each entrance to a radiation room at a panoramic irradiator shall have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It shall not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed shall cause the sources to return promptly to the shielded position. The personnel entrance door or barrier shall have a lock that is operated by the same key used to move the sources. The doors and barriers shall not prevent any individual in the radiation room from leaving.

Cont'd...

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