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RULE §289.233Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine

(a) Purpose. This section establishes the following requirements for radiation machines used in veterinary medicine.

  (1) Fees for certificates of registration for veterinary facilities and provisions for payment will be processed in accordance with §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), as amended.

  (2) Requirements for the registration of persons using radiation machines used in veterinary medicine.

  (3) Requirements that are intended to control the receipt, possession, use, and transfer of radiation machines by any person so the total dose to an individual, including doses resulting from all radiation machines other than background radiation, does not exceed the standards for protection against radiation prescribed in this section. However, nothing in this section shall be construed as limiting actions that may be necessary to protect public health and safety during an emergency.

  (4) Requirements for the use of radiation machines including that the registrant shall ensure the requirements of this section are met in the operation of such radiation machines and only persons who have received proper instructions in the safe use of radiation machines shall be permitted to operate the radiation machines.

  (5) Requirements for specific record keeping and general provisions for records and reports.

  (6) Requirements for providing notices to employees and instructions and options available to such individuals in connection with agency inspections of registrants to determine compliance with the provisions of the Texas Radiation Control Act (Act), Texas Health and Safety Code, Chapter 401, and requirements of this section, orders, and certificates of registration issued thereunder regarding radiological working conditions.

  (7) In accordance with the Act, Texas Health and Safety Code, Chapter 401; the Administrative Procedure Act, Texas Government Code, Chapter 2001; 1 TAC Chapter 155; and §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures) governing of:

    (A) proceedings for the granting, denying, renewing, transferring, amending, suspending, revoking, or annulling of a certificate of registration;

    (B) determining compliance with or granting of exemptions from requirements of this section, an order, or a condition of certificate of registration;

    (C) assessing administrative penalties; and

    (D) determining propriety of other agency orders.

(b) Scope.

  (1) Except as specifically provided in other sections of this chapter, this section applies to persons who receive, possess, use, or transfer radiation machines used in veterinary medicine.

    (A) The dose limits in this section do not apply to doses received from background radiation or voluntary participation in medical research programs.

    (B) Facilities conducting animal research must register under §289.228 of this title (relating to Radiation Safety Requirements for Industrial Radiation Machines).

    (C) No radiation may be deliberately applied to animals except by or under the supervision of a veterinarian authorized by the Texas Board of Veterinary Medical Examiners to engage in veterinary medicine.

  (2) A person who receives, possesses, uses, owns, or acquires radiation machines before receiving a certificate of registration is subject to the requirements of this chapter.

  (3) Registrants who are also registered by the agency to receive, possess, acquire, transfer, or use Class IIIb and Class IV lasers in veterinary medicine shall also comply with the requirements of §289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices).

  (4) The agency may, by requirements in this chapter, an order, or a condition of certificate of registration, impose upon any registrant such requirements in addition to those established in this section as it deems appropriate or necessary to minimize danger to public health and safety, property, or the environment.

  (5) Registrants who are also specifically licensed by the agency to receive, possess, use, and transfer radioactive materials must also comply with the applicable requirements of:

    (A) §289.201 of this title (relating to General Provisions for Radioactive Material);

    (B) §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Materials);

    (C) §289.252 of this title (relating to Licensing of Radioactive Material);

    (D) §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material); and

    (E) §289.257 of this title (relating to Packaging and Transportation of Radioactive Material).

  (6) In addition to this section, the veterinary registrant must meet the requirements in:

    (A) §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections);

    (B) §289.204 of this title;

    (C) §289.205 of this title (relating to Hearing and Enforcement Procedures);

    (D) §289.226 of this title (relating to Registration of Machine Use and Services); and

    (E) §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation).

(c) Prohibitions.

  (1) The agency may prohibit use of radiation machines that pose significant threat or endanger occupational and public health and safety, in accordance with this subsection and subsections (a), (b), and (d) - (g) of this section.

  (2) Individuals shall not be exposed to the useful beam.

  (3) In no case shall an individual hold the tube or tube housing assembly support during any radiographic exposure. Hand-held radiation machines shall be held only in the manner specified by the manufacturer.

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

  (1) Absorbed dose--The energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

  (2) Accessible surface--The external surface of the enclosure or housing provided by the manufacturer.

  (3) Act--Texas Radiation Control Act, Texas Health and Safety Code, Chapter 401.

  (4) Adult--An individual who is 18 years or older.

  (5) Agency--The Department of State Health Services.

  (6) Agreement state--Any state with which the United States Nuclear Regulatory Commission (NRC) has entered into an effective agreement under Section 274b of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

  (7) Air kerma--The kinetic energy released in air by ionizing radiation. Kerma is the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is Gy. For purposes of this section, when exposure in air measured in roentgen (R) is to be converted to dose in air measured in Gy, a nationally recognized standard air conversion factor shall be used.

  (8) Applicant--A person seeking a certificate of registration issued in accordance with the provisions of the Act and the requirements in this section.

  (9) As low as is reasonably achievable (ALARA)--Making every reasonable effort to maintain exposures to radiation as far below the dose limits in this section as is practical, consistent with the purpose for which the registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of ionizing radiation and radiation machines in the public interest.

  (10) Attenuate--To reduce the air kerma rate upon passage of radiation through matter.

  (11) Attenuation block--A block or stack, having dimensions 20 centimeters (cm) by 20 cm by 3.8 cm, of type 1100 aluminum alloy or other materials having equivalent attenuation. The nominal chemical composition of type 1100 aluminum alloy is 99 percent minimum aluminum, 0.12 percent copper.

  (12) Automatic exposure control--A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation at preselected locations (See definition for phototimer).

  (13) Background radiation--Radiation from cosmic sources; non‑technologically enhanced naturally occurring radioactive material, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents, such as Chernobyl, that contribute to background radiation and are not under the control of the registrant. "Background radiation" does not include radiation from radiation machines regulated by the agency.

  (14) Barrier--See definition for protective barrier.

  (15) Beam axis--A line from the source through the centers of the x-ray fields.

  (16) Beam-limiting device--A device that provides a means to restrict the dimensions of the x-ray field.

  (17) Beam quality (diagnostic x-ray)--A term that describes the penetrating power of the x-ray beam. This is identified numerically by half-value layer and is influenced by kilovolt peak (kVp) and filtration.

  (18) 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.

  (19) Certificate of registration--A form of permission given by the agency to an applicant who has met the requirements for registration set out in the Act and this chapter.

  (20) Collective dose--The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

  (21) Commissioner--The Commissioner of the Department of State Health Services.

  (22) Committed Effective Dose Equivalent (HE,50 )--The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (HE,50 = ΣWT HT.50 ).

  (23) Computed tomography (CT)--The production of a tomogram by the acquisition and computer processing of x-ray transmission data.

  (24) Control panel--The part of the radiation machine control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors.

  (25) CT conditions of operation--All selectable parameters governing the operation of a CT system including, nominal tomographic section thickness, filtration, and the technique factors as defined in this subsection.

  (26) CT gantry--The tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames that hold these components.

  (27) Declared pregnant woman--A woman who has voluntarily informed the registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman voluntarily withdraws the declaration in writing or is no longer pregnant.

  (28) Deep dose equivalent (Hd ) that applies to external whole-body exposure--The dose equivalent at a tissue depth of 1 cm (1,000 milligrams per square centimeter (mg/cm2 )).

  (29) Diagnostic source assembly--The tube housing assembly with a beam-limiting device attached.

  (30) Dose--A generic term that means absorbed dose, dose equivalent, or total effective dose equivalent. For purposes of this section, "radiation dose" is an equivalent term.

  (31) Dose equivalent (Ht )--The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

  (32) Dose limits--The permissible upper bounds of radiation doses established in accordance with this chapter. For purposes of this section, "limits" is an equivalent term.

  (33) Effective dose equivalent (HE )--The sum of the products of the dose equivalent to the organ or tissue (HT ) and the weighting factors (WT ) applicable to each of the body organs or tissues that are irradiated (HE = ΣWT HT ).

  (34) Embryo/fetus--The developing human organism from conception until the time of birth.


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