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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER EREGISTRATION REGULATIONS
RULE §289.232Radiation Control Regulations for Dental Radiation Machines

(a) Purpose. This section establishes the requirements for the use of dental radiation machines.

  (1) Fees for certificates of registration for dental facilities and provisions for their payment will be processed in accordance with subsection (h) of this section or §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 of persons using radiation machines are as follows.

    (A) No person shall use radiation machines except as authorized in a certificate of registration issued by the agency in accordance with the requirements of this section.

    (B) 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) Requirements 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 sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this chapter. However, nothing in this section shall be construed as limiting actions that may be necessary to protect health and safety in an emergency.

  (4) Requirements for the use of radiation machines include 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 are included in this section.

  (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, Health and Safety Code, Chapter 401, and requirements of this section, orders, and certificates of registration issued thereunder regarding radiological working conditions.

  (7) Governing of the following in accordance with the Texas Radiation Control Act, Health and Safety Code, Chapter 401; the Texas Administrative Procedure Act, Texas Government Code, Chapter 2001; Title 1, Texas Administrative Code, Chapter 155; and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title:

    (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 the 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 dental radiation machines.

    (A) The dose limits in this section do not apply to doses due to background radiation, to exposure of patients to radiation for dental diagnosis, to exposure from individuals administered radioactive material and released in accordance with this chapter, or to voluntary participation in medical research programs.

    (B) No radiation may be deliberately applied to human beings except by or under the supervision of a dentist licensed by the Texas State Board of Dental Examiners.

  (2) Registrants who are also registered by the agency to receive, possess, acquire, transfer, or use class IIIb and class IV lasers in dentistry 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).

  (3) Dental radiation machines located in a facility that also has other healing arts radiation machines will be inspected at the intervals specified in §289.231(ll)(2) of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation).

  (4) The agency may, by requirements in this chapter, an order, or a condition of the 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 or the environment.

  (5) Registrants who are also specifically licensed by the agency to receive, possess, use, and transfer radioactive materials shall also comply with the applicable 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 Materials), §289.203 of this title (relating to Notice, Instructions, and Reports to Workers; Inspections), §289.204 of this title, §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.252 of this title (relating to Licensing of Radioactive Material), §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material), and §289.257 of this title (relating to Packaging and Transportation of Radioactive Material).

(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 subsections (a) - (g) and (l)(3) of this section.

  (2) Individuals shall not be exposed to the useful beam except for healing arts purposes authorized by a dentist. This provision specifically prohibits deliberate exposure for the following purposes:

    (A) exposure of an individual for training, demonstration, or other non-healing arts purposes; or

    (B) exposure of an individual for research except as authorized by subsection (j)(6) of this section.

  (3) No person shall cause the operation of a radiation machine that results in exposure of an individual to the useful beam for training, demonstration, or other non-healing arts purposes.

  (4) 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 manufacturer recommendation.

(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, Health and Safety Code, Chapter 401.

  (4) Administrative law judge (ALJ)--A judge employed by the State Office of Administrative Hearings.

  (5) Administrative penalty--A monetary penalty assessed by the agency in accordance with Health and Safety Code, §401.384, to emphasize the need for lasting remedial action and to deter future violations.

  (6) Adult--An individual 18 or more years of age.

  (7) Agency--The Department of State Health Services or its successor.

  (8) Agreement State--Any state with which the United States Nuclear Regulatory Commission (NRC) has entered into an effective agreement under §274b of the Atomic Energy Act of 1954 (42 United States Code et seq.), as amended (73 Stat. 689).

  (9) 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 the gray. For purposes of this section, when exposure in air measured in roentgen (R) is to be converted to dose in air measured in gray, a nationally recognized standard air conversion factor shall be used.

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

  (11) 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.

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

  (13) 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).

  (14) 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 sources of radiation regulated by the agency.

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

  (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) 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.

  (19) Certified radiation machines--Radiation machines that have been certified in accordance with Title 21, Code of Federal Regulations (CFR).

  (20) Coefficient of variation or C--The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

Attached Graphic

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

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

  (23) 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 = &Sgr;WT HT.50 ).

  (24) Contested case--A proceeding in which the agency determines the legal rights, duties, or privileges of a party after an opportunity for adjudicative hearing.

  (25) Continuous pressure type switch--A switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

  (26) Consultant--An individual who is not routinely engaged in work under the registrant who provides advice related to compliance with this chapter.

  (27) Control panel--The part of the radiation machine where the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors are located.

  (28) 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.

  (29) Deep dose equivalent (Hd ), that applies to external whole body exposure--The dose equivalent at a tissue depth of 1 centimeter (1000 milligrams per square centimeter).

  (30) Dentist--An individual licensed to practice dentistry by the Texas State Board of Dental Examiners.

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

  (32) Director--The director of the radiation control program under the agency's jurisdiction.

  (33) 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.

  (34) 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.

Cont'd...

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