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RULE §289.232Radiation Control Regulations for Dental Radiation Machines

(a) Purpose. This section establishes the following.

  (1) Fees for certificates of registration for dental facilities and provisions for their payment.

  (2) Requirements for the registration of persons using radiation machines. 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. A person who receives, possesses, uses, owns, or acquires radiation machines prior to 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 section. 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 dental radiation machines. The registrant shall assure that the requirements of this section are met in the operation of such radiation machines.

  (5) Specific record keeping requirements 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 ascertain compliance with the provisions of the Texas Radiation Control Act, Health and Safety Code, Chapter 401, and requirements of this chapter, orders, and certificates of registration issued thereunder regarding radiological working conditions.

  (7) Governing of the following in accordance with the Texas Radiation Control Act, the Texas Administrative Procedure Act, Health and Safety Code, Chapter 401; Texas Government Code, Chapter 2001; Title 1 Texas Administrative Code (TAC), 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 agency rule, order, or 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 dental radiation machines. The dose limits in this section do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of dental diagnosis, to exposure from individuals administered radioactive material and released in accordance with this chapter, or to voluntary participation in medical research programs. 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) Persons 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).

  (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) and equipment performance evaluations shall be performed at the interval specified for a medical facility in §289.227(o)(1) of this title (relating to Use of Radiation Machines in the Healing Arts).

  (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 chapter as it deems appropriate or necessary to minimize danger to public health and safety or the environment.

  (5) Registrants who are also licensed by the agency to receive, possess, use, and transfer radioactive materials must 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), §289.252 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) 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 the Texas Radiation Control Act, 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) 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) 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).

  (11) 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.

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

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

  (14) 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.

  (15) 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 Texas Radiation Control Act and this section.

  (16) Certified equipment--Equipment that has been certified in accordance with Title 21, Code of Federal Regulations.

  (17) 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

  (18) 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.

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

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

  (21) 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.

  (22) 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.

  (23) 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.

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

  (25) Dentist--An individual licensed by the Texas State Board of Dental Examiners.

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

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

  (28) Dose--For external exposure to x-ray radiation from radiation machines, 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.

  (29) Dose equivalent--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.

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

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

  (32) Entrance exposure--The exposure expressed in roentgens (R), measured in air with the specified technique, calculated or adjusted to represent the exposure at the point where the center of the useful beam enters the patient.

  (33) Exposure--The quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The International System of Units (SI) unit of exposure is the coulomb per kilogram. For purposes of this section, this term is used as a noun.

  (34) Exposure rate--The exposure per unit of time.

  (35) External dose--That portion of the dose equivalent received from any source of radiation outside the body.

  (36) Extremity--Hand, elbow, arm below the elbow, foot, knee, and leg below the knee. The arm above the elbow and the leg above the knee are considered part of the whole body.

  (37) Field emission equipment--Equipment that uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

  (38) Filter--Material placed in the useful beam to preferentially absorb selected radiations.

  (39) Gray--The SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram or 100 rad.

  (40) Half-value layer--The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value.

  (41) Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.

  (42) Hearing--A proceeding to examine an application or other matter before the agency in order to adjudicate rights, duties, or privileges.

  (43) Human use--For exposure to x-ray radiation from radiation machines, the external administration of radiation to human beings for healing arts purposes or research and/or development specifically authorized by the agency.

  (44) Image receptor--Any device, such as a fluorescent screen or radiographic film, that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.

  (45) Individual--Any human being.

  (46) Individual monitoring--The assessment of dose equivalent to an individual by the use of:

    (A) individual monitoring devices; or


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