| (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 = ΣWT 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... |
