| (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.
Cont'd... |
