Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter E - REGISTRATION REGULATIONS
Section 289.232 - Radiation Control Regulations for Dental Radiation Machines
Universal Citation: 25 TX Admin Code ยง 289.232
Current through Reg. 49, No. 38; September 20, 2024
(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:
(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;WTHT.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.
(35) 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.
(36) 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 =
&Sgr;WTHT).
(37) Embryo/fetus--The developing human
organism from conception until the time of birth.
(38) Entrance exposure (Entrance air
kerma)--The entrance exposure in air expressed in roentgens or the entrance
dose in air (air kerma) expressed in gray, measured at the point where the
center of the useful beam enters the patient.
(39) Equipment performance evaluations
(EPE)--Required testing performed by a registered service provider at a
specified interval to ensure radiation machines operate in compliance with this
chapter.
(40) 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. The roentgen is the special unit of
exposure. For purposes of this section, this term is used as a noun.
(41) Exposure rate (air kerma rate)--The
exposure per unit of time. For purposes of this section, "air kerma rate" is an
equivalent term.
(42) External
dose--That portion of the dose equivalent received from any source of radiation
outside the body.
(43)
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.
(44) 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.
(45) Filter--Material placed in the useful
beam to absorb selected radiations preferentially.
(46) Gray (Gy)--The SI unit of absorbed dose.
One gray is equal to an absorbed dose of one joule per kilogram or 100
rad.
(47) Half-value layer
(HVL)--The thickness of a specified material that attenuates the beam of
radiation to an extent such that the exposure rate (air kerma rate) is reduced
to one-half of its original value.
(48) 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.
(49) Hearing--A
proceeding to examine an application or other matter before the agency in order
to adjudicate rights, duties, or privileges.
(50) 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 or development specifically
authorized by the agency.
(51)
Image receptor--Any device, such as a fluorescent screen, radiographic film, or
digital sensor 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.
(52)
Individual--Any human being.
(53)
Individual monitoring--The assessment of dose equivalent to an individual by
the use of:
(A) individual monitoring
devices; or
(B) survey
data.
(54) Individual
monitoring devices--Devices designed to be worn by a single individual for the
assessment of dose equivalent. For purposes of this section, "personnel
dosimeter," "dosimeter," and "personnel monitoring equipment" are equivalent
terms. Examples of individual monitoring devices include, but are not limited
to, film badges, thermoluminescence dosimeters, optically stimulated
luminescence dosimeters, pocket ionization chambers (pocket dosimeters), and
electronic personal dosimeters.
(55) Informal conference--A meeting held by
the agency with a person to discuss the following:
(A) safety, safeguards, or environmental
problems;
(B) compliance with
regulatory or registration condition requirements;
(C) proposed corrective measures, including,
but not limited to, schedules for implementation; and
(D) enforcement options available to the
agency.
(56)
Inspection--An official thorough examination or observation, including, but not
limited to, records, tests, surveys, and monitoring to effectively determine
compliance with the Act and requirements of this section, orders, and
conditions of the agency.
(57)
Institutional Review Board (IRB)--Any board, committee, or other group formally
designated by an institution to review, approve the initiation of, and conduct
periodic review of biomedical research involving human subjects.
(58) Ionizing radiation--Any electromagnetic
or particulate radiation capable of producing ions, directly or indirectly, in
its passage through matter. Ionizing radiation includes gamma rays and x-rays,
alpha and beta particles, high-speed electrons, neutrons, and other nuclear
particles.
(59)
kV--Kilovolt.
(60) kVp--Kilovolt
peak (See definition for peak tube potential).
(61) kWs--Kilowatt-second. It is equivalent
to 10 E 3 watt-second, where 1 watt-second =1 kilovolt x 1 milliampere x 1
second.
(62) Lead equivalent--The
thickness of lead affording the same attenuation, under specified conditions,
as the material in question.
(63)
Leakage radiation--Radiation emanating from the diagnostic assembly except for
the useful beam and radiation produced when the exposure switch or timer is not
activated.
(64) Lens dose
equivalent--The external dose equivalent to the lens of the eye at a tissue
depth of 0.3 centimeters (300 milligrams per square centimeter).
(65) License--A form of permission given by
the agency to an applicant who has met the requirements for licensing set out
in the Act and this chapter.
(66)
Licensed material--Radioactive material received, possessed, used, or
transferred under a general or specific license issued by the agency.
(67) Licensee--Any person who is licensed by
the agency in accordance with the Act and this chapter.
(68) mA--Milliampere.
(69) mAs--Milliampere-second.
(70) Medical research--The investigation of
various health risks and diseases.
(71) Member of the public--Any individual,
except when that individual is receiving an occupational dose.
(72) Minor--An individual less than 18 years
of age.
(73) Mobile service
operation--The provision of radiation machines and personnel at temporary
locations for limited time periods.
(74) Monitoring--The measurement of radiation
and the use of the results of these measurements to evaluate potential
exposures and doses. For purposes of this section, "radiation monitoring" and
"radiation protection monitoring" are equivalent terms.
(75) Notice of violation--A written statement
prepared by the agency of one or more alleged infringements of a legally
binding requirement.
(76)
Occupational dose--The dose received by an individual in the course of
employment in which the individual's assigned duties involve exposure to
radiation from licensed/registered and unlicensed/unregistered sources of
radiation, whether in the possession of the licensee/registrant or other
person. Occupational dose does not include dose received from background
radiation, from any medical administration the individual has received, from
exposure to individuals administered radioactive material and released in
accordance with this section, from voluntary participation in medical research
programs, or as a member of the public.
(77) Order--A specific directive contained in
a legal document issued by the agency.
(78) Party--A person designated as such by
the ALJ. A party may consist of the following:
(A) the agency;
(B) an applicant, licensee, registrant,
accredited mammography facility, or certified industrial radiographer;
and
(C) any person
affected.
(79)
Patient--An individual subjected to dental examination, diagnosis, or
treatment.
(80) Peak tube
potential--The maximum value of the potential difference in kilovolts across
the x-ray tube during an exposure.
(81) Person--Any individual, corporation,
partnership, firm, association, trust, estate, public or private institution,
group, agency, local government, any other state or political subdivision or
agency thereof, or any other legal entity, and any legal successor,
representative, agent, or agency of the foregoing, other than the United States
Nuclear Regulatory Commission, and other than federal government agencies
licensed or exempted by the United States Nuclear Regulatory
Commission.
(82) Personnel
monitoring equipment--(See definition for individual monitoring
devices).
(83) Phototimer--A method
for controlling radiation exposures to image receptors by the amount of
radiation that reaches a radiation detection device. The radiation detection
device is part of an electronic circuit that controls the duration of time the
tube is activated (See definition for automatic exposure control).
(84) Primary protective barrier--(See
definition for protective barrier).
(85) Protective barrier--A barrier of
radiation absorbing materials used to reduce radiation exposure. The types of
protective barriers are as follows:
(A)
primary protective barrier--A barrier sufficient to attenuate the useful beam
to the required degree; or
(B)
secondary protective barrier--A barrier sufficient to attenuate the stray
radiation to the required degree.
(86) Public dose--The dose received by a
member of the public from exposure to radiation from licensed/registered and
unlicensed/unregistered sources of radiation, whether in the possession of the
licensee/registrant or other person. It does not include occupational dose or
doses received from background radiation, from any medical administration the
individual has received, from exposure to individuals administered radioactive
material and released in accordance with this section, or from voluntary
participation in medical research programs, or as a member of the
public.
(87) Rad--The special unit
of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or
0.01 joule per kilogram (0.01 Gy).
(88) Radiation--One or more of the following:
(A) gamma and x-rays, alpha and beta
particles, and other atomic or nuclear particles or rays;
(B) radiation emitted to energy density
levels that could reasonably cause bodily harm from an electronic device;
or
(C) sonic, ultrasonic, or
infrasonic waves from any electronic device or resulting from the operation of
an electronic circuit in an electronic device in the energy range to reasonably
cause detectable bodily harm.
(89) Radiation area--Any area, accessible to
individuals, in which radiation levels could result in an individual receiving
a dose equivalent in excess of 0.005 rem (0.05 millisievert) in one hour at 30
centimeters from the radiation machine or from any surface that the radiation
penetrates.
(90) Radiation
machine--An x-ray system, subsystem, or component capable of producing ionizing
radiation except those devices with radioactive material as the only source of
radiation. For purposes of this section, "radiation machine," "x-ray
equipment," "x-ray system," and "x-ray unit" are equivalent terms. Types of
radiation machines include, but are not limited to:
(A) Stationary radiation machine--A radiation
machine that is installed in a fixed location.
(B) Hand-held radiation machine--A radiation
machine that is designed to be hand-held during operation.
(C) Portable radiation machine--A radiation
machine that is mounted on a permanent base with wheels or casters for moving
while completely assembled, including a hand-carried radiation machine that is
designed to be mounted on a support while operating.
(D) Mobile radiation machine--A radiation
machine that is transported in a vehicle to be used at various temporary
locations.
(91) Radiation
safety officer (RSO)--An individual who has a knowledge of and the authority
and responsibility to apply appropriate radiation protection rules, standards,
and practices, who shall be specifically authorized on a certificate of
registration, and who is the primary contact with the agency.
(92) Radiograph--An image receptor on which
the image is created directly or indirectly by an x-ray exposure and results in
a permanent record.
(93)
Registrant--Any person issued a certificate of registration by the agency in
accordance with the Act and this chapter.
(94) Regulation--(See definition for
rule).
(95) Rem--The special unit
of any of the quantities expressed as dose equivalent. The dose equivalent in
rem sievert (Sv) is equal to the absorbed dose in rad or gray multiplied by the
quality factor (1 rem = 0.01 Sv).
(96) Remote inspection--An examination by the
agency of information submitted by the registrant on a form provided by the
agency.
(97) Research and
development--Research and development is defined as:
(A) theoretical analysis, exploration, or
experimentation; or
(B) the
extension of investigative findings and theories of a scientific or technical
nature into practical application for experimental and demonstration purposes,
including the experimental production and testing of models, devices,
equipment, radiation machines, materials, and processes.
(98) Restricted area--An area, access to
which is limited by the registrant for protecting individuals against undue
risks from exposure to radiation. Restricted area does not include areas used
as residential quarters, but separate rooms in a residential building may be
set apart as a restricted area.
(99) Roentgen (R)--The special unit of
exposure. One roentgen (R) equals 2.58 x 10'4 coulombs per kilogram of air.
(See definition for exposure.)
(100) Rule--Any agency statement of general
applicability that implements, interprets, or prescribes law or policy, or
describes the procedure or practice requirements of an agency. The term
includes the amendment or repeal of a section but does not include statements
concerning the internal management or organization of any agency and does not
affect private rights or procedures. The word "rule" was formerly referred to
as "regulation."
(101) Scattered
radiation--Radiation that has been deviated in direction during passage through
matter.
(102) Secondary protective
barrier--(See definition for protective barrier).
(103) Severity level--A classification of
violations based on relative seriousness of each violation and the significance
of the effect of the violation on the occupational or public health or safety
or the environment.
(104) Shallow
dose equivalent (Hs) (that applies to the external
exposure of the skin of the whole body or the skin of an extremity)--The dose
equivalent at a tissue depth of 0.007 centimeters (7 milligrams per square
centimeter).
(105) SI--The
abbreviation for the International System of Units.
(106) Sievert--The SI unit of any of the
quantities expressed as dose equivalent. The dose equivalent in sievert is
equal to the absorbed dose in gray multiplied by the quality factor (1 sievert
= 100 rem).
(107) Source of
radiation--Any radioactive material or device that is capable of emitting or
producing ionizing radiation.
(108)
Source-to-image receptor distance--The distance from the source to the center
of the input surface of the image receptor.
(109) Source-to-skin distance--The distance
from the source to the skin of the patient.
(110) Special units--The conventional units
historically used by registrants, i.e., rad (absorbed dose), and rem (dose
equivalent).
(111) Stray
radiation--The sum of leakage and scattered radiation.
(112) Supervision--The delegating of the task
of applying radiation in accordance with this section to persons not licensed
in dentistry, who perform tasks under the dentist's control. The dentist
assumes full responsibility for these tasks and shall assure that the tasks
will be administered correctly.
(113) Survey--An evaluation of the
radiological conditions and potential hazards incident to the production, use,
transfer, and disposal of radiation machines. When appropriate, such survey
includes, but is not limited to, tests, physical examination of location of
equipment or radiation machines, and measurements of levels of radiation
present, and evaluation of administrative and engineered controls.
(114) Technique chart--A chart that provides
technical factors, anatomical examination, and patient size for examination
being performed needed to make clinical radiographs when the radiation machine
is in manual mode.
(115) Technique
factors--The conditions of operation that are specified as follows:
(A) for capacitor energy storage equipment,
peak tube potential in kilovolt and quantity of charge in
milliampere-second;
(B) for field
emission equipment rated for pulsed operation, peak tube potential in kilovolt
and number of x-ray pulses; and
(C)
for all other radiation machines, peak tube potential in kilovolt and either
tube current in milliamperes and exposure time in seconds or the product of
tube current and exposure time in milliampere-second.
(116) Termination--A release by the agency of
the obligations and authorizations of the registrant under the terms of the
certificate of registration. It does not relieve a person of duties and
responsibilities imposed by law or rule.
(117) Texas Regulations for Control of
Radiation--All sections of Chapter 289 of this title.
(118) Total effective dose equivalent--The
sum of the effective dose equivalent (for external exposures) and the committed
effective dose equivalent (for internal exposures).
(119) Traceable to a national standard--This
indicates that a quantity or a measurement has been compared to a national
standard, for example, the National Institute of Standards and Technology,
directly or indirectly through one or more intermediate steps and that all
comparisons have been documented.
(120) Tube--An x-ray tube, unless otherwise
specified.
(121) Tube housing
assembly--The tube housing with tube installed. It includes high-voltage and/or
filament transformers and other appropriate elements when such are contained
within the tube housing.
(122)
Unrestricted area (uncontrolled area)--An area, access to which is neither
limited nor controlled by the registrant. For purposes of this section,
"uncontrolled area" is an equivalent term.
(123) Useful beam--Radiation that passes
through the window, aperture, core, or other collimating device of the source
housing. Also referred to as the primary x-ray beam.
(124) Violation--An infringement of any rule,
license or registration condition, order of the agency, or any provision of the
Act.
(125) Whole body--For purposes
of external exposure, head, trunk, including male gonads, arms above the elbow,
or legs above the knee.
(126)
Worker--An individual engaged in work under the certificate of registration
issued by the agency.
(127) X-ray
control panel--A device that controls input power to the x-ray high-voltage
generator or the x-ray tube. It includes components such as timers,
phototimers, automatic brightness stabilizers, and similar devices that control
the technique factors of an x-ray exposure.
(128) X-ray field--That area of the
intersection of the useful beam and any one of the set of planes parallel to
and including the plane of the image receptor, whose perimeter is the locus of
points at which the exposure rate (air kerma rate) is one-fourth of the maximum
in the intersection.
(129) X-ray
high-voltage generator--A device that transforms electrical energy from the
potential supplied by the x-ray control to the tube operating potential. The
device may also include means for transforming alternating current to direct
current, filament transformers for the x-ray tubes, high-voltage switches,
electrical protective devices, and other appropriate elements.
(130) X-ray system--An assemblage of
components for the controlled production of x-rays. It includes, minimally, an
x-ray high-voltage generator, an x-ray control, a tube housing assembly, a
beam-limiting device, and the necessary supporting structures. Additional
components that function with the system are considered integral parts of the
system.
(131) X-ray subsystem--Any
combination of two or more components of an x-ray system.
(132) X-ray tube--Any electron tube that is
designed to be used primarily for the production of x-rays.
(133) Year--The period of time beginning in
January used to determine compliance with the provisions of this chapter. The
registrant may change the starting date of the year used to determine
compliance by the registrant if the change is made at the beginning of the year
and that no day is omitted or duplicated in consecutive years.
(e) Exemptions.
(1) The agency may, upon application or upon
its own initiative, exempt a source of radiation or a kind of use or user from
the requirements of this section if the agency determines that the law does not
prohibit the exemption and it will not result in a significant risk to public
health or safety or the environment. In determining such exemptions, the agency
will consider:
(A) state of
technology;
(B) economic
considerations in relation to benefits to the public health and safety;
and
(C) other societal,
socioeconomic, or public health and safety considerations.
(2) Electronic equipment that produces
radiation incidental to its operation for other purposes is exempt from the
registration and notification requirements of this section, if the dose
equivalent rate averaged over an area of 10 square centimeters does not exceed
0.5 millirem (5 microsieverts) per hour at 5 centimeters from any accessible
surface of such equipment. The production, testing, or factory servicing of
such equipment shall not be exempt.
(3) Radiation machines in transit or in
storage incident to transit are exempt from the requirements of this section.
This exemption does not apply to the providers of radiation machines for mobile
services.
(4) Facilities that have
placed all radiation machines in storage, including on-site storage secured
from unauthorized use or removal, and have notified the agency in writing, are
exempt from the requirements of this section. This exemption is void if any
radiation machine is energized resulting in the production of radiation. Before
resuming use of the radiation machine for human use, the radiation machine
shall meet all requirements of this section.
(5) Inoperable radiation machines are exempt
from the requirements of this section. For the purposes of this section, an
inoperable radiation machine means a radiation machine that cannot be energized
when connected to a power supply without repair or modification.
(6) A person who takes possession of a
radiation machine as the result of foreclosure, bankruptcy, or other default of
payment may possess the radiation machine without registering it. If the
radiation machine is energized, it shall be in accordance with this
chapter.
(7) No individual
monitoring shall be required for personnel operating only dental radiation
machines for dental diagnostic purposes.
(8) Portable radiation machines designed to
be hand-held are exempt from the requirements of subsections (c)(4) and
(j)(5)(C) of this section. The portable radiation machines shall be held
according to manufacturer's specifications.
(9) Individuals who are sole practitioners
and sole operators, and the only occupationally exposed individual are exempt
from the following requirements:
(A)
operating and safety procedures specified in subsection (j)(2) of this
section;
(B) instruction to workers
specified in subsection (j)(3)(D) of this section; and
(C) posting of notices to workers specified
in subsection (j)(4)(B) and (C) of this section.
(10) In accordance with Texas Occupations
Code, §
258.054,
dental practices are exempt from the Medical Physics Practice Act, Texas
Occupations Code, Chapter 602. Registrants required to have EPE tests performed
in accordance with subsection (j)(5)(J) of this section may select any
qualified person authorized by registration through the Department of State
Health Services, Radiation Control.
(f) Communications.
(1) Except where otherwise specified, all
communications and reports concerning this chapter and applications filed under
the communications and reports should be mailed by postal service to Radiation
Control, Department of State Health Services, P.O. Box 149347, MC 2003, Austin,
Texas 78714-9347. Communications, reports, and applications may be delivered in
person to the agency's office located at 8407 Wall Street, Austin, Texas,
78754.
(2) Documents received by
the agency will be deemed to have been received on the date of the postmark,
facsimile, or other electronic media transmission.
(g) Interpretations. Except as specifically authorized by the agency in writing, no interpretation of the meaning of this chapter by any officer or employee of the agency other than a written legal interpretation by the agency, will be considered binding upon the agency.
(h) Fees for certificates of registration for dental facilities.
(1)
Payment of fees.
(A) Each application for a
certificate of registration shall be accompanied by a nonrefundable fee
specified in §
289.204
of this title, as amended. No application will be accepted for filing or
processed before payment of the full amount specified.
(B) A nonrefundable fee specified in §
289.204
of this title, as amended, shall be paid for each certificate of registration
for radiation machines used in dentistry. The fee shall be paid every two years
and shall be paid in full and on or before the due date stated on the invoice.
(i) For each additional use location where
radiation machines or services are authorized under the same registration,
there will be an additional charge of 30% of the applicable fee.
(ii) In the case of a single certificate of
registration that authorizes more than one category of radiation machine use,
the category listed in §
289.204
of this title that is assigned the higher fee will be used.
(C) Each application for reciprocal
recognition of an out-of-state registration in accordance with subsection
(i)(8) of this section shall be accompanied by the non-refundable fee specified
in §
289.204
of this title, as amended, provided that no such fee has been submitted within
24 months of the date of commencement of the proposed activity.
(D) Fee payments shall be in cash or by check
or money order made payable to the Department of State Health Services. The
payments may be made by personal delivery to the central office, Radiation
Control, Department of State Health Services, 1100 West 49th Street, Austin,
Texas 78756-3199 or mailed to Radiation Control, Department of State Health
Services, P.O. Box 149347, MC 2003, Austin, Texas
78714-9347.
(2) Failure
to pay prescribed fees.
(A) In any case where
the agency finds that an applicant for a certificate of registration has failed
to pay the non-refundable fee prescribed in §
289.204
of this title, as amended, the agency will not process that application until
such fee is paid.
(B) In any case
where the agency finds that a registrant has failed to pay a fee prescribed by
§
289.204
of this title, as amended, by the due date, the agency may implement compliance
procedures as provided in subsection (l)(3)(C) of this
section.
(3) Electronic
fee payments. Renewal payments may be processed through www.texas.gov. or
another electronic payment system specified by the agency. For all types of
electronic fee payments, the agency will collect additional fees, in amounts
determined by www.texas.gov to recover costs associated with electronic payment
processing.
(i) Registration of radiation machine use.
(1)
Application for registration of radiation machines.
(A) Application for registration shall be
completed on forms prescribed by the agency and shall contain all the
information required by the form and accompanying instructions. For initial
registrations with multiple radiation machine use locations, a separate
application shall be completed for each use location under the
registration.
(B) Each person
having a radiation machine used in dentistry shall apply for registration with
the agency within 30 days after beginning use of the radiation machine, except
for mobile services that shall be registered in accordance with paragraph (2)
of this subsection and clinical trial evaluations that shall be registered in
accordance with paragraph (5)(K) of this subsection.
(C) If the application is incomplete 60 days
after submission, the agency may abandon the application and return the
original application. The applicant will cease use of all radiation machines
once the application has been abandoned.
(D) The applicant shall ensure that radiation
machines will be operated by individuals qualified by reason of training and
experience to use the radiation machines for the purpose requested in
accordance with this section in such a manner as to minimize danger to
occupational and public health and safety.
(E) A radiation safety officer shall be
designated on each application form. The qualifications of that individual
shall be submitted to the agency with the application. The radiation safety
officer shall meet the applicable qualifications of clause (i) of this
subparagraph and carry out the responsibilities specified in clause (v) of this
subparagraph.
(i) The radiation safety officer
shall have the following qualifications:
(I)
knowledge of potential hazards and emergency precautions; and
(II) educational courses completed that
relate to ionizing radiation safety or a radiation safety officer course;
or
(III) experience in the use and
familiarity of the type of radiation machine used; and
(ii) In addition to the qualifications in
clause (i) of this subparagraph, documentation of the following shall be
submitted to the agency:
(I) for dentist
radiation safety officers, a dental licensing board number and their signature
on the application;
(II) for a
practitioner radiation safety officer, documentation of a licensing board
number; or
(III) for
non-practitioner radiation safety officers, any one of the following:
(-a-) evidence of a valid general certificate
issued under the Medical Radiologic Technologist Certification Act, Texas
Occupations Code, Chapter 601, and at least two years of supervised experience
or supervised use of radiation machines;
(-b-) evidence of a valid limited general
certificate issued under the Medical Radiologic Technologist Certification Act,
Texas Occupations Code, Chapter 601, and at least four years of supervised
experience or supervised use of radiation machines;
(-c-) evidence of registry by the American
Registry of Radiologic Technologists and at least two years of supervised
experience or supervised use of radiation machines;
(-d-) evidence of associate degree in
radiologic technology, health physics, or nuclear technology, and at least two
years of supervised experience or supervised use of radiation
machines;
(-e-) evidence of
registration with the Texas Board of Nursing as a Registered Nurse and at least
two years of supervised experience or supervised use of radiation machines in
the respective specialty;
(-f-)
evidence of registration with the Texas Physician Assistant Board, and at least
two years of supervised use of radiation machines in the respective
specialty;
(-g-) evidence of:
(-1-) registration with the Texas State Board
of Dental Examiners to perform radiologic procedures under a dentist's
instruction and direction or evidence of a valid certificate as a registered
dental hygienist; and
(-2-) at
least four years of supervised use of radiation machines in the respective
dentist's specialty;
(-h-) evidence of bachelor's (or higher)
degree in a natural or physical science, health physics, radiological science,
nuclear medicine, or nuclear engineering; or
(-i-) evidence of a current Texas license
under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, in
medical health physics, diagnostic medical physics, or nuclear medical physics
for diagnostic x-ray facilities.
(iii) Academic institutions and research and
development facilities shall have radiation safety officers who are faculty or
staff members in radiation protection, radiation engineering, or related
disciplines. (This individual may also serve as the radiation safety officer
over the dental section of the facility.)
(iv) The radiation safety officer identified
on a certificate of registration for use of dental radiation machines issued
before September 1, 1993, need not comply with the qualification requirements
in this subsection.
(v) Specific
duties of the radiation safety officer include, but are not limited to, the
following:
(I) establishing and overseeing
operating and safety procedures that maintain radiation exposures as low as
reasonably achievable, and reviewing the procedures at intervals not to exceed
12 months to ensure that the procedures are current and conform with this
section;
(II) investigating and
reporting to the agency each:
(-a-) known or
suspected case of radiation exposure to an individual or radiation level
detected in excess of limits established by this section; and
(-b-) theft or loss of radiation machines,
determining the cause, and taking steps to prevent its recurrence;
(III) assuming control and having
the authority to institute corrective actions, including shutdown of operations
when necessary in emergencies or unsafe conditions;
(IV) making and maintaining records as
required by this section; and
(V)
ensuring that personnel are adequately trained and complying with this section,
the conditions of the certificate of registration, and the operating and safety
procedures of the registrant.
(F) At any time after the filing of the
original application, the agency may require additional information to
determine whether the certificate of registration is issued or
denied.
(G) An application for a
certificate of registration may include a request for a certificate of
registration authorizing one or more activities or radiation machine use
locations. If an application includes a request for an additional authorization
other than use of a dental radiation machine, compliance with other applicable
sections of this chapter will be required.
(H) Each application for a certificate of
registration shall be accompanied by the fee prescribed in §
289.204
of this title, as amended. No application will be accepted for filing or
processed before payment of the full amount specified.
(I) Each application shall be accompanied by
a completed RC Form 226-1, Business Information Form that shall contain the
legal name of the entity or business. The form can be found at
http://dshs.texas.gov/radiation/x-ray/medical-faq.aspx.
Unless exempt in accordance with the Business and Commerce Code, Chapter 71,
the applicant shall:
(i) be authorized to
conduct business in the State of Texas as listed on the Texas Secretary of
State (SOS) website; and
(ii) file
an assumed name certificate with the Texas SOS if using an assumed name in
their application or the office of the county clerk in the county where the
business is located.
(J)
An application for use of a dental radiation machine shall be signed by a
licensed dentist. The signature of the administrator, president, or chief
executive officer will be accepted in lieu of a licensed dentist's signature if
the facility has more than one licensed dentist who may direct the operation of
radiation machines. The application shall also be signed by the radiation
safety officer.
(K) Applications
and documents submitted to the agency may be made available for public
inspection except that the agency may withhold any document or part thereof
from public inspection in accordance with subsection (k)(1)(J) and (K) of this
section.
(2) Application
for registration of mobile service operation used in dentistry. In addition to
the requirements of paragraph (1) of this subsection, each applicant shall
apply for and receive authorization from the agency for mobile service
operation before beginning mobile service operation. The following shall be
submitted:
(A) An established main location
where the radiation machines and related compliance documents and records will
be maintained for inspection. This shall be a street address, not a post office
box number.
(B) A sketch or
description of the normal configuration of each radiation machine's use,
including the operator's position and any ancillary personnel's location during
exposures. If a mobile van is used with a fixed radiation machine inside,
furnish the floor plan indicating protective shielding and the operator's
position.
(C) A current copy of the
applicant's operating and safety procedures regarding radiological practices
for protection of patients, operators, employees, and the public.
(3) Issuance of certificate of
registration.
(A) A certificate of
registration will be approved if the agency determines that an application
meets the requirements of the Act and the requirements of this chapter. The
certificate of registration authorizes the proposed activity and contains the
conditions and limitations, as the agency deems appropriate or
necessary.
(B) The agency may
incorporate in the certificate of registration at the time of issuance, or
thereafter by amendment, additional requirements and conditions concerning the
registrant's possession, use, and transfer of radiation machines subject to
this chapter, as it deems appropriate or necessary in order to:
(i) minimize danger to occupational and
public health and safety;
(ii)
require additional records and the keeping of additional records as may be
appropriate or necessary; and
(iii)
prevent loss or theft of radiation machines subject to this chapter.
(C) The agency may request, and
the registrant shall provide, additional information after the certificate of
registration has been issued to enable the agency to determine whether the
certificate of registration should be modified in accordance with paragraph (7)
of this subsection.
(4)
Terms and conditions of certificates of registration.
(A) Each certificate of registration issued
in accordance with this section shall be subject to the applicable provisions
of the Act, now or hereafter in effect, and to the applicable requirements of
this chapter and orders of the agency.
(B) No certificate of registration issued or
granted under this section shall be transferred, assigned, or in any manner
disposed of, either voluntarily or involuntarily, to any person unless the
agency authorizes the transfer in writing.
(C) Each person registered by the agency for
radiation machine use in accordance with this section shall confine use and
possession of the radiation machine registered to the locations and purposes
authorized in the certificate of registration.
(D) In making a determination whether to
grant, deny, amend, revoke, suspend, or restrict a certificate of registration,
the agency may consider the technical competence and compliance history of an
applicant or holder of a certificate of registration. After an opportunity for
a hearing, the agency shall deny an application for a certificate of
registration or an amendment to a certificate of registration if the
applicant's compliance history reveals that at least three agency actions have
been issued against the applicant, within the previous six years, that assess
administrative or civil penalties against the applicant, or that revoke or
suspend the certificate of registration.
(5) Responsibilities of the registrant.
(A) The registrant is responsible for
complying with this section and the conditions of the certificate of
registration.
(B) The registrant
shall designate an individual qualified in accordance with paragraph (1)(E)(i)
of this subsection as the radiation safety officer and shall ensure the
individual continually performs the duties of the radiation safety officer as
identified in paragraph (1)(E)(v) of this subsection.
(C) Persons using radiation machines in
accordance with subsection (i)(2) of this section, concerning application for
mobile services, shall have a valid certificate of registration issued by the
agency before initiation of the mobile services.
(D) No person shall use a radiation machine
unless the person has applied for registration within 30 days after beginning
use of the radiation machine in accordance with subsection (i)(1)(B) of this
section.
(E) No registrant shall
engage any person for services described in §
289.226(b)(11)
of this title (relating to Registration of Radiation Machine Use and Services)
until such person provides to the registrant evidence of registration with the
agency.
(F) No person shall provide
radiation machine services for a person who cannot produce evidence of a
completed application for registration or a valid certificate of registration
issued by the agency except for:
(i) the
initial installation of the first radiation machine for a new certificate of
registration; and
(ii) the
registrant authorized for demonstration and sale may demonstrate a radiation
machine in accordance with paragraph (5)(D) of this subsection, except as
prohibited by subsection (c) of this section.
(G) The registrant shall notify the agency in
writing of any changes that would render the information contained in the
application for registration or the certificate of registration inaccurate. The
notification shall be in writing and signed by an authorized representative.
(i) Notification is required within 30 days
after the following changes:
(I) legal
business name;
(II) mailing
address;
(III) street address where
radiation machine will be used;
(IV) additional radiation machine
location;
(V) radiation safety
officer; or
(VI) name and
registration number of the contracted "provider of equipment," registered in
accordance with §
289.226
of this title.
(ii) The
registrant shall notify the agency within 30 days after changes in the
radiation machines that include:
(I) any
change in the category of radiation machine type or type of use as authorized
in the certificate of registration (for example, addition of a computerized
tomography radiation machine); or
(II) any increase in the number of radiation
machines authorized by the certificate of registration in any radiation machine
type or type of use category.
(H) The registrant, or the parent company,
shall notify the agency, in writing, immediately following the filing of a
voluntary or involuntary petition for bankruptcy. This notification shall
include:
(i) the bankruptcy court in which the
petition for bankruptcy was filed; and
(ii) the case name and number, and date of
filing the petition.
(I)
The registrant shall inventory all radiation machines in the registrant's
possession at an interval not to exceed one year.
(i) The inventory shall include:
(I) manufacturer's name;
(II) model and serial number of the control
panel; and
(III) location of all
radiation machines, for example, room number.
(ii) Records of the inventory shall be made
and maintained in accordance with subsection (k)(2) of this section for
inspection by the agency.
(J) Receipt, transfer, and disposal of
radiation machines.
(i) The registrant shall
make and maintain records of receipt, transfer, and disposal of radiation
machines. The records shall include the following:
(I) manufacturer's name and model and serial
number from the control panel;
(II)
date of the receipt, transfer, and disposal;
(III) name and address of person the
radiation machines received from, transferred to, or disposed of; and
(IV) name of the individual recording the
information.
(ii) Records
of receipt, transfer, and disposal of radiation machines shall be made and
maintained in accordance with subsection (k)(2) of this section for inspection
by the agency.
(K) The
following criteria applies to loaner radiation machines.
(i) For persons having a valid certificate of
registration, loaner radiation machines may be used for up to 30 days. If the
loaner radiation machine is used for more than 30 days, the registrant is
required, within the next 30 days, to complete the following:
(I) notify the agency of any change in the
category of radiation machine type or type of use as authorized in the
certificate of registration (for example, addition of a computerized tomography
radiation machine); or
(II) notify
the agency of any increase in the number of radiation machines authorized by
the certificate of registration in any radiation machine type or type of use
category; and
(III) perform an EPE
on the radiation machines in accordance with subsection (j)(5)(J) of this
section.
(ii) For persons
who do not hold a valid certificate of registration, loaner radiation machines
may be used for human use up to 30 days, by or under the supervision of a
dentist licensed by Texas State Board of Dental Examiners, before applying for
a certificate of registration in accordance with this section.
(6) Termination of
certificates of registration. When a registrant decides to terminate all
activities involving radiation machines authorized under the certificate of
registration, the registrant shall notify the agency immediately and:
(A) request termination of the certificate of
registration in writing. The request shall be signed by the radiation safety
officer, owner, or an individual authorized to act on behalf of the
registrant;
(B) submit to the
agency a record of the disposition of the radiation machines and, if
transferred, to whom transferred; and
(C) pay any outstanding fees in accordance
with subsection (h) of this section.
(7) Modification, suspension, and revocation
of certificates of registration.
(A) The terms
and conditions of all certificates of registration shall be subject to revision
or modification. A certificate of registration may be suspended or revoked by
reason of amendments to the Act, by reason of requirements of this chapter or
orders issued by the agency.
(B)
Any certificate of registration may be revoked, suspended, or modified, in
whole or in part in accordance with subsection (l)(3)(C)(iii) of this
section.
(C) Each certificate of
registration revoked by the agency ends at the end of the day on the date of
the agency's final determination to revoke the certificate of registration, or
on the revocation date stated in the determination, or as otherwise provided by
the agency order.
(D) Except in
cases in which the occupational and public health or safety requires otherwise,
no certificate of registration shall be suspended or revoked unless, before the
institution of proceedings therefore, facts or conduct that may warrant such
action shall have been called to the attention of the registrant in writing and
the registrant shall have been afforded an opportunity to demonstrate
compliance with all lawful requirements.
(8) Reciprocal recognition of out-of-state
certificates of registration.
(A) Whenever
any radiation machine is to be brought into the State of Texas for any
temporary use, the person proposing to bring the radiation machine into the
state shall apply for and receive a notice from the agency granting reciprocal
recognition before beginning operations. The request for reciprocity shall
include the following:
(i) completed RC Form
226-1 (Business Information Form);
(ii) completed RC Form 252-3 (Notice of
Intent to Work in Texas Under Reciprocity);
(iii) name and Texas licensing board number
of the dentist if the radiation machines are used on humans;
(iv) copy of the applicant's current state
certificate of registration or equivalent document;
(v) copy of the applicant's current operating
and safety procedures pertinent to the proposed use;
(vi) fee as specified in subsection (h)(1) of
this section; and
(vii)
qualifications of personnel who will be operating the radiation
machines.
(B) Upon a
determination that the request for reciprocity meets the requirements of the
agency, the agency may issue a notice granting reciprocal recognition
authorizing the proposed radiation machine use.
(C) Once reciprocity is granted, the
out-of-state registrant shall file a RC Form 252-3 with the agency before each
entry into the state. This form shall be filed at least three working days
before the radiation machine is used in the state. At determination of the
agency, the out-of-state registrant may, for a specific case, obtain permission
to proceed sooner if the three-day period would impose an undue
hardship.
(D) When radiation
machines are used as authorized under reciprocity, the out-of-state registrant
shall have the following in its possession at all times for inspection by the
agency:
(i) completed RC Form
252-3;
(ii) copy of the notice from
the agency granting reciprocity;
(iii) copy of the out-of-state registrant's
operating and safety procedures; and
(iv) copy of the applicable rules as
specified in the notice granting reciprocity.
(E) If the state from which the radiation
machine is proposed to be brought does not issue certificates of registration
or equivalent documents, a certificate of registration shall be obtained from
the agency in accordance with the requirements of this section.
(F) The agency may withdraw, limit, or
qualify its acceptance of any certificate of registration or equivalent
document issued by another agency upon determining that such action is
necessary in order to prevent undue hazard to occupational and public health
and safety or property or environment.
(G) Reciprocal recognition will expire two
years from the date it is granted. A new request for reciprocity shall be
submitted to the agency every two years and the items in subparagraph (A) of
this paragraph shall be included.
(H) Radiation services provided by a person
from out-of-state will not be granted reciprocity. Whenever radiation services
are to be provided by a person from out-of-state, that person shall apply for
and receive a certificate of registration from the agency before providing
radiation services. The application shall be filed in accordance with this
subsection, as applicable.
(j) Use of radiation machines.
(1) As low as reasonably achievable. Persons
shall use, to the extent practical, procedures and engineering controls based
upon sound radiation protection principles to achieve occupational doses and
public doses that are as low as reasonably achievable.
(2) Operating and safety procedures. Each
registrant shall have and implement written operating and safety procedures.
These procedures shall be read by and accessible to each individual before
operating a radiation machine, including any restrictions of the operating
technique required for the safe operation of the particular radiation machine.
(A) The registrant shall ensure and document
that each individual has read the operating and safety procedures before
operating a radiation machine and reviewed the procedures annually not to
exceed 12 months. This documentation shall be maintained in accordance with
subsection (k)(2) of this section for inspection by the agency. The
documentation shall include the following:
(i)
name and signature of individual;
(ii) date individual read the operating and
safety procedures; and
(iii)
initials of the radiation safety officer.
(B) The operating and safety procedures shall
include, but are not limited to, the following procedures as applicable:
(i) ordering x-ray exams in accordance with
subsection (b)(1)(A) and (B) of this section;
(ii) providing radiation dose requirements in
accordance with paragraph (3)(A) of this subsection;
(iii) instructing workers in accordance with
paragraph (3)(D) of this subsection;
(iv) posting notices to workers in accordance
with paragraph (4)(B) of this subsection;
(v) posting of a radiation area in accordance
with paragraph (4)(C) and (D) of this subsection;
(vi) using a technique chart in accordance
with paragraph (5)(A) of this subsection;
(vii) holding of patients or film in
accordance with paragraph (11)(A) and (B) of this subsection and subsection
(c)(4) of this section;
(viii)
following film for processing program or digital imaging acquisition system
protocols in accordance with paragraphs (12) - (14) of this
subsection;
(ix) notifying and
reporting to individuals in accordance with subsection (k)(2) and (3) of this
section; and
(x) ensuring security
and control of radiation machines in accordance with paragraph (4)(E)(i) of
this subsection.
(3) Personnel requirements.
(A) Occupational dose limits.
(i) The registrant shall control the
occupational dose to individuals, to the following dose limits.
(I) An annual limit shall be the total
effective dose equivalent being equal to 5 rems (0.05 sievert).
(II) The annual limits to the lens of the
eye, to the skin of the whole body, and to the skin of any extremities shall
be:
(-a-) a lens dose equivalent of 15 rems
(0.15 sievert); and
(-b-) a shallow
dose equivalent of 50 rems (0.5 sievert) to the skin of the whole body or to
the skin of any extremity.
(III) The annual limits for a minor shall be
10% of the annual occupational dose limits specified in subclauses (I) and (II)
of this clause.
(IV) If a woman
declares her pregnancy, the registrant shall ensure that the dose equivalent to
an embryo/fetus during the entire pregnancy, due to occupational exposure of a
declared pregnant woman, does not exceed 0.5 rem (5 millisievert). If a woman
chooses not to declare pregnancy, the occupational dose limits specified in
subclauses (I) and (II) of this clause are applicable to the woman.
(V) The registrant shall make efforts to
avoid substantial variation above a uniform monthly exposure rate (air kerma
rate) to a declared pregnant woman to satisfy the limit in clause (i) of this
subparagraph. The National Council on Radiation Protection and Measurements
recommended in NCRP Report No. 116 "Limitation of Exposure to Radiation" (March
31, 1993) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received
in any one month.
(ii)
The assigned deep dose equivalent shall be for the portion of the body
receiving the highest exposure. The assigned shallow dose equivalent shall be
the dose averaged over the contiguous 10 cm2 of the skin receiving the highest
exposure.
(iii) The deep dose
equivalent, lens dose equivalent, and shallow dose equivalent may be assessed
from surveys or radiation measurements for demonstrating compliance with the
occupational dose limits.
(iv) The
registrant shall reduce the dose that an individual may be allowed to receive
in the current year by the amount of occupational dose received from radiation
machines or radioactive materials while employed by any other person.
(v) The agency may impose additional
requirements for controlling occupational exposure to restrict or assess the
collective dose.
(B) Dose
limits for individual members of the public.
(i) Each registrant shall conduct operations
so that:
(I) the total effective dose
equivalent to individual members of the public from exposure to radiation from
radiation machines does not exceed 0.5 rem (5 millisieverts) in a year,
exclusive of the dose contribution from background radiation, exposure of
patients to radiation for medical diagnosis or therapy, or to voluntary
participation in medical research programs; and
(II) the dose in any unrestricted area from
external sources does not exceed 0.002 rem (0.02 millisieverts) in any one
hour.
(ii) If the
registrant permits members of the public to have access to restricted areas,
the limits for members of the public continue to apply to those
individuals.
(iii) The agency may
impose additional restrictions on radiation levels in unrestricted areas in
order to restrict the collective dose.
(C) Occupational doses from other sources of
radiation. Individuals who receive occupational doses from sources of radiation
other than dental radiation machines may be required to comply with the
requirements of §289.231(n) and (q) - (s) of this title.
(D) Instructions to workers. The registrant
shall provide instructions to radiation workers before beginning initial work
in restricted areas. These instructions shall include the following:
(i) precautions or procedures to minimize
exposure;
(ii) the applicable
provisions of agency requirements and certificates of registration for the
protection of personnel from exposures to radiation occurring in such areas;
and
(iii) the radiation worker's
responsibility to report promptly to the registrant any condition that may
constitute, lead to, or cause a violation of agency requirements or certificate
of registration conditions, or unnecessary exposure to radiation.
(4) Facility
requirements.
(A) Caution signs. Unless
otherwise authorized by the agency, the standard radiation symbol prescribed
shall use the colors magenta, purple or black on yellow background. The
standard radiation symbol prescribed is the three-bladed design as follows:
(i) the cross-hatched area of the symbol is
to be magenta, purple, or black; and
(ii) the background of the symbol is to be
yellow.
(B) Posting of
notices to workers.
(i) Each registrant shall
post current copies of the following documents:
(I) RC Form 232-1, "Notice to Employees," or
an equivalent document containing at least the same wording as RC Form 232-1;
and
(II) a
notice that describes the following documents and states where the documents
may be examined:
(-a-) a copy of this
section;
(-b-) the certificate of
registration and conditions or documents incorporated into the certificate of
registration by reference and amendments thereto;
(-c-) the operating procedures applicable to
work under the certificate of registration; and
(-d-) any notice of violation, if applicable,
involving radiological working conditions, or order issued in accordance with
subsections (b) and (l)(3) of this section and documentation of the corrections
of any violations.
(ii) Documents, notices, or forms posted in
accordance with this subsection shall:
(I)
appear in an area visible to all workers to permit individuals engaged in work
under the certificate of registration to observe the documents on the way to or
from any particular work location to which the document applies;
(II) be conspicuous; and
(III) be replaced if defaced or
altered.
(C)
Posting requirements. The registrant shall post each radiation area with a
conspicuous sign or signs bearing the radiation symbol and the words "CAUTION,
RADIATION AREA."
(D) Exceptions to
posting requirements. Registrants are exempt from the posting of the radiation
area requirements in subparagraph (C) of this paragraph if the operator has
continuous surveillance and access control of the radiation area.
(E) Security and control of radiation
machines.
(i) The registrant shall establish
a protocol to ensure radiation machines are secure from unauthorized
removal.
(ii) The registrant shall
use devices and administrative procedures to prevent unauthorized use of
radiation machines.
(iii) Any
person using hand-held dental radiation machines shall ensure proper storage of
the unit to include:
(I) securing the unit
against theft or unauthorized use; and
(II) storing the unit in locked cabinets,
storage rooms or work areas when not under immediate supervision of authorized
users.
(5) Radiation machine requirements.
(A) Technique chart.
(i) A technique chart relevant to the
particular radiation machine shall be provided or electronically displayed near
the control panel and used by all operators.
(ii) Technique and exposure indicators.
(I) The technique factors to be used during
an exposure shall be indicated before the exposure begins except:
(-a-) when automatic exposure controls are
used, in which case the technique factors that are set before the exposure
shall be indicated; or
(-b-) unless
prevented by the design of the certified radiation machine.
(II) On radiation machines having
fixed technique factors, the requirement of subclause (I) of this clause may be
met by permanent markings.
(III)
The x-ray control shall provide visual indication of the production of x-rays.
In addition, a signal audible to the operator shall indicate that the exposure
has terminated.
(IV) The indicated
technique factors shall be accurate to within manufacturer's specifications. If
these specifications are not available from the manufacturer, the factors shall
be accurate to within plus or minus 10% of the indicated setting.
(B) Labeling radiation
machines. Each registrant shall ensure that each radiation machine is labeled
in a conspicuous manner that cautions individuals that radiation is produced
when it is energized. This label shall be affixed in a clearly visible location
on the face of the radiation machine.
(C) Mechanical support of tube head. The tube
housing assembly shall be adjusted to remain stable during an exposure unless
tube housing movement is a designed function of the radiation
machine.
(D) Battery charge
indicator. On battery-powered x-ray generators, visual means shall be provided
on the control panel to indicate whether the battery is in a state of charge
adequate for proper operation.
(E)
Beam quality. The following requirements apply to beam quality.
(i) Half-value layer.
(I) The half-value layer of the useful beam
for a given x-ray tube potential shall not be less than the values shown in the
following table. If it is necessary to determine such half-value layer at an
x-ray tube potential that is not listed in the table, linear interpolation may
be made.
(II) For
capacitor energy storage equipment, compliance with the requirements of this
subparagraph shall be determined with the maximum quantity of charge per
exposure.
(ii) Filtration
controls.
(I) For radiation machines that have
variable kilovolt peak and variable filtration for the useful beam, a device
shall link the kilovolt peak selector with the filters and shall prevent an
exposure unless the minimum amount of filtration required by clause (i) of this
subparagraph is in the useful beam for the given kilovolt peak that has been
selected.
(II) Any other radiation
machine having removable filters shall be required to have the minimum amount
of filtration as required by clause (i)(I) of this subparagraph permanently
located in the useful beam during each exposure.
(F) Multiple tubes. Where two or more
radiographic tubes are controlled by one exposure switch, the tube or tubes
that have been selected shall be clearly indicated before initiation of the
exposure. This indication shall be both on the x-ray control panel and at or
near the tube housing assembly that has been selected.
(G) X-ray control. An x-ray control shall be
incorporated into each radiation machine such that an exposure can be
terminated by the operator at any time, except for exposures of 0.5 second or
less. The exposure switch shall be of the continuous pressure type.
(H) Radiation machines needing correction or
repair. The correction or repair shall begin within 30 days following the
failure and the registrant shall perform or cause to be performed the
correction or repair according to a designated plan. Correction or repair shall
be completed no longer than 90 days from discovery unless authorized in writing
by the agency.
(I) Records of
radiation machine corrections or repairs. The registrant shall maintain records
of corrections or repairs and any tests, measurements or numerical readings
listed in subparagraph (J) of this paragraph in accordance with subsection
(k)(2) of this section for inspection by the agency.
(J) Equipment performance evaluations (EPE).
(i) For all dental radiation machines, the
registrant shall perform, or cause to be performed, EPE tests for each item
specified in clauses (v) - (xi) of this subparagraph as follows:
(I) within 30 days after initial installation
of radiation machines:
(II) within
30 days after reinstallation of a radiation machine; and
(III) within 30 days after repair of a
radiation machine component that would affect the radiation output that
includes, but is not limited to, the timer, tube, and power
supply.
(ii) Frequency of
EPE. For x-ray and CT systems, an EPE shall be performed at the frequency
listed in the following table.
(iii)
Records of the EPE results shall be available for inspection by the agency and
shall include the following:
(I) measurements
and numerical readings;
(II)
indication of pass or fail for each test; and
(III) maintenance by the registrant in
accordance with subsection (k)(2) of this section for inspection by the
agency.
(iv) Radiation
machines needing correction or repair. If a radiation machine requires
correction or repair following an EPE, the correction or repair shall begin
within 30 days following the failure and the registrant shall perform or cause
to be performed the correction or repair according to a designated plan.
Correction or repair shall be completed no longer than 90 days from discovery
unless authorized in writing by the agency.
(v) Timer.
(I) The accuracy of the timer shall meet the
manufacturer's specifications. If the manufacturer's specifications are not
obtainable, the timer accuracy shall be plus or minus 10% of the indicated time
with testing performed at 0.5 second.
(II) Means shall be provided to terminate the
exposure at a preset time interval, a preset product of current and time, a
preset number of pulses, or a preset radiation exposure to the image receptor.
In addition, it shall not be possible to make an exposure when the timer is set
to a "zero" or "off" position if either position is provided.
(vi) Exposure reproducibility.
When all technique factors are held constant, including control panel
selections associated with automatic exposure control systems, the coefficient
of variation of exposure for both manual and automatic exposure control systems
shall not exceed 0.05. This requirement applies to clinically used
techniques.
(vii) Kilovolt peak. If
the registrant possesses documentation of the appropriate manufacturer's
kilovolt peak specifications, the radiation machine shall meet those
specifications. If the registrant does not possess documentation of the
appropriate manufacturer's kilovolt peak specifications, the indicated kilovolt
peak shall be accurate to within plus or minus 10% of the indicated settings.
For radiation machines with fewer than three fixed kilovolt peak settings, the
radiation machine shall be checked at those settings.
(viii) Tube stability. The x-ray tube shall
remain physically stable during exposures. In cases where tubes are designed to
move during exposure, the registrant shall assure proper and free movement of
the radiation machine.
(ix)
Collimation. Field limitation shall meet the requirements of paragraphs (9) and
(10) of this subsection.
(x)
Entrance exposure limits (air kerma limits) for dental facilities. The in-air
exposure (entrance air kerma) for an adult bite wing view shall be determined
from the exposure technique used by the registrant for the average adult
patient. The in-air exposure (entrance air kerma) for intraoral (bite wing)
dental radiography shall not exceed the following entrance exposure limits (air
kerma limits):
(xi)
Measurements of the radiation output for a radiation machine. Measurements of
the radiation output for a radiation machine shall be performed with a
calibrated dosimetry system in accordance with the following.
(I) The dosimetry system calibration shall be
traceable to a national standard.
(II) Dosimetry systems shall be calibrated
within 24 months from the date of the prior calibration.
(xii) Record of dosimetry system calibration.
The registrant shall verify all dosimetry equipment meets the requirements of
clause (xi) of this subparagraph.
(6) Dental research.
(A) Any research using radiation machines on
humans shall be approved by an Investigational Review Board (IRB) as required
by Title 45, CFR, Part 46, and Title 21, CFR, Part 56. The IRB shall include at
least one licensed dentist to direct any use of radiation in accordance with
this section.
(B) Facilities with
radiation machines with investigational device exemptions that are involved in
clinical studies shall comply with primary regulations that govern the conduct
of clinical studies and that apply to the manufacturers, sponsors, clinical
investigators, institutional review boards, and the medical device. These
regulations include the following:
(i) 21
CFR, Part 812, Investigational Device Exemptions;
(ii) 21 CFR, Part 50, Protection of Human
Subjects;
(iii) 21 CFR, Part 56,
Institutional Review Boards;
(iv)
21 CFR, Part 54, Financial Disclosure by Clinical Investigators; and
(v) 21 CFR, Part 820, Subpart C, Design
Controls of the Quality System Regulation.
(7) Educational facilities. Facilities
conducting training using non-humans are held to all the requirements of this
section except for paragraph (5)(J) of this subsection concerning EPE and for
paragraphs (12) and (13) of this subsection concerning image
processing.
(8) Certified radiation
machines for dental facilities. The registrant shall not make, nor cause to be
made, any modification of components or installations of components certified
in accordance with the United States Food and Drug Administration Title 21,
CFR, Part 1020, "Performance Standards for Ionizing Radiation Emitting
Products," as amended, in any manner that could cause the installations or the
components to fail to meet the requirements of the applicable parts of the
standards specified in Title 21, CFR, Part 1020, except where a variance has
been granted by the Director, Center for Devices and Radiological Health,
United States Food and Drug Administration. A copy of the variance shall be
maintained by the registrant in accordance with subsection (k)(2) of this
section for inspection by the agency. All modifications of components or
installation of components must be approved by the manufacturer.
(9) Additional requirements for dental
intraoral radiation machines.
(A)
Source-to-skin distance. Radiation machines designed for use with an intraoral
image receptor shall be provided with means to limit source-to-skin distance to
not less than:
(i) 18 centimeters if operable
above 50 kilovolt peak; or
(ii) 10
centimeters if not operable above 50 kilovolt peak.
(B) Field limitation. Radiation machines
designed for use with an intraoral image receptor shall be provided with means
to limit the x-ray beam such that:
(i) if the
minimum source-to-skin distance is 18 centimeters or more, the x-ray field at
the minimum source-to-skin distance shall be restricted to a dimension of no
more than seven centimeters; and
(ii) if the minimum source-to-skin distance
is less than 18 centimeters, the x-ray field at the minimum source-to-skin
distance shall be restricted to a dimension of no more than six
centimeters.
(10) Additional requirements for dental
extraoral radiation machines.
(A) Dental
panoramic radiation machines shall be provided with means to restrict the x-ray
beam to the following:
(i) the imaging slit in
the transverse axis; and
(ii) no
more than a total of 0.5 inches larger than the imaging slit in the vertical
axis.
(B) All other
dental extraoral radiation machines (e.g., cephalometric) shall be provided
with means to restrict the x-ray field to the image receptor. The x-ray field
shall not exceed the image receptor by more than:
(i) 2.0% of the source-to-image receptor
distance for the length or width of the image receptor for rectangular
collimation; or
(ii) 2.0% of the
source-to-image receptor distance for the diagonal of the image receptor for
circular or polygon collimation.
(11) Additional operational controls.
(A) When a patient or image receptor must be
held in position during radiography, mechanical supporting or restraining
devices shall be used when the exam permits except in individual cases in which
the registrant has determined that the holding devices are
contraindicated.
(B) The
registrant's written operating and safety procedures required by paragraph (2)
of this subsection shall include the following:
(i) a list of circumstances in which
mechanical holding devices cannot be routinely utilized; and
(ii) a procedure used for selecting an
individual to hold or support the patient or image receptor.
(C) The operator position during
the exposure shall be such that the operator's exposure is as low as reasonably
achievable and the operator is a minimum of six feet from the useful beam or
behind a protective barrier. The operator shall maintain verbal, aural, and
visual contact with the patient.
(12) Automatic and manual film processing for
dental facilities and mobile dental services.
(A) Films shall be developed in accordance
with the time-temperature relationships recommended by the film manufacturer.
The specified developer temperature for automatic processing and the
time-temperature chart for manual processing shall be posted in the processing
area. If the registrant determines an alternate time-temperature relationship
is more appropriate for a specific facility, that time-temperature relationship
shall be documented and posted.
(B)
Chemicals shall be replaced according to the chemical manufacturer or
supplier's recommendations or at an interval not to exceed three
months.
(C) Darkroom light leak
tests shall be performed at intervals not to exceed six months.
(D) Lighting in the film processing/loading
area shall be maintained with the filter, bulb wattage, and distances
recommended by the film manufacturer for that film emulsion or with products
that provide an equivalent level of protection against fogging.
(E) Corrections or repairs of the light leaks
or other deficiencies in subparagraphs (B) - (D) of this paragraph shall be
initiated within 72 hours after discovery and completed no longer than 15 days
from detection of the deficiency unless a longer time is authorized by the
agency. Records of the corrections or repairs shall include the date and
initials of the individual performing these functions and the registrant shall
maintain the records in accordance with subsection (k)(2) of this section for
inspection by the agency.
(F)
Documentation of the items in subparagraphs (B), (C), and (E) of this paragraph
shall be maintained at the site where performed and shall include the date and
initials of the individual completing these items. These records shall be made
and maintained in accordance with subsection (k)(2) of this section for
inspection by the agency.
(13) Alternative processing systems. Users of
daylight processing systems, laser processors, self-processing film systems, or
other alternative processing systems shall follow manufacturer's
recommendations for image processing. Documentation that the registrant is
following manufacturer's recommendations shall include the date and initials of
the individual completing the document and shall be made and maintained at the
authorized use location where performed in accordance with subsection (k)(2) of
this section for inspection by the agency.
(14) Digital imaging acquisition systems.
(A) Users of digital imaging acquisition
systems shall follow quality assurance/quality control (QA/QC) protocol for
digital imaging established by the manufacturer.
(i) The registrant shall include the
protocols established in paragraph (2) of this subsection in its operating and
safety procedures.
(ii) The
registrant shall document the frequency at which the quality assurance/quality
control protocol is performed. Documentation shall:
(I) include the date and initials of the
individual completing the document and the images acquired; and
(II) be maintained and available at the
authorized use location where performed in accordance with subsection (k)(2) of
this section for inspection by the agency.
(B) If a protocol cannot be established by
the manufacturer, it shall be developed and implemented by the registrant.
(i) The QA/QC protocol, as developed and
implemented by the registrant, shall include image quality testing for, but not
limited to, spatial resolution, noise, artifacts and contrast by using a
commercially purchased testing tool or an inanimate object of at least three
varying densities.
(I) Images shall be
acquired with each x-ray image receptor at an interval not to exceed three
months.
(II) Test images shall be
compared to previous test images to assess degradation of image
quality.
(III) If a radiation
machine or components of the digital imaging acquisition system require
correction or repair following a quality test, the correction or repair shall
begin within 30 days following the failure and the registrant shall perform or
cause to be performed the correction or repair according to a designated plan.
Correction or repair shall be completed no longer than 90 days from discovery
unless authorized in writing by the agency.
(ii) The registrant shall include the
protocols established in paragraph (2) of this subsection in its operating and
safety procedures.
(iii) The
registrant shall document the frequency at which the quality assurance/quality
control protocol is performed. Documentation shall:
(I) include the date and initials of the
individual completing the document and the images acquired; and
(II) be maintained and available at the
authorized use location where performed in accordance with subsection (k)(2) of
this section for inspection by the agency.
(k) Records and reports.
(1) General provisions for records and
reports.
(A) Each registrant shall maintain
records at each site, including sites authorized by the certificate of
registration, conditions, and records sites for mobile services. The records
shall include those specified in paragraph (2) of this subsection and shall be
maintained at the time interval indicated for inspection by the agency. These
records may be maintained in electronic format. These records shall be
accessible to radiation machine operators during working hours.
(B) All records required by this section
shall be accurate and factual.
(C)
Each registrant shall use the SI units gray, sievert, and coulomb per kilogram,
or the special units rad, rem, and roentgen, including multiples and
subdivisions, and shall clearly indicate the units of all quantities on records
required by this section.
(D) The
registrant shall make a clear distinction among the quantities entered on the
records required by this section, such as, total effective dose equivalent,
shallow dose equivalent, lens dose equivalent, and deep dose
equivalent.
(E) Each record
required by this section shall be legible throughout the specified retention
period.
(F) The record shall be the
original, a reproduced copy, or a microform, if the authorized personnel
authenticate the copy or microform and that the microform is capable of
producing a clear copy throughout the required retention period.
(G) The record may also be stored in
electronic format with the capability for producing legible, accurate, and
complete records during the required retention period.
(H) The registrant shall maintain adequate
safeguards against tampering with and loss of records.
(I) Copies of records required in subsections
(i)(5)(I) and (J), (j)(5)(J), and (j)(12)(F) of this section and by certificate
of registration condition that are relevant to operations at an additional
authorized use location shall be maintained at that location in addition to the
main site specified on a certificate of registration in accordance with
subsection (k)(2) of this section.
(J) Subject to the limitations provided in
the Texas Public Information Act, Government Code, Chapter 552, all information
and data collected, assembled, or maintained by the agency are public records
open to inspection and copying during regular office hours.
(K) Any person who submits written
information or data to the agency and requests that the information be
considered confidential, privileged, or otherwise not available to the public
under the Texas Public Information Act, shall justify such request in writing,
including statutes and cases where applicable, addressed to the agency.
(i) Documents containing information that is
claimed to fall within an exception to the Texas Public Information Act shall
be marked to indicate that fact. Markings shall be placed on the document on
origination or submission.
(I) The words "NOT
AN OPEN RECORD" shall be placed conspicuously at the top and bottom of each
page containing information claimed to fall within one of the
exceptions.
(II) The following
wording shall be placed at the bottom of the front cover and title page, or
first page of text if there is no front cover or title page:
(ii) The agency requests, whenever possible,
that all information submitted under the claim of an exception to the Texas
Public Information Act be extracted from the main body of the application and
submitted as a separate annex or appendix to the application.
(iii) Failure to comply with any of the
procedures that are described in clauses (i) and (ii) of this subparagraph may
result in all information in the agency file being disclosed upon an open
records request.
(L) The
agency will determine whether information falls within one of the exceptions to
the Texas Public Information Act. The agency will determine whether there has
been a previous determination that the information falls within one of the
exceptions to the Texas Public Information Act. If there has been no previous
determination and the agency believes that the information falls within one of
the exceptions, an opinion of the Attorney General will be requested. If the
agency agrees in writing to the request, the information shall not be open for
public inspection unless the Attorney General's office subsequently determines
that it is not an exception.
(M)
Requests for information.
(i) All requests
for open records information shall be in writing and refer to documents
currently in possession of the agency.
(ii) The agency will determine whether the
information may be released or whether it falls within an exception to the
Texas Public Information Act.
(I) The agency
may take a reasonable period to determine whether information falls within one
of the exceptions to the Texas Public Information Act.
(II) If the information is determined to be
public, it will be presented for inspection and copies of documents will be
furnished within a reasonable period. A fee will be charged to recover agency
costs for copies.
(iii)
Original copies of public records may not be removed from the agency. Under no
circumstances shall material be removed from existing
records.
(2)
Records requirements.
(A) Each registrant
shall maintain the following records at each site, including authorized records
sites for mobile services, at the time intervals specified and make available
to the agency for inspection. The records may be maintained in electronic
format.
(B) For
radiation machines authorized for mobile service, copies of the records
specified in the table in subparagraph (A)(iii)-(v) of this paragraph shall be
maintained with the radiation machine in accordance with subparagraph (A) of
this paragraph for inspection by the agency. If on-board processors are
utilized, image processing records shall also be made on board in accordance
with subsection (j)(12), (13), and (14) of this section and maintained in
accordance with subparagraph (A) of this paragraph for inspection by the
agency.
(C) For authorized records
sites for mobile services, copies of the records specified in subparagraph
(A)(ii) and (vi)-(xii) of this paragraph shall be maintained in accordance with
subparagraph (A) of this paragraph for inspection by the agency.
(3) Reports.
(A) Reports of stolen, lost, or missing
radiation machines.
(i) Each registrant shall
report to the agency by telephone a stolen, lost, or missing radiation machine
immediately after its occurrence becomes known to the registrant.
(ii) Within 30 days after making the
telephone report, each registrant required to make a report according to clause
(i) of this subparagraph shall make a written report to the agency that
includes the following information:
(I) a
description of the radiation machine involved, including the manufacturer name,
model and serial number;
(II) a
description of the circumstances under which the loss or theft
occurred;
(III) actions that have
been taken, or will be taken, to recover the radiation machine; and
(IV) procedures or measures that have been,
or will be, adopted to ensure against a recurrence of the loss or theft of
radiation machines.
(iii)
Subsequent to filing the written report, the registrant shall also report
additional information pertaining to the loss or theft within 30 days after the
registrant learns of such information.
(iv) The registrant shall prepare any report
filed with the agency in accordance with this subsection so that names of
individuals who may have received exposure to radiation are stated in a
separate and detachable portion of the report.
(B) Reports of incidents.
(i) Notwithstanding other requirements for
notification, each registrant shall immediately report each event involving a
radiation machine possessed by the registrant that may have caused or threatens
to cause an individual, except radiation administered for healing arts
purposes, to receive:
(I) a total effective
dose equivalent of 25 rems (0.25 sievert) or more;
(II) a lens dose equivalent of 75 rems (0.75
sievert) or more; or
(III) a
shallow dose equivalent to the skin of the whole body or to the skin of any
extremities of 250 rads (2.5 grays) or more.
(ii) Within 24 hours of discovery of the
event, each registrant shall report to the agency each event involving loss of
control of a radiation machine possessed by the registrant that may have
caused, or threatens to cause an individual to receive, in a period of 24
hours:
(I) a total effective dose equivalent
exceeding 5 rems (0.05 sievert);
(II) a lens dose equivalent exceeding 15 rems
(0.15 sievert); or
(III) a shallow
dose equivalent to the skin of the whole body or to the skin of any extremities
exceeding 50 rems (0.5 sievert).
(iii) Registrants shall make the initial
notification reports required by clauses (i) and (ii) of this subparagraph by
telephone to the agency and shall confirm the initial notification report
within 24 hours by facsimile or other electronic media to the agency.
(iv) The registrant shall prepare each report
filed with the agency in accordance with this section so that names of
individuals who have received exposure to sources of radiation are stated in a
separate and detachable portion of the report.
(C) Reports of exposures and radiation levels
exceeding the limits.
(i) In addition to the
notification required by subparagraph (B) of this paragraph, each registrant
shall submit a written report within 30 days after learning of any of the
following occurrences:
(I) incidents for which
notification are required by subparagraph (B) of this paragraph;
(II) doses in excess of any of the following:
(-a-) the occupational dose limits for adults
in subsection (j)(3)(A)(i) of this section;
(-b-) the occupational dose limits for a
minor in subsection (j)(3)(A)(i)(III) of this section;
(-c-) the limits for an embryo/fetus of a
declared pregnant woman in subsection (j)(3)(A)(i)(IV) and (V) of this
section;
(-d-) the limits for an
individual member of the public in subsection (j)(3)(B) of this section;
or
(-e-) any applicable limit in
the certificate of registration;
(III) levels of radiation in:
(-a-) a restricted area in excess of
applicable limits in the certificate of registration; or
(-b-) an unrestricted area in excess of 10
times the applicable limit set forth in this section or in the certificate of
registration conditions, whether or not involving exposure of any individual in
excess of the limits in subsection (j)(3)(B) of this section.
(ii) Each report
required by clause (i) of this subparagraph shall describe the extent of
exposure of individuals to radiation, including, as appropriate:
(I) estimates of each individual's
dose;
(II) the levels of radiation
involved;
(III) the cause of the
elevated exposures, dose rates; and
(IV) corrective steps taken or planned to
ensure against a recurrence, including the schedule for achieving conformance
with applicable limits, and associated registration conditions.
(iii) Each report filed in
accordance with clause (i) of this subparagraph shall include, for each
individual exposed, the name, a unique identification number, and date of
birth. With respect to the limit for the embryo/fetus in subsection
(j)(3)(A)(i)(IV) and (V) of this section, the identifiers should be those of
the declared pregnant woman. The report shall be prepared so that this
information is stated in a separate and detachable portion of the
report.
(D) Reports to
individuals of exposures.
(i) If applicable,
radiation exposure data for an individual shall be reported to the individual
as specified in this paragraph. The information reported shall include data and
results obtained in accordance with requirements of this section, orders,
certificate of registration conditions, as shown in records made and maintained
by the registrant in accordance with this subsection. Each notification and
report shall:
(I) be in writing;
(II) include appropriate identifying data
such as the name of the registrant, the name of the individual, and the
individual's identification number;
(III) include the individual's exposure
information; and
(IV) contain the
following statement: "This report is furnished to you under the provisions of
the Texas Regulations for Control of Radiation, 25 Texas Administrative Code
§ 289.232(j)(3)(A) - (C). You should preserve this report for further
reference."
(ii) If
applicable, each registrant shall provide an annual written report to advise
each worker of the worker's estimated dose, received in that monitoring year,
as shown in records made and maintained by the registrant in accordance with
subparagraph (C) of this paragraph if:
(I)
the individual's occupational dose exceeds 100 mrem (1 mSv) total effective
dose equivalent or 100 mrem (1 mSv) to any individual organ or tissue;
or
(II) the individual requests his
or her annual dose report in writing.
(iii) When a registrant is required in
accordance with subparagraphs (B) and (C) of this paragraph to report to the
agency any exposure of an identified occupationally exposed individual, or an
identified member of the public, to radiation, the registrant shall also notify
the individual and provide the individual with a copy of the report submitted
to the agency, including the information required by clause (i) of this
subparagraph. Such reports shall be transmitted no later than the transmittal
to the agency.
(l) Compliance and hearing procedures.
(1) Inspections. The agency may enter public
or private property at reasonable times to determine whether, in a matter under
the agency's jurisdiction, there is compliance with the Act, the requirements
of this section, certificate of registration conditions, and orders issued by
the agency.
(A) Each registrant shall perform,
upon instructions from the agency, or shall permit the agency to perform such
reasonable surveys, as the agency deems appropriate or necessary, including,
but not limited to, surveys of:
(i) radiation
machines;
(ii) facilities where
radiation machines are used; and
(iii) other radiation machines and devices
used in connection with utilization of radiation machines.
(B) The routine inspection interval for
dental facilities is four years. On-site inspections and remote inspections may
be alternated as determined by the agency. The inspection interval specified is
based upon the average number of health-related violations per inspection, as
determined from compliance history data. Registrant's having certificates of
registration authorizing multiple radiation machine use categories will be
inspected on-site at the most frequent interval specified for the radiation
machine uses authorized.
(i) Notwithstanding
the inspection interval specified in this subparagraph, the agency may inspect
registrants more frequently due to:
(I) the
persistence or severity of violations found during an inspection;
(II) investigation of an incident or
complaint concerning the facility;
(III) a request for an inspection by a worker
in accordance with paragraph (2) of this subsection;
(IV) any change in a facility or radiation
machine that might cause a significant increase in radiation output or hazard;
or
(V) a mutual agreement between
the agency and registrant.
(ii) The agency will conduct inspections of
dental radiation machines in a manner designed to cause as little disruption of
a dental practice as is practicable.
(C) On-site Inspections.
(i) Each registrant shall afford to the
agency at all reasonable times opportunity to inspect materials, radiation
machines, activities, facilities, premises, and records in accordance with this
section.
(ii) During an inspection,
agency inspectors may obtain and retain paper or electronic copies of requested
documentation in accordance with this section.
(iii) Each registrant shall make available to
the agency for inspection records made and maintained in accordance with this
section.
(iv) Agency inspectors may
consult privately with workers concerning matters of occupational radiation
protection and other matters related to applicable provisions of agency
regulations and certificates of registration to the extent the inspectors deem
necessary for the conduct of an inspection.
(v) An employee who routinely is engaged in
work under control of the registrant, operating the radiation machines for
healing arts purposes, shall be made available to operate the radiation
machines at the time of the inspection and engage in the inspection
process.
(vi) Notwithstanding the
other provisions of this section, agency inspectors are authorized to refuse to
permit accompaniment by any individual who interferes, delays, or causes to be
delayed an inspection.
(D) For remote inspection of dental radiation
machines, each registrant shall:
(i) respond
to a request from the agency for a remote inspection;
(ii) complete the remote inspection forms in
accordance with the instructions included with the forms; and
(iii) return to the agency the completed
remote inspection forms, including documentation of the most recent EPE
performed in accordance with subsection (j)(5)(J) of this section and an
inventory in accordance with subsection (i)(5)(I) of this section by the
deadline indicated on the forms.
(E) During the course of an inspection, any
worker may privately inform the inspectors, either verbally or in writing, any
past or present condition which that individual has reason to believe may have
contributed to or caused any violation of the Act, the requirements in this
section, certificate of registration conditions, or any unnecessary exposure of
an individual to radiation from any radiation machine source of radiation under
the registrant's control. Any such notice in writing shall comply with the
requirements of paragraph (2) of this subsection.
(F) The provisions of subparagraph (E) of
this paragraph shall not be interpreted as authorization to disregard
instructions in accordance with subsection (j)(3)(D) of this section.
(2) Complaints. Any worker or
representative of a worker who believes that a violation of the Act, the
requirements of this section, or certificate of registration conditions exists
or has occurred in work under a certificate of registration with regard to
radiological working conditions in which the worker is engaged, may request an
inspection by giving notice of the alleged violation to the agency. Any such
notice shall be in writing, shall set forth the specific grounds for the
notice, and the worker or representative of the worker shall sign the notice. A
copy shall be provided to the registrant by the agency no later than at the
time of inspection except that, upon the request of the worker giving such
notice, the worker's name and the name of individual referred to therein shall
not appear in such copy or on any record published, released, or made available
by the agency, except for good cause shown.
(A) If, upon receipt of such notice, the
agency determines that the request meets the requirements set forth in this
paragraph, and that there are reasonable grounds to believe that the alleged
violation exists or has occurred, an inspection shall be made as soon as
practicable to determine if such alleged violation exists or has occurred.
Inspections in accordance with this section need not be limited to matters
referred in the request.
(B) No
registrant, contractor or subcontractor of a registrant shall discharge or in
any manner discriminate against any worker because of the following:
(i) such worker has filed any request or
instituted or caused to be instituted any proceeding under this
section;
(ii) such worker has
testified or is about to testify in any such proceeding; or
(iii) because of the exercise by such worker
on behalf of that individual or others of any option afforded by this
section.
(C) Inspections
not warranted.
(i) If the agency determines,
with respect to a request under subparagraphs (A) and (B) of this paragraph,
that an inspection is not warranted because there are no reasonable grounds to
believe that a violation exists or has occurred, the agency shall notify the
requestor in writing of such determination. The requestor may obtain review of
such determination in accordance with the provisions of the Act and the
Government Code, Chapters 2001 and 2002.
(ii) If the agency determines that an
inspection is not warranted because the requirements of this paragraph have not
been met, the agency shall notify the requestor in writing of such
determination. Such determination shall be without prejudice to the filing of a
new request meeting the requirements of this paragraph.
(D) Agency inspectors are required to have
special training in the design and uses of medical x-ray equipment. Inspector
training requirements and standards will be detailed in the Radiation Control
Program policies and procedures manual.
(3) Hearing and enforcement procedures.
(A) Violations.
(i) A court injunction or agency order may be
issued prohibiting any violation of any provision of the Act or any requirement
of this section or order issued thereunder.
(ii) Any person who violates any provision of
the Act or any requirement of this section or order issued thereunder may be
subject to civil or administrative penalties.
(iii) Such person may also be guilty of a
misdemeanor and upon conviction, may be punished by fine or imprisonment or
both, as provided by law.
(B) Denial of an application for a
certificate of registration.
(i) When the
agency contemplates denial of an application for certificate of registration as
outlined in subparagraph (A)(i) of this paragraph, the registrant shall be
afforded the opportunity for a hearing. Notice of the denial shall be delivered
to the registrant by mail, addressed to the last known address of the
registrant.
(ii) Any applicant or
registrant against whom the agency contemplates denial of an application may
request a hearing by submitting a written request to the director within 30
days after service of the notice or date of mailing.
(I) The written request for a hearing shall
contain the following:
(-a-) statement
requesting a hearing; and
(-b-)
name and address of the applicant or registrant.
(II) Failure to submit a written request for
a hearing within 30 days after notice is sent will render the agency action
final.
(C)
Compliance procedures for registrants and other persons.
(i) A registrant or other person who commits
a violation will be issued a notice of violation. The person receiving the
notice shall provide the agency with a written statement and supporting
documentation by the date stated in the notice describing the following:
(I) steps taken by the person and the results
achieved;
(II) corrective steps to
be taken to prevent recurrence; and
(III) the date when full compliance was or is
expected to be achieved. The agency may require responses to notices of
violation to be under oath.
(ii) The terms and conditions of all
certificates of registration shall be subject to amendment or modification. A
certificate of registration may be modified, suspended, or revoked by reason of
amendments to the Act, or for violation of the Act, the requirements of this
section, a condition of the certificate of registration, or an order of the
agency.
(iii) Any certificate of
registration may be modified, suspended, or revoked in whole or in part, for
any of the following:
(I) any material false
statement in the application or any statement of fact required in accordance
with provisions of the Act;
(II)
conditions revealed by such application or statement of fact or any report,
record, or inspection, or other means that would warrant the agency to refuse
to grant a certificate of registration on an original application;
(III) violation of, or failure to observe any
of the applicable terms and conditions of the Act, this section, or of the
certificate of registration, or order of the agency; or
(IV) existing conditions that constitute a
substantial threat to the public health or safety or the environment.
(iv) If another state or federal
entity takes an action such as modification, revocation, or suspension of the
certificate of registration, the agency may take a similar action against the
registrant.
(v) When the agency
determines that the action provided for in clause (viii) of this subparagraph
or subparagraph (D) of this paragraph is not to be taken immediately, the
agency may offer the registrant an opportunity to attend an informal conference
to discuss the following with the agency:
(I)
methods and schedules for correcting the violations; or
(II) methods and schedules for showing
compliance with applicable provisions of the Act, the requirements of this
section, certificate of registration conditions, or any orders of the
agency.
(vi) Notice of
any informal conference shall be delivered by personal service, or certified
mail, addressed to the last known address. An informal conference is not a
prerequisite for the action to be taken in accordance with clause (viii) of
this subparagraph or subparagraph (D) of this paragraph.
(vii) Except in cases in which the
occupational and public health or safety requires otherwise, no certificate of
registration shall be suspended or revoked unless, before the institution of
proceedings therefore, facts or conduct that may warrant such action shall have
been called to the attention of the registrant in writing, and the registrant
shall have been afforded an opportunity to demonstrate compliance with all
lawful requirements.
(viii) When
the agency contemplates modification, suspension, or revocation of the
certificate of registration, the registrant shall be afforded the opportunity
for a hearing. Notice of the contemplated action, along with a complaint, shall
be given to the registrant by personal service or certified mail, addressed to
the last known address.
(ix) Any
applicant or registrant against whom the agency contemplates an action
described in clause (viii) of this subparagraph may request a hearing by
submitting a written request to the director within 30 days after service of
the notice.
(I) The written request for a
hearing shall contain the following:
(-a-)
statement requesting a hearing;
(-b-) name, address, and identification
number of the registrant against whom the action is being taken.
(II) Failure to submit a written
request for a hearing within 30 days after notice is sent will render the
agency action final.
(D) Assessment of administrative penalties.
(i) When the agency determines that monetary
penalties are appropriate, proposals for assessment of and hearings on
administrative penalties shall be made in accordance with Health and Safety
Code, §
401.384;
Title 1, Texas Administrative Code, Chapter 155; and applicable sections of the
Formal Hearing Procedures, §§
1.21,
1.23,
1.25, and
1.27 of
this title.
(ii) Assessment of
administrative penalties shall be based on the following criteria:
(I) the seriousness of the
violations;
(II) previous
compliance history;
(III) the
amount necessary to deter future violations;
(IV) efforts to correct the violations;
and
(V) any other mitigating or
enhancing factors.
(iii)
Application of administrative penalties. The agency may impose differing levels
of penalties for different severity level violations and different classes of
users as follows.
(I) Administrative
penalties may be imposed for severity level I and II violations. Administrative
penalties may be imposed for severity level III, IV, and V violations when the
violations are combined with those of higher severity levels or for repeated
violations.
(II) The following
Tables A and B show the base administrative penalties.
(III)
Adjustments to the percentages of base amounts in Table B may be made for the
presence or absence of the following factors:
(-a-) prompt identification and
reporting;
(-b-) corrective action
to prevent recurrence;
(-c-)
compliance history;
(-d-) prior
notice of similar event;
(-e-)
multiple occurrences; and
(-f-)
negligence that resulted in or increased adverse effects.
(IV) The penalty for each violation may be in
an amount not to exceed $10,000 a day for a person who violates the Act or
requirements of this section, order, or certificate of registration issued in
accordance with the Act. Each day a violation continues may be considered a
separate violation for purposes of penalty assessment.
(iv) The agency may conduct settlement
negotiations.
(E)
Severity levels of violations for registrants or other persons.
(i) Violations for registrants or other
persons shall be categorized by one of the following severity levels.
(I) Severity level I are violations that are
most significant and may have a significant negative impact on occupational or
public health and safety or on the environment.
(II) Severity level II are violations that
are very significant and may have a negative impact on occupational or public
health and safety or on the environment.
(III) Severity level III are violations that
are significant and which, if not corrected, could threaten occupational or
public health and safety or the environment.
(IV) Severity level IV are violations that
are of more than minor significance, but if left uncorrected, could lead to
more serious circumstances.
(V)
Severity level V are violations that are of minor safety or environmental
significance.
(ii)
Criteria to elevate or reduce severity levels.
(I) Severity levels may be elevated to a
higher severity level for the following reasons:
(-a-) more than one violation resulted from
the same underlying cause;
(-b-) a
violation contributed to or was the consequence of the underlying cause, such
as a management breakdown or breakdown in the control of registered
activities;
(-c-) a violation
occurred multiple times between inspections;
(-d-) a violation was willful or grossly
negligent;
(-e-) compliance history;
or
(-f-) other mitigating
factors.
(II) Severity
levels may be reduced to a lower level for the following reasons:
(-a-) the registrant identified and corrected
the violation before the agency inspection;
(-b-) the registrant's actions corrected the
violation and prevented recurrence; or
(-c-) other mitigating factors.
(iii) Examples of
severity levels. Examples of severity levels are available upon request to the
agency.
(F) Impoundment
of radiation machines. Radiation machines shall be subject to impounding in
accordance with Health and Safety Code, §
401.068
and this paragraph.
(i) In the event of an
emergency, the agency shall have the authority to impound or order the
impounding of radiation machines possessed by any person not equipped to
observe or failing to observe the provisions of the Act, or any requirements of
this section, certificate of registration conditions, or orders issued by the
agency. The agency shall submit notice of the action to be published in the
Texas Register no later than 30 days following the end of the
month in which the action was taken.
(ii) At the agency's discretion, the
impounded radiation machines may be disposed of by:
(I) returning the radiation machine to a
properly registered owner, upon proof of ownership, who did not cause the
emergency;
(II) releasing the
radiation machine as evidence to police or courts;
(III) returning the radiation machine to a
registrant after the emergency is over and settlement of any compliance action;
or
(IV) selling, destroying or
other disposition within the agency's discretion.
(iii) If agency action is necessary to
protect the public health and safety, no prior notice need be given the owner
or possessor. If agency action is not necessary to protect the public health
and safety, the agency will give written notice to the owner or the possessor
of the impounded radiation machine of the intention to dispose of the radiation
machine. Notice shall be the same as provided in subparagraph (C)(viii) of this
paragraph. The owner or possessor shall have 30 days from the date of personal
service or mailing to request a hearing under Title 1, Texas Administrative
Code, Chapter 155, and the Formal Hearing Procedures, §§
1.21,
1.23,
1.25, and
1.27 of
this title, and in accordance with subparagraph (C)(ix) of this paragraph,
concerning the intention of the agency. If no hearing is requested within that
period, the agency may take the contemplated action, and such action is
final.
(iv) Upon agency disposition
of a radiation machine, the agency may notify the owner or possessor of any
expense the agency may have incurred during the impoundment or disposition and
request reimbursement. If the amount is not paid within 60 days from the date
of notice, the agency may request the Attorney General to file suit against the
owner or possessor for the amount requested.
(v) If the agency determines from the facts
available that an impounded radiation machine is abandoned, with no reasonable
evidence showing its owner or possessor, the agency may make such disposition
of the radiation machine as it sees fit.
(G) Emergency orders.
(i) When an emergency exists requiring
immediate action to protect the public health or safety or the environment, the
agency may, without notice or hearing, issue an order citing the existence of
such emergency and require that certain actions be taken as the agency directs
to meet the emergency. No later than 30 days following the end of the month in
which the action was taken, the agency shall submit notice of the action for
publication in the Texas Register. The action taken will
remain in full force and effect unless and until modified by subsequent action
of the agency.
(ii) An emergency
order takes effect immediately upon service.
(iii) Any person receiving an emergency order
shall comply immediately.
(iv) The
person receiving the order shall be afforded the opportunity for a hearing on
an emergency order. Notice of the action, along with a complaint, shall be
given to the person by personal service or certified mail, addressed to the
last known address. A hearing shall be held on an emergency order if the person
receiving the order submits a written request to the director within 30 days
after the date of the order.
(I) The hearing
shall be held not less than 10 days nor more than 20 days after receipt of the
written application for hearing.
(II) At the conclusion of the hearing and
after the proposal for decision is made as provided in the Texas Administrative
Procedure Act, Texas Government Code, Chapter 2001, the commissioner shall take
one of the following actions:
(-a-) determine
that no further action is warranted;
(-b-) amend the certificate of
registration;
(-c-) revoke or
suspend the certificate of registration;
(-d-) rescind the emergency order;
or
(-e-) issue such other order as
is appropriate.
(III) The
application and hearing shall not delay compliance with the emergency
order.
(H)
Miscellaneous provisions.
(i) Computation of
time. A time established by the requirements of this section shall begin on the
first day after the event that invokes the time. When the last day of the
period falls on a Saturday, Sunday, or state or federal holiday, the time shall
end on the next day that is not a Saturday, Sunday, or state or federal
holiday. The time shall expire at 5:00 p.m. of the last day of the computed
time.
(ii) Hearing location.
Hearings will be held at the offices of the State Office of Administrative
Hearings in Austin unless the administrative law judge specifies another
location.
(iii) Non-party witness
and mileage fees.
(I) A witness or deponent
who is not a party (or an employee, agent, or representative of a party) and
who is subpoenaed or otherwise compelled to attend an agency hearing or a
proceeding to give a deposition, or to produce books, records, papers,
accounts, documents, or other objects necessary and proper for the purposes of
the hearing or proceeding may receive reimbursement for transportation and
other costs at rates established by the current Appropriations Act for state
employees.
(II) The person
requesting the attendance of the witness or deponent shall deposit with the
agency the funds estimated to accrue in accordance with subclause (I) of this
clause when filing a motion for the issuance of a subpoena or a commission to
take a deposition.
(iv)
Service. A return of service by the person who performed personal service,
postal return receipt, or proof of mailing to the last known address shall be
conclusive evidence of service.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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