Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 289.
RADIATION CONTROL
The Texas Department of Health (department) proposes the repeal of §289.119
and new §289.229, concerning radiation safety requirements for accelerators,
therapeutic radiation machines, and simulators.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.119 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist; however revisions to the rule are necessary.
The section proposed for repeal adopts by reference Part 35, titled "Radiation
Safety Requirements for Particle Accelerators" of the
Texas Regulations for Control of Radiation
. The proposed new section
incorporates language from Part 35 that has been rewritten into
Texas Register
format and includes addition and revision of subsections
of the section. The repeal and new section are part of the renumbering phase
in the process of rewriting the department's radiation rules in the
Definitions that apply to therapeutic radiation machines and radiation
therapy simulation systems (simulators) are added. Language is added to the
section to incorporate radiation safety requirements for therapeutic radiation
machines and simulators that were previously included in other sections of
this chapter. References to other sections of this chapter are clarified to
reflect the
Texas Register
format. Grammatical
changes are made to the section for clarification. This section is also part
of the department's continuing effort to update, clarify, and simplify its
rules regarding the control of radiation based upon technological changes,
public concerns, legislative directives, or other factors.
The department published a Notice of Intention to Review for §289.119
as required by Government Code §2001.039 in the
Texas Register
(25 TexReg 219) on January 7, 2000. No comments were
received by the department on this section.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the sections will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the sections as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed sections will be in effect, the public benefit anticipated
as a result of enforcing the sections will be to ensure that registrants comply
with radiation safety requirements for accelerators, therapeutic radiation
machines, and therapy simulations systems (simulators) and that equipment
is properly used and maintained, ensuring the safety of workers and the public
is protected from unnecessary exposure to radiation. There will be no effect
on micro businesses or small businesses. There are no anticipated economic
costs to persons who are required to comply with the sections as proposed.
There is no anticipated impact on local employment. The new rule primarily
reformats, clarifies, and consolidates existing requirements. It imposes no
additional requirements such as record keeping, procedures, or processes.
Therefore, there are no economic effects associated with the section as proposed.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 1:30 p.m., Tuesday,
June 20, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
Subchapter C. TEXAS REGULATIONS FOR CONTROL OF RADIATION
25 TAC §289.119
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety
Code, Chapter 401, which provides the Texas Board of Health (board) with authority
to adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The repeal affects Health and Safety Code, Chapter 401; the Health and
Safety Code, Chapter 12; and Government Code §2001.039.
§289.119.Radiation Safety Requirements for Particle Accelerators.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State, on May 22, 2000.
TRD-200003515
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
25 TAC §289.229
The new section is proposed under the Health and Safety Code,
Chapter 401, which provides the Texas Board of Health (board) with authority
to adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The new section affects Health and Safety Code, Chapter 401; the Health
and Safety Code, Chapter 12; and Government Code §2001.039.
§289.229.Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, and Simulators.
(a)
Purpose. This section establishes radiation safety requirements
for the use of accelerators, therapeutic radiation machines, and radiation
therapy simulation systems (simulators). No person shall possess, use, transfer,
or acquire an accelerator, a therapeutic radiation machine, or a radiation
therapy simulation system (simulator) except as authorized in a certificate
of registration issued in accordance with §289.226 of this title (relating
to Registration of Radiation Machine Use and Services) or as otherwise provided
for in this chapter.
(b)
Scope.
(1)
This section applies to persons who receive, possess, use
or transfer accelerators used in industrial operations and research and development,
and therapeutic radiation machines and radiation therapy simulation systems
(simulators) used in the healing arts and veterinary medicine. Use of therapeutic
radiation machines in the healing arts or veterinary medicine under this section
shall be made by or under the supervision of a practitioner of the healing
arts or a veterinarian. The registrant shall be responsible for the administrative
control and for directing the use of the accelerators, other therapeutic radiation
machines, or simulators.
(2)
The requirements of this section are in addition to
and not in substitution for other applicable requirements of §289.203
of this title (relating to Notices, Instructions, and Reports to Workers;
Inspections), §289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material Licenses, Emergency Planning and Implementation,
and Other Regulatory Services), §289.205 of this title (relating to Hearing
and Enforcement Procedures), §289.226 of this title, and §289.231
of this title (relating to General Provisions and Standards for Protection
Against Machine-Produced Radiation).
(3)
Registrants engaged in industrial radiographic operations
are subject to the requirements of §289.255 of this title (relating to
Radiation Safety Requirements and Licensing and Registration Procedures for
Industrial Radiography).
(c)
Prohibitions.
(1)
The agency may prohibit use of accelerators, therapeutic
radiation machines, and simulators that pose significant threat or endanger
public health and safety, in accordance with §289.205 of this title and §289.231
of this title.
(2)
Individuals shall not be exposed to the useful beam
except for healing arts purposes and unless such exposure has been authorized
by a licensed practitioner of the healing arts. This provision specifically
prohibits deliberate exposure of an individual for training, demonstration,
or other non-healing arts purposes.
(3)
No research and/or development using radiation machines
on humans shall be conducted unless approved by an Institutional Review Board
(IRB) as required by Title 45, Code of Federal Regulations (CFR) Part 46 and
Title 21, CFR Part 56. The IRB must include at least one practitioner of the
healing arts to direct any use of radiation in accordance with §289.231(b)
of this title.
(d)
Exemptions.
(1)
Veterinary facilities are exempt from the aural communication
requirements for radiation therapy systems and radiation therapy simulators
in subsection (h)(2)(B)(i), (h)(3)(B)(v), or (h)(4)(A)(iv) of this section.
(2)
Individuals who are sole practitioners and sole operators
and the only occupationally exposed individual are exempt from the following
requirements:
(A)
§289.203(b) of this title; and
(B)
subsection (h)(1)(D) of this section.
(e)
Definitions. The following words and terms when used in
this section shall have the following meaning unless the context clearly indicates
otherwise.
(1)
Aluminum equivalent - The thickness of type 1100 aluminum
alloy affording the same attenuation, under specified conditions, as the material
in question. The nominal chemical composition of type 1100 aluminum alloy
is 99% minimum aluminum, 0.12% copper.
(2)
Attenuate - To reduce the exposure rate upon passage
of radiation through matter.
(3)
Automatic exposure control (AEC) - 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).
(4)
Automatic exposure rate control (AERC) - A device
that automatically controls one or more technique factors in order to obtain
a required quantity of radiation per unit time at preselected locations.
(5)
Barrier (See definition for protective barrier).
(6)
Beam axis - A line from the source through the centers
of the x-ray field.
(7)
Beam-flattening filter - A filter used to provide
dose uniformity over the area of a useful x-ray beam at a specified depth.
(8)
Beam-limiting device - A device that provides a means
to restrict the dimensions of the x-ray field.
(9)
Beam quality - 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.
(10)
Beam quality (accelerator) - A term that describes
the type and penetrating power of the ionizing radiation produced for certain
machine settings.
(11)
Beam monitoring system - A dosimetry system designed
to detect and measure the radiation present in the useful beam.
(12)
Beam scattering foil - A foil used to scatter a beam
of electrons.
(13)
Calibration of machines - The measurement and specification
of absorbed dose to a medium, or exposure in air, at a defined point in a
radiation beam.
(14)
Central axis of the beam - An imaginary line passing
through the center of the useful beam and the center of the plane figure formed
by the edge of the first beam-limiting device.
(15)
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:
Figure: 25 TAC §289.229(e)(15)
(16)
Collimator - A device or mechanism by which the x-ray
beam is restricted in size.
(17)
Computed tomography (CT) - The production of a tomogram
by the acquisition and computer processing of x-ray transmission data.
(18)
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.
(19)
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.
(20)
CT conditions of operation - All selectable parameters
governing the operation of a CT x-ray system including, but not limited to,
nominal tomographic section thickness, filtration, and the technique factors
as defined in this subsection.
(21)
CT gantry - The tube housing assemblies, beam-limiting
devices, detectors, and the supporting structures and frames that hold these
components.
(22)
Diagnostic x-ray system - An x-ray system designed
for irradiation of any part of the human body or any animal for the purpose
of diagnosis or visualization.
(23)
Diaphragm - A device or mechanism by which the x-ray
beam is restricted in size.
(24)
Dose monitoring system - A system of devices for
the detection, measurement, and display of quantities of radiation.
(25)
Dose monitor unit - A unit response from the dose
monitoring system from which the absorbed dose can be calculated.
(26)
Existing equipment - Therapy systems subject to subsections
(h)(2) and (h)(3) of this section that were manufactured on or before March
1, 1989.
(27)
Field size - The dimensions along the major axes
of an area in a plane perpendicular to the central axis of the beam at the
normal treatment or examination source to image distance and defined by the
intersection of the major axes and the 50% isodose line.
(28)
Filter - Material placed in the useful beam to preferentially
absorb selected radiations.
(29)
Focal spot - The area projected on the anode of the
x-ray tube that is bombarded by the electrons accelerated from the cathode
and from which the useful beam originates.
(30)
Gantry - That part of the system supporting and allowing
possible movement of the radiation source.
(31)
Half-value layer (HVL) - The thickness of a specified
material that attenuates the beam of radiation to an extent such that the
exposure rate is reduced to one-half of its original value.
(32)
Healing arts - Any 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.
(33)
Image intensifier - A device, installed in its housing,
that instantaneously converts an x-ray pattern into a corresponding light
image of higher energy density.
(34)
Image receptor - Any device, such as a fluorescent
screen or radiographic film, that transforms incident x-ray photons either
into a visible image or into another form that can be made into a visible
image by further transformations.
(35)
Inherent filtration - The filtration of the useful
beam provided by the permanently installed components of the x-ray tube housing
assembly.
(36)
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.
(37)
Interlock - A device preventing the start or continued
operation of equipment unless certain predetermined conditions prevail.
(38)
Interruption of irradiation - The stopping of irradiation
with the possibility of continuing irradiation without resetting of operating
conditions at the control panel.
(39)
Isocenter - A fixed point in space located at the
center of the smallest sphere through which the central axis of the beam passes
in all conditions.
(40)
Kilovolt - kV (See definition for peak tube potential).
(41)
Kilovolt peak - kVp (See definition for peak tube
potential).
(42)
Lead equivalent - The thickness of lead affording
the same attenuation, under specified conditions, as the material in question.
(43)
Leakage radiation - Radiation emanating from the
source(s) assembly except for the useful beam and radiation produced when
the exposure switch or timer is not activated.
(44)
Leakage technique factors - The technique factors
associated with the source assembly that is used in measuring leakage radiation.
(45)
Licensed medical physicist - An individual holding
a current Texas license under the Medical Physics Practice Act, Texas Civil
Statutes, Article 4512n.
(46)
Medical research - The investigation of various health
risks and diseases using radiation machines as part of the evaluation process.
(47)
Moving beam radiation therapy - Radiation therapy
with any planned displacement of radiation field or with any planned change
of absorbed dose distribution.
(48)
New equipment - Systems subject to subsections (h)(2)
and (h)(3) of this section that were manufactured after March 1, 1989.
(49)
Nominal treatment distance - The following treatment
distances shall apply.
(A)
For electron irradiation, the distance from the scattering
foil or exit window of the electron beam to the surface along the central
axis of the useful beam, as specified by the manufacturer.
(B)
For x-ray irradiation, the distance from the target along
the central axis of the useful beam to the isocenter. For non-isocentric equipment,
this distance shall be that specified by the manufacturer.
(50)
Peak tube potential - The maximum value of the
potential difference (in kilovolts) across the x-ray tube during an exposure.
(51)
Phototimer - A method for controlling radiation exposures
to image receptors by the amount of radiation that reaches a radiation monitoring
device. The radiation monitoring device is part of an electronic circuit that
controls the duration of time the tube is activated (See definition for automatic
exposure control).
(52)
Port film - An x-ray exposure made with a therapy
system to visualize a patient's treatment area using radiographic film.
(53)
Practitioner of the healing arts (practitioner) -
A person licensed to practice healing arts by either the Texas State Board
of Medical Examiners as a physician, the Texas State Board of Dental Examiners,
the Texas Board of Chiropractic Examiners, or the Texas State Board of Podiatry
Examiners.
(54)
Primary dose monitoring system - A system that will
monitor the useful beam during irradiation and that will terminate irradiation
when a preselected number of dose monitor units have been acquired.
(55)
Primary protective barrier - (See definition for
protective barrier).
(56)
Protective apron - An apron made of radiation absorbing
materials used to reduce radiation exposure.
(57)
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.
(B)
secondary protective barrier - A barrier sufficient to
attenuate the stray radiation to the required degree.
(58)
Protective glove - A glove made of radiation
absorbing materials used to reduce radiation exposure.
(59)
Radiation oncologist - A practitioner with a specialty
in radiation therapy.
(60)
Radiation therapy simulation system (simulator) -
An x-ray system intended for localizing and confirming the volume to be irradiated
during radiation treatment and confirming the position and size of the therapeutic
irradiation field.
(61)
Scan - The complete process of collecting x-ray transmission
data for the production of a tomogram. Data can be collected simultaneously
during a single scan for the production of one or more tomograms.
(62)
Scan increment - The amount of relative displacement
of the patient with respect to the CT x-ray system between successive scans
measured along the direction of such displacement.
(63)
Scan sequence - A preselected set of two or more
scans performed consecutively under preselected CT conditions of operation.
(64)
Scan time - The period of time between the beginning
and end of x-ray transmission data accumulation for a single scan.
(65)
Scattered radiation - Radiation that has been deviated
in direction during passage through matter.
(66)
Secondary dose monitoring system - A system that
will terminate irradiation in the event of failure of the primary system.
(67)
Secondary protective barrier (See definition for
protective barrier).
(68)
Shutter - A device attached to the tube housing assembly
that can totally intercept the useful beam and that has a lead equivalency
not less than that of the tube housing assembly.
(69)
Source-to-image receptor distance (SID) - The distance
from the source to the center of the input surface of the image receptor.
(70)
Source-to-skin distance (SSD) - The distance from
the source to the skin of the patient.
(71)
Spot check - Those tests and analyses performed at
specified intervals for the purpose of verifying the consistent operation
of radiation equipment.
(72)
Stationary beam therapy - Radiation therapy without
relative displacement of the useful beam.
(73)
Supervision - The delegating of the task of applying
radiation in accordance with this section to persons not licensed in the healing
arts or veterinary medicine, who provide services under the practitioner's
control. The licensed practitioner or veterinarian assumes full responsibility
for these tasks and must assure that the tasks will be administered correctly.
(74)
Termination of irradiation - The stopping of irradiation
in a fashion that will not permit continuance of irradiation without the resetting
of operating conditions at the control panel.
(75)
Therapy system - An x-ray system that utilizes prescribed
doses of ionizing radiation for treatment.
(76)
Traceable to a national standard - This indicates
that a quantity or a measurement has been compared to a national standard,
for example, National Institute of Standards and Technology, directly or indirectly
through one or more intermediate steps and that all comparisons have been
documented.
(77)
Useful beam - Radiation that passes through the window,
aperture, cone, or other collimating device of the source housing. Also referred
to as the primary beam.
(78)
Veterinarian - An individual licensed by the Texas
Board of Veterinary Medical Examiners.
(79)
Wedge filter - An added filter effecting continuous
progressive attenuation on all or part of the useful beam.
(f)
Accelerators used for research and development and industrial
operations.
(1)
Registration. Each person possessing an accelerator shall
apply for and receive a certificate of registration in accordance with §289.226(j)
of this title before activation of the accelerator, including acceptance testing.
(2)
Facility requirements.
(A)
Each accelerator facility shall be provided with primary
and/or secondary barriers as are necessary to assure compliance with §289.231(m)
and (o) of this title.
(B)
A radiation survey shall be conducted when the accelerator
is registered and is capable of producing radiation to determine compliance
with §289.231(m) and (o) of this title.
(C)
Initial surveys shall be performed as follows.
(i)
All new and existing facilities not previously surveyed
shall have a survey made by a physicist, who shall provide a written report
of the survey to the registrant.
(ii)
The survey report shall include, but not be limited to,
the following:
(I)
a diagram of the facility that details building structures
and the position of the accelerator, control panel, and associated equipment;
(II)
a description of the accelerator including the manufacturer,
model and serial number, beam type, and beam energy;
(III)
a description of the instrumentation used to determine
radiation measurements, including the date and source of the most recent calibration
for each instrument used;
(IV)
conditions under which radiation measurements were taken;
and
(V)
survey data including:
(-a-)
projected annual total effective dose equivalent (TEDE)
in areas adjacent to the accelerator; and
(-b-)
a description of workload, use, and occupancy factors
employed in determining the projected annual TEDE.
(iii)
The registrant shall maintain a copy of the survey report
for inspection by the agency in accordance with subsection (k) of this section.
(iv)
The survey report shall include documentation of all instances
where the facility is in violation of applicable requirements of this chapter.
Any deficiencies detected during the survey shall be corrected prior to using
the accelerator.
(3)
Safety requirements.
(A)
Interlock systems shall comply with the following requirements.
(i)
Instrumentation, readouts, and controls in the accelerator
console shall be clearly identified.
(ii)
Each entrance into a target room or other high radiation
area shall be provided with a safety interlock that shuts down the machine
under conditions of barrier penetration.
(iii)
When the production of radiation has been interrupted,
it shall only be possible to resume operation of the accelerator by manually
resetting the console.
(iv)
Each safety interlock shall be on an electrical circuit
that allows the interlock to operate independently of all other safety interlocks.
(v)
All safety interlocks shall be designed so that any defect
or component failure in the interlock system prevents operation of the accelerator.
(vi)
A scram button or other emergency power cut-off switches
shall be labeled. The scram button or cut-off switches shall include a manual
reset so that the accelerator cannot be restarted from the accelerator console
without resetting the cut-off switch.
(vii)
The safety interlock system shall have a visible or audible
alarm that will indicate when any interlock has been activated.
(viii)
All interlocks and visible or audible alarms shall be
tested for proper operation at intervals not to exceed three months.
(ix)
If an interlock or alarm is operating improperly, it shall
be immediately labeled as defective and repaired within seven calendar days.
(x)
Records of tests and repairs required by this paragraph
shall be made and maintained in accordance with subsection (k) of this section
for inspection by the agency.
(B)
Each registrant shall develop and implement written operating
and safety procedures. The procedures shall include, but may not be limited
to, the following:
(i)
methods used to secure the accelerator from unauthorized
use;
(ii)
methods of testing and training operators in accordance
with subsection (f)(4) of this section;
(iii)
procedures for notifying the proper personnel in the
event of an accident;
(iv)
posting requirements;
(v)
procedures for testing interlocks, entrance controls, and
alarm systems;
(vi)
personnel monitoring;
(vii)
maintenance of records; and
(viii)
procedures for necessary area surveys and time intervals.
(C)
There shall be available at each accelerator facility,
appropriate portable monitoring equipment that is operable and has been calibrated
for the appropriate radiations being produced at the facility. The equipment
shall be calibrated in accordance with §289.231(s)(2) of this title.
(D)
A radiation protection survey shall be performed and the
results recorded when changes have been made in shielding, operation, equipment,
or occupancy of adjacent areas.
(E)
For portable or mobile accelerators, such as neutron generators
that are used at temporary job sites where permanent shielding is not available,
radiation protection shall be provided by temporary shielding or by providing
an adequate exclusion area around the accelerator while it is in use.
(F)
Records of calibration and survey results made in accordance
with subparagraphs (C) and (D) of this paragraph shall be maintained in accordance
with subsection (k) of this section.
(4)
Training requirements for operators.
(A)
No person shall be permitted to operate an accelerator
unless such person has received instruction in and demonstrated competence
with the following:
(i)
operating and safety procedures in accordance with paragraph
(3)(B);
(ii)
radiation warning and safety devices incorporated into
the equipment and in the room;
(iii)
identification of radiation hazards associated with the
use of the equipment; and
(iv)
procedures for reporting an actual or suspected exposure.
(B)
Records of the training specified in subparagraph (A) of
this paragraph shall be made and maintained for agency inspection in accordance
with subsection (k) of this section.
(5)
Records/documents.
(A)
The registrant shall maintain copies of the following records/documents
at authorized use locations in accordance with subsection (k) of this section:
(i)
current applicable sections of this chapter as listed on
the certificate of registration;
(ii)
current certificate of registration;
(iii)
surveys of radiation levels in unrestricted areas in
accordance with paragraph (2)(B) of this subsection;
(iv)
personnel monitoring records of occupationally exposed
individuals in accordance with §289.231(f) and (r) of this title, as
applicable;
(v)
current operating and safety procedures in accordance with
paragraph (3)(B) of this subsection or §289.255 of this title, as applicable;
(vi)
operator training in accordance with paragraph (4)(B)
of this subsection;
(vii)
notice of violation from last inspection, if applicable,
and documentation of corrections of violations;
(viii)
receipt, transfer, and disposal of accelerators including
the date, the manufacturer name, any model and serial number from the control
panel or console of the radiation machine, and identification of the person
making the record;
(ix)
latest calibrations for each survey instrument in use
at the authorized use location in accordance with paragraph (3)(F) of this
subsection;
(x)
interlock and alarm tests in accordance with paragraph
(3)(A)(x) of this subsection; and
(xi)
latest radiation survey records in accordance with paragraphs
(2)(C)(iii) or (3)(F) of this subsection.
(B)
Records specified in subparagraph (A) of this paragraph
may be maintained in electronic format.
(g)
Requirements for accelerator(s) used in industrial radiography.
In addition to the requirements in subsections (f)(1), (2), (3)(C)-(F), and
(5) of this section, accelerators used for industrial radiography shall meet
the applicable requirements of §289.255 of this title.
(h)
Therapeutic radiation machines and simulators used in the
healing arts and veterinary medicine.
(1)
General requirements.
(A)
Each person possessing a therapeutic radiation machine
capable of operating at or above 1 million electron volts (MeV) shall apply
for and receive a certificate of registration from the agency before activation
of the radiation machine, including acceptance testing.
(B)
Each person possessing a simulator and/or a therapeutic
radiation machine capable of operating below 1 MeV shall apply for a certificate
of registration within 30 days after energizing the equipment.
(C)
Individuals who operate radiation machines for human use
shall meet the appropriate credentialing requirements issued in accordance
with the Medical Radiologic Technologist Act, Texas Civil Statutes, Article
4512m. Copies of the credentialing document shall be maintained at the locations(s)
where the individual is working.
(D)
Each registrant shall develop and implement written operating
and safety procedures. These procedures shall be made available to each individual
operating radiation machines and simulators, including any restrictions of
the operating technique required for the safe operation of the particular
therapeutic radiation system. These procedures shall include, but are not
limited to the following:
(i)
use of a technique chart in accordance with paragraph (4)(A)(i)
of this subsection;
(ii)
radiation dose requirements in accordance with §289.231(m)
and (o) of this title;
(iii)
personnel monitoring requirements in accordance with §289.231(n)
of this title;
(iv)
use of protective devices in accordance with paragraph
(4)(A)(iii) of this subsection;
(v)
credentialing requirements for individuals operating radiation
machines in accordance with subparagraph (C) of this paragraph;
(vi)
exposure of individuals other than the patient in accordance
with paragraphs (2)(D)(iv)(IV), and (3)(C)(v)(I) of this subsection;
(vii)
film processing program in accordance with paragraph
(4)(A)(vi) and (vii) of this subsection;
(viii)
procedures for restriction and alignment of beam in
accordance with paragraph (4)(B)(iii) of this subsection;
(ix)
posting notices to workers in accordance with §289.203(b)
of this title;
(x)
instructions to workers in accordance with §289.203(c)
of this title;
(xi)
notifications and reports to individuals in accordance
with §289.203(d) of this title; and
(xii)
posting of a radiation area in accordance with §289.231(x)
and (y) of this title.
(E)
Registrants with equipment that has been issued variances
by the United States Food and Drug Administration (FDA) to Title 21, CFR Part
1020 shall maintain copies of those variances at authorized use locations
in accordance with subsection (k) of this section.
(2)
Therapeutic radiation machines capable of operating
at energies below 1 MeV.
(A)
Equipment requirements.
(i)
When the tube is operated at its leakage technique factors,
the leakage radiation shall not exceed the values specified at the distance
stated for the classification of that radiation machine system shown in the
following Table I. The leakage technique factors are the maximum-rated peak
tube potential and the maximum-rated continuous tube current for the maximum-rated
peak tube potential.
Figure: 25 TAC §289.229(h)(2)(A)(i)
(ii)
Permanent fixed diaphragms or cones used for limiting
the useful beam shall provide the same or a higher degree of protection as
required for the tube housing assembly.
(iii)
Removable and adjustable beam-limiting devices shall
meet the following requirements.
(I)
Removable beam-limiting devices shall, for the portion
of the useful beam to be blocked by these devices, transmit not more than
1.0% of the useful beam at the maximum kVp and maximum treatment filter. This
requirement does not apply to auxiliary blocks or materials placed in the
x-ray field to shape the useful beam to the individual patient.
(II)
Adjustable beam-limiting devices installed before March
1, 1989, shall, for the portion of the x-ray beam to be blocked by these devices,
transmit not more than 5.0% of the useful beam at the maximum kVp and maximum
treatment filter.
(III)
Adjustable beam-limiting devices installed after March
1, 1989, shall meet the requirements of subclause (I) of this clause.
(iv)
The filter system shall be so designed that:
(I)
the filters cannot be accidentally displaced at any possible
tube orientation;
(II)
for equipment installed after March 1, 1989, an interlock
system prevents irradiation if the proper filter is not in place;
(III)
the radiation at 5 centimeters (cm) from the filter insertion
slot opening does not exceed 30 roentgens per hour (R/hr) under any operating
conditions; and
(IV)
each filter is marked as to its material of construction
and its thickness. For wedge filters, the wedge angle shall appear on the
wedge or wedge tray.
(v)
The tube housing assembly shall be capable of being immobilized
for stationary treatments.
(vi)
The tube housing assembly shall be so marked that it is
possible to determine the location of the focal spot to within 5 millimeters
(mm), and such marking shall be readily accessible for use during calibration
procedures.
(vii)
Contact therapy tube housing assemblies shall have a
removable shield of at least 0.5 mm lead equivalency at 100 kVp that can be
positioned over the entire useful beam exit port during periods when the beam
is not in use.
(viii)
The timer shall:
(I)
have a display provided at the treatment control panel
and a pre-set time selector;
(II)
activate with the production of radiation and retain its
reading after irradiation is interrupted. After irradiation is terminated
and before irradiation can be reinitiated, it shall be necessary to reset
the elapsed time indicator to zero;
(III)
terminate irradiation when a pre-selected time has elapsed,
if any dose monitoring system present has not previously terminated irradiation;
(IV)
permit selection of exposure times as short as one second;
(V)
not permit an exposure if set at zero;
(VI)
not activate until the shutter is opened when irradiation
is controlled by a shutter mechanism unless calibration includes a timer factor
to compensate for mechanical lag; and
(VII)
be accurate to within 1.0% of the selected value or one
second, whichever is greater.
(ix)
The control panel, in addition to the displays required
in clause (viii)(I) of this subparagraph, shall have the following:
(I)
an indication of whether electrical power is available
at the control panel and if activation of the x-ray tube is possible;
(II)
an indication of whether x rays are being produced;
(III)
means for indicating x-ray tube potential and current;
(IV)
means for terminating an exposure at any time;
(V)
a locking device that will prevent unauthorized use of
the therapeutic radiation system (a computerized pass-word system would also
constitute a locking device);
(VI)
for therapeutic radiation systems manufactured after March
1, 1989, a positive display of specific filters in the beam; and
(VII)
emergency buttons/switches that shall be clearly labeled
as to their functions.
(x)
There shall be means of determining initially the SSD to
within 1 cm and of reproducing this measurement to within 2 mm thereafter.
(xi)
Unless it is possible to bring the radiation output to
the prescribed exposure parameters within five seconds, the beam shall be
attenuated by a shutter having a lead equivalency not less than that of the
tube housing assembly. After the unit is at operating parameters, the shutter
shall be controlled electrically by the operator from the control panel. An
indication of shutter position shall appear at the control panel.
(xii)
Each therapeutic radiation system equipped with a beryllium
or other low-filtration window shall be clearly labeled as such upon the tube
housing assembly and at the control panel.
(B)
Facility requirements for therapeutic radiation systems
capable of operating above 50 kVp.
(i)
Provision shall be made for two-way aural communication
between the patient and the operator at the control panel.
(ii)
Windows, mirrors, closed-circuit television, or an equivalent
system shall be provided to permit continuous observation of the patient during
irradiation and shall be so located that the operator can observe the patient
from the control panel.
(I)
When the primary viewing system is by electronic means,
an alternate viewing system, which may be electronic, shall be available for
use in the event of failure of the primary viewing system.
(II)
Should both systems described in subclause (I) of this
clause fail or be inoperative, treatment shall not be performed with the unit
until one of the systems is restored.
(C)
Additional facility requirements for therapeutic radiation
systems capable of operation above 150 kVp.
(i)
Each installation shall be provided with primary and/or
secondary barriers as are necessary to assure compliance with §289.231(m)
and (o) of this title. All protective barriers shall be fixed except for entrance
doors or beam interceptors.
(ii)
The control panel shall be located outside the treatment
room or in an enclosed booth inside the room.
(iii)
Interlocks shall be provided such that all entrance doors
must be closed, including doors to any interior booths, before treatment can
be initiated or continued. If the radiation beam is interrupted by any door
opening, it shall not be possible to restore the machine to operation without
closing the door and reinitiating irradiation by manual action at the control
panel. When any door is opened while the x-ray tube is activated, the exposure
at a distance of 1 meter (m) from the source shall be reduced to less than
100 mR/hr.
(D)
Surveys, calibrations, spot checks, and additional operating
procedures.
(i)
Surveys shall be performed as follows.
(I)
All new and existing facilities not previously surveyed
shall have a survey made by a licensed medical physicist with a specialty
in therapeutic radiological physics or medical health physics, who shall provide
a written report of the survey to the registrant. Additional surveys shall
be done after any change in the facility, facility design, or equipment that
might cause a significant increase in radiation hazard.
(II)
The registrant shall maintain a copy of the initial survey
report and all subsequent survey reports required by subclause (I) of this
clause in accordance with subsection (k) of this section for inspection by
the agency.
(III)
The survey report shall indicate all instances where
the installation is in violation of applicable requirements of this chapter.
(ii)
Calibrations shall be performed as follows.
(I)
The calibration of a therapeutic radiation system shall
be performed at intervals not to exceed one year and after any change or replacement
of components that could cause a change in the radiation output. The calibrations
shall be such that the dose at a reference point in a water or plastic phantom
can be calculated to within an uncertainty of 5.0%.
(II)
The calibration of the radiation output of the therapeutic
radiation system shall be performed by a licensed medical physicist with a
specialty in therapeutic radiological physics who is physically present at
the facility during such calibration.
(III)
The calibration of the therapeutic radiation system shall
include, but not be limited to, the following determinations:
(-a-)
verification that the therapy system is operating in
compliance with the design specifications;
(-b-)
HVL for each kV setting and filter combination used;
(-c-)
the exposure rates as a function of field size,
technique factors, filter, and treatment distance used; and
(-d-)
the degree of congruence between the radiation field
and the field indicated by the localizing device, if such device is present,
shall be within 5 mm for any field edge.
(IV)
Calibration of the radiation output of a therapeutic radiation
system shall be performed with a calibrated dosimetry system. The dosimetry
system shall be calibrated within the previous 24 months and shall be traceable
to a national standard. During the calendar year in which the dosimetry system
is not calibrated, an intercomparison to a system calibrated within the previous
12 months shall be performed.
(V)
Records of calibration measurements specified in clause
(ii) of this subparagraph shall be made and maintained by the registrant in
accordance with subsection (k) of this section for inspection by the agency.
(VI)
A copy of the latest calibrated absorbed dose rate measured
on a particular therapeutic radiation system shall be available at a designated
area within the therapy facility housing that therapeutic radiation system.
(iii)
Spot checks shall be performed on therapeutic radiation
systems capable of operation at greater than 150 kVp. Such measurements shall
meet the following requirements.
(I)
The spot check procedures shall be in writing and shall
have been developed by a licensed medical physicist with a specialty in therapeutic
radiological physics.
(II)
If a licensed medical physicist does not perform the spot
check measurements, the results of the spot check measurements shall be reviewed
by a licensed medical physicist with a specialty in therapeutic radiological
physics within five treatment days and a record made of the review. If the
output varies by more than 5.0% from the expected value, a licensed medical
physicist shall be notified immediately.
(III)
The written spot check procedures shall specify the frequency
that tests or measurements are to be performed and that the spot check shall
be performed during the calibration specified in clause (ii) of this subparagraph.
The acceptable tolerance for each parameter measured when compared to the
value for that parameter determined in the calibration specified in clause
(ii) of this subparagraph shall be stated.
(IV)
The written spot check procedures shall include special
operating instructions that shall be carried out whenever a parameter in subclause
(III) of this clause exceeds an acceptable tolerance.
(V)
Whenever a spot check indicates a significant change in
the operating characteristics of a system, as specified in the procedures,
the system shall be recalibrated, as required in clause (ii) of this subparagraph.
(VI)
Records of written spot checks and any necessary corrective
actions shall be maintained by the registrant in accordance with subsection
(k) of this section for inspection by the agency. A copy of the most recent
spot check shall be available at a designated area within the therapy facility
housing of that therapeutic radiation system.
(VII)
When a spot check involves a radiation measurement, such
measurement shall be obtained using a system satisfying the requirements of
clause (ii)(IV) of this subparagraph or that has been intercompared with a
system meeting those requirements within the previous year.
(iv)
In addition to the items listed in paragraph (1)(D) of
this subsection, operating and safety procedures shall also include procedures
to ensure the following requirements are met.
(I)
Therapeutic radiation systems shall not be left unattended
unless the system is secured against unauthorized use.
(II)
Restraining or mechanical supporting devices shall be
used when a patient or port film must be immobilized in position for radiation
therapy.
(III)
The tube housing assembly shall not be held by hand during
operation unless the system is designed to require such holding and the peak
tube potential of the system does not exceed 50 kVp. In such cases, the holder
shall wear protective gloves and apron of not less than 0.5 mm lead equivalency
at 100 kVp.
(IV)
For therapeutic radiation systems operating at or below
150 kVp, no individual other than the patient shall be in the treatment room
unless such individual is protected by a barrier sufficient to meet the requirements
of §289.231(o) of this title. No individual other than the patient shall
be in the treatment room during exposures from therapeutic radiation systems
operating above 150 kVp.
(V)
The therapeutic radiation system shall not be used in the
administration of radiation therapy unless the requirements of clauses (ii)
and (iii)(V) of this subparagraph have been met.
(3)
Therapeutic radiation machines capable
of operating at energies of 1 MeV and above.
(A)
Equipment requirements.
(i)
For operating conditions producing maximum leakage radiation,
the absorbed dose in rads due to leakage radiation, including x rays, electrons,
and neutrons, at any point in a circular plane of 2 m radius centered on and
perpendicular to the central axis of the beam at the isocenter or normal treatment
distance and outside the maximum useful beam size shall not exceed 0.1% of
the maximum absorbed dose in rads of the unattenuated useful beam measured
at the point of intersection of the central axis of the beam and the plane
surface. Measurements excluding those for neutrons shall be averaged over
an area up to, but not exceeding, 100 square centimeters (cm
2
) at the positions specified. Measurements of the portion of the leakage
radiation dose contributed by neutrons shall be averaged over an area up to,
but not exceeding, 200 cm
2
. For each system,
the registrant shall determine or obtain from the manufacturer the leakage
radiation existing at the positions specified for the specified operating
conditions. Records on leakage radiation measurements shall be made and maintained
in accordance with subsection (k) of this section for inspection by the agency.
(ii)
Each wedge filter that is removable from the system shall
be clearly marked with an identification number. Documentation available at
the control panel shall contain a description of the filter. The wedge angle
shall appear on the wedge or wedge tray (if permanently mounted to the tray).
If the wedge tray is damaged, the wedge transmission factor shall be redetermined.
New equipment shall meet the following requirements.
(I)
Irradiation shall not be possible until a selection of
a filter or a positive selection to use "no filter" has been made at the treatment
control panel, either manually or automatically.
(II)
An interlock system shall be provided to prevent irradiation
if the filter selected is not in the correct position.
(III)
A display shall be provided at the treatment control
panel showing the beam quality in use.
(IV)
An interlock shall be provided to prevent irradiation
if any filter selection operation carried out in the treatment room does not
agree with the filter selection operation carried out at the treatment control
panel.
(iii)
The registrant shall determine data sufficient to assure
that the following beam quality requirements in tissue equivalent material
are met.
(I)
The absorbed dose resulting from x rays in a useful electron
beam at a point on the central axis of the beam 10 cm greater than the practical
range of the electrons shall not exceed the values stated in the following
Table II. Linear interpolation shall be used for values not stated.
Figure: 25 TAC §289.229(h)(3)(A)(iii)(I)
(II)
Compliance with subclause (I) of this clause shall be
determined using:
(-a-)
a measurement within a tissue equivalent phantom with
the incident surface of the phantom at the normal treatment distance and normal
to the central axis of the beam;
(-b-)
a field size of 10 cm by 10 cm; and
(-c-)
a phantom whose cross-sectional dimensions exceed
the measurement radiation field by at least 5 cm and whose depth is sufficient
to perform the required measurement.
(III)
The absorbed dose at a surface located at the normal
treatment distance, at the point of intersection of that surface with the
central axis of the useful beam during x-ray irradiation, shall not exceed
the limits stated in the following Table III. Linear interpolation shall be
used for values not stated.
Figure: 25 TAC §289.229(h)(3)(A)(iii)(III)
(IV)
Compliance with subclause (III) of this clause shall be
determined by measurements made as follows:
(-a-)
within a tissue equivalent phantom using an instrument
that will allow extrapolation to the surface absorbed dose;
(-b-)
using a phantom whose size and placement meet the
requirements of subclause (II) of this clause;
(-c-)
after removal of all beam modifying devices that
can be removed without the use of tools, except for beam scattering or beam-flattening
filters; and
(-d-)
using the largest field size available that does
not exceed 15 cm by 15 cm.
(iv)
All therapeutic radiation systems shall be provided with
radiation detectors in the radiation head. These shall include the following,
as appropriate.
(I)
New equipment shall be provided with at least two independent
radiation detectors. The detectors shall be incorporated into two independent
dose monitoring systems.
(II)
Existing equipment shall be provided with at least one
radiation detector. This detector shall be incorporated into a primary dose
monitoring system.
(III)
The detector and the system into which that detector
is incorporated shall meet the following requirements.
(-a-)
Each detector shall be removable only with tools and
shall be interlocked to prevent incorrect positioning.
(-b-)
Each detector shall form part of a dose monitoring
system from whose readings in dose monitor units the absorbed dose at a reference
point in the treatment volume can be calculated.
(-c-)
Each dose monitoring system shall be capable of
independently monitoring, interrupting, and terminating irradiation.
(-d-)
For new equipment, the design of the dose monitoring
systems shall assure that the malfunctioning of one system shall not affect
the correct functioning of the secondary system; and failure of any element
common to both systems that could affect the correct function of both systems
shall terminate irradiation.
(-e-)
Each dose monitoring system shall have a legible
display at the treatment control panel. For new equipment, each display shall:
(-1-)
maintain a reading until intentionally reset to zero;
(-2-)
have only one scale and no scale multiplying factors;
(-3-)
utilize a design such that increasing dose is displayed
by increasing numbers and shall be so designed that, in the event of an overdosage
of radiation, the absorbed dose may be accurately determined; and
(-4-)
retain the dose monitoring information in at least one
system for a 20-minute period of time in the event of a power failure.
(v)
In new equipment inherently capable of producing useful
beams with unintentional asymmetry exceeding 5.0%, the asymmetry of the radiation
beam in two orthogonal directions shall be monitored before the beam passes
through the beam-limiting device. If the difference in dose rate between one
region and another region symmetrically displaced from the central axis of
the beam exceeds 5.0% of the central axis dose rate, indication of this condition
shall be at the control panel; and if this difference exceeds 10% of the central
axis dose rate, the irradiation shall be terminated.
(vi)
Selection and display of dose monitor units shall meet
the following requirements.
(I)
Irradiation shall not be possible until a selection of
a number of dose monitor units has been made at the treatment control panel.
(II)
The preselected number of dose monitor units shall be
displayed at the treatment control panel until reset manually for the next
irradiation.
(III)
After termination of irradiation, it shall be necessary
to reset the dosimeter display to zero before subsequent treatment can be
initiated.
(IV)
For new equipment, after termination of irradiation, it
shall be necessary to manually reset the preselected dose monitor units before
irradiation can be initiated.
(vii)
Termination of irradiation by the dose monitoring system
or systems during stationary beam therapy shall meet the following requirements.
(I)
Each primary system shall terminate irradiation when the
preselected number of dose monitor units has been detected by the system.
(II)
If original design of the equipment includes a secondary
dose monitoring system, that system shall be capable of terminating irradiation
when not more than 15% or 40 dose monitor units, whichever is smaller, above
the preselected number of dose monitor units set at the control panel has
been detected by the secondary dose monitoring system.
(III)
For new equipment, a secondary dose monitoring system
shall be present. That system shall be capable of terminating irradiation
when not more than 10% or 25 dose monitoring units, whichever is smaller,
above the preselected number of dose monitor units set at the control panel
has been detected by the secondary dose monitoring system.
(IV)
For new equipment, an indicator on the control panel shall
show which dose monitoring system has terminated irradiation.
(viii)
A locking device shall be provided in the system to
prevent unauthorized use of the x-ray system. A computerized password system
would also constitute a locking device.
(ix)
It shall be possible to interrupt irradiation and equipment
movements at any time from the operator's position at the treatment control
panel. Following an interruption, it shall be possible to restart irradiation
by operator action without any reselection of operating conditions. If any
change is made of a preselected value during an interruption, irradiation
and equipment movements shall be automatically terminated.
(x)
It shall be possible to terminate irradiation and equipment
movements or go from an interruption condition to termination conditions at
any time from the operator's position at the treatment control panel.
(xi)
Timers shall meet the following requirements.
(I)
A timer that has a display shall be provided at the treatment
control panel. The timer shall have a preset time selector and an elapsed
time indicator.
(II)
The timer shall be a cumulative timer that activates with
the production of radiation and retains its reading after irradiation is interrupted
or terminated. After irradiation is terminated and before irradiation can
be reinitiated, it shall be necessary to reset the elapsed time indicator
to zero.
(III)
For new equipment, after termination of irradiation and
before irradiation can be reinitiated, it shall be necessary to manually reset
the preset time selector.
(IV)
The timer shall terminate irradiation when a preselected
time has elapsed if the dose monitoring systems have not previously terminated
irradiation.
(xii)
Equipment capable of producing more than one radiation
type shall meet the following additional requirements.
(I)
Irradiation shall not be possible until a selection of
radiation type has been made at the treatment control panel.
(II)
An interlock system shall be provided to:
(-a-)
ensure that the equipment can emit only the radiation
type that has been selected;
(-b-)
prevent irradiation if any selected operations carried
out in the treatment room do not agree with the selected operations carried
out at the treatment control panel;
(-c-)
prevent irradiation with x-rays except to obtain
a port film when electron applicators are fitted; and
(-d-)
prevent irradiation with electrons when accessories
specific for x-ray therapy are fitted.
(III)
The radiation type selected shall be displayed at the
treatment control panel before and during irradiation.
(xiii)
Equipment capable of generating radiation beams of different
energies shall meet the following requirements.
(I)
Irradiation shall not be possible until a selection of
energy has been made at the treatment control panel.
(II)
An interlock system shall be provided to prevent irradiation
if any selected operations carried out in the treatment room do not agree
with the selected operations carried out at the treatment control panel.
(III)
The nominal energy value selected shall be displayed
at the treatment control panel before and during irradiation.
(xiv)
Equipment capable of both stationary beam therapy and
moving beam therapy shall meet the following requirements.
(I)
Irradiation shall not be possible until a selection of
stationary beam therapy or moving beam therapy has been made at the treatment
control panel.
(II)
An interlock system shall be provided to prevent irradiation
if any selected operations carried out in the treatment room do not agree
with the selected operations carried out at the treatment control panel.
(III)
The selection of stationary or moving beam shall be displayed
at the treatment control panel. An interlock system shall be provided to ensure
that the equipment can only operate in the mode that has been selected.
(IV)
For new equipment, an interlock system shall be provided
to terminate irradiation if movement of the gantry occurs during stationary
beam therapy or stops during moving beam therapy unless such stoppage is a
preplanned function.
(V)
Moving beam therapy shall be controlled to obtain the selected
relationships between incremental dose monitor units and incremental angle
of movement.
(-a-)
For new equipment, an interlock system shall be provided
to terminate irradiation if the number of dose monitor units delivered in
any 10 degrees of arc differs by more than 20% from the selected value.
(-b-)
For new equipment, where gantry angle terminates
the irradiation in arc therapy, the dose monitor units shall differ by less
than 5.0% from the value calculated from the absorbed dose per unit angle
relationship.
(VI)
Where the dose monitor system terminates the irradiation
in moving beam therapy, the termination of irradiation shall be as required
by clause (vii) of this subparagraph.
(xv)
For new equipment, a system shall be provided from whose
readings the absorbed dose rate at a reference point in the treatment volume
can be calculated. The radiation detectors specified in subparagraph (iv)
of this paragraph may form part of this system. In addition, the dose monitor
unit rate shall be displayed at the treatment control panel. If the equipment
can deliver under any conditions an absorbed dose rate at the normal treatment
distance more than twice the maximum value specified by the manufacturer for
any machine parameters utilized, a device shall be provided that terminates
irradiation when the absorbed dose rate exceeds a value twice the specified
maximum. The dose rate at which the irradiation will be terminated shall be
in a record maintained by the registrant in accordance with subsection (k)
of this section for agency inspection.
(xvi)
The registrant shall determine, or obtain from the manufacturer,
the location with reference to an accessible point on the radiation head of
the x-ray target or the virtual source of x-rays and the electron window or
the virtual source of electrons if the system has electron beam capabilities.
(xvii)
Capabilities shall be provided so that all radiation
safety interlocks can be checked for correct operation.
(B)
Facility and shielding requirements.
(i)
Each installation shall be provided with primary and/or
secondary barriers as are necessary to assure compliance with §289.231(m)
and (o) of this title.
(ii)
All protective barriers shall be fixed except for entrance
doors or beam interceptors.
(iii)
The control panel shall be located outside the treatment
room and all emergency buttons/switches shall be clearly labeled as to their
functions.
(iv)
Windows, mirrors, closed-circuit television, or an equivalent
system shall be provided to permit continuous observation of the patient following
positioning and during irradiation and shall be so located that the operator
may observe the patient from the control panel. When the primary viewing system
is by electronic means, an alternate viewing system, which may be electronic,
shall be available for use in the event of failure of the primary viewing
system.
(v)
Provision shall be made for continuous two-way aural communication
between the patient and the operator at the control panel independent of the
particle accelerator. However, where excessive noise levels or treatment requirements
make aural communication impractical, other methods of communication shall
be used. When this is the case, a description of the alternate method shall
be submitted to and approved by the agency.
(vi)
Treatment room entrances shall be provided with a warning
light in a readily observable position near the outside of all access doors
to indicate when the useful beam is "on".
(vii)
Interlocks shall be provided such that all entrance doors
must be closed before treatment can be initiated or continued. If the radiation
beam is interrupted by any door opening, it shall not be possible to restore
the machine to operation without closing the door and reinitiating irradiation
by manual action at the control panel.
(C)
Surveys, calibrations, spot checks, operational requirements,
and additional operating procedures.
(i)
Surveys shall be performed as follows.
(I)
All new and existing facilities not previously surveyed
shall have a survey made by a licensed medical physicist with a specialty
in therapeutic radiological physics or medical health physics, who shall provide
a written report of the survey to the registrant. The physicist who performs
the survey shall be a person who did not consult in the design of the therapeutic
radiation machine installation and is not employed by or within any corporation
or partnership with the person who consulted in the design of the installation.
In addition, such surveys shall be done after any change in the facility or
equipment that might cause a significant increase in radiation hazard.
(II)
The survey report shall include, but not be limited to
the following:
(-a-)
a diagram of the facility that details building structures
and the position of the control panel, therapeutic radiation machine, and
associated equipment;
(-b-)
a description of the therapeutic radiation system,
including the manufacturer, model and serial number, beam type, and beam energy;
(-c-)
a description of the instrumentation used to determine
radiation measurements, including the date and source of the most recent calibration
for each instrument used;
(-d-)
conditions under which radiation measurements were
taken; and
(-e-)
survey data including:
(-1-)
projected annual TEDE in areas adjacent to the therapy
room; and
(-2-)
a description of workload, use, and occupancy factors
employed in determining the projected annual TEDE.
(III)
The registrant shall maintain a copy of the survey report
and a copy of the survey report shall be provided to the agency within 30
days of completion of the survey. Records of survey report shall be maintained
in accordance with subsection (k) of this section for inspection by the agency.
(IV)
The survey report shall include documentation of all instances
where the installation is in violation of applicable regulations. Any deficiencies
detected during the survey shall be corrected prior to using the machine.
(ii)
Calibrations of therapeutic systems shall be performed
as follows.
(I)
The calibration of systems subject to this subsection shall
be performed in accordance with an established calibration protocol before
the system is first used for irradiation of a patient and thereafter at time
intervals that do not exceed 12 months and after any change that might significantly
alter the calibration, spatial distribution, or other characteristics of the
therapy beam. The calibration procedures shall be in writing, and shall have
been developed by a licensed medical physicist with a specialty in therapeutic
radiological physics. The calibration protocol entitled, "Protocol for Clinical
Reference Dosimetry of High-Energy Photon and Electron Beams," Task Group
51, Radiation Therapy Committee, American Association of Physicists in Medicine,
Medical Physics 26(9): 1847-1870, September 1999, is accepted as an established
protocol. If Task Group 51 protocol for calibration is not used, at a minimum
the calibration protocol shall include items in subclauses (III)-(V) of this
clause below.
(II)
The calibration shall be performed by a licensed medical
physicist with a specialty in therapeutic radiological physics who is physically
present at the facility during the calibration.
(III)
Calibration radiation measurements required by subclause
(I) of this clause shall be performed using a dosimetry system:
(-a-)
having a calibration factor for cobalt-60 gamma rays
traceable to a national standard;
(-b-)
that has been calibrated within the previous 24
months and after any servicing that may have affected its calibration. During
the calendar years in which the dosimetry system is not calibrated, an intercomparison
to a system calibrated within the previous 12 months shall be performed;
(-c-)
that has been calibrated in such a fashion that
an uncertainty can be stated for the radiation quantities monitored by the
system; and
(-d-)
that has had constancy checks performed on the system
as specified by the licensed medical physicist with a specialty in therapeutic
radiological physics.
(IV)
Calibrations shall be in sufficient detail that the dose
at a reference point in a tissue equivalent phantom can be calculated to within
an uncertainty of 5.0%.
(V)
The calibration of the therapy unit shall include, but
not be limited to, the following determinations.
(-a-)
Verification that the equipment is operating in compliance
with the design specifications concerning the light field, patient positioning
lasers, and back-pointer lights with the isocenter when applicable, variation
in the axis of rotation for the table, gantry, and collimator system, and
beam flatness and symmetry at the specified depth.
(-b-)
The absorbed dose rate at various depths in a tissue
equivalent phantom for the range of field sizes used, for each effective energy,
that will verify the accuracy of the dosimetry of all therapy procedures utilized
with that therapy beam.
(-c-)
The uniformity of the radiation field to include
symmetry, flatness, and dependence on gantry angle.
(-d-)
Verification that existing isodose charts applicable
to the specific machine continue to be valid or are updated to existing machine
conditions.
(-e-)
Verification of transmission factors for all accessories
such as wedges, block trays, and/or universal and custom made beam modifying
devices.
(VI)
Records of calibration measurements specified in subclause
(I) of this clause and dosimetry system calibrations specified in subclause
(III) of this clause shall be maintained by the registrant in accordance with
subsection (k) of this section for inspection by the agency.
(VII)
A copy of the latest calibrated absorbed dose rate measured
in accordance with subclause (I) of this clause shall be available at a designated
area within the facility housing that therapy system.
(iii)
Spot checks shall be performed on systems subject to
this paragraph during calibrations and thereafter at weekly intervals with
the period between spot checks not to exceed five treatment days. Such radiation
output measurements shall meet the following requirements.
(I)
The spot check procedures shall be performed in accordance
with established protocol, shall be in writing, and shall have been developed
by a licensed medical physicist with a specialty in therapeutic radiological
physics. The spot check protocol entitled, "Comprehensive QA for Radiation
Oncology," Task Group 40, Radiation Therapy Committee, American Association
of Physicists in Medicine, Medical Physics 21(4): 581- 618, April, 1994, is
accepted as an established protocol. If Task Group 40 protocol for spot checks
is not used, at a minimum, the spot check protocol shall include items in
subclauses (III)-(VI) of this clause below.
(II)
If a licensed medical physicist does not perform the spot
check measurements, the results of the spot check measurements shall be reviewed
by a licensed medical physicist at a frequency not to exceed five treatment
days and a record kept of the review. If the output varies by more than 3.0%
from the expected value, a licensed medical physicist shall be notified immediately.
(III)
The written spot check procedures shall specify the frequency
at which tests or measurements are to be performed and the acceptable tolerance
for each parameter measured in the spot check when compared to the value for
that parameter determined in the calibration.
(IV)
Where a system has built-in devices that provide a measurement
of any parameter during irradiation, such measurement shall not be utilized
as a spot check measurement.
(V)
A parameter exceeding a tolerance set by a licensed medical
physicist shall be corrected before the system is used for patient irradiation.
(VI)
Whenever a spot check indicates a significant change in
the operating characteristics of a system, as specified in a licensed medical
physicist's written procedures, the system shall be recalibrated, as required
in this clause of this subparagraph.
(VII)
Records of spot check measurements and any necessary
corrective actions shall be maintained by the registrant in accordance with
subsection (k) of this section for inspection by the agency.
(VIII)
When a spot check involves a radiation measurement,
such measurement shall be obtained using a system satisfying the requirements
of subclause (III) of this clause or that has been intercompared with a system
meeting those requirements within the previous year.
(iv)
Facilities with therapeutic radiation machines with energies
of 1 MeV and above shall procure the services of a licensed medical physicist
with a specialty in therapeutic radiological physics.
(I)
The physicist shall be responsible for:
(-a-)
calibration of radiation machines;
(-b-)
supervision and review of beam and clinical dosimetry;
(-c-)
measurement, analysis, and tabulation of beam data;
(-d-)
establishment of quality assurance procedures and
performance of spot check review; and
(-e-)
review of absorbed doses delivered to patients.
(II)
The licensed medical physicist described in subclause
(I) of this clause shall also be available and responsive to immediate problems
or emergencies.
(v)
In addition to the items listed in paragraph (1)(D) of
this subsection, operating and safety procedures shall also include procedures
to ensure the following requirements are met.
(I)
No individual other than the patient shall be in the treatment
room during treatment of a patient.
(II)
Restraining or mechanical supporting devices shall be
used if a patient or port film must be immobilized in position during treatment.
(III)
The therapeutic system shall not be used in the administration
of radiation therapy unless the requirements of clauses (i)-(v) of this subparagraph
have been met.
(4)
Radiation therapy simulators.
(A)
General requirements. In addition to the general requirements
in subsections (h)(1)(B)-(E) of this section, radiation therapy simulators
shall comply with the following:
(i)
Technique chart. A technique chart relevant to the particular
radiation machine shall be provided or electronically displayed in the vicinity
of the control panel and used by all operators.
(ii)
Operating and safety procedures. Each registrant shall
have and implement written operating and safety procedures in accordance with
subsection (h)(1)(D) of this section.
(iii)
Protective devices. When utilized, protective devices
shall meet the following requirements.
(I)
Protective devices shall be made of no less than 0.25 millimeter
(mm) lead equivalent material.
(II)
Protective devices, including aprons, gloves, and shields
shall be checked annually for defects, such as holes, cracks, and tears. These
checks may be performed by the registrant by visual, tactile, or x-ray imaging.
If a defect is found, equipment shall be replaced or removed from service
until repaired. A record of this test shall be made and maintained by the
registrant in accordance with subsection (k) of this section for inspection
by the agency.
(iv)
Viewing system. Windows, mirrors, closed circuit television,
or an equivalent system shall be provided to permit the operator to continuously
observe the patient during irradiation. The operator shall be able to maintain
verbal, visual, and aural contact with the patient.
(v)
Operator position. The operator's position during the exposure
shall be such that the operator's exposure is as low as reasonably achievable
(ALARA) and/or protected by an apron, gloves, or other shielding having a
minimum of 0.25 mm lead equivalent material.
(vi)
No individuals other than the patient and the operator(s)
shall be in the treatment room during operation of the simulator.
(vii)
Film processing.
(I)
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 darkroom. 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.
(II)
Chemicals shall be replaced according to the chemical
manufacturer's or supplier's recommendations or at an interval not to exceed
three months.
(III)
Darkroom light leak tests shall be performed and any
light leaks corrected at intervals not to exceed six months.
(IV)
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.
(V)
Corrections or repairs of the light leaks or other deficiencies
in subclauses (II), (III), and (IV) of this clause shall be initiated within
72 hours of 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 correction or repairs shall include the date and initials of the individual
performing these functions and shall be maintained in accordance with subsection
(k) of this section for inspection by the agency.
(VI)
Documentation of the items in subclauses (II), (III),
and (IV) of this clause 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 kept in accordance with subsection (k) of this section
for inspection by the agency.
(viii)
Alternative processing systems. Users of daylight processing
systems, laser processors, self-processing film units, or other alternative
processing systems shall follow manufacturer's recommendations for image processing.
(B)
Additional requirements for radiation therapy simulators
used in the general radiographic mode of operation.
(i)
Beam quality (HVL). 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 IV. If it is necessary to determine such half-value
layer at an x-ray tube potential that is not listed in Table IV, linear interpolation
may be made.
Figure: 25 TAC §289.229(h)(4)(B)(i)
(ii)
Technique and exposure indicators.
(I)
The technique factors to be used during an exposure shall
be indicated before the exposure begins except when automatic exposure controls
are used, in which case the technique factors that are set prior to the exposure
shall be indicated.
(II)
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 ±10% of the
indicated setting.
(iii)
Beam limitation.
(I)
The beam limiting device (collimator) shall restrict the
useful beam to the area of clinical interest.
(II)
A method shall be provided to visually define the center
(cross-hair centering) of the x-ray field to within a 2 mm diameter.
(III)
A method shall be provided to accurately indicate the
distance to within 2 mm.
(IV)
The delineator wires shall be accurate with the indicated
setting within 2 mm.
(V)
The x-ray field shall be congruent with the light field
within 2 mm.
(iv)
Timers. 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 and a visual
and/or audible signal shall indicate when an exposure has been terminated.
(v)
AEC. When an AEC is provided, an indication shall be made
on the control panel when this mode of operation is selected.
(vi)
Timer reproducibility. When all technique factors are
held constant, including control panel selections associated with AEC systems,
the coefficient of variation of exposure interval for both manual and AEC
systems shall not exceed 0.05. This requirement applies to clinically used
techniques.
(vii)
Exposure reproducibility. When all technique factors
are held constant, including control panel selections associated with AEC
systems, the coefficient of variation of exposure for both manual and AEC
systems shall not exceed 0.05. This requirement applies to clinically used
techniques.
(viii)
Linearity.
Figure: 25 TAC §289.229(h)(4)(B)(viii)
(C)
Additional requirements for radiation therapy simulators
utilizing fluoroscopic capabilities.
(i)
X-ray production in the fluoroscopic mode shall be controlled
by a device that requires continuous pressure by the fluoroscopist for the
entire time of the exposure (continuous pressure type switch).
(ii)
During fluoroscopy and cinefluorography, the kV and the
mA shall be continuously indicated at the control panel and/or the fluoroscopist's
position.
(iii)
The SSD shall not be less than the 20 cm for image-intensified
fluoroscopes used for examinations as specified in the registrant's operating
and safety procedures. The written operating and safety procedures shall provide
precautionary measures to be adhered to during the use of this device. The
procedures must provide information on the means to restore the unit to a
30 cm SSD when the unit is returned to general service.
(iv)
Fluoroscopic timers shall meet the following requirements.
(I)
Means shall be provided to preset the cumulative on-time
of the fluoroscopic x-ray tube. The maximum cumulative time of the timing
device shall not exceed five minutes without resetting.
(II)
A signal audible to the fluoroscopist shall indicate the
completion of any preset cumulative on-time. Such signal shall continue to
sound while x-rays are produced until the timing device is reset. In lieu
of such signal, the timer shall terminate the beam after the preset cumulative
on-time is completed.
(v)
The exposure foot switch shall be permanently mounted in
the control booth to ensure that the operator cannot enter the simulator room
while the fluoroscope is activated.
(vi)
Simulators must duplicate the geometric conditions of
the radiation therapy equipment plan and therefore spot checks regarding geometric
conditions shall be performed in accordance with subsection (h)(3)(C)(iii)(I)
of this section.
(D)
Additional requirements for radiation therapy simulators
utilizing CT capabilities. CT simulators producing digital images only are
exempt from the requirements of this subparagraph and paragraph (h)(4)(A)(i),
(vii), and (viii) of this subsection.
(i)
Equipment requirements.
(I)
Tomographic systems shall meet the following requirements.
(-a-)
For any single tomogram system, means shall be provided
to permit visual determination of the tomographic plane or a reference plane
offset from the tomographic plane.
(-b-)
For any multiple tomogram system, means shall be
provided to permit visual determination of the tomographic plane or a reference
plane offset from the tomographic plane.
(-c-)
If a device using a light source is used to satisfy
the requirements of item (-a-) or (-b-) of this subclause, the light source
shall provide illumination levels sufficient to permit visual determination
of the location of the tomographic plane or reference plane under ambient
light conditions of up to 500 lux.
(II)
The CT x-ray system shall be designed such that the CT
conditions of operation to be used during a scan or a scan sequence are indicated
prior to the initiation of a scan or a scan sequence. On equipment having
all or some of these conditions of operation at fixed values, this requirement
may be met by permanent markings. Indication of CT conditions shall be visible
from any position from which scan initiation is possible.
(III)
The x-ray control and gantry shall provide visual indication
whenever x rays are produced and, if applicable, whether the shutter is open
or closed.
(IV)
Means shall be provided to require operator initiation
of each individual scan or series of scans.
(V)
All emergency buttons/switches shall be clearly labeled
as to their functions.
(VI)
Termination of exposure shall be as follows.
(-a-)
Means shall be provided to terminate the x-ray exposure
automatically by either de-energizing the x-ray source or shuttering the x-ray
beam in the event of equipment failure affecting data collection. Such termination
shall occur within an interval that limits the total scan time to no more
than 110% of its preset value through the use of either a backup timer or
devices that monitor equipment function.
(-b-)
A signal visible to the operator shall indicate
when the x-ray exposure has been terminated through the means required by
item (-a-) of this subclause.
(-c-)
The operator shall be able to terminate the x-ray
exposure at any time during a scan or series of scans under CT x-ray system
control, of greater than 0.5 second duration. Termination of the x-ray exposure
shall necessitate resetting of the CT conditions of operation prior to initiation
of another scan.
(VII)
CT x-ray systems containing a gantry manufactured after
September 3, 1985 shall meet the following requirements.
(-a-)
The total error in the indicated location of the tomographic
plane or reference plane shall not exceed 5 mm.
(-b-)
If the x-ray production period is less than 0.5
second, the indication of x-ray production shall be actuated for at least
0.5 second. Indicators at or near the gantry shall be discernible from any
point external to the patient opening where insertion of any part of the human
body into the primary beam is possible.
(-c-)
The deviation of indicated scan increment versus
actual increment shall not exceed ±1 mm with any mass from 0 to 100
kilograms (kg) resting on the support device. The patient support device shall
be incremented from a typical starting position to the maximum incremented
distance or 30 cm, whichever is less, and then returned to the starting position.
Measurement of actual versus indicated scan increment can be taken anywhere
along this travel.
(ii)
Facility design requirements.
(I)
Provision shall be made for two-way aural communication
between the patient and the operator at the control panel.
(II)
Windows, mirrors, closed-circuit television, or an equivalent
shall be provided to permit continuous observation of the patient during irradiation
and shall be so located that the operator can observe the patient from the
control panel. When the primary viewing system is by electronic means, an
alternate viewing system, which may be electronic, shall be available for
use in the event of failure of the primary viewing system.
(iii)
Dose measurements of the radiation output of the CT x-ray
system.
(I)
Dose measurements of the radiation output of the CT x-ray
system shall be performed by a licensed medical physicist with a specialty
in diagnostic radiological physics. The measurements shall be performed as
follows:
(-a-)
at intervals not to exceed 12 months;
(-b-)
when major maintenance, except x-ray tube replacement,
that could affect radiation output is performed; or
(-c-)
when a major change in equipment operation (e.g.
introduction of a new software package) is accomplished.
(II)
Measurements of the radiation output of a CT x-ray system
shall be performed with a calibrated dosimetry system. The dosimetry system
shall have been calibrated within the preceding 24 months and shall be traceable
to a national standard. During the calendar year in which the dosimetry system
is not calibrated, an intercomparison to a system calibrated within the previous
12 months shall be performed.
(III)
Records of dose measurements shall be maintained by the
registrant in accordance with subsection (k) of this section.
(iv)
A maintenance schedule shall be developed in accordance
with the manufacturer's United States Department of Health and Human Services
maintenance schedule. The schedule shall include, but need not be limited
to the following:
(I)
dose measurements required by clause (iii)(I) of this subparagraph;
and
(II)
acquisition of images obtained with phantoms using the
same processing mode and CT conditions of operation as are used to perform
dose measurements required by clause (iii)(I) of this subparagraph. The registrant
shall retain either of the following in accordance with subsection (k) of
this section for inspection by the agency:
(-a-)
photographic copies of the images obtained from the image
display device; or
(-b-)
images stored in digital form.
(5)
Records/documents.
(A)
The registrant shall maintain copies of the following records/documents
at authorized use locations in accordance with subsection (k) of this section
for inspection by the agency:
(i)
current applicable sections of this chapter as listed on
the certificate of registration;
(ii)
current certificate of registration;
(iii)
current operating and safety procedures in accordance
with subsection (h)(1)(D) of this section;
(iv)
receipt, transfer, disposal, surveys, and calibrations
of radiation machines specific to that location including the date, the manufacturer
name, model and serial number from the control panel or console of the radiation
machine and identification of the person making the record;
(v)
credentials of operators of radiation machines operating
at that location in accordance with subsection (h)(1)(D) of this section;
(vi)
film processing records for that location in accordance
with subsection (h)(4)(A)(vii) of this section, as applicable;
(vii)
FDA variances of machines at that location in accordance
with subsection (h)(1) of this section;
(viii)
CT dose measurements and CT quality control films or
images at that location in accordance with subsection (h)(4)(D)(iii)(I) and
(II) of this section;
(ix)
therapy (below 1 MeV) surveys and calibrations of equipment
at that location in accordance with subsection (h)(2)(D)(i) and (ii) of this
section;
(x)
therapy (1 MeV and above) surveys and calibrations of equipment
at that location in accordance with subsection (h)(3)(C)(i) and (ii) of this
section;
(xi)
records, notices, and reports of therapy events in accordance
with subsection (j) of this section; and
(xii)
notice of violations from last inspection, if applicable,
and documentation of corrections of any violations.
(B)
Records specified in subparagraph (A) may be maintained
in electronic format.
(i)
Therapy events (misadministrations).
(1)
Therapy events involving equipment operating at energies
below 1 MeV shall be reported when:
(A)
the event involves the wrong individual, or wrong treatment
site;
(B)
the treatment consists of three or fewer fractions and
the calculated total administered dose differs form the total prescribed dose
by more than 10% of the total prescribed dose; or
(C)
the calculated total administered dose differs from the
total prescribed dose by more than 20% of the total prescribed dose.
(2)
Therapy events involving equipment operating
with energies of 1 MeV and above shall be reported when:
(A)
the event involves the wrong individual, wrong type of
radiation, wrong energy, or wrong treatment site;
(B)
the treatment consists of three or fewer fractions and
the calculated total administered dose differs from the total prescribed dose
by more than 10% of the total prescribed dose; or
(C)
the calculated total administered dose differs from the
total prescribed dose by more than 20% of the total prescribed dose.
(j)
Reports of therapy events (misadministrations).
(1)
For a therapy event, a registrant shall do the following:
(A)
notify the agency by telephone no later than 24 hours after
discovery of the event;
(B)
notify the referring physician and also notify the patient
of the event no later than 24 hours after its discovery, unless the referring
physician personally informs the registrant either that he or she will inform
the patient or that, based on medical judgement, telling the patient would
be harmful. The registrant is not required to notify the patient without first
consulting the referring physician. If the referring physician or patient
cannot be reached within 24 hours, the registrant shall notify the patient
as soon as possible thereafter. The registrant may not delay any appropriate
medical care for the patient, including any necessary remedial care as a result
of the event, because of any delay in notification;
(C)
submit a written report to the agency within 15 days after
the discovery of the event. The report must not include the patient's name
or other information that could lead to identification of the patient. The
written report must include the following:
(i)
registrant's name and certificate of registration number;
(ii)
prescribing physician's name;
(iii)
a brief description of the event;
(iv)
why the event occurred;
(v)
the effect on the patient;
(vi)
what improvements are needed to prevent recurrence;
(vii)
actions taken to prevent recurrence;
(viii)
whether the registrant notified the patient, or the
patient's responsible relative or guardian (this person will be subsequently
referred to as "the patient"); and if not, why not; and
(ix)
if the patient was notified, what information was provided
to the patient; and
(D)
furnish the following to the patient within 15 days after
discovery of the event if the patient was notified:
(i)
a copy of the report that was submitted to the agency;
or
(ii)
a brief description of both the event and the consequences,
as they may affect the patient, provided a statement is included that the
report submitted to the agency can be obtained from the registrant.
(2)
Each registrant shall retain a record of
each event in accordance with subsection (k) of this section for inspection
by the agency. The record shall contain the following:
(A)
the names of all individuals involved (including the prescribing
physician, allied health personnel, the patient, and the patient's referring
physician);
(B)
the patient's identification number;
(C)
a brief description of the event;
(D)
why it occurred;
(E)
the effect on the patient;
(F)
what improvements are needed to prevent recurrence; and
(G)
the actions taken to prevent recurrence.
(3)
Aside from the notification requirement, nothing
in subsection (i) of this section and paragraphs (1) and (2) of this subsection
shall affect any rights or duties of registrants, and physicians in relation
to each other, patients, or the patient's responsible relatives or guardians.
(k)
Records/documents for agency inspection. Each registrant
shall make the following records/documents available to the agency for inspection,
upon reasonable notice.
Figure: 25 TAC §289.229(k)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State, on May 22, 2000.
TRD-200003516
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
25 TAC §289.226
The Texas Department of Health (department) proposes an amendment
to §289.226, concerning the registration of radiation machine use and
services.
The amendment clarifies when the use of accelerators and therapy radiation
machines must be registered. Requirements for radiation safety officers for
dental facilities are deleted because these requirements have been incorporated
in another section. Requirements concerning the approval of a healing arts
screening program are deleted from another section and more appropriately
incorporated in this section. Requirements for providers of equipment and
for persons who sell, lease, loan, install, assemble, and transfer radiation
machines are added to formalize in rule what is currently required by certificate
of registration condition. References are updated and minor clarifying language
is added throughout the rule. This amendment is part of the department's continuing
effort to update, clarify, and simplify its rules regarding the control of
radiation based upon technological advances, public concerns, legislative
directives, or other factors.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section will be in effect, the public benefit anticipated
as a result of enforcing the section will be to ensure continued protection
of the public and workers from unnecessary exposure to radiation by ensuring
requirements are in place for registering all types of radiation machines.
There will be no effect on micro businesses or small businesses. There are
no anticipated economic costs to persons who are required to comply with the
section as proposed. There is no anticipated impact on local employment. The
amendment clarifies the registration requirements for accelerators, deletes
requirements incorporated in another section, and incorporates requirements
that are deleted from another section and more appropriately placed in this
section. Because the amendment imposes no additional requirements such as
record keeping, regulatory limits, procedures, or processes, there are no
economic effects associated with the section as proposed.
Comments on the proposal may be presented to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834- 6688 or electronic mail at Ruth.Mcburney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 10:00 a.m., Thursday,
June 15, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The amendment is proposed under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The amendment affects Health and Safety Code, Chapter 401 and Chapter 12.
§289.226. Registration of Radiation Machine Use and Services.
(a)
Purpose.
[
[
This section provides for the registration
of persons using radiation machines and persons who are in the business of
providing radiation machine installation or radiation services. No person
shall use radiation machines or perform radiation services except as authorized
in a certificate of registration issued by the agency in accordance with the
requirements of this section. A person who
receives, possesses, uses,
owns, or acquires radiation machines
[
(b)
Scope.
(1)
[
(2)
Registrants using radiation machines
in the healing arts and veterinary medicine are subject to the requirements
of §289.227 of this title (relating to Use of Radiation Machines in the
Healing Arts and Veterinary Medicine).
(3)
Registrants using analytical and
other industrial radiation machines, such as x-ray equipment used for cathodoluminescence,
ion implantation, gauging, or electron beam welding, are subject to the requirements
of §289.228 of this title (relating to Radiation Safety Requirements
for Analytical and Other Industrial Radiation Machines).
(4)
Registrants using accelerators, therapeutic
radiation machines, and simulators are subject to the requirements of §289.229
of this title (relating to Radiation Safety Requirements for Accelerators,
Therapeutic Radiation Machines, and Simulators).
(5)
Registrants using mammography radiation
machines are subject to the requirements of §289.230 of this title (relating
to Certification of Mammography Systems and Accreditation of Mammography Facilities).
(6)
Registrants using radiation machines
in industrial radiographic operations are subject to the requirements of §289.255
of this title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography).
(7)
Services listed in paragraph (8)
of this subsection may constitute the practice of medical physics and, therefore,
may require individuals performing those services to have a license from the
Texas Board of Licensure for Professional Medical Physicists in accordance
with the Medical Physics Practice Act, Texas Civil Statutes, Article 4512n.
(8)
[
(A)
provision of radiation protection or health physics consultations
or surveys that require the consultant to operate or cause a radiation machine
to be operated in order to make measurements or gather data;
(B)
presentation of agency-accepted training courses
that are specifically required by this chapter
;
(C)
calibration of radiation machine output;
(D)
calibration of survey and measurement instruments;
(E)
demonstration and sales of radiation machines that require
the individual to operate or cause a radiation machine to be operated in order
to demonstrate or sell;
(F)
assembly
, installation or repair
[
(G)
provision of personnel monitoring services;
(H)
performance of equipment performance evaluations on radiation
machines; or
(I)
provision of radiation machines on a routine basis to a
facility for limited time periods. For purposes of this section, a person
providing the services described in this subparagraph is a provider of equipment.
For healing arts facilities, the use of radiation machines shall be directed
by a licensed practitioner employed by the contracting facility.
(9)
[
(c)
[
(d)
[
(1)
Electronic equipment that produces radiation incidental
to its operation for other purposes is exempt from the registration and notification
requirements of this section, provided that the dose equivalent rate averaged
over an area of 10 square centimeters (cm
2
)
does not exceed 0.5 millirem per hour (mrem/hr) at 5 centimeters (cm) from
any accessible surface of such equipment. The production, testing, or factory
servicing of such equipment shall not be exempt.
(2)
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.
Facilities that have placed all radiation machines in storage, including
on-site
storage
,
[
(3)
Domestic television receivers and video display terminals,
including the servicing of such devices, are exempt from the requirements
of this section.
(4)
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.
(5)
Financial institutions that take possession of radiation
machines as the result of foreclosure, bankruptcy, or other default of payment
are exempt from the requirements in this section to the extent that they demonstrate
that the unit is operable for the sole purpose of selling, leasing, or transferring.
(6)
Facilities, including academic institutions and research
and/or development facilities, registered for the use of radiation machines
are exempt from the registration requirements of
subsections (g) and
(l)
[
(e)
[
(1)
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.
(2)
A radiation safety officer (RSO) shall be designated
on each application form. The qualifications of that individual shall be submitted
to the agency with the application. The RSO shall meet the applicable requirements
of subsection
(w)(1)
[
(3)
The agency may at any time after the filing of the
original application, require further statements in order to enable the agency
to determine whether the certificate of registration should be issued
or
[
(4)
An application for a certificate of registration may
include a request for a certificate of registration authorizing one or more
activities. Applications for certification of mammography systems must be
made separately.
(5)
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
§289.231(aa)
[
(6)
Each application for a certificate of registration
shall be accompanied by the fee prescribed in §289.204 of this title.
(7)
BRC Form 226-1
(Franchise Tax Form)
shall
be submitted with the application to confirm that no tax owed
to
the state under Tax Code, Chapter 171, is delinquent.
(f)
[
(1)
Each person having a radiation machine used in healing
arts or veterinary medicine shall apply for registration with the agency within
30 days
after beginning use of
[
(2)
Each person having an accelerator
or therapeutic
radiation machine at or above 1 million electron volts (MeV)
for human
use shall apply for and receive a certificate of registration from the agency
before activation, including acceptance testing, of the accelerator.
(3)
Each person having a simulator and/or
therapeutic radiation machine below 1 MeV for human use shall apply for registration
with the agency within 30 days of energizing the equipment.
(4)
[
(5)
[
(6)
[
(7)
[
(A)
§289.229(h)(2)(B) and (C) of this
title for equipment with energies below 1 MeV; and
(B)
§289.229(h)(3)(B) of this title for
equipment with energies above 1 MeV.
[
(g)
[
(1)
Each person who intends to engage in the business of providing
radiation services described in subsection
(b)(8)
[
(2)
An application for radiation services shall be signed
by the applicant or registrant or a person duly authorized to act for and
on the applicant's or registrant's behalf. The application shall also be signed
by the RSO if the RSO is someone other than the applicant or registrant.
(3)
The applicant shall submit to the agency written documentation
of the specific training and experience that qualifies each individual to
discharge the duties of this service. Documentation of each individual's training
shall be maintained for inspection by the agency. As a minimum, each applicant
shall submit the following:
(A)
for assembler and/or calibration of
radiation machines
[
(B)
for all other services, the qualifications listed in subsection
(w)(1)(A)
[
(4)
No person shall perform services specified in
this subsection that are not specifically authorized by the agency.
(5)
No person shall perform these machine services, other
than initial installation of the first machine on the premises, for an individual
who cannot produce evidence of registration with the agency authorizing the
possession and use of the machines in question.
(6)
The applicant shall submit the interval to be followed
to calibrate electronic equipment used in radiation machine servicing
, for example, kVp meters and voltmeters
[
(7)
Each applicant for providers of equipment shall submit
the following:
(A)
an established main location where the
machines,
[
(B)
evidence that the healing arts facility responsible for
administering or supervising the administering of radiation is registered
in accordance with the
requirements
[
(C)
a
current copy of the applicant's operating
and safety procedures
is required when personnel is also provided.
[
[
(h)
[
(1)
Each person who intends to provide personnel monitoring
services shall apply for and receive a certificate of registration from the
agency before providing such services.
(2)
An application for personnel monitoring services shall
be signed by the applicant or registrant or a person duly authorized to act
for and on the applicant's or registrant's behalf. The application shall also
be signed by the RSO if the RSO is someone other than the applicant or registrant.
(3)
The applicant shall submit documentation that the
facility has been accredited by the National Voluntary Laboratory Accreditation
for Personnel Dosimetry Processors of the National Institute of Science and
Technology in accordance with accreditation criteria established in
Title
15
,
Code of Federal Regulations (CFR)
,
Part 7b, as amended.
(4)
The maximum allowable time delay between the end date
of the monitoring period and the date at which processing will not be performed
shall be stated.
(5)
The maximum time between processing and reporting
results shall be stated.
(i)
[
(1)
an
[
(2)
a
[
(3)
for
[
(j)
Application for registration of healing
arts screening and medical research.
(1)
In addition to the requirements of subsections
(e) and (f) of this section or §289.230(f) of this title, as applicable,
each applicant shall apply for and receive authorization for healing arts
screening before initiating a screening program. The information and evaluation
in subsection (w)(4) of this section shall be submitted with the application.
(2)
In addition to the requirements of
subsections (e) and (f) of this section, any research using radiation machines
on humans must receive prior approval from the agency and must be approved
by an Institutional Review Board (IRB) as required by Title 45, CFR Part 46
and Title 21, CFR, Part 56. The IRB must include at least one practitioner
of the healing arts to direct any use of radiation in accordance with §289.231(b)(1)
of this title.
(k)
[
(1)
Each person having an accelerator for
non-human use shall apply for and receive a certificate of registration from
the agency before beginning use of the accelerator.
(2)
Each person having an accelerator
for non-human use shall submit the following:
(A)
operating and safety procedures as described
in §289.229(f)(3)(C) of this title; and
(B)
a description of the applicant's proposed
facilities in accordance with §289.229(f)(2) and (f)(3)(A), (B), and
(D) of this title.
(3)
Each person having a radiation
machine for non- human use other than veterinary medicine shall apply for
registration with the agency within 30 days after beginning use of the machine.
(4)
Each applicant for industrial radiographic
operations shall submit the information required in §289.255(u)(7) of
this title.
(5)
An application for the uses specified
in this subsection shall be signed by the applicant or registrant or a person
duly authorized to act for and on the applicant's or registrant's behalf.
The application shall also be signed by the RSO if the RSO is someone other
than the applicant or registrant.
[
[
[
[
[
[
[
(l)
[
(1)
Each person who intends to engage in the business of providing
calibration of survey and measurement instruments shall apply for and receive
a certificate of registration from the agency before providing services.
(2)
An application for calibration of survey and measurement
instruments shall be signed by the applicant or registrant or a person duly
authorized to act for and on the applicant's or registrant's behalf. The application
shall also be signed by the RSO if the RSO is someone other than the applicant
or registrant.
(3)
Each applicant shall submit the following:
(A)
procedures for calibration;
(B)
qualifications of personnel performing the calibration;
(C)
a copy of the calibration certificate to be used; and
(D)
a copy of the expiration sticker to be used.
(m)
[
(1)
Each person who intends to engage in the business of providing
agency-accepted training courses
specifically required by this chapter
shall apply for and receive a certificate of registration from the
agency before providing training.
(2)
An application for agency-accepted training courses
shall be signed by the applicant or registrant or a person duly authorized
to act for and on the applicant's or registrant's behalf. The application
shall also be signed by the RSO if the RSO is someone other than the applicant
or registrant.
(3)
Each applicant shall submit the following:
(A)
a course syllabus;
(B)
the number of instructional hours for each subject;
(C)
a list of training resources
, for example, reference
books, texts, workbooks, physical facilities, etc.
[
(D)
all test questions and corresponding answers; and
(E)
resumes containing the radiation safety training, education,
and experience of each instructor.
(n)
[
(1)
Upon a determination that an application meets the requirements
of the Texas Radiation Control Act (Act) and the requirements of the agency,
the agency may issue a certificate of registration authorizing the proposed
activity in such form and containing such conditions and limitations as it
deems appropriate or necessary.
(2)
The agency may incorporate in the certificate of registration
at the time of issuance, or thereafter by amendment, such additional requirements
and conditions with respect to the registrant's possession, use, and transfer
of radiation machines subject to this
chapter
[
(A)
minimize danger to
occupational and
public health
and safety;
(B)
require such reports and the keeping of such records, and
to provide for such inspections of activities under the registration as may
be appropriate or necessary; and
(C)
prevent loss or theft of radiation machines subject to
this section.
(o)
[
(1)
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
rules
[
(2)
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.
(3)
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.
(p)
[
(1)
The registrant shall notify the agency in writing of any
changes that would render the information contained in the application for
registration and/or the certificate of registration inaccurate.
(A)
Notification is required within 30 days of any change of
radiation machine inventory. This includes installation or removal and the
disposition of any machine disposed of or transferred. The assembler's notification
of installation may be accepted in lieu of notification by the registrant
with the exception of mammographic x-ray units. This does not relieve the
registrant of the responsibility to assure that proper notification has been
made.
(B)
Notification is required within 30 days of the following
changes:
(i)
name and mailing address;
(ii)
street address where
machine
[
(iii)
RSO
[
(iv)
type of servicing and/or services provided; or
(v)
name of facility contracted for "provider of equipment."
(C)
Notification is required prior to any changes that would
render the information contained in the application or the certification of
mammography systems inaccurate.
(2)
The following criteria applies to
radiation
machines used for clinical trial evaluations and
loaner
or demonstration
radiation machines.
[
(A)
Radiation machines used for clinical trial evaluations
and
loaner or demonstration radiation machines
[
[
(B)
No fees will be assessed for the operation
of radiation machines for clinical trial evaluations or loaner or demonstration
radiation machines used for a period of 60 days or less at a facility with
a current certificate of registration.
[
(3)
No registrant shall engage any person for services
described in subsection
(g)
[
(4)
Records of training and experience required by this
section shall be maintained for review until disposal is authorized by the
agency.
(5)
The following applies to voluntary or involuntary
petitions for bankruptcy.
(A)
Each registrant shall notify the agency,
in writing, immediately following the filing of a voluntary or involuntary
petition for bankruptcy. This notification must include:
(i)
the bankruptcy court in which the petition
for bankruptcy was filed; and
(ii)
the date of the filing of the petition.
(B)
A copy of the "petition for bankruptcy"
shall be submitted to the agency along with the written notification.
[
[
[
[
[
[
[
[
(6)
The registrant is responsible for complying with
this chapter and the conditions of the certificate of registration.
(7)
No person shall use
radiation
machines
or perform services that are not authorized in the certificate of registration
issued by the agency.
(8)
Assembler [
(A)
No person shall transfer a radiation machine to or install
for, other than initial installation of the first machine on the premises,
any person who does not possess a current certificate of registration issued
by the agency in accordance with this section.
(B)
Any person who sells, leases, lends, disposes, assembles,
installs, or otherwise transfers radiation machines in the state shall notify
the agency of the following information within
30
[
(i)
the name, address, and certificate of registration number,
except in the case of initial machine installation, of persons who have received
such machines;
(ii)
the type of radiation machine, the
manufacturer's
name
[
(iii)
the date of transfer or disposal of each radiation machine.
(C)
In the case of diagnostic x-ray systems that contain certified
components, a copy of the assembler's report on United States Food and Drug
Administration (FDA) form 2579, prepared in compliance with requirements
of the federal diagnostic x-ray
standard
[
(D)
No person shall make, sell, lease, transfer, lend, assemble,
or install radiation machines or the components of such machines unless such
machines and equipment, when properly placed in operation and used, meet the
applicable requirements of this chapter.
(9)
Providers of equipment shall
keep a log of radiation machines provided in Texas. The record shall be maintained
for inspection by the agency and shall list the following current information:
(A)
date machine is provided; and
(B)
name of customer and customer's certificate
of registration number.
(q)
Sale, lease, loan, installation, assembly,
disposal, and transfer of radiation machines.
(1)
No person shall transfer a radiation machine
to or install for, other than initial installation of the first machine on
the premises, any person who does not possess a current certificate of registration
issued by the agency in accordance with this section.
(2)
Any person who sells, leases, lends,
disposes, assembles, installs, or otherwise transfers radiation machines in
the state shall notify the agency of the following information within 30 days
of such action:
(A)
the name, address, and certificate of
registration number, except in the case of initial machine installation, of
persons who have received such machines;
(B)
the type of radiation machine, the manufacturer's
name, model number, and control panel serial number of each radiation machine;
and
(C)
the date of transfer or disposal of each
radiation machine.
(3)
No person shall make, sell,
lease, transfer, lend, assemble, or install radiation machines or the components
of such machines unless such machines and equipment, when properly placed
in operation and used, meet the applicable requirements of this chapter.
(r)
[
(1)
Except as provided by subsection
(t)
[
(2)
If a registrant does not submit an application for
renewal of the certificate of registration under subsection
(t)
[
(A)
terminate use of all radiation machines and/or terminate
radiation machine servicing or radiation services;
(B)
submit a record of the disposition of the
radiation
machines;
[
(C)
pay any outstanding fees in accordance with §289.204
of this title.
(s)
[
(1)
request termination of the certificate of registration
in writing;
(2)
submit a record of the disposition of the
radiation
machines;
[
(3)
pay any outstanding fees in accordance with §289.204
of this title.
(t)
[
(1)
Application for renewal of registration shall be filed
in accordance with subsection
(e)(1)-(5)
[
(2)
If a registrant files an application in proper form
before the existing certificate of registration expires, such existing certificate
of registration shall not expire until the application status has been determined
by the agency.
(u)
[
(1)
The terms and conditions of all certificates of registration
shall be subject to amendment, revision, or modification. A certificate of
registration may be suspended or revoked by reason of amendments to the Act,
or by reason of rules in this chapter and orders issued by the agency.
(2)
Any certificate of registration may be revoked, suspended,
or modified, in whole or in part, for any of the following:
(A)
any material false statement in the application or any
statement of fact required under provisions of the Act;
(B)
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; or
(C)
violation of, or failure to observe any of the terms and
conditions of the Act, this chapter, or of the certificate of registration,
or order of the agency.
(3)
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.
(4)
[
(v)
[
(1)
Whenever any radiation machine is to be brought into the
state for any temporary use, the person proposing to bring such machine into
the state shall file written notice with the agency at least three working
days before such machine is to be used in the state. The notice shall include:
(A)
the number and type of radiation machine;
[
(B)
the nature, start date, duration, and scope of use;
(C)
the exact location where the radiation machine is
to be used;
[
(D)
the
name
[
(E)
a copy of the person's operating and safety procedures;
and
(F)
the name and address where the machine user can be
reached while in the state.
[
(2)
If, for a specific case, the three-day period
would impose an undue hardship on the person, he/she may, at the determination
of the agency, obtain permission to proceed sooner.
(3)
The out-of-state person shall provide a copy of their
certificate of registration or equivalent document. If the state from which
the
machine is
[
(4)
In addition, the out-of-state person shall:
(A)
submit an annual fee as specified in
§289.204(e)
[
(B)
comply with all applicable requirements of the agency;
and
(C)
supply the agency with such other information as the agency
may reasonably request.
(5)
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 public health and safety or property.
(6)
Whenever radiation services are to be provided by
a person from out-of-state for any temporary use, that person shall apply
for and receive a certificate of registration from the agency before providing
services. The application shall be filed in accordance with
subsections
(e), (g)-(h), and (k)-(m) of this section,
[
(w)
[
(1)
Requirements for RSOs for registrants.
(A)
All RSOs shall meet the following general requirements
in addition to requirements in specific categories
,
except for
industrial radiography RSOs:
(i)
educational courses related to ionizing radiation safety
or a radiation safety officer course;
(ii)
experience in the use and familiarity of the type of equipment
used; and
(iii)
knowledge of potential radiation hazards or emergency
precautions.
(B)
Specific requirements for RSOs by facility are as follows
.
[
(i)
Healing
[
(I)
licensed practitioner RSOs with documentation of licensing
board number; or
(II)
non-practitioner RSOs with the following:
(-a-)
evidence of a valid general certificate issued under
the Medical Radiologic Technologist Certification Act, Texas Civil Statutes,
Article 4512m, and at least two years of supervised use of radiation machines;
(-b-)
evidence of a valid limited general certificate
issued under the Medical Radiologic Technologist Certification Act, Texas
Civil Statutes, Article 4512m, and at least four years of supervised use of
radiation machines;
(-c-)
evidence of registry by the American Registry of
Radiologic Technologists (ARRT) or the American Registry of Clinical Radiologic
Technologists (ARCRT) and at least two years of 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
use of radiation machines;
(-e-)
evidence of registration with the Board of Nurse
Examiners as a Registered Nurse or a Registered Nurse with an extended scope
of practice (Nurse Practitioner) performing radiologic procedures, and at
least two years of supervised use of radiation machines in the respective
practitioners' specialty;
(-f-)
evidence of registration with the Texas State Board
of Physician Assistant Examiners, and at least two years of supervised use
of radiation machines in the respective practitioners' specialty;
(-g-)
evidence of:
(-1-)
registration with the Texas State Board of Medical Examiners
performing radiologic procedures under a physician's instruction and direction;
[
(-2-)
[
(-3-)
[
(-4-)
[
(-h-)
for radiotherapy facilities, evidence of registry
by the ARRT or ARCRT and at least four years of supervised experience in radiotherapy;
(-i-)
evidence of bachelor's (or higher) degree in a natural
or physical science, health physics, radiological science, nuclear medicine,
or nuclear engineering; or
(-j-)
evidence of a current Texas license under the Medical
Physics Practice Act, Texas Civil Statutes, Article 4512n, in one or more
of the following appropriate specialties:
(-1-)
medical health physics, diagnostic radiological physics,
or medical nuclear physics for diagnostic x-ray facilities; or
(-2-)
medical health physics or therapeutic radiological physics
for radiotherapy facilities.
(ii)
Veterinary facilities shall have:
(I)
veterinarian RSOs with documentation of veterinary license
board number; or
(II)
non-veterinarian RSOs with two years minimum experience
in the use of radiation machines in veterinary medicine under the supervision
of a licensed veterinarian.
(iii)
Academic institutions and/or research and development
facilities shall have RSOs who are faculty or staff members in radiation protection,
radiation engineering, or related disciplines. (This individual may also serve
as the RSO over the healing arts section of the facility
.
) [
(iv)
Industrial radiography operations shall have RSOs who
meet the requirements of
§289.225(m)(4)(B) of this title.
[
(C)
Exemptions. The RSO identified on a certificate of registration
issued before September 1, 1993, need not comply with the training requirements
in this subsection.
(2)
Responsibilities of
RSOs
[
(A)
establishing and overseeing operating and safety procedures
that maintain radiation exposures as low as reasonably achievable (ALARA),
and to review them regularly to ensure that the procedures are current and
conform with this chapter;
(B)
ensuring that
individual
[
(C)
investigating and reporting to the agency each known or
suspected case of radiation exposure to an individual or radiation level detected
in excess of limits established by this chapter and each theft or loss of
source(s) of radiation, determining the cause, and taking steps to prevent
its recurrence;
(D)
having a thorough knowledge of management policies and
administrative procedures of the registrant and keeping management informed
on a periodic basis of the performance of the registrant's radiation protection
program
, if applicable
;
(E)
assuming control and having the authority to institute
corrective actions including shut-down of operations when necessary in emergency
situations or unsafe conditions;
(F)
maintaining records as required by this chapter;
(G)
ensuring that personnel are adequately trained and complying
with this chapter, the conditions of the certificate of registration, and
the operating and safety procedures of the registrant.
(3)
Minimum education and training for persons performing
radiation machine assembly,
installation or
[
(A)
General requirements include:
(i)
experience or education providing familiarity with the
type(s) of equipment to be serviced to include radiation safety;
(ii)
knowledge of protective measures to reduce potentially
hazardous conditions; and
(iii)
six months of supervised assembly and repair of the type(s)
of equipment to be serviced.
(B)
Specialized requirements include:
(i)
one year of formal training (may be satisfied by factory
school, military technical training school, or other courses in radiation
machine assembly,
installation or
[
(ii)
a
bachelor's degree in electrical engineering
with specialized training in radiation producing devices; or
(iii)
a
combination of training and experience equal
to clause (i) of this subparagraph.
(C)
Exemptions. A registrant holding a valid certificate of
registration who has hired individuals to perform services before September
1, 1993, need not comply with the education and training requirements in this
paragraph. Individuals hired after September 1, 1993, must comply with the
education and training requirements in this paragraph.
(4)
Information to be submitted
by persons proposing to conduct healing arts screening. Persons requesting
that the agency approve a healing arts screening program shall submit the
following information and evaluation.
(A)
Administrative controls to include the
following:
(i)
the name and address of the applicant
and, where applicable, the names and addresses of agents within Texas;
(ii)
the diseases or conditions for which
the x-ray examinations are to be used in diagnoses;
(iii)
a detailed description of the x-ray
examinations proposed in the screening program;
(iv)
a description of the population to be
examined in the screening program, for example, age, sex, physical condition,
and other appropriate information; and
(v)
an evaluation of any known alternate methods
not involving ionizing radiation that could achieve the goals of the screening
program and why these methods are not used instead of the x-ray examination.
(B)
Operating procedures for all x-ray systems
(except bone densitometers) to include the following:
(i)
an evaluation of the x-ray systems to
be used in the screening program. The evaluation shall be performed by a licensed
medical physicist with a specialty in diagnostic radiological physics. The
evaluation shall show that such systems do satisfy all requirements of this
section;
(ii)
a description of the diagnostic film
quality control program; and
(iii)
a copy of the technique chart for the
x-ray examination procedures to be used.
(C)
Operating procedures for bone densitometers
to include the manufacturer's evaluation of the system to be used in the screening
program. The evaluation shall show that such systems satisfy all requirements
of this section.
(D)
Training data to include the following:
(i)
the qualifications of each individual
who will be operating the x-ray systems;
(ii)
the qualifications of the individual
who will be supervising the operators of the x-ray systems. The extent of
supervision and the method of work performance evaluation shall be specified;
and
(iii)
the name and address of the practitioner
who will interpret the radiographs.
(E)
Records to include the following:
(i)
a description of the procedures to be
used in advising the individuals screened, and their private practitioners
of the healing arts, of the results of the screening procedure and any further
medical needs indicated; and
(ii)
a description of the procedures for the
retention or disposition of the radiographs and other records pertaining to
the x-ray examinations.
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed with the Office of
the Secretary of State, on May 22, 2000.
TRD-200003595
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
25 TAC §289.227
The Texas Department of Health (department) proposes the
repeal of §289.227 and new §289.227, concerning the use of radiation
machines in the healing arts and veterinary medicine.
The proposed section deletes the requirements for therapeutic radiation
machines, simulators, and therapy misadministrations. These requirements are
incorporated in a separate section, §289.229 (concerning Radiation Safety
Requirements for Accelerators, Therapeutic Radiation Machines, and Simulators).
In addition, the requirements for dental facilities are deleted and incorporated
in a separate section, §289.232 (concerning Radiation Control Regulations
for Dentists Using Radiation Machines). Requirements for calibration of equipment
used to measure dose rate for fluoroscopy and computed tomography are updated.
The proposed section will enable a registrant to calibrate the dosimetry system
every two years instead of annually, with an intercomparison of the dosimetry
system required in the year in which the calibration of the system is not
traceable to a national standard. The remaining subsections of the rule are
rearranged for clarity, references are updated, and clarifying language is
added to the technical standards throughout the rule. The proposed new section
is part of the department's continuing effort to update, clarify, and simplify
its rules regarding the control of radiation based upon technological advances,
public concerns, or other factors.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the sections will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the sections as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed sections will be in effect, the public benefit anticipated
as a result of enforcing the sections will be to ensure that registrants comply
with the use of radiation machines in the healing arts and veterinary medicine,
ensuring the safety of workers and that the public is protected from unnecessary
exposure to radiation. The updated calibration requirements will reduce the
cost to calibrate dosimetry systems because the required interval for calibration
is changed from annually to once every two years. Micro businesses, small
businesses, and persons required to comply with the sections as proposed will
have a savings every other year ranging from $550 to $700. There are no anticipated
increased economic costs to micro businesses, small businesses, or persons
who are required to comply with the sections as proposed. There is no anticipated
impact on local employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, (512) 834-6688 or electronic mail at Ruth.Mcburney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 2:00 p.m., Thursday,
June 15, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
(Editor's note: The text of the following section proposed
for repeal will not be published. The section may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The repeal affects Health and Safety Code, Chapter 401 and Chapter 12.
§289.227.Use of Radiation Machines in the Healing Arts and Veterinary Medicine.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State, on May 22, 2000.
TRD-200003517
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
The new section is proposed under the
Health and Safety Code, Chapter 401, which provides the Texas Board of Health
(board) with authority to adopt rules and guidelines relating to the control
of radiation; and §12.001, which provides the board with the authority
to adopt rules for the performance of each duty imposed by law on the board,
the department, and the commissioner of health.
The new section affects Health and Safety Code, Chapter 401 and Chapter
12.
§289.227.Use of Radiation Machines in the Healing Arts and Veterinary Medicine.
(a)
Purpose. This section establishes requirements for the
use of radiation machines in the healing arts and in veterinary medicine.
All usage of such machines under this section shall be made by or under the
supervision of a practitioner of the healing arts for human use or licensed
veterinarian for veterinary use. The use of mammography radiation machines
is exempt from this section and is covered in §289.230 of this title
(relating to Certification of Mammography Systems and Accreditation of Mammography
Facilities), with the exceptions listed in §289.230(e)(1) and (2) of
this title. The use of dental radiation machines is exempt from this section
and is covered in §289.232 of this title (relating to Radiation Control
Regulations for Dentists Using Radiation Machines).
(b)
Scope.
(1)
The registrant shall be responsible for directing the operation
of the radiation machines under the administrative control of the registrant.
The registrant shall assure that the requirements of this section are met
in the operation of such radiation machines.
(2)
In addition to the requirements of this section, all
registrants, unless otherwise specified, are subject to the requirements of §289.203
of this title (relating to Notices, Instructions, and Reports to Workers;
Inspections), §289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material Licenses, Emergency Planning and Implementation,
and Other Regulatory Services), §289.205 of this title (relating to Hearing
and Enforcement Procedures), §289.226 of this title (relating to Registration
of Radiation Machine Use and Services), and §289.231 of this title (relating
to General Provisions and Standards for Protection Against Machine Produced
Radiation).
(c)
Prohibitions.
(1)
The agency may prohibit use of radiation machines that
pose significant threat or endanger occupational and public health and safety,
in accordance with §289.205 of this title and §289.231 of this title.
(2)
Individuals shall not be exposed to the useful beam
except for healing arts purposes and unless such exposure has been authorized
by a licensed practitioner of the healing arts. This provision specifically
prohibits deliberate exposure for the following purposes:
(A)
exposure of an individual for training, demonstration,
or other non-healing arts purposes;
(B)
exposure of an individual for the purpose of healing arts
screening, except as authorized by §289.226(j)(1) of this title; and
(C)
exposure of an individual for the purpose of research,
except as authorized by §289.226(j)(2) of this title.
(3)
Non-image-intensified fluoroscopic equipment
shall not be used.
(d)
Exemptions.
(1)
Portable radiation machines designed to be hand-held are
exempt from the requirements of subsection (i)(11) of this section. The portable
radiation machine must be held by the tube housing support or handle.
(2)
Veterinary facilities are exempt from the aural communication
requirements for computed tomography (CT) in subsection (p)(2)(A) of this
section.
(3)
Individuals who are sole practitioners and sole operators
and the only occupationally exposed individual are exempt from the following
requirements:
(A)
§289.203(b) of this title; and
(B)
operating and safety procedures in accordance with subsection
(i)(2) of this section.
(4)
Registrants are exempt from the posting of the
radiation area requirements in §289.231(x)(1) of this title provided
that the operator has continuous surveillance and access control of the radiation
area.
(e)
Definitions. The following words and terms when used in
this section shall have the following meaning unless the context clearly indicates
otherwise.
(1)
Accessible surface - The external surface of the enclosure
or housing provided by the manufacturer.
(2)
Aluminum equivalent - The thickness of type 1100 aluminum
alloy affording the same attenuation, under specified conditions, as the material
in question. The nominal chemical composition of type 1100 aluminum alloy
is 99% minimum aluminum, 0.12% copper.
(3)
Attenuate -To reduce the exposure rate upon passage
of radiation through matter.
(4)
Attenuation block - A block or stack, having dimensions
20 centimeters (cm) by 20 cm by 3.8 cm, of type 1100 aluminum alloy or other
materials having equivalent attenuation. The nominal chemical composition
of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper.
(5)
Automatic exposure control (AEC) - 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).
(6)
Automatic exposure rate control (AERC) - A device
that automatically controls one or more technique factors in order to obtain
a required quantity of radiation per unit time at preselected locations.
(7)
Barrier (See definition for protective barrier).
(8)
Beam axis - A line from the source through the centers
of the x-ray fields.
(9)
Beam-limiting device - A device that provides a means
to restrict the dimensions of the x-ray field.
(10)
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.
(11)
Bone densitometer - A device intended for medical
purposes to measure bone density and mineral content by x-ray transmission
measurements through the bone and adjacent tissues.
(12)
Calibration of instruments - The comparative response
or reading of an instrument relative to a series of known radiation values
over the range of the instrument.
(13)
Calibration of machines - The measurement and specification
of absorbed dose to a medium, or exposure in air, at a defined point in a
radiation beam.
(14)
Central axis of the beam - A line passing through
the virtual source and the center of the plane figure formed by the edge of
the first beam-limiting device.
(15)
Certified equipment - Equipment that has been certified
in accordance with Title 21, Code of Federal Regulations (CFR).
(16)
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:
Figure: 25 TAC §289.227(e)(16)
(17)
Collimator - A device or mechanism by which the x-ray
beam is restricted in size.
(18)
Computed tomography (CT) - The production of a tomogram
by the acquisition and computer processing of x-ray transmission data.
(19)
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.
(20)
Contrast scale (CS) - The change in the linear attenuation
coefficient per CT number (CTN) relative to water; that is:
Figure: 25 TAC §289.227(e)(20)
(21)
Control panel - The part of the radiation machine
control upon which are mounted the switches, knobs, push buttons, and other
hardware necessary for manually setting the technique factors.
(22)
CT conditions of operation - All selectable parameters
governing the operation of a CT x-ray system including, but not limited to,
nominal tomographic section thickness, filtration, and the technique factors
as defined in this subsection.
(23)
CT gantry - The tube housing assemblies, beam-limiting
devices, detectors, and the supporting structures and frames that hold these
components.
(24)
CT number (CTN) - The number used to represent the
x-ray attenuation associated with each elemental area of the CT image, that
is:
Figure: 25 TAC §289.227(e)(24)
(25)
Diagnostic source assembly - The tube housing assembly
with a beam-limiting device attached.
(26)
Diagnostic x-ray system - An x-ray system designed
for irradiation of any part of the human body or any animal for the purpose
of diagnosis or visualization.
(27)
Diaphragm - A device or mechanism by which the x-ray
beam is restricted in size.
(28)
Entrance exposure - The exposure expressed in roentgens
(R), measured in air with the specified technique, calculated or adjusted
to represent the exposure at the point where the center of the useful beam
enters the patient.
(29)
Entrance exposure rate - The exposure per unit time
at the point where the center of the useful beam enters the patient.
(30)
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.
(31)
Field size - The dimensions along the major axes
of an area in a plane perpendicular to the central axis of the beam at the
normal treatment or examination source to image distance and defined by the
intersection of the major axes and the 50% isodose line.
(32)
Filter - Material placed in the useful beam to preferentially
absorb selected radiations.
(33)
Fluoroscopic imaging assembly - A subsystem in which
x-ray photons produce a fluoroscopic image. It includes the image receptors
such as the image intensifier and spot-film device, electrical interlocks,
if any, and structural material providing linkage between the image receptor
and diagnostic source assembly.
(34)
Focal spot - The area projected on the anode of the
x-ray tube bombarded by the electrons accelerated from the cathode and from
which the useful beam originates.
(35)
Gantry - That part of the system supporting and allowing
possible movement of the radiation source.
(36)
General purpose x-ray system - Any radiographic x-ray
system that is not limited by design to radiographic examinations of specific
anatomical regions.
(37)
Gonadal shield - A protective barrier for the testes
or ovaries.
(38)
Half-value layer (HVL) - The thickness of a specified
material that attenuates the beam of radiation to an extent such that the
exposure rate is reduced to one-half of its original value.
(39)
Healing art - 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.
(40)
Healing arts screening - The testing of asymptomatic
human beings using radiation machines for the detection or evaluation of health
indications when such tests are not specifically and individually ordered
by a licensed practitioner of the healing arts legally authorized to prescribe
such x-ray tests for the purpose of diagnosis or treatment.
(41)
High level control for fluoroscopy - Any selected
mode having an entrance exposure rate above 10 roentgens per minute (R/min).
This mode must meet the high level requirements in subsection (o)(3)(A)(i)(II),
(ii)(II), or (iii)(II) of this section.
(42)
Image intensifier - A device, installed in its housing,
that instantaneously converts an x-ray pattern into a corresponding light
image of higher energy density.
(43)
Image receptor - Any device, such as a fluorescent
screen or radiographic film, that transforms incident x-ray photons either
into a visible image or into another form that can be made into a visible
image by further transformations.
(44)
Irradiation - The exposure of matter to ionizing
radiation.
(45)
kV - Kilovolt.
(46)
kVp - Kilovolt peak (See definition for peak tube
potential).
(47)
kWs - Kilowatt-second. It is equivalent to 10 E 3
watt-second, where 1 watt-second =1 kV x 1milliampere (mA) x 1 second.
(48)
Lead equivalent - The thickness of lead affording
the same attenuation, under specified conditions, as the material in question.
(49)
Leakage radiation - Radiation emanating from the
diagnostic or therapeutic source assembly except for the useful beam and radiation
produced when the exposure switch or timer is not activated.
(50)
Leakage technique factors - The technique factors
associated with the diagnostic source assembly that are used in measuring
leakage radiation. They are defined as follows:
(A)
for diagnostic source assemblies intended for capacitor
energy storage equipment, the maximum-rated peak tube potential and the maximum-rated
number of exposures in an hour for operation at the maximum-rated peak tube
potential with the quantity of charge per exposure being 10 millicoulombs
(10 milliampere-second (mAs)) or the minimum obtainable from the unit, whichever
is larger;
(B)
for diagnostic source assemblies intended for field emission
equipment rated for pulsed operation, the maximum-rated peak tube potential
and the maximum-rated number of x-ray pulses in an hour for operation at the
maximum-rated peak tube potential; or
(C)
for all other diagnostic source assemblies, the maximum-rated
peak tube potential and the continuous tube current for the maximum-rated
peak tube potential.
(51)
Licensed medical physicist - An individual holding
a current Texas license under the Medical Physics Practice Act, Texas Civil
Statutes, Article 4512n.
(52)
Linear attenuation coefficient (u) - The quotient
of dN/N by dl when dN/N is the fraction of uncharged ionizing radiation that
experiences interactions in traversing a distance dl in a specified material.
(53)
mA - Milliampere.
(54)
mAs - Milliampere-second.
(55)
Medical research - The investigation of various health
risks and diseases using radiation machines as part of the evaluation process.
(56)
Mobile services - The utilization of radiation machines
in temporary locations for limited time periods. The radiation machines may
be fixed inside a mobile van or transported to temporary locations.
(57)
Mobile x-ray equipment - (See definition for x-ray
equipment).
(58)
Multiple tomogram system - A computed tomography
x-ray system that obtains x-ray transmission data simultaneously during a
single scan to produce more than one tomogram.
(59)
Nominal tomographic section thickness - The full-width
at half-maximum of the sensitivity profile taken at the center of the cross
sectional volume over which x-ray transmission data are collected.
(60)
Non-certified equipment - Equipment manufactured
and assembled prior to certification requirements of Title 21, CFR, effective
as specified in Title 21, CFR, Part 1020.30(a).
(61)
Patient - An individual subjected to healing arts
examination, diagnosis, or treatment.
(62)
Peak tube potential - The maximum value of the potential
difference in kilovolts across the x-ray tube during an exposure.
(63)
Phantom - A volume of material behaving in a manner
that can be related to tissue with respect to the attenuation and scattering
of radiation.
(64)
Phototimer - A method for controlling exposures to
image receptors by the amount of radiation that reaches a radiation monitoring
device. The radiation monitoring device is part of an electronic circuit that
controls the duration of time the tube is activated (See definition for automatic
exposure control).
(65)
Portable x-ray equipment (See definition for x-ray
equipment).
(66)
Practitioner of the healing arts (practitioner) -
A person licensed to practice healing arts by either the Texas State Board
of Medical Examiners as a physician, the Texas Board of Chiropractic Examiners,
or the Texas State Board of Podiatry Examiners.
(67)
Primary protective barrier - (See definition for
protective barrier).
(68)
Protective apron - An apron made of radiation absorbing
materials used to reduce radiation exposure.
(69)
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.
(B)
secondary protective barrier - A barrier sufficient to
attenuate the stray radiation to the required degree.
(70)
Protective glove - A glove made of radiation
absorbing materials used to reduce radiation exposure.
(71)
Radiograph - An image receptor on which the image
is created directly or indirectly by an x-ray exposure and results in a permanent
record.
(72)
Reference plane - A plane that is displaced from
and parallel to the tomographic plane.
(73)
Scan - The complete process of collecting x-ray transmission
data for the production of a tomogram. Data can be collected simultaneously
during a single scan for the production of one or more tomograms.
(74)
Scan increment - The amount of relative displacement
of the patient with respect to the CT x-ray system between successive scans
measured along the direction of such displacement.
(75)
Scan sequence - A preselected set of two or more
scans performed consecutively under preselected CT conditions of operation.
(76)
Scan time - The period of time between the beginning
and end of x-ray transmission data accumulation for a single scan.
(77)
Scattered radiation - radiation that has been deviated
in direction during passage through matter.
(78)
Secondary protective barrier (See definition for
protective barrier).
(79)
Shutter - A device attached to the tube housing assembly
that can totally intercept the useful beam and that has a lead equivalency
not less than that of the tube housing assembly.
(80)
Single tomogram system - CT x-ray system that obtains
x-ray transmission data during a scan to produce a single tomogram .
(81)
Source - The focal spot of the x-ray tube.
(82)
Source-to-image receptor distance (SID) - The distance
from the source to the center of the input surface of the image receptor.
(83)
Source-to-skin distance (SSD) - The distance from
the source to the skin of the patient.
(84)
Spacer - A device designed to limit the target to
skin distance.
(85)
Special purpose x-ray system - Any radiographic x-ray
system that is limited by design to radiographic examinations of specific
anatomical regions. Special purpose x-ray systems include, but are not limited
to, dedicated chest units, cystography units, and head and skull units.
(86)
Special procedures - The application of special x-ray
equipment and specialized techniques to obtain required diagnostic information.
This usually provides enhanced detail of a given anatomical structure but
with reduced visualization of others. Special procedures include, but are
not limited to, angiography, cardiac catheterization, myelogram, and surgery.
(87)
Spot film - A radiograph that is made during a fluoroscopic
examination to permanently record conditions that exist during that fluoroscopic
procedure.
(88)
Spot film device - A device intended to transport
and/or position a radiographic image receptor between the x-ray source and
fluoroscopic image receptor. It includes a device intended to hold a cassette
over the input end of an image intensifier for the purpose of making a radiograph.
(89)
Stationary x-ray equipment - (See definition for
x-ray equipment).
(90)
Stray radiation - The sum of leakage and scattered
radiation.
(91)
Supervision - The delegating of the task of applying
radiation in accordance with this section to persons not licensed in the healing
arts or veterinary medicine, who provide services under the practitioner's
control. The licensed practitioner or veterinarian assumes full responsibility
for these tasks and must assure that the tasks will be administered correctly.
(92)
Target - The part of a radiation head that by design
intercepts a beam of accelerated particles with subsequent emission of other
radiation.
(93)
Technique chart - A chart that provides all necessary
generator control settings and geometry needed to make clinical radiographs
when the radiography system is in manual mode.
(94)
Technique factors - The conditions of operation that
are specified as follows:
(A)
for capacitor energy storage equipment, peak tube potential
in kV and quantity of charge in mAs;
(B)
for field emission equipment rated for pulsed operation,
peak tube potential in kV and number of x-ray pulses;
(C)
for CT equipment designed for pulsed operations, peak tube
potential in kV, scan time in seconds, and either tube current in mA, x-ray
pulse width in seconds, and the number of x-ray pulses per scan or the product
of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;
(D)
for CT equipment not designed for pulsed operation, peak
tube potential in kV, and either tube current in mA and scan time in seconds
or the product of tube current and exposure time in mAs when the scan time
and exposure time are equivalent; and
(E)
for all other equipment, peak tube potential in kV and
either tube current in mA and exposure time in seconds or the product of tube
current and exposure time in mAs.
(95)
Tomogram - The depiction of the x-ray attenuation
properties of a section through the body.
(96)
Tomographic plane - The geometric plane that is identified
as corresponding to the output.
(97)
Tomographic section - The volume of an object whose
x-ray attenuation properties are imaged in a tomogram.
(98)
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.
(99)
Tube - An x-ray tube, unless otherwise specified.
(100)
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.
(101)
Useful beam - Radiation that passes through the
window, aperture, cone, or other collimating device of the source housing.
Also referred to as the primary beam.
(102)
Veterinarian - An individual licensed by the Texas
Board of Veterinary Medical Examiners.
(103)
X-ray control - A device that controls input power
to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment
such as timers, phototimers, automatic brightness stabilizers, and similar
devices that control the technique factors of an x-ray exposure.
(104)
X-ray equipment - An x-ray system, subsystem, or
component thereof. Types of x-ray equipment are as follows:
(A)
mobile x-ray equipment - x-ray equipment mounted on a permanent
base with wheels and/or casters for moving while completely assembled;
(B)
portable x-ray equipment - x-ray equipment designed to
be hand-carried; or
(C)
stationary x-ray equipment - x-ray equipment that is installed
in a fixed location.
(105)
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 is one-fourth of the maximum in the intersection.
(106)
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.
(107)
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.
(108)
X-ray subsystem - Any combination of two or more
components of an x-ray system.
(109)
X-ray tube - Any electron tube that is designed
to be used primarily for the production of x rays.
(f)
Educational facilities. Facilities conducting training
using non-humans shall comply with all the requirements of this section except
for subsection (i)(5) of this section concerning operator credentialing, subsection
(k) of this section concerning radiographic entrance exposure limits, subsections
(r) and (s) of this section concerning film processing, and subsection (q)
of this section concerning equipment performance evaluation.
(g)
Requirements for bone densitometers. Bone densitometers
shall be exempt from this chapter except for the following:
(1)
§289.203 of this title, §289.204 of this title, §289.205
of this title, §289.231 of this title, and §289.226 of this title;
(2)
healing arts screening and medical research in accordance
with §289.226(j) of this title;
(3)
purpose and scope in accordance with subsections (a)
and (b) of this section;
(4)
prohibitions in accordance with subsection (c)(1)
and (2) of this section;
(5)
exemptions in accordance with subsection (d)(1),(3),
and (4) of this section;
(6)
definitions in accordance with subsection (e) of this
section, as applicable;
(7)
operating and safety procedures in accordance with
subsection (i)(2) of this section;
(8)
operator credentialing in accordance with subsection
(i)(5) of this section;
(9)
gonadal shielding in accordance with subsection (j)(3)
of this section;
(10)
warning labels in accordance with subsection (l)(1)
of this section;
(11)
records in accordance with subsection (t) of this
section;
(12)
record requirements for authorized use locations
and authorized records locations for mobile services in accordance with subsection
(t)(1)-(3) of this section; and
(13)
record requirements for mobile services in accordance
with subsection (t)(3) of this section;
(h)
Certified equipment for chiropractic, medical, and podiatric
facilities. This subsection does not apply to veterinary facilities. In addition
to the requirements of this chapter, 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
(FDA) 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 21 CFR, Part 1020, except where a variance has
been granted by the Director, Center for Devices and Radiological Health,
FDA. A copy of the variance shall be maintained by the registrant in accordance
with subsection (t)(1) of this section for inspection by the agency.
(i)
General requirements for chiropractic, medical, podiatric,
and veterinary facilities.
(1)
Technique chart. A technique chart relevant to the particular
radiation machine shall be provided or electronically displayed in the vicinity
of the control panel and used by all operators.
(2)
Operating and safety procedures. Each registrant shall
have and implement written operating and safety procedures. These procedures
shall be made available to each individual operating a radiation machine,
including any restrictions of the operating technique required for the safe
operation of the particular x-ray system. These procedures shall include,
but are not limited to, the items in subsection (u) of this section.
(3)
Occupational dose limits and personnel monitoring.
Except as otherwise exempted, all individuals who are associated with the
operation of a radiation machine are subject to the occupational dose limits
of §289.231(m) of this title regarding dose limits to individuals, and
the personnel monitoring requirements of §289.231(n) of this title.
(4)
Protective devices. Protective devices shall be utilized
when required, as in subsection (i)(8)(B) and (D), (i)(10), and (o)(8) of
this section.
(A)
Protective devices shall be made of no less than 0.25 millimeter
(mm) lead equivalent material.
(B)
Protective devices, including aprons, gloves, and shields
shall be checked annually for defects such as holes, cracks, and tears. These
checks may be performed by the registrant by visual or tactile means, or x-ray
imaging. If a defect is found, protective devices shall be replaced or removed
from service until repaired. A record of this test shall be made and maintained
by the registrant in accordance with subsection (t)(1) of this section for
inspection by the agency.
(5)
Operator credentialing. Individuals who operate
radiation machines shall meet the appropriate credentialing requirements of
rules issued in accordance with the Medical Radiologic Technologist Act, Texas
Civil Statutes, Article 4512m. Copies of the credentialing document shall
be maintained at the locations(s) where the individual is working.
(6)
Practice of Medical Physics. Surveys, tests, or evaluations
required by this section may constitute the practice of medical physics and,
therefore, require a license from the Texas Board of Licensure for Professional
Medical Physicists in accordance with the Medical Physics Practice Act, Texas
Civil Statutes, Article 4512n.
(7)
Exposure of individuals other than the patient. No
individual other than a patient, operator, and ancillary personnel shall be
in the x-ray room or area while exposures are being made unless such individual's
assistance is required.
(8)
Holding of patient or film (image receptor).
(A)
When a patient or film (image receptor) must be held in
position during radiography, mechanical supporting or restraining devices
shall be used when the exam permits.
(B)
If a patient or film (image receptor) must be held by an
individual during an exposure, that individual shall be protected with appropriate
shielding devices described in paragraph (4) of this subsection.
(C)
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 film (image receptor).
(D)
In those cases where the patient must hold the film (image
receptor), any portion of the body other than the area of clinical interest
struck by the useful beam shall be protected by not less than 0.25 mm lead
equivalent material.
(9)
Viewing system. Windows, mirrors, closed circuit
television, or a method shall be provided to permit the operator to continuously
observe the patient during irradiation.
(10)
Operator position. The operator position during the
exposure shall be such that the operator's exposure is as low as reasonably
achievable (ALARA) and the operator is a minimum of six feet from the source
of radiation or protected by an apron, gloves, or other shielding having a
minimum of 0.25 lead equivalent material.
(11)
Holding of tube. In no case shall an individual hold
the tube or tube housing assembly supports during any radiographic exposure.
(j)
Requirements specifically for chiropractic, medical, and
podiatric facilities.
(1)
Patient protection. Notwithstanding the provisions of subsection
(i)(7) of this section, other patients who are in line with the primary beam
and who cannot be removed from the room shall be protected by whole body protective
barriers of a minimum of 0.25 mm lead equivalent material or so positioned
that the nearest portion of their body is at least six feet from both the
tube head and the nearest edge of the image receptor.
(2)
Contact with the patient. The operator shall be able
to maintain verbal, visual, and aural contact with the patient.
(3)
Gonadal shielding. Gonadal shielding shall be used
on patients when the gonads are in or within 5 cm of the useful beam. This
requirement does not apply if the shielding will interfere with the diagnostic
procedure. Gonadal shielding shall be of at least 0.5 mm lead equivalent material.
(k)
Radiographic entrance exposure limits for chiropractic,
medical, and podiatric facilities. This subsection does not apply to veterinary
facilities. The in-air exposure determined for the technique used for the
specified average human adult patient thickness for routine medical radiography
shall not exceed the entrance exposure limits in the following Table I.
Figure: 25 TAC §289.227(k)
(l)
General requirements for all diagnostic x-ray systems for
chiropractic, medical, podiatric, and veterinary facilities.
(1)
Warning label. The warning label will meet the requirements
of §289.231(z) of this title.
(2)
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 x-ray system.
(3)
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.
(4)
Radiation from components other than the diagnostic
source assembly. The radiation emitted by a component other than the diagnostic
source assembly shall not exceed 2 milliroentgens (mR) in one hour at 5 cm
from any accessible surface of the component when it is operated in an assembled
x-ray system under any conditions for which it was designed. Measurement is
averaged over an area of 100 square centimeters (cm
2
) with no linear dimension greater than 20 cm.
(5)
Beam quality. The following requirements apply to
beam quality.
(A)
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
II. If it is necessary to determine such half-value layer at an x-ray tube
potential that is not listed in Table II, linear interpolation may be made.
Figure: 25 TAC §289.227(l)(5)(A)(i)
(ii)
For capacitor energy storage equipment, compliance with
the requirements of paragraph (5) of this subsection shall be determined with
the maximum quantity of charge per exposure.
(B)
Filtration controls.
(i)
For x-ray systems that have variable kVp and variable filtration
for the useful beam, a device shall link the kVp selector with the filters
and shall prevent an exposure unless the minimum amount of filtration required
by subparagraph (A) of this paragraph is in the useful beam for the given
kVp that has been selected.
(ii)
Any other system having removable filters shall be required
to have the minimum amount of filtration as required by subparagraph (A)(i)
of this paragraph permanently located in the useful beam during each exposure.
(6)
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 prior to 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.
(7)
Technique and exposure indicators.
(A)
The technique factors to be used during an exposure shall
be indicated before the exposure begins except when automatic exposure controls
are used, in which case the technique factors that are set prior to the exposure
shall be indicated.
(B)
On equipment having fixed technique factors, the requirement
of subparagraph (A) of this paragraph may be met by permanent markings.
(C)
The x-ray control shall provide visual indication of the
production of x rays.
(D)
The indicated technique factors shall be accurate to meet
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.
(m)
Additional requirements specifically for chiropractic,
medical, and podiatric x-ray systems. This subsection does not apply to fluoroscopic,
veterinary, or CT x-ray systems.
(1)
Beam limitation. Beam limitation shall be as follows.
(A)
Stationary general purpose x-ray systems.
(i)
Beam-limiting devices shall restrict the useful beam to
the area of clinical interest as follows:
(I)
the misalignment of the x-ray field for a manual rectangular
collimator shall be within 2.0% of the SID for the length or width of the
image receptor;
(II)
the x-ray field for a circular or polygon collimator shall
not exceed the diagonal of the image receptor by more than 2.0% of the SID;
or
(III)
the misalignment of the x-ray field for an automatic
or semi-automatic collimator shall be within 3.0% of the SID for the length
and width of the image receptor and must be within 4.0% of the SID, without
regard to the sign, of the sum of the difference of the length and width of
the image receptor.
(ii)
A method shall be provided for visually defining the perimeter
of the x-ray field. The total misalignment of the edges of the visually defined
field with the respective edges, either the length or width, of the x-ray
field shall not exceed 2.0% of the SID.
(iii)
An SID indicator shall be present and shall be accurate
to within 2.0% of the SID.
(iv)
The system shall indicate when the axis of the x-ray field
is perpendicular to the plane of the image receptor.
(v)
The center of the x-ray field, when perpendicular to the
image receptor, shall be accurate to within 2.0% of the SID with respect to
the center of the image receptor.
(vi)
The beam-limiting device shall numerically indicate the
field size in the plane of the image receptor.
(vii)
Indication of field size dimensions and SIDs shall be
specified in inches and/or centimeters.
(viii)
The field size indicated on the beam-limiting device
shall be within 2.0% of the SID along the width and length, separately, of
the actual x-ray field size.
(B)
Mobile x-ray systems. Mobile x-ray systems shall comply
with the requirements in subparagraph (A)(i)-(iii) of this paragraph.
(C)
Radiographic systems designed for one image receptor size.
Radiographic equipment designed for only one image receptor size at a fixed
SID shall provide a means to do the following:
(i)
limit the x-ray field to no greater than the dimensions
of the image receptor at the SID, and to align the center of the x-ray field
with the center of the image receptor to within 2.0% of the SID center; or
(ii)
align the x-ray field such that the x-ray field does not
extend beyond any edge of the image receptor at the SID.
(D)
Special purpose x-ray systems.
(i)
When the x-ray beam is perpendicular to the plane of the
image receptor, a means shall be provided to do the following:
(I)
limit the x-ray field such that the x-ray field does not
exceed each dimension of the image receptor by more than 2.0% of the SID;
and
(II)
align the center of the x-ray field with the center of
the image receptor to within 2.0% of the SID.
(ii)
The requirements of clause (i) of this subparagraph may
be met with a system that meets the requirements for a general purpose x-ray
system as specified in subparagraphs (A)(i)-(iv) of this paragraph or, when
alignment means are also provided, may be met with either of the following:
(I)
an assortment of removable, fixed-aperture, beam-limiting
devices sufficient to meet the requirement for each combination of image receptor
size and SID for which the unit is designed with each such device having clear
and permanent markings to indicate the image receptor size and SID for which
it is designed; or
(II)
a beam-limiting device having multiple fixed apertures
sufficient to meet the requirement for each combination of image receptor
size and SID for which the radiation machine is designed. Permanent, clearly
legible markings shall indicate the image receptor size and SID for which
each aperture is designed and shall indicate which aperture is in position
for use.
(2)
Radiation exposure control devices.
Radiation exposure control devices shall include the following:
(A)
X-ray control. An x-ray control shall be incorporated into
each x-ray system such that an exposure can be terminated by the operator
at any time except for an exposure of 0.5 seconds or less or during serial
radiography when means shall be provided to permit completion of any single
exposure of the series in process. The exposure switch shall be of the continuous
pressure type.
(B)
Timers. 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.
(C)
AEC. When an AEC is provided, the following shall occur.
(i)
Indication shall be made on the control panel when this
mode of operation is selected.
(ii)
If the x-ray tube potential is equal to or greater than
50 kVp, the minimum exposure time for field emission equipment rated for pulsed
operation shall be equal to or less than a time interval equivalent to two
pulses.
(iii)
The minimum exposure time for all equipment other than
that specified in clause (ii) of this subparagraph shall be equal to or less
than 0.0167 second or a time interval required to deliver 5 mAs, whichever
is greater.
(iv)
Either the product of peak x-ray tube potential, current,
and exposure time shall be limited to not more than 60 kWs per exposure, or
the product of x-ray tube current and exposure time shall be limited to not
more than 600 mAs per exposure except that, when the x-ray tube potential
is less than 50 kVp, the product of x-ray tube current and exposure time shall
be limited to not more than 2,000 mAs per exposure.
(v)
A visible and/or audible signal shall indicate when an
exposure has been terminated at the limits required by clause (iv) of this
subparagraph, and manual resetting shall be required before further automatically
timed exposures can be made.
(D)
Exposure interval reproducibility. When all technique factors
are held constant, including control panel selections associated with AEC
systems, the coefficient of variation of exposure interval for both manual
and AEC systems shall not exceed 0.05. This requirement applies to clinically
used techniques.
(3)
SSD. All mobile or portable radiographic systems
shall be provided with means to limit the SSD to equal to or greater than
30 cm.
(4)
Exposure reproducibility. When all technique factors
are held constant, including control panel selections associated with AEC
systems, the coefficient of variation of exposure for both manual and AEC
systems shall not exceed 0.05. This requirement applies to clinically used
techniques.
(5)
Linearity.
Figure: 25 TAC §289.227(m)(5)
(6)
Radiation from capacitor energy storage equipment
in standby status. Radiation emitted from the x-ray tube when the exposure
switch or timer is not activated shall not exceed a rate of 2 milliroentgens
per hour (mR/hr) at 5 cm from any accessible surface of the diagnostic source
assembly, with the beam-limiting device fully open.
(n)
Additional requirements specifically for veterinary x-ray
systems.
(1)
The x-ray control shall provide visual or audible indication
of the production of x-rays observable at or from the operator's protected
position whenever xrays are produced.
(2)
Beam limiting devices shall do the following:
(A)
provide the same degree of protection as is required of
the housing;
(B)
restrict the useful beam to the area of clinical interest;
(C)
limit the x-ray field such that the x-ray field shall not
exceed:
(i)
2.0% of the SID for the length or width of the rectangular
image receptor; or
(ii)
2.0% of the SID for the diagonal of the image receptor
for circular image receptors.
(3)
A means shall be provided to center the
primary beam to the image receptor within 2.0% of the SID.
(4)
A means shall be provided to terminate the exposure
at the following:
(A)
a preset time interval;
(B)
a preset product of current and time;
(C)
a preset number of pulses; or
(D)
a preset radiation exposure to the image receptor.
(5)
The radiation machine shall not be able to make
an exposure when the timer is set to a "zero" or "off" position if either
position is provided.
(6)
All stationary, mobile, or portable x-ray systems
used for veterinary x rays shall be provided with the following:
(A)
a continuous pressure type exposure switch; and
(B)
either a six and one-half foot high protective barrier
for operator protection during exposures; or
(C)
a means provided for the operator to be at least six feet
from the tube housing assembly.
(7)
Operators using portable radiation machines designed
to be hand-held are exempt from the requirements of paragraph (6) of this
subsection. The hand-held portable radiation machine shall be held by the
tube housing support or handle. The operator shall wear protective devices
in accordance with subsection (i)(4) of this section.
(8)
When all technique factors are held constant, including
control panel selections associated with AEC systems, the coefficient of variation
of exposure for both manual and AEC systems shall not exceed 0.05. This requirement
applies to clinically used techniques.
(9)
The technique factors to be used during an exposure
shall be indicated before the exposure begins. If AECs are used, the technique
factors that are set prior to the exposure shall be indicated.
(10)
For machines having fixed technique factors, the
requirements of paragraph (9) of this subsection may be met by permanent markings
on the equipment. Indication of technique factors shall be visible from the
operator's position except in the case of spot films made by the fluoroscopist.
(11)
Fluoroscopic and CT units used in veterinary facilities
shall meet the requirements of subsections (o) and (p) of this section. Therapy
systems used in veterinary facilities shall meet the requirements of §289.229
of this title.
(12)
Portable machines shall be used in a manner that
complies with this section.
(13)
All exams and retakes shall be ordered by the veterinarian.
(o)
Fluoroscopic x-ray systems and spot-film devices for all
facilities.
(1)
Limitation of the useful beam. Limitation of the useful
beam shall be as follows.
(A)
Primary barrier.
(i)
The fluoroscopic imaging assembly shall be provided with
a primary protective barrier that intercepts the entire cross section of the
useful beam at any SID.
(ii)
The x-ray tube used for fluoroscopy shall not produce
x rays unless the barrier is in position to intercept the useful beam and
the imaging device is in place and operable.
(iii)
The exposure rate due to transmission through the barrier
with the attenuation block in the useful beam, combined with radiation through
the image intensifier if provided, shall not exceed 3.34 x 10
-3
% of the entrance exposure rate at a distance of 10 cm from any accessible
surface of the fluoroscopic imaging assembly beyond the plane of the image
receptor.
(B)
Measuring compliance of barrier transmission.
(i)
The exposure rate due to transmission through the primary
protective barrier combined with radiation through the image intensifier shall
be determined by measurements averaged over an area of 100 cm
2
with no linear dimension greater than 20 cm.
(ii)
If the source is below the tabletop, the measurement shall
be made with the input surface of the fluoroscopic imaging assembly positioned
30 cm above the tabletop.
(iii)
If the source is above the tabletop and the SID is variable,
the measurement shall be made with the end of the beam-limiting device or
spacer as close to the tabletop as it can be placed, provided that it shall
not be closer than 30 cm.
(iv)
Movable grids and compression devices shall be removed
from the useful beam during the measurement.
(v)
The attenuation block shall be positioned in the useful
beam 10 cm from the point of measurement of entrance exposure rate and between
this point and the input surface of the fluoroscopic imaging assembly.
(vi)
The collimator shall be fully open when the measurement
is made.
(C)
X-ray field.
(i)
Compliance with clauses (ii)-(vii) of this subparagraph
shall be determined with the beam axis perpendicular to the plane of the image
receptor.
(ii)
Equipment with a fixed SID and the capability of a visible
area of no greater than 300 cm
2
shall be provided
with either stepless adjustment of the x-ray field or a means to further limit
the x-ray field at the image receptor to 125 cm
2
or less. If the equipment is provided with stepless adjustment, the minimum
x-ray field size at the maximum SID shall be less than or equal to 5 cm by
5 cm at the image receptor.
(iii)
Equipment with a variable SID or a fixed SID with the
capability of a visible area of greater than 300 cm
2
shall be provided with stepless adjustment of the field size. The
minimum x-ray field size at the maximum SID shall be less than or equal to
5 cm by 5 cm at the image receptor.
(iv)
Neither the length nor the width of the x-ray field in
the plane of the image receptor shall exceed that of the visible area of the
image receptor by more than 3.0% of the SID. The sum of the excess length
and the excess width shall be no greater than 4.0% of the SID.
(v)
For rectangular x-ray fields used with circular image receptors,
the error in alignment shall be determined along the length and width dimensions
of the x-ray field that pass through the center of the visible area of the
image receptor.
(vi)
For fluoroscopic equipment with only a manual mode of
collimation, the x-ray field produced shall be limited to the area of the
spot-film cassette at 16 inches above tabletop. Additionally, during fluoroscopy,
the beam shall be restricted to the area of the input phosphor.
(vii)
Spot-film devices shall meet the following additional
requirements.
(I)
Means shall be provided between the source and the patient
for adjustment of the x-ray field size in the plane of the film to the size
of that portion of the film that has been selected on the spot-film selector.
(-a-)
Such adjustment shall be automatically accomplished except
when the x-ray field size in the plane of the film is smaller than that of
the selected portion of the film.
(-b-)
The total misalignment of the edges of the x-ray
field with the respective edges of the selected portion of the image receptor
along the length or width dimensions of the x-ray field in the plane of the
image receptor shall not exceed 3.0% of the SID when adjusted for full coverage
of the selected portion of the image receptor.
(-c-)
The sum, without regard to sign of the misalignment
along any two orthogonal dimensions, shall not exceed 4.0% of the SID.
(II)
The center of the x-ray field in the plane of the film
shall be aligned with the center of the selected portion of the film to within
2.0% of the SID.
(2)
Activation of the fluoroscopic tube.
X-ray production in the fluoroscopic mode shall be controlled by a device
that requires continuous pressure by the fluoroscopist for the entire time
of the exposure (continuous pressure type switch). When recording serial fluoroscopic
images, the fluoroscopist shall be able to terminate the x-ray exposures at
any time, but means may be provided to permit completion of any single exposure
of the series in process.
(3)
Entrance exposure rate allowable limits.
(A)
The following requirements apply to fluoroscopic equipment
manufactured prior to May 19, 1995.
(i)
Equipment with AERC. Fluoroscopic equipment that is provided
with AERC shall not be operable at any combination of tube potential and current
that will result in an exposure rate in excess of 2.58 x 10
-3
coulomb per kilogram per minute (C/kg/min) (10 roentgens per minute
(10 R/min)) at the point where the center of the useful beam enters the patient,
except:
(I)
during recording of fluoroscopic images, excluding last
image hold; or
(II)
when an optional high-level control is provided. When
so provided, the equipment shall not be operable at any combination of tube
potential and current that will result in an exposure rate in excess of 1.29
x 10
-3
C/kg/min (5 R/min) at the point where
the center of the useful beam enters the patient, unless the high-level control
is activated. Special means of activation of high-level controls shall be
required. The high- level control shall be operable only when continuous manual
activation is provided by the operator. A continuous signal audible to the
fluoroscopist shall indicate that the high-level control is being employed.
(ii)
Equipment without AERC (manual mode). Fluoroscopic equipment
that is not provided with AERC shall not be operable at any combination of
tube potential and current that will result in an exposure rate in excess
of 1.29 x 10
-3
C/kg/min (5 R/min) at the point
where the center of the useful beam enters the patient, except:
(I)
during recording of fluoroscopic images, excluding last
image hold; or
(II)
when an optional high-level control is activated. Special
means of activation of high-level controls shall be required. The high-level
control shall be operable only when continuous manual activation is provided
by the operator. A continuous signal audible to the fluoroscopist shall indicate
that the high-level control is being employed.
(iii)
Equipment with both an AERC mode and a manual mode. Fluoroscopic
equipment that is provided with both an AERC mode and a manual mode shall
not be operable at any combination of tube potential and current that will
result in an exposure rate in excess of 2.58 x 10
-3
C/kg/min (10 R/min) in either mode at the point where the center of
the useful beam enters the patient except:
(I)
during recording of fluoroscopic images, excluding last
image hold; or
(II)
when the mode or modes have an optional high-level control,
in which case that mode or modes shall not be operable at any combination
of tube potential and current that will result in an exposure rate in excess
of 1.29 x 10
-3
C/kg/min (5 R/min) at the point
where the center of the useful beam enters the patient, unless the high level
control is activated. Special means of activation of high-level control shall
be required. The high level control shall be operable only when continuous
manual activation is provided by the operator. A continuous signal audible
to the fluoroscopist shall indicate that the high-level is being employed.
(iv)
Measuring compliance. Compliance with subparagraph (A)
of this paragraph shall be determined as follows.
(I)
If the source is below the x-ray table, the exposure rate
shall be measured at 1 cm above the tabletop or cradle.
(II)
If the source is above the x-ray table, the exposure rate
shall be measured at 30 cm above the tabletop with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of measurement.
(III)
In a C-arm type of fluoroscope, the exposure rate shall
be measured at 30 cm from the input surface of the fluoroscopic imaging assembly
provided that the end of the beam-limiting device or spacer is no closer than
30 cm from the input surface of the fluoroscopic imaging assembly. The applicable
limit shall not be exceeded at any available SID.
(IV)
In a lateral (horizontal) type of fluoroscope, the exposure
rate shall be measured at a point 15 cm from the centerline of the x-ray table
and in the direction of the x-ray source with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of measurement.
If the table top is movable, it shall be positioned as closely as possible
to the lateral x-ray source, with the end of the beam-limiting device or spacer
no closer than 15 cm to the centerline of the x-ray table.
(B)
The following requirements apply to fluoroscopic equipment
manufactured on and after May 19, 1995.
(i)
Fluoroscopic equipment operable at any combination of tube
potential and current that will result in an exposure rate greater than 1.29
x 10
-3
C/kg/min (5 R/min) at the point where
the center of the useful beam enters the patient shall be equipped with AERC.
Provision for manual selection of technique factors may be provided.
(ii)
Fluoroscopic equipment shall not be operable at any combination
of tube potential and current that will result in an exposure rate in excess
of 2.58 x 10
-3
C/kg/min (10 R/min) at the point
where the center of the useful beam enters the patient except:
(I)
During the recording of images from an x-ray image- intensifier
tube using photographic film or a video camera when the x-ray source is operated
in a pulsed mode.
(II)
When the high-level control is activated, the equipment
shall not be operable at any combination of tube potential and current that
will result in an exposure rate in excess of 5.16 x 10
-3
C/kg/min (20 R/min) at the point where the center of the useful
beam enters the patient. Special means of activation of high-level controls
shall be required. The high-level control shall only be operable when continuous
manual activation is provided by the operator. A continuous signal audible
to the fluoroscopist shall indicate that the high-level control is being employed.
(iii)
Measuring compliance. Compliance with subparagraph (B)
of this paragraph shall be determined as follows.
(I)
If the source is below the x-ray table, the exposure rate
shall be measured at 1 cm above the tabletop or cradle.
(II)
If the source is above the x-ray table, the exposure rate
shall be measured at 30 cm above the tabletop with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of measurement.
(III)
In a C-arm type of fluoroscope, the exposure rate shall
be measured at 30 cm from the input surface of the fluoroscopic imaging assembly
provided that the end of the beam-limiting device or spacer is no closer than
30 cm from the input surface of the fluoroscopic imaging assembly. The applicable
limit shall not be exceeded at any available SID.
(IV)
In a lateral (horizontal) type of fluoroscope, the exposure
rate shall be measured at a point 15 cm from the centerline of the x-ray table
and in the direction of the x-ray source with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of measurement.
If the table top is movable, it shall be positioned as closely as possible
to the lateral x-ray source, with the end of the beam-limiting device or spacer
no closer than 15 cm to the centerline of the x-ray table.
(C)
For hand-held fluoroscopes, the exposure rate shall be
measured at the point closest to the source.
(D)
Periodic measurement of entrance exposure rate shall be
performed as follows by a licensed medical physicist with a specialty in diagnostic
radiological physics.
(i)
Such measurements shall be made within 30 days of installation,
annually, and within 30 days after any maintenance of the system that might
affect the exposure rate.
(ii)
Results of these measurements shall be posted where any
fluoroscopist may have ready access to such results while using the fluoroscope
and maintained in accordance with subsection (t)(1) of this section for inspection
by the agency. The measurement results shall be stated in R/min and include
the technique factors used in determining such results. The name of the person
performing the measurements and the date the measurements were performed shall
be included in the results.
(iii)
Conditions of periodic measurement of entrance exposure
rate are as follows.
(I)
The measurement shall be made in accordance with subparagraph
(A)(iv) or (B)(iii) of this paragraph, as applicable.
(II)
X-ray systems that do not incorporate an AERC shall utilize
a milliamperage and kVp typical of the clinical use of the x-ray system. Materials
should be placed in the useful beam between the detection and imaging systems
when conducting these periodic measurements to protect the imaging system.
(III)
X-ray systems that do incorporate an AERC shall have
sufficient material placed in the useful beam to produce a milliamperage and
kVp typical of the clinical use of the x-ray system.
(4)
Measurements of the output rate. Measurements
of the output rate of the fluoroscopic unit shall be performed with a calibrated
dosimetry system. The dosimetry system shall have been calibrated within the
preceding 24 months and the calibration shall be traceable to a national standard.
During the calendar year in which the dosimetry system is not calibrated,
an intercomparison to a system calibrated within the previous 12 months shall
be performed.
(5)
Indication of potential and current. During fluoroscopy
and cinefluorography, the kV and the mA shall be continuously indicated at
the control panel and/or the fluoroscopist's position.
(6)
SSD. The SSD shall not be less than the following:
(A)
38 cm on stationary fluoroscopes installed after March
1, 1989;
(B)
35.5 cm on stationary fluoroscopes that were in operation
prior to March 1, 1989;
(C)
30 cm on all mobile and portable fluoroscopes;
(D)
20 cm for image-intensified fluoroscopes used for examinations
as specified in the registrant's operating and safety procedures. The written
operating and safety procedures shall provide precautionary measures to be
adhered to during the use of this device. The procedures must provide information
on the means to restore the unit to a 30 cm SSD when the unit is returned
to general service; and
(E)
the FDA approved variance for a specific manufacturer of
a hand- held fluoroscope.
(7)
Fluoroscopic timer.
(A)
Means shall be provided to preset the cumulative on-time
of the fluoroscopic x-ray tube. The maximum cumulative time of the timing
device shall not exceed five minutes without resetting.
(B)
A signal audible to the fluoroscopist shall indicate the
completion of any preset cumulative on-time. Such signal shall continue to
sound while x rays are produced until the timing device is reset. In lieu
of such signal, the timer shall terminate the beam after the preset cumulative
on-time is completed.
(8)
Control of scattered radiation.
(A)
Fluoroscopic configuration, including fluoroscopic table
designs, shall not permit any portion of any individual's body, except the
head, neck, and extremities, to be exposed to scattered radiation emanating
from above or below the tabletop unless the radiation has passed through not
less than a total of 0.25 mm lead equivalent material. The material may be,
but is not limited to, drapes, self-supporting curtains, or viewing shields,
in addition to any lead equivalency provided by a protective apron.
(B)
Where sterile fields or special procedures prohibit the
use of normal protective barriers or drapes, all of the following conditions
shall be met.
(i)
All persons, except the patient, in the room where fluoroscopy
is performed shall wear protective aprons that provide a shielding equivalent
of 0.5 mm of lead.
(ii)
The fluoroscopic field size shall be reduced to the absolute
minimum required for the procedure being performed (area of clinical interest).
(iii)
Operating and safety procedures shall reflect the above
conditions, and fluoroscopy personnel shall exhibit awareness of situations
requiring the use and/or nonuse of the protective drapes.
(C)
For image-intensified fluoroscopic equipment with only
a manual mode of collimation, the x-ray field produced shall be limited to
the area of the spot-film cassette at 16 inches above tabletop. Additionally,
during fluoroscopy, the beam shall be restricted to the area of the input
phosphor.
(p)
CT x-ray systems.
(1)
Equipment requirements shall include the following.
(A)
Tomographic plane indication and alignment.
(i)
For any single tomogram system, means shall be provided
to permit visual determination of the tomographic plane or a reference plane
offset from the tomographic plane.
(ii)
For any multiple tomogram system, means shall be provided
to permit visual determination of the location of a reference plane. The reference
plane can be offset from the location of the tomographic planes.
(iii)
If a device using a light source is used to satisfy the
requirements of clause (i) or (ii) of this subparagraph, the light source
shall provide illumination levels sufficient to permit visual determination
of the location of the tomographic plane or reference plane under ambient
light conditions of up to 500 lux.
(B)
Indication of CT conditions of operation. The CT x-ray
system shall be designed such that the CT conditions of operation to be used
during a scan or a scan sequence are indicated prior to the initiation of
a scan or a scan sequence. On equipment having all or some of these conditions
of operation at fixed values, this requirement may be met by permanent markings.
Indication of CT conditions of operation shall be visible from any position
from which scan initiation is possible.
(C)
Initiation of operation.
(i)
The x-ray control and gantry shall provide visual indication
whenever x rays are produced and, if applicable, whether the shutter is open
or closed.
(ii)
Means shall be provided to require operator initiation
of each individual scan or series of scans.
(iii)
All emergency buttons/switches shall be clearly labeled
as to their functions.
(D)
Termination of exposure.
(i)
Means shall be provided to terminate the x-ray exposure
automatically by either de-energizing the x-ray source or shuttering the x-ray
beam in the event of equipment failure affecting data collection. Such termination
shall occur within an interval that limits the total scan time to no more
than 110% of its preset value through the use of either a backup timer or
devices that monitor equipment function.
(ii)
A signal visible to the operator shall indicate when the
x-ray exposure has been terminated through the means required by clause (i)
of this subparagraph.
(iii)
The operator shall be able to terminate the x-ray exposure
at any time during a scan or series of scans under CT x-ray system control,
of greater than 0.5 seconds duration. Termination of the x-ray exposure shall
necessitate resetting of the CT conditions of operation prior to initiation
of another scan.
(E)
Additional requirements applicable to CT x-ray systems.
Additional requirements applicable to CT x-ray systems containing a gantry
manufactured after September 3, 1985, are as follows.
(i)
The total error in the indicated location of the tomographic
plane or reference plane shall not exceed 5 mm.
(ii)
If the x-ray production period is less than 0.5 seconds,
the indication of x-ray production shall be actuated for at least 0.5 seconds.
Indicators at or near the gantry shall be discernible from any point external
to the patient opening where insertion of any part of the human body into
the primary beam is possible.
(iii)
The deviation of indicated scan increment versus actual
increment shall not exceed plus or minus 1 mm with any mass from 0 to 100
kilograms (kg) resting on the support device. The patient support device shall
be incremented from a typical starting position to the maximum incremented
distance or 30 cm, whichever is less, and then returned to the starting position.
Measurement of actual versus indicated scan increment can be taken anywhere
along this travel.
(2)
Facility design requirements shall include
the following.
(A)
Provision shall be made for two-way aural communication
between the patient and the operator at the control panel.
(B)
Windows, mirrors, closed-circuit television, or an equivalent
shall be provided to permit continuous observation of the patient during irradiation
and shall be so located that the operator can observe the patient from the
control panel. When the primary viewing system is by electronic means, an
alternate viewing system, which may be electronic, shall be available for
use in the event of failure of the primary viewing system.
(3)
Dose measurements of the radiation output of
the CT x-ray system shall be performed as follows by a licensed medical physicist
with a specialty in diagnostic radiological physics.
(A)
Performance of the measurements shall be:
(i)
at intervals not to exceed 12 months;
(ii)
when major maintenance, except x-ray tube replacement,
that could affect radiation output is performed; and
(iii)
when a major change in equipment operation is accomplished,
for example, introduction of a new software package.
(B)
Measurements of the radiation output of a CT x-ray system
shall be performed with a calibrated dosimetry system. The dosimetry system
shall have been calibrated within the preceding 24 months and the calibration
shall be traceable to a national standard. During the calendar year in which
the dosimetry system is not calibrated, an intercomparison to a system calibrated
within the previous 12 months shall be performed.
(C)
Records of dose measurements shall be maintained by the
registrant in accordance with subsection (t)(1) of this section for inspection
by the agency.
(4)
A maintenance schedule shall be developed. This
schedule shall be included in the registrant's operating and safety procedures
and shall include but may not be limited to the following:
(A)
dose measurements required by paragraph (3)(A) of this
subsection; and
(B)
acquisition of images obtained with phantoms using the
same processing mode and CT conditions of operation as are used to perform
dose measurements required by paragraph (3)(A) of this subsection. The registrant
shall maintain either of the following in accordance with subsection (t)(1)
of this section for inspection by the agency:
(i)
photographic copies of the images obtained from the image
display device; or
(ii)
images stored in digital form.
(q)
Equipment performance evaluation for chiropractic, medical,
and podiatric facilities. This subsection does not apply to veterinary facilities.
(1)
For all x-ray systems listed in paragraphs (5)-(7) of this
subsection, the registrant shall perform, or cause to be performed, tests
necessary to assure proper function of equipment with the indicated standard
for each item specified. Such tests shall be performed at the frequency listed
in the following table.
Figure: 25 TAC §289.227(q)(1)
(2)
Records of the test results, including any numerical
readings shall be maintained by the registrant in accordance with subsection
(t)(1) of this section for inspection by the agency.
(3)
Any items not meeting the specifications of the tests
shall be corrected or repaired. The correction or repair shall begin within
30 days following the check and shall be performed according to a plan designated
by the registrant. Correction or repair shall be completed no longer than
90 days from discovery unless authorized by the agency. Records of corrections
or repairs shall be maintained by the registrant in accordance with subsection
(t)(1) of this section for inspection by the agency.
(4)
Measurements of the radiation output of an x-ray system
shall be performed with a calibrated dosimetry system. The dosimetry system
shall have been calibrated within the preceding 24 months and the calibration
shall be traceable to a national standard. During the calendar year in which
the dosimetry system is not calibrated, an intercomparison to a system calibrated
within the previous 12 months shall be performed.
(5)
Radiographic x-ray equipment performance evaluation.
(A)
Timer. 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.
(B)
Exposure reproducibility. Exposure reproducibility shall
meet the requirements of subsection (m)(4) of this section.
(C)
Linearity. mR/mAs stations shall meet the requirements
of subsection (m)(5) of this section.
(D)
kVp. If the registrant possesses documentation of the appropriate
manufacturer's kVp specifications, the radiation machine shall meet those
specifications. If the registrant does not possess documentation of the appropriate
manufacturer's kVp specifications, the indicated kVp shall be accurate to
within plus or minus 10% of the indicated setting at no less than three points
over the usual operating range of the machine.
(E)
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 unit.
(F)
Collimation. The following items shall meet the requirements
of subsection (m)(1) of this section:
(i)
numerical indicators of x-ray field size;
(ii)
light field versus x-ray field congruence;
(iii)
automatic and semi-automatic collimators unless disabled;
and
(iv)
center of x-ray field alignment with center of image receptor.
(6)
Fluoroscopic x-ray systems and spot film
devices equipment performance evaluation. Fluoroscopic equipment shall meet
the requirements of subsection (o) of this section.
(7)
CT x-ray systems equipment performance evaluation.
CT x-ray systems shall meet the requirements of subsection (p) of this section.
(r)
Automatic and manual film processing for chiropractic,
medical, podiatric, and veterinary facilities and mobile services.
(1)
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 darkroom. 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.
(2)
Chemicals shall be replaced according to the chemical
manufacturer's or supplier's recommendations or at an interval not to exceed
three months.
(3)
Darkroom light leak tests shall be performed and any
light leaks corrected at intervals not to exceed six months.
(4)
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.
(5)
Corrections or repairs of the light leaks or other
deficiencies in paragraphs (2)-(4) of this subsection shall be initiated within
72 hours of 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 correction or repairs shall include the date and initials of the individual
performing these functions and shall be maintained in accordance with subsection
(t)(1) of this section for inspection by the agency.
(6)
Documentation of the items in paragraphs (2), (3),
and (5) of this subsection 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 maintained in accordance with subsection (t)(1)
of this section for inspection by the agency.
(s)
Alternative processing systems. Users of daylight processing
systems, laser processors, self-processing film units, 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 maintained at the site where performed in accordance with subsection
(t)(1) of this section for inspection by the agency.
(t)
Record/document requirements for mobile services and authorized
use locations for chiropractic, medical, podiatric, and veterinary facilities.
(1)
Each registrant shall maintain the following records/documents
at each site, including authorized records sites for mobile services, for
inspection by the agency. The records may be maintained in electronic format.
Figure: 25 TAC §289.227(t)(1)
(2)
Records required in paragraph (1)(F), (Q), and (R)
of this subsection shall include the following:
(A)
manufacturer's name, model and serial number from the control
panel or console of the radiation machine or from the survey instrument;
(B)
dates of receipt, transfer, and disposal for records required
by paragraph (1)(Q) of this subsection; and
(C)
name of the individual recording the information.
(3)
Copies of the records/documents in paragraph
(1)(A)-(D), (H), (J), and (N)-(P) of this subsection shall be kept with radiation
machines authorized to be used for mobile services. Mobile services with on-board
film processors shall maintain the records in paragraph (1)(O) and/or (P)
of this subsection as applicable with the processor for a period of no less
than one year.
(u)
Appendices. The registrant's operating and safety procedures
shall include, but are not limited to, the following procedures as applicable:
(1)
posting notices to workers in accordance with §289.203(b)
of this title;
(2)
instructions to workers in accordance with §289.203(c)
of this title;
(3)
notifications and reports to individuals in accordance
with §289.203(d) of this title;
(4)
ordering x-ray exams in accordance with §289.231(b)(1)
of this title;
(5)
occupational dose requirements in accordance with §289.231(m)
of this title;
(6)
personnel monitoring requirements in accordance with §289.231(n),
(q), and (s) of this title;
(7)
posting of a radiation area in accordance with §289.231(x)
of this title;
(8)
use of a technique chart in accordance with subsection
(i)(1) of this section;
(9)
use of protective devices in accordance with subsection
(i)(4) of this section;
(10)
credentialing requirements for individuals operating
radiation machines in accordance with subsection (i)(5) of this section;
(11)
exposure of individuals other than the patient in
accordance with subsection (i)(7) of this section;
(12)
holding of patients or film (image receptors) in
accordance with subsection (i)(8) of this section;
(13)
gonadal shielding in accordance with subsection (j)(3)
of this section;
(14)
use of 20 cm SSD (spacers) in accordance with subsection
(o)(6)(D) of this section;
(15)
control of scattered radiation in accordance with
subsection (o)(8) of this section; and
(16)
film processing program in accordance with subsections
(r) and (s) of this section.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State, on May 22, 2000.
TRD-200003518
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
25 TAC §289.251
The Texas Department of Health (department) proposes an amendment
to §289.251, concerning exemptions, general licenses, and general license
acknowledgements for radioactive material.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.251 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist; however revisions to the rule are necessary.
The amendment incorporates an exemption for capsules containing carbon-14
urea for "in vivo" diagnostic use in humans. This exemption is an item of
compatibility with the United States Nuclear Regulatory Commission (NRC) and
as an agreement state, Texas must adopt it. The amendment incorporates additional
information required to be furnished by the holder of a general license acknowledgement
concerning certain measuring, gauging, and controlling devices. Language was
added regarding appointment by the general license acknowledgement holder
of an individual responsible for having knowledge of the appropriate agency
requirements and the authority for taking required actions to comply with
agency requirements. In addition, the amendment clarifies requirements for
reporting of changes of address (including change in the name of the holder
of a general license acknowledgement) and adds a two-year storage restriction
for devices that are not in use. The amendment reflects corrections of references
to other sections of this chapter. This amendment is also part of the department's
continuing effort to update, clarify, and simplify its rules regarding the
control of radiation based upon technological advances, public concerns, legislative
directives, compatibility with NRC, or other factors.
The department published a Notice of Intention to Review for §289.251
as required by Government Code §2001.039 in the
Texas Register
(25 TexReg 219) on January 7, 2000. No comments were
received by the department on this section.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section will be in effect, the public benefit anticipated
as a result of enforcing the section will be to ensure continued protection
of the public, workers, and the environment from unnecessary exposure to radiation
and to provide greater accountability for devices containing radioactive material.
There will be no effect on micro businesses or small businesses. There are
no anticipated economic costs to persons who are required to comply with the
section as proposed. There is no anticipated impact on local employment. Adding
the exemption for capsules containing carbon-14 urea for "in vivo" diagnostic
use incorporates in rule an exemption that is currently being handled on a
case-by-case basis. The requirement for appointing a responsible individual
does not cause the general license acknowledgement holder to obtain additional
training or certification for that individual, simply a written acceptance
of that responsibility. General licensees are currently required to properly
dispose of devices containing radioactive material, but the current rule does
not specify when disposition is appropriate. The proposed section specifies
a time interval for appropriate disposition. Therefore, there are no economic
effects associated with the section as proposed.
Comments on the proposal may be presented to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834- 6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 9:00 a.m., Tuesday,
June 13, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The amendment is proposed under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The amendment affects Health and Safety Code, Chapter 401 and Chapter 12,
and Government Code §2001.039.
§289.251. Exemptions, General Licenses, and General License Acknowledgements.
(a)
Purpose
[
(b)
Scope.
Except as otherwise authorized,
no person shall receive, possess, use, transfer, own, or acquire radioactive
material except as authorized in a general license or general license acknowledgement
issued in accordance with this section, or in a specific license issued in
accordance with [
(c)
[
(1)
General license - An authorization granted in accordance
with this section. General licenses provided in this section are effective
without the filing of applications with the agency or the issuance of licensing
documents to the particular persons. The general licensee is subject to all
other applicable portions of this chapter and any limitations of the general
license.
(2)
General license acknowledgement - A written recognition
of a general license issued in accordance with this section. General license
acknowledgements require the submission of an application to the agency and
the issuance of a written acknowledgement of a general license granted in
accordance with this section. The holder of a general license acknowledgement
is subject to all other applicable portions of this chapter as well as any
limitations specified in the acknowledgement document.
(d)
[
(1)
Any person is exempt from this section and §289.252
of this title if that person receives, possesses, uses, or transfers source
material in any chemical mixture, compound, solution, or alloy in which the
source material is by weight less than 1/20 of 1.0% (0.05%) of the mixture,
compound, solution, or alloy.
(2)
Any person is exempt from this section and §289.252
of this title if that person receives, possesses, uses, or transfers unrefined
and unprocessed ore containing source material; provided that, except as authorized
in a specific license, such person shall not refine or process such ore. This
exemption does not apply to the mining of ore containing source material.
(3)
Any person is exempt from this section and §289.252
of this title if that person receives, possesses, uses, or transfers:
(A)
any quantities of thorium contained in:
(i)
incandescent gas mantles;
(ii)
vacuum tubes;
(iii)
welding rods;
(iv)
electric lamps for illuminating purposes provided that
each lamp does not contain more than 50 milligrams
(mg)
of thorium;
(v)
germicidal lamps, sunlamps, and lamps for outdoor or industrial
lighting provided that each lamp does not contain more than two grams of thorium;
(vi)
rare earth metals and compounds, mixtures, and products
containing not more than 0.25% by weight thorium, uranium, or any combination
of these; or
(vii)
personnel neutron dosimeters, provided that each dosimeter
does not contain more than 50
mg
[
(B)
source material contained in the following products:
(i)
glazed
ceramics, for example tableware,
[
(ii)
glassware containing not more than 10% by weight source
material, but not including commercially manufactured glass brick, pane glass,
ceramic tile, or other glass or ceramic used in construction;
(iii)
glass enamel or glass enamel frit containing not more
than 10% by weight source material imported or ordered for importation into
the United States, or initially distributed by manufacturers in the United
States, before July 25, 1983; or
(iv)
piezoelectric ceramic containing not more than 2.0% by
weight source material;
(C)
photographic film, negatives, and prints containing uranium
or thorium;
(D)
any finished product or part fabricated of, or containing,
metal-thorium alloys, provided that the thorium content of the alloy does
not exceed 4% by weight and that the exemption contained in this subparagraph
shall not be deemed to authorize the chemical, physical, or metallurgical
treatment or processing of any such product or part;
(E)
depleted uranium contained in counterweights installed
in aircraft, rockets, projectiles, and missiles, or stored or handled in connection
with installation or removal of such counterweights, provided that:
(i)
the counterweights are manufactured in accordance with
a specific license issued by the
United States Nuclear Regulatory Commission
(NRC)
[
(ii)
each counterweight has been impressed with the following
legend clearly legible through any plating or other covering: "DEPLETED URANIUM,"
(The requirements specified in this clause need not be met by counterweights
manufactured prior to December 31, 1969, provided that such counterweights
are impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM,"
as previously required by this chapter);
(iii)
each counterweight is durably and legibly labeled or
marked with the identification of the manufacturer and the statement: "UNAUTHORIZED
ALTERATIONS PROHIBITED," (The requirements specified in this clause need not
be met by counterweights manufactured prior to December 31, 1969, provided
that such counterweights are impressed with the legend, "CAUTION - RADIOACTIVE
MATERIAL - URANIUM," as previously required by this chapter); and
(iv)
the exemption contained in this subparagraph shall not
be deemed to authorize the chemical, physical, or metallurgical treatment
or processing of any such counterweights other than repair or restoration
of any plating, covering, or labeling;
(F)
depleted uranium used as shielding constituting part of
any shipping container, provided that:
(i)
the shipping container is conspicuously and legibly impressed
with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM;" and
(ii)
the uranium metal is encased in a one-eighth inch minimum
wall thickness of mild steel or equally fire resistant material;
(G)
thorium contained in finished optical lenses, provided
that each lens does not contain more than 30% by weight of thorium, and that
the exemption contained in this subparagraph shall not be deemed to authorize
either:
(i)
the shaping, grinding, or polishing of such lens or manufacturing
processes other than the assembly of such lens into optical systems and devices
without any alteration of the lens; or
(ii)
the receipt, possession, use, or transfer of thorium contained
in contact lenses, or in spectacles, or in eyepieces in binoculars or in other
optical instruments;
(H)
uranium contained in detector heads for use in fire detection
units, provided that each detector head contains not more than 0.005 microcurie
(µCi)
of uranium; or
(I)
thorium contained in any finished aircraft engine part
containing nickel-thoria alloy, provided that:
(i)
the thorium is dispersed in the nickel-thoria alloy in
the form of finely divided thoria (thorium dioxide); and
(ii)
the thorium content in the nickel-thoria alloy does not
exceed 4.0% by weight.
(4)
The exemptions in
subsection (d)(3)
of this section
[
(e)
[
(1)
Exempt concentrations.
(A)
Except as provided in subparagraph (B) of this paragraph,
any person is exempt from this section and §289.252 of this title if
that person receives, possesses, uses, transfers, or acquires products or
materials containing radioactive material in concentrations not in excess
of those listed in subsection (q)(1) of this section.
(B)
No person may introduce radioactive material into a product
or material, including waste, knowing or having reason to believe that it
will be transferred to persons exempt in accordance with subparagraph (A)
of this paragraph or equivalent regulations of the
NRC
[
(2)
Exempt quantities.
(A)
Except as provided in subparagraph (C) of this paragraph,
any person is exempt from these rules if that person receives, possesses,
uses, transfers, or acquires radioactive material in individual quantities,
each of which does not exceed the applicable quantity set forth in subsection
(q)(2) of this section.
(B)
Any person who possesses radioactive material received
or acquired,
prior to September 25, 1971,
in accordance with the
general license provided in subsection
(h)(1)(B)
[
(C)
This paragraph does not authorize the production, packaging,
or repackaging of radioactive material for purposes of commercial distribution,
or the incorporation of radioactive material into products intended for commercial
distribution.
(D)
No person may, for purposes of commercial distribution,
transfer radioactive material in quantities greater than the individual quantities
set forth in subsection (q)(2) of this section, knowing or having reason to
believe that such quantities of radioactive material will be transferred to
persons exempt in accordance with this paragraph or equivalent regulations
of the
NRC
[
(E)
The schedule of quantities set forth in subsection (q)(2)
of this section applies only to radioactive materials distributed as exempt
quantities in accordance with a specific license issued by the agency, another
licensing state, or the commission. Subsection (q)(2) of this section does
not apply to radioactive materials that have decayed from quantities not originally
exempt and does not make such material, or the sources or devices in which
the material is contained, exempt from the licensing requirements in this
section or §289.252 of this title.
(3)
Exempt items.
(A)
Certain items containing radioactive material.
(i)
Except for persons who apply radioactive material to, or
persons who incorporate radioactive material into the following products,
any person is exempt from this chapter if that person receives, possesses,
uses, transfers, or acquires the following products:
(I)
timepieces, hands, or dials containing not more than the
following specified quantities of radioactive material and not exceeding the
following specified levels of radiation:
(-a-)
25 millicuries
(mCi)
of tritium per timepiece;
(-b-)
5
mCi
[
(-c-)
15
mCi
[
(-d-)
100
µCi
[
(-e-)
20
µCi
[
(-f-)
60
µCi
[
(-g-)
the levels of radiation from hands and dials containing
promethium-147 will not exceed, when measured through 50 milligrams per square
centimeter
(mg/cm
2
)
of absorber:
(-1-)
for wrist watches, 0.1 millirad per hour
(mrad/hr)
at
10
[
(-2-)
for pocket watches, 0.1
mrad/hr
[
(-3-)
for any other timepiece, 0.2
(mrad/hr)
[
(-h-)
1 µCi
[
(II)
lock illuminators containing not more than 15
mCi
[
(III)
balances of precision containing not more than
1 mCi
[
(IV)
automobile shift quadrants containing not more than 25
mCi
[
(V)
marine compasses containing not more than 750
mCi
[
(VI)
thermostat dials and pointers containing not more than
25
mCi
[
(VII)
electron tubes
,
[
(-a-)
150
mCi
[
(-b-)
1 µCi
[
(-c-)
5 µCi
[
(-d-)
30
µCi
[
(-e-)
5 µCi
[
(-f-)
30
µCi
[
(VIII)
ionizing radiation measuring instruments containing,
for purposes of internal calibration or standardization, a source of radioactive
material not exceeding the applicable quantity set forth in subsection (q)(2)
of this section or 0.05
µCi
[
(IX)
spark gap irradiators containing not more than
1 µCi
[
(ii)
Authority to transfer possession or control by the manufacturer,
processor, or producer of any equipment, device, commodity, or other product
containing source material or byproduct material whose subsequent possession,
use, transfer, and disposal by all other persons are exempted from regulatory
requirements may be obtained only from the United States Nuclear Regulatory
Commission, Washington, DC 20555.
(B)
Self-luminous products containing tritium, krypton-85,
promethium-147, or radium-226.
(i)
Except for persons who manufacture, process, or produce
self-luminous products containing tritium, krypton-85, or promethium-147,
any person is exempt from this chapter if that person receives, possesses,
uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147
in self-luminous products manufactured, processed, produced, imported, or
transferred in accordance with a specific license issued by the
NRC
[
(ii)
Any person is exempt from this chapter if that person
receives, possesses, uses, transfers, or owns articles acquired prior to January
1, 1986, each of which contains less than 0.1
µCi
[
(C)
Gas and aerosol detectors containing radioactive material.
(i)
Except for persons who manufacture, process, or produce
gas and aerosol detectors containing radioactive material, any person is exempt
from this chapter if that person receives, possesses, uses, transfers, owns,
or acquires radioactive material in gas and aerosol detectors designed to
protect life or property from fires and airborne hazards provided that:
(I)
detectors containing radioactive material shall have been
manufactured, imported, or transferred in accordance with a specific license
issued by the
NRC
[
(II)
the specific license issued in accordance with §289.252
of this title authorizes the transfer of the detectors to persons who are
exempt from regulatory requirements.
(ii)
Authority to transfer possession or control by the manufacturer,
processor, or producer of any equipment, device, commodity, or other product
containing source material or byproduct material whose subsequent possession,
use, transfer, and disposal by all other persons are exempted from regulatory
requirements may be obtained only from the United States Nuclear Regulatory
Commission, Washington, DC 20555.
(iii)
Gas and aerosol detectors previously manufactured and
distributed to general licensees in accordance with a specific license issued
by an agreement state or a licensing state shall be considered exempt in accordance
with clause (i) of this subparagraph, provided that the devices are labeled
in accordance with the specific license authorizing distribution of the generally
licensed device, and provided further that they meet the requirements of §289.252
of this title.
(D)
Resins containing scandium-46 and designed for sand consolidation
in oil wells. Any person is exempt from this chapter if that person receives,
possesses, uses, transfers, or acquires synthetic plastic resins containing
scandium-46, which are designed for sand consolidation in oil wells. Such
resins shall have been manufactured or imported in accordance with a specific
license issued by the
NRC
[
(4)
Exemption for capsules containing
carbon-14 urea for "in vivo" diagnostic use in humans.
(A)
Except as provided in subparagraphs (B)
and (C) of this paragraph, a person is exempt from the requirements of this
section and §289.256 of this title (relating to Medical and Veterinary
Use of Radioactive Material) provided that such person receives, possesses,
uses, transfers, owns, or acquires capsules containing 1µCi (37 kilobecquerels)
or less of carbon-14 urea each (allowing for nominal variation that may occur
during the manufacturing process), for "in vivo" diagnostic use in humans.
(B)
A person desiring to use the capsules
for research involving human subjects shall apply for and receive a specific
license in accordance with §289.256 of this title.
(C)
A person desiring to manufacture, prepare,
process, produce, package, repackage, or transfer for commercial distribution
such capsules shall apply for and receive a specific license in accordance
with Title 10, CFR, §32.21.
(D)
Nothing in this subsection relieves a
person from complying with applicable requirements of the United States Food
and Drug Administration (FDA) and other federal and state requirements governing
the receipt, administration, and use of drugs.
(f)
[
(g)
[
(1)
A general license is hereby issued authorizing commercial
and industrial firms, research, educational and medical institutions, and
state and local government agencies to use and transfer not more than 15 pounds
of source material at any one time for research, development, educational,
commercial, or operational purposes. A person authorized to use or transfer
source material, in accordance with this general license, may not possess
more than a total of 150 pounds of source material in any one calendar year.
(2)
Persons who receive, possess, use, or transfer source
material in accordance with the general license in paragraph (1) of this subsection
are prohibited from administering source material, or the radiation therefrom,
either externally or internally, to humans except as may be authorized by
the agency in a specific license.
(3)
A general license is hereby issued to own source material
without regard to quantity. This general license does not authorize any person
to receive, possess, use, or transfer source material.
(4)
A general license is hereby issued to mine, transport,
and transfer ores containing source material without regard to quantity.
In addition to
[
(5)
A general license is hereby issued to receive, acquire,
possess, use, or transfer depleted uranium contained in products or devices
for the purpose of providing shielding, including beam shaping and collimation,
in accordance with the provisions of subparagraphs (A), (B), (C), and (D)
of this paragraph.
(A)
The general license in this paragraph applies only to products
or devices that have been manufactured either in accordance with a specific
license issued by the agency to the manufacturer of the products or devices
in accordance with §289.252
(s)
[
(B)
Persons who receive, acquire, possess, or use depleted
uranium in accordance with the general license in this paragraph shall notify
the agency within 30 days after the first receipt of acquisition of such depleted
uranium. The general licensee shall furnish the following information and
such other information as may be required by the agency:
(i)
name and address of the general licensee;
(ii)
a statement that the general licensee has developed and
will maintain procedures designed to establish physical control over the depleted
uranium in accordance with this paragraph and designed to prevent transfer
of such depleted uranium in any form, including metal scrap, to persons not
authorized to receive the depleted uranium; and
(iii)
name and/or title, address, and telephone number of the
individual duly authorized to act for and on behalf of the general licensee
in supervising the procedures identified in clause (ii) of this subparagraph.
(C)
The general licensee possessing or using depleted uranium
in accordance with the general license in this paragraph shall report in writing
to the agency any changes in information furnished by the general licensee.
The report shall be submitted within 30 days after the effective date of such
change.
(D)
A person who receives, acquires, possesses, or uses depleted
uranium in accordance with the general license in this paragraph:
(i)
shall not introduce such depleted uranium, in any form,
into a chemical, physical, or metallurgical treatment or process, except a
treatment or process for repair or restoration of any plating or other covering
of the depleted uranium;
(ii)
shall not abandon such depleted uranium;
(iii)
shall transfer or dispose of such depleted uranium only
in accordance with the provisions of §289.252
(cc)
[
(iv)
in each calendar quarter, shall report in writing to the
agency the name and address of the person receiving the depleted uranium in
accordance with such transfer; and
(v)
shall not export such depleted uranium except in accordance
with a license issued by the
NRC
[
(E)
Any person receiving, acquiring, possessing, using, or
transferring depleted uranium in accordance with the general license in this
paragraph is exempt from the requirements of
§289.202 of this title
and §289.203 of this title (relating to Notices, Instructions, and Reports
to Workers; Inspections)
[
(h)
[
(1)
Certain devices and equipment. A general license is hereby
issued to transfer, receive, acquire, possess, and use radioactive material
incorporated in the devices or equipment specified in
the following
subparagraphs (A) and (B) of this paragraph that have been manufactured, tested,
and labeled by the manufacturer in accordance with a specific license issued
to the manufacturer by the
NRC
[
(A)
static
[
(B)
ion
[
(C)
other
[
(i)
shall assure that all labels
bearing a statement that
removal of the label is prohibited, are affixed to the device at the time
of receipt, are maintained on the device and, are clearly visible and legible.
[
(ii)
shall assure that the device is tested for leakage of
radioactive material and proper operation of the "on-off" mechanism and indicator,
if any, at no longer than six-month intervals or at such other intervals as
specified in the label; however:
(I)
devices containing only krypton need not be tested for
leakage of radioactive material; and
(II)
devices containing only tritium or not more than 100
µCi
[
(iii)
shall assure that the tests required by clause (ii) of
this subparagraph and other testing, installation, servicing, and removal
from location of installation involving the radioactive materials, shielding
or containment, are performed:
(I)
in accordance with the instructions provided by the labels;
(II)
in accordance with written instructions provided by the
manufacturer as specified in §289.252
(l)(3)
[
(III)
by a person holding a specific license from the agency,
the
NRC
[
(iv)
shall maintain records showing compliance with the requirements
of clauses (ii) and (iii) of this subparagraph. The records shall show the
test results. The records also shall identify the device tested by manufacturer,
model
and
[
(v)
upon the occurrence of failure or damage to, or any indication
of a possible failure or damage to, the radioactive material shielding or
the "on-off" mechanism, or upon the detection of 0.005
µCi
[
(vi)
shall not abandon the device containing radioactive material;
(vii)
except as provided in clause (viii) of this subparagraph,
shall transfer or dispose of the device containing radioactive material only
by transfer to a specific licensee of the agency, the
NRC
[
(viii)
shall transfer the device to another general license(e)
only:
(I)
where the device remains in use at a particular location.
In such case, the transferor shall give the transferee a copy of this rule
and any safety documents identified in the label on the device and, within
30 days of the transfer, report to the agency the manufacturer's name and
model number of device transferred, the serial number of the sealed source
transferred, the name and address of the transferee, and the name and/or position
of an individual who may constitute a point of contact between the agency
and the transferee; or
(II)
where the device is stored in the original shipping container
at its intended location of use prior to initial use by the holder of a general
license acknowledgement; and
(ix)
shall submit the written instructions specified in
clause (iii) (II) of this subparagraph
[
(2)
Luminous safety devices for aircraft.
(A)
A general license is hereby issued to receive, acquire,
possess, and use tritium or promethium-147 contained in luminous safety devices
for use in aircraft, provided:
(i)
each device contains not more than
10
[
(ii)
each device has been manufactured, assembled, or imported
in accordance with a specific license issued by the
NRC
[
(B)
The general license in subparagraph (A) of this paragraph
does not authorize the manufacture, assembly, or repair of luminous safety
devices containing tritium or promethium-147.
(C)
The general license in subparagraph (A) of this paragraph
does not authorize the receipt, acquisition, possession, or use of tritium
or promethium-147 contained in instrument dials.
[
(3)
Ownership of radioactive material. A general
license is hereby issued to own radioactive material without regard to quantity.
Notwithstanding any other provisions of this section, this general license
does not authorize the manufacture, production, transfer, receipt, possession,
or use of radioactive material.
(4)
Calibration, stabilization, and reference sources.
(A)
A general license is hereby issued to those persons listed
below to receive, acquire, possess, use, and transfer, in accordance with
the provisions of subparagraphs (B) and (C) of this paragraph, americium-241,
plutonium, and/or radium-226, in the form of calibration, stabilization, or
reference sources:
(i)
any person who holds a specific license issued by the agency
that authorizes that person to receive, possess, use, and transfer radioactive
material; and
(ii)
any person who holds a specific license issued by the
NRC
[
(B)
The general license in subparagraph (A) of this paragraph
applies only to calibration, stabilization, or reference sources that have
been manufactured in accordance with the specifications contained in a specific
license issued to the manufacturer or importer of the sources by the
NRC
[
(C)
Persons
[
(i)
shall not possess at any one time, at any one location
of storage or use, more than 5
µCi
[
(ii)
shall not receive, possess, use, or transfer such source
unless the source or the storage container bears a label that includes the
following statements, or a substantially similar statement that contains the
information in the following statements:
(I)
option 1, as appropriate:
Figure: 25 TAC §289.251(h)(4)(C)(ii)(I)
[
(II)
option 2, as appropriate:
Figure: 25 TAC §289.251(h)(4)(C)(ii)(II)
[
(iii)
shall not transfer, abandon, or dispose of such source
except by transfer to a person authorized by a specific license from the agency,
the
NRC
[
(iv)
shall store such source, except when the source is being
used, in a closed container designed and constructed to contain americium-241,
plutonium-238, plutonium-239, or radium-226; and
(v)
shall not use such source for any purpose other than the
calibration of radiation detectors or the standardization of other sources.
(D)
The general license in subparagraph (A) of this paragraph
does not authorize the manufacture of calibration or reference sources containing
americium-241, plutonium-238, plutonium-239, or radium-226.
(5)
Ice detection devices.
(A)
A general license is hereby issued to receive, acquire,
possess, use, and transfer strontium-90 contained in ice detection devices,
provided each device contains not more than 50
µCi
[
(B)
Persons who receive, acquire, possess, use, or transfer
strontium-90 contained in ice detection devices in accordance with the general
license in subparagraph (A) of this paragraph:
(i)
shall, upon occurrence of visually observable damage, such
as bend or crack or discoloration from overheating to the device, discontinue
use of the device until it has been inspected, tested for leakage, and repaired
by a person holding a specific license from the
NRC
[
(ii)
shall assure that all labels affixed to the device at
the time of receipt, and which bear a statement prohibiting removal of the
labels, are maintained
on the device
[
(C)
The general license in subparagraph (A) of this paragraph
does not authorize the manufacture, assembly, disassembly, or repair of strontium-90
in ice detection devices.
[
(i)
[
(1)
A general license is hereby issued to any common or contract
carrier to transport and store radioactive material in the regular course
of their carriage for another or storage incident
to transport
[
(2)
A general license is hereby issued to any private
carrier to transport radioactive material, provided the transportation is
in accordance with the applicable requirements [
(j)
[
(k)
[
(1)
Certain measuring, gauging, and controlling devices.
(A)
A general license is hereby issued to commercial and industrial
firms and to research, educational, and medical institutions, individuals
in the conduct of their business, and state or local government agencies to
receive, acquire, possess, use, or transfer in accordance with the provisions
of subparagraphs
(B)-(E)
[
(B)
The general license in subparagraph (A) of this paragraph
applies only to radioactive material contained in devices that have been manufactured
and labeled in accordance with the authorizations contained in a specific
license issued by the agency in accordance with §289.252
(l)
[
(C)
Within 30 days following the receipt, acquisition, or possession
of radioactive material in a device, except for calibration, stabilization,
[
(i)
Name and mailing address of the general
licensee.
(ii)
Information about each device to include
the manufacturer, model number, serial number of the device and sealed source,
and the radioisotope and activity (as indicated on the label).
(iii)
Name and telephone number of the responsible
person designated as a representative of the holder of a general licensee
acknowledgement in accordance with subparagraph (E)(xii) of this paragraph.
(iv)
Address at which the device(s) are used
and/or stored. For portable devices, the address of the primary place of storage.
(v)
Certification by the responsible representative
of the general licensee that the information concerning the device(s) has
been verified through a physical inventory and checking of label information.
(vi)
Certification by the responsible representative
of the general licensee that they are aware of the requirements of this section.
(D)
Each application shall be accompanied by
BRC Form
252-1, Business Information Form and the applicable fee as required by §289.204
of this title
[
(E)
Any person who receives, acquires, possesses, uses, or
transfers radioactive material in a device in accordance with the general
license in subparagraph (A) of this paragraph:
(i)
shall assure that all labels
bearing a statement that
removal of the label is prohibited, are affixed to the device at the time
of receipt, are maintained on the device and, are clearly visible and legible.
[
(ii)
shall assure that the device is tested for leakage of
radioactive material and proper operation of the "on-off" mechanism and indicator,
if any, at no longer than six-month intervals or at such other intervals as
specified in the label; however:
(I)
devices containing only krypton need not be tested for
leakage of radioactive material; and
(II)
devices containing only tritium or not more than 100
µCi
[
(iii)
shall assure that the tests required by clause (ii) of
this subparagraph and other testing, installation (removal of the manufacturer's
lock and initial alignment of the radiation beam), servicing, and removal
from location of installation involving the radioactive materials, shielding
or containment, are performed:
(I)
in accordance with the instructions provided by the labels;
(II)
in accordance with written instructions provided by the
manufacturer as specified in §289.252
(l)(3)
[
(III)
by a person holding a specific license from the agency,
the
NRC
[
(iv)
shall maintain records showing compliance with the requirements
of clauses (ii) and (iii) of this subparagraph. The records shall show the
test results. The records also shall identify the device tested by manufacturer,
model
and
[
(v)
shall maintain assignment records for portable or mobile
devices for inspection by the agency at the location listed in the general
license acknowledgement. These records shall include:
(I)
a unique identification (e.g. serial number) of each portable
or mobile device;
(II)
the location(s) where each portable or mobile device is
assigned; and
(III)
the date(s) each portable or mobile device is assigned
to the location(s) in accordance with subclause (II) of this clause
;
[
(vi)
shall maintain utilization records for each portable or
mobile device used at the location(s) in accordance with clause (v)(II) of
this subparagraph for inspection by the agency at that location(s);
(vii)
shall have a copy of the appropriate operating and instruction
manual at each temporary site for agency inspection;
(viii)
upon the occurrence of failure or damage to, or any
indication of a possible failure or damage to, the radioactive material shielding
or the "on-off" mechanism, or upon the detection of 0.005
µCi
[
(ix)
shall not abandon the device containing radioactive material;
(x)
except as provided in clause (xi) of this subparagraph,
shall transfer or dispose of the device containing radioactive material only
by transfer to a person holding a specific license issued by the agency in
accordance with §289.252
(l)
[
(xi)
shall transfer the device to another general license(e)
only:
(I)
where the device remains in use at a particular location.
In such case, the transferor shall give the transferee a copy of this rule
and any safety documents identified in the label on the device and, within
30 days of the transfer, report to the agency the manufacturer's name
,
[
(II)
where the device is
held in storage by an intermediate
person
[
(xii)
shall appoint an individual responsible
for having knowledge of the appropriate agency requirements and the authority
for taking required actions to comply with appropriate agency requirements.
The general licensee, through this appointed individual, shall ensure the
day-to-day compliance with appropriate agency requirements. This appointment
does not relieve the general licensee of responsibility in this regard;
(xiii)
shall report changes of address (including
change in the name of the holder of a general license acknowledgement) to
the agency within 30 days of the effective date of the change. If it is a
portable device, a report of address change is only required for a change
in the device's primary place of storage; and
(xiv)
shall not hold devices that are not
in use for longer than two years. If devices with shutters are not being used,
the shutter must be locked in the closed position. The testing required by
clause (ii) of this subparagraph need not be performed during the period of
storage only. However, when devices are put back into service or transferred
to another person, and have not been tested within the required test interval,
they must be tested for leakage before use or transfer and the shutter tested
before use.
(F)
The general license in subparagraph (A) of this paragraph
does not authorize the manufacture of devices containing radioactive material.
(G)
The written instructions specified in subparagraph (E)(iii)(II)
of this paragraph shall be followed while performing the testing and shall
be maintained for inspection by the agency.
(2)
General license acknowledgements for use of radioactive
material for certain
in vitro
clinical or
laboratory testing
, not to include research and development
. (The
New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern
the availability and use of any specific diagnostic drugs in interstate commerce.)
(A)
A general license is hereby issued to any physician, veterinarian,
clinical laboratory, or hospital to receive, acquire, possess, transfer, or
use, for any of the following stated tests, in accordance with the provisions
of subparagraphs (B), (C), and (D) of this paragraph, the following radioactive
materials in prepackaged units:
(i)
iodine-125, in units not exceeding
10 µCi
[
(ii)
iodine-131, in units not exceeding
10 µCi
[
(iii)
carbon-14, in units not exceeding
10 µCi
[
(iv)
hydrogen-3 (tritium), in units not exceeding 50
µCi
[
(v)
iron-59, in units not exceeding 20
µCi
[
(vi)
selenium-75, in units not to exceed
10 µCi
[
(vii)
mock iodine-125 reference or calibration sources, in
units not exceeding 0.05
µCi
[
(viii)
cobalt-57, in units not exceeding
10 µCi
[
(B)
No person shall receive, acquire, possess, use, or transfer
radioactive material in accordance with the general license in subparagraph
(A) of this paragraph until that person has filed an application for an acknowledgement
on a form prescribed by the agency and has received from the agency an acknowledgement
with an assigned number. The applicant shall furnish the following information
and such other information as may be required by the agency:
(i)
name and address of the physician, veterinarian, clinical
laboratory, or hospital;
(ii)
the location of use;
(iii)
a statement that the physician, veterinarian, clinical
laboratory, or hospital has appropriate radiation measuring instruments to
carry out
in vitro
clinical or laboratory
tests with radioactive material as authorized in accordance with the general
license in subparagraph (A) of this paragraph, and that such tests will be
performed only by personnel trained specifically in the use of such instruments
and in the handling of the radioactive material;
(iv)
name, title, address, and telephone number of the individual
duly authorized to act for and on behalf of the general licensee supervising
the use of radioactive material authorized by subparagraph (A) of this paragraph;
and
(v)
BRC Form 252-1, Business Information Form and the
applicable fee as required by §289.204 of this title
[
(C)
A person who receives, acquires, possesses, or uses radioactive
material in accordance with the general license in subparagraph (A) of this
paragraph shall comply with the following.
(i)
The holder of the general license acknowledgement shall
not possess at any one time, at any one location of storage or use, a total
amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt- 57
in excess of 200
µCi
[
(ii)
The holder of the general license acknowledgement shall
store the radioactive material in the original shipping container or in a
container providing equivalent radiation protection and meeting the requirements
of
§289.202(cc)
[
(iii)
The holder of the general license acknowledgement shall
use the radioactive material only for the uses authorized by subparagraph
(A) of this paragraph.
(iv)
The holder of the general license acknowledgement shall
not transfer the radioactive material to a person who is not authorized to
receive it in accordance with a specific license issued by the agency, the
NRC
[
(v)
The holder of the general license acknowledgement shall
dispose of the mock iodine-125 reference or calibration sources described
in subparagraph (A)(vii) of this paragraph as required by
§289.202(ff)
[
(D)
The holder of the general license acknowledgement [
(i)
except as prepackaged units that are labeled in accordance
with the provisions of an applicable specific license issued in accordance
with §289.252
(p)
[
(ii)
unless one of the statements in the following figures,
as appropriate, or a substantially similar statement that contains the information
called for in one of the following statements, appears on a label affixed
to each prepackaged unit or appears in a leaflet or brochure that accompanies
the package:
(I)
option 1, as appropriate: [
Figure: 25 TAC §289.251(k)(2)(D)(ii)(I)
(II)
option 2, as appropriate: [
Figure: 25 TAC §289.251(k)(2)(D)(ii)(II)
(l)
[
(1)
Upon a determination that the information submitted by
the applicant meets the requirements of the Texas Radiation Control Act (Act)
and the rules of the agency, the agency will issue a general license acknowledgement
recognizing the proposed activity in such form and containing such conditions
and limitations as it deems appropriate or necessary.
(2)
The agency may incorporate in any general license
acknowledgement at the time of issuance, or thereafter by amendment, additional
requirements and conditions governing the receipt, possession, use, transfer,
and disposal of radioactive material subject to this section as it deems appropriate
or necessary in order to:
(A)
minimize danger to
occupational and
public health
and safety or the environment;
(B)
require such reports and the keeping of such records, and
to provide for such inspections of activities in accordance with the license
as may be appropriate or necessary; and
(C)
prevent loss or theft of material subject to this section.
(m)
[
(1)
Each general license acknowledgement 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 rules and orders of the
agency.
(2)
Each person holding a general license acknowledgement
issued by the agency in accordance with this section shall confine use and
possession of the material licensed to the locations and purpose authorized
in the general license acknowledgement.
(3)
Each holder of a general license acknowledgement shall
notify the agency, in writing, immediately following the filing of a voluntary
or involuntary petition for bankruptcy
.
[
[
[
[
(4)
The notification in paragraph (3) of this subsection
must
include
[
(A)
the bankruptcy court in which the petition for bankruptcy
was filed; and
(B)
the date of the filing of the petition.
(5)
A copy of the "Petition for Bankruptcy" shall
be submitted to the agency with the written notification.
(n)
[
[
(1)
[
[
(2)
[
(A)
terminate use of radioactive material;
and
(B)
dispose of radioactive material in accordance
with this section and/or §289.202(ff) of this title.
[
[
[
[
[
[
(o)
Amendment of general license acknowledgements.
(1)
The holder of the general license acknowledgement in accordance
with the general license in subsections
(k)(1)(A)
[
(2)
Applications for amendments of a general license acknowledgement
shall be filed in accordance with subsection
(k)(1)(C)
[
(p)
Modification and revocation of [
(1)
The terms and conditions of all general license acknowledgements
shall be subject to amendment, revision, or modification.
(2)
A general license acknowledgement may be suspended
or revoked by reason of amendments to the Act, or by reason of rules
in this chapter
and orders issued by the agency. [
(3)
Any general license acknowledgement may be revoked,
suspended, or modified, in whole or in part
, for any of the following
:
(A)
[
[
(B)
[
(C)
[
[
(4)
Except in cases [
(q)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State, on May 22, 2000.
TRD-200003514
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
25 TAC §289.252
The Texas Department of Health (department) proposes the
repeal of §289.252 and new §289.252, concerning licensing of radioactive
material.
The new section adds self-guarantee as an approved method of financial
assurance and clarifies financial assurance requirements for governmental
entities. These requirements are items of compatibility with the United States
Nuclear Regulatory Commission (NRC) and as an agreement state, Texas must
adopt these requirements. The new section adds radiation safety officer (RSO)
qualifications for licenses with broad scope authorization for research and
development and duties and responsibilities for radiation safety committees
(RSC). The requirement for a specific licensee who manufactures and distributes
devices to general licensees to furnish information is clarified. The specific
licensee must furnish such information prior to the transfer of devices to
a general licensee. Requirements for sealed source and device evaluations
have been revised to clarify what type of sealed sources and devices do not
require a safety review. All requirements for medical licensing that are currently
located in the proposed repeal of §289.252 will be transferred to §289.256
of this title (relating to Medical and Veterinary Use of Radioactive Material).
This will provide clarification that §289.252 addresses licensing the
use of radioactive material in industrial settings and the commercial manufacture
and distribution of radioactive material. The new section is part of the department's
continuing effort to update, clarify, and simplify its rules regarding the
control of radiation based upon technological advances, public concerns, legislative
directives, compatibility with NRC, or other factors.
Mrs. Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the sections are in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the sections as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the sections are in effect, the public benefit anticipated as a result
of enforcing the sections will be protection of the public and the environment
from unnecessary exposure to radiation by ensuring that RSOs and RSCs are
qualified to perform their duties and responsibilities and that general licensees
are sufficiently made aware of their responsibilities with regard to devices
containing radioactive material. There will be no effect on micro businesses
or small businesses. There are no anticipated economic costs to persons who
are required to comply with the sections as proposed. There is no anticipated
impact on local employment. The addition of an option for complying with financial
assurance requirements does not alleviate the requirement for financial assurance;
it simply provides an additional method of compliance. The addition of specific
RSO qualifications and RSC duties and responsibilities formalizes in rule
current agency policy. The clarification of types of sealed sources and devices
that do not require a safety review also formalizes in rule what is currently
agency policy. Because the amendment is clarifying and does not impose any
additional requirements such as record keeping, regulatory limits, procedures,
or processes, there are no economic effects associated with the section as
proposed.
Comments on the proposal may be presented to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834- 6688 or electronic mail at Ruth.Mcburney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 10:00 a.m., Tuesday,
June 13, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
(Editor's note: The text of the following section proposed
for repeal will not be published. The section may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with authority to adopt rules for the performance
of every duty imposed by law on the board, the department, and the commissioner
of health.
The repeal affects Health and Safety Code, Chapter 401 and Chapter 12.
§289.252. Licensing of Radioactive Material.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State, on May 22, 2000.
TRD-200003512
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
The new section is proposed under the
Health and Safety Code, Chapter 401, which provides the Texas Board of Health
(board) with authority to adopt rules and guidelines relating to the control
of radiation; and §12.001, which provides the board with authority to
adopt rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
The new section affects Health and Safety Code, Chapter 401 and Chapter
12.
§289.252. Licensing of Radioactive Material.
(a)
Purpose. The intent of this section is as follows.
(1)
This section provides for the specific licensing of radioactive
material.
(2)
Unless otherwise exempted, no person shall receive,
possess, use, transfer, own, or acquire radioactive material except as authorized
by the following:
(A)
a specific license issued in accordance with this section
and/or any of the following sections:
(i)
§289.254 of this title (relating to Licensing of
Radioactive Waste Processing and Storage Facilities);
(ii)
§289.255 of this title (relating to Radiation Safety,
Requirements and Licensing and Registration Procedures for Industrial Radiography);
(iii)
§289.256 of this title (relating to Medical and
Veterinary Use of Radioactive Material);
(iv)
§289.258 of this title (relating to Licensing and
Radiation Safety Requirements for Irradiators);
(v)
§289.259 of this title (relating to Licensing of
Naturally Occurring Radioactive Material (NORM));
(vi)
§289.260 of this title (relating to Licensing of
Uranium Recovery and Byproduct Material Disposal Facilities); or
(B)
a general license or general license acknowledgment issued
in accordance with §289.251 of this title (relating to Exemptions, General
Licenses, and General License Acknowledgements).
(3)
A person who receives, possesses, uses, transfers,
owns, or acquires radioactive materials prior to receiving a license is subject
to the requirements of this chapter.
(b)
Scope. In addition to the requirements of this section,
the following additional requirements are applicable.
(1)
All licensees, unless otherwise specified, are subject
to the requirements in the following sections:
(A)
§289.201 of this title (relating to General Provisions
for Radioactive Material);
(B)
§289.202 of this title (relating to Standards for
Protection Against Radiation from Radioactive Material);
(C)
§289.203 of this title (relating to Notices, Instructions,
and Reports to Workers; Inspections);
(D)
§289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material Licenses, Emergency Planning and Implementation,
and Other Regulatory Services);
(E)
§289.205 of this title (relating to Hearing and Enforcement
Procedures); and
(F)
§289.257 of this title (relating to Packaging and
Transportation of Radioactive Material).
(2)
Licensees engaged in well logging service operations
and tracer studies are subject to the requirements of §289.253 of this
title (relating to Radiation Safety Requirements for Well Logging Service
Operations and Tracer Studies).
(3)
Licensees engaged in radioactive waste processing
and/or storage are subject to the requirements of §289.254 of this title.
(4)
Licensees engaged in industrial radiographic operations
are subject to the requirements of §289.255 of this title.
(5)
Licensees using radioactive material for medical
or veterinary use are subject to the requirements of §289.256 of this
title.
(6)
Licensees using sealed sources in irradiators are
subject to the requirements of §289.258 of this title.
(7)
Licensees possessing or using naturally occurring
radioactive material are subject to the requirements of §289.259 of this
title.
(8)
Licensees engaged in uranium recovery and byproduct
material disposal are subject to the requirements of §289.260 of this
title.
(c)
Types of licenses. Licenses for radioactive materials
are of two types: general and specific.
(1)
General licenses provided in §289.251 and §289.259
of this title are effective without the filing of applications with the agency
or the issuance of licensing documents to the particular persons, although
the filing of an application for acknowledgement with the agency may be required
for a particular general license. The general licensee is subject to any other
applicable portions of this chapter and any limitations of the general license.
(2)
Specific licenses require the submission of an application
to the agency and the issuance of a licensing document by the agency. The
licensee is subject to all applicable portions of this chapter as well as
any limitations specified in the licensing document.
(d)
Filing application for specific licenses. The agency may,
at any time after the filing of the original application, require further
statements in order to enable the agency to determine whether the application
should be denied or the license should be issued.
(1)
Applications for specific licenses shall be filed in a
manner prescribed by the agency.
(2)
Each application shall be signed by management.
(3)
An application for a license may include a request
for a license authorizing one or more activities. The agency may require the
issuance of separate specific licenses for those activities.
(4)
Each application for a specific license, other than
a license exempted from §289.204 of this title, shall be accompanied
by the fee prescribed in §289.204 of this title.
(5)
Each application shall be accompanied by a completed
BRC Form 252-1 (Business Information Form).
(6)
Applications for licenses shall be processed in accordance
with the following time periods.
(A)
The first period is the time from receipt of an application
by the Division of Licensing, Registration and Standards to the date of issuance
or denial of the license or a written notice outlining why the application
is incomplete or unacceptable. This time period is 60 days.
(B)
The second period is the time from receipt of the last
item necessary to complete the application to the date of issuance or denial
of the license. This time period is 30 days.
(C)
These time periods are exclusive of any time period incident
to hearings and post-hearing activities required by the Government Code, Chapters
2001.
(7)
Notwithstanding the provisions of §289.204(e)(1)
of this title, reimbursement of application fees may be granted in the following
manner.
(A)
In the event the application is not processed in the time
periods as stated in paragraph (6) of this subsection, the applicant has the
right to request of the director of the Radiation Control Program full reimbursement
of all application fees paid in that particular application process. If the
director does not agree that the established periods have been violated or
finds that good cause existed for exceeding the established periods, the request
will be denied.
(B)
Good cause for exceeding the period established is considered
to exist if:
(i)
the number of applications for licenses to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(ii)
another public or private entity utilized in the application
process caused the delay; or
(iii)
other conditions existed giving good cause for exceeding
the established periods.
(C)
If the request for full reimbursement authorized by subparagraph
(A) of this paragraph is denied, the applicant may then request a hearing
by appeal to the Commissioner of Health for a resolution of the dispute. The
appeal will be processed in accordance with the Formal Hearing Procedures, §§1.21-1.34
of this title (relating to the Texas Board of Health).
(8)
Applications for licenses may be denied for
the following reasons:
(A)
any material false statement in the application or any
statement of fact required under provisions of the Texas Radiation Control
Act (Act); and
(B)
conditions revealed by the application or statement of
fact or any report, record, or inspection, or other means that would warrant
the agency to refuse to grant a license on an application.
(e)
General requirements for the issuance of specific licenses.
A license application will be approved if the agency determines that:
(1)
the applicant and all personnel who will be handling the
radioactive material are qualified by reason of training and experience to
use the material in question for the purpose requested in accordance with
this chapter in such a manner as to minimize danger to occupational and public
health and safety or the environment;
(2)
the applicant's proposed equipment, facilities, and
procedures are adequate to minimize danger to occupational and public health
and safety or the environment;
(3)
the issuance of the license will not be inimical
to the health and safety of the public;
(4)
the applicant satisfies any applicable special requirement
in this section and other sections as specified in subsection (a)(2)(A) of
this section;
(5)
the radiation safety information submitted for requested
sealed source(s) or device(s) containing radioactive material is in accordance
with subsection (v) of this section;
(6)
qualifications of the designated radiation safety
officer (RSO) as specified in subsection (f) of this section are adequate
for the purpose requested in the application;
(7)
the applicant submits an adequate operating, safety,
and emergency procedures manual;
(8)
the applicant's permanent facility is located in
Texas (if the applicant's permanent facility is not located in Texas, reciprocal
recognition must be sought as required by subsection (ee) of this section);
and
(9)
the owner of the property is aware that radioactive
material is stored and/or used on the property, if the proposed storage facility
is not owned by the applicant. The applicant shall provide a written statement
from the owner indicating such.
(f)
Radiation safety officer.
(1)
An RSO shall be designated for every license issued by
the agency.
(2)
The RSO's documented qualifications shall include
as a minimum:
(A)
possession of a high school diploma or a certificate of
high school equivalency based on the GED test;
(B)
completion of the training and testing requirements specified
in this chapter for the activities for which the license application is submitted;
and
(C)
training and experience necessary to supervise the radiation
safety aspects of the licensed activity.
(3)
The specific duties of the RSO include, but
are not limited to, the following:
(A)
to establish and oversee operating, safety, emergency,
and as low as reasonably achievable (ALARA) procedures, and to review them
at least annually to ensure that the procedures are current and conform with
this chapter;
(B)
to oversee and approve all phases of the training program
for operations and/or personnel so that appropriate and effective radiation
protection practices are taught;
(C)
to ensure that required radiation surveys and leak tests
are performed and documented in accordance with this chapter, including any
corrective measures when levels of radiation exceed established limits;
(D)
to ensure that individual monitoring devices are used
properly by occupationally-exposed personnel, that records are kept of the
monitoring results, and that timely notifications are made in accordance with §289.203
of this title;
(E)
to investigate and cause a report to be submitted to the
agency for each known or suspected case of radiation exposure to an individual
or radiation level detected in excess of limits established by this chapter
and each theft or loss of source(s) of radiation, to determine the cause(s),
and to take steps to prevent a recurrence;
(F)
to investigate and cause a report to be submitted to the
agency for each known or suspected case of release of radioactive material
to the environment in excess of limits established by this chapter;
(G)
to have a thorough knowledge of management policies and
administrative procedures of the licensee;
(H)
to assume control and have the authority to institute
corrective actions, including shutdown of operations when necessary in emergency
situations or unsafe conditions;
(I)
to ensure that records are maintained as required by this
chapter;
(J)
to ensure the proper storing, labeling, transport, use
and disposal of sources of radiation, storage, and/or transport containers;
(K)
to ensure that inventories are performed in accordance
with the activities for which the license application is submitted;
(L)
to ensure that personnel are complying with this chapter,
the conditions of the license, and the operating, safety, and emergency procedures
of the licensee; and
(M)
to serve as the primary contact with the agency.
(4)
Requirements for RSOs for specific licenses
for broad scope authorization for research and development. In addition to
the requirements in paragraphs (1) and (3) of this subsection, the RSO's qualifications
for specific licenses for broad scope authorization for research and development
shall include evidence of the following:
(A)
a bachelor's degree in health physics, radiological health,
physical science or a biological science with a physical science minor and
four years of applied health physics experience in a program with radiation
safety problems similar to those in the program to be managed;
(B)
a master's degree in health physics or radiological health
and three years of applied health physics experience in a program with radiation
safety problems similar to those in the program to be managed; or
(C)
two years of applied health physics experience in a program
with radiation safety problems similar to those in the program to be managed
and one of the following:
(i)
doctorate degree in health physics or radiological health;
(ii)
comprehensive certification by the American Board of
Health Physics;
(iii)
certification by the American Board of Radiology in
Medical Nuclear Physics;
(iv)
certification by the American Board of Science in Nuclear
Medicine in Radiation Protection; or
(v)
certification by the American Board of Medical Physics
in Medical Health Physics.
(5)
The qualifications in paragraph (4)(A)-(C)
do not apply to RSOs on licenses issued prior to October 1, 2000.
(g)
The duties and responsibilities of the Radiation Safety
Committee (RSC) include but are not limited to the following:
(1)
meeting as often as necessary to conduct business but
not less than every three months;
(2)
reviewing personnel dosimetry data;
(3)
reviewing the results of required radiation safety
surveys and any significant incidents, including spills, contamination, or
medical events;
(4)
reviewing the results of inspections and taking appropriate
action when noncompliance is identified;
(5)
reviewing the program for maintaining doses ALARA,
and providing any necessary recommendations to ensure doses are ALARA;
(6)
reviewing the overall compliance status for authorized
users;
(7)
sharing responsibility with the RSO to conduct periodic
audits of the radiation safety program;
(8)
reviewing the audit of the radiation safety program
and acting upon the findings;
(9)
developing criteria to evaluate training and experience
of new authorized user applicants;
(10)
evaluating and approving authorized user applicants
who request authorization to use radioactive material at the facility;
(11)
evaluating new uses of radioactive material; and
(12)
reviewing and approving permitted program and procedural
changes prior to implementation.
(h)
Specific licenses for broad scope authorization for multiple
quantities or types of radioactive material for use in research and development.
(1)
In addition to the requirements in subsection (e) of this
section, a specific license for multiple quantities or types of radioactive
material for use in research and development, not to include the internal
or external administration of radiation or radioactive material to humans,
will be issued if the agency approves the following information submitted
by the applicant:
(A)
evidence that staff has substantial experience in the
use of a variety of radioisotopes for a variety of research and development
uses;
(B)
documentation of a full-time RSO meeting the requirements
of subsection (f)(4) of this section;
(C)
evidence of an established RSC, including names and qualifications,
with duties and responsibilities in accordance with subsection (g) of this
section. The RSC shall be composed of an RSO, a representative of executive
management, and one or more persons trained or experienced in the safe use
of radioactive materials.
(2)
Unless specifically authorized, persons licensed
according to paragraph (1) of this subsection shall not conduct tracer studies
involving direct release of radioactive material to the environment.
(3)
Unless specifically authorized, in accordance with
a separate license, persons licensed according to paragraph (1) of this subsection
shall not:
(A)
receive, acquire, own, possess, use, or transfer devices
containing 100,000 curies or more of radioactive material in sealed sources
used for irradiation of materials;
(B)
conduct activities for which a specific license issued
by the agency in accordance with subsections (i)-(u) of this section and §§289.254,
289.255, 289.256, and §289.259 of this title is required;
(C)
add or cause the addition of radioactive material to any
food, beverage, cosmetic, drug, or other product designed for ingestion or
inhalation by, or application to, a human being; or
(D)
commercially distribute radioactive material.
(i)
Specific licenses for introduction of radioactive material
into products in exempt concentrations.
(1)
In addition to the requirements in subsection (e) of this
section, a specific license authorizing the introduction of radioactive material
into a product or material in the possession of the licensee or another to
be transferred to persons exempt from this chapter in accordance with §289.251(e)(1)(A)
of this title will be issued if the agency approves the following information
submitted by the applicant:
(A)
a description of the product or material into which the
radioactive material will be introduced;
(B)
intended use of the radioactive material and the product
or material into which it is introduced;
(C)
method of introduction;
(D)
initial concentration of the radioactive material in the
product or material;
(E)
control methods to assure that no more than the specified
concentration is introduced into the product or material;
(F)
estimated time interval between introduction and transfer
of the product or material;
(G)
estimated concentration of the radioactive material in
the product or material at the time of transfer; and
(H)
procedures for disposition of unwanted or unused radioactive
material; and
(2)
the applicant provides reasonable assurance
that:
(A)
the concentrations of radioactive material at the time
of transfer will not exceed the concentrations in §289.251(r)(1) of this
title;
(B)
reconcentration of the radioactive material in concentrations
exceeding those in §289.251(r)(1) of this title will not occur;
(C)
the use of lower concentrations is not feasible; and
(D)
the product or material is not to be incorporated in any
food, beverage, cosmetic, drug, or other commodity or product designed for
ingestion or inhalation by, or application to, a human.
(3)
Each person licensed in accordance with this
subsection shall file an annual report with the agency and shall identify
the type and quantity of each product or material into which radioactive material
has been introduced during the reporting period. The report shall cover the
year ending June 30, shall be filed within 30 days thereafter, and shall include
the following:
(A)
name and address of the person who owned or possessed
the product or material when the radioactive material was introduced;
(B)
the type and quantity of radionuclide introduced into
each such product or material; and
(C)
the initial concentrations of the radionuclide in the
product or material at time of transfer of the radioactive material by the
licensee.
(4)
If no transfers of radioactive material have
been made in accordance with this subsection during the reporting period,
the report shall so indicate.
(j)
Specific licenses for commercial distribution of radioactive
material in exempt quantities.
(1)
Authority to transfer possession or control by the manufacturer,
processor, or producer of any equipment, device, commodity, or other product
containing source material or byproduct material whose subsequent possession,
use, transfer, and disposal by all other persons are exempted from regulatory
requirements may be obtained only from the United States Nuclear Regulatory
Commission, Washington, DC 20555.
(2)
In addition to the requirements in subsection (e)
of this section, a specific license to distribute naturally occurring or accelerator-produced
radioactive material (NARM) to persons exempt from this chapter in accordance
with §289.251(e)(2) of this title will be issued if the agency approves
the following information submitted by the applicant:
(A)
that the radioactive material is not contained in any
food, beverage, cosmetic, drug, or other commodity designed for ingestion
or inhalation by, or application to, a human;
(B)
that the radioactive material is in the form of processed
chemical elements, compounds, or mixtures, tissue samples, bioassay samples,
counting standards, plated or encapsulated sources, or similar substances,
identified as radioactive and to be used for its radioactive properties, but
is not incorporated into any manufactured or assembled commodity, product,
or device intended for commercial distribution;
(C)
copies of prototype labels and brochures; and
(D)
procedures for disposition of unwanted or unused radioactive
material.
(3)
The license issued in accordance with paragraph
(2) of this subsection is subject to the following conditions.
(A)
No more than ten exempt quantities shall be sold or commercially
distributed in any single transaction. However, an exempt quantity may be
composed of fractional parts of one or more of the exempt quantities provided
the sum of the fractions shall not exceed unity.
(B)
Each exempt quantity shall be separately and individually
packaged. No more than 10 such packaged exempt quantities shall be contained
in any other package for commercial distribution to persons exempt from this
chapter in accordance with §289.251(e)(2) of this title. The outer package
shall be such that the dose rate at the external surface of the package does
not exceed 0.5 millirem per hour (mrem/hr).
(C)
The immediate container of each quantity or separately
packaged fractional quantity of radioactive material shall bear a durable,
legible label that:
(i)
identifies the radionuclide and the quantity of radioactivity;
and
(ii)
bears the words "Radioactive Material."
(D)
In addition to the labeling information required by subparagraph
(C) of this paragraph, the label affixed to the immediate container, or an
accompanying brochure, shall:
(i)
state that the contents are exempt from the United States
Nuclear Regulatory Commission (NRC), agreement state, or licensing state requirements;
(ii)
bear the words "Radioactive Material--Not for Human Use--
Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into
Products Manufactured for Commercial Distribution is Prohibited--Exempt Quantities
Should Not Be Combined"; and
(iii)
set forth appropriate additional radiation safety precautions
and instructions relating to the handling, use, storage, and disposal of the
radioactive material.
(4)
Each person licensed in accordance with
this subsection shall maintain records identifying, by name and address, each
person to whom radioactive material is commercially distributed for use in
accordance with §289.251(e)(2) of this title or the equivalent regulations
of an agreement state or a licensing state, and stating the kinds and quantities
of radioactive material commercially distributed. An annual summary report
stating the total quantity of each radionuclide commercially distributed in
accordance with the specific license shall be filed with the agency. Each
report shall cover the year ending June 30, and shall be filed within 30 days
thereafter. If no commercial distributions of radioactive material have been
made in accordance with this subsection during the reporting period, the report
shall so indicate.
(5)
Licenses issued in accordance with this subsection
do not authorize the following:
(A)
combining of exempt quantities of radioactive material
in a single device;
(B)
any program advising persons to combine exempt quantity
sources and providing devices for them to do so; and
(C)
the possession and use of combined exempt sources, in
a single unregistered device, by persons exempt from licensing in accordance
with §289.251(e)(2) of this title.
(k)
Specific licenses for incorporation of NARM into gas and
aerosol detectors. In addition to the requirements in subsection (e) of this
section, a specific license authorizing the incorporation of NARM into gas
and aerosol detectors to be distributed to persons exempt from this chapter
in accordance with §289.251(e)(3)(C) of this title will be issued if
the agency approves the information submitted by the applicant. This information
shall satisfy the requirements equivalent to those contained in Title 10,
Code of Federal Regulations (CFR), 32.26.The maximum quantity of radium-226
in each device shall not exceed 0.1 µCi.
(l)
Specific licenses for the manufacture and commercial distribution
of devices to persons generally licensed in accordance with §289.251(k)(1)
of this title.
(1)
In addition to the requirements in subsection (e) of this
section, a specific license to manufacture or commercially distribute devices
containing radioactive material to persons generally licensed in accordance
with §289.251(h)(1)(C) and (k)(1) of this title or equivalent requirements
of the NRC, an agreement state, or a licensing state will be issued if the
agency approves the following information submitted by the applicant:
(A)
the design, manufacture, prototype testing, quality control,
labels, proposed uses, installation, servicing, leak testing, operating and
safety instructions, and potential hazards of the device to provide reasonable
assurance that:
(i)
the device can be safely operated by persons not having
training in radiological protection;
(ii)
under ordinary conditions of handling, storage, and use
of the device, the radioactive material contained in the device will not be
released or inadvertently removed from the device, and it is unlikely that
any person will receive in any period of one year a dose in excess of 10%
of the limits specified in §289.202(f) of this title; and
(iii)
under accident conditions (such as fire and explosion)
associated with handling, storage, and use of the device, it is unlikely that
any person would receive an external radiation dose or dose commitment in
excess of the following organ doses:
(I)
15 rems to the whole body; head and trunk; active blood-forming
organs; gonads; or lens of eye;
(II)
200 rems to the hands and forearms; feet and ankles;
localized areas of skin averaged over areas no larger than 1 square centimeter
(cm
2
); or
(III)
50 rems to other organs;
(B)
procedures for disposition of unused or unwanted radioactive
material;
(C)
each device bears a durable, legible, clearly visible
label or labels approved by the agency that contain the following in a clearly
identified and separate statement:
(i)
instructions and precautions necessary to assure safe
installation, operation, and servicing of the device (documents such as operating
and service manuals may be identified in the label and used to provide this
information);
(ii)
the requirement, or lack of requirement, for leak testing,
or for testing any "on-off" mechanism and indicator, including the maximum
time interval for such testing, and the identification of radioactive material
by isotope, quantity of radioactivity, and date of determination of the quantity;
and
(iii)
the information called for in one of the following statements,
as appropriate, in the same or substantially similar form:
(I)
For radioactive materials other than NARM, the following
statement is appropriate:
Figure: 25 TAC §289.252(l)(1)(C)(iii)(I)
(II)
For NARM, the following statement is appropriate:
Figure: 25 TAC §289.252(l)(1)(C)(iii)(II)
(III)
The model and serial number and name of manufacturer
or distributor may be omitted from this label provided they are elsewhere
stated in labeling affixed to the device.
(2)
In the event the applicant desires
that the device be required to be tested at intervals longer than six months,
either for proper operation of the "on-off" mechanism and indicator, if any,
or for leakage of radioactive material, or for both, the applicant shall include
in the application sufficient information to demonstrate that the longer interval
is justified by performance characteristics of the device or similar devices
and by design features that have a significant bearing on the probability
or consequences of radioactive material leakage from the device or failure
of the "on-off" mechanism and indicator. In determining the acceptable interval
for the test for radioactive material leakage, the agency will consider information
that includes, but is not limited to the following:
(A)
primary containment (sealed source capsule);
(B)
protection of primary containment;
(C)
method of sealing containment;
(D)
containment construction materials;
(E)
form of contained radioactive material;
(F)
maximum temperature withstood during prototype tests;
(G)
maximum pressure withstood during prototype tests;
(H)
maximum quantity of contained radioactive material;
(I)
radiotoxicity of contained radioactive material; and
(J)
operating experience with identical devices or similarly
designed and constructed devices.
(3)
In the event the applicant desires that the
general licensee in accordance with §289.251(h)(1)(C) and (k)(1) of this
title or in accordance with equivalent regulations of the NRC, an agreement
state, or a licensing state, be authorized to mount the device, collect the
sample to be analyzed by a specific licensee for radioactive material leakage,
perform maintenance of the device consisting of replacement of labels, rust
and corrosion prevention, and for fixed gauges, repair and maintenance of
sealed source holder mounting brackets, test the "on-off" mechanism and indicator,
or remove the device from installation, the applicant shall include in the
application written instructions to be followed by the general licensee, estimated
annual doses associated with such activity or activities, and bases for such
estimates. The submitted information shall demonstrate that performance of
such activity or activities by an individual untrained in radiological protection,
in addition to other handling, storage, and use of devices in accordance with
the general license, is unlikely to cause that individual to receive an annual
dose in excess of 10% of the limits specified in §289.202(f) of this
title.
(4)
Before the device may be transferred, each person
licensed in accordance with this subsection to commercially distribute devices
to generally licensed persons shall furnish:
(A)
a copy of the general license in §289.251(h)(1)(C)
and (k)(1) of this title to each person to whom the licensee directly commercially
distributes radioactive material in a device for use in accordance with the
general license in §289.251(h)(1)(C) and (k)(1) of this title;
(B)
a copy of the general license in the NRC's, agreement
state's, or licensing state's regulation equivalent to §289.251(h)(1)(C)
and (k)(1) of this title, or alternatively, a copy of the general license
in §289.251(h)(1)(C) and (k)(1) of this title to each person to whom
the licensee directly commercially distributes radioactive material in a device
for use in accordance with the general license of the NRC, the agreement state,
or the licensing state. If a copy of the general license in §289.251(h)(1)(C)
and (k)(1) of this title is furnished to such a person, it shall be accompanied
by an explanation that the use of the device is regulated by the NRC, agreement
state, or licensing state in accordance with requirements substantially the
same as those in §289.251(h)(1)(C) and (k)(1) of this title;
(C)
a copy of §289.251(h)(1)(C) and (k)(1) of this title;
(D)
a list of the services that can only be performed by a
specific licensee;
(E)
information on acceptable disposal options including estimated
costs of disposal; and
(F)
the name, address, and phone number of a contact person
at the agency, an agreement state, or licensing state from which additional
information may be obtained.
(5)
In the case of a transfer through an intermediate
person, each licensee who commercially distributes radioactive material in
a device for use in accordance with the general license in §289.251(h)(1)(C)
and (k)(1) of this title, shall furnish the information in paragraph (4) of
this subsection to the intended user prior to the initial transfer to the
intermediate person.
(6)
Each person licensed in accordance with this subsection
to commercially distribute devices to generally licensed persons shall:
(A)
report to the agency all commercial distributions of devices
to persons for use in accordance with the general license in §289.251(h)(1)(C)
and (k)(1) of this title.
(i)
The report shall cover each calendar quarter, shall be
filed within 30 days thereafter, and shall include:
(I)
identity of each general licensee by name and address;
(II)
identity of an individual by name and/or position who
may constitute a point of contact between the agency and the general licensee;
(III)
the type, model and serial number of device, and serial
number of sealed source commercially distributed; and
(IV)
the quantity and type of radioactive material contained
in the device.
(ii)
If one or more intermediate persons will temporarily
possess the device at the intended place of use prior to its possession by
the user, the report shall also include identification of each intermediate
person by name, address, contact, and relationship to the intended user.
(iii)
If no commercial distributions have been made to persons
generally licensed in accordance with §289.251(h)(1)(C) and (k)(1) of
this title during the reporting period, the report shall so indicate.
(B)
report the following to the NRC to include covering each
calendar quarter to be filed within 30 days thereafter:
(i)
all commercial distributions of such devices to persons
for use in accordance with the NRC general license in Title 10, CFR, §31.5
including:
(I)
identity of each general licensee by name and address;
(II)
identity of an individual by name and/or position who
may constitute a point of contact between the agency and the general licensee;
(III)
the type, model and serial number of device, and serial
number of sealed source commercially distributed; and
(IV)
the quantity and type of radioactive material contained
in the device; or
(ii)
if no commercial distributions have been made to the
NRC licensees during the reporting period; the report shall so indicate; and
(C)
report to the appropriate agreement state or licensing
state all transfers of devices manufactured and commercially distributed in
accordance with this subsection for use in accordance with a general license
in that state's requirements equivalent to §289.251(h)(1)(C) and (k)(1)
of this title.
(i)
The report shall be submitted within 30 days after the
end of each calendar quarter in which such a device is commercially distributed
to the generally licensed person and shall include the following:
(I)
identity of each general licensee by name and address;
(II)
identity of an individual by name and/or position who
may constitute a point of contact between the agency and the general licensee;
(III)
the type, model and serial number of the device, and
serial number of sealed source commercially distributed; and
(IV)
the quantity and type of radioactive material contained
in the device.
(ii)
If one or more intermediate persons will temporarily
possess the device at the intended place of use prior to its possession by
the user, the report shall also include identification of each intermediate
person by name, address, contact, and relationship to the intended user; and
(D)
keep records showing the name, address, and the point
of contact for each general licensee to whom the licensee directly or through
an intermediate person commercially distributes radioactive material in devices
for use in accordance with the general license provided in §289.251(h)(1)(C)
and (k)(1) of this title, or equivalent requirements of the NRC, an agreement
state, or a licensing state.
(i)
The records shall show the following:
(I)
date of each commercial distribution;
(II)
the isotope and the quantity of radioactivity in each
device commercially distributed;
(III)
the identity of any intermediate person; and
(IV)
compliance with the reporting requirements of this subsection.
(ii)
If no commercial distributions have been made to persons
generally licensed in accordance with §289.251(h)(1)(C) and (k)(1) of
this title during the reporting period, the records shall so indicate.
(7)
If a notification of bankruptcy has been
made in accordance with subsection (x)(4) of this section or the license is
to be terminated, each person licensed under this subsection shall provide,
upon request to the NRC and to any appropriate agreement state or licensing
state, records of final disposition required under subsection (y)(14)(A) of
this section.
(m)
Specific licenses for the manufacture, assembly, or repair
of luminous safety devices for use in aircraft for commercial distribution
to persons generally licensed in accordance with §289.251(h)(4) of this
title. In addition to the requirements in subsection (e) of this section,
a specific license to manufacture, assemble, or repair luminous safety devices
containing tritium or promethium-147 for use in aircraft, for commercial distribution
to persons generally licensed in accordance with §289.251(h)(4) of this
title, will be issued if the agency approves the information submitted by
the applicant. The information shall satisfy the requirements of Title 10,
CFR, §§32.53, 32.54, 32.55, 32.56, and 32.101 or their equivalent.
(n)
Specific licenses for the manufacture of calibration sources
containing americium-241, plutonium, or radium-226 for commercial distribution
to persons generally licensed in accordance with §289.251(h)(6) of this
title. In addition to the requirements in subsection (e) of this title, a
specific license to manufacture calibration sources containing americium-241,
plutonium, or radium-226 to persons generally licensed in accordance with §289.251(h)(6)
of this title will be issued if the agency approves the information submitted
by the applicant. The information shall satisfy the requirements of Title
10, CFR, §§32.57, 32.58, 32.59, and 32.102, and 10 CFR 70.39 or
their equivalent.
(o)
Specific licenses for the manufacture and commercial distribution
of sealed sources or devices containing radioactive material for medical use.
(1)
In addition to the requirements in subsection (e) of this
section, a specific license to manufacture and commercially distribute sealed
sources and devices containing radioactive material to persons licensed for
use of sealed sources in the healing arts for use as a calibration or reference
source will be issued if the agency approves the following information submitted
by the applicant:
(A)
an evaluation of the radiation safety of each type of
sealed source or device including the following:
(i)
the radioactive material contained, its chemical and physical
form, and amount;
(ii)
details of design and construction of the sealed source
or device;
(iii)
procedures for, and results of, prototype tests to demonstrate
that the sealed source or device will maintain its integrity under stresses
likely to be encountered in normal use and accidents;
(iv)
for devices containing radioactive material, the radiation
profile of a prototype device;
(v)
details of quality control procedures to assure that production
sources and devices meet the standards of the design and prototype tests;
(vi)
procedures and standards for calibrating sealed sources
and devices;
(vii)
instructions for handling and storing the sealed source
or device from the radiation safety standpoint. These instructions are to
be included on a durable label attached to the sealed source or device or
attached to a permanent storage container for the sealed source or device,
provided that instructions that are too lengthy for the label may be summarized
on the label and printed in detail on a brochure that is referenced on the
label; and
(viii)
procedures for disposition of unwanted or unused radioactive
material; and
(B)
documentation that the label affixed to the sealed source
or device, or to the permanent storage container for the sealed source or
device, contains information on the radionuclide, quantity, and date of assay,
and a statement that the name of the sealed source or device is licensed by
the agency for commercial distribution to persons licensed for use of sealed
sources in the healing arts or by equivalent licenses of the NRC, an agreement
state, or a licensing state, provided that the labeling for sealed sources
that do not require long-term storage may be on a leaflet or brochure that
accompanies the sealed source;
(C)
documentation that in the event the applicant desires
that the sealed source or device be required to be tested for radioactive
material leakage at intervals longer than six months, the applicant shall
include in the application sufficient information to demonstrate that the
longer interval is justified by performance characteristics of the sealed
source or device or similar sources or devices and by design features that
have a significant bearing on the probability or consequences of radioactive
material leakage from the sealed source; and
(D)
documentation that in determining the acceptable interval
for testing radioactive material leakage, information will be considered that
includes, but is not limited to the following:
(i)
primary containment (sealed source capsule);
(ii)
protection of primary containment;
(iii)
method of sealing containment;
(iv)
containment construction materials;
(v)
form of contained radioactive material;
(vi)
maximum temperature withstood during prototype tests;
(vii)
maximum pressure withstood during prototype tests;
(viii)
maximum quantity of contained radioactive material;
(ix)
radiotoxicity of contained radioactive material; and
(x)
operating experience with identical sealed sources or
devices or similarly designed and constructed sealed sources or devices.
(p)
Specific licenses for the manufacture and commercial distribution
of radioactive material for certain in vitro clinical or laboratory testing
in accordance with the general license. In addition to the requirements in
subsection (e) of this section, a specific license to manufacture or commercially
distribute radioactive material for use in accordance with the general license
in §289.251(k)(2) of this title will be issued if the agency approves
the following information submitted by the applicant:
(1)
that the radioactive material will be prepared for distribution
in prepackaged units of:
(A)
iodine-125 in units not exceeding 10 microcuries (µCi)
each;
(B)
iodine-131 in units not exceeding 10 µCi each;
(C)
carbon-14 in units not exceeding 10 µCi each;
(D)
hydrogen-3 (tritium) in units not exceeding 50 µCi
each;
(E)
iron-59 in units not exceeding 20 µCi each;
(F)
cobalt-57 in units not exceeding 10 µCi each;
(G)
selenium-75 in units not exceeding 10 µCi each;
or
(H)
mock iodine-125 in units not exceeding 0.05 µCi
of iodine-129 and 0.005 µCi of americium-241 each;
(2)
that each prepackaged unit bears a durable,
clearly visible label:
(A)
identifying the radioactive contents as to chemical form
and radionuclide, and indicating that the amount of radioactivity does not
exceed 10 µCi of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75;
50 µCi of hydrogen-3 (tritium); 20 µCi of iron-59; or mock iodine-125
in units not exceeding 0.05 µCi of iodine-129 and 0.005 µCi of
americium-241; and
(B)
displaying the radiation caution symbol in accordance
with §289.202(z) of this title and the words, "CAUTION, RADIOACTIVE MATERIAL,"
and "Not for Internal or External Use in Humans or Animals";
(3)
that one of the following statements, as appropriate,
or a substantially similar statement appears on a label affixed to each prepackaged
unit or appears in a leaflet or brochure that accompanies the package:
(A)
option 1:
Figure: 25 TAC §289.252(p)(3)(A)
(B)
option 2:
Figure: 25 TAC §289.252(p)(3)(B)
(4)
that the label affixed to the unit, or the leaflet
or brochure that accompanies the package, contains adequate information as
to the precautions to be observed in handling and storing the radioactive
material. In the case of a mock iodine-125 reference or calibration source,
the information accompanying the source must also contain directions to the
licensee regarding the waste disposal requirements of §289.202(ff) of
this title.
(q)
Specific licenses for the manufacture and commercial distribution
of ice detection devices. In addition to the requirements of subsection (e)
of this section, a specific license to manufacture and commercially distribute
ice detection devices to persons generally licensed in accordance with §289.251(h)(8)
of this title will be issued if the agency approves the information submitted
by the applicant. This information shall satisfy the requirements of Title
10, CFR, §§32.61, 32.62, and 32.103.
(r)
Specific licenses for the manufacture, preparation, or
transfer for commercial distribution of radioactive drugs containing radioactive
materials for medical use.
(1)
In addition to the requirements in subsection (e) of this
section, a specific license to manufacture, prepare, or transfer for commercial
distribution, radioactive drugs containing radioactive material for use by
persons authorized in accordance with §289.256 of this title will be
issued if the agency approves the following information submitted by the applicant:
(A)
evidence that the applicant is at least one of the following:
(i)
registered or licensed with the United States Food and
Drug Administration (FDA) as a drug manufacturer;
(ii)
registered or licensed with a state agency as a drug
manufacturer; or
(iii)
licensed as a pharmacy by the Texas State Board of Pharmacy;
and
(B)
radionuclide data relating to the following:
(i)
chemical and physical form;
(ii)
maximum activity per vial, syringe, generator, or other
container of the radioactive drug;
(iii)
shielding provided by the packaging to show it is appropriate
for the safe handling and storage of the radioactive drugs by medical use
licensees; and
(C)
labeling requirements including the following:
(i)
that each transport radiation shield, whether it is constructed
of lead, glass, plastic, or other material, of a radioactive drug to be transferred
for commercial distribution shall include the following:
(I)
radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL"
or "DANGER, RADIOACTIVE MATERIAL;"
(II)
name of the radioactive drug or its abbreviation;
(III)
quantity of radioactivity at a specified date and time
(the time may be omitted for radioactive drugs with a half life greater than
100 days); and
(ii)
that each syringe, vial, or other container used to hold
a radioactive drug to be transferred for commercial distribution shall include
the following:
(I)
radiation symbol and the words, "CAUTION, RADIOACTIVE
MATERIAL" or "DANGER, RADIOACTIVE MATERIAL;"
(II)
name of the radioactive drug or its abbreviation;
(III)
quantity of radioactivity at a specified date and time
(the time may be omitted for radioactive drugs with a half life greater than
100 days); or
(IV)
an identifier that ensures that the syringe, vial, or
other container can be correlated with the information on the transport radiation
shield.
(2)
A licensee shall possess and use instrumentation
to measure the radioactivity of radioactive drugs and shall have procedures
for the use of the instrumentation. The licensee shall measure, by direct
measurement or by a combination of measurements and calculations, the amount
of radioactivity in dosages of alpha, beta, or photon-emitting radioactive
drugs prior to transfer for commercial distribution. In addition, the licensee
shall:
(A)
perform tests before initial use, periodically, and following
repair, on each instrument for accuracy, linearity, and geometry dependence,
as appropriate for the use of the instrument; and make adjustments when necessary;
(B)
check each instrument for constancy and proper operation
at the beginning of each day of use; and
(C)
maintain records of the tests and checks in this paragraph
for a minimum of three years for inspection by the agency.
(3)
A licensee described in paragraph (1)(A)(iii)
of this subsection shall do the following:
(A)
prepare radioactive drugs for medical use as described
in §289.256 of this title, provided that the radioactive drugs are prepared
by a nuclear pharmacist(s) designated in the application as the individual
user(s) who has completed the training and experience requirements specified
in the rules of the Texas State Board of Pharmacy, contained in Title 22,
Texas Administrative Code, §291.52; and
(B)
provide to the agency a copy of each individual's certification
by the Texas State Board of Pharmacy or the permit issued by a licensee of
broad scope, and a copy of the state pharmacy license. If the licensee adds
a nuclear pharmacist(s) to the license, this shall be completed no later than
30 days after the date that the licensee allows the individual(s) to work
as a nuclear pharmacist.
(4)
Nothing in this subsection relieves the licensee
from complying with applicable FDA, other federal, and state requirements
governing radioactive drugs.
(s)
Specific licenses for the manufacture and commercial distribution
of products containing depleted uranium for mass-volume applications.
(1)
In addition to the requirements in subsection (e) of this
section, a specific license to manufacture products and devices containing
depleted uranium for use in accordance with §289.251(g)(5) of this title
or equivalent regulations of the NRC or an agreement state, will be issued
if the agency approves the following information submitted by the applicant:
(A)
the design, manufacture, prototype testing, quality control
procedures, labeling or marking, proposed uses, and potential hazards of the
product or device to provide reasonable assurance that possession, use, or
commercial distribution of the depleted uranium in the product or device is
not likely to cause any individual to receive in any period of one year a
radiation dose in excess of 10% of the limits specified in §289.202(f)
of this title; and
(B)
reasonable assurance is provided that unique benefits
will accrue to the public because of the usefulness of the product or device.
(2)
In the case of a product or device whose unique
benefits are questionable, the agency will issue a specific license in accordance
with paragraph (1) of this subsection only if the product or device is found
to combine a high degree of utility and low probability of uncontrolled disposal
and dispersal of significant quantities of depleted uranium into the environment.
(3)
The agency may deny any application for a specific
license in accordance with this subsection if the end use(s) of the product
or device cannot be reasonably foreseen.
(4)
Each person licensed in accordance with paragraph
(1) of this subsection shall:
(A)
maintain the level of quality control required by the
license in the manufacture of the product or device, and in the installation
of the depleted uranium into the product or device;
(B)
label or mark each unit to:
(i)
identify the manufacturer of the product or device and
the number of the license under which the product or device was manufactured,
the fact that the product or device contains depleted uranium, and the quantity
of depleted uranium in each product or device, and
(ii)
state that the receipt, possession, use, and commercial
distribution of the product or device are subject to a general license or
the equivalent and the requirements of the NRC or of an agreement state;
(C)
assure that before being installed in each product or
device, the depleted uranium has been impressed with the following legend
clearly legible through any plating or other covering: "Depleted Uranium";
(D)
furnish a copy of the following:
(i)
the general license in §289.251(g)(5) of this title
to each person to whom the licensee commercially distributes depleted uranium
in a product or device for use in accordance with the general license in §289.251(g)(5)
of this title, or
(ii)
the NRC's or agreement state's requirements equivalent
to the general license in §289.251(g)(5) of this title and a copy of
the NRC's or agreement state's certificate;
(E)
report to the agency all commercial distributions of products
or devices to persons for use in accordance with the general license in §289.251(g)(5)
of this title.
(i)
The report shall be submitted within 30 days after the
end of each calendar quarter in which such a product or device is commercially
distributed to the generally licensed person and shall include the following:
(I)
identity of each general licensee by name and address;
(II)
identity of an individual by name and/or position who
may constitute a point of contact between the agency and the general licensee;
(III)
the type and model number of devices commercially distributed;
and
(IV)
the quantity of depleted uranium contained in the product
or device.
(ii)
If no commercial distributions have been made to persons
generally licensed in accordance with §289.251(g)(5) of this title during
the reporting period, the report shall so indicate;
(F)
report to the NRC and each responsible agreement state
agency all commercial distributions of industrial products or devices to persons
for use in accordance with the general license in the NRC's or agreement state's
equivalent requirements to §289.251(g)(5) of this title. The report shall
meet the provisions of subparagraph (E)(i) and (ii) of this paragraph; and
(G)
keep records showing the name, address, and point of contact
for each general licensee to whom the licensee commercially distributes depleted
uranium in products or devices for use in accordance with the general license
provided in §289.251(g)(5) of this title or equivalent requirements of
the NRC or of an agreement state. The records shall be maintained for a period
of two years for inspection by the agency and shall show the date of each
commercial distribution, the quantity of depleted uranium in each product
or device commercially distributed, and compliance with the report requirements
of this section.
(t)
Specific licenses for the processing of loose radioactive
material for manufacture and commercial distribution. In addition to the requirements
in subsection (e) of this section, a license to process loose radioactive
material for manufacture and commercial distribution of radioactive material
to persons authorized to possess such radioactive material in accordance with
this chapter will be issued if the agency approves the following information
submitted by the applicant:
(1)
radionuclides to be used, including the chemical and/or
physical form and the maximum activity of each radionuclide;
(2)
intended use of each radionuclide and the sealed
sources and/or other products to be manufactured that includes:
(A)
receipt of radioactive material;
(B)
chemical or physical preparations;
(C)
sealed source construction;
(D)
final assembly or processing;
(E)
quality assurance testing;
(F)
quality control program;
(G)
leak testing;
(H)
American National Standards Institute (ANSI) testing procedures;
(I)
transportation containers;
(J)
shipping procedures; and
(K)
disposition of unwanted or unused radioactive material;
(3)
scaled drawings of the facility to include,
but not be limited to:
(A)
air filtration;
(B)
ventilation system;
(C)
plumbing; and
(D)
radioactive material handling systems and, when applicable,
remote handling hot cells;
(4)
details of the environmental monitoring program;
and
(5)
documentation of training as specified in subsection
(ii)(1) of this section for all personnel who will be handling radioactive
materials.
(u)
Specific licenses for other manufacture and commercial
distribution of radioactive material. In addition to the requirements in subsection
(e) of this section, a license to manufacture and commercially distribute
radioactive material to persons authorized to possess such radioactive material
in accordance with these requirements will be issued if the agency approves
the following information submitted by the applicant:
(1)
the radionuclides to be used, including the chemical and/or
physical form and the maximum activity of each radionuclide;
(2)
the intended use of each radionuclide and the sealed
sources and/or other products to be manufactured that includes:
(A)
receipt of radioactive material;
(B)
chemical or physical preparations;
(C)
sealed source construction;
(D)
final assembly or processing;
(E)
quality assurance testing;
(F)
quality control program;
(G)
leak testing;
(H)
ANSI testing procedures;
(I)
transportation containers;
(J)
shipping procedures; and
(K)
disposition of unwanted or unused radioactive material;
(3)
scaled drawings of radioactive material handling
systems and;
(4)
documentation of training as specified in subsection
(ii)(1) of this section for all personnel who will be handling radioactive
material.
(v)
Sealed source or device evaluation. Except as provided
in paragraphs (7) and (8) of this subsection, no sealed source or device containing
radioactive material shall be authorized on a specific license or general
license until radiation safety information for that sealed source or device
has been evaluated by the agency, the NRC, another agreement state, or a licensing
state.
(1)
An applicant shall submit a request to the agency for
evaluation of radiation safety information about the sealed source or device
containing a sealed source.
(2)
The request for review shall be submitted in duplicate
accompanied by the appropriate fee in §289.204 of this title.
(3)
The request for review shall contain sufficient information
about the sealed source or device to include the following:
(A)
the radioactive material contained, its chemical and physical
form, and amount;
(B)
details of design and construction;
(C)
procedures for, and results of, prototype tests to demonstrate
that the sealed source or device will maintain its integrity under stresses
likely to be encountered in normal use and accidents;
(D)
details of quality control procedures to assure that production
of sealed sources and devices meet the standards of the design and prototype
tests;
(E)
labeling;
(F)
proposed uses; and
(G)
procedures for leak testing.
(4)
For a device containing radioactive material,
the request shall also contain sufficient information about the device to
include:
(A)
the radiation profile of a prototype device;
(B)
method of installation;
(C)
service and maintenance requirements; and
(D)
operating and safety instructions.
(5)
After review of the request, the agency may
issue an evaluation documenting the information in paragraph (3) of this subsection
for sealed sources and paragraph (4) of this subsection for devices containing
radioactive material.
(6)
The applicant submitting the request for evaluation
of the safety information about the product shall manufacture and distribute
or cause the product to be manufactured or distributed in accordance with:
(A)
the statements and representations contained in the request;
(B)
documentation required to support the request; and
(C)
the provisions of the evaluation.
(7)
Sealed sources or devices that do not require
radiation safety evaluations are as follows:
(A)
calibration and reference sources of 100 µCi or
less for beta or gamma-emitting radionuclides and 10 µCi or less for
alpha-emitting radionuclides; and
(B)
custom (one-of-a-kind) sources or devices used in research
and development. If the same device is manufactured and transferred to a second
licensee, it ceases to be custom. The licensee must be qualified by sufficient
training and experience and have sufficient facilities and equipment to safely
use the requested quantity of radioactive material in unsealed form.
(8)
Sealed sources or devices used in research and
development that require modified safety evaluations.
(A)
For sealed sources or devices used in research and development,
the following shall be submitted:
(i)
the radioactive material contained, its chemical and physical
form, and amount;
(ii)
details of the design and construction sufficient to
determine that no obvious mechanical flaws exist;
(iii)
information that demonstrates that sealed sources meet
ANSI/HPS N43.6-1997 criteria for the particular category of use and that devices
will maintain their integrity during normal use and accident conditions; and
(iv)
procedures for use that demonstrate a safe environment
for users and others nearby.
(B)
A safety evaluation is not required if the licensee is
qualified by sufficient training and experience and has sufficient facilities
and equipment to safely use the requested quantity of radioactive material
in unsealed form.
(w)
Issuance of specific licenses.
(1)
When the agency determines that an application meets the
requirements of the Act and the rules of the agency, the agency will issue
a specific license authorizing the proposed activity in such form and containing
the conditions and limitations as it deems appropriate or necessary.
(2)
The agency may incorporate in any license at the
time of issuance, or thereafter by amendment, additional requirements and
conditions with respect to the licensee's receipt, possession, use, and transfer
of radioactive material subject to this section as it deems appropriate or
necessary in order to:
(A)
minimize danger to occupational and public health and
safety or the environment;
(B)
require reports and the keeping of records, and to provide
for inspections of activities in accordance with the license as may be appropriate
or necessary; and
(C)
prevent loss or theft of radioactive material subject
to this chapter.
(x)
Specific terms and conditions of licenses.
(1)
Each license issued in accordance with
this section shall be subject to the applicable provisions of the Act and
to applicable rules, now or hereafter in effect, and orders of the agency.
(2)
No license issued or granted in accordance with this
section and no right to possess or utilize radioactive material granted by
any license issued in accordance with this section shall be transferred, assigned,
or in any manner disposed of, either voluntarily or involuntarily, directly
or indirectly, through transfer of control of any license to any person unless
the agency shall, after securing full information, find that the transfer
is in accordance with the provisions of the Act and to applicable rules, now
or hereafter in effect, and orders of the agency, and shall give its consent
in writing.
(3)
Each person licensed by the agency in accordance
with this section shall confine use and possession of the radioactive material
licensed to the locations and purposes authorized in the license.
(4)
Each licensee shall notify the agency, in writing,
immediately following the filing of a voluntary or involuntary petition for
bankruptcy.
(5)
The notification in paragraph (4) of this subsection
must include:
(A)
the bankruptcy court in which the petition for bankruptcy
was filed; and
(B)
the date of the filing of the petition.
(6)
A copy of the petition for bankruptcy shall
be submitted to the agency along with the written notification.
(y)
Expiration and termination of licenses and decommissioning
of sites and separate buildings or outdoor areas.
(1)
Except as provided in paragraph (2) of this subsection
and subsection (z)(2) of this section, each specific license expires at the
end of the day, in the month and year stated in the license.
(2)
All license provisions continue, in effect, beyond
the expiration date, with respect to possession of radioactive material until
the agency notifies the former licensee in writing that the provisions of
the license are no longer binding. During this time, the former licensee shall:
(A)
be limited to actions involving radioactive material that
are related to decommissioning; and
(B)
continue to control entry to restricted areas until the
location(s) is suitable for release for unrestricted use in accordance with
the requirements in §289.202(ddd) of this title.
(3)
Within 60 days of the occurrence of any of the
following, each licensee shall provide notification to the agency in writing
and either begin decommissioning its site, or any separate building or outdoor
area that contains residual radioactivity, so that the building and/or outdoor
area is suitable for release in accordance with §289.202(eee) of this
title, or submit within 12 months of notification a decommissioning plan,
if required by paragraph (6) of this subsection, and begin decommissioning
upon approval of that plan:
(A)
the license has expired in accordance with this subsection
or subsection (dd)(3) of this section; or
(B)
the licensee has decided to permanently cease principal
activities, as defined in §289.201(b) of this title, at the entire site
or in any separate building or outdoor area; or
(C)
no principal activities under the license have been conducted
for a period of 24 months; or
(D)
no principal activities have been conducted for a period
of 24 months in any separate building or outdoor area that contains residual
radioactivity such that the building or outdoor area is unsuitable for release
in accordance with §289.202(eee) of this title.
(4)
Coincident with the notification required by
paragraph (3) of this subsection, the licensee shall maintain in effect all
decommissioning financial assurances established by the licensee in accordance
with subsection (gg) of this section in conjunction with a license issuance
or renewal or as required by this section. The amount of the financial assurance
must be increased, or may be decreased, as appropriate, to cover the detailed
cost estimate for decommissioning established in accordance with paragraph
(9)(E) of this subsection.
(A)
Any licensee who has not provided financial assurance
to cover the detailed cost estimate submitted with the decommissioning plan
shall do so by March 1, 1998.
(B)
Following approval of the decommissioning plan, a licensee
may reduce the amount of the financial assurance as decommissioning proceeds
and radiological contamination is reduced at the site with the approval of
the agency.
(5)
The agency may grant a request to delay or postpone
initiation of the decommissioning process if the agency determines that such
relief is not detrimental to the occupational and public health and safety
and is otherwise in the public interest. The request must be submitted no
later than 30 days before notification in accordance with paragraph (3) of
this subsection. The schedule for decommissioning set forth in paragraph (3)
of this subsection may not commence until the agency has made a determination
on the request.
(6)
A decommissioning plan must be submitted if required
by license condition or if the procedures and activities necessary to carry
out decommissioning of the site or separate building or outdoor area have
not been previously approved by the agency and these procedures could increase
potential health and safety impacts to workers or to the public, such as in
any of the following cases:
(A)
procedures would involve techniques not applied routinely
during cleanup or maintenance operations;
(B)
workers would be entering areas not normally occupied
where surface contamination and radiation levels are significantly higher
than routinely encountered during operation;
(C)
procedures could result in significantly greater airborne
concentrations of radioactive materials than are present during operation;
or
(D)
procedures could result in significantly greater releases
of radioactive material to the environment than those associated with operation.
(7)
The agency may approve an alternate schedule
for submittal of a decommissioning plan required in accordance with paragraph
(3) of this subsection if the agency determines that the alternative schedule
is necessary to the effective conduct of decommissioning operations and presents
no undue risk from radiation to the occupational and public health and safety
and is otherwise in the public interest.
(8)
The procedures listed in paragraph (6) of this subsection
may not be carried out prior to approval of the decommissioning plan.
(9)
The proposed decommissioning plan for the site or
separate building or outdoor area must include the following:
(A)
a description of the conditions of the site or separate
building or outdoor area sufficient to evaluate the acceptability of the plan;
(B)
a description of planned decommissioning activities;
(C)
a description of methods used to ensure protection of
workers and the environment against radiation hazards during decommissioning;
(D)
a description of the planned final radiation survey;
(E)
an updated detailed cost estimate for decommissioning,
comparison of that estimate with present funds set aside for decommissioning,
and a plan for assuring the availability of adequate funds for completion
of decommissioning; and
(F)
for decommissioning plans calling for completion of decommissioning
later than 24 months after plan approval, a justification for the delay based
on the criteria in paragraph (13) of this subsection.
(10)
The proposed decommissioning plan will be approved
by the agency if the information in the plan demonstrates that the decommissioning
will be completed as soon as practicable and that the health and safety of
workers and the public will be adequately protected.
(11)
Except as provided in paragraph (13) of this subsection,
licensees shall complete decommissioning of the site or separate building
or outdoor areas as soon as practicable but no later than 24 months following
the initiation of decommissioning.
(12)
Except as provided in paragraph (13) of this subsection,
when decommissioning involves the entire site, the licensee shall request
license termination as soon as practicable but no later than 24 months following
the initiation of decommissioning.
(13)
The agency may approve a request for an alternate
schedule for completion of decommissioning of the site or separate building
or outdoor area, and license termination if appropriate, if the agency determines
that the alternative is warranted by consideration of the following:
(A)
whether it is technically feasible to complete decommissioning
within the allotted 24 month period;
(B)
whether sufficient waste disposal capacity is available
to allow completion of decommissioning within the allotted 24 month period;
(C)
whether a significant volume reduction in wastes requiring
disposal will be achieved by allowing short-lived radionuclides to decay;
(D)
whether a significant reduction in radiation exposure
to workers can be achieved by allowing short-lived radionuclides to decay;
and
(E)
other site-specific factors that the agency may consider
appropriate on a case-by-case basis, such as the regulatory requirements of
other government agencies, lawsuits, groundwater treatment activities, monitored
natural ground-water restoration, actions that could result in more environmental
harm than deferred cleanup, and other factors beyond the control of the licensee.
(14)
As the final step in decommissioning, the licensee
shall do the following:
(A)
certify the disposition of all licensed material, including
accumulated wastes; and
(B)
conduct a radiation survey of the premises where the licensed
activities were carried out and submit a report of the results of this survey
unless the licensee demonstrates that the premises are suitable for release
in accordance with the radiological requirements for license termination specified
in §289.202(ddd) of this title. The licensee shall do the following,
as appropriate:
(i)
report levels of gamma radiation in units of millisieverts
per hour (mSv/hr) (microroentgen per hour (µR/hr)) at 1 m from surfaces,
and report levels of radioactivity, including alpha and beta, in units of
megabecquerels (MBq) (disintegrations per minute (dpm) or µCi) per 100
cm
2
removable and fixed for surfaces, MBq (µCi)
per milliliter (ml) for water, and becquerels (Bq) (picocuries (pCi)) per
gram (g) for solids such as soils or concrete; and
(ii)
specify the manufacturer's name and model and serial
number of survey instrument(s) used and certify that each instrument is properly
calibrated and tested.
(15)
The agency will provide written notification
to specific licenses, including former licenses with provisions continued
in effect beyond the expiration date in accordance with subsection (y)(2)
of this section, that the provisions of the license are no longer binding.
The agency will provide such notification when the agency determines that:
(A)
radioactive material has been properly disposed;
(B)
reasonable effort has been made to eliminate residual
radioactive contamination, if present;
(C)
a radiation survey has been performed that demonstrates
that the premises are suitable for release in accordance with the radiological
requirements for license termination specified in §289.202(ddd) of this
title. or other information submitted by the licensee is sufficient to demonstrate
that the premises are suitable for release in accordance with the radiological
requirements for license termination specified in §289.202(ddd) of this
title; and
(D)
any outstanding fees in accordance with §289.204
of this title are paid and any outstanding notices of violations of this chapter
or of license conditions are resolved.
(16)
Each licensee shall submit to the agency all
records required by §289.202(nn)(2) of this title before the license
is terminated.
(z)
Renewal of license.
(1)
Requests for renewal of specific licenses shall be filed
in accordance with subsection (d)(1)-(3) and (5) of this section.
(2)
In any case in which a licensee, not less than 30
days prior to expiration of an existing license, has filed a request in proper
form for renewal or for a new license authorizing the same activities, such
existing license shall not expire until the request has been finally determined
by the agency. In any case in which a licensee, not more than 90 days after
the expiration of an existing license, has filed a request in proper form
for renewal or for a new license authorizing the same activities, the agency
may reinstate the license and extend the expiration until the request has
been finally determined by the agency.
(aa)
Amendment of licenses at request of licensee.
(1)
Requests for amendment of a license shall be filed in
accordance with subsection (d)(1)-(3) of this section shall be signed by management
or the RSO, and shall specify the respects in which the licensee desires a
license to be amended and the grounds for the amendment.
(2)
Requests for amendments to delete a subsite from
a license shall be filed in accordance with subsections (d)(1) and (2) and
(y)(3) and (15) of this section.
(bb)
Agency action on requests to renew or amend. In considering
a request by a licensee to renew or amend a license, the agency will apply
the criteria in subsection (e) of this section as applicable.
(cc)
Transfer of material.
(1)
No licensee shall transfer radioactive material except
as authorized in accordance with this chapter. This subsection does not include
transfer for commercial distribution.
(2)
Except as otherwise provided in a license and subject
to the provisions of paragraphs (3) and (4) of this subsection, any licensee
may transfer radioactive material:
(A)
to the agency (A licensee may transfer material to the
agency only after receiving prior approval from the agency.);
(B)
to the United States Department of Energy (DOE);
(C)
to any person exempt from this section to the extent permitted
in accordance with such exemption;
(D)
to any person authorized to receive such material in accordance
with the terms of a general license or its equivalent, or a specific license
or equivalent licensing document, issued by the agency, the NRC, any agreement
state, or any licensing state, or to any person otherwise authorized to receive
such material by the federal government or any agency of the federal government,
the agency, any agreement state, or any licensing state; or
(E)
as otherwise authorized by the agency in writing.
(3)
Before transferring radioactive material to
a specific licensee of the agency, the NRC, an agreement state, or a licensing
state, or to a general licensee who is required to register with the agency,
the NRC, an agreement state, or a licensing state prior to receipt of the
radioactive material, the licensee transferring the material shall verify
that the transferee's license authorizes the receipt of the type, form, and
quantity of radioactive material to be transferred.
(4)
The following methods for the verification required
by paragraph (3) of this subsection are acceptable.
(A)
The transferor may possess and have read a current copy
of the transferee's specific license.
(B)
When a current copy of the transferee's specific license
described in subparagraph (A) of this paragraph is not readily available or
when a transferor desires to verify that information received is correct or
up-to-date, the transferor may obtain and record confirmation from the agency,
the NRC, or the licensing agency of an agreement state or a licensing state
that the transferee is licensed to receive the radioactive material.
(5)
Preparation for shipment and transport of radioactive
material shall be in accordance with the provisions of subsection (ff) of
this section.
(dd)
Modification and revocation of licenses.
(1)
The terms and conditions of all licenses shall be subject
to amendment, revision, or modification. A license may be suspended or revoked
by reason of amendments to the Act, or by reason of rules in this chapter
and orders issued by the agency.
(2)
Any license may be revoked, suspended, or modified,
in whole or in part, for any of the following:
(A)
any material false statement in the application or any
statement of fact required under provisions of the Act;
(B)
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 license on an original application; or
(C)
violation of, or failure to observe any of the terms and
conditions of the Act, this chapter, or of the license, or order of the agency.
(3)
Each specific license revoked by the agency
ends at the end of the day on the date of the agency's final determination
to revoke the license, or on the revocation date stated in the determination,
or as otherwise provided by the agency order.
(4)
Except in cases in which the occupational and public
health, interest or safety requires otherwise, no license shall be modified,
suspended, or revoked unless, prior to the institution of proceedings therefore,
facts or conduct that may warrant such action shall have been called to the
attention of the licensee in writing and the licensee shall have been accorded
an opportunity to demonstrate compliance with all lawful requirements.
(ee)
Reciprocal recognition of licenses.
(1)
Subject to this section, any person who holds a specific
license from the NRC, any agreement state, or any licensing state, and issued
by the agency having jurisdiction where the licensee maintains an office for
directing the licensed activity and at which radiation safety records are
normally maintained, is hereby granted a general license to conduct the activities
authorized in such licensing document within the state of Texas provided that:
(A)
the licensing document does not limit the activity authorized
by such document to specified installations or locations;
(B)
the out-of-state licensee notifies the agency in writing
at least three working days prior to engaging in such activity. If, for a
specific case, the three working-day period would impose an undue hardship
on the out-of-state licensee, the licensee may, upon application to the agency,
obtain permission to proceed sooner. The agency may waive the requirement
for filing additional written notifications during the remainder of the calendar
year following the receipt of the initial notification from a person engaging
in activities in accordance with the general license provided in this subsection.
Such notification shall include:
(i)
the exact location, start date, duration, and type activity
to be conducted;
(ii)
the identification of the sealed sources of radiation
to be used;
(iii)
the name(s) and in-state address(es) of the individual(s)
performing the activity;
(iv)
a copy of the pertinent license;
(v)
a copy of the licensee's operating, safety, and emergency
procedures; and
(vi)
an annual fee as specified in §289.204 of this title.
(C)
the out-of-state licensee complies with all applicable
rules of the agency and with all the terms and conditions of the licensee's
licensing document, except any such terms and conditions that may be inconsistent
with applicable rules of the agency;
(D)
the out-of-state licensee supplies such other information
as the agency may request; and
(E)
the out-of-state licensee shall not transfer or dispose
of radioactive material possessed or used in accordance with the general license
provided in this subsection except by transfer to a person:
(i)
specifically licensed by the agency, the NRC, another
agreement state, or another licensing state to receive such material, or
(ii)
exempt from the requirements for a license for such material
in accordance with §289.251(e)(1) of this title.
(2)
In addition to the provisions of paragraph
(1) of this subsection, any person who holds a specific license issued by
the NRC, an agreement state, or a licensing state authorizing the holder to
manufacture, transfer, install, or service the device described in §289.251
(h)(1)(C) and (k)(1) of this title, within areas subject to the jurisdiction
of the licensing body, is hereby granted a general license to install, transfer,
demonstrate, or service the device in the state of Texas provided that:
(A)
the person files a report with the agency within 30 days
after the end of each calendar quarter in which any device is transferred
to or installed in the state of Texas. Each report shall identify by name
and address, each general licensee to whom the device is transferred, the
type of device transferred by manufacturer's name, model and serial number
of the device, and serial number of the sealed source, and the quantity and
type of radioactive material contained in the device;
(B)
the device has been manufactured, labeled, installed,
and serviced in accordance with applicable provisions of the specific license
issued to the person by the NRC, an agreement state, or a licensing state;
(C)
the person assures that any labels required to be affixed
to the device in accordance with requirements of the authority that licensed
manufacture of the device bear a statement that "Removal of this label is
prohibited"; and
(D)
the holder of the specific license furnishes to each general
licensee to whom the holder of the specific license transfers the device,
or on whose premises the holder of the specific license installs the device,
a copy of the general license contained in §289.251(h)(1)(C) and (k)(1)
of this title.
(3)
The agency may withdraw, limit, or qualify its
acceptance of any specific license or equivalent licensing document issued
by another agency, or any product distributed in accordance with the licensing
document, upon determining that the action is necessary in order to prevent
undue hazard to occupational and public health and safety or the environment.
(ff)
Preparation of radioactive material for transport. Requirements
for the preparation of radioactive material for transport are specified in §289.257
of this title.
(gg)
Financial assurance and record keeping for decommissioning.
(1)
The applicant for each specific license authorizing the
possession and use of unsealed radioactive material with a half-life greater
than 120 days and in quantities exceeding 10
5
times the applicable quantities set forth in subsection (ii)(2) of this section
shall submit a decommissioning funding plan as described in paragraph (5)
of this subsection in an amount sufficient to allow the agency to engage a
third party to decommission the license. The decommissioning funding plan
must also be submitted when a combination of isotopes is involved if R divided
by 10
5
is greater than 1 (unity rule), where
R is defined as the sum of the ratios of the quantity of each isotope to the
applicable value in subsection (ii)(2) of this section.
(2)
The applicant for each specific license authorizing
possession and use of radioactive material of half-life greater than 120 days
and in quantities specified in paragraph (4) of this subsection shall either:
(A)
submit a decommissioning funding plan as described in
paragraph (5) of this subsection in an amount sufficient to allow the agency
to engage a third party to decommission the license; or
(B)
submit a certification that financial assurance for decommissioning
has been provided in the amount in accordance with paragraph (4) of this subsection
using one of the methods described in paragraph (6) of this subsection in
an amount sufficient to allow the agency to engage a third party to decommission
the license. For an applicant, this certification may state that the appropriate
assurance will be obtained after the application has been approved and the
license issued, but prior to the receipt of licensed material. If the applicant
defers execution of the financial instrument until after the license has been
issued, a signed original of the financial instrument obtained to satisfy
the requirements of paragraph (6) of this subsection shall be submitted to
the agency before receipt of licensed material. If the applicant does not
defer execution of the financial instrument, as part of the certification,
a signed original of the financial instrument obtained to satisfy the requirements
of paragraph (6) of this subsection shall be submitted to the agency.
(3)
The holder of each specific license issued:
(A)
on or after January 1, 1995, that is of a type described
in paragraph (2) of this subsection shall provide financial assurance for
decommissioning in accordance with the criteria specified in this section;
(B)
before January 1, 1995, and of a type described in paragraph
(1) of this subsection, shall submit on or before January 1, 1995, a decommissioning
funding plan or a certification of financial assurance for decommissioning
in an amount at least equal to $750,000, in accordance with the criteria specified
in this section. If the licensee submits the certification of financial assurance
rather than a decommissioning funding plan at this time, the licensee shall
include a decommissioning funding plan in any application for license renewal;
(C)
before January 1, 1995, and of a type described in paragraph
(2) of this subsection, shall submit on or before January 1, 1995, a certification
of financial assurance for decommissioning or a decommissioning funding plan
in accordance with the criteria specified in this section.
(4)
The required amounts of financial assurance
for decommissioning are determined by quantity of material and are as follows:
(A)
$750,000 for quantities of material greater than 10
(B)
$150,000 for quantities of material greater than 10
(C)
$75,000 for quantities of material greater than 10
(5)
Each decommissioning funding plan must contain
a cost estimate for decommissioning in an amount sufficient to allow the agency
to engage a third party to decommission the license and a description of the
method of assuring funds for decommissioning from paragraph (6) of this subsection,
including means of adjusting cost estimates and associated funding levels
periodically over the life of the facility. The decommissioning funding plan
shall also contain a certification by the licensee that financial assurance
for decommissioning has been provided in an amount sufficient to allow the
agency to engage a third party to decommission the license and a signed original
of the financial instrument obtained to satisfy the requirements of paragraph
(6) of this subsection.
(6)
Financial assurance for decommissioning must be provided
by one or more of the following methods and must be reviewed and approved
by the agency.
(A)
Prepayment. Prepayment is the deposit prior to the start
of operation into an account segregated from licensee assets and outside the
licensee's administrative control of cash or liquid assets such that the amount
of funds would be sufficient to pay decommissioning costs. Prepayment may
be in the form of a trust, escrow account, government fund, certificate of
deposit, or deposit of government securities.
(B)
A surety method, insurance, or other guarantee method.
These methods guarantee that decommissioning costs will be paid. A surety
method may be in the form of a surety bond, letter of credit, or line of credit.
A parent company guarantee of funds for decommissioning costs based on a financial
test may be used if the guarantee and test are as contained in subsection
(ii)(3) of this section. A parent company guarantee may not be used in combination
with other financial methods to satisfy the requirements of this section.
For commercial corporations that issue bonds, a guarantee of funds by the
applicant or licensee for decommissioning costs based on a financial test
may be used if the guarantee and test are as contained in subsection (ii)(4)
of this section. For commercial companies that do not issue bonds, a guarantee
of funds by the applicant or licensee for decommissioning costs may be used
if the guarantee and test are as contained in subsection (ii)(5) of this section.
For nonprofit entities, such as colleges, universities, and nonprofit hospitals,
a guarantee of funds by the applicant or licensee may be used if the guarantee
and test are as contained in subsection (ii)(6) of this section. A guarantee
by the applicant or licensee may not be used in combination with any other
financial methods to satisfy the requirements of this section or in any situation
where the applicant or licensee has a parent company holding majority control
of the voting stock of the company. Any surety method or insurance used to
provide financial assurance for decommissioning must contain the following
conditions.
(i)
The surety method or insurance must be open-ended or,
if written for a specified term, such as five years, must be renewed automatically
unless 90 days or more prior to the renewal date, the issuer notifies the
agency, the beneficiary, and the licensee of its intention not to renew. The
surety method or insurance must also provide that the full face amount be
paid to the beneficiary automatically prior to the expiration without proof
of forfeiture if the licensee fails to provide a replacement acceptable to
the agency within 30 days after receipt of notification of cancellation.
(ii)
The surety method or insurance must be payable to a trust
established for decommissioning costs. The trustee and trust must be acceptable
to the agency. An acceptable trustee includes an appropriate state or federal
government agency or an entity that has the authority to act as a trustee
and whose trust operations are regulated and examined by a federal or state
agency.
(iii)
The surety method or insurance must remain in effect
until the agency has terminated the license.
(C)
An external sinking fund in which deposits are made at
least annually, coupled with a surety method or insurance, the value of which
may decrease by the amount being accumulated in the sinking fund. An external
sinking fund is a fund established and maintained by setting aside funds periodically
in an account segregated from licensee assets and outside the licensee's administrative
control in which the total amount of funds would be sufficient to pay decommissioning
costs at the time termination of operation is expected. An external sinking
fund may be in the form of a trust, escrow account, government fund, certificate
of deposit, or deposit of government securities. The surety or insurance provisions
must be in accordance with subparagraph (B) of this paragraph.
(D)
In the case of federal, state, or local government licensees,
a statement of intent containing a cost estimate for decommissioning or an
amount in accordance with paragraph (4) of this subsection, and indicating
that funds for decommissioning will be obtained when necessary.
(E)
When a governmental entity is assuming custody and ownership
of a site, there shall be an arrangement that is deemed acceptable by such
governmental entity.
(7)
Each person licensed in accordance with this
section shall keep records of information important to the safe and effective
decommissioning of the facility in an identified location until the license
is terminated by the agency. If records of relevant information are kept for
other purposes, reference to these records and their locations may be used.
Information the agency considers important to decommissioning consists of
the following:
(A)
records of spills or other unusual occurrences involving
the spread of contamination in and around the facility, equipment, or site.
These records may be limited to instances when contamination remains after
any cleanup procedures or when there is reasonable likelihood that contaminants
may have spread to inaccessible areas, as in the case of possible seepage
into porous materials such as concrete. These records must include any known
information on identification of involved nuclides, quantities, forms, and
concentrations;
(B)
as-built drawings and modifications of structures and
equipment in restricted areas where radioactive materials are used and/or
stored, and of locations of possible inaccessible contamination such as buried
pipes that may be subject to contamination. If required drawings are referenced,
each relevant document need not be indexed individually. If drawings are not
available, the licensee shall substitute appropriate records of available
information concerning these areas and locations;
(C)
except for areas containing only sealed sources (provided
the sealed sources have not leaked or no contamination remains after any leak)
or byproduct materials having only half-lives of less than 65 days, a list
contained in a single document and updated every two years, of the following:
(i)
all areas designated and formerly designated as restricted
areas as defined in §289.201(b) of this title;
(ii)
all areas outside of restricted areas that require documentation
under subparagraph (A) of this paragraph; and
(iii)
all areas outside of restricted areas where current
and previous wastes have been buried as documented in accordance with §289.202(tt)
of this title; and
(D)
records of the cost estimate performed for the decommissioning
funding plan or of the amount certified for decommissioning, and records of
the funding method used for assuring funds if either a funding plan or certification
is used.
(8)
Any licensee who has submitted an application
before January 1, 1995, for renewal of license in accordance with this section
shall provide financial assurance for decommissioning in accordance with paragraphs
(1) and (2) of this subsection. This assurance shall be submitted when this
section becomes effective March 1, 1998.
(hh)
Emergency plan for responding to a release.
(1)
A new or renewal application for each specific license
to possess radioactive materials in unsealed form, on foils or plated sources,
or sealed in glass in excess of the quantities in subsection (ii)(7) of this
section must contain either:
(A)
an evaluation showing that the maximum dose to a person
offsite due to a release of radioactive material would not exceed 1 rem effective
dose equivalent or 5 rems to the thyroid; or
(B)
an emergency plan for responding to a release of radioactive
material.
(2)
One or more of the following factors may be
used to support an evaluation submitted in accordance with paragraph (1)(A)
of this subsection:
(A)
the radioactive material is physically separated so that
only a portion could be involved in an accident;
(B)
all or part of the radioactive material is not subject
to release during an accident because of the way it is stored or packaged;
(C)
the release fraction in the respirable size range would
be lower than the release fraction in subsection (ii)(7) of this section due
to the chemical or physical form of the material;
(D)
the solubility of the radioactive material would reduce
the dose received;
(E)
facility design or engineered safety features in the facility
would cause the release fraction to be lower than that in subsection (ii)(7)
of this section;
(F)
operating restrictions or procedures would prevent a release
fraction as large as that in subsection (ii)(7) of this section; or
(G)
other factors appropriate for the specific facility.
(3)
An emergency plan for responding to a release
of radioactive material submitted in accordance with paragraph (1)(B) of this
subsection must include the following information.
(A)
Facility description. A brief description of the licensee's
facility and area near the site.
(B)
Types of accidents. An identification of each type of
radioactive materials accident for which protective actions may be needed.
(C)
Classification of accidents. A classification system for
classifying accidents as alerts or site area emergencies.
(D)
Detection of accidents. Identification of the means of
detecting each type of accident in a timely manner.
(E)
Mitigation of consequences. A brief description of the
means and equipment for mitigating the consequences of each type of accident,
including those provided to protect workers onsite, and a description of the
program for maintaining the equipment.
(F)
Assessment of releases. A brief description of the methods
and equipment to assess releases of radioactive materials.
(G)
Responsibilities. A brief description of the responsibilities
of licensee personnel should an accident occur, including identification of
personnel responsible for promptly notifying offsite response organizations
and the agency; also, responsibilities for developing, maintaining, and updating
the plan.
(H)
Notification and coordination. A commitment to and a brief
description of the means to promptly notify offsite response organizations
and request offsite assistance, including medical assistance for the treatment
of contaminated injured onsite workers when appropriate. A control point must
be established. The notification and coordination must be planned so that
unavailability of some personnel, parts of the facility, and some equipment
will not prevent the notification and coordination. The licensee shall also
commit to notify the agency immediately after notification of the appropriate
offsite response organizations and not later than one hour after the licensee
declares an emergency. These reporting requirements do not supersede or release
licensees of complying with the requirements in accordance with the Emergency
Planning and Community Right-to-Know-Act of 1986, Title III, Publication L.
99-499 or other state or federal reporting requirements.
(I)
Information to be communicated. A brief description of
the types of information on facility status, radioactive releases, and recommended
protective actions, if necessary, to be given to offsite response organizations
and to the agency.
(J)
Training. A brief description of the frequency, performance
objectives, and plans for the training that the licensee will provide workers
on how to respond to an emergency, including any special instructions and
orientation tours the licensee would offer to fire, police, medical, and other
emergency personnel. The training shall familiarize personnel with site-specific
emergency procedures. Also, the training shall thoroughly prepare site personnel
for their responsibilities in the event of accident scenarios postulated as
most probable for the specific site, including the use of team training for
such scenarios.
(K)
Safe shutdown. A brief description of the means of restoring
the facility to a safe condition after an accident.
(L)
Exercises. Provisions for conducting quarterly communications
checks with offsite response organizations at intervals not to exceed three
months and biennial onsite exercises to test response to simulated emergencies.
Communications checks with offsite response organizations must include the
check and update of all necessary telephone numbers. The licensee shall invite
offsite response organizations to participate in the biennial exercises. Participation
of offsite response organizations in biennial exercises, although recommended,
is not required. Exercises must use accident scenarios postulated as most
probable for the specific site and the scenarios shall not be known to most
exercise participants. The licensee shall critique each exercise using individuals
not having direct implementation responsibility for the plan. Critiques of
exercises must evaluate the appropriateness of the plan, emergency procedures,
facilities, equipment, training of personnel, and overall effectiveness of
the response. Deficiencies found by the critiques must be corrected.
(M)
Hazardous chemicals. A certification that the applicant
has met its responsibilities in accordance with the Emergency Planning and
Community Right-to-Know Act of 1986, Title III, Publication L. 99-499, if
applicable to the applicant's activities at the proposed place of use of the
radioactive material.
(4)
The licensee shall allow the offsite response
organizations expected to respond in case of an accident 60 days to comment
on the licensee's emergency plan before submitting it to the agency. The licensee
shall provide any comments received within the 60 days to the agency with
the emergency plan.
(ii)
Appendices.
(1)
Subjects to be included in training courses:
(A)
fundamentals of radiation safety:
(i)
characteristics of radiation;
(ii)
units of radiation dose (rem) and activity of radioactivity
(curie);
(iii)
significance of radiation dose;
(I)
radiation protection standards; and.
(II)
biological effects of radiation;
(iv)
levels of radiation from sources of radiation;
(v)
methods of controlling radiation dose;
(I)
time;
(II)
distance; and
(III)
shielding;
(vi)
radiation safety practices, including prevention of contamination
and methods of decontamination; and
(vii)
discussion of internal exposure pathways;
(B)
radiation detection instrumentation to be used:
(i)
radiation survey instruments:
(I)
operation;
(II)
calibration; and
(III)
limitations;
(ii)
survey techniques;
(iii)
individual monitoring devices;
(C)
equipment to be used:
(i)
handling equipment and remote handling tools;
(ii)
sources of radiation;
(iii)
storage, control, disposal, and transport of equipment
and sources of radiation;
(iv)
operation and control of equipment; and
(v)
maintenance of equipment;
(D)
the requirements of pertinent federal and state regulations;
(E)
the licensee's written operating, safety, and emergency
procedures; and
(F)
the licensee's record keeping procedures.
(2)
Isotope quantities (for use in subsection (gg)
of this section).
Figure: 25 TAC §289.252(ii)(2)
(3)
Criteria relating to use of financial tests and parent
company guarantees for providing reasonable assurance of funds for decommissioning.
(A)
Introduction. An applicant or licensee may provide reasonable
assurance of the availability of funds for decommissioning based on obtaining
a parent company guarantee that funds will be available for decommissioning
costs and on a demonstration that the parent company passes a financial test.
This paragraph establishes criteria for passing the financial test and for
obtaining the parent company guarantee.
(B)
Financial test.
(i)
To pass the financial test, the parent company must meet
the criteria of either subclause (I) or (II) of this clause.
(I)
The parent company must have:
(-a-)
two of the following three ratios:
(-1-)
a ratio of total liabilities to net worth less than
2.0;
(-2-)
a ratio of the sum of net income plus depreciation,
depletion, and amortization to total liabilities greater than 0.1; and
(-3-)
a ratio of current assets to current liabilities greater
than 1.5;
(-b-)
net working capital and tangible net worth
each at least six times the current decommissioning cost estimates for the
total of all facilities or parts thereof (or prescribed amount if a certification
is used);
(-c-)
tangible net worth of at least $10 million; and
(-d-)
assets located in the United States amounting to
at least 90% of total assets or at least six times the current decommissioning
cost estimates for the total of all facilities or parts thereof (or prescribed
amount if a certification is used.)
(II)
The parent company must have:
(-a-)
a current rating for its most recent bond issuance of
AAA, AA, A, or BBB as issued by Standard and Poor's or Aaa, Aa, A, or Baa
as issued by Moody's;
(-b-)
tangible net worth each at least six times the
current decommissioning cost estimate for the total of all facilities or parts
thereof (or prescribed amount if a certification is used);
(-c-)
tangible net worth of at least $10 million; and
(-d-)
assets located in the United States amounting to
at least 90% of total assets or at least six times the current decommissioning
cost estimates for the total of all facilities or parts thereof (or prescribed
amount if certification is used).
(ii)
The parent company's independent certified public accountant
must have compared the data used by the parent company in the financial test,
which is derived from the independently audited, year-end financial statements
for the latest fiscal year, with the amounts in such financial statement.
In connection with that procedure, the licensee shall inform the agency within
90 days of any matters coming to the auditor's attention that cause the auditor
to believe that the data specified in the financial test should be adjusted
and that the company no longer passes the test.
(iii)
After the initial financial test, the parent company
must repeat the passage of the test within 90 days after the close of each
succeeding fiscal year.
(iv)
If the parent company no longer meets the requirements
of clause (i) of this subparagraph, the licensee must send notice to the agency
of intent to establish alternate financial assurance as specified in the agency's
regulations. The notice must be sent by certified mail within 90 days after
the end of the fiscal year for which the year end financial data show that
the parent company no longer meets the financial test requirements. The licensee
must provide alternate financial assurance within 120 days after the end of
such fiscal year.
(C)
Parent company guarantee. The terms of a parent company
guarantee that an applicant or licensee obtains must provide that:
(i)
the parent company guarantee will remain in force unless
the guarantor sends notice of cancellation by certified mail to the licensee
and the agency. Cancellation may not occur, however, during the 120 days beginning
on the date of receipt of the notice of cancellation by both the licensee
and the agency, as evidenced by the return receipts;
(ii)
if the licensee fails to provide alternate financial
assurance as specified in the agency's rules within 90 days after receipt
by the licensee and the agency of a notice of cancellation of the parent company
guarantee from the guarantor, the guarantor will provide such alternative
financial assurance in the name of the licensee;
(iii)
the parent company guarantee and financial test provisions
must remain in effect until the agency has terminated the license; and
(iv)
if a trust is established for decommissioning costs,
the trustee and trust must be acceptable to the agency. An acceptable trustee
includes an appropriate state or federal government agency or an entity that
has the authority to act as a trustee and whose trust operations are regulated
and examined by a federal or state agency.
(4)
Criteria relating to use of financial tests
and self guarantees for providing reasonable assurance of funds for decommissioning.
(A)
Introduction. An applicant or licensee may provide reasonable
assurance of the availability of funds for decommissioning based on furnishing
its own guarantee that funds will be available for decommissioning costs and
on a demonstration that the company passes a financial test of subparagraph
(B) of this paragraph. Subparagraph (B) of this paragraph establishes criteria
for passing the financial test for the self guarantee and establishes the
terms for a self guarantee.
(B)
Financial test.
(i)
To pass the financial test, a company must meet all of
the following criteria:
(I)
tangible net worth at least 10 times the total current
decommissioning cost estimate for the total of all facilities or parts thereof
(or the current amount required if certification is used for all decommissioning
activities for which the company is responsible as self guaranteeing licensee
and as parent-guarantor);
(II)
assets located in the United States amounting to at least
90% of total assets or at least 10 times the total current decommissioning
cost estimate (or the current amount required if certification is used for
all decommissioning activities for which the company is responsible as self-guaranteeing
licensee and as parent-guarantor); and
(III)
a current rating for its most recent bond issuance of
AAA, AA, A as issued by Standard and Poor's, or Aaa, Aa, A as issued by Moody's.
(ii)
To pass the financial test, a company must meet all of
the following additional criteria:
(I)
the company must have at least one class of equity securities
registered under the Securities Exchange Act of 1934.
(II)
the company's independent certified public accountant
must have compared the data used by the company in the financial test which
is derived from the independently audited year-end financial statements, based
on United States generally accepted accounting practices, for the latest fiscal
year, with the amounts in such financial statement. In connection with that
procedure, the licensee shall inform the agency within 90 days of any matters
coming to the auditor's attention that cause the auditor to believe that the
data specified in the financial test should be adjusted and that the company
no longer passes the test; and
(III)
after the initial financial test, the company must repeat
the passage of the test within 90 days after the close of each succeeding
fiscal year.
(iii)
If the licensee no longer meets the criteria of clause
(i) of this subparagraph, the licensee must send immediate notice to the agency
of its intent to establish alternate financial assurance as specified in the
agency's rules within 120 days of such notice.
(C)
Company self guarantee. The terms of a self guarantee
that an applicant or licensee furnishes must provide that:
(i)
the company guarantee will remain in force unless the
licensee sends notice of cancellation by certified mail to the agency. Cancellation
may not occur, however, during the 120 days beginning on the date of receipt
of the notice of cancellation by the agency, as evidenced by the return receipt;
(ii)
the licensee shall provide alternate financial assurance
as specified in the agency's rules within 90 days following receipt by the
agency of a notice of cancellation of the guarantee;
(iii)
the guarantee and financial test provisions must remain
in effect until the agency has terminated the license or until another financial
assurance method acceptable to the agency has been put in effect by the licensee;
(iv)
the licensee will promptly forward to the agency and
the licensee's independent auditor all reports covering the latest fiscal
year filed by the licensee with the Securities and Exchange Commission in
accordance with the requirements of the Securities and Exchange Act of 1934, §13;
(v)
if, at any time, the licensee's most recent bond issuance
ceases to be rated in any category of "A" or above by either Standard and
Poor's or Moody's, the licensee will provide notice in writing of such fact
to the agency within 20 days after publication of the change by the rating
service. If the licensee's most recent bond issuance ceases to be rated in
any category of A or above by both Standard and Poor's and Moody's, the licensee
no longer meets the criteria of subparagraph (B)(i) of this paragraph; and
(vi)
the applicant or licensee must provide to the agency
a written guarantee (a written commitment by a corporate officer) that states
that the licensee will fund and carry out the required decommissioning activities
or, upon issuance of an order by the agency, the licensee will set up and
fund a trust in the amount of the current cost estimates for decommissioning.
(5)
Criteria relating to use of financial tests
and self guarantees for providing reasonable assurance of funds for decommissioning
by commercial companies that have no outstanding rated bonds.
(A)
Introduction. An applicant or licensee may provide reasonable
assurance of the availability of funds for decommissioning based on furnishing
its own guarantee that funds will be available for decommissioning costs and
on a demonstration that the company passes the financial test of subparagraph
(B) of this paragraph. The terms of the self-guarantee are in subparagraph
(C) of this paragraph. This paragraph establishes criteria for passing the
financial test for the self-guarantee and establishes the terms for a self-guarantee.
(B)
Financial test.
(i)
To pass the financial test a company must meet the following
criteria:
(I)
tangible net worth greater than $10 million, or at least
10 times the total current decommissioning cost estimate (or the current amount
required if certification is used), whichever is greater, for all decommissioning
activities for which the company is responsible as self-guaranteeing licensee
and as parent-guarantor;
(II)
assets located in the United States amounting to at least
90% of total assets or at least ten times the total current decommissioning
cost estimate (or the current amount required if certification is used) for
all decommissioning activities for which the company is responsible as self-guaranteeing
licensee and as parent-guarantor; and
(III)
a ratio of cash flow divided by total liabilities greater
than 0.15 and a ratio of total liabilities divided by net worth less than
1.5.
(ii)
In addition, to pass the financial test, a company must
meet all of the following requirements:
(I)
the company's independent certified public accountant
must have compared the data used by the company in the financial test, which
is required to be derived from the independently audited year end financial
statement based on United States generally accepted accounting practices for
the latest fiscal year, with the amounts in the financial statement. In connection
with that procedure, the licensee shall inform the agency within 90 days of
any matters that may cause the auditor to believe that the data specified
in the financial test should be adjusted and that the company no longer passes
the test;
(II)
after the initial financial test, the company must repeat
passage of the test within 90 days after the close of each succeeding fiscal
year; and
(III)
if the licensee no longer meets the requirements of
subparagraph (B)(i) of this paragraph, the licensee must send notice to the
agency of intent to establish alternative financial assurance as specified
in the agency's rules. The notice must be sent by certified mail, return receipt
requested, within 90 days after the end of the fiscal year for which the year
end financial data show that the licensee no longer meets the financial test
requirements. The licensee must provide alternative financial assurance within
120 days after the end of such fiscal year.
(C)
Company self-guarantee. The terms of a self-guarantee
that an applicant or licensee furnishes must provide the following.
(i)
The guarantee shall remain in force unless the licensee
sends notice of cancellation by certified mail, return receipt requested,
to the agency. Cancellation may not occur until an alternative financial assurance
mechanism is in place.
(ii)
The licensee shall provide alternative financial assurance
as specified in the agency rules within 90 days following receipt by the agency
of a notice of cancellation of the guarantee.
(iii)
The guarantee and financial test provisions must remain
in effect until the agency has terminated the license or until another financial
assurance method acceptable to the agency has been put in effect by the licensee.
(iv)
The applicant or licensee must provide to the agency
a written guarantee (a written commitment by a corporate officer) that states
that the licensee will fund and carry out the required decommissioning activities
or, upon issuance of an order by the agency, the licensee will set up and
fund a trust in the amount of the current cost estimates for decommissioning.
(6)
Criteria relating to use of financial tests
and self-guarantee for providing reasonable assurance of funds for decommissioning
by nonprofit entities, such as colleges, universities, and nonprofit hospitals.
(A)
Introduction. An applicant or licensee may provide reasonable
assurance of the availability of funds for decommissioning based on furnishing
its own guarantee that funds will be available for decommissioning costs and
on a demonstration that the applicant or licensee passes the financial test
of subparagraph (B) of this paragraph. The terms of the self- guarantee are
in subparagraph (C) of this paragraph. This paragraph establishes criteria
for passing the financial test for the self-guarantee and establishes the
terms for a self-guarantee.
(B)
Financial test.
(i)
To pass the financial test, a college or university must
meet the criteria of subclause (I) or (II) of this clause. The college or
university must meet one of the following:
(I)
for applicants or licensees that issue bonds, a current
rating for its most recent uninsured, uncollateralized, and unencumbered bond
issuance of AAA, AA, or A as issued by Standard and Poors or Aaa, Aa, or A
as issued by Moodys.
(II)
for applicants or licensees that do not issue bonds,
unrestricted endowment consisting of assets located in the United States of
at least $50 million, or at least 30 times the total current decommissioning
cost estimate (or the current amount required if certification is used), whichever
is greater, for all decommissioning activities for which the college or university
is responsible as a self-guaranteeing licensee.
(ii)
To pass the financial test, a hospital must meet the
criteria in subclause (I) or (II) of this clause. The hospital must meet one
of the following:
(I)
for applicants or licensees that issue bonds, a current
rating for its most recent uninsured, uncollateralized, and unencumbered bond
issuance of AAA, AA, or A as issued by Standard and Poors or Aaa, Aa, or A
as issued by Moodys;
(II)
for applicants or licensees that do not issue bonds,
all the following tests must be met:
(-a-)
(total revenues less total expenditures) divided by
total revenues must be equal to or greater than 0.04;
(-b-)
long term debt divided by net fixed assets must
be less than or equal to 0.67;
(-c-)
(current assets and depreciation fund) divided
by current liabilities must be greater than or equal to 2.55; and
(-d-)
operating revenues must be at least 100 times the
total current decommissioning cost estimate (or the current amount required
if certification is used) for all decommissioning activities for which the
hospital is responsible as a self-guaranteeing license.
(iii)
In addition, to pass the financial test, a licensee
must meet all the following requirements:
(I)
the licensee's independent certified public accountant
must have compared the data used by the licensee in the financial test that
is required to be derived from the independently audited year-end financial
statements, based on United States generally accepted accounting practices,
for the latest fiscal year, with the amounts in the financial statement. In
connection with that procedure, the licensee shall inform the agency within
90 days of any matters coming to the attention of the auditor that cause the
auditor to believe that the data specified in the financial test should be
adjusted and that the licensee no longer passes the test;
(II)
after the initial financial test, the licensee must repeat
passage of the test within 90 days after the close of each succeeding fiscal
year;
(III)
if the licensee no longer meets the requirements of
subparagraph (A) of this paragraph, the licensee must send notice to the agency
of its intent to establish alternative financial assurance as specified in
the agency's rules. The notice must be sent by certified mail, return receipt
requested, within 90 days after the end of the fiscal year for which the year
end financial data show that the licensee no longer meets the financial test
requirements. The licensee must provide alternate financial assurance within
120 days after the end of such fiscal year.
(C)
Self-guarantee. The terms of a self-guarantee that an
applicant or licensee furnishes must provide the following:
(i)
The guarantee shall remain in force unless the licensee
sends notice of cancellation by certified mail, and/or return receipt requested,
to the agency. Cancellation may not occur unless an alternative financial
assurance mechanism is in place.
(ii)
The licensee shall provide alternative financial assurance
as specified in the agency's regulations within 90 days following receipt
by the agency of a notice of cancellation of the guarantee.
(iii)
The guarantee and financial test provisions must remain
in effect until the agency has terminated the license or until another financial
assurance method acceptable to the agency has been put in effect by the licensee.
(iv)
The applicant or licensee must provide to the agency
a written guarantee (a written commitment by a corporate officer or officer
of the institution) that states that the licensee will fund and carry out
the required decommissioning activities or, upon issuance of an order by the
agency, the licensee will set up and fund a trust in the amount of the current
cost estimates for decommissioning.
(v)
If, at any time, the licensee's most recent bond issuance
ceases to be rated in any category of "A" or above by either Standard and
Poors or Moodys, the licensee shall provide notice in writing of the fact
to the agency within 20 days after publication of the change by the rating
service.
(7)
Quantities of radioactive materials requiring
consideration of the need for an emergency plan for responding to a release.
The following table contains quantities of radioactive materials requiring
consideration of the need for an emergency plan for responding to a release.
Figure: 25 TAC §289.252(ii)(7)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State, on May 22, 2000.
TRD-200003513
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
25 TAC §289.253
The Texas Department of Health (department) proposes an amendment
to §289.253, concerning radiation safety requirements for well logging
service operations and tracer studies.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.253 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist; however, revisions to the rule are necessary.
The amendment deletes the definition for "Licensing state" because it is
already defined in another section of this chapter. Language is added to the
definitions of "Field station" and "Radiation safety officer" to clarify the
intent of the definitions. The words "field station" and "radioactive material"
are replaced with the words "additional authorized use/storage location and
"sources of radiation" throughout the rule to clarify the intent of the section.
Additional units of measurement for radiation survey instruments are added
to reflect the International System units of measurement. Language is changed
in the design and performance criteria for sealed sources used in well logging
prototype testing to reflect appropriate terminology. Optically stimulated
luminescence devices are added as an additional option for an appropriate
individual monitoring device. Requirements for maintaining records/documents
are clarified to specify what records/documents are required for inspection
by the agency at additional/authorized use/storage locations and temporary
job sites. The time interval for keeping certain records/documents is changed
to reflect the agency's current inspection interval. An additional requirement
is added to clarify that a licensee must consult with the well operator, well
owner, drilling contractor, or land owner regarding retrieval methods for
sources disconnected downhole. References to other sections of this chapter
are clarified to reflect the
Texas Register
format. Grammatical changes are made for clarification. This amendment is
also part of the department's continuing effort to update, clarify, and simplify
its rules regarding the control of radiation based upon technological advances,
public concerns, legislative directives, or other factors.
The department published a Notice of Intention to Review for §289.253
as required by Government Code §2001.039 in the
Texas Register
(25 TexReg 219) on January 7, 2000. No comments were
received by the department on this section.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section will be in effect, the public benefit anticipated
as a result of enforcing the section will be to ensure continued protection
of the public, workers, and the environment from unnecessary exposure to radiation.
There will be no effect on micro businesses or small businesses. There are
no anticipated economic costs to persons who are required to comply with the
section as proposed. There is no anticipated impact on local employment. Licensees
are currently required to have a written agreement with the well operator,
well owner, drilling contractor or land owner concerning sources that are
lost downhole. The additional requirement simply requires the licensee to
consult concerning the methods of retrieval. The other revisions are clarifying
only and do not impose new requirements or alleviate current requirements.
Therefore, there are no economic effects associated with the section as proposed.
Comments on the proposal may be presented to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834- 6688 or electronic mail at Ruth.Mcburney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 9:00 a.m., Tuesday,
June 20, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The amendment is proposed under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The amendment affects Health and Safety Code, Chapter 401 and Chapter 12,
and Government Code §2001.039.
§289.253. Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies.
(a)
Purpose [
(b)
Scope. This section applies to all licensees
or registrants who use sources of radiation for well logging service operations,
radioactive markers, mineral exploration and tracer studies. In addition to
the requirements of this section, licensees and registrants are subject to
the 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 Material), §289.203
of this title (relating to Notices, Instructions, and Reports to Workers;
Inspections), §289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material Licenses, Emergency Planning and Implementation,
and Other Regulatory Services), §289.205 of this title (relating to Hearing
and Enforcement Procedures), §289.226 of this title (relating to Registration
of Radiation Machine Use and Services), §289.229 of this title (relating
to Radiation Safety Requirements for Particle Accelerators, Therapeutic Radiation
Machines, and Simulators), §289.231 of this title (relating to General
Provisions and Standards for Protection Against Machine-Produced Radiation), §289.252
of this title (relating to Licensing of Radioactive Material), and §289.257
of this title (relating to Packaging and Transportation of Radioactive Material).
(c)
[
(1)
Field station
(additional authorized use/storage
location)
-- A facility where sources of radiation may be stored or
used and from which equipment is dispatched to temporary job sites.
(2)
Injection tool -- A device used for controlled injection
of radioactive tracer material.
[
Licensing state -- Any
state with rules equivalent to the Suggested State Regulations for Control
of Radiation relating to, and an effective program for, the regulatory control
of naturally occurring or accelerator-produced radioactive material (NARM)
and has been designated as such by the Conference of Radiation Control Program
Directors, Inc.]
(3)
[
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
[
(21)
[
(d)
[
(1)
No licensee shall perform well logging service operations
with a sealed source(s) in any well or wellbore unless, prior to commencement
of the operation, the licensee has a written agreement with the well operator,
well owner, drilling contractor, or land owner that specifies who will be
responsible for ensuring the following requirements are met:
(A)
a reasonable effort at recovery will be made in the event
a sealed source is lost or lodged downhole;
(B)
a person shall not attempt to recover a sealed source
in a manner that, in the licensee's opinion, could result in a source rupture;
(C)
in the event the environment, any equipment, or personnel
are contaminated with radioactive material, decontamination to levels specified
in
§289.202(f), (n), and (eee)
[
(D)
the requirements of subsection (aa)(4) of this section
shall be met in the event a decision is made to abandon the sealed source
downhole.
(2)
No licensee shall perform tracer study operations
with a substance tagged with radioactive material in any well or wellbore
unless, prior to commencement of the operation, the licensee has a written
agreement with the well operator, well owner, drilling contractor or land
owner, and the service company to which the licensee's equipment is connected,
as applicable, that specifies who will be responsible for ensuring the following
requirements are met:
(A)
in the event the service company's personnel or equipment
are contaminated with radioactive material, they must be decontaminated in
accordance with
§289.202(n) or (eee)
[
(B)
in the event the well head or job site
is
[
(C)
in the event radioactive material is to be reversed from
the well or the well screens out, the licensee must have established procedures
and equipment or facilities to do the following:
(i)
reverse material into a preconstructed pit that is specifically
established in the event of a screen out; or
(ii)
reverse material into suitable transport container(s)
in the event of a screen out.
(3)
The licensee shall maintain a
[
(e)
[
(f)
[
(1)
Each source of radiation, except accelerators, shall be
provided with a storage and/or transport container.
Each
[
(2)
Each area or room in which sources of radiation are
stored shall be posted in accordance with §289.202(aa)(5)
or §289.231(x)
of this title
, as applicable
.
(3)
Sources of radiation shall be stored downhole or
in a bunker in order to minimize the danger from explosion and/or fire.
(4)
Sources of radiation may not be stored in residential
locations. This section does not apply to storage of radioactive material
in a vehicle in transit for use at temporary job sites, if the licensee complies
with subsection
(y)(2)
[
(5)
Sources of radiation in storage shall be secured
to prevent tampering, or removal by unauthorized individuals.
(g)
[
(h)
[
(1)
The licensee or registrant shall maintain a sufficient
number of calibrated and operable radiation survey instruments at each location
where
sources of radiation are
[
(2)
A licensee using tracer material shall have available
at each
additional authorized use/storage location
[
(3)
Each radiation survey instrument shall be calibrated:
(A)
by a person specifically licensed or registered by the
agency, another agreement state or licensing state or the United States Nuclear
Regulatory Commission (NRC) to perform such service;
(B)
at intervals not to exceed six months and after each survey
instrument repair;
(C)
for the types of radiation used and at energies appropriate
for use; and
(D)
at an accuracy within
ñ
[
(4)
The licensee or registrant shall maintain
calibration records
[
(i)
[
(j)
[
(1)
the quantities and kinds of sources of radiation;
(2)
the location where sources of radiation are assigned;
(3)
a unique identification of each source of radiation;
(4)
the date of the inventory; and
(5)
the name of the individual conducting the inventory.
(k)
[
(1)
identification of each source of radiation to include:
(A)
the make and model number and/or serial number (or if
absent, a description) of each sealed source used; or
(B)
the radionuclide and activity of tracer materials and
radioactive markers used at a particular well site and the disposition of
any unused tracer materials.
(2)
the identity of the logging supervisor or individual
who is responsible for receiving sources of radiation, to whom assigned; and
(3)
the locations where used and dates of use.
(l)
[
(1)
Each sealed source manufactured after August 1, 1992,
(except those containing radioactive material in gaseous form) [
(A)
The sealed source is of doubly encapsulated construction.
(B)
The sealed source contains radioactive material with a
chemical/physical form as insoluble and nondispersible as practicable.
(C)
The sealed source's prototype has been tested and found
to maintain its integrity after each of the following tests.
(i)
Temperature. The test source must be held at -40 degrees
Celsius
[
(ii)
Impact. A 5 kilogram
(kg)
steel hammer, 2.5
centimeters
(cm)
in diameter, must be dropped from a height of
1 meter
(m)
onto the test source.
(iii)
Vibration. The test source must be subjected to a vibration
from 25
Hertz (Hz)
[
(iv)
Puncture. A 1
gm
[
(v)
Pressure. The test source must be subjected to an external
pressure of 24,600 pounds per square inch absolute
(1.695 x 10
7
pascals)
[
(2)
In the absence of prototype testing required
by paragraph (1)(C) of this subsection, sealed sources (except those containing
radioactive material in gaseous form) used after January 1, 1993, shall be
certified to meet the requirements of paragraph (1)(C) of this subsection.
(3)
Certification of source criteria as required by paragraphs
(1) and (2) of this subsection shall be performed only by persons specifically
authorized to do so by the agency, another agreement or licensing state, or
the NRC.
(4)
Certification documents shall be maintained by the
licensee for inspection by the agency for a period of
three
[
(m)
[
(1)
Each source, source holder, or logging tool containing
radioactive material
in
other than
an
exempt quantity,
shall bear a durable, legible, and clearly visible marking or label that has,
as a minimum, the standard radiation caution symbol with no color requirement,
and the wording DANGER (or CAUTION), RADIOACTIVE--DO NOT HANDLE, NOTIFY CIVIL
AUTHORITIES (OR NAME OF COMPANY).
(2)
The labeling specified in paragraph (1) of this subsection
shall be on the smallest component
, source, source holder, or logging
tool,
[
(3)
Each transport container shall have permanently attached
to it a durable, legible, and clearly visible label that has, as a minimum,
the standard radiation caution symbol and the wording DANGER (or CAUTION),
RADIOACTIVE, NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY).
(4)
Each
[
(n)
[
(1)
Each licensee or registrant shall conduct, at intervals
not to exceed six months, a program of visual inspection and maintenance of
source holders (or sealed source, if there is no source holder), logging tools,
source handling tools, storage containers, transport containers, and injection
tools to assure proper labeling and physical condition. The inspection program
may be performed concurrently with routine leak testing of sealed sources.
Records of inspection and maintenance shall be
made and
maintained
by the licensee or registrant
for a period of
three
[
(2)
If any inspection conducted in accordance with paragraph
(1) of this subsection reveals damage to labeling or components critical to
radiation safety, the device shall be removed from service
at the time
the damage is discovered and
until repairs have been made.
(3)
Any operation, such as drilling, cutting, or chiseling
on a source holder containing a sealed source, shall be performed
on
the source holder
only by persons specifically licensed to do so by
the agency, another agreement or licensing state, or the NRC.
The provisions
of this paragraph do not apply to logging tool recovery (fishing) operations
conducted in accordance with the provisions of subsection (aa)(3) of this
section.
(4)
The repair, opening, or modification of any sealed
source shall be performed only by persons specifically licensed to do so by
the agency, another agreement or licensing state, or the NRC.
(o)
[
(1)
No licensee or registrant shall permit any individual
to act as a logging supervisor until such individual has
met the following
requirements
:
(A)
successfully completed
an agency-accepted course
or
[
(B)
received copies of and instruction in
the following
:
(i)
the
requirements
[
(ii)
the conditions of the appropriate license or certificate
of registration; and
(iii)
the licensee's or registrant's operating
, safety
, and emergency procedures;
(C)
demonstrated understanding of the requirements in subparagraph
(A) and (B) of this paragraph by successfully completing a written examination
administered by the licensee or registrant;
(D)
completed two months of on-the-job training under the
supervision of a logging supervisor; and
(E)
demonstrated through a field evaluation, competence in
the use of sources of radiation, related handling tools, and the type of radiation
survey instruments that will be used in the job assignment.
(2)
No licensee or registrant shall permit any individual
to act as a logging assistant until such individual has
met the following
requirements
:
(A)
received copies of and instruction in the applicable subsections
of §§[
(B)
demonstrated understanding of the requirements in subparagraph
(A) of this paragraph by successfully completing a written examination administered
by the licensee or registrant; and
(C)
demonstrated competence to use, under the personal supervision
of the logging supervisor, the sources of radiation, related handling tools,
and radiation survey instruments that will be used in the job assignment.
(3)
The licensee or registrant shall provide an
annual radiation safety review for logging supervisors and logging assistants.
(4)
Each licensee or registrant shall maintain records
that document that the requirements of paragraphs
(1)-(3)
[
(p)
[
(q)
[
(1)
In addition to the requirements of
§289.202(p)(3)
and (q)
[
(2)
When necessary in order to aid in determining the
extent of an individual's exposure to concentrations of radioactive material,
the agency may require a licensee to make available to the individual appropriate
bioassay services and to furnish a copy of the reports of such services to
the agency.
(3)
Personnel monitoring records shall be maintained
by the licensee or registrant
for inspection by the agency until the
agency authorizes their disposal.
(r)
[
(1)
A radiation safety officer (RSO) shall be designated for
every license and certificate of registration issued by the agency.
(2)
The RSO's documented qualifications shall include:
(A)
possession of a high school diploma or a certificate of
high school equivalency based on the GED test;
(B)
completion of the training and testing requirements of
subsection
(o)(1)
[
(C)
two years of experience as a logging supervisor to include
knowledge of well logging service operations and tracer studies.
(3)
The [
(A)
[
(B)
[
(C)
[
(D)
[
(E)
[
(F)
[
(G)
[
(H)
[
(I)
[
(J)
[
(K)
[
(L)
be the primary contact
with the agency.
(s)
[
(t)
[
(u)
[
(1)
Appropriate
[
(2)
No licensee shall permit the injection of radioactive
material into usable quality groundwater (3,000 parts per million (ppm) total
dissolved solids or less) without prior written authorization from the agency.
(v)
[
(w)
[
(x)
[
(y)
[
(1)
Radiation surveys (and calculations[
(2)
Radiation surveys (and calculations[
(3)
If the sealed source assembly is removed from the
logging tool before departing the job site, a survey
of the tool
[
(4)
If the licensee has reason to believe that the encapsulation
of the sealed source could be damaged by an operation, the licensee shall
immediately conduct a radiation survey, including a contamination survey,
during and after the operation.
(5)
Radiation surveys shall be made and recorded at the
job site and/or well head for each tracer operation except for those utilizing
hydrogen-3, carbon-14, sulfur-35, or krypton-85. These surveys shall include
measurements of radiation levels before and after the operation.
(6)
Records required in accordance with paragraphs (1)-(5)
of this subsection shall also include the dates, the identification of individual(s)
making the survey, the unique identification of survey instrument(s) used,
radiation measurements in milliroentgen per hour (mR/hr), calculations in
millirem per hour
(mrem/hr)
, and an exact description of the location
of the survey.
Each licensee or registrant shall make and maintain records
[
(z)
[
(1)
Each licensee or registrant shall maintain
the records/documents specified in subsection (bb)(5) of this section for
inspection by the agency.
(2)
[
[
a copy of the appropriate
license or certificate of registration;]
[
operating and emergency procedures;]
[
applicable rules as listed
in the license or certificate of registration;]
[
survey records required in
accordance with subsection (x) of this section;]
[
quarterly inventories required
in accordance with subsection (i) of this section;]
[
utilization records required
in accordance with subsection (j) of this section;]
[
records of inspection and
maintenance required in accordance with subsection (m) of this section;]
[
records of the survey instrument
calibration and leak test for the specific devices and sources at the field
station;]
[
records of personnel monitoring
required in accordance with subsection (p) of this section for personnel employed
at the field station;]
[
training records required
in accordance with subsection (n) of this section;]
[
shipping papers for the transportation
of radioactive material; and]
[
records of receipt, transfer,
and disposal of radioactive material at the field station.]
(3)
[
(4)
[
[
a copy of the appropriate
license or certificate of registration;]
[
operating and emergency
procedures;]
[
survey records required
in accordance with subsection (x) of this section for the period of operation
at that site;]
[
evidence of current
calibration for the radiation survey instruments in use at the site;]
(5)
Records/documents required by paragraph (4)
of this subsection shall be maintained at the temporary job site for the period
of operation at that site for inspection by the agency.
[
[
shipping papers for
the transportation of radioactive material.]
(aa)
Notification of incidents and lost sources; abandonment
procedures for irretrievable sources.
(1)
Notification of incidents and sources lost in other than
downhole well logging operations shall be made in accordance with appropriate
provisions of §289.202 of this title
, or §289.231 of this title,
as applicable
.
(2)
(No change.)
(3)
Whenever a sealed source or device containing radioactive
material is lost downhole, the licensee shall
do the following
:
(A)
consult with the well operator,
well owner, drilling contractor, or land owner regarding methods to retrieve
the source or device that may reduce the likelihood that the source or device
will be damaged or ruptured during the logging tool recovery (fishing) operations;
(B)
[
(C)
[
(4)
When it becomes apparent that efforts to recover
the radioactive source will not be successful, the licensee shall
do
the following
:
(A)
advise the well operator of the Texas Railroad Commission
requirements
[
(i)-(iii)
(No change.)
(B)
(No change.)
(C)
file a written report with the agency within 30 days of
the abandonment,
providing
[
(i)-(viii)
(No change.)
(5)
Whenever a sealed source containing radioactive
material is abandoned downhole, the licensee shall provide a permanent plaque
(an example of a suggested plaque is shown in subsection (bb)(3) of this section)
for posting
on
the well or wellbore. This plaque shall
meet
the following requirements
:
(A)
be constructed of long-lasting material such as stainless
steel, brass, bronze, or monel. The size of the plaque should be convenient
for use on active or inactive wells;
for example
[
(B)
contain the following engraved information on its face:
(i)
the word "CAUTION
;
"[
(ii)-(vii)
(No change.)
(viii)
an appropriate warning, depending on the specific circumstances
of each abandonment, such as the following:
(I)
"Do not drill below plug back depth
;
"[
(II)
"Do not enlarge casing
;
"[
(III)
(No change.)
(6)-(7)
(No change.)
(bb)
Appendices.
(1)
Subjects to be included in training courses for well logging
service operations and/or tracer studies are as follows:
(A)
(No change.)
(B)
radiation detection instrumentation to be used that includes:
(i)-(ii)
(No change.)
(iii)
use of
individual
[
(C)
(No change.)
(D)
[
(E)
the licensee's or registrant's written operating
, safety,
and emergency procedures;
(F)-(G)
(No change.)
(2)-(3)
(No change.)
(4)
The licensee's or registrant's operating
, safety,
and emergency procedures shall include descriptions of and instructions
in at least the following:
(A)
(No change.)
(B)
the handling and use of sources of radiation to be employed
so that no individual is likely to be exposed to radiation doses in excess
of the limits established in §289.202 of this title
, or §289.231
of this title, as applicable
. Every reasonable effort shall be made
to keep radiation exposures and releases of radioactive material in soils
and effluents to unrestricted areas as low as is reasonably achievable;
(C)-(R)
(No change.)
(S)
actions to be taken if a sealed source is ruptured, including
actions to prevent the spread of contamination and minimize inhalation and
ingestion of radioactive material, and actions to obtain suitable radiation
survey instruments as required by subsection
(h)
[
(5)
The following records/documents shall be
maintained by the licensee or registrant for inspection by the agency.
[
Figure: 25 TAC §289.253(bb)(5)
[
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State, on May 22, 2000.
TRD-200003511
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
25 TAC §289.256
The Texas Department of Health (department) proposes the
repeal of §289.256 and new §289.256, concerning medical and veterinary
use of radioactive material.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.256 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist; however revisions to the rule are necessary.
The new section adds requirements for licensing medical uses of radioactive
material that are deleted from another section, concerning licensing of radioactive
material. The new section adds requirements for the veterinary use of radioactive
material. The requirement concerning patient release criteria for individuals
receiving radioactive material therapy is changed from an activity-based to
a dose-based criteria. This revision is an item of compatibility with the
United States Nuclear Regulatory Commission (NRC) and as agreement state,
Texas must adopt it. The new section adds specific requirements from the proposed
NRC medical licensing rules concerning remote control brachytherapy units,
teletherapy units, and gamma stereotactic radiosurgery units. Criteria for
written directives and revised requirements for reports and notifications
of medical events (misadministrations) are added and are also based on NRC
proposed medical rules. When adopted, the proposed NRC medical rules will
be items of compatibility. Qualifications for radiation safety officers (RSO)
for licenses with and without broad scope authorization are added. Duties
and responsibilities of the radiation safety committee (RSC) are revised.
Records/documents to be kept at authorized use sites are specified. The new
section is also part of the department's continuing effort to update, clarify,
and simplify its rules regarding the control of radiation based upon technological
advances, public concerns, legislative directives, or other factors.
The department published a Notice of Intention to Review for §289.256
as required by Government Code §2001.039 in the
Texas Register
(25 TexReg 219) on January 7, 2000. No comments were
received by the department on this section.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the sections will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the sections as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed sections will be in effect, the public benefit anticipated
as a result of enforcing the sections will be to ensure continued protection
of the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that licensees are aware of the requirements for the medical use
of radioactive material and that RSOs and RSCs are qualified to perform their
duties and responsibilities. The addition of specific RSO qualifications and
RSC duties and responsibilities formalizes in rule current agency policy.
The addition of requirements for veterinary use of radioactive material likewise
formalizes in rule what is currently agency policy. The addition of requirements
for remote control brachytherapy units, teletherapy units, and gamma stereotactic
radiosurgery units also formalizes in rule what is currently agency policy.
Therefore, there are anticipated economic costs to micro businesses, small
businesses, or persons required to comply with these proposed requirements.
The revision of the patient release criteria from an activity- based criteria
to a dose-based criteria will require additional time for record keeping and
instruction to the patient. The additional time is estimated to be 15 minutes
per patient released. If the individual responsible for record keeping and
provision of the patient instruction has an hourly salary ranging from $30
to $50, the additional cost would be approximately $7 to $12 per patient released
under the proposed criteria. The requirement for written directives is estimated
to require one to two minutes for preparation of the written directive. If
the individual preparing the written directive has an hourly salary ranging
from $75 to $100, the additional cost would be approximately $2 to $3 per
written directive. These costs will be the same for micro businesses, small
businesses, and persons required to comply with the proposed requirements.
However, a written directive is already a standard of practice for most radioactive
material therapy, thus, no additional costs would be incurred by these individuals.
There is no anticipated impact on local employment.
Comments on the proposal may be presented to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.Mcburney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 1:30 p.m., Tuesday,
June 13, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
(Editor's note: The text of the following section proposed
for repeal will not be published. The section may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The repeal affects Health and Safety Code, Chapter 401 and Chapter 12,
and Government Code §2001.039.
§289.256.Use of Sealed Sources in the Healing Arts.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State, on May 22, 2000.
TRD-200003509
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
The new section is proposed under the
Health and Safety Code, Chapter 401, which provides the Texas Board of Health
(board) with authority to adopt rules and guidelines relating to the control
of radiation; and §12.001, which provides the board with the authority
to adopt rules for the performance of each duty imposed by law on the board,
the department, and the commissioner of health.
The new section affects Health and Safety Code, Chapter 401 and Chapter
12, and Government Code §2001.039.
§289.256.Medical and Veterinary Use of Radioactive Material.
(a)
Purpose. This section establishes requirements for the
medical and veterinary use of radioactive material and for the issuance of
specific licenses authorizing the medical and veterinary use of radioactive
material. Unless otherwise exempted, no person shall receive, possess, use,
transfer, own, or acquire radioactive material for medical or veterinary use
except as authorized in a license issued in accordance with this section.
A person who receives, possesses, uses, transfers, owns, or acquires radioactive
material prior to receiving a license is subject to the requirements of this
chapter.
(b)
Scope.
(1)
In addition to the requirements of this section, all licensees,
unless otherwise specified, are subject to the 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 Material), §289.203 of this title (relating to Notices, Instructions,
and Reports to Workers; Inspections), §289.204 of this title (relating
to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency
Planning and Implementation, and Other Regulatory Services), §289.205
of this title (relating to Hearing and Enforcement Procedures), §289.252
of this title (relating to Licensing of Radioactive Material), and §289.257
of this title (relating to Packaging and Transportation of Radioactive Material).
(2)
Veterinarians who receive, possess, use, transfer,
own, or acquire radioactive material in the practice of veterinary medicine
shall do the following:
(A)
comply with the requirements in this subsection and subsections
(a), (c), (e)-(j), (k)(2)-(7), (m)-(p), (s), (t), (v), (x), (y)(1), (z)(1),
(aa)(1)-(3), and (bb)(1)-(7) of this section; and
(B)
verify that the training and experience specified in subsection
(c)(3)(B) of this section has been obtained within the five years preceding
the date of application or the individual must have had related continuing
education and experience since the required training and experience was completed.
(c)
Definitions. The following words and terms when used in
this section shall have the following meaning unless the context clearly indicates
otherwise.
(1)
Address of use - The building or buildings that are identified
on the license and where radioactive material may be prepared, received, used,
or stored.
(2)
Area of use - A portion of an address of use that
has been set aside for the purpose of preparing, receiving, using, or storing
radioactive material.
(3)
Authorized user - Authorized user is defined as either
of the following:
(A)
for medical use, a physician licensed by the Texas State
Board of Medical Examiners who meets the applicable requirements in subsections
(y)-(dd) of this section; or
(B)
for veterinary use, a veterinarian licensed by the Texas
Board of Veterinary Medical Examiners and certified by the American College
of Veterinary Radiology who is authorized for the use of radioactive materials
in veterinary medicine.
(4)
Brachytherapy - A method of radiation therapy
in which plated, embedded, activated, or sealed sources are utilized to deliver
a radiation dose at a distance of up to a few centimeters, by surface, intracavitary,
intraluminal, or interstitial application.
(5)
Brachytherapy sealed source - A sealed source or a
manufacturer-assembled source train, or a combination of these sources that
is designed to deliver a therapeutic dose within a distance of a few centimeters.
(6)
High dose-rate remote afterloader - A device that
remotely delivers a dose rate in excess of 1200 rads (12 gray (Gy)) per hour
at the point or surface where the dose is prescribed.
(7)
Institutional Review Board (IRB) - Any board, committee,
or other group formally designated by an institution and approved by the United
States Food and Drug Administration to review, approve the initiation of,
and conduct periodic review of biomedical research involving human subjects.
(8)
Low dose-rate remote afterloader - A device that remotely
delivers a dose rate of less than or equal to 200 rads (2 Gy) per hour at
the point or surface where the dose is prescribed.
(9)
Licensed medical physicist - An individual holding
a current Texas license under the Medical Physics Practice Act, Article 4512n,
in therapeutic radiological physics.
(10)
Management - The chief executive officer or other
individual delegated the authority to manage, direct, or administer the licensee's
activities.
(11)
Manual brachytherapy - A type of brachytherapy in
which the sealed sources, for example, seeds and ribbons, are manually inserted
either into the body cavities that are in close proximity to a treatment site
or directly in the tissue volume.
(12)
Medical institution - An organization in which several
medical disciplines are practiced.
(13)
Medical use - The intentional internal or external
administration of radioactive material, or the radiation from radioactive
material, to patients or human research subjects under the supervision of
an authorized user.
(14)
Medical event - An event that meets the criteria
in subsection (ee)(1) of this section.
(15)
Medium dose-rate afterloader - A device that remotely
delivers a dose rate greater than 200 rads (2 Gy) and less than or equal to
1200 rads (12 Gy) per hour at the point or surface where the dose is prescribed.
(16)
Output - The exposure rate, dose rate, or a quantity
related in a known manner to these rates from a teletherapy unit, a brachytherapy
source, a remote afterloader unit, or a gamma stereotactic radiosurgery unit,
for a specified set of exposure conditions.
(17)
Preceptor - An individual who provides or directs
the training and experience requirements.
(18)
Permanent facility - A building or buildings that
are identified on the license within the state of Texas and where radioactive
material may be prepared, received, used, or stored. This may also include
an area or areas where administrative activities related to the license are
performed.
(19)
Prescribed dosage - The specified activity or range
of activity of a radiopharmaceutical as documented in a written directive
or in accordance with the directions of the authorized user for procedures
in subsections (y) and (z) of this section.
(20)
Prescribed dose - Prescribed dose means one of the
following:
(A)
for gamma stereotactic radiosurgery, the total dose as
documented in the written directive;
(B)
for teletherapy, the total dose and dose per fraction as
documented in the written directive;
(C)
for brachytherapy, either the total sealed source strength
and exposure time, or the total dose, as documented in the written directive;
or
(D)
for remote afterloaders, the total dose and dose per fraction
as documented in the written directive.
(21)
Pulsed dose-rate remote afterloader - A special
type of remote afterloading device that uses a single sealed source capable
of delivering dose rates greater than 1200 rads (12 Gy) per hour, but is approximately
one-tenth of the activity of typical high dose-rate remote afterloader sealed
sources and is used to simulate the radiobiology of a low dose rate remote
afterloader treatment by inserting the sealed source for a given fraction
of each hour.
(22)
Sealed source and device registry - The national
registry that contains all the registration certificates, generated by both
the NRC and the agreement states, that summarize the radiation safety information
for sealed sources and devices and describe the licensing and use conditions
approved for the product.
(23)
Stereotactic radiosurgery - The use of external radiation
in conjunction with a guidance device to very precisely deliver a dose to
a tissue volume by the use of three- dimensional coordinates.
(24)
Technologist - Technologist is defined as either
of the following:
(A)
in nuclear medicine, a person (nuclear medicine technologist)
skilled in the performance of nuclear medicine procedures under the supervision
of a physician; and/or
(B)
in therapy, as described in subsections (bb) and (dd) of
this section, a person (radiation therapy technologist or radiation therapist)
who delivers courses of radiation therapy as prescribed by a radiation oncologist.
(25)
Teletherapy - Therapeutic irradiation in which
the sealed source is at a distance from the patient or human research subject.
(26)
Therapeutic dosage - The specified activity or range
of activity of radioactive material that is intended to deliver a radiation
dose to a patient or human research subject for palliative or curative treatment.
(27)
Therapeutic dose - A radiation dose delivered from
a sealed source containing radioactive material to a patient or human research
subject for palliative or curative treatment.
(28)
Treatment site - The anatomical description of the
tissue intended to receive a radiation dose, as described in a written directive.
(29)
Type of use - Use of radioactive material as specified
under the following subsections:
(A)
training, uptake, and dilution studies in subsection (y)
of this section;
(B)
imaging and localization studies in subsection (z) of this
section;
(C)
therapy with unsealed radioactive material in subsection
(aa) of this section;
(D)
manual brachytherapy with sealed sources in subsection
(bb) of this section;
(E)
sealed sources for diagnosis in subsection (cc) of this
section; and
(F)
sealed source in a remote afterloader unit, teletherapy
unit, or gamma stereotactic radiosurgery unit in subsection (dd) of this section.
(30)
Unit dosage - A dosage prepared for medical
use for administration as a single dosage to a patient or human research subject
without any further modification of the dosage after it is initially prepared.
(31)
Veterinary use - The intentional internal or external
administration of radioactive material, or the radiation from radioactive
material, to animal patients under the supervision of an authorized user.
(32)
Written directive - An authorized user's written
order for the administration of radioactive material or radiation from radioactive
material to a specific patient or human research subject, as specified in
subsection (p) of this section.
(d)
Provisions for research involving human subjects.
(1)
A licensee may only conduct research involving human subjects
if medical use of radioactive material is authorized on the license.
(2)
The licensee may conduct research specified in paragraph
(1) of this subsection provided that:
(A)
the research is conducted, funded, supported, or regulated
by a federal agency that has implemented the Federal Policy for the Protection
of Human Subjects as required by Title 10, Code of Federal Regulations (CFR), §35.6;
and
(B)
the licensee has applied for and received approval of a
specific amendment to its license before conducting the research.
(3)
Prior to conducting research as specified in
paragraph (1) of this subsection, the licensee shall obtain the following:
(A)
"informed consent," as defined and described in the Federal
Policy, from the human research subjects; and
(B)
prior review and approval of the research activities from
an IRB as required by Title 45, CFR, Part 46 and Title 21, CFR Part 56, and
in accordance with the Federal Policy. The IRB must include at least one authorized
user to direct any human use of radioactive material in accordance with §289.202(b)
of this title.
(4)
Nothing in this subsection relieves licensees
from complying with the other requirements of this chapter.
(e)
Implementation.
(1)
If a license condition exempted a licensee from a provision
of this section or §289.252 of this title on October 1, 2000, then the
license condition continues to exempt the licensee from the requirements in
the corresponding provision until there is a license amendment or license
renewal that modifies or removes the license condition.
(2)
When a requirement in this section differs from the
requirement in an existing license condition, the requirement in this section
shall govern.
(3)
Licensees shall continue to comply with any license
condition that requires implementation of procedures required by subsection
(dd)(4) and (10)-(12) of this section until there is a license amendment or
renewal that modifies the license condition.
(f)
Specific requirements for the issuance of licenses. In
addition to the requirements in §289.252(e) of this title and subsections
(j)-(l) of this section, as applicable, a license will be approved if the
agency determines that:
(1)
the applicant satisfies any applicable special requirement
in this section;
(2)
qualifications of the designated radiation safety
officer (RSO) as specified in subsection (h) of this section are adequate
for the purpose requested in the application; and
(3)
the following submitted by the applicant is approved:
(A)
an operating, safety, and emergency procedures manual to
include:
(i)
specific information on the following:
(I)
radiation safety precautions and instructions;
(II)
methodology for measurement of dosages or doses to be
administered to patients or human research subjects; and
(III)
calibration, maintenance, and repair of instruments and
equipment necessary for radiation safety; and
(ii)
any additional information requested by the agency to
assist in its review of the application;
(B)
full page drawings of each room used for preparing, compounding,
using, and storing radioactive material;
(C)
qualifications of the following:
(i)
RSO in accordance with subsection (h) of this section;
(ii)
authorized user(s) in accordance with subsection (ff)(1)
of this section as applicable to the use(s) being requested; and
(iii)
radiation safety committee (RSC), if applicable, in accordance
with subsection (i) of this section;
(4)
the applicant's permanent facility is located
in Texas; and
(5)
the owner of the property is aware that radioactive
material is stored and/or used on the property, if the proposed storage facility
is not owned by the applicant. The applicant shall provide a written statement
from the owner indicating such.
(g)
Radiation safety officer.
(1)
Every license issued by the agency shall have an RSO designated
by the licensee's management. The licensee shall:
(A)
establish in writing the authority, duties, and responsibilities
of the RSO;
(B)
provide the RSO sufficient authority, organizational freedom,
time, resources, and management prerogative, to perform the following duties:
(i)
establish and oversee operating, safety, emergency, and
as low as reasonably achievable (ALARA) procedures, and to review them at
least annually to ensure that the procedures are current and conform with
this chapter;
(ii)
ensure that required radiation surveys and leak tests
are performed and documented in accordance with this chapter, including any
corrective measures when levels of radiation exceed established limits;
(iii)
ensure that individual monitoring devices are used properly
by occupationally-exposed personnel, that records are kept of the monitoring
results, and that timely notifications are made in accordance with §289.203
of this title;
(iv)
investigate and cause a report to be submitted to the
agency for each known or suspected case of radiation exposure to an individual
or radiation level detected in excess of limits established by this chapter
and each theft or loss of source(s) of radiation, to determine the cause(s),
and to take steps to prevent a recurrence;
(v)
investigate and cause a report to be submitted to the agency
for each known or suspected case of release of radioactive material to the
environment in excess of limits established by this chapter;
(vi)
have a thorough knowledge of management policies and administrative
procedures of the licensee;
(vii)
assume control and institute corrective actions, including
shutdown of operations when necessary, in emergency situations or unsafe conditions;
(viii)
ensure that records are maintained as required by this
chapter.
(ix)
ensure the proper storing, labeling, transport, use, and
disposal of sources of radiation, storage, and/or transport containers;
(x)
ensure that inventories are performed in accordance with
the activities for which the license application is submitted;
(xi)
ensure that personnel are complying with this chapter,
the conditions of the license, and the operating, safety, and emergency procedures
of the licensee; and
(xii)
serve as the primary contact with the agency; and
(C)
have the RSO agree in writing to be responsible for implementing
the radiation safety program.
(2)
The RSO's documented qualifications shall include
training and experience in accordance with subsection (h) of this section.
(3)
For up to 60 days each calendar year, a licensee may
permit an authorized user or an individual qualified to be an RSO to function
as a temporary RSO and to perform the duties of an RSO in accordance with
paragraph (1)(A) and (C) of this subsection, provided the licensee takes the
actions required in paragraphs (1) and (2) of this subsection, and the RSO
meets the qualifications in subsection (h) of this section. Records of qualifications
and dates of service shall be maintained in accordance with subsection (ff)(2)
of this section for inspection by the agency.
(h)
Qualifications for radiation safety officer.
(1)
The qualifications for RSOs for licenses for medical use
of radioactive material without broad-scope authorization shall include the
following:
(A)
certification by a speciality board whose certification
process includes all of the requirements in subparagraph (B) of this paragraph
and whose certification has been recognized by the agency; or
(B)
completion of a structured educational program consisting
of the following:
(i)
200 hours of didactic training in the following areas:
(I)
radiation physics and instrumentation;
(II)
radiation protection;
(III)
mathematics pertaining to the use and measurement of
radioactivity;
(IV)
radiation biology; and
(V)
radiation dosimetry; and
(ii)
one year of full-time radiation safety experience under
the supervision of the individual identified as the RSO on an agency, NRC,
agreement state, or licensing state license that authorizes similar type(s)
of use(s) of radioactive material involving the following:
(I)
shipping, receiving, and performing related radiation surveys;
(II)
using and performing checks for proper operation of dose
calibrators, survey meters, and instruments used to measure radionuclides;
(III)
securing and controlling radioactive material;
(IV)
using administrative controls to avoid mistakes in the
administration of radioactive material;
(V)
using procedures to prevent or minimize radioactive contamination
and using proper decontamination procedures; and
(VI)
disposing of radioactive material; and
(iii)
has obtained written certification, signed by the supervising
RSO, specified in clause (ii) of this subparagraph, that the individual has
satisfactorily completed the requirements in clauses (i) and (ii) of this
subparagraph and has achieved a level of radiation safety knowledge sufficient
to independently function as an RSO for medical uses of radioactive material;
or
(C)
is an authorized user or licensed medical physicist identified
on the licensee's radioactive material license and has experience with the
radiation safety aspects of similar types of use of radioactive material for
which the individual has RSO responsibilities.
(2)
The qualifications for RSOs for licenses for
medical use of radioactive material with broad-scope authorization shall include
the following:
(A)
a bachelor's degree in health physics, radiological health,
physical science or a biological science with a physical science minor and
four years of applied health physics experience in a program with radiation
safety problems similar to those in the program to be managed;
(B)
a master's degree in health physics or radiological health
and three years of applied health physics experience in a program with radiation
safety problems similar to those in the program to be managed; or
(C)
two years of applied health physics experience in a program
with radiation safety problems similar to those in the program to be managed
and one of the following:
(i)
doctorate degree in health physics or radiological health;
(ii)
comprehensive certification by the American Board of Health
Physics;
(iii)
certification by the American Board of Radiology in Medical
Nuclear Physics;
(iv)
certification by the American Board of Science in Nuclear
Medicine in Radiation Protection; or
(v)
certification by the American Board of Medical Physics
in Medical Health Physics.
(3)
The qualifications in paragraphs (1)(A)-(C)
and (2)(A)-(C) of this subsection do not apply to RSOs on radioactive material
licenses issued prior to October 1, 2000.
(i)
Radiation safety committee. Licensees with broad scope
authorization and licensees who are authorized for two or more different types
of uses of radioactive material under subsections (aa), (bb), and (dd) of
this section, or two or more types of units under subsection (dd) of this
section shall establish an RSC to oversee all uses of radioactive material
permitted by the license.
(1)
The RSC for licenses for medical use with broad scope authorization
shall be composed of the following individuals as approved by the agency:
(A)
authorized users from each type of use of radioactive material
(including research, diagnostic, and therapeutic uses);
(B)
the RSO;
(C)
a representative of nursing service;
(D)
a representative of management who is neither an authorized
user nor the RSO;
(E)
a technologist representative; and
(F)
may include other members as the licensee deems appropriate.
(2)
The RSC for licenses for medical use authorized
for two or more different types of uses of radioactive material under subsections
(aa), (bb), and (dd) of this section, or two or more types of units under
subsection (dd) of this section shall be composed of the following individuals
as approved by the agency:
(A)
an authorized user of each type of use permitted by the
license;
(B)
the RSO;
(C)
a representative of nursing service;
(D)
a representative of management who is neither an authorized
user nor the RSO;
(E)
a technologist representative; and
(F)
may include other members as the licensee deems appropriate.
(3)
Duties and responsibilities of the RSC.
(A)
For licensees without broad scope authorization, the duties
and responsibilities of the RSC include, but are not limited to, the following:
(i)
meeting as often as necessary to conduct business but not
less than every three months;
(ii)
reviewing personnel dosimetry data;
(iii)
reviewing the results of required radiation safety surveys
and any significant incidents, including spills, contamination, or medical
events;
(iv)
reviewing the results of inspections and taking appropriate
action when noncompliance is identified;
(v)
reviewing the program for maintaining doses ALARA, and
providing any necessary recommendations to ensure doses are ALARA; and
(vi)
reviewing the audit of the radiation safety program and
acting upon the findings.
(B)
For licensees with broad scope authorization, the duties
and responsibilities of the RSC include, but are not limited to, the items
in subparagraph (A) of this paragraph and the following:
(i)
reviewing the overall compliance status for authorized
users;
(ii)
sharing responsibility with the RSO to conduct periodic
audits of the radiation safety program;
(iii)
developing criteria to evaluate training and experience
of new authorized user applicants;
(iv)
evaluating and approving authorized user applicants who
request authorization to use radioactive material at the facility; and
(v)
reviewing and approving permitted program and procedural
changes prior to implementation.
(j)
Licenses for medical uses of radioactive material without
broad scope authorization. In addition to the requirements of subsection (f)
of this section, a license for medical use of radioactive material as described
in the applicable subsections (y), (z), and (aa)-(cc) of this section will
be issued if the agency approves the following information submitted by the
applicant:
(1)
documentation that the physician(s) designated on the application
as the authorized user(s) is qualified in accordance with subsections (y),
(z), and (aa)-(cc) of this section as applicable;
(2)
evidence that the radiation detection and measuring
instrumentation is appropriate for performing surveys and procedures for the
uses involved;
(3)
documentation that the radiation safety operating
procedures are adequate for the handling and disposal of the radioactive material
involved in the uses; and
(4)
evidence of an established RSC in accordance with
subsection (i)(2) of this section, if applicable.
(k)
License for medical uses of radioactive material with broad
scope authorization. In addition to the requirements in subsection (f) of
this section, a license for medical use of radioactive material with broad
scope authorization will be issued if the agency approves the following information
submitted by the applicant:
(1)
documentation that the review of authorized user qualifications
by the RSC is in accordance with subsections (y), (z), and (aa)-(dd) of this
section, as applicable;
(2)
evidence that the application is for a license authorizing
unspecified forms and/or multiple types of radioactive material for medical
research, diagnosis, and therapy;
(3)
evidence that the radiation detection and measuring
instrumentation is appropriate for performing surveys and procedures for the
uses involved;
(4)
documentation that the radiation safety operating
procedures are adequate for the handling and disposal of the radioactive material
involved in the uses;
(5)
evidence that staff has substantial experience in
the use of a variety of radioactive material for a variety of human uses;
(6)
documentation of a full-time RSO meeting the requirements
of subsection (h)(2) of this section; and
(7)
evidence of an established RSC in accordance with
subsection (i)(1) of this section.
(l)
License for the use of remote control brachytherapy units,
teletherapy units, or gamma stereotactic radiosurgery units. In addition to
the requirements in subsection (f) of this section, a license for the use
of remote control brachytherapy (RCB) units, teletherapy units, or gamma stereotactic
radiosurgery units will be issued if the agency approves the following information
submitted by the applicant:
(1)
documentation that the physician(s) designated on the application
as the authorized user(s) is qualified in accordance with subsection (dd)
of this section;
(2)
evidence that the radiation detection and measuring
instrumentation is appropriate for performing surveys and procedures for the
uses involved;
(3)
documentation that the radiation safety operating
procedures are adequate for the handling and disposal of the radioactive material
involved in the uses; and
(4)
documentation of the following:
(A)
list of radioactive isotopes to be possessed;
(B)
the sealed source manufacturer(s) name(s) and the model
number(s) of the sealed source(s) to be installed;
(C)
the maximum number of sealed sources of each isotope to
be possessed, including the activity of each sealed source;
(D)
the manufacturer and model name and/or number of the following
units, as applicable:
(i)
RCB unit;
(ii)
teletherapy unit; or
(iii)
gamma stereotactic radiosurgery unit;
(E)
the licensed medical physicist's current Texas license
in therapeutic radiological physics;
(F)
the successful completion of unit-specific, manufacturer-provided
training that includes standard clinical and emergency procedures for remote
control brachytherapy and gamma stereotactic radiosurgery units for the following
personnel:
(i)
licensed medical physicist;
(ii)
technologists; and
(iii)
authorized user;
(G)
safety procedures and instructions as required by subsection
(dd)(4) of this section;
(H)
spot check procedures as required by subsection (dd)(10)-(12),
as applicable; and
(I)
an established RSC in accordance with subsection (i)(1)
or (2) of this section if applicable.
(m)
Amendment of licenses at request of licensee.
(1)
Requests for amendment of a license or deletion of a subsite
shall be filed in accordance with §289.252(aa) of this title.
(2)
A licensee without broad-scope authorization shall
apply for and must receive a license amendment prior to the following:
(A)
receiving or using radioactive material for a type of use
that is permitted under this section, but that is not authorized on their
current license issued in accordance with this section;
(B)
permitting anyone to work as an authorized user or licensed
medical physicist under the license;
(C)
changing RSOs, except as provided in subsection (g)(3)
of this section;
(D)
receiving radioactive material in excess of the amount
or in a different form, or receiving a different radionuclide than is authorized
on the license;
(E)
adding or changing the areas identified in the application
or on the license;
(F)
changing the address(es) of use identified in the application
or on the license; and
(G)
changing operating, safety, and emergency procedures.
(3)
A licensee with broad-scope authorization shall
apply for and must receive a license amendment prior to paragraph (2)(A) and
(C)-(G) of this subsection.
(n)
Records/documents to be kept at authorized use site(s).
Each licensee shall maintain copies of the records and documents specified
in subsection (ff)(2) of this section.
(o)
Supervision. A licensee may permit the receipt, possession,
use, or transfer of radioactive material by an individual under the supervision
of an authorized user, unless prohibited by license condition.
(1)
A licensee who permits the receipt, possession, use, or
transfer of radioactive material by an individual under the supervision of
an authorized user shall do the following:
(A)
instruct the supervised individual in the licensee's written
operating, safety, and emergency procedures, written directive procedures,
requirements of this chapter, and license conditions with respect to the use
of radioactive material; and
(B)
require the supervised individual to follow the instructions
of the supervising authorized user for medical uses of radioactive material,
written operating, safety, and emergency procedures established by the licensee,
requirements of this chapter, and license conditions with respect to the medical
use of radioactive material.
(2)
A licensee who permits the preparation of radioactive
material for medical use by an individual under the supervision of an authorized
user, shall do the following:
(A)
instruct the supervised individual in the preparation of
radioactive material for medical use, as appropriate to that individual's
involvement with radioactive material; and
(B)
require the supervised individual to follow the instructions
of the supervising authorized user regarding the preparation of radioactive
material for medical use, the written operating, safety, and emergency procedures
established by the licensee, the requirements of this chapter, and license
conditions.
(3)
A licensee who permits supervised activities
under paragraphs (1) and (2) of this subsection is responsible for the acts
and omissions of the supervised individual.
(p)
Written directives.
(1)
A written directive must be dated and signed by an authorized
user prior to administration of sodium iodide I-131 greater than 30 microcuries
(µCi)(1.11 MBq), any therapeutic dosage of unsealed radioactive material,
or any therapeutic dose of radiation from radioactive material.
(A)
A written revision to an existing written directive may
be made provided that the revision is dated and signed by an authorized user
prior to the administration of the dosage of radioactive drug containing radioactive
material, the brachytherapy dose, the gamma stereotactic radiosurgery dose,
the teletherapy dose, or the next fractional dose.
(B)
If, because of the emergent nature of the patient's condition,
a delay in order to provide a written directive or to revise a written directive
would jeopardize the patient's health, an oral directive or an oral revision
to an existing written directive is acceptable. The information contained
in the oral directive or oral revision shall be documented as soon as possible
in writing in the patient's record. A written directive shall be prepared
and signed by the authorized user within 48 hours of the oral directive or
oral revision.
(2)
The written directive shall contain the patient
or human research subject's name and the following information:
(A)
for any administration of quantities greater than 30 µCi
(1.11 MBq) of sodium iodide I-131: the dosage;
(B)
for an administration of a therapeutic dosage of a radiopharmaceutical
other than sodium iodide I-131: the radiopharmaceutical, dosage, and route
of administration;
(C)
for gamma stereotactic radiosurgery: the total dose, treatment
site, and number of target coordinate settings per treatment for each anatomically
distinct treatment site;
(D)
for teletherapy: the total dose, dose per fraction, number
of fractions, and treatment site;
(E)
for high-dose rate remote afterloading brachytherapy: the
radionuclide, treatment site, dose per fraction, number of fractions, and
total dose; or
(F)
for all other brachytherapy:
(i)
prior to implantation: the treatment site, the radionuclide,
number of sealed sources, and dose; and
(ii)
after implantation but prior to completion of the procedure:
the radionuclide, treatment site, number of sealed sources, total sealed source
strength and exposure time or, equivalently, the total dose.
(3)
The licensee shall maintain the written
directive in accordance with subsection (ff)(2) of this section.
(4)
Procedures for administrations requiring a written
directive.
(A)
For any administration requiring a written directive, the
licensee shall develop, implement, and maintain written procedures to ensure
that:
(i)
the patient's or human research subject's identity is verified
before each administration; and
(ii)
each administration is in accordance with the written
directive.
(B)
The procedures required by subparagraph (A) of this paragraph
must, at a minimum, address the following items that are applicable for the
licensee's use of radioactive material:
(i)
verification of the identity of the patient or human research
subject;
(ii)
verification that the specific details of the administration
are in accordance with the treatment plan, if applicable, and the written
directive;
(iii)
a check of both manual and computer-generated dose calculations;
and
(iv)
verification that any computer-generated dose calculations
are correctly transferred into the consoles of therapeutic medical units authorized
by subsection (dd) of this section.
(q)
Possession, use, and calibration of dose calibrators to
measure the activity of unsealed radioactive material.
(1)
For direct measurements performed in accordance with subsection
(r) of this section, the licensee shall possess and use instrumentation to
measure the activity of unsealed radioactive material before it is administered
to each patient or human research subject.
(2)
The licensee shall calibrate the instrumentation as
specified in paragraph (1) of this subsection in accordance with nationally
recognized standards or the manufacturer's instructions.
(3)
The calibration required by paragraph (2) of this
subsection shall include tests for constancy, accuracy, linearity, and geometry
dependence, as appropriate to demonstrate proper operation of the instrument.
The tests for constancy, accuracy, linearity, and geometry dependence shall
be conducted at the following intervals:
(A)
constancy at least once each day prior to assay of patient
dosages;
(B)
linearity at installation and at least quarterly thereafter;
(C)
geometry dependence at installation; and
(D)
accuracy at installation and at least annually thereafter.
(4)
The licensee shall maintain a record of each
instrument calibration in accordance with subsection (ff)(2) of this section.
The record shall include the following:
(A)
model and serial number of the instrument and calibration
sources;
(B)
dates of the calibration;
(C)
results of the calibration; and
(D)
name of the individual who performed the calibration.
(r)
Determination of dosages of radioactive material for medical
use.
(1)
Before medical use, the licensee shall perform the following:
(A)
record the activity of each dosage; and
(B)
determine the activity of each dosage using a dose calibrator,
by direct measurement of radioactivity, or a decay correction, based on the
activity or activity concentration determined by the following:
(i)
a manufacturer or preparer licensed in accordance with §289.252(r)
of this title, or under an equivalent NRC, agreement state, or licensing state
license; or
(ii)
an NRC or agreement state licensee for use in research
in accordance with a Radioactive Drug Research Committee-approved protocol
or an Investigational New Drug (IND) protocol accepted by the FDA.
(2)
For other than unit dosages, this determination
shall be made by:
(A)
direct measurement of radioactivity; or
(B)
combination of direct measurement of radioactivity and
mathematical calculations.
(3)
Unless otherwise directed by the authorized user,
a licensee shall not use a dosage if the dosage does not fall within the prescribed
dosage range or if the dosage differs from the prescribed dosage by more than
20%.
(4)
A licensee restricted to only unit doses prepared
in accordance with §289.252(r) need not comply with the requirements
in paragraph (1)(B) of this subsection, unless the administration time of
the unit dose deviates from the nuclear pharmacy's pre-calibrated time by
15 minutes or more.
(5)
A licensee shall maintain a record of the dosage determination
required by this subsection in accordance with subsection (ff)(2) of this
section. The record shall contain the following:
(A)
radionuclide, generic name, trade name, or abbreviation
of the radiopharmaceutical;
(B)
patient's or human research subject's name or identification
number if one has been assigned;
(C)
prescribed dosage;
(D)
determined dosage or a notation that the total activity
is less than 30 µCi (1.1 MBq);
(E)
the date and time of the dosage determination; and
(F)
the name of the individual who determined the dosage.
(s)
Authorization for calibration and reference sources. Any
licensee authorized by subsections (j)-(l) of this section for medical use
of radioactive material may receive, possess, and use the following radioactive
material for check, calibration, and reference use:
(1)
sealed sources manufactured and distributed by a person
licensed in accordance with §289.252 of this title and that do not exceed
30 millicurie (mCi) (1.11GBq) each;
(2)
any radioactive material with a half-life not longer
than 120 days in individual amounts not to exceed 15 mCi (0.555 Gbq);
(3)
any radioactive material with a half-life longer than
120 days in individual amounts not to exceed the smaller of 200 µCi
(7.4 MBq) or 1000 times the quantities in §289.252(w)(6) of this title;
and
(4)
technetium-99m in amounts as needed.
(t)
Requirements for possession of sealed sources and brachytherapy
sealed sources. A licensee in possession of any sealed source or brachytherapy
source shall:
(1)
follow the radiation safety and handling instructions supplied
by the manufacturer and the leakage test requirements in accordance with §289.201(g)
of this title.
(2)
conduct a physical inventory at intervals not to exceed
six months to account for all sealed sources received, possessed, and transferred.
Records of the inventories shall be maintained for inspection by the agency
in accordance with subsection (ff)(2) of this section and shall include the
quantities and kinds of radioactive material, sealed source identification
numbers, location of sealed sources, the dates of the inventory, and the identification
of the individual(s) making the record.
(u)
Labeling of vials and syringes. Each syringe and vial that
contains a radiopharmaceutical shall be labeled to identify the radioactive
drug. Each syringe shield and vial shield shall also be labeled unless the
label on the syringe or vial is visible when shielded.
(v)
Surveys for ambient radiation exposure rate.
(1)
Except as provided in paragraph (2) of this subsection,
a licensee shall survey with a radiation detection survey instrument at the
end of each day of use all areas where radioactive material requiring a written
directive was prepared for use or administered.
(2)
A licensee does not need to perform the surveys required
by paragraph (1) of this subsection in an area(s) where patients or human
research subjects are confined when they cannot be released in accordance
with subsection (w) of this section.
(3)
A record of each survey shall be maintained in accordance
with subsection (ff)(2) of this section. The record shall include the following:
(A)
dates of the survey;
(B)
results of the survey;
(C)
manufacturer's name and model and serial number of the
instrument used to make the survey; and
(D)
name of the individual who performed the survey.
(w)
Release of individuals containing radioactive drugs or
implants containing radioactive material.
(1)
The licensee may authorize the release from its control
any individual who has been administered radioactive drugs or implants containing
radioactive material in accordance with a written directive specified in subsection
(p) of this section if the total effective dose equivalent (TEDE) to any other
individual from exposure to the released individual is not likely to exceed
0.5 rem (5 mSv). Patients treated with temporary eye plaques may be released
from the hospital provided that the procedures ensure that the exposure rate
from the patient is less than 5 milliroentgens per hour at a distance of 1
meter from the eye plaque location;
(2)
The licensee shall provide the released individual,
or the individual's parent or guardian, with written instructions on actions
recommended to maintain doses to other individuals ALARA if the TEDE to any
other individual is likely to exceed 0.1 rem (1 mSv). If the TEDE to a breast-feeding
infant or child could exceed 0.1 rem (1 mSv), assuming there was no interruption
of breast-feeding, the instructions shall also include the following:
(A)
guidance on the interruption or discontinuation of breast-feeding;
and
(B)
information on the potential consequences, if any, of failure
to follow the guidance.
(3)
The licensee shall maintain a record in accordance
with subsection (ff)(2) of this section of each patient released in accordance
with paragraph (1) of this subsection. The record shall include the following:
(A)
the basis for authorizing the release of an individual;
and
(B)
the instructions provided to a breast-feeding woman if
the radiation dose to the infant or child from continued breast-feeding could
result in a TEDE exceeding 0.5 rem (5 mSv).
(x)
Decay-in-storage.
(1)
The licensee may hold radioactive material with a physical
half-life of less than 65 days for decay-in-storage and dispose of it without
regard to its radioactivity if the licensee does the following:
(A)
monitors radioactive material at the surface before disposal
and determines that its radioactivity cannot be distinguished from the background
radiation level with an appropriate radiation detection survey meter set on
its most sensitive scale and with no interposed shielding; and
(B)
removes or obliterates all radiation labels, except for
material that will be handled as biomedical waste after it has been released.
(2)
The licensee shall maintain a record of each
disposal permitted under paragraph (1) of this subsection in accordance with
subsection (ff)(2) of this section. The record shall include the following:
(A)
dates of the disposal;
(B)
manufacturer's name and model and serial number of the
survey instrument used;
(C)
background dose rate;
(D)
dose rate measured at the surface of each waste container;
and
(E)
name of the individual who performed the disposal.
(y)
Use of and training for radioactive material for uptake,
dilution, and excretion studies that do not require a written directive.
(1)
Use of radioactive material for uptake, dilution, and excretion
studies. Except for quantities that require a written directive in accordance
with subsection (p) of this section, the licensee may use any unsealed radioactive
material prepared for medical use for uptake, dilution, or excretion studies
that meets the following:
(A)
is obtained from a manufacturer or preparer licensed in
accordance with §289.252 of this title or equivalent NRC, agreement state,
or licensing state requirements;
(B)
is prepared by a physician who is an authorized user and
who meets the requirements specified in paragraph (2) of this subsection,
or an individual under the supervision of an authorized user as specified
in subsection (o) of this section;
(C)
is obtained from an NRC, agreement state, or licensing
state licensee for use in research in accordance with a Radioactive Drug Research
Committee-approved protocol or an IND protocol accepted by the FDA; or
(D)
is prepared by the licensee for use in research in accordance
with a Radioactive Drug Research Committee-approved application or an IND
protocol accepted by the FDA.
(2)
Training for uptake, dilution, and excretion
studies. An authorized user of radiopharmaceuticals for the uses authorized
in paragraph (1) of this subsection shall be a physician who meets the requirements
of subsection (ff)(1)(A) and (I) or (ff)(1)(H) and (I) of this section.
(z)
Use of and training for radioactive material for imaging
and localization studies that do not require a written directive.
(1)
Use of radioactive material for imaging and localization
studies. Except for quantities that require a written directive in accordance
with subsection (p) of this section, the licensee may use any unsealed radioactive
material prepared for medical use for imaging and localization studies that
meets the following:
(A)
is obtained from a manufacturer or preparer licensed in
accordance with § 289.252 of this title or equivalent NRC, agreement
state, or licensing state requirements;
(B)
is prepared by a physician who is an authorized user and
who meets the requirements specified in paragraph (4) of this subsection,
or an individual under the supervision of an authorized user as specified
in subsection (o) of this section;
(C)
is obtained from an NRC, agreement state, or licensing
state licensee for use in research in accordance with a Radioactive Drug Research
Committee-approved protocol or an Investigational New Drug (IND) protocol
accepted by the FDA; or
(D)
is prepared by the licensee for use in research in accordance
with a Radioactive Drug Research Committee-approved application or an IND
protocol accepted by FDA.
(2)
Any licensee who processes and prepares radiopharmaceuticals
for human use shall do so according to instructions that are furnished by
the manufacturer on the label attached to or in the FDA-accepted instructions
in the leaflet or brochure that accompanies the generator or reagent kit.
(3)
Permissible molybdenum-99 concentration.
(A)
The licensee may not administer to humans a radiopharmaceutical
containing more than 0.15 µCi of molybdenum-99 per millicurie of technetium-99m
(0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m).
(B)
The licensee who uses molybdenum-99/technetium-99m generators
for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99
concentration of the first eluate after receipt of a generator to demonstrate
compliance with paragraph (1) of this subsection.
(C)
If the licensee is required to measure the molybdenum-99
concentration, the licensee shall maintain a record of each measurement in
accordance with subsection (ff)(2) of this section. The record shall include
the following for each measured elution of technetium-99m:
(i)
ratio of the measures expressed as microcuries of molybdenum-99
per millicurie of technetium-99m (kilobecquerel of molybdenum-99 per megabecquerel
of technetium-99m);
(ii)
times and dates of the measurement; and
(iii)
name of the individual who made the measurement.
(4)
Training for imaging and localization studies.
An authorized user of radiopharmaceuticals for the uses authorized in paragraph
(1) of this subsection shall be a physician who meets the requirements of
subsection (ff)(1)(B) and (I) or (ff)(1)(H) and (I) of this section.
(aa)
Use of and training for unsealed radioactive material
for therapy that requires a written directive.
(1)
Use of unsealed radioactive material for therapy. A licensee
may use any unsealed radioactive material prepared for medical use that requires
a written directive in accordance with subsection (p) of this section that
meets the following:
(A)
is obtained from a manufacturer or preparer licensed in
accordance with §289.252 of this title or equivalent NRC, agreement state,
or licensing state requirements;
(B)
is prepared by a physician who is an authorized user and
who meets the requirements specified in paragraph (4) of this subsection,
or an individual under the supervision of an authorized user as specified
in subsection (o) of this section;
(C)
is obtained from an NRC, agreement state, or licensing
state licensee for use in research in accordance with an IND application accepted
by the FDA; or
(D)
is prepared by the licensee for use in research in accordance
with an IND protocol accepted by FDA.
(2)
Safety instruction to personnel.
(A)
The licensee shall provide radiation safety instruction,
initially and at least annually, to personnel caring for patients or human
research subjects who have received therapy with a drug containing radioactive
material and cannot be released in accordance with subsection (w) of this
section. The instruction must be appropriate to the personnel's assigned duties
and include the following:
(i)
patient or human research subject control; and
(ii)
visitor control to include the following:
(I)
routine visitation to hospitalized individuals in accordance
with §289.202(n) of this title;
(II)
contamination control;
(III)
waste control; and
(IV)
notification of the RSO, or his or her designee, and the
authorized user if the patient or the human research subject dies or has a
medical emergency.
(B)
The licensee shall maintain a record, in accordance with
subsection (ff)(2) of this section, of individuals receiving instruction.
The record shall include the following:
(i)
list of the topics covered;
(ii)
date of the instruction or training;
(iii)
name(s) of the attendee(s); and
(iv)
name(s) of the individual(s) who provided the instruction.
(3)
Safety precautions for patients or human
research subjects receiving radiopharmaceutical therapy.
(A)
For each patient or human research subject receiving radiopharmaceutical
therapy and hospitalized in accordance with subsection (w) of this section,
the licensee shall do the following:
(i)
provide a private room with a private sanitary facility;
(ii)
post the patient's or the human research subject's room
with a "Radioactive Materials" sign and note on the door and in the patient's
or human research subject's chart where and how long visitors may stay in
the patient's or the human research subject's room; and
(iii)
either monitor material and items removed from the patient's
or the human research subject's room to determine that their radioactivity
cannot be distinguished from the natural background radiation level with a
radiation detection survey instrument set on its most sensitive scale and
with no interposed shielding, or handle such material and items as radioactive
waste.
(B)
The RSO, or his or her designee, and the authorized user
shall be notified immediately if the patient or human research subject has
a medical emergency or if the patient dies.
(4)
Training for use of radioactive material for
therapy that requires a written directive. An authorized user of radiopharmaceuticals
for the uses authorized in paragraph (1) of this subsection shall be a physician
who meets the requirements of subsection (ff)(1)(C) and (I) or (ff)(1)(H)
and (I) of this section.
(bb)
Use of and training for sealed sources for manual brachytherapy.
(1)
Use of sealed sources for manual brachytherapy. The licensee
shall use only brachytherapy sealed sources for therapeutic medical uses as
follows:
(A)
as approved in the Sealed Source and Device Registry; or
(B)
in research in accordance with an effective Investigational
Device Exemption (IDE) application accepted by the FDA and as approved by
the agency.
(2)
Surveys after sealed source implants and removal.
(A)
Immediately after implanting sealed sources in a patient
or a human research subject, the licensee shall perform a survey to locate
and account for all sealed sources that have not been implanted.
(B)
Immediately after removing the last temporary implant sealed
source from a patient or a human research subject, the licensee shall make
a survey of the patient or the human research subject with a radiation detection
survey instrument to confirm that all sealed sources have been removed.
(C)
A record of each survey shall be maintained in accordance
with subsection (ff)(2) of this section. The record shall include the following:
(i)
dates of the survey;
(ii)
results of the survey;
(iii)
manufacturer's name and model and serial number of the
instrument used to make the survey; and
(iv)
name of the individual who performed the survey.
(3)
Brachytherapy sealed sources inventory.
(A)
The licensee shall maintain accountability at all times
for all brachytherapy sealed sources in storage or use.
(B)
Promptly after removing sealed sources from a patient or
a human research subject, the licensee shall return brachytherapy sealed sources
to a secure storage area.
(C)
The licensee shall maintain a record of the brachytherapy
sealed source accountability in accordance with subsection (ff)(2) of this
section.
(i)
The following information shall be recorded when temporary
implants are removed from storage:
(I)
number and activity of sealed sources;
(II)
times and dates;
(III)
name of the individual who removed them from storage;
(IV)
location of use; and
(V)
when returned to storage, the information in subclauses
(I)-(III) of this clause.
(ii)
The following information shall be recorded when permanent
implants are removed from storage:
(I)
number and activity of sealed sources;
(II)
dates;
(III)
name of the individual who removed them from storage;
(IV)
the information in subclauses (I)-(III) of this clause
for all sealed sources not implanted; and
(V)
the number and activity of sealed sources permanently implanted
in the patient or human research subject.
(4)
Safety instruction to personnel. The
licensee shall provide radiation safety instruction, initially and at least
annually, to personnel caring for patients or human research subjects who
are undergoing implant therapy and who cannot be released in accordance with
subsection (w) of this section.
(A)
The instruction must be appropriate to the personnel's
assigned duties and include the following:
(i)
size and appearance of brachytherapy sealed sources;
(ii)
safe handling and shielding instructions;
(iii)
patient or human research subject control;
(iv)
visitor control to include visitation to hospitalized
individuals in accordance with §289.202(n) of this title; and
(v)
notification of the RSO, or his or her designee, and an
authorized user if the patient or the human research subject dies or has a
medical emergency.
(B)
A licensee shall maintain a record, in accordance with
subsection (ff)(2) of this section, of individuals receiving instruction.
The record shall include the following:
(i)
list of the topics covered;
(ii)
date of the instruction or training;
(iii)
name(s) of the attendee(s); and
(iv)
name(s) of the individual(s) who provided the instruction.
(5)
Safety precautions for the use of brachytherapy.
(A)
For each patient or human research subject who is receiving
brachytherapy and cannot be released in accordance with subsection (w) of
this section, the licensee shall:
(i)
provide a private room with a private sanitary facility;
(ii)
post the patient's or the human research subject's room
with a "Radioactive Materials" sign and note on the door or in the patient's
or human research subject's chart where and how long visitors may stay in
the patient's or the human research subject's room; and
(iii)
have available near each treatment room emergency response
equipment to respond to a sealed source that is inadvertently dislodged from
the patient or inadvertently lodged within the patient following removal of
the sealed source applicators.
(B)
The RSO, or his or her designee, and the authorized user
shall be notified if the patient or human research subject has a medical emergency
and, immediately, if the patient dies.
(6)
Calibration measurements of brachytherapy sealed
sources.
(A)
Prior to the first medical use of a brachytherapy sealed
source on or after October 1, 2000, the licensee shall do the following:
(i)
determine the sealed source output or activity using a
dosimetry system that meets the requirements of subsection (dd)(6) of this
section;
(ii)
determine sealed source positioning accuracy within applicators;
and
(iii)
use published protocols accepted by nationally recognized
bodies to meet the requirements of clauses (i) and (ii) of this subparagraph.
(B)
The licensee may use measurements provided by the sealed
source manufacturer that are made in accordance with subparagraph (A) of this
paragraph.
(C)
The licensee shall mathematically correct the outputs or
activities determined in subparagraph (A) of this paragraph for physical decay
at intervals consistent with 1.0% physical decay.
(D)
The licensee shall maintain a record of each calibration
in accordance with subsection (ff)(2) of this section. The record shall include
the following:
(i)
dates of the calibration;
(ii)
manufacturer's name and model and serial number for the
sealed source and instruments used to calibrate the sealed source;
(iii)
sealed source output or activity;
(iv)
sealed source positioning accuracy within applicators;
and
(v)
signature of a licensed medical physicist.
(7)
Therapy-related computer systems. The licensee
shall perform acceptance testing on the treatment planning system in accordance
with published protocols accepted by nationally recognized bodies. At a minimum,
the acceptance testing must include, as applicable, verification of the following:
(A)
the sealed source-specific input parameters required by
the dose calculation algorithm;
(B)
the accuracy of dose, dwell time, and treatment time calculations
at representative points;
(C)
the accuracy of isodose plots and graphic displays; and
(D)
the accuracy of the software used to determine radioactive
sealed source positions from radiographic images.
(8)
Training for use of manual brachytherapy sealed
sources.
(A)
An authorized user of sealed sources for the uses authorized
in paragraph (1) of this subsection shall be a physician who meets the requirements
of subsection (ff)(1)(D), (E), and (I) or (ff)(1)(H) and (I) of this section.
(B)
An authorized user who is limited to the use of eye applicators
shall be a physician who meets the requirements of subsection (ff)(1)(E) and
(I) or (ff)(1)(H) and (I) of this section.
(cc)
Use of and training for sealed sources for diagnosis.
(1)
Use of sealed sources for diagnosis. The licensee shall
use only sealed sources for diagnostic medical uses as approved in the Sealed
Source and Device Registry.
(2)
Training for use of sealed sources for diagnosis.
An authorized user of radiopharmaceuticals for the uses authorized in paragraph
(1) of this subsection shall be a physician who meets the requirements of
subsection (ff)(1)(F) and (I) or (ff)(1)(H) and (I) of this section.
(dd)
Use of and training for a sealed source in a remote afterloader
unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
(1)
Use of a sealed source in a remote afterloader unit, teletherapy
unit, or gamma stereotactic radiosurgery unit. The licensee shall use sealed
sources in photon-emitting remote afterloader units, teletherapy units, or
gamma stereotactic units for therapeutic medical uses as follows:
(A)
as approved in the Sealed Source and Device Registry; or
(B)
in research in accordance with an effective Investigational
Device Exemption (IDE) application accepted by the FDA.
(2)
Surveys of patients and human research subjects
treated with a remote afterloader unit.
(A)
Before releasing a patient or a human research subject
from licensee control, the licensee shall perform a survey of the patient
or the human research subject and the remote afterloader unit with a portable
radiation detection survey instrument to confirm that the sealed source(s)
has been removed from the patient or human research subject and returned to
the safe shielded position.
(B)
The licensee shall maintain a record of the surveys in
accordance with subsection (ff)(2) of this section. The record shall include
the following:
(i)
dates of the survey;
(ii)
results of the survey;
(iii)
manufacturer's name and model and serial number of the
survey instrument used; and
(iv)
name of the individual who made the survey.
(3)
Installation, maintenance, adjustment, and
repair.
(A)
Only a person specifically licensed by the agency, the
NRC, an agreement state, or licensing state shall install, maintain, adjust,
or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic
radiosurgery unit that involves work on the sealed source(s) shielding, the
sealed source(s) driving unit, or other electronic or mechanical component
that could expose the sealed source(s), reduce the shielding around the sealed
source(s), or compromise the radiation safety of the unit or the sealed source(s).
(B)
Except for low dose-rate remote afterloader units, only
a person specifically licensed by the agency, the NRC, an agreement state,
or licensing state shall install, replace, relocate, or remove a sealed source
or sealed source contained in other remote afterloader units, teletherapy
units, or gamma stereotactic units.
(C)
For a low dose-rate remote afterloader unit, only a person
specifically licensed by the agency, the NRC, an agreement state, a licensing
state, or a licensed medical physicist shall install, replace, relocate, or
remove a sealed source(s) contained in the unit.
(D)
The licensee shall maintain a record of the installation,
maintenance, adjustment and repair done on remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units in accordance with subsection
(ff)(2) of this section. For each installation, maintenance, adjustment and
repair, the record shall include the dates, description of the service, and
name(s) of the individual(s) who performed the work.
(4)
Safety procedures and instructions for remote
afterloader units, teletherapy units, and gamma stereotactic radiosurgery
units. A licensee shall do the following:
(A)
secure the unit, the console, the console keys, and the
treatment room when not in use or unattended;
(B)
permit only individuals approved by the authorized user,
RSO, or licensed medical physicist to be present in the treatment room during
treatment with the sealed source(s);
(C)
prevent dual operation of more than one radiation producing
device in a treatment room if applicable;
(D)
develop, implement, and maintain written procedures for
responding to an abnormal situation when the operator is unable to place the
sealed source(s) in the shielded position, or remove the patient or human
research subject from the radiation field with controls from outside the treatment
room;
(i)
The procedure required by this paragraph must include the
following:
(I)
instructions for responding to equipment failures and the
names of the individuals responsible for implementing corrective actions;
(II)
the process for restricting access to and posting of the
treatment area to minimize the risk of inadvertent exposure; and
(III)
the names and telephone numbers of the authorized users,
the licensed medical physicist, and the RSO to be contacted if the unit or
console operates abnormally.
(ii)
A copy of the procedures required by this paragraph must
be physically located at the unit console.
(E)
post instructions at the unit console to inform the operator
of the following:
(i)
the location of the procedures required by subparagraph
(D) of this paragraph; and
(ii)
the names and telephone numbers of the authorized users,
the licensed medical physicist, and the RSO to be contacted if the unit or
console operates abnormally;
(F)
provide instruction initially and at least annually, to
all individuals who operate the unit, as appropriate to the individual's assigned
duties, in the following:
(i)
procedures identified in subparagraph (D) of this paragraph;
and
(ii)
operating procedures for the unit;
(G)
ensure that operators, licensed medical physicists, and
authorized users participate in drills of the emergency procedures, initially
and at least annually; and
(H)
maintain a record, in accordance with subsection (ff)(2)
of this section, of individuals receiving instruction and participating in
drills required by subparagraphs (F) and (G) of this paragraph. The record
shall include the following:
(i)
a list of the topics covered;
(ii)
date of the instruction or drill;
(iii)
name(s) of the attendee(s); and
(iv)
name(s) of the individual(s) who provided the instruction.
(5)
Safety precautions for remote afterloader
units, teletherapy units, and gamma stereotactic radiosurgery units. The licensee
shall do the following:
(A)
control access to the treatment room by a door at each
entrance;
(B)
equip each entrance to the treatment room with an electrical
interlock system that will do the following:
(i)
prevent the operator from initiating the treatment cycle
unless each treatment room entrance door is closed;
(ii)
cause the sealed source(s) to be shielded promptly when
an entrance door is opened; and
(iii)
prevent the sealed source(s) from being exposed following
an interlock interruption until all treatment room entrance doors are closed
and the sealed source(s) "on-off" control is reset at the console;
(C)
require any individual entering the treatment room to assure,
through the use of appropriate radiation monitors, that radiation levels have
returned to ambient levels;
(D)
except for low-dose remote afterloader units, construct
or equip each treatment room with viewing and intercom systems to permit continuous
observation of the patient or the human research subject from the treatment
console during irradiation;
(E)
for licensed activities where sealed sources are placed
within the patient's or human research subject's body, only conduct treatments
that allow for expeditious removal of a decoupled or jammed sealed source;
(F)
in addition to the requirements specified in subparagraph
(B) of this paragraph, require the following for low dose-rate, medium dose-rate,
and pulsed dose-rate remote afterloader units:
(i)
a licensed medical physicist and either an authorized user
or a physician, under the supervision of an authorized user, who has been
trained in the operation and emergency response for the unit, be physically
present during the initiation of all patient treatments involving the unit;
and
(ii)
a licensed medical physicist and either an authorized
user or an individual, under the supervision of an authorized user, who has
been trained to remove the sealed source applicator(s) in the event of an
emergency involving the unit, be immediately available during continuation
of all patient treatments involving the unit;
(G)
in addition to the requirements specified in subparagraphs
(A) and (B) of this paragraph, require the following for high dose-rate remote
afterloader units:
(i)
an authorized user and a licensed medical physicist be
physically present during the initiation of all patient treatments involving
the unit; and
(ii)
a licensed medical physicist and either an authorized
user or a physician, under the supervision of an authorized user, who has
been trained in the operation and emergency response for the unit, be physically
present during continuation of all patient treatments involving the unit;
(H)
in addition to the requirements specified in subparagraphs
(A) and (B) of this paragraph, require that an authorized user and a licensed
medical physicist be physically present throughout all patient treatments
involving gamma stereotactic radiosurgery units;
(I)
notify the RSO, or his or her designee, and an authorized
user as soon as possible, if the patient or human research subject has a medical
emergency and, immediately, if the patient dies; and
(J)
have available, near each treatment room, emergency response
equipment, as applicable, to respond to a sealed source that inadvertently
remains in the unshielded position or inadvertently lodges within the patient
following completion of the treatment.
(6)
Dosimetry equipment.
(A)
Except for low dose-rate remote afterloader sealed sources
where the sealed source output or activity is determined by the manufacturer,
the licensee shall have a calibrated dosimetry system available for use. To
satisfy this requirement, one of the following two conditions must be met.
(i)
The system must have been calibrated using a system or
sealed source traceable to the National Institute of Standards and Technology
(NIST) and published protocols accepted by nationally recognized bodies; or
by a calibration laboratory accredited by the American Association of Physicists
in Medicine (AAPM). The calibration must have been performed within the previous
two years and after any servicing that may have affected system calibration.
(ii)
The system must have been calibrated within the previous
four years. Eighteen to 30 months after that calibration, the system must
have been intercompared with another dosimetry system that was calibrated
within the past 24 months by NIST or by a calibration laboratory accredited
by the AAPM. The results of the intercomparison must have indicated that the
calibration factor of the licensee's system had not changed by more than 2.0%.
The licensee may not use the intercomparison result to change the calibration
factor. When intercomparing dosimetry systems to be used for calibrating sealed
sources for therapeutic unit, the licensee shall use a comparable unit with
beam attenuators or collimators, as applicable, and sealed sources of the
same radionuclide as the sealed source used at the licensee's facility.
(B)
The licensee shall have available for use a dosimetry system
for spot check output measurements, if applicable. To satisfy this requirement,
the system may be compared with a system that has been calibrated in accordance
with subparagraph (A) of this paragraph. This comparison must have been performed
within the previous year and after each servicing that may have affected system
calibration. The spot check system may be the same system used to meet the
requirement in subparagraph (A) of this paragraph.
(C)
The licensee shall maintain a record of each calibration,
intercomparison, and comparison of dosimetry equipment in accordance with
subsection (ff)(2) of this section. The record shall include the following:
(i)
dates of the calibration;
(ii)
model and serial numbers of the instruments that were
calibrated, intercompared, or compared;
(iii)
the correction factor that was determined from the calibration
or comparison or the apparent correction factor that was determined from an
intercomparison; and
(iv)
the names of the individuals who performed the calibration,
intercomparison, or comparison.
(7)
Full calibration measurements on teletherapy
units.
(A)
The licensee shall perform full calibration measurements
on each teletherapy unit as follows:
(i)
before the first medical use of the unit; and
(ii)
before medical use under the following conditions:
(I)
whenever spot check measurements indicate that the output
differs by more than 5.0% from the output obtained at the last full calibration
corrected mathematically for radioactive decay;
(II)
following replacement of the sealed source or following
reinstallation of the teletherapy unit in a new location;
(III)
following any repair of the teletherapy unit that includes
removal of the sealed source or major repair of the components associated
with the sealed source exposure assembly; and
(iii)
at intervals not to exceed one year.
(B)
Full calibration measurements must include determination
of the following:
(i)
output within plus or minus 3.0% for the range of field
sizes and for the distance or range of distances used for medical use;
(ii)
the coincidence of the radiation field and the field indicated
by the light beam localizing device;
(iii)
uniformity of the radiation field and its dependence
on the orientation of the useful beam;
(iv)
timer constancy and linearity over the range of use;
(v)
"on-off" error; and
(vi)
the accuracy of all distance measuring and localization
devices in medical use.
(C)
The licensee shall use the dosimetry system described in
paragraph(6)(A) of this subsection to measure the output for one set of exposure
conditions. The remaining radiation measurements required in subparagraph
(B)(i) of this paragraph may be made using a dosimetry system that indicates
relative dose rates.
(D)
The licensee shall make full calibration measurements required
by subparagraph (A) of this paragraph in accordance with published protocols
accepted by nationally recognized bodies.
(E)
The licensee shall mathematically correct the outputs determined
in subparagraph (B)(i) of this paragraph for physical decay at intervals not
to exceed one month for cobalt-60, six months for cesium-137, or at intervals
consistent with 1.0% decay for all other nuclides.
(F)
Full calibration measurements required by subparagraph
(A) of this paragraph and physical decay corrections required by paragraph
(E) of this subsection must be performed by a licensed medical physicist.
(G)
The licensee shall maintain a record of each calibration
in accordance with subsection (ff)(2) of this section. The record shall include
the following:
(i)
dates of the calibration;
(ii)
manufacturer's name and model and serial number for the
unit's sealed source;
(iii)
instruments used to calibrate the unit;
(iv)
results and an assessment of the full calibration; and
(v)
signature of the licensed medical physicist who performed
the full calibration.
(8)
Full calibration measurements on remote
afterloader units.
(A)
The licensee shall perform full calibration measurements
on each remote afterloader unit as follows:
(i)
before the first medical use of the unit; and
(ii)
before medical use under the following conditions:
(I)
following replacement of the sealed source;
(II)
following reinstallation of the unit in a new location
outside the facility;
(III)
following any repair of the unit that includes removal
of the sealed source or major repair of the components associated with the
sealed source exposure assembly;
(iii)
at intervals not to exceed three months for high dose-rate,
medium dose-rate, and pulsed dose-rate remote afterloader units with sealed
sources whose half- life exceeds 75 days; and
(iv)
at intervals not to exceed one year for low dose rate
afterloader units.
(B)
Full calibration measurements must include, as applicable,
determination of the following:
(i)
the output within plus or minus 5.0%;
(ii)
sealed source positioning accuracy to within plus or minus
1 mm;
(iii)
sealed source retraction with backup battery upon power
failure;
(iv)
length of the sealed source transfer tubes;
(v)
timer accuracy and linearity over the typical range of
use;
(vi)
length of the applicators; and
(vii)
function of the sealed source transfer tubes, applicators,
and transfer tube-applicator interfaces.
(C)
A licensee shall use the dosimetry system described in
paragraph (6)(A) of this subsection to measure the output.
(D)
A licensee shall make full calibration measurements required
by subparagraph (A) of this paragraph in accordance with published protocols
accepted by nationally recognized bodies.
(E)
In addition to the requirements for full calibrations for
low dose-rate remote afterloader units in subparagraph (B) of this paragraph,
a licensee shall perform an autoradiograph of the sealed source(s) to verify
inventory and sealed source(s) arrangement at intervals not to exceed three
months.
(F)
For low dose-rate remote afterloader units, a licensee
may use measurements provided by the sealed source manufacturer that are made
in accordance with subparagraphs (A)-(E) of this paragraph.
(G)
The licensee shall mathematically correct the outputs determined
in subparagraph (B)(i) of this paragraph for physical decay at intervals consistent
with 1.0% physical decay.
(H)
Full calibration measurements required by subparagraph
(A) of this paragraph and physical decay corrections required by subparagraph
(G) of this paragraph must be performed by a licensed medical physicist.
(I)
The licensee shall maintain a record of each calibration
in accordance with subsection (ff)(2) of this section. In addition to the
items in paragraph (7)(G) of this subsection, the record shall also include
results of the autoradiograph required for low dose-rate remote afterloader
units.
(9)
Full calibration measurements on gamma stereotactic
radiosurgery units.
(A)
The licensee shall perform full calibration measurements
on each gamma stereotactic radiosurgery unit as follows:
(i)
before the first medical use of the unit;
(ii)
before medical use under the following conditions:
(I)
whenever spot check measurements indicate that the output
differs by more than 5.0% from the output obtained at the last full calibration
corrected mathematically for radioactive decay;
(II)
following replacement of the sealed sources or following
reinstallation of the gamma stereotactic radiosurgery unit in a new location;
(III)
following any repair of the gamma stereotactic radiosurgery
unit that includes removal of the sealed sources or major repair of the components
associated with the sealed source exposure assembly; and
(iii)
at intervals not to exceed one year.
(B)
Full calibration measurements must include determination
of the following:
(i)
the output within plus or minus 3.0%;
(ii)
relative helmet factors;
(iii)
isocenter coincidence;
(iv)
timer accuracy and linearity over the range of use;
(v)
"on-off" error;
(vi)
trunnion centricity;
(vii)
treatment table retraction mechanism, using backup battery
power or hydraulic backups with the unit "off";
(viii)
helmet microswitches;
(ix)
emergency timing circuits; and
(x)
stereotactic frames and localizing devices (trunnions).
(C)
The licensee shall use the dosimetry system described in
paragraph (6)(A) of this subsection to measure the output for one set of exposure
conditions. The remaining radiation measurements required in subparagraph
(B)(i) of this paragraph may be made using a dosimetry system that indicates
relative dose rates.
(D)
The licensee shall make full calibration measurements required
by subparagraph (A) of this paragraph in accordance with published protocols
accepted by nationally recognized bodies.
(E)
The licensee shall mathematically correct the outputs determined
in subparagraph (B)(i) of this paragraph at intervals not to exceed one month
for cobalt-60 and at intervals consistent with 1.0% physical decay for all
other radionuclides.
(F)
Full calibration measurements required by subparagraph
(A) of this paragraph and physical decay corrections required by subparagraph
(E) of this paragraph must be performed by a licensed medical physicist.
(G)
The licensee shall maintain a record of each calibration
in accordance with subsection (ff)(2) of this section. The record shall include
the following:
(i)
dates of the calibration;
(ii)
manufacturer's name and model and serial number for the
unit's sealed source;
(iii)
instruments used to calibrate the unit;
(iv)
results and an assessment of the full calibration; and
(v)
signature of the licensed medical physicist who performed
the full calibration.
(10)
Periodic spot checks for teletherapy units.
(A)
The licensee authorized to use teletherapy units for medical
use shall perform output spot checks on each teletherapy unit once in each
calendar month that include determination of the following:
(i)
timer constancy and linearity over the range of use;
(ii)
"on-off" error;
(iii)
the coincidence of the radiation field and the field
indicated by the light beam localizing device;
(iv)
the accuracy of all distance measuring and localization
devices used for medical use;
(v)
the output for one typical set of operating conditions
measured with the dosimetry system described in paragraph (6)(A) of this subsection;
and
(vi)
the difference between the measurement made in subparagraph
(A)(v) of this section and the anticipated output, expressed as a percentage
of the anticipated output, the value obtained at last full calibration corrected
mathematically for physical decay.
(B)
The licensee shall perform measurements required by subparagraph
(A) of this paragraph in accordance with procedures established by a licensed
medical physicist. That individual need not actually perform the spot check
measurements.
(C)
The licensee authorized to use a teletherapy unit for medical
use shall perform safety spot checks of each teletherapy facility once in
each calendar month and after each sealed source installation to assure proper
operation of the following:
(i)
electrical interlocks at each teletherapy room entrance;
(ii)
electrical or mechanical stops installed for the purpose
of limiting use of the primary beam of radiation (restriction of sealed source
housing angulation or elevation, carriage or stand travel and operation of
the beam "on-off" mechanism);
(iii)
sealed source exposure indicator lights on the teletherapy
unit, on the control console, and in the facility;
(iv)
viewing and intercom systems;
(v)
treatment room doors from inside and outside the treatment
room; and
(vi)
electrically assisted treatment room doors with the teletherapy
unit electrical power turned "off".
(D)
The licensee shall have a licensed medical physicist review
the results of each spot check and submit a written report to the licensee
within 15 days of the spot check.
(E)
If the results of the checks required in subparagraph (C)
of this paragraph indicate the malfunction of any system, the licensed medical
physicist shall immediately notify the licensee and the licensee shall lock
the control console in the "off" position and not use the unit except as may
be necessary to repair, replace, or check the malfunctioning system.
(F)
The licensee shall maintain a record of each spot check
required by subparagraphs (A) and (D) of this paragraph, in accordance with
subsection (ff)(2) of this section. The record shall include the following:
(i)
dates of the spot-check;
(ii)
manufacturer's name and model and serial number for the
teletherapy unit, and sealed source and instrument used to measure the output
of the teletherapy unit;
(iii)
assessment of timer linearity and constancy;
(iv)
calculated "on-off" error;
(v)
determination of the coincidence of the radiation field
and the field indicated by the light beam localizing device;
(vi)
the determined accuracy of each distance measuring and
localization device;
(vii)
the difference between the anticipated output and the
measured output;
(viii)
notations indicating the operability of each entrance
door electrical interlock, each electrical or mechanical stop, each sealed
source exposure indicator light, and the viewing and intercom system and doors;
(ix)
name of the individual who performed the periodic spot-check;
and
(x)
the signature of the licensed medical physicist who reviewed
the record of the spot check.
(11)
Periodic spot checks for remote afterloader
units.
(A)
The licensee shall perform spot checks of each remote afterloader
facility and on each unit as follows:
(i)
at the beginning of each day of use of a high dose-rate,
medium dose-rate, or pulsed dose-rate remote afterloader unit;
(ii)
before each patient treatment with a low dose-rate remote
afterloader unit; and
(iii)
after each sealed source installation.
(B)
The licensee shall perform the measurements required by
subparagraph (A) of this paragraph in accordance with written procedures established
by a licensed medical physicist. That individual need not actually perform
the spot check measurements.
(C)
The licensee shall have a licensed medical physicist review
the results of each spot check and submit a written report to the licensee
within 15 days of the spot check.
(D)
To satisfy the requirements of subparagraph (A) of this
paragraph, spot checks must, at a minimum, assure proper operation of the
following:
(i)
electrical interlocks at each remote afterloader unit room
entrance;
(ii)
sealed source exposure indicator lights on the remote
afterloader unit, on the control console, and in the facility;
(iii)
viewing and intercom systems in each high dose-rate,
medium dose-rate, and pulsed dose-rate remote afterloader facility;
(iv)
emergency response equipment;
(v)
radiation monitors used to indicate the sealed source position;
(vi)
timer accuracy;
(vii)
clock (date and time) in the unit's computer; and
(viii)
decayed sealed source(s) activity in the unit's computer.
(E)
If the results of the checks required in subparagraph (D)
of this paragraph indicate the malfunction of any system, the licensee shall
lock the control console in the "off" position and not use the unit except
as may be necessary to repair, replace, or check the malfunctioning system.
(F)
The licensee shall maintain a record, in accordance with
subsection (ff)(2) of this section, of each check required by subparagraph
(A) of this paragraph. The record shall include the following, as applicable:
(i)
dates of the spot-check;
(ii)
manufacturer's name and model and serial number for the
remote afterloader unit and sealed source;
(iii)
an assessment of timer accuracy;
(iv)
notations indicating the operability of each entrance
door electrical interlock, radiation monitors, sealed source exposure indicator
lights, viewing and intercom systems, clock, and decayed sealed source activity
in the unit's computer;
(v)
name of the individual who performed the periodic spot-check;
and
(vi)
the signature of the licensed medical physicist who reviewed
the record of the spot check.
(12)
Periodic spot checks for gamma stereotactic
radiosurgery units.
(A)
The licensee shall perform spot checks of each gamma stereotactic
radiosurgery facility and on each unit as follows:
(i)
monthly;
(ii)
at the beginning of each day of use; and
(iii)
after each source installation.
(B)
The licensee shall perform the measurements required by
subparagraph (A) of this paragraph in accordance with written procedures established
by a licensed medical physicist. That individual need not actually perform
the spot check measurements.
(C)
The licensee shall have a licensed medical physicist review
the results of each spot check and submit a written report to the licensee
within 15 days of the spot check.
(D)
To satisfy the requirements of subparagraph (A)(i) of this
paragraph, spot checks must, at a minimum, achieve the following by:
(i)
assurance of proper operation of these items:
(I)
treatment table retraction mechanism, using backup battery
power or hydraulic backups with the unit "off";
(II)
helmet microswitches;
(III)
emergency timing circuits; and
(IV)
stereotactic frames and localizing devices (trunnions);
and
(ii)
determination of the following:
(I)
the output for one typical set of operating conditions
measured with the dosimetry system described in paragraph (6)(A) of this subsection;
(II)
the difference between the measurement made in subclause
(I) of this clause and the anticipated output, expressed as a percentage of
the anticipated output, the value obtained at last full calibration corrected
mathematically for physical decay;
(III)
sealed source output against computer calculation;
(IV)
timer accuracy and linearity over the range of use;
(V)
"on-off" error; and
(VI)
trunnion centricity.
(E)
To satisfy the requirements of subparagraph (A)(ii) and
(iii) of this paragraph, spot checks must assure proper operation of the following:
(i)
electrical interlocks at each gamma stereotactic radiosurgery
room entrance;
(ii)
sealed source exposure indicator lights on the gamma stereotactic
radiosurgery unit, on the control console, and in the facility;
(iii)
viewing and intercom systems;
(iv)
timer termination;
(vi)
radiation monitors used to indicate room exposures; and
(vii)
emergency "off" buttons.
(F)
The licensee shall arrange for prompt repair of any system
identified in subparagraph (D) of this paragraph that is not operating properly.
(G)
If the results of the checks required in subparagraph (D)
of this paragraph indicate the malfunction of any system, the licensee shall
lock the control console in the "off" position and not use the unit except
as may be necessary to repair, replace, or check the malfunctioning system.
(H)
The licensee shall retain a record of each check required
by subparagraphs (D) and (E) of this paragraph in accordance with subsection
(ff)(2) of this section. The record shall include the following:
(i)
dates of the spot check;
(ii)
manufacturer's name and model and serial number for the
gamma stereotactic radiosurgery unit and the instrument used to measure the
output of the unit;
(iii)
an assessment of timer linearity and accuracy;
(iv)
the calculated "on-off" error;
(v)
a determination of trunnion centricity;
(vi)
the difference between the anticipated output and the
measured output;
(vii)
an assessment of sealed source output against computer
calculations;
(viii)
notations indicating the operability of radiation monitors,
helmet microswitches, emergency timing circuits, emergency "off" buttons,
electrical interlocks, sealed source exposure indicator lights, viewing and
intercom systems, timer termination treatment table retraction mechanism,
and stereotactic frames and localizing devices (trunnions);
(ix)
the name of the individual who performed the periodic
spot check; and
(x)
the signature of the licensed medical physicist who reviewed
the record of the spot check.
(13)
Additional technical requirements for mobile
remote afterloader units.
(A)
The licensee providing mobile remote afterloader service
shall do the following:
(i)
check survey instruments before medical use at each address
of use or on each day of use, whichever is more frequent; and
(ii)
account for all sealed sources before departure from a
client's address of use.
(B)
In addition to the periodic spot checks required by paragraph
(11) of this subsection, the licensee shall perform checks on each remote
afterloader unit before medical use at each address of use. At a minimum,
checks must be made to verify the operation of the following:
(i)
electrical interlocks on treatment area access points;
(ii)
sealed source exposure indicator lights on the remote
afterloader unit, on the control console, and in the facility;
(iii)
viewing and intercom systems;
(iv)
applicators, sealed source transfer tubes, and transfer
tube- applicator interfaces;
(v)
radiation monitors used to indicate room exposures;
(vi)
sealed source positioning (accuracy); and
(vii)
radiation monitors used to indicate whether the sealed
source has returned to a safe shielded position.
(C)
In addition to the requirements for checks in subparagraph
(B) of this paragraph, the licensee shall ensure overall proper operation
of the remote afterloader unit by conducting a simulated cycle of treatment
before use at each address of use.
(D)
If the results of the checks required in subparagraph (B)
of this paragraph indicate the malfunction of any system, the licensee shall
lock the control console in the "off" position and not use the unit except
as may be necessary to repair, replace, or check the malfunctioning system.
(E)
The licensee shall retain a record, in accordance with
subsection (ff)(2) of this section, of each check required by subparagraph
(B) of this paragraph. The record shall include the following:
(i)
dates of the check;
(ii)
manufacturer's name and model and serial number of the
remote afterloader unit;
(iii)
notations accounting for all sealed sources before the
licensee departs from a facility;
(iv)
notations indicating the operability of each entrance
door electrical interlock, radiation monitors, sealed source exposure indicator
lights, viewing and intercom system, applicators and sealed source transfer
tubes, and sealed source positioning accuracy; and
(v)
the signature of the individual who performed the check.
(14)
Radiation surveys.
(A)
In addition to the survey requirement in §289.202(p)
of this title, a person licensed to use sealed sources in this subsection
shall make surveys as defined in the Sealed Source and Device Registry to
assure that the maximum radiation levels and average radiation levels from
the surface of the main sealed source safe with the sealed source(s) in the
shielded position do not exceed the levels stated in the Registry.
(B)
The licensee shall make the survey required by paragraph
(A) of this section at installation of a new sealed source and following repairs
to the sealed source(s) shielding, the sealed source(s) driving unit, or other
electronic or mechanical component that could expose the sealed source, reduce
the shielding around the sealed source(s), or compromise the radiation safety
of the unit or the sealed source(s).
(C)
The licensee shall retain a record, in accordance with
subsection (ff)(2) of this section, of the radiation surveys required by subparagraph
(A) of this paragraph. The record shall include:
(i)
dates of the measurements;
(ii)
manufacturer's name and model and serial number of the
treatment unit, sealed source, and instrument used to measure radiation levels;
(iii)
each dose rate measured around the sealed source while
the unit is in the "off" position and the average of all measurements; and
(iv)
the signature of the individual who performed the test.
(15)
Five-year inspection for teletherapy and
gamma stereotactic radiosurgery units.
(A)
The licensee shall have each teletherapy unit and gamma
stereotactic radiosurgery unit fully inspected and serviced during sealed
source replacement or at intervals not to exceed five years, whichever comes
first, to assure proper functioning of the sealed source exposure mechanism.
(B)
This inspection and servicing may only be performed by
persons specifically licensed to do so by the agency, the NRC, an agreement
state, or licensing state.
(C)
The licensee shall keep a record of the inspection and
servicing in accordance with subsection (ff)(2) of this section. The record
shall include the following:
(i)
dates of inspection;
(ii)
manufacturer's name and model and serial number of both
the treatment unit and the sealed source;
(iii)
a list of components inspected and serviced, and the
type of service; and
(iv)
the radioactive material license number and the signature
of the individual performing the inspection.
(16)
Therapy-related computer systems. The licensee
shall perform acceptance testing on the treatment planning system in accordance
with published protocols accepted by nationally recognized bodies. At a minimum,
the acceptance testing must include, as applicable, verification of the following:
(A)
the sealed source-specific input parameters required by
the dose calculation algorithm;
(B)
the accuracy of dose, dwell time, and treatment time calculations
at representative points;
(C)
the accuracy of isodose plots and graphic displays;
(D)
the accuracy of the software used to determine sealed source
positions from radiographic images; and
(E)
the accuracy of electronic transfer of the treatment delivery
parameters to the treatment delivery unit from the treatment planning system.
(17)
Training for use of remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units. An authorized
user of radiopharmaceuticals for the uses authorized in paragraph (1) of this
subsection shall be a physician who meets the requirements of subsection (ff)(1)(G)
and (I) or (ff)(1)(H) and (I) of this section.
(ee)
Report and notification of a medical event.
(1)
The licensee shall report any event, except for events
that result from intervention by a patient or human research subject, in which
the administration of radioactive material, or radiation from radioactive
material, results in the following:
(A)
a dose that differs from the prescribed dose by more than
5 rem (0.05 Sv) effective dose equivalent, 50 rem (0.5 Sv) to an organ or
tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin and either:
(i)
the total dose delivered differs from the prescribed dose
by 20% or more;
(ii)
the total dosage delivered differs from the prescribed
dosage by 20% or more or falls outside the prescribed dosage range; or
(iii)
the fractionated dose delivered differs from the prescribed
dose, for a single fraction, by 50% or more.
(B)
a dose that exceeds 5 rem (0.05 Sv) effective dose equivalent,
50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent
to the skin from any of the following:
(i)
an administration of a wrong radioactive drug containing
radioactive material;
(ii)
an administration of a radioactive drug containing radioactive
material by the wrong route of administration;
(iii)
an administration of a dose or dosage to the wrong individual
or human research subject;
(iv)
an administration of a dose or dosage delivered by the
wrong mode of treatment; or
(v)
a leaking sealed source.
(C)
a dose to the skin or an organ or tissue other than the
treatment site that exceeds by 50 rem (0.5 Sv) to an organ or tissue and 50%
of the dose expected from the administration defined in the written directive
(excluding, for permanent implants, seeds that were implanted in the correct
site but migrated outside the treatment site).
(2)
The licensee shall report any event resulting
from intervention of a patient or human research subject in which the administration
of radioactive material, or radiation from radioactive material, results or
will result in an unintended permanent functional damage to an organ or a
physiological system, as determined by a physician.
(3)
The licensee shall notify the agency by telephone
no later than the next calendar day after discovery of the medical event.
(4)
The licensee shall submit a written report to the
agency within 15 days after discovery of the medical event. The written report
shall include the following, excluding the individual's name or any other
information that could lead to identification of the individual:
(A)
the licensee's name and radioactive material license number;
(B)
the name of the prescribing physician;
(C)
a brief description of the medical event;
(D)
why the event occurred;
(E)
the effect, if any, on the individual(s) who received the
administration;
(F)
actions, if any, that have been taken, or are planned,
to prevent recurrence;
(G)
whether the licensee notified the individual (or the individual's
responsible relative or guardian), and if not, why not; and
(H)
if there was notification, what information was provided.
(5)
The licensee shall notify the referring physician
and also notify the individual who is the subject of the medical event no
later than 24 hours after its discovery, unless the referring physician personally
informs the licensee either that he or she will inform the individual or that,
based on medical judgement, telling the individual would be harmful. The licensee
is not required to notify the individual without first consulting the referring
physician. If the referring physician or the affected individual cannot be
reached within 24 hours, the licensee shall notify the individual as soon
as possible thereafter. The licensee shall not delay any appropriate medical
care for the individual, including any necessary remedial care as a result
of the medical event, because of any delay in notification. To meet the requirements
of this subsection, the notification of the individual who is the subject
of the medical event may be made instead to that individual's responsible
relative or guardian. If a verbal notification is made, the licensee shall
inform the individual or appropriate responsible relative or guardian, that
a written description of the event can be obtained from the licensee upon
request. The licensee shall provide the written description if requested.
(6)
Aside from the notification requirement, nothing in
this section affects any rights or duties of licensees and physicians in relation
to each other, to individuals affected by the medical event, or to that individual's
responsible relatives or guardians.
(7)
The licensee shall maintain a record of the medical
event in accordance with subsection (ff)(2) of this section. A copy of the
record shall be provided to the referring physician if other than the licensee.
The record shall contain the following:
(A)
licensee's name and radioactive material license number;
(B)
names of the individuals involved;
(C)
the identification number of the individual who is the
subject of the medical event;
(D)
brief description of the event and why it occurred;
(E)
the effect, if any, on the individual; and
(F)
the actions, if any, taken, or planned, to prevent recurrence;
and
(G)
whether the licensee notified the individual or the individual's
responsible relative or guardian, and if not, whether the failure to notify
was based on guidance from the referring physician.
(8)
The licensee shall report any dose to an embryo/fetus
that is greater than 5 rem (50 mSv) dose equivalent that is a result of an
administration of radioactive material or radiation from radioactive material
to a pregnant individual, unless the dose to the embryo/fetus was specifically
approved, in advance, by the authorized user.
(9)
The licensee shall report any dose to a nursing child
that is a result of an administration of radioactive material to a breast
feeding individual that:
(A)
is greater than 5 rem (50 mSv) TEDE; or
(B)
has resulted in unintended permanent functional damage
to an organ or a physiological system, as determined by a physician.
(10)
The licensee shall notify the agency by telephone
no later than the next calendar day after discovery of a dose to the embryo/fetus
or nursing child that requires a report in accordance with paragraphs (8)
or (9) of this subsection.
(11)
The licensee shall submit a written report to the
agency no later than 15 days after discovery of a dose to the embryo/fetus
or nursing child that requires a report in accordance with paragraphs (8)
or (9) of this subsection. The written report shall include the items in paragraph
(4)(A)-(F) of this subsection, excluding the individual's or child's name
or any other information that could lead to identification of the individual
or child.
(12)
The licensee shall notify the referring physician
and also notify the pregnant individual or mother, both hereafter referred
to as the mother, no later than 24 hours after discovery of an event that
would require reporting in accordance with paragraphs (8) or (9) of this subsection,
unless the referring physician personally informs the licensee either that
he or she will inform the mother or that, based on medical judgement, telling
the mother would be harmful.
(13)
To meet the requirements of this subsection, the
notification may be made to the mother's or child's responsible relative or
guardian instead of the mother, when appropriate.
(14)
The licensee is not required to notify the mother
without first consulting with the referring physician. If the referring physician
or mother cannot be reached within 24 hours, the licensee shall make the appropriate
notifications as soon as possible thereafter. The licensee may not delay any
appropriate medical care for the embryo/fetus or for the nursing child, including
any necessary remedial care as a result of the event, because of any delay
in notification.
(15)
If notification was made in accordance with paragraphs
(12) and (13) of this subsection, the licensee shall also furnish, within
15 days after discovery of the event, a written report to the mother or responsible
relative or guardian, by sending either of the following:
(A)
a copy of the report that was submitted to the agency;
or
(B)
a brief description of both the event and the consequences
as they may affect the embryo/fetus or nursing child.
(16)
The licensee shall retain a record of a dose
to an embryo/fetus or a nursing child in accordance with subsection (ff)(2)
of this section. The record shall contain items in paragraph (7)(A) of this
subsection.
(ff)
Appendices.
(1)
Acceptable training and experience for medical uses of
radioactive material.
(A)
Training for uptake, dilution, and excretion studies.
(i)
The licensee shall require the authorized user of radiopharmaceuticals
for uptake, dilution, and excretion studies to be a physician who:
(I)
is certified in:
(-a-)
nuclear medicine by the American Board of Nuclear Medicine
(ABNM);
(-b-)
diagnostic radiology or radiology by the American
Board of Radiology (ABR);
(-c-)
diagnostic radiology or radiology by the American
Osteopathic Board of Radiology (AOBR);
(-d-)
nuclear medicine by the Royal College of Physicians
and Surgeons of Canada (RCPSC); or
(-e-)
nuclear medicine by the American Osteopathic Board
of Nuclear Medicine (AOBNM); or
(II)
has successfully completed classroom and laboratory training
in basic radioisotope handling techniques applicable to the use of prepared
radiopharmaceuticals and supervised clinical experience as follows:
(-a-)
40 hours of classroom and laboratory training that includes:
(-1-)
radiation physics and instrumentation;
(-2-)
radiation protection;
(-3-)
mathematics pertaining to the use and measurement of
radioactivity;
(-4-)
radiation biology; and
(-5-)
radiopharmaceutical chemistry; and
(-b-)
20 hours of supervised clinical experience
under the supervision of an authorized user and that includes:
(-1-)
examining patients and reviewing their case histories
to determine their suitability for radioisotope diagnosis, limitations, or
contraindications;
(-2-)
selecting the suitable radiopharmaceuticals and calculating
and measuring the dosages;
(-3-)
administering dosages to patients and using syringe radiation
shields;
(-4-)
collaborating with the authorized user in the interpretation
of radioisotope test results; and
(-5-)
patient follow-up; or
(-c-)
has successfully completed a six-month training
program in nuclear medicine as part of a residency program that has been accredited
by the Accreditation Council for Graduate Medical Education (ACGME) or the
Council on Postdoctoral Training of the American Osteopathic Association (COPT-AOA)
and that included classroom and laboratory training, work experience, and
supervised clinical experience in all the topics identified in this subclause.
(ii)
Training in all the topics identified in clause (i)(II)(-a-)
of this subparagraph, which is not a part of a residency program as in clause
(i)(II)(-c-) of this subparagraph, shall be obtained in an ACGME- or COPT-AOA-accredited
medical teaching institution. The 40 hours of classroom and laboratory training
in clause (i)(II)(-a-) of this subparagraph shall have been initiated prior
to completion of the clinical experience in clause (i)(II)(-b-) of this subparagraph.
The clinical experience described in clause (i)(II)(-b-) of this subparagraph
shall be supervised by a physician licensed for the full scope of diagnostic
nuclear medicine procedures or by an authorized physician in an ACGME- or
COPT-AOA- accredited medical teaching institution.
(iii)
Notwithstanding the requirements of clauses (i) and (ii)
of this subparagraph, proof of alternative training that includes the topics
and hours listed in subparagraph (B)(i)(II) of this paragraph may be accepted
on a case-by-case basis if the agency, after providing the Medical Committee
of the Texas Radiation Advisory Board with the opportunity to review and comment,
determines that the alternative training would give an equal or greater level
of training to the standards in clauses (i) and (ii) of this subparagraph.
(B)
Training for imaging and localization studies.
(i)
The licensee shall require the authorized user of a radiopharmaceuticals
for imaging and localization studies to be a physician who:
(I)
is certified in:
(-a-)
nuclear medicine by the ABNM;
(-b-)
diagnostic radiology or radiology by the ABR;
(-c-)
diagnostic radiology or radiology by the AOBR;
(-d-)
nuclear medicine by the RCPSC; or
(-e-)
nuclear medicine by the AOBNM; or
(II)
has successfully completed classroom and laboratory training
in basic radioisotope handling techniques applicable to the use of prepared
radiopharmaceuticals, generators, and reagent kits, supervised work experience,
and supervised clinical experience as follows:
(-a-)
200 hours of classroom and laboratory training that includes:
(-1-)
radiation physics and instrumentation;
(-2-)
radiation protection;
(-3-)
mathematics pertaining to the use and measurement of
radioactivity;
(-4-)
radiopharmaceutical chemistry; and
(-5-)
radiation biology; and
(-b-)
500 hours of supervised work experience under
the supervision of an authorized user that includes:
(-1-)
ordering, receiving, and unpacking radioactive materials
safely and performing the related radiation surveys;
(-2-)
calibrating dose calibrators and diagnostic instruments
and performing checks for proper operation of survey meters;
(-3-)
calculating and safely preparing patient dosages;
(-4-)
using administrative controls to prevent the misadministration
of byproduct material;
(-5-)
using procedures to contain spilled byproduct material
safely and using proper decontamination procedures; and
(-6-)
eluting technetium-99m from generator systems, measuring
and testing the eluate for molybdenum-99 and alumina contamination, and processing
the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals;
and
(-c-)
500 hours of supervised clinical experience
under the supervision of an authorized user that includes:
(-1-)
examining patients and reviewing their case histories
to determine their suitability for radioisotope diagnosis, limitations, or
contraindications;
(-2-)
selecting the suitable radiopharmaceuticals and calculating
and measuring the dosages;
(-3-)
administering dosages to patients and using syringe radiation
shields;
(-4-)
collaborating with the authorized user in the interpretation
of radioisotope test results; and
(-5-)
patient follow-up; or
(-d-)
has successfully completed a six-month training
program in nuclear medicine as part of a residency program that has been accredited
by the ACGME or the COPT-AOA and that included classroom and laboratory training,
work experience, and supervised clinical experience in all the topics identified
in this subclause.
(ii)
Training in all the topics identified in clause (i)(II)(-a-)
of this subparagraph, which is not a part of a residency program as in clause
(i)(II)(-d-) of this subparagraph, shall be obtained in a medical teaching
institution that provides appropriate training programs that have been accredited
by the ACGME or the COPT-AOA. The 200 hours of classroom and laboratory training
in clause (i)(II)(-a-) of this subparagraph shall have been initiated prior
to completion of the work and clinical experience in clauses (i)(II)(-b-)
and (-c-) of this subparagraph. The work and clinical experience described
in clause (i)(II)(-b-) and (-c-) of this subparagraph shall be supervised
by a physician licensed for the full scope of diagnostic nuclear medicine
procedures or by a licensed authorized physician in a medical teaching institution
that also provides appropriate training programs that have been accredited
by the ACGME or the COPT-AOA. The experience in clause (i)(II)(-b-) and (-c-)
of this subparagraph may be obtained concurrently.
(iii)
Classroom and laboratory training identified in clause
(i)(II)(-a-) of this subparagraph that was initiated before October 1, 1995,
and completed by October 1, 1997, will be accepted if it is obtained in an
accredited medical school, a federal teaching hospital, or a training program
for medical use of radioactive material that has been accepted by the agency,
NRC, or another agreement state.
(iv)
Notwithstanding the requirements of clauses (i) and (ii)
of this subparagraph, proof of alternative training that includes the topics
and hours listed in clause (i)(II) of this subparagraph may be accepted on
a case-by-case basis if the agency, after providing the Medical Committee
of the Texas Radiation Advisory Board with the opportunity to review and comment,
determines that the alternative training would give an equal or greater level
of training to the standards in clauses (i) and (ii) of this subparagraph.
(C)
Training for the therapeutic use of radiopharmaceuticals.
(i)
The licensee shall require the authorized user of radiopharmaceuticals
for therapeutic use to be a physician who:
(I)
is certified in:
(-a-)
nuclear medicine by the ABNM;
(-b-)
radiology or therapeutic radiology by the ABR;
(-c-)
therapeutic radiology or radiology by the AOBR;
(-d-)
nuclear medicine by the RCPSC; or
(-e-)
nuclear medicine by the AOBNM; or
(II)
has classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of therapeutic radiopharmaceuticals
and supervised clinical experience as follows:
(-a-)
80 hours of classroom and laboratory training that includes:
(-1-)
radiation physics and instrumentation;
(-2-)
radiation protection;
(-3-)
mathematics pertaining to the use and measurement of
radioactivity; and
(-4-)
radiation biology; and
(-b-)
supervised clinical experience under the supervision
of an authorized physician user for the type of therapy authorization requested
from the following list:
(-1-)
use of iodine-131 for diagnosis of thyroid function and
the treatment of hyperthyroidism in 10 individuals;
(-2-)
use of iodine-131 for treatment of thyroid carcinoma
in three individuals;
(-3-)
use of colloidal phosphorus-32 for intracavitary treatment
in three patients;
(-4-)
use of phosphorus-32 for treatment of polycythemia vera,
leukemia and/or bone metastasis in three patients;
(-5-)
use of colloidal gold-198 for intracavitary treatment
in three patients; or
(-6-)
use of radiopharmaceuticals not listed in subitems (-1-)
through (-5-) of this item for therapeutic treatment in three patients; or
(-7-)
has successfully completed a six-month training program
in nuclear medicine as part of a residency program that has been accredited
by the ACGME or the COPT-AOA and that included classroom and laboratory training,
work experience and supervised clinical experience in all the topics identified
in this subclause.
(ii)
Training in all the topics identified in clause (i)(II)
of this subparagraph, which is not a part of a residency program as in clause
(i)(II)(-b-) of this subparagraph, shall be obtained in a medical teaching
institution accredited by the ACGME or the COPT-AOA.
(D)
Training for use of brachytherapy sealed sources (except
for beta applicators - See subparagraph (E) of this paragraph).
(i)
The licensee shall require the authorized user of a brachytherapy
sealed source to be a physician who:
(I)
is certified in:
(-a-)
therapeutic radiology, radiation oncology, or radiology
by the ABR; or
(-b-)
therapeutic radiology, radiation oncology, or radiology
by the AOBR; or
(-c-)
radiology with specialization in radiotherapy, as
a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College
of Radiology"; or
(-d-)
therapeutic radiology by the Canadian Royal College
of Physicians and Surgeons; or
(II)
is in the active practice of therapeutic radiology, has
had classroom training in radioisotope handling techniques applicable to the
therapeutic use of brachytherapy sealed sources, and supervised clinical experience
as follows:
(-a-)
200 hours of classroom and laboratory training that includes:
(-1-)
radiation physics and instrumentation;
(-2-)
radiation protection;
(-3-)
mathematics pertaining to the use and measurement of
radioactivity; and
(-4-)
radiation biology; and
(-b-)
500 hours of supervised work experience under
the supervision of an authorized user at a medical institution that includes:
(-1-)
ordering, receiving, and unpacking radioactive materials
safely and performing the related radiation surveys;
(-2-)
checking survey meters for proper operation;
(-3-)
preparing, implanting, and removing sealed sources;
(-4-)
maintaining running inventories of material on hand;
(-5-)
using administrative controls to prevent the misadministration
of byproduct material; and
(-6-)
using emergency procedures to control byproduct material;
and
(-c-)
three years of supervised clinical experience
that includes one year in a formal training program approved by the Residency
Review Committee for Radiology of the ACGME or the COPT-AOA, and an additional
two years of clinical experience in therapeutic radiology under the supervision
of an authorized user at a medical institution that includes:
(-1-)
examining individuals and reviewing their case histories
to determine their suitability for brachytherapy treatment, and any limitations
or contraindications;
(-2-)
selecting the proper brachytherapy sealed sources and
dose and method of administration;
(-3-)
calculating the dose; and
(-4-)
post-administration follow-up and review of case histories
in collaboration with the authorized user.
(ii)
Training in all the topics identified in clause (i)(II)(-a-)
of this subparagraph shall be accredited by the ACGME or the COPT-AOA. The
clinical experience described in clause (i)(II)(-b-) and (-c-) of this subparagraph
should be supervised by a physician licensed to use brachytherapy sealed sources.
The experience in clause (i)(II)(-b-) and (-c-) of this subparagraph may be
obtained concurrently.
(E)
Training for ophthalmic use of strontium-90.
(i)
The licensee shall require the authorized user of only
strontium-90 for ophthalmic radiotherapy to be a physician who:
(I)
is certified in:
(-a-)
therapeutic radiology, radiation oncology, or radiology
by the ABR;
(-b-)
therapeutic radiology, radiation oncology, or radiology
by the AOBR;
(-c-)
radiology with specialization in radiotherapy, as
a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College
of Radiology"; or
(-d-)
therapeutic radiology by the Canadian Royal College
of Physicians and Surgeons; or
(II)
is in the active practice of therapeutic radiology or
ophthalmology, and has had classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy,
and a period of supervised clinical training in ophthalmic radiotherapy as
follows:
(-a-)
24 hours of classroom and laboratory training that includes:
(-1-)
radiation physics and instrumentation;
(-2-)
radiation protection;
(-3-)
mathematics pertaining to the use and measurement of
radioactivity; and
(-4-)
radiation biology; and
(-b-)
supervised clinical training in ophthalmic
radiotherapy under the supervision of an authorized user at a medical institution
that includes the use of strontium-90 for the ophthalmic treatment of five
individuals that includes:
(-1-)
examination of each individual to be treated;
(-2-)
calculation of the dose to be administered;
(-3-)
administration of the dose; and
(-4-)
follow-up and review of each individual's case history.
(ii)
Training in all the topics identified in clause (i)(II)(-a-)
of this subparagraph shall be obtained in a medical teaching institution or
shall be accredited by the ACGME or the COPT-AOA. The clinical experience
described in clause (i)(II)(-b-) of this subparagraph shall be supervised
by a physician licensed for the use of sealed sources in therapy.
(F)
Training for use of sealed sources for diagnosis.
(i)
The licensee shall require the authorized user of a sealed
source in the devices listed in clause (ii) of this subparagraph, to be a
physician, dentist, or podiatrist who:
(I)
is certified in:
(-a-)
therapeutic radiology, diagnostic radiology, radiation
oncology, or radiology by the ABR;
(-b-)
nuclear medicine by the ABNM;
(-c-)
diagnostic radiology or radiology by the AOBR; or
(-d-)
nuclear medicine by the RCPSC; or
(-e-)
nuclear medicine by the AOBNM; or
(II)
has had eight hours of classroom and laboratory training
in radioisotope handling techniques specifically applicable to the use of
the device that includes:
(-a-)
radiation physics, mathematics pertaining to the use
and measurement of radioactivity, and instrumentation;
(-b-)
radiation biology;
(-c-)
radiation protection; and
(-d-)
training in the use of the device for the uses requested.
(ii)
The following sealed sources shall be used in accordance
with the manufacturer's radiation safety and handling instructions:
(I)
iodine-125, americium-241, or gadolinium-153 as a sealed
source in a device for bone mineral analysis; and
(II)
iodine-125 as a sealed source in a portable imaging device.
(iii)
Training in all the topics identified in clause (i)(II)
of this subparagraph shall be obtained in a medical teaching institution or
shall be accredited by the ACGME or the COPT-AOA. The clinical experience
shall be supervised by a physician, dentist, or podiatrist licensed to use
the devices.
(G)
Training for teletherapy, remote afterloader units, and
gamma stereotactic radiosurgery.
(i)
The licensee shall require the authorized user of a sealed
source in a teletherapy unit to be a physician who:
(I)
is certified in:
(-a-)
therapeutic radiology, radiation oncology, or radiology
by the ABR;
(-b-)
therapeutic radiology, radiation oncology, or radiology
by the AOBR;
(-c-)
radiology with specialization in radiotherapy, as
a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College
of Radiology"; or
(-d-)
therapeutic radiology by the Canadian Royal College
of Physicians and Surgeons; or
(II)
is in the active practice of therapeutic radiology, and
has had classroom and laboratory training in basic radioisotope techniques
applicable to the use of a sealed source in a teletherapy unit, supervised
work experience, and supervised clinical experience as follows:
(-a-)
200 hours of classroom and laboratory training that includes:
(-1-)
radiation physics and instrumentation;
(-2-)
radiation protection;
(-3-)
mathematics pertaining to the use and measurement of
radioactivity; and
(-4-)
radiation biology; and
(-b-)
500 hours of supervised work experience under
the supervision of an authorized user at a medical institution that includes:
(-1-)
review of the full calibration measurements and periodic
spot checks;
(-2-)
preparing treatment plans and calculating treatment times;
(-3-)
using administrative controls to prevent misadministration;
(-4-)
implementing emergency procedures to be followed in the
event of the abnormal operation of a teletherapy unit or console; and
(-5-)
checking and using survey meters; and
(-c-)
three years of supervised clinical experience
that includes one year in a formal training program accredited by the ACGME
or the COPT-AOA and an additional two years of clinical experience in therapeutic
radiology under the supervision of an authorized user at a medical institution
that includes:
(-1-)
examining individuals and reviewing their case histories
to determine their suitability for teletherapy treatment; and any limitations
or contraindications;
(-2-)
selecting the proper dose and how it is to be administered;
(-3-)
calculating the therapy doses and collaborating with
the authorized user in the review of patients' progress and consideration
of the need to modify originally prescribed doses as warranted by patients'
reaction to radiation; and
(-4-)
post-administration follow-up and review of case histories.
(ii)
Training in all the topics identified in clause (i)(II)(-a-)
of this subparagraph shall be accredited by the ACGME or the COPT-AOA. The
clinical experience described in clause (i)(II)(-b-) and (-c-) of this subparagraph
shall be supervised by a physician licensed for teletherapy procedures. The
experience in clause (i)(II)(-b-) and (-c-) of this subparagraph may be obtained
concurrently.
(H)
Training for experienced authorized users. Physicians,
dentists, or podiatrists identified as authorized users for the medical, dental,
or podiatric use of radioactive material on a NRC or agreement state license
issued before September 1, 1993, and those issued by the agency before October
1, 1995, who perform only those methods of use for which they were authorized
on that date need not comply with the training requirements in this paragraph.
(I)
Recentness of training. The training and experience specified
in this paragraph for medical use must have been obtained within the five
years preceding the date of application or the individual must have had related
continuing education and experience since the required training and experience
was completed.
(2)
Records/documents for agency inspection. Each
licensee shall make the following records/documents available to the agency
for inspection, upon reasonable notice.
Figure: 25 TAC §289.256(ff)(2)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State, on May 22, 2000.
TRD-200003510
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
25 TAC §289.258
The Texas Department of Health (department) proposes an amendment
to §289.258 concerning licensing and radiation safety requirements for
irradiators.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.118 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist; however revisions to the rule are necessary.
The proposed amendment adds the definitions for "Category I self-contained,
dry-source irradiator" and "Onsite" to clarify the intent of the rule. Language
is added that clarifies that cesium-137 can only be used with Category I self-contained,
dry-source irradiators. Additional language was added to clarify the requirements
for operator attendance during irradiator operations. The amendment reflects
corrections of references to other sections of this chapter. Grammatical changes
are made for clarification. This amendment is also part of the department's
continuing effort to update, clarify, and simplify its rules regarding the
control of radiation based upon technological advances, public concerns, legislative
directives, or other factors.
The department published a Notice of Intention to Review for §289.258
as required by Government Code §2001.039 in the
Texas Register
on January 7, 2000 (25 TexReg 219). No comments were
received by the department on this section.
Mrs. Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for the first
five-year period the section is in effect, there will be no fiscal implications
for state or local government as a result of enforcing or administering the
section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the section is in effect, the public benefit anticipated as a result
of enforcing the section will be to ensure that new and operating irradiators
are used in accordance with standardized requirements designed to protect
public health and safety and the environment. There will be no effect on micro
businesses or small businesses. There are no anticipated economic costs to
persons who are required to comply with the section as proposed. There is
no anticipated impact on local employment. The requirement for limiting use
of cesium-137 to Category I self-contained, dry-source irradiators formalizes
in rule agency policy for licensing irradiators. The addition of the definition
of "onsite" and the language concerning operator attendance clarify the intent
of existing requirements concerning the availability of trained individuals
during irradiator operation. Because the amendment is clarifying and does
not impose any additional requirements such as record keeping, regulatory
limits, procedures, or processes, there are no economic effects associated
with the section as proposed.
Comments on the proposal may be presented in writing to Mrs. Ruth E. McBurney,
C.H.P., Director, Division of Licensing, Registration and Standards, Bureau
of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756-3189, (512)834-6688. Public comments will be accepted for 30 days
following publication of these proposed changes in the
Texas Register
. In addition, a public meeting will be held at 10:30
a.m., Tuesday, June 20, 2000, in conference room N218, Texas Department of
Health, Bureau of Radiation Control, located at the Exchange Building, 8407
Wall Street, Austin, Texas.
The amendment is proposed under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The amendment affects Health and Safety Code, Chapter 401 and Chapter 12,
and Government Code §2001.039.
§289.258.Licensing and Radiation Safety Requirements for Irradiators.
(a)
Purpose. This section contains requirements
for the issuance of a license authorizing the use of sealed sources containing
radioactive material in irradiators that irradiate objects or materials using
gamma radiation. This section also contains radiation safety requirements
for operating irradiators.
[
[
[
[
(b)
Scope.
(1)
In addition to the requirements of this
section, all licensees, unless otherwise specified, are subject to the 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 Material), §289.203 of this title
(relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §289.205 of this title (relating to Hearing and Enforcement
Procedures), §289.252 of this title (relating to Licensing of Radioactive
Material), and §289.257 of this title (relating to Packaging and Transportation
of Radioactive Material). Nothing in this section relieves the licensee from
complying with other applicable federal, state and local regulations governing
the siting, zoning, land use, and building code requirements for industrial
facilities.
(2)
The requirements in this section
apply to panoramic irradiators that have either dry or wet storage of the
radioactive sealed sources and to underwater irradiators in which both the
source and the product being irradiated are under water. Irradiators whose
dose rates exceed 500 rads (5 grays) per hour at 1 meter from the radioactive
sealed sources in air or in water, as applicable for the irradiator type,
are covered by this section.
(3)
The requirements in this section
do not apply to self- contained, dry-source-storage irradiators (those in
which both the source and the area subject to irradiation are contained within
a device and are not accessible by personnel), medical radiology or teletherapy,
radiography (the irradiation of materials for nondestructive testing purposes),
gauging, or open-field (agricultural) irradiations.
(c)
[
(1)
Annually - At intervals not to exceed 390 days.
(2)
Doubly encapsulated sealed source - A sealed source
in which the radioactive material is sealed within a capsule and that capsule
is sealed within another capsule.
(3)
Category I self-contained, dry- source
irradiator - An irradiator in which the sealed source is completely contained
in a dry container constructed of solid materials and is shielded at all times,
and in which human access to the sealed source and the volume undergoing irradiation
is not physically possible in its designed configuration.
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
Onsite - A physical presence within
the building housing the irradiator or on property controlled by the licensee
that is contiguous with the building housing the irradiator.
(12)
[
(13)
[
(14)
[
(d)
[
(e)
[
(1)
The agency will approve an application for a specific license
for the use of licensed material in an irradiator if the applicant meets the
requirements contained in this section.
(2)
The applicant shall satisfy the general requirements
specified in §289.252 of this title and the requirements contained in
this section.
(3)
The application shall describe the training provided
to irradiator operators including:
(A)
classroom training;
(B)
on-the-job or simulator training;
(C)
safety reviews;
(D)
means employed by the applicant to test each operator's
understanding of the agency's
rules
[
(E)
minimum training and experience of personnel who may provide
training.
(4)
The application shall include a copy of the written
operating, safety, and emergency procedures as outlined in subsection
(t)
[
(5)
The application shall describe the organizational
structure for managing the irradiator, specifically the radiation safety responsibilities
and authorities of the radiation safety officer
(RSO)
and those
management personnel who have radiation safety responsibilities or authorities.
In particular, the application shall specify who, within the management structure,
has the authority to stop unsafe operations. The application shall also describe
the training and experience required for the position of
RSO
[
(6)
The application shall include a description of the
access control systems required by subsection
(i)
[
(7)
If the applicant intends to perform and analyze leak
tests of dry-source- storage sealed sources, the applicant shall establish
procedures for leak testing and submit a description of these procedures to
the agency. The description shall include at least the following:
(A)
instruments to be used;
(B)
methods of performing the analysis; and
(C)
pertinent experience of the individual who analyzes the
samples.
(8)
If licensee personnel are to load or unload sources,
the applicant shall describe the qualifications and training of the personnel
and the procedures to be used. If the applicant intends to contract for source
loading or unloading at its facility, the loading or unloading shall be done
by a person specifically authorized by the agency, the
United States
Nuclear Regulatory Commission (NRC)
[
(9)
The applicant shall describe the inspection and maintenance
checks, including the frequency of the checks required by subsection
(x)
[
(f)
[
(g)
[
(h)
[
(1)
Cesium-137 shall not be used in any irradiator
other than a Category I self-contained, dry-source irradiator as defined in
subsection (c) of this section.
(2)
[
(A)
have been evaluated in accordance with §289.252(i)
of this title;
(B)
be doubly encapsulated;
(C)
use radioactive material that is as nondispersible as practical
and that is as insoluble as practical if the source is used in a wet-source-storage
or wet-source-change irradiator;
(D)
be encapsulated in a material resistant to general corrosion
and to localized corrosion, such as 316L stainless steel or other material
with equivalent resistance if the sources are for use in irradiator pools;
and
(E)
have been leak tested and found leak-free in prototype
testing of the sealed source after each of the tests described in paragraphs
(3)-(8)
[
(3)
[
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(i)
[
(1)
Each entrance to a radiation room at a panoramic irradiator
shall have a door or other physical barrier to prevent inadvertent entry of
personnel if the sources are not in the shielded position. Product conveyor
systems may serve as barriers as long as they reliably and consistently function
as a barrier. It shall not be possible to move the sources out of their shielded
position if the door or barrier is open. Opening the door or barrier while
the sources are exposed shall cause the sources to return promptly to the
shielded position. The personnel entrance door or barrier shall have a lock
that is operated by the same key used to move the sources. The doors and barriers
shall not prevent any individual in the radiation room from leaving.
(2)
In addition, each entrance to a radiation room at
a panoramic irradiator shall have an independent backup access control to
detect personnel entry while the sources are exposed. Detection of entry while
the sources are exposed shall cause the sources to return to their fully shielded
position and shall also activate a visible and audible alarm to make the individual
entering the room aware of the hazard. The alarm shall also make at least
one other individual who is onsite aware of the entry. That individual shall
be trained on how to respond to the alarm and be prepared to promptly render
or summon assistance.
(3)
A radiation monitor shall be provided to detect the
presence of high radiation levels in the radiation room of a panoramic irradiator
before personnel entry. The monitor shall be integrated with personnel access
door locks to prevent room access when radiation levels are high. Attempted
personnel entry while the monitor measures high radiation levels shall activate
the alarm described in paragraph (2) of this subsection. The monitor may be
located in the entrance (normally referred to as the maze) but not in the
direct radiation beam.
(4)
Before the sources move from their shielded position
in a panoramic irradiator, the source control shall automatically activate
conspicuous visible and audible alarms to alert people in the radiation room
that the sources will be moved from their shielded position. The alarms shall
give individuals enough time to leave the room and to operate the control
described in paragraph (5) of this subsection before the sources leave the
shielded position.
(5)
Each radiation room at a panoramic irradiator shall
have a clearly visible and readily accessible control that allows an individual
in the room to return the sources to their fully shielded position.
(6)
Each radiation room of a panoramic irradiator shall
contain a control that prevents the sources from moving from the shielded
position unless the control has been activated and the door or barrier to
the radiation room has been closed within a preset time after activation of
the control.
(7)
Each entrance to the radiation room of a panoramic
irradiator and each entrance to the area within the personnel access barrier
of an underwater irradiator shall have a sign bearing the radiation symbol
and the words, "CAUTION (or DANGER), RADIOACTIVE MATERIAL." Panoramic irradiators
shall also have a sign stating "CAUTION (or DANGER), HIGH RADIATION AREA,"
or "GRAVE DANGER, VERY HIGH RADIATION AREA," whichever is applicable, but
the sign may be removed, covered, or otherwise made inoperative when the sources
are fully shielded.
(8)
If the radiation room of a panoramic irradiator has
roof plugs or other movable shielding, it shall not be possible to operate
the irradiator unless the shielding is in its proper location. The requirement
may be met by interlocks that prevent operation if shielding is not placed
properly or by an operating procedure requiring inspection of shielding before
operating.
(9)
Underwater irradiators shall have a personnel access
barrier around the pool that shall be locked to prevent access when the irradiator
is not attended. Only operators and facility management may have access to
keys to the personnel access barrier. There shall be an intrusion alarm to
detect unauthorized entry when the personnel access barrier is locked. Activation
of the intrusion alarm shall alert an individual (not necessarily onsite)
who is prepared to respond or summon assistance.
(j)
[
(1)
The radiation dose rate in areas that are normally occupied
during operation of a panoramic irradiator may not exceed 2 millirems
(mrem)
(0.02 millisievert
(mSv)
) per hour at any location
30 centimeters
(cm)
or more from the wall of the room when the
sources are exposed. The dose rate shall be averaged over an area not to exceed
100 square centimeters
(cm
2
)
having
no linear dimension greater than 20
cm
[
(2)
The radiation dose at 30
cm
[
(3)
The radiation dose rate at 1
m
[
(k)
[
(1)
The radiation room at a panoramic irradiator shall have
heat and smoke detectors. The detectors shall activate an audible alarm. The
alarm shall be capable of alerting a person who is prepared to summon assistance
promptly. The sources shall automatically become fully shielded if a fire
is detected.
(2)
The radiation room at a panoramic irradiator shall
be equipped with a fire extinguishing system capable of extinguishing a fire
without the entry of personnel into the room. If water is used, the system
for the radiation room shall have a shut-off valve to control flooding into
unrestricted areas.
(l)
[
(1)
Irradiators with automatic product conveyor systems shall
have a radiation monitor with an audible alarm located to detect loose radioactive
sources that are carried toward the product exit. If the monitor detects a
source, an alarm shall sound and product conveyors shall stop automatically.
The alarm shall be capable of alerting an individual in the facility who is
prepared to summon assistance. Underwater irradiators in which the product
moves within an enclosed stationary tube are exempt from the requirements
of this paragraph.
(2)
Underwater irradiators that are not in a shielded
radiation room shall have a radiation monitor over the pool to detect abnormal
radiation levels. The monitor shall have an audible alarm and a visible indicator
at entrances to the personnel access barrier around the pool. The audible
alarm may have a manual shut-off. The alarm shall be capable of alerting an
individual who is prepared to respond promptly.
(m)
[
(1)
The mechanism that moves the sources of a panoramic irradiator
shall require a key to actuate. Actuation of the mechanism shall cause an
audible signal to indicate that the sources are leaving the shielded position.
Only one key may be in use at any time, and only operators or facility management
may possess it. The key shall be attached to a portable radiation survey meter
by a chain or cable. The lock for source control shall be designed so that
the key may not be removed if the sources are in an unshielded position. The
door to the radiation room shall require the same key.
(2)
The console of a panoramic irradiator shall have a
source position indicator that indicates when the sources are in the fully
shielded position, when they are in transit, and when the sources are in the
fully exposed position.
(3)
The control console of a panoramic irradiator shall
have a control that when activated, shall return the source to its fully shielded
position within its normal transit time.
(4)
Each control for a panoramic irradiator shall be clearly
marked as to its function.
(n)
[
(1)
For licenses initially issued after August 1, 1996, irradiator
pools shall either:
(A)
have a water-tight stainless steel liner or a liner metallurgically
compatible with other components in the pool; or
(B)
be constructed so that there is a low likelihood of substantial
leakage and have a surface designed to facilitate decontamination. In either
case, the licensee shall have a method to safely store the sources during
repairs of the pool.
(2)
For licenses initially issued after August 1,
1996, irradiator pools shall have no outlets more than 0.5
m
[
(3)
A means shall be provided to replenish water losses
from the pool.
(4)
A visible indicator shall be provided in a clearly
visible location to indicate if the pool water level is below the normal low
water level or above the normal high water level.
(5)
Irradiator pools shall be equipped with a purification
system designed to be capable of maintaining the water during normal operation
at a conductivity of 20 microsiemens per centimeter or less and with a clarity
so that the sources can be seen clearly.
(6)
A physical barrier, such as a railing or cover, shall
be used around or over irradiator pools during normal operation to prevent
personnel from accidentally falling into the pool. The barrier may be removed
during maintenance, inspection, and service operations.
(7)
If long-handled tools or poles are used in irradiator
pools, the radiation dose rate on the handling areas of the tools may not
exceed 2
mrem
[
(o)
[
(p)
[
(1)
If electrical power at a panoramic irradiator is lost for
longer than 10 seconds, the sources shall automatically return to the shielded
position.
(2)
The lock on the door of the radiation room of a panoramic
irradiator shall not be deactivated by a power failure.
(3)
During a power failure, the area of any irradiator
where sources are located may be entered only when using an operable and calibrated
radiation survey meter.
(q)
[
(1)
Shielding. For panoramic irradiators, the licensee shall
design shielding walls to meet generally accepted building code requirements
for reinforced concrete and design the walls, wall penetrations, and entrance
ways to meet the radiation shielding requirements of subsection
(j)
[
(2)
Foundations. For panoramic irradiators, the licensee
shall design the foundation, with consideration given to soil characteristics,
to ensure it is adequate to support the weight of the facility shield walls.
(3)
Pool integrity. For pool irradiators, the licensee
shall design the pool to assure that it is leak resistant, that it is strong
enough to bear the weight of the pool water and shipping casks, that a dropped
cask would not fall on sealed sources, that all outlets or pipes meet the
requirements of subsection
(n)(2)
[
(4)
Water handling system. For pool irradiators, the licensee
shall verify that the design of the water purification system is adequate
to meet the requirements of subsection
(n)(5)
[
(5)
Radiation monitors. For all irradiators, the licensee
shall evaluate the location and sensitivity of the monitor to detect sources
carried by the product conveyor system as required by subsection
(l)(1)
[
(6)
Source rack. For pool irradiators, the licensee shall
verify that there are no crevices on the source or between the source and
source holder that would promote corrosion on a critical area of the source.
For panoramic irradiators, the licensee shall determine that source rack drops
due to loss of power will not damage the source rack and that source rack
drops due to failure of cables (or alternate means of support) will not cause
loss of integrity of sealed sources. For panoramic irradiators, the licensee
shall review the design of the mechanism that moves the sources to assure
that the likelihood of a stuck source is low and that, if the rack sticks,
a means exists to free it with minimal risk to personnel.
(7)
Access control. For panoramic irradiators, the licensee
shall verify from the design and logic diagram that the access control system
will meet the requirements of subsection
(i)
[
(8)
Fire protection. For panoramic irradiators, the licensee
shall verify that the number, locations, and spacing of the smoke and heat
detectors are appropriate to detect fires and that the detectors are protected
from mechanical and radiation damage. The licensee shall verify that the design
of the fire extinguishing system provides the necessary discharge patterns,
densities, and flow characteristics for complete coverage of the radiation
room and that the system is protected from mechanical and radiation damage.
(9)
Source return. For panoramic irradiators, the licensee
shall verify that the source rack will automatically return to the fully shielded
position if power is lost for more than 10 seconds.
(10)
Seismic. For panoramic irradiators to be built in
seismic areas, the licensee shall design the reinforced concrete radiation
shields to retain their integrity in the event of an earthquake by designing
to the seismic requirements of an appropriate source such as American Concrete
Institute Standard ACI 318-89, "Building Code Requirements for Reinforced
Concrete," Chapter 21, "Special Provisions for Seismic Design," or local building
codes, if current.
(11)
Wiring. For panoramic irradiators, the licensee shall
verify that electrical wiring and electrical equipment in the radiation room
are selected to minimize failures due to prolonged exposure to radiation.
(r)
[
(1)
Shielding. For panoramic irradiators, the licensee shall
monitor the construction of the shielding to verify that its construction
meets design specifications and generally accepted building code requirements
for reinforced concrete.
(2)
Foundations. For panoramic irradiators, the licensee
shall monitor the construction of the foundations to verify that the foundation
construction meets design specifications.
(3)
Pool integrity. For pool irradiators, the licensee
shall verify that the pool meets design specifications and shall test the
integrity of the pool. The licensee shall verify that outlets and pipes meet
the requirements of subsection
(n)(2)
[
(4)
Water handling system. For pool irradiators, the licensee
shall verify that the water purification system, the conductivity meter, and
the water level indicators operate properly.
(5)
Radiation monitors. For all irradiators, the licensee
shall verify the proper operation of the monitor to detect sources carried
on the product conveyor system and the related alarms and interlocks required
by subsection
(l)(1)
[
(6)
Source rack. For panoramic irradiators, the licensee
shall test the movement of the source racks for proper operation prior to
source loading
.
[
(7)
Access control. For panoramic irradiators, the licensee
shall test the completed access control system to assure that it functions
as designed and that all alarms, controls, and interlocks work properly.
(8)
Fire protection. For panoramic irradiators, the licensee
shall test the ability of the heat and smoke detectors to detect a fire, to
activate alarms, and to cause the source rack to automatically become fully
shielded. The licensee shall test the operability of the fire extinguishing
system.
(9)
Source return. For panoramic irradiators, the licensee
shall demonstrate that the source racks can be returned to their fully shielded
positions without power.
(10)
Computer systems. For panoramic irradiators that
use a computer system to control the access control system, the licensee shall
verify that the access control system will operate properly if power is lost
and shall verify that the computer has security features that prevent an irradiator
operator from commanding the computer to override the access control system
when it is required to be operable.
(11)
Wiring. For panoramic irradiators, the licensee shall
verify that the electrical wiring and electrical equipment that were installed
meet the design specifications.
(s)
[
(1)
Before an individual is permitted to operate an irradiator
without a supervisor present, who has completed the requirements of this paragraph
and paragraphs (2) and (3) of this subsection, the individual shall be instructed
in:
(A)
the fundamentals of radiation protection applied to irradiators
(including the differences between external radiation and radioactive contamination,
units of radiation dose, dose limits, why large radiation doses shall be avoided,
how shielding and access controls prevent large doses, how an irradiator is
designed to prevent contamination, the proper use of survey meters and
individual monitoring devices
[
(B)
the requirements of this section and
§289.203
[
(C)
the operation of the irradiator;
(D)
those operating, safety, and emergency procedures listed
in subsection
(t)
[
(E)
case histories of accidents or problems involving irradiators.
(2)
Before an individual is permitted to operate
an irradiator without a supervisor present, who has completed the requirements
of this paragraph and paragraphs (1) and (3) of this subsection, the individual
shall pass a written test on the instruction received consisting primarily
of questions based on the licensee's operating, safety, and emergency procedures
that the individual is responsible for performing and other operations necessary
to safely operate the irradiator without supervision.
(3)
Before an individual is permitted to operate an irradiator
without a supervisor present, who has completed the requirements of this paragraph
and paragraphs (1) and (2) of this subsection, the individual shall have received
on-the-job training or simulator training in the use of the irradiator as
described in the license application. The individual shall also demonstrate
the ability to perform those portions of the operating, safety, and emergency
procedures that he or she is to perform.
(4)
The licensee shall conduct safety reviews for irradiator
operators at least annually. The licensee shall give each operator a brief
written test on the information. Each safety review shall include, to the
extent appropriate, each of the following:
(A)
changes in operating, safety, and emergency procedures
since the last review, if any;
(B)
changes in rules and license conditions since the last
review, if any;
(C)
reports on recent accidents, mistakes, or problems that
have occurred at irradiators, if any;
(D)
relevant results of inspections of operator safety performance;
(E)
relevant results of the facility's inspection and maintenance
checks; and
(F)
a drill to practice an emergency or abnormal event procedure.
(5)
The licensee shall evaluate the safety performance
of each irradiator operator at least annually to ensure that
agency rules
[
(6)
Individuals who will be permitted unescorted access
to the radiation room of the irradiator or the area around the pool of an
underwater irradiator, but who have not received the training required for
operators and the
RSO
[
(7)
Individuals who shall be prepared to respond to alarms
required by subsections
(i)(2) and (9), (k), (l), and (w)(2)
[
(t)
[
(1)
The licensee shall have and follow written operating
, safety, and emergency
procedures for:
(A)
operation of the irradiator, including entering and leaving
the radiation room;
(B)
use of
individual monitoring devices
[
(C)
surveying the shielding of panoramic irradiators;
(D)
monitoring pool water for contamination while the water
is in the pool and before release of pool water to unrestricted areas;
(E)
leak testing of sources;
(F)
inspection and maintenance checks required by subsection
(x)
[
(G)
loading, unloading, and repositioning sources, if the operations
will be performed by the licensee; and
(H)
inspection of movable shielding required by subsection
(i)(8)
[
(2)
The licensee shall have and follow emergency
or abnormal event procedures, appropriate for the irradiator type, for:
(A)
sources stuck in the unshielded position;
(B)
personnel overexposures;
(C)
a radiation alarm from the product exit portal monitor
or pool monitor;
(D)
detection of leaking source, pool contamination, or alarm
caused by contamination of pool water;
(E)
a low or high water level indicator, an abnormal water
loss, or leakage from the source storage pool;
(F)
a prolonged loss of electrical power;
(G)
a fire alarm or explosion in the radiation room;
(H)
an alarm indicating unauthorized entry into the radiation
room, area around pool, or another alarmed area;
(I)
natural phenomena, including an earthquake, a tornado,
flooding, or other phenomena as appropriate for the geographical location
of the facility; and
(J)
the jamming of automatic conveyor systems.
(3)
The licensee may revise operating, safety, and
emergency procedures without agency approval only if all of the following
conditions are met:
(A)
the revisions do not reduce the safety of the facility;
(B)
the revisions are consistent with the outline or summary
of procedures including procedures for changes to operating, safety, and emergency
procedures submitted with the license application;
(C)
the revisions have been reviewed and approved by the radiation
safety officer;
and
(D)
the users or operators are instructed and tested on the
revised procedures before they are put into use
.
[
[
(4)
Changes to operating, safety,
and emergency procedures shall be submitted to the agency after the provisions
of paragraph (3) of this subsection are completed.
(u)
[
(1)
Irradiator operators shall wear either a film badge
,
[
(2)
Other individuals who enter the radiation room of
a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter.
For groups of visitors, only two people who enter the radiation room are required
to wear dosimeters. If pocket dosimeters are used to meet the requirements
of the paragraph, a check of their response to radiation shall be done at
least annually. Acceptable dosimeters shall read within plus or minus 30%
of the true radiation dose.
(v)
[
(1)
A radiation survey of the area outside the shielding of
the radiation room of a panoramic irradiator shall be conducted with the sources
in the exposed position before the facility starts to operate. A radiation
survey of the area above the pool of pool irradiators shall be conducted after
the sources are loaded but before the facility starts to operate. Additional
radiation surveys of the shielding shall be performed at intervals not to
exceed three years and before resuming operation after addition of new sources
or any modification to the radiation room shielding or structure that might
increase dose rates.
(2)
If the radiation levels specified in subsection
(j)
[
(3)
Portable radiation survey meters shall be calibrated
at least annually to an accuracy of plus or minus 20% for the gamma energy
of the sources in use. The calibration shall be done at two points on each
scale or, for digital instruments, at one point per decade over the range
that will be used. Portable radiation survey meters shall be of a type that
does not saturate and read zero at high radiation dose rates.
(4)
Water from the irradiator pool, other potentially
contaminated liquids, and sediments from pool vacuuming shall be monitored
for radioactive contamination before release to unrestricted areas. Radioactive
concentrations shall not exceed those specified in Table 2, Column 2 or Table
3 of §289.202(ggg)(2) of this title.
(5)
Before releasing resins for unrestricted use, they
shall be monitored in an area with a background level less than 0.05
mrem
[
(w)
[
(1)
Each dry-source-storage sealed source shall be tested for
leakage at intervals not to exceed six months using a leak test kit or method
approved by the agency, the commission, an agreement state, or a licensing
state. In the absence of a certificate from a transferor that a test has been
made within the six months before the transfer, the sealed source may not
be used until tested. The test shall be capable of detecting the presence
of 0.005 microcurie (200 becquerels) of radioactive material and shall be
performed by a person approved by the agency, the
NRC
[
(2)
For pool irradiators, sources may not be put into
the pool unless the licensee tests the sources for leaks or has a certificate
from a transferor that a leak test has been done within the six months before
the transfer. Water from the pool shall be checked for contamination each
day the irradiator operates. The check may be done either by using a radiation
monitor on a pool water circulating system or by analysis of a sample of pool
water. If a check for contamination is done by analysis of a sample of pool
water, the results of the analysis shall be available within 24 hours. If
the licensee uses a radiation monitor on a pool water circulating system,
the detection of above normal radiation levels shall activate an alarm. The
alarm set-point shall be set as low as practical, but high enough to avoid
false alarms. The licensee may reset the alarm set-point to a higher level
if necessary to operate the pool water purification system to clear up contamination
in the pool if specifically provided for in written emergency procedures.
(3)
If a leaking source is detected, the licensee shall
arrange to remove the leaking source from service and have it decontaminated,
repaired, or disposed of by an agency,
NRC
[
(x)
[
(1)
The licensee shall perform inspection and maintenance checks
that include, as a minimum, each of the following at the frequency specified
in the license or license application:
(A)
operability of each aspect of the access control system
required by subsection
(i)
[
(B)
functioning of the source position indicator required by
subsection
(m)(2)
[
(C)
operability of the radiation monitor for radioactive contamination
in pool water required by subsection
(w)(2)
[
(D)
operability of the over-pool radiation monitor at underwater
irradiators as required by subsection
(l)(2)
[
(E)
operability of the product exit monitor required by subsection
(l)(1)
[
(F)
operability of the emergency source return control required
by subsection
(m)(3)
[
(G)
leak-tightness of systems through which pool water circulates
(visual inspection);
(H)
operability of the heat and smoke detectors and extinguisher
system required by subsection
(k)
[
(I)
operability of the means of pool water replenishment required
by subsection
(n)(3)
[
(J)
operability of the indicators of high and low pool water
levels required by subsection
(n)(4)
[
(K)
operability of the intrusion alarm required by subsection
(i)(8)
[
(L)
functioning and wear of the system, mechanisms, and cables
used to raise and lower sources;
(M)
condition of the barrier to prevent products from hitting
the sources or source mechanism as required by subsection
(o)
[
(N)
amount of water added to the pool to determine if the pool
is leaking;
(O)
electrical wiring on required safety systems for radiation
damage; [
(P)
pool water conductivity measurements and analysis as required
by subsection
(y)(2)
[
(Q)
operability of automatic communications
systems used to alert individuals to alarms, emergencies, or abnormal event
conditions if required by subsection (z)(2)(A) of this section.
(2)
Malfunctions and defects found during inspection
and maintenance checks shall be repaired without undue delay. If repairs are
required, the irradiator shall not be operated unless alternative methods
are utilized to provide an equivalent level of safety until repairs are completed.
(y)
[
(1)
Pool water purification system shall be run sufficiently
to maintain the conductivity of the pool water below 20 microsiemens per centimeter
under normal circumstances. If pool water conductivity rises above 20 microsiemens
per centimeter, the licensee shall take prompt actions to lower the pool water
conductivity and shall take corrective actions to prevent future recurrences.
(2)
The licensee shall measure the pool water conductivity
frequently enough, but no less than weekly, to assure that the conductivity
remains below 20 microsiemens per centimeter. Conductivity meters shall be
calibrated at least annually.
(z)
[
(1)
Both an irradiator operator and at least one other individual,
who is trained on how to respond
to alarms in accordance with subsection
(s)(7) of this section
and is prepared to promptly render or summon
assistance [
[
[
(2)
At least one individual who
has received the training on how to respond to alarms described in subsection
(s)(7) of this section shall be available and prepared to promptly respond
to alarms, emergencies, or abnormal event conditions at any time a panoramic
irradiator is operating. If the individual is not onsite, the following requirements
shall be met.
(A)
Automatic means of communications shall
be provided from the irradiator control system to alert the individual to
alarms, emergencies, or abnormal event conditions. As a minimum, the automatic
communication system shall alert the individual to those emergency or abnormal
events listed in subsection (t)(2) of this section.
(B)
The irradiator control system must be
secured from unauthorized access at any time an irradiator operator is not
onsite. This security must include physically securing the key described in
subsection (m)(1) of this section to ensure the key is not removed from the
control console.
[
(3)
At an underwater irradiator, an irradiator operator
shall be present at the facility whenever the product is moved into or out
of the pool. Individuals who move the product into or out of the pool of an
underwater irradiator need not be qualified as irradiator operators; however,
they shall have received the training described in subsection
(s)(6)
and (7)
[
(aa)
[
(1)
Upon first entering the radiation room of a panoramic irradiator
after an irradiation, the irradiator operator shall use a survey meter to
determine that the source has returned to its fully shielded position. The
operator shall check the functioning of the survey meter with a radiation
check source prior to entry.
(2)
Before exiting from and locking the door to the radiation
room of a panoramic irradiator prior to a planned irradiation, the irradiator
operator shall
do the following
:
(A)
visually inspect the entire radiation room to verify that
no one else is in it; and
(B)
activate a control in the radiation room that permits the
sources to be moved from the shielded position only if the door to the radiation
room is locked within a preset time after setting the control.
(3)
During a power failure, the area around the pool
of an underwater irradiator may not be entered without using an operable and
calibrated radiation survey meter unless the over-the-pool monitor required
by subsection
(l)(2)
[
(bb)
[
(1)
Irradiation of explosive material is prohibited unless
the licensee has received prior written authorization from the agency. Authorization
will not be granted unless the licensee can demonstrate that detonation of
the explosive would not rupture the sealed sources, injure personnel, damage
safety systems, or cause radiation overexposures of personnel.
(2)
Irradiation of more than small quantities of flammable
material (flash point below 140 degrees Fahrenheit) is prohibited in panoramic
irradiators unless the licensee has received prior written authorization from
the agency. Authorization will not be granted unless the licensee can demonstrate
that a fire in the radiation room could be controlled without damage to sealed
sources or safety systems and without radiation overexposures of personnel.
(cc)
[
(1)
a
[
(2)
records of each individual's training, tests, and
safety reviews provided to meet the requirements of subsection
(s)(1)-(4),
(6), and (7)
[
(3)
records of the annual evaluations of the safety performance
of irradiator operators required by subsection
(s)(5)
[
(4)
a copy of the current operating, safety, and emergency
procedures required by subsection
(t)
[
(5)
film badge
,
[
(6)
records of radiation surveys required by subsection
(v)
[
(7)
records of radiation survey meter calibrations required
by subsection
(v)
[
(8)
records of the results of leak tests required by subsection
(w)(1)
[
(9)
records of inspection and maintenance checks required
by subsection
(x)
[
(10)
records of major malfunctions, significant defects,
operating difficulties or irregularities, and major operating problems that
involve required radiation safety equipment for three years after repairs
are completed;
(11)
records of the receipt, transfer and disposal, of
all licensed sealed sources as required by §289.201(d) and
§289.252(x)
and (cc)
[
(12)
records on the design checks required by subsection
(q)
[
(13)
records related to decommissioning of the irradiator
as required by
§289.252(gg)(7)
[
(dd)
[
(1)
In addition to the reporting requirements in other sections
of this title, the licensee shall report the following events if not reported
under other sections of this title:
(A)
source stuck in an unshielded position;
(B)
any fire or explosion in a radiation room;
(C)
damage to the source racks;
(D)
failure of the cable or drive mechanism used to move the
source racks;
(E)
inoperability of the access control system;
(F)
detection of radiation source by the product exit monitor;
(G)
detection of radioactive contamination attributable to
licensed radioactive material;
(H)
structural damage to the pool liner or walls;
(I)
abnormal water loss or leakage from the source storage
pool; and
(J)
pool water conductivity exceeding 100 microsiemens per
centimeter during normal operations.
(2)
The report shall include a telephone report within
24 hours as described in
§289.202(xx)(8)(A)
[
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State, on May 22, 2000.
TRD-200003527
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 2, 2000
For further information, please call: (512) 458-7236
Subchapter C. TEXAS ASBESTOS HEALTH PROTECTION
Subchapter E. REGISTRATION REGULATIONS
Scope and purpose.
]
(1)
]
has made application for
registration in accordance with this section and is using a radiation machine
] prior to receiving a certificate of registration is subject to the
requirements of this chapter.
(2)
] In addition to the requirements
of this section, all registrants are subject to the requirements of
§289.203 of this title (relating to Notices, Instructions, and Reports
to Workers; Inspections), §289.204 of this title (relating to Fees for
Certificates of Registration, Radioactive Material Licenses, Emergency Planning
and Implementation, and Other Regulatory Services), §289.205 of this
title (relating to Hearing and Enforcement Procedures), and §289.231
of this title (relating to General Provisions and Standards for Protection
Against Machine-Produced Radiation).
[
§289.112 of this title
(relating to Hearing and Enforcement Procedures), §289.114 of this title
(relating to Notices, Instructions, and Reports to Workers; Inspections), §289.201
of this title (relating to General Provisions), §289.202 of this title
(relating to Standards for Protection Against Radiation), and §289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory
Services). Registrants using radiation machines in industrial radiographic
operations are subject to the requirements of §289.115 of this title
(relating to Radiation Safety Requirements and Licensing and Registration
Procedures for Industrial Radiography); registrants using machines in the
healing arts and veterinary medicine are subject to the requirements of §289.227
of this title (relating to Use of Radiation Machines in the Healing Arts and
Veterinary Medicine); registrants using mammography x-ray equipment are subject
to the requirements of §289.230 of this title (relating to Certification
of Mammography Systems); registrants using analytical x-ray equipment are
subject to the requirements of §289.118 of this title (relating to Radiation
Safety Requirements for Analytical X-Ray Equipment); and registrants using
particle accelerators are subject to the requirements of §289.119 of
this title (relating to Radiation Safety Requirements for Particle Accelerators).
If an accelerator is used to produce radioactive materials, a license issued
in accordance with §289.252 of this title (relating to Licensing of Radioactive
Material) is required. Services listed in subsection (a)(3) of this section
may constitute the practice of medical physics and, therefore, require a license
from the Texas Board of Licensure for Professional Medical Physicists in accordance
with the Medical Physics Practice Act, Texas Civil Statutes, Article 4512n.
]
(3)
] For the purposes of this
section, radiation services shall include, but may not be limited to the following:
(i.e.,
installation, repair, or maintenance)
];
(4)
] For purposes of
this section, a practitioner of the healing arts is a person licensed to practice
healing arts by either the Texas State Board of Medical Examiners as a physician,
[
the Texas State Board of Dental Examiners,
] the Texas Board of
Chiropractic Examiners, or the Texas State Board of Podiatry Examiners.
(5)
]
Prohibition.
Exposure
of an individual for training, demonstration, or other non-healing arts purposes
is prohibited.
(b)
] Exemptions.
in place,
] 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.
subsection (e) of this section and subsection (i)
] of
this section to the extent that their personnel perform radiation services
only for the facility by whom they are employed.
(c)
] Application for registration.
(s)(1)
] of this section and carry
out the responsibilities of subsection
(w)(2)
[
(s)(2)
]
of this section.
,
] denied
.
[
, modified, or revoked.
]
§289.201(n)
] of this title.
(d)
] Application for registration
for human or veterinary use of radiation machines. In addition to the requirements
of subsection
(e)
[
(c)
] of this section, each applicant
shall comply with the following.
following the commencement
of the operation of
] the radiation machine, except for mobile services
that shall be registered in accordance with subsection
(i)
[
(g)
] of this section, [
clinical trial evaluations that shall be
registered in accordance with subsection (m)(2)(B) of this section,
]
and healing arts screening programs that shall be approved in accordance with
subsection
(j) of this section.
[
(f)(1) of §289.227 of
this title.
]
(3)
] The applicant shall be
qualified by reason of training and experience to use the radiation
machine
[
machine(s)
] for the purpose requested in accordance
with this section in such a manner as to minimize danger to
occupational
and
public health and safety.
(4)
] The applicant's proposed
equipment, facilities, and operating and safety procedures shall be adequate
to minimize danger to
occupational and
public health and safety.
(5)
] An application for healing
arts must be signed by a licensed practitioner and an application for veterinary
medicine must be signed by a licensed veterinarian. The signature of the administrator,
president, or chief executive officer will be accepted in lieu of a licensed
practitioner's signature if the facility
has more than one licensed practitioner
who may direct the operation of radiation machines.
[
is a licensed
hospital or a medical facility with more than ten radiation machines.
]
The application shall also be signed by the RSO if the RSO is someone other
than the licensed practitioner or licensed veterinarian.
(6)
] An application for accelerators
or therapeutic radiation machines
for human use must be signed by a
practitioner licensed by the Texas State Board of Medical Examiners. The signature
of the administrator, president, or chief executive officer will be accepted
in lieu of a licensed practitioner's signature if the facility
has more
than one licensed practitioner who may direct the operation of radiation machines.
[
is a licensed hospital or a medical facility with more than ten
radiation machines.
] The application shall also be signed by the RSO
if the RSO is someone other than the licensed practitioner. Each applicant
shall submit operating and safety procedures as described in
§289.229(h)(1)(D)
of this title and a description of the proposed facilities in accordance with
the following:
35.3 and 35.10 of Texas Regulations
for Control of Radiation (TRCR) Part 35 as adopted by reference in §289.119
of this title, and a description of the proposed facilities in accordance
with 35.7-35.9 and 35.12 of TRCR Part 35 as adopted by reference in §289.119
of this title.
]
(e)
] Application for registration
of radiation machine assembly,
installation,
calibration, or repair,
consultants, providers of equipment, and radiation services other than providers
of personnel monitoring service, agency-accepted training courses, and calibration
of survey and measurement instruments. In addition to the requirements of
subsection
(e)
[
(c)
] of this section, each applicant
shall comply with the following.
(a)(3)
] of this section shall apply for and receive a certificate of registration
from the agency before providing such service.
x-ray
] equipment, the qualifications listed in subsection
(w)(3)
[
(s)(3)
] of this section;
(s)(1)(A)
] of this section.
(e.g., kVp meters, voltmeters)
].
machine,
] records, etc. will be maintained for inspection. This
must be a street address, not a post office box number;
rules
] in this
section;
and
; and
]
(D)
a list of facilities where equipment will
be provided.
]
(f)
] Application for registration
for provider of personnel monitoring services. In addition to the requirements
of subsection
(e)
[
(c)
] of this section, each applicant
shall comply with the following.
(g)
] Application for registration
of mobile services used in the healing arts and veterinary medicine. In addition
to the requirements of subsections
(e) and (f)
[
(c) and (d)
] of this section or §289.230(f) of this title, as applicable,
each applicant shall apply for and receive authorization for mobile services
before beginning mobile service operation. The following shall be submitted
:
[
.
]
An
] established main location
where the
machine(s),
[
machine,
] records, etc. will
be maintained for inspection. This must be a street address, not a post office
box number
;
[
.
]
A
] sketch or description
of the normal configuration of each
radiation machine's
[
x-ray unit's
] use, including the operator's position and any ancillary
personnel's location during exposures. If a mobile van is used with a fixed
unit inside, furnish the floor plan indicating protective shielding and the
operator's location
; and
[
.
]
For
] mobile services used
in the healing arts,
a
current copy of the applicant's operating
and safety procedures regarding radiological practices for protection of patients,
operators, employees, and the general public.
(h)
]
Application for registration
of radiation machines for non-human use other than veterinary medicine.
[
Application for registration for use of radiation machines in industrial
radiography, analytical equipment, accelerators for non-human use, and academic
and/or research and development facilities.
] In addition to the requirements
of subsection
(e)
[
(c)
] of this section, each applicant
shall comply with the following.
(1)
Each person having analytical equipment
or radiation machines in an academic institution and/or research and development
facility, shall apply for registration with the agency within 30 days following
the commencement of the operation of the radiation machines.
]
(2)
Each person having an accelerator
for non-human use or a radiation machine used in industrial radiographic operations
shall apply for and receive a certificate of registration from the agency
before beginning use of the accelerator or radiation machine.
]
(3)
An application for industrial radiographic
operations, analytical x-ray, accelerators for non-human use and radiation
machines in academic institutions and/or research and development facilities
shall be signed by the applicant or registrant or a person duly authorized
to act for and on the applicant's or registrant's behalf. The application
shall also be signed by the RSO if the RSO is someone other than the applicant
or registrant.
]
(4)
Each applicant for industrial radiographic
operations shall submit the information required in 31.46 of TRCR Part 31
as adopted by reference in §289.115 of this title.
]
(5)
Each applicant for accelerators for
non-human use shall submit the following:
]
(A)
operating and safety procedures as described
in 35.3 and 35.10 of TRCR Part 35 as adopted by reference in §289.119
of this title; and
]
(B)
a description of the applicant's proposed
facilities in accordance with 35.7-35.9, and 35.12 of TRCR Part 35 as adopted
by reference in §289.119 of this title.
]
(i)
] Application for registration
of calibration of survey and measurement instruments. In addition to the requirements
of subsection
(e)
[
(c)
] of this section, each applicant
shall comply with the following.
(j)
] Application for registration
of agency-accepted training courses
specifically required by this chapter
. In addition to the requirements of subsection
(e)
[
(c)
] of this section, each applicant shall comply with the following.
(e.g., reference
books, texts, workbooks, physical facilities, etc.)
];
(k)
] Issuance of certificate of
registration.
part
]
as it deems appropriate or necessary in order to:
(l)
] Specific terms and conditions
of certificates of registration.
requirements
] and orders of the agency.
(m)
] Responsibilities of registrant.
machine(s)
] will be used;
radiation safety officer
];
units and units used for clinical trial evaluations.
]
units
]
may be used for up to 60 days without adding the
radiation machine
[
unit
] to an existing certificate of registration. [
The facility
is required to notify the agency in writing of the period of use.
] If
the use period will exceed 60 days, the facility will be required to add the
radiation machine
[
unit
] to their certificate of registration
and a fee will be assessed.
Radiation machines shall be registered in
accordance with subsection (f)(1) of this section.
(B)
Facilities who do not have existing certificates
of registration may not evaluate radiation machines unless an application
for a certificate of registration has been submitted to the agency along with
the appropriate fees prior to beginning use of the unit
].
(C)
No fees will be assessed for the operation
of loaner units or evaluation periods of 60 days or less unless the loaner
units or evaluation periods are in a facility described in subparagraph (B)
of this paragraph.
]
(e)
] of this section until
such person provides evidence of registration with the agency.
(A)
Each registrant shall notify the agency,
in writing, immediately following the filing of a voluntary or involuntary
petition for bankruptcy under any Chapters of Title 11 (Bankruptcy) of the
United States Code (11 USC) by or against:
]
(i)
a registrant;
]
(ii)
an entity (as that term is defined in
11 U.S.C. 101(14)) controlling a registrant or listing the certificate of
registration or registrant as property of the estate; or
]
(iii)
an affiliate (as that term is defined
in 11 U.S.C. 101(2)) of the registrant.
]
(B)
This notification must include:
]
(i)
the bankruptcy court in which the petition
for bankruptcy was filed; and
]
(ii)
the date of the filing of the petition.
]
(C)
A copy of the "petition for bankruptcy"
shall be submitted to the agency along with the written notification.
]
and/or transferor
] obligations
are as follows.
15
]
days of such action:
manufacturer
], model
number
, and control
panel serial number of each radiation machine; and
standards
]
(
Title
21
,
CFR
, §
1020.30(d)), shall
be submitted to the agency within 15 days following completion of the assembly.
Such report shall suffice in lieu of any other
assembly
report
submitted
by the assembler to the agency.
(n)
] Expiration of certificates
of registration.
(p)
] of this section, each certificate of registration that specifies
an expiration date expires at the end of the day on that date. Expiration
of the certificate of registration does not relieve the registrant of the
requirements of this chapter.
(p)
] of this section, as applicable, the registrant shall on or
before the expiration date specified in the certificate of registration:
x-ray units;
] and
(o)
] Termination of certificates
of registration. When a registrant decides to terminate all activities involving
radiation machines or services authorized under the certificate of registration,
the registrant shall notify the agency immediately and
do the following
:
x-ray units;
] and
(p)
] Renewal of certificate of
registration.
(c)(1)-(5)
]
of this section, [
and
] applicable paragraphs of subsections
(f)-(h) and (k)-(m)
[
(d)-(f)
] of this section [
and subsections
(h)-(j) of this section
], and §289.230(f) of this title
,
as applicable.
(q)
] Modification and revocation
of certificates of registration.
(3)
] Except in cases of willfulness
or those in which the
occupational and
public health, interest
or safety requires otherwise, no certificate of registration shall be modified,
suspended, or revoked unless, prior to 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 or achieve compliance with all lawful
requirements.
(r)
] Reciprocal recognition of
out-of-state certificates of registration.
the number(s) and type(s) of radiation machine(s);
]
the exact location(s) where the radiation machine(s)
is(are) to be used;
]
name(s)
] of the Texas licensed
practitioner
[
practitioner(s)
] if the machines are used to
irradiate human beings;
the name(s) and address(es) where
the machine user(s) can be reached while in the state.
]
machines are
] proposed to be brought
does not issue certificates of registration or equivalent documents, a certificate
of registration
shall
[
must
] be obtained from the agency
in accordance with the provisions of this section.
§289.204(e)(7)
] of this title;
subsection (c) of this
section and subsections (e)-(f) of this section and subsections (i)-(j) of
this section
] as applicable.
(s)
] Appendices.
:
]
healing
] arts facilities
shall have:
(-2-)
registration with the Texas State Board
of Dental Examiners performing radiologic procedures under a dentist's instruction
and direction or evidence of a valid certificate as a registered dental hygienist;
]
(-3-)
] registration with the
Texas State Board of Chiropractic Examiners performing radiologic procedures
under a chiropractor's instruction and direction; or
(-4-)
] registration with the
Texas State Board of Podiatry Examiners performing radiologic procedures under
a podiatrist's instruction and direction; and
(-5-)
] at least four years of
supervised use of radiation machines in the respective practitioners' specialty;
.
]
31.23 of TRCR Part 31 as adopted by reference in §289.115 of this
title.
]
radiation
safety officers for
] certificates of registration. Specific duties of
the RSO include, but are not limited to, the following:
personnel
]
monitoring devices are properly used by occupationally-exposed personnel,
that records are kept of the monitoring results, and that timely notifications
are made as required by
§289.203
[
§289.114
]
of this title;
maintenance,
and
] repair. All persons performing radiation machine assembly,
installation or
[
maintenance, and
] repair shall meet the
general requirements in subparagraph (A) of this paragraph and one or more
of the specialized requirements in subparagraph (B) of this paragraph.
maintenance, and
]
repair techniques) or an associate's degree in biomedical equipment repair;
Subchapter F. LICENSE REGULATIONS
Scope and purpose
]. This
section provides for exemptions to licensing requirements, general licensing
of radioactive material, and acknowledgement of general licenses.
§289.115 of this title (relating to Radiation Safety
Requirements and Licensing and Registration Procedures for Industrial Radiography), §289.127
of this title (relating to Licensing of Naturally Occurring Radioactive Material
(NORM)),
] §289.252 of this title (relating to Licensing of Radioactive
Material), [
or
] §289.254 of this title (relating to Licensing
of Radioactive Waste Processing and Storage Facilities),
§289.255
of this title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography), or §289.259 of this
title (relating to Licensing of Naturally Occurring Radioactive Material
(NORM)).
(b)
] Definitions. The following
terms when used in this chapter shall have the following meanings[
,
]
unless the text clearly indicates otherwise.
(c)
] Exemptions for source material.
milligrams
] of thorium;
ceramic tableware,
] provided that the glaze contains not more than 20%
by weight source material;
commission
] authorizing distribution by the licensee
in accordance with
Title
10
,
Code of Federal Regulations
(CFR)
,
Part 40;
paragraph (3) of this subsection
] do not
authorize the manufacture of any of the products described.
(d)
] Exemptions for radioactive
material other than source material.
commission
], any agreement state, or any licensing state, except in accordance
with a specific license issued in accordance with §289.252
(i)
[
(h)(1)
] of this title or the general license provided in §289.252
(ee)
[
(s)
] of this title.
(g)(1)(B)
] of this section is exempt from the requirements for a license set
forth in §289.252 of this title if that person possesses, uses, or transfers
such radioactive material.
commission
], any agreement state, or any
licensing state, except in accordance with a specific license issued by the
NRC
[
commission
] in accordance with
Title
10
,
CFR
, §
32.18 or by the agency in accordance with §289.252
(j)
[
(h)(2)
] of this title, which states that the radioactive
material may be transferred by the licensee to persons exempt in accordance
with this paragraph or the equivalent regulations of the
NRC
[
commission
], any agreement state, or any licensing state.
millicuries
] of tritium
per hand;
millicuries
] of tritium
per dial (bezels when used shall be considered as part of the dial);
microcuries
]
of promethium-147 per watch or 200 µCi [
microcuries
] of promethium-147
per any other timepiece;
microcuries
]
of promethium-147 per watch hand or 40
µCi
[
microcuries
] of promethium-147 per other timepiece hand;
microcuries
]
of promethium-147 per watch dial or 120
µCi
[
microcuries
] of promethium-147 per other timepiece dial (bezels when used shall
be considered as part of the dial);
ten
] centimeters
(cm)
from
any surface;
millirad
per hour
] at
1 cm
[
one centimeter
] from any surface;
and
millirad per hour
] at
10 cm
[
ten centimeters
]
from any surface; or
one microcurie
] of radium-226 per timepiece in timepieces, hands, or dials manufactured
or initially distributed prior to January 1, 1986;
millicuries
] of tritium or not more than 2
mCi
[
millicuries
] of promethium-147 installed in automobile locks.
The levels of radiation from each lock illuminator containing promethium-147
will not exceed
1 mrad/hr
[
one millirad per hour
] at
1 cm
[
one centimeter
] from any surface when measured through
50
mg/cm
2
[
milligrams per square
centimeter
] of absorber;
one millicurie
] of tritium per balance or not more
than 0.5
mCi
[
millicurie
] of tritium per balance part;
millicuries
] of tritium;
millicuries
] of tritium gas and other marine navigational
instruments containing not more than 250
mCi
[
millicuries
] of tritium gas;
millicuries
] of tritium per thermostat;
;
] provided that
each tube does not contain more than one of the following specified quantities
of radioactive material and that the levels of radiation from each electron
tube containing byproduct material do not exceed
1 mrad/hr
[
one millirad per hour
] at
1 cm
[
one centimeter
]
from any surface when measured through
7 mg/cm
2
[
seven milligrams per square centimeter
] of absorber[
:
] (For purposes of this clause, "electron tubes" include spark gap
tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave
tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any
other completely sealed tube designed to control electrical currents):
millicuries
] of tritium
per microwave receiver protector tube or
10 mCi
[
ten millicuries
] of tritium per any other electron tube;
one microcurie
]
of cobalt-60;
five microcuries
]
of nickel-63;
microcuries
]
of krypton-85;
five microcuries
]
of cesium-137; or
microcuries
]
of promethium-147;
microcurie
] of americium-241;
or
one microcurie
] of cobalt-60 per spark gap irradiator for
use in electrically ignited fuel oil burners having a firing rate of at least
3
[
three
] gallons per hour.
commission
] in accordance with
Title
10
,
CFR
, §
32.22, which authorizes the transfer of the product
to persons who are exempt from regulatory requirements. The exemption in this
subparagraph does not apply to tritium, krypton-85, or promethium-147 used
in products for frivolous purposes or in toys or adornments.
microcurie
] of radium-226.
commission
] in accordance with
Title
10
,
CFR
, §
32.26, or an agreement state
or a licensing state in accordance with §289.252
(k)
[
(h)(3)
] of this title; and
commission
], or shall have
been manufactured in accordance with the specifications contained in a specific
license issued by the agency or any agreement state to the manufacturer of
such resins in accordance with licensing requirements equivalent to those
in
Title
10
,
CFR
, §
32.16 and
§
32.17. This exemption does not authorize the manufacture of any resins
containing scandium-46.
(e)
] General licenses. In addition
to the requirements of this section, all general licenses, unless otherwise
specified, are subject to the requirements of
§289.201 of this title
(relating to General Provisions for Radioactive Material), §289.202(ww)
and (xx) of this title (relating to Standards for Protection Against Radiation
from Radioactive Material), §289.204 of this title (relating to Fees
for Certificates of Registration, Radioactive Material Licenses, Emergency
Planning and Implementation, and Other Regulatory Services), §289.205
of this title (relating to Hearing and Enforcement Procedures), and §289.257
of this title (relating to Packaging and Transportation of Radioactive Material)
[
§289.112 of this title (relating to Hearing and Enforcement
Procedures), §289.126 of this title (relating to Fees for Certificates
of Registration, Radioactive Material(s) Licenses, Emergency Planning and
Implementation, and Other Regulatory Services), and §289.201 of this
title (relating to General Provisions
] [
21.1201(a), (b), (c), and
(d) of Texas Regulations for Control of Radiation (TRCR) as adopted by reference
in §289.113 of this title (relating to Standards for Protection Against
Radiation), and §289.252(r) of this title
].
(f)
] General licenses for source
material.
Notwithstanding
] the provisions of subsection
(f)
[
(e)
] of this section, persons who mine, transport, and
transfer ores containing source material in accordance with this
section
[
part
] shall [
also
] comply with the provisions
of
§289.202(n), (ff), and (gg)
[
21.301, 21.1001, and
21.1003 of TRCR Part 21 as adopted by reference in §289.113
] of
this title.
(h)(12)
] of this
title or in accordance with a specific license issued to the manufacturer
by another agreement state or the
NRC
[
commission
] that
authorizes manufacture of the products or devices for distribution to persons
generally licensed by another agreement state or the
NRC
[
commission
].
(p)
] of this title. In the case where the transferee receives the depleted
uranium in accordance with the general license in this paragraph or equivalent
rule of the
NRC
[
commission
] or an agreement state,
the transferor shall furnish the transferee a copy of this paragraph;
commission
] in accordance
with
Title
10
,
CFR
,
Part 110.
§289.113 of this title (relating
to Standards for Protection Against Radiation) and §289.114 of this title
] with respect to the depleted uranium covered by that general license.
(g)
] General licenses for radioactive
material other than source material.
commission
] authorizing
distribution in accordance with this general license or its equivalent. A
general license is hereby issued to transfer, receive, acquire, possess, and
use radioactive material incorporated in the devices or equipment specified
in
the following
subparagraph (C) of this paragraph that have been
manufactured, tested, and labeled by the manufacturer in accordance with a
specific license issued to the manufacturer by the
NRC
[
commission
], an agreement state, or a licensing state authorizing distribution
in accordance with this general license or its equivalent.
In addition
to
[
Notwithstanding
] the provisions of subsection
(f)
[
(e)
] of this section, this general license is subject to
the provisions of subsection
(e)(1)(B)
[
(d)(1)(B)
] of
this section[
,
] and §289.252
(cc)
[
(p) and
(t)
] of this title
:
[
.
]
Static
] elimination devices
designed for use as static eliminators that contain, as a sealed source or
sources, radioactive material totaling not more than 500
µCi
[
microcuries
] of polonium-210 per device
;
[
. The
general license in this subparagraph does not authorize the manufacture of
devices containing radioactive material.
]
Ion
] generating tubes designed
for ionization of air that contain, as a sealed source or sources, radioactive
material totaling not more than 500
µCi
[
microcuries
] of polonium-210 per device or a total of not more than 50
mCi
[
millicuries
] of tritium per device
;
or [
.
]
Other
] devices designed and
manufactured for the purpose of producing light or an ionized atmosphere.
Any person who receives, possesses, uses, or transfers radioactive material
in a device in accordance with the general license in this subparagraph:
affixed to the device at the time of receipt, and bearing a statement
that removal of the label is prohibited, are maintained thereon, are clearly
visible and legible, and
]
The general licensee
shall comply
with all instructions and precautions provided by such labels;
microcuries
] of other beta and/or gamma emitting
material or
10 µCi
[
ten microcuries
] of alpha
emitting material and devices held in storage in the original shipping container
prior to initial installation need not be tested for any purpose; provided
that each source is tested for leakage within six months prior to being used
or transferred;
(h)(4)(C)
] of this title; or
commission
], an agreement state, or a licensing
state to perform such activities;
number,
] serial number of the device
,
[
and
] serial number of the sealed source,
and
show the dates of performance and the names of persons performing testing,
installation, servicing, and removal from location of installation, of the
radioactive material, its shielding or containment;
microcuries
] or more of removable radioactive contamination, shall
immediately suspend operation of the device until it has been repaired by
the manufacturer or other person holding a specific license from the agency,
the
NRC
[
commission
], an agreement state, or a licensing
state to repair such devices, or disposed of by transfer to a person authorized
by a specific license to receive the radioactive material contained in the
device and, within 30 days, furnish the agency with a report containing a
brief description of the event and the remedial action taken;
commission
], an agreement state, or a licensing state, whose specific
license authorizes the receipt of the device, and within 30 days after transfer
of a device to a specific licensee, shall furnish the agency with a report
containing identification of the device by manufacturer's name, model
and
[
number,
] serial number of the device
,
[
and
] serial number of the sealed source, and address of the person receiving
the device;
subparagraph (C)(iii)(II)
of this paragraph
] which shall be followed while performing the testing
and shall be maintained for inspection by the agency.
ten
] curies
(Ci)
of tritium or 300
mCi
[
millicuries
] of promethium-147; and
commission
], or each device has been manufactured or assembled in accordance
with the specifications contained in a specific license issued by the agency
or any agreement state to the manufacturer or assembler of such device in
accordance with licensing requirements equivalent to those in
Title
10
,
CFR
, §
32.53.
(D)
Notwithstanding the provisions of subsection
(e) of this section, the general license in subparagraph (A) of this paragraph
is subject to the provisions of §289.252(t) of this title.
]
Commission
] that authorizes that person to receive,
possess, use, and transfer radioactive material.
commission
] in accordance with
Title
10
,
CFR
, §
32.57 or
Title
10
,
CFR
, §
70.39 or that have been manufactured in accordance with the
authorizations contained in a specific license issued to the manufacturer
by the agency, any agreement state, or any licensing state, in accordance
with licensing requirements equivalent to those contained in 10 CFR
§
32.57 or 10 CFR
§
70.39.
Notwithstanding the provisions
of subsection (e) of this section, the general license provided in subparagraph
(A) of this paragraph is subject to the provisions of §289.252(t) of
this title. In addition, persons
] who receive, acquire, possess, use,
or transfer one or more calibration or reference sources in accordance with
these general licenses:
microcuries
]
each of americium-241, plutonium-238, plutonium-239, and radium-226 in such
sources;
Figure: 25 TAC §289.251(g)(4)(C)(ii)(I)
]
Figure: 25 TAC §289.251(g)(4)(C)(ii)(II)
]
commission
], an agreement state, or a licensing
state to receive the source;
microcuries
] of strontium-90 and each device has been manufactured or
imported in accordance with a specific license issued by the
NRC
[
commission
] or each device has been manufactured in accordance
with the authorizations contained in a specific license issued by the agency
or any agreement state to the manufacturer of such device in accordance with
licensing requirements equivalent to those in
Title
10
,
CFR
, §
32.61.
commission
] or an agreement state to manufacture or service such devices; or shall
dispose of the device by transfer to a person authorized by a specific license
from the agency, the
NRC
[
commission
], or an agreement
state; and
thereon
].
(D)
Notwithstanding the provisions of subsection
(e) of this section, the general license in subparagraph (A) of this paragraph
is subject to the provisions of §289.252(t) of this title.
]
(h)
] Intrastate transportation
of radioactive material.
thereto
], provided the transportation and storage is in accordance
with the applicable requirements of
§289.257 of this title
[
the regulations, appropriate to the mode of transport, of the United
States Department of Transportation (DOT)
] insofar as such
requirements
[
regulations
] relate to the loading and storage of packages,
placarding of the transporting vehicle, and incident reporting. Any notification
of incidents referred to in those requirements shall be filed with the agency
and the
United States Department of Transportation (DOT)
[
DOT
]. Persons who transport and store radioactive material in accordance
with the general license in this paragraph are exempt from the requirements
of
§289.202 and §289.203 of this title
[
§289.113
of this title and §289.114 of this title (relating to Notices, Instructions,
and Reports to Workers; Inspections)
].
of the regulations
],
appropriate to the mode of transport, of the DOT insofar as such
requirements
[
regulations
] relate to the loading and storage of packages,
placarding of the transporting vehicle, and incident reporting. Any notification
of incidents referred to in those requirements shall be filed with the agency
and the DOT.
(i)
] General license acknowledgements.
In addition to the requirements of this section, all general license acknowledgement
holders, unless otherwise specified, are subject to the requirements of §§
289.201, 289.202(ww) and (xx), 289.204, 289.205, and §289.257
[
289.112, and 289.126, of this title, and 21.1201(a), (b), (c), and (d), 21.1202(a),
(b), (c), and (d) of TRCR Part 21 as adopted by reference in §289.113
of this title, and §289.252(r)
] of this title.
(j)
] General license acknowledgements
for radioactive material other than source material.
(B), (C), (D), and (E)
] of
this paragraph, radioactive material, excluding special nuclear material,
contained in devices designed and manufactured for the purpose of detecting,
measuring, gauging or controlling thickness, density, level, interface location,
radiation, leakage, or qualitative or quantitative chemical composition.
(h)(4)
] of this title or in accordance with the authorizations
contained in a specific license issued by the
NRC
[
commission
], an agreement state, or a licensing state, which authorizes distribution
of devices to persons generally licensed by the
NRC
[
commission
], an agreement state, or a licensing state.
and
] reference sources,
electron capture detector cells,
ion mobility spectrometers, beta backscatter gauges, and static meters
issued in accordance with the general license in subparagraph (A) of this
paragraph, the general licensee shall file an application for an acknowledgement
on a form prescribed by the agency. The application shall be signed by the
individual duly authorized to act for or on behalf of the general licensee.
In filing the application for acknowledgement, the general licensee shall
furnish the following information and any other information specifically requested
by the agency.
TRC Form 12-2
].
affixed to the device at the time of receipt, and bearing a statement
that removal of the label is prohibited, are maintained thereon, are clearly
visible and legible, and
]
The general licensee
shall comply
with all instructions and precautions provided by such labels;
microcuries
] of other beta and/or gamma emitting
material or
10 µCi
[
ten microcuries
] of alpha
emitting material and devices held in storage in the original shipping container
prior to initial installation need not be tested for any purpose, provided
that each source is tested for leakage within six months prior to being used
or transferred;
(h)(4)(C)
] of this title; or
commission
], an agreement state, or a licensing
state to perform such activities;
number,
] serial number of the device
,
[
and
] serial number of the sealed source, and show the
dates of performance of and the names of persons performing testing, installation,
servicing, and removal from location of installation, of the radioactive material,
its shielding or containment;
.
]
microcuries
] or more of removable radioactive contamination, shall
immediately suspend operation of the device until it has been repaired by
the manufacturer or other person holding a specific license from the agency,
the
NRC
[
commission
], an agreement state, or a licensing
state to repair such devices, or disposed of by transfer to a person authorized
by a specific license to receive the radioactive material contained in the
device and, within 30 days, furnish the agency with a report containing a
brief description of the event and the remedial action taken
and in the
case of detection of 0.005 µCi or more removable radioactive material
or failure of or damage to a source likely to result in contamination of the
premises or the environs, a plan for ensuring that the premises and environs
are acceptable for unrestricted use. Under these circumstances, the requirements
in §289.202(eee) of this title may be applicable, as determined by the
agency on a case-by-case basis
;
(h)(4)
] of this title,
or an equivalent specific license issued by the
NRC
[
commission
], an agreement state, or a licensing state, whose specific license
authorizes the receipt of the device, or as otherwise authorized by the agency
in writing, and within 30 days after transfer of a device to a specific licensee,
shall furnish the agency
and agreement states
with a report containing
identification of the device by manufacturer's name, model
and
[
number,
] serial number of the device and serial number of the
sealed source, [
and
]
the name,
address
, and license
number
of the person receiving the device (except when the device is
temporarily transferred to the specific licensee for repair of the device)
, and the date of the transfer
; [
and
]
and
]
the
model
and serial
number
of
the
device transferred, the serial number of the sealed source
transferred, the name and address of the transferee, and the name
and
telephone number of the responsible individual identified by the transferee
in accordance with clause (xii) of this subparagraph to have knowledge of
and authority to take actions to ensure compliance with the appropriate agency
requirements
and/or position of an individual who may constitute a point
of contact between the agency and the transferee, or
stored
] in the original shipping container at its
intended location of use prior to initial use by the holder of a general license
acknowledgement
;
[
.
]
ten microcuries
] each for use in
in vitro
clinical or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or animals;
ten microcuries
] each for use in
in vitro
clinical or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or animals;
ten microcuries
] each for use in
in vitro
clinical or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or animals;
microcuries
] each for use in
in vitro
clinical or laboratory tests not involving internal or external
administration of radioactive material, or the radiation therefrom, to humans
or animals;
microcuries
] each for use in
in vitro
clinical or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or animals;
ten microcuries
] each for use in
in vitro
clinical or laboratory tests not involving internal or external
administration of radioactive material, or the radiation therefrom, to humans
or animals;
microcurie
] of iodine-129
and 0.005
µCi
[
microcurie
] of americium-241 each
for use in
in vitro
clinical or laboratory
tests not involving internal or external administration of radioactive material,
or the radiation therefrom, to humans or animals; or
ten microcuries
] each for use in
in vitro
clinical or laboratory tests not involving internal or external
administration of radioactive material, or the radiation therefrom, to humans
or animals.
TRC
Form 12-2
].
microcuries
].
21.904 of TRCR Part 21 as adopted by
reference in §289.113
] of this title until used.
commission
], any agreement state, or any licensing state,
nor transfer the radioactive material in any manner other than in the unopened,
labeled shipping container as received from the supplier.
21.1001 of TRCR Part 21 as adopted by reference in §289.113
] of this title.
in accordance with the general license in subparagraph (A) of this paragraph
] shall not receive, acquire, possess, or use radioactive material
in accordance with the general license in subparagraph (A) of this paragraph
:
(h)(8)
] of this title or in accordance
with the provisions of a specific license issued by the
NRC
[
commission
], any agreement state, or any licensing state that authorizes
the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3
(tritium), iron-59, selenium-75, cobalt-57, or mock iodine-125 to persons
holding general license acknowledgements in accordance with this paragraph
or its equivalent; and
"This radioactive material
shall be received, acquired, possessed, and used only by physicians, veterinarians,
clinical laboratories, or hospitals and only for in vitro clinical or laboratory
tests not involving internal or external administration of the material, or
the radiation therefrom, to human beings or animals. Its receipt, acquisition,
possession, use, and transfer are subject to the regulations and a general
license of the commission or of a state with which the commission has entered
into an agreement for the exercise of regulatory authority. __________ Name
of Manufacturer"; or
]
"This radioactive material
shall be received, acquired, possessed, and used only by physicians, veterinarians,
clinical laboratories, or hospitals and only for in vitro clinical or laboratory
tests not involving internal or external administration of the material, or
the radiation therefrom, to human beings or animals. Its receipt, acquisition,
possession, use, and transfer are subject to the rules and a general license
of a licensing state. __________ Name of Manufacturer."
]
(k)
] Issuance of general license
acknowledgements.
(l)
] Specific terms and conditions.
in accordance with
any Chapters of Title 11 (Bankruptcy) of the United States Code (11 U.S.C.)
by or against:
]
(A)
a holder of a general license acknowledgement;
]
(B)
an entity (as that term is defined in
11 U.S.C. 101(14)) controlling the holder of a general license acknowledgement
or listing the general license acknowledgement or the holder of the general
license acknowledgement as property of the estate; or
]
(C)
an affiliate, (as that term is defined
in 11 U.S.C. 101(2)) of the holder of a general license acknowledgement.
]
indicate
]:
(m)
]
Termination
[
Expiration and termination
] of general license acknowledgements.
(1)
Each general license acknowledgement expires
at the end of the day, in the month and year stated in the general license
acknowledgement.
]
(2)
] Each holder of a general
license acknowledgement shall notify the agency immediately, in writing, and
request termination of the general license acknowledgement when the holder
of the general license acknowledgement decides to terminate all activities
involving materials specified in the general license acknowledgement.
(3)
No less than 30 days before the expiration
date specified in a general license acknowledgement, the holder of the general
license acknowledgement shall submit an application for general license acknowledgement
renewal in accordance with subsection (n) of this section.
]
(4)
] Each holder of a general
license acknowledgement shall, no less than 30 days before vacating or relinquishing
possession of control of premises that have been used as a place of storage
or use of radioactive material as a result of general licensed activities,
notify the agency in writing of intent to vacate
and do the following:
[
.
]
(5)
If a holder of a general license
acknowledgement does not submit an application for renewal in accordance with
subsection (n) of this section, such person shall on or before the expiration
date specified in the general license acknowledgement:
]
(A)
terminate use of radioactive material;
and
]
(B)
dispose of radioactive material in accordance
with this section and/or 21.1001 of TRCR Part 21 as adopted by reference in §289.113
of this title.
]
(n)
Renewal of general license acknowledgements.
]
(1)
Applications for renewal of general license
acknowledgements shall be filed in accordance with subsection (j)(1)(C) or
(2)(B) of this section, as applicable.
]
(2)
If a holder of a general license
acknowledgement has properly filed a renewal application for the same activities
at least 30 days before the expiration of the existing general license acknowledgement
in accordance with this section, such existing general license acknowledgement
shall not expire until the application has been finally determined by the
agency.
]
(j)(1)(A)
] and (2)(A) of this section shall report in writing to the agency any
changes in information furnished by the holder of the general license acknowledgement.
The report shall be submitted within 30 days after the effective date of such
change.
(j)(1)(C)
] or (2)(B) of this section, as applicable, and shall specify the respects
in which the holder of a general license acknowledgement desires a general
license acknowledgement to be amended.
general licenses and
] general license acknowledgements.
The agency may
incorporate in the general license acknowledgement at the time of issuance
or thereafter by appropriate rule, regulation, or order, such additional requirements
and conditions with respect to the general license acknowledgement holder's
possession, use, and transfer of radioactive material as it deems appropriate
or necessary.
]
for
] any material false statement in the application
or any statement of fact required in accordance with provisions of the Act;
(B)
because of the Act;
]
(C)
] [
because of
] 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 general license acknowledgement on an original application;
or
(D)
] [
for
] violation
of, or failure to observe, any of the terms and conditions of the Act
, this chapter,
or of the general license acknowledgement
, or order
of the agency.
[
; or
]
(E)
or of any rule or order of the agency.
]
of willfulness or those
] in which the
occupational and
public health, interest,
or safety requires otherwise, no general license acknowledgement shall be
modified, suspended, or revoked unless, prior to the institution of proceedings
therefore, facts or conduct that may warrant such action shall have been called
to the attention of the holder of the general license acknowledgement in accordance
with
§289.205
[
§289.112
] of this title and
the holder of the general license acknowledgement
shall have been accorded
[
has
] an opportunity to demonstrate [
or achieve
]
compliance with all lawful requirements
in writing
.
and scope
]. This section establishes
radiation safety requirements for persons using sources of radiation for well
logging service operations, including radioactive markers, mineral exploration
and tracer studies. [
The requirements of this section are in addition
to, and not in substitution for, the requirements of §289.112 of this
title (relating to Hearing and Enforcement Procedures), §289.114 of this
title (relating to Notices, Instructions, and Reports to Workers; Inspections), §289.119
of this title (relating to Radiation Safety Requirements for Particle Accelerators), §289.122
of this title (relating to Registration of Radiation Machine Use and Services), §289.126
of this title (relating to Fees for Certificates of Registration, Radioactive
Material(s) Licenses, Emergency Planning and Implementation, and other Regulatory
Services), §289.201 of this title (relating to General Provisions), §289.202
of this title (relating to Standards for Protection Against Radiation), and §289.252
of this title (relating to Licensing of Radioactive Material). This section
applies to all licensees or registrants who use sources of radiation for well
logging service operations, radioactive markers, mineral exploration and tracer
studies.
]
(b)
] Definitions. The following
words and terms when used in this section shall have the following meaning
unless the context clearly indicates otherwise.
(3)
(4)
] Logging assistant (equipment
operator) -- Any individual who, under the personal supervision of a logging
supervisor, handles sealed sources or tracers that are not in logging tools
or shipping containers or who performs surveys required by subsection
(y)
[
(x)
] of this section.
(5)
] Logging supervisor (field
engineer) -- The individual who provides personal supervision of the
use
[
utilization
] of sources of radiation at temporary job
sites.
(6)
] Logging tool -- A device
used subsurface to perform well logging.
(7)
] Mineral logging -- Any
logging performed for the purpose of mineral exploration other than oil or
gas.
(8)
] Personal supervision
-- Guidance and instruction by the supervisor, who is physically present at
the job site and in such proximity that visual contact can be maintained and
immediate assistance given as required.
(9)
] Radiation safety officer
-- An individual named by the licensee or registrant
and listed on the
license or certificate of registration
who has a knowledge of, responsibility
for, and authority to enforce appropriate radiation protection rules, standards,
and practices on behalf of the licensee and/or registrant; and who meets the
requirements of subsection
(r)
[
(q)
] of this section.
(10)
] Radioactive marker --
Radioactive material placed subsurface or upon a structure intended for subsurface
use for the purpose of depth determination or direction orientation.
(11)
] Residential location
-- Any area where structures in which people lodge or live are located, and
the grounds on which these structures are located including, but not limited
to, houses, apartments, condominiums, and garages.
(12)
] Service company --
Any contracted or subcontracted company that is present at the temporary job
site, specifically, that company to which the licensee's equipment is connected
and that is exposed to radioactive material.
(13)
] Source holder -- A
housing or assembly into which a radioactive source is placed for the purpose
of facilitating the handling and use of the source.
(14)
] Storage container --
A container designed to provide radiation safety and security when sources
of radiation are being stored.
(15)
] Temporary job site
-- A location where well logging or tracer studies are performed other than
the specific location(s) listed on a license or certificate of registration.
(16)
] Tracer study -- The
release of a substance tagged with radioactive material for the purpose of
tracing the movement or position of the tagged substance in the wellbore,
at the wellhead, or adjacent formation.
(17)
] Transport container
-- A container that meets the
requirements
[
regulations
]
of the United States Department of Transportation (DOT) and is designed to
provide radiation safety and security when sources of radiation are being
transported.
(18)
] Uranium sinker bar
-- A weight containing depleted uranium used to aid in the descent of a logging
tool down toward the bottom of a wellbore.
(19)
] Wellbore -- A drilled
hole in which wireline service operations are performed.
(20)
] Well logging -- All
operations involving the lowering and raising of measuring devices or logging
tools (that may or may not contain sources of radiation) into wellbores or
cavities for the purpose of obtaining information about the well and/or adjacent
formations.
(21)
] Wireline -- An armored
steel cable containing one or more electrical conductors used to lower and
raise logging tools in the wellbore.
(22)
] Wireline service operation
-- Any mechanical service that is performed in the wellbore using devices
that are lowered into the well on a wireline for purposes of evaluation.
(c)
]
Prohibitions
[
Prohibition.
]
§289.202(o) and
(eee)
] of this title must be performed; and
§289.202(eee)
] of this title before release from the job site or release for unrestricted
use;
are
] contaminated with radioactive material,
it
[
they
] must be decontaminated in accordance with
§289.202(eee)
[
§289.202(ddd)
] of this title [
to the concentration
limits specified Table II, Column 2 in §289.202(ggg)(1) of this title,
with the units changed from microcuries per milliliter to microcuries per
gram before release for unrestricted use
]; and
A
] copy of the written agreement in accordance with paragraphs
(1) or (2) of this subsection [
shall be maintained
] for inspection
by the agency for a period of five years following completion of the well
logging service operation or tracer study.
(d)
] Limits on levels of radiation.
Sources of radiation shall be used, stored, and transported in such a manner
that the requirements of §289.202 of this title,
§289.231 of
this title,
and
§289.257
[
§289.252(t)
]
of this title
,
as applicable, are met.
(e)
] Storage precautions.
The
] container shall have a lock (or tamper seal for calibration sources)
to prevent unauthorized removal of, or exposure to, the source of radiation.
(x)(2)
] of this section.
(f)
] Transport precautions. Transport
containers shall be locked and physically secured to the transporting vehicle
to prevent shifting during transport, accidental loss, tampering, or unauthorized
removal.
(g)
] Radiation survey instruments.
radioactive material is
]
stored or used to make physical radiation surveys as required by this section
and by §289.202(p) or
§289.231(s),
of this title
, as applicable
. Instrumentation shall be capable of measuring 0.1 milliroentgen
per hour
(mR/hr) (1 microsievert per hour (µSv/hr))
through
at least 50
mR/hr (500 µSv/hr)
[
milliroentgens per hour
]. (Instrumentation capable of measuring 0.1 mR/hr
(1µSv/hr)
through 50 mR/hr
(500 µSv/hr)
may not be sufficient
to determine compliance with [
the regulations of the
] DOT
requirements
.)
field
station
] and temporary job site additional calibrated and operable radiation
survey instruments sensitive enough to detect the radioactive surface contamination
limits specified in §289.202(eee) of this title.
plus or
minus
] 20% of the true radiation level at each calibration point.
Calibration records shall be maintained
]
for a period of
three
[
five
] years from the date of
calibration for inspection by the agency.
(h)
] Leak testing of sealed sources.
Sealed sources
[
Sources of radioactive material
] shall be
tested for leakage and contamination in accordance with §289.201(g) of
this title.
The licensee shall maintain records
[
Records
]
of leak tests [
shall be maintained
] for
inspection by the
agency [
inspection
] for
three
[
five
]
years from the date of the leak test.
(i)
] Quarterly inventory. Each
licensee or registrant shall conduct a [
quarterly
] physical inventory
to account for all sources of radiation received or possessed at intervals
not to exceed three months.
The licensee or registrant shall make and
maintain records
[
Records
] of inventories [
shall be
maintained
] for
three
[
five
] years from the date
of the inventory for inspection by the agency and shall include:
(j)
] Utilization records.
Each licensee or registrant shall make and maintain utilization records. Utilization
records shall be maintained for three years from the date of the inventory
for inspection by the agency and shall include the following information for
each source of radiation:
[
Each licensee or registrant shall maintain
current records, that shall be kept available for inspection by the agency
for five years from the date of the recorded event, showing the following
information for each source of radiation:
]
(k)
] Design and performance criteria
for sealed sources used in well logging operations.
used
in well logging operations
] shall be certified at the time of manufacture
to meet the following minimum criteria.
Centigrade
] for 20 minutes, 600 degrees
Celsius
[
Centigrade
] for one hour, and then be subjected to a thermal
shock test with a temperature drop from 600 degrees
Celsius
[
Centigrade
] to 20 degrees
Celsius
[
Centigrade
]
within 15 seconds.
Hz
] to 500 Hz
with a peak amplitude
of five times the acceleration of gravity
[
at 5 g amplitude
]
for 30 minutes.
gram
] hammer
and pin, 0.3
cm
[
centimeter
] pin diameter, must be dropped
from a height of 1
m
[
meter
] onto the test source.
1.695 x 107 Pascal)
] without leakage.
five
] years after source disposal.
(l)
] Labeling.
(i.e., source, source holder, or logging tool)
] that
is transported as a separate piece of equipment.
After August 1, 1993, each
] transport container shall have attached to it a durable, legible,
and clearly visible label(s) that has, as a minimum, the licensee's name,
address, and telephone number, the radionuclide, its activity, and [
the
] assay date.
(m)
] Inspection and maintenance.
five
] years for inspection by the agency.
(n)
] Training requirements.
in
] a course recognized by [
the agency,
] another
agreement or licensing state, or the NRC,
including
at least 24
hours of formal training in the subjects outlined in subsection (bb)(1) of
this section;
rules
] contained
in this section and the applicable subsections of §§[
289.114,
] 289.201, 289.202,
289.203
, and 289.231
of this
title or their equivalent
, as applicable
;
289.114
,] 289.201, 289.202
, 289.203, and 289.231
of this title or their equivalent
, as applicable,
and the
licensee's or registrant's operating and emergency procedures;
(1), (2), and (3)
] of this subsection are met. Such records shall be
maintained for inspection by the agency
for three years after the employee
terminates employment with the licensee or registrant
[
until the
agency authorizes their disposal
].
(o)
] Operating
, safety,
and emergency procedures. The licensee or registrant shall maintain written
operating
, safety,
and emergency procedures that include descriptions
of and directions in at least the items listed in subsection (bb)(4) of this
section.
(p)
] Personnel monitoring.
§289.202(p) and (q)
] of this title
or §289.231(n)
and (s)(3) of this title, as applicable,
no licensee or registrant shall
permit any individual to act as a logging supervisor or logging assistant
unless that individual wears either a film badge
,
[
or
]
a thermoluminescent dosimeter (TLD)
, or an optically stimulated luminescence
device (OSL)
at all times during well logging service operations and/or
tracer studies utilizing sources of radiation. Each film badge
,
[
or
] TLD
, or OSL
shall be assigned to and worn by only
one individual. Film badges must be replaced at least monthly
. TLDs
and OSLs must be
[
and TLDs
] replaced at least quarterly.
After replacement, each film badge
,
[
or
] TLD
, or
OSL
must be returned to the supplier for processing within 14 calendar
days or as soon as practicable. In circumstances that make it impossible to
return each film badge
,
[
or
] TLD
, or OSL
within 14 calendar days, such circumstances must be documented and available
for review by the agency.
(q)
] Radiation safety officer.
(n)(1)
] of this section; and
specific
] duties of the RSO
include, but are not limited to, the following:
to
] establish and oversee operating
,
safety, and
[
,
] emergency, and as low as reasonably achievable
(ALARA) procedures, and to review them regularly to ensure that the procedures
are current and conform with this chapter;
to
] oversee and approve all phases of the
training program for well logging service operations and/or tracer studies
personnel so that appropriate and effective radiation protection practices
are taught;
to
] ensure that required radiation surveys
and leak tests are performed and documented in accordance with this chapter,
including any corrective measures when levels of radiation exceed established
limits;
to
] ensure that personnel monitoring is used
properly by occupationally-exposed personnel, that records are kept of the
monitoring results, and that timely notifications are made as required by
§289.203
[
§289.114
] of this title;
to
] investigate and report to the agency each
known or suspected case of radiation exposure to an individual or radiation
level detected in excess of limits established by this chapter and each theft
or loss of source(s) of radiation, to determine the cause, and to take steps
to prevent its recurrence;
to
] have a thorough knowledge of management
policies and administrative procedures of the licensee or registrant;
to
] assume control and have the authority
to institute corrective actions including shutdown of operations when necessary
in emergency situations or unsafe conditions;
to
] maintain records as required by this chapter
(see subsection (bb)(5) of this section);
to
] ensure the proper storing, labeling, transport,
and use of sources of radiation, storage, and/or transport containers;
to
] ensure that [
quarterly
] inventories
are performed in accordance with subsection
(j)
[
(i)
]
of this section; [
and
]
to
] ensure that personnel are complying with
this chapter, the conditions of the license or the registration, and the operating
, safety,
and emergency procedures of the licensee or registrant
; and
[
.
]
(r)
] Security. During each well
logging or tracer application, the logging supervisor or other [
designated
] employee
who is authorized by the specific licensee for that
activity,
is responsible for protecting against unautho rized and/or
unnecessary entry into a restricted area, as defined in
§289.201(b)
[
§289.201
] of this title,
or §289.231 of
this title, as applicable
.
(s)
] Handling tools. The licensee
shall provide and require the use of tools that will assure remote handling
of sealed sources other than low activity calibration sources.
(t)
] Tracer studies.
Protective gloves and other
appropriate
] protective clothing and equipment shall be used by all
personnel handling radioactive tracer material. Precautions shall be taken
to avoid ingestion or inhalation of radioactive material, and to avoid contamination
of field stations, temporary job sites, vehicles, associated equipment, and
clothing.
(u)
] Particle accelerators. No
licensee or registrant shall permit above-ground testing of particle accelerators
that results in the production of radiation except in areas or facilities
controlled or shielded to meet the requirements of §289.202(f) or (n)
of this title,
or §289.231(m) or (o) of this title,
as applicable.
(v)
] Radioactive markers. The licensee
may use radioactive markers in wells only if the individual markers contain
quantities of radioactive material not exceeding the quantities specified
in
§289.251(r)(2)
[
§289.251(q)(2)
] of this
title. The use of markers is subject only to the provisions of this subsection
and subsection
(j)
[
(i)
] of this section.
(w)
] Uranium sinker bars. The licensee
may use a depleted uranium sinker bar in well logging service operations only
if it is legibly impressed with the wording DANGER (or CAUTION), RADIOACTIVE-DEPLETED
URANIUM, NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY).
(x)
] Radiation surveys.
,
] for
neutron sources) shall be made and recorded for each area where radioactive
materials are stored.
,
]
for neutron sources) of the radiation levels in occupied positions and on
the exterior of each vehicle used to transport radioactive materials shall
be made and recorded. Such surveys (and calculations[
,
] for neutron
sources) shall include
all sources
[
each source
] of
radiation [
and combination of sources of radiation
] transported
in the vehicle.
meter
] shall be
performed
[
used
] to verify
that the logging tool is free of contamination.
Records
] of these surveys [
shall be maintained
]
for inspection by the agency for
three
[
two
] years after
completion of the survey.
(y)
]
Records/documents for
inspection by the agency.
[
Records and documents required at field
stations.
]
(1)
] Each licensee or registrant
maintaining
additional authorized use/storage locations
[
field stations
] from which well logging service operations are conducted
shall have
copies of
the [
following
]
records/documents
specified in subsection (bb)(5)(B)-(E) and (G)-(O) of this section that are
specific to the site
[
records and documents
] available at
each
site
[
station
] for inspection by the agency
.
[
:
]
(A)
(B)
(C)
(D)
(E)
(F)
(G)
(H)
(I)
(J)
(K)
(L)
(2)
] Records
/documents
required in accordance with paragraph
(2)
[
(1)(A)-(L)
] of this subsection shall be maintained in accordance with subsection
(bb)(5) of this section.
(z)
] [
Records and documents
required at temporary job sites.
] Each licensee or registrant conducting
well logging service operations at a temporary job site shall have
copies
of
the
records/documents specified in subsection (bb)(5)(B), (C),
(I), (K), (L), and (N) of this section
[
following records and documents
] available at that site for inspection by the agency
.
[
:
]
(1)
(2)
(3)
(4)
a copy
of the current leak test record for the source(s) in use; and
]
(6)
(A)
] monitor with a radiation survey
instrument (or logging tool adjusted to detect gamma emissions from source(s)
lost downhole), at the surface for the presence of radioactive contamination
during logging tool recovery (fishing) operations; and
(B)
] notify the agency immediately
by telephone and submit written notification within 30 days if radioactive
contamination is detected at the surface or if the source appears to be damaged.
rules
] regarding abandonment and an appropriate
method of abandonment, that shall include
the following
:
setting forth
] the following
information:
e.g.
],
a 7-inch square. Letter size of the word "CAUTION" should be approximately
twice the letter size of the rest of the information;
for example
[
e.g.
], 1/2 inch and 1/4 inch letter size, respectively; and
;
]
;
]
;
] or
personnel
]
monitoring
devices, including
[
equipment specifying
]
film badges,
TLDs
[
thermoluminescent dosimeters (TLDs)
],
OSLs,
and pocket dosimeters;
the requirements of
] pertinent federal and
state
requirements
[
regulations
];
(g)
]
of this section.
The following are time retention requirements for record keeping.
]
Figure: 25 TAC §289.253(bb)(5)
]
(a)
Purpose and scope.
]
(1)
This section contains requirements for
the issuance of a license authorizing the use of sealed sources containing
radioactive material in irradiators that irradiate objects or materials using
gamma radiation. This section also contains radiation safety requirements
for operating irradiators. In addition to the requirements of this section,
all licensees, unless otherwise specified, are subject to the requirements
of §289.112 of this title (relating to Hearing and Enforcement Procedures), §289.114
of this title (relating to Notices, Instructions, and Reports to Workers;
Inspections), §289.126 of this title (relating to Fees for Certificates
of Registration, Radioactive Material(s) Licenses, Emergency Planning and
Implementation, and other Regulatory Services), §289.201 of this title
(relating to General Provisions), §289.202 of this title (relating to
Standards for Protection of Radiation), and §289.252 of this title (relating
to Licensing of Radioactive Material). Nothing in this section relieves the
licensee from complying with other applicable federal, state and local regulations
governing the siting, zoning, land use, and building code requirements for
industrial facilities.
]
(2)
The requirements in this section
apply to panoramic irradiators that have either dry or wet storage of the
radioactive sealed sources and to underwater irradiators in which both the
source and the product being irradiated are underwater. Irradiators whose
dose rates exceed 500 rads (5 grays) per hour at 1 meter from the radioactive
sealed sources in air or in water, as applicable for the irradiator type,
are covered by this section.
]
(3)
The requirements in this section
do not apply to self-contained, dry-source- storage irradiators (those in
which both the source and the area subject to irradiation are contained within
a device and are not accessible by personnel), medical radiology or teletherapy,
radiography (the irradiation of materials for nondestructive testing purposes),
gauging, or open- field (agricultural) irradiations.
]
(b)
] Definitions. The following
words and terms, when used in these sections, shall have the following meanings,
unless the context clearly indicates otherwise.
(3)
] Irradiator - A facility
that uses radioactive sealed sources for the irradiation of objects or materials
and in which radiation
dose
[
doses
] rates exceeding
500 rads (5 grays) per hour exist at 1 meter (m) from the sealed radioactive
sources in air or water, as applicable for the irradiator type, but does not
include irradiators in which both the sealed source and the area subject to
irradiation are contained within a device and are not accessible to personnel.
(4)
] Irradiator operator -
An individual who has successfully completed the training and testing described
in subsection
(s)
[
(r)
] of this section and is authorized
by the terms of the license to operate the irradiator without a supervisor
who is
present
and
[
,
] who has completed the requirements
of subsection
(s)(1)-(3)
[
(r)(1)-(3)
] of this section.
(5)
] Panoramic dry-source-storage
irradiator - An irradiator in which the irradiations occur in air in areas
potentially accessible to personnel and in which the sources are stored in
shields made of solid materials. The term includes beam-type dry- source-storage
irradiators in which only a narrow beam of radiation is produced for performing
irradiations.
(6)
] Panoramic irradiator
- An irradiator in which the irradiations are done in air in areas potentially
accessible to personnel. The term includes beam- type irradiators.
(7)
] Panoramic wet-source-storage
irradiator - An irradiator in which the irradiations occur in air in areas
potentially accessible to personnel and in which the sources are stored under
water in a storage pool.
(8)
] Pool irradiator - Any
irradiator in which the sources are stored or used in a pool of water, including
panoramic wet-source-storage irradiators and underwater irradiators.
(9)
] Product conveyor system
- A system for moving the product to be irradiated to, from, and within the
area where irradiation takes place.
(10)
] Radiation room - A
shielded room in which irradiations take place. Underwater irradiators do
not have radiation rooms.
(11)
] Seismic area - Any
area where the probability of horizontal acceleration in rock of more than
0.3 times the acceleration of gravity in 250 years is greater than 10%, as
designated by the United States Geological Survey.
(12)
] Underwater irradiator
- An irradiator in which the sources always remain shielded
under water
[
underwater
] and humans do not have access to the sealed
sources or the space subject to irradiation without entering the pool.
(c)
] Application for a specific
license. Applications for specific licenses shall be filed in accordance with §289.252(d)
of this title.
(d)
] Specific licenses for irradiators.
regulations
] and
licensing requirements and the irradiator operating, safety, and emergency
procedures; and
(s)
] of this section that describes the radiation safety
aspects of the procedures.
radiation safety officer
].
(h)
]
of this section, the radiation monitors required by subsection
(l)
[
(k)
] of this section, the method of detecting leaking sources
required by subsection
(w)
[
(v)
] of this section, including
the sensitivity of the method, and a diagram of the facility that shows the
locations of all required interlocks and radiation monitors.
commission
], an agreement
state, or a licensing state to load or unload irradiator sources.
(w)
] of this section.
(e)
] Start of construction. The
applicant may not begin construction of a new irradiator prior to the submission
to the agency of both an application for a license for the irradiator and
the fee required by
§289.204
[
§289.126
] of
this title. As used in this section, the term "construction" includes the
construction of any portion of the permanent irradiator structure on the site
but does not include: engineering and design work; purchase of a site; site
surveys or soil testing; site preparation; site excavation; construction of
warehouse or auxiliary structures; and other similar tasks. Any construction
activities undertaken prior to the issuance of a license are entirely at the
risk of the applicant and have no bearing on the issuance of a license with
respect to the requirements of the Texas Radiation Control Act (Act), rules,
[
regulations,
] and orders issued under the Act.
(f)
] Applications for exemptions.
Any applications for a license or for amendment of a license authorizing use
of a teletherapy-type unit for irradiation of materials or objects may include
proposed alternatives for the requirements of this section. The agency will
approve the proposed alternatives if the applicant provides adequate rationale
for the proposed alternatives and demonstrates that they are likely to provide
an adequate level of safety for workers and the public.
(g)
] Performance criteria for sealed
sources.
(1)
] Sealed sources. Sealed
sources installed after August 1, 1996 shall
meet the following requirements
:
(2)-(7)
] of this subsection.
(2)
] Temperature. The
test source shall be held at -40 degrees Celsius for 20 minutes, 600 degrees
Celsius for
one
[
1
] hour, and then be subjected to thermal
shock test with a temperature drop from 600 degrees Celsius to 20 degrees
Celsius within 15 seconds.
(3)
] Pressure. The test source
shall be twice subjected for at least
five
[
5
] minutes
to an external pressure (absolute) of 2 million newtons per square meter.
(4)
] Impact. A 2-kilogram steel
weight, 2.5 centimeters in diameter, shall be dropped from a height of 1 meter
onto the test source.
(5)
] Vibration. The test source
shall be subjected three times for
ten
[
10
] minutes each
to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of
five times the acceleration of gravity. In addition, each test source shall
be vibrated for 30 minutes at each resonant frequency found.
(6)
] Puncture. A 50-gram weight
and pin, 0.3-centimeter pin diameter, shall be dropped from a height of 1
m
[
meter
] onto the test source.
(7)
] Bend. If the length of
the source is more than 15 times larger than the minimum cross-sectional dimension,
the test source shall be subjected to a force of 2,000 newtons at its center
equidistant from two support cylinders, the distance between which is 10 times
the minimum cross-sectional dimension of the source.
(h)
] Access control requirements
in addition to the requirements of §289.202(u) of this title.
(i)
] Shielding.
centimeters
].
Areas where the radiation dose rate exceeds 2
mrem
[
millirems
] (0.02
mSv
[
millisievert
]) per hour shall be
locked, roped off, or posted.
centimeters
] over the edge of the pool of a pool irradiator may not exceed 2
mrem
[
millirems
] (0.02
mSv
[
millisievert
]) per hour when the sources are in the fully shielded position.
meter
] from the shield of a dry-source-storage panoramic irradiator when
the source is shielded may not exceed 2
mrem
[
millirems
]
(0.02
mSv
[
millisievert
]) per hour and at 5
cm
[
centimeters
] from the shield may not exceed 20
mrem
[
millirems
] (0.2
mSv
[
millisievert
])
per hour.
(j)
] Fire protection.
(k)
] Radiation monitors.
(l)
] Control of source movement.
(m)
] Irradiator pools.
meter
] below the normal low water level that could allow water to drain
out of the pool. Pipes that have openings more than 0.5
m
[
meter
] below the normal low water level and that could act as siphons
shall have siphon breakers to prevent the siphoning of pool water.
millirems
] (0.02
mSv
[
millisievert
]) per hour.
(n)
] Source rack protection. If
the product to be irradiated moves on a product conveyor system, the source
rack and the mechanism that moves the rack shall be protected by a carrier
or guides to prevent products and product carriers from hitting or touching
the rack or mechanism.
(o)
] Power failures.
(p)
] Design requirements for irradiators.
The following are design
[
Design
] requirements for irradiators
that have construction beginning after August 1, 1996.
(i)
] of this section. If the irradiator will use more than 5 million
curies (2 x 10
17
becquerels) of activity, the
licensee shall evaluate the effects of heating of the shielding walls by the
irradiator sources.
(m)(2)
] of this section,
and that metal components are metallurgically compatible with other components
in the pool.
(m)(5)
]
of this section. The system shall be designed so that water leaking from the
system does not drain to unrestricted areas without being monitored.
(k)(1)
] of this section. The licensee shall verify that
the product conveyor is designed to stop before a source on the product conveyor
would cause a radiation overexposure to any person. For pool irradiators,
if the licensee uses radiation monitors to detect contamination under subsection
(w)(2)
[
(v)(2)
] of this section, the licensee shall verify
that the design of radiation monitoring systems to detect pool contamination
includes sensitive detectors located close to where contamination is likely
to concentrate.
(h)
] of
this section.
(q)
] Construction monitoring and
acceptance testing requirements
. The following are construction monitoring
and acceptance testing requirements
to be met prior
to
loading
sources
in
[
for
] irradiators that have
begun
construction [
beginning
] after August 1, 1996.
(m)(2)
] of this
section.
(k)(1)
] of this section. For pool
irradiators, the licensee shall verify the proper operation of the radiation
monitors and the related alarm if used to meet subsection
(w)(2)
[
(v)(2)
] of this section. For underwater irradiators, the licensee
shall verify the proper operation of the over-the-pool monitor, alarms, and
interlocks required by subsection
(l)(2)
[
(k)(2)
] of
this section.
;
]
Testing
[
testing
] shall include source rack lowering due to simulated loss of power.
For all irradiators with product conveyor systems, the licensee shall observe
and test the operation of the conveyor system to assure that the requirements
in subsection
(o)
[
(n)
] of this section are met for
protection of the source rack and the mechanism that moves the rack
.
[
;
]
Testing
[
testing
] shall include
tests of any limit switches and interlocks used to protect the source rack
and mechanism that moves that rack from moving product carriers.
(r)
] Training.
personnel dosimeters
], other
radiation safety features of an irradiator, and the basic function of the
irradiator);
§289.114
] of this title that are relevant to the irradiator;
(s)
] of this section that the individual
is responsible for performing; and
regulations
], license conditions, and operating, safety,
and emergency procedures are followed. The licensee shall discuss the results
of the evaluation with the operator and shall instruct the operator on how
to correct any mistakes or deficiencies observed.
radiation safety officer
], shall
be instructed and tested in any precautions they should take to avoid radiation
exposure, any procedures or parts of procedures listed in subsection
(t)
[
(s)
] of this section that they are expected to perform
or comply with, and their proper response to alarms required in this section.
Tests may be oral.
(h)(2) and (9), (j), (k), and (v)(2)
] of this section shall be trained
and tested on how to respond. Each individual shall be retested at least once
a year. Tests may be oral.
(s)
] Operating, safety, and emergency
procedures.
personnel dosimeters
];
(w)
] of this section;
(h)(8)
] of this section, if applicable.
; and
]
(E)
changes to operating, safety, and emergency
procedures shall be submitted to the agency after subparagraphs (A)-(D) of
this paragraph are completed.
]
(t)
] Personnel monitoring.
or
] a thermoluminescent dosimeter (TLD)
, or optically
stimulated luminescence device (OSL)
while operating a panoramic irradiator
or while in the area around the pool of an underwater irradiator. The film
badge
,
[
or
] TLD
, or OSL
processor shall be
accredited by the National Voluntary Laboratory Accreditation Program for
high energy photons in the normal and accident dose ranges (see §289.202(p)(3)
of this title). Each film badge
,
[
or
] TLD
, or OSL
shall be assigned to and worn by only one individual. Film badges shall
be replaced at an interval not to exceed monthly and TLDs
or OSLs
shall be replaced at an interval not to exceed three months. After replacement,
each film badge
,
[
or
] TLD
, or OSL
shall be
returned to the supplier for processing within 14 calendar days of the exchange
date specified by the personnel monitoring supplier or as soon as practicable.
In circumstances that make it impossible to return each film badge
,
[
or
] TLD
, or OSL
within 14 calendar days, such circumstances
shall be documented and available for review by the agency.
(u)
] Radiation surveys.
(i)
] of this section are exceeded, the facility shall
be modified to comply with the requirements in subsection
(j)
[
(i)
] of this section.
millirem
] (0.5
µSv
[
microsievert
]) per hour. The resins may be released only if the survey does not
detect radiation levels above background radiation levels. The survey meter
used shall be capable of detecting radiation levels of 0.05
mrem
[
millirem
] (0.5
µSv
[
microsievert
])
per hour.
(v)
] Detection of leaking sources.
commission
], an agreement state, or a licensing state to perform the test.
commission
],
agreement state, or licensing state licensee who is authorized to perform
these functions. The licensee shall promptly check its personnel, equipment,
facilities, and irradiated product for radioactive contamination. No product
may be shipped until the product has been checked and found free of contamination.
If a product has been shipped that may have been inadvertently contaminated,
the licensee shall arrange to locate and survey that product for contamination.
If any personnel are found to be contaminated, decontamination shall be performed
promptly. If contaminated equipment, facilities, or products are found, the
licensee shall arrange to have them decontaminated or disposed of by an agency,
NRC
[
commission
], agreement state, or licensing state licensee
who is authorized to perform these functions. If a pool is contaminated, the
licensee shall arrange to clean the pool until the contamination levels do
not exceed the appropriate concentration in Table 2, Column 2 of §289.202(ggg)(2)
of this title. (See §289.202(xx)
and (yy)
of this title for
reporting requirements.)
(w)
] Inspection and maintenance.
(h)
] of this section;
(l)(2)
] of this section;
(v)(2)
]
of this section using a radiation check source, if applicable;
(k)(2)
]
of this section;
(k)(1)
] of this section;
(l)(3)
] of this section;
(j)
] of this section
(but without turning extinguishers on);
(m)(3)
] of this section;
(m)(4)
] of this
section;
(h)(8)
] of this section, if applicable;
(n)
] of this section;
and
]
(x)(2)
] of this section
;
and
[
.
]
(x)
] Pool water purity.
(y)
] Attendance during operation.
if the access control alarm sounds
], shall be present
onsite whenever
it is necessary to enter the radiation room.
[
the:
]
(A)
irradiator is operated using an automatic
product conveyor system; and
]
(B)
product is moved into or out of the radiation
room when the irradiator is operated in a batch mode.
]
(2)
At a panoramic irradiator at
which static irradiations (no movement of the product) are occurring, a person
who has received the training on how to respond to alarms described in subsection
(r)(7) of this section shall be onsite.
]
(r)(6) and (7)
] of this section. Static irradiations
may be performed without a person present at the facility.
(z)
] Entering and leaving the
radiation room.
(k)(2)
] of this section is operating
with backup power.
(aa)
] Irradiation of explosive
or flammable materials.
(bb)
]
Records/documents.
The licensee shall maintain the following records/documents at the irradiator
for the time intervals indicated for inspection by the agency:
[
Records to be kept at the irradiator and retention periods.
]
A
] copy of the license, license
conditions, documents incorporated into a license by reference, and amendments
to the license
[
thereto
] until superseded by new documents
or until the agency terminates the license;
(r)(1)-(4), (6) and (7)
] of this section until
three years after the individual terminates work;
(r)(5)
] of this section for three years after the evaluation;
(s)
] of this
section until superseded or the agency terminates the license. Records of
the
RSO
[
radiation safety officers
] review and approval
of changes in procedures as required by subsection
(t)(3)(C)
[
(s)(3)(C)
] of this section, retained for three years from the date of
the change;
and
] TLD
,
or OSL
results required by subsection
(u)
[
(t)
]
of this section until the agency terminates the license;
(u)
] of this section for three years from the date of
the survey;
(u)
] of this section and pool water
conductivity meter calibrations required by subsection
(y)(2)
[
(x)(2)
] of this section until three years from the date of calibration;
(v)(1)
] of this section and the results of contamination
checks required by subsection
(w)(2)
[
(v)(2)
] of this
section for three years from the date of each test;
(w)
] of this section for three years;
§289.252(k) and (p)
] of this title;
(p)
] of this section and the construction control checks
as required by subsection
(r)
[
(q)
] of this section
until the license is terminated. The records shall be signed and dated. The
title or qualification of the person signing shall be included; and
§289.252(u)(7)
]
of this title.
(cc)
] Reports.
§289.252(r)(3)(A)
] of this title, and a written report within 30 days as described in
§289.202(xx)(8)(B)
[
§289.252(r)(3)(B)
] of this
title.
Chapter 295.
OCCUPATIONAL HEALTH