Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter D - GENERAL
Section 289.204 - Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services
Universal Citation: 25 TX Admin Code ยง 289.204
Current through Reg. 49, No. 38; September 20, 2024
(a) Purpose. The requirements in this section establish fees for licensing, registration, emergency planning and implementation, and other regulatory services, and provide for their payment.
(b) Scope. Except as otherwise specifically provided, the requirements in this section apply to any person who is the following:
(1) an applicant
for, or holder of:
(A) a radioactive material
license issued in accordance with §
289.252
of this title (relating to Licensing of Radioactive Material), or §
289.259
of this title (relating to Licensing of Naturally Occurring Radioactive
Material (NORM)); or
(B) a general
license acknowledgment issued in accordance with §
289.251
of this title (relating to Exemptions, General Licenses, and General License
Acknowledgments); or
(C) a
certificate of registration for radiation machines and/or services, or sources
of laser radiation, issued in accordance with §
289.226
of this title (relating to Registration of Radiation Machine Use and Services),
§
289.230
of this title (relating to Certification of Mammography Systems and Mammography
Machines Used for Interventional Breast Radiography), a certificate of
registration for dental radiation machines in accordance with §
289.232
of this title (relating to Radiation Control Regulations for Dental Radiation
Machines), a certificate of registration for radiation machines used in
veterinary medicine in accordance with §
289.233
of this title (relating to Radiation Control Regulations for Radiation Machines
Used in Veterinary Medicine), §
289.234
of this title (relating to Mammography Accreditation), or §
289.301
of this title (relating to Registration and Radiation Safety Requirements for
Lasers and Intense-Pulsed Light Devices); or
(2) the holder of a fixed nuclear facility
construction permit or operating license issued by the United States Nuclear
Regulatory Commission (NRC) in accordance with Title 10, Code of Federal
Regulations, Part 50; or
(3) the
operator of any other fixed nuclear facility.
(c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.
(1)
Contiguous properties--Those locations adjacent to an existing licensed or
permitted area.
(2) Decontamination
services--Providing deliberate operations to reduce or remove residual
radioactivity from equipment, facilities, and land owned, possessed, or
controlled by other persons to a level that permits release of equipment,
facilities, and land for unrestricted use and/or termination of a
license.
(3) Emergency planning and
implementation--The development and application of those capabilities necessary
for the protection of the public and the environment from the effects of an
accidental or uncontrolled release of radioactive materials, including the
equipping, training and periodic retraining of response personnel.
(4) Fixed nuclear facility--The following are
considered fixed nuclear facilities:
(A) any
nuclear reactor(s) at a single site;
(B) any facility designed or used for the
assembly or disassembly of nuclear weapons; or
(C) any other facility using special nuclear
material for which the agency conducts off-site environmental surveillance
and/or emergency planning and implementation to protect the public health and
safety or the environment.
(5) Limited manufacturer--A
manufacturer/distributor of radioactive material that is not required to submit
a decommissioning funding plan or an emergency plan in accordance with §
289.252
of this title.
(6) Processor of
radioactive material--A manufacturer/distributor who converts normal form
radioactive material into special form or a manufacturer/distributor of
radioactive sealed sources.
(d) Payment of fees.
(1) Each application for a specific license,
general license acknowledgement, or certificate of registration for which a fee
is prescribed in subsection (e), (g), or (j) of this section shall be
accompanied by a nonrefundable fee equal to the appropriate fee. Each request
for evaluation of a sealed source and/or device shall be accompanied by a
nonrefundable fee prescribed in subsection (f) of this section. Each
application for accreditation of a mammography facility shall be accompanied by
a nonrefundable fee prescribed in subsection (h) of this section. Each
application for an industrial radiographer certification and an industrial
radiographer examination shall be accompanied by a nonrefundable and
non-transferable fee prescribed in subsection (i) of this section.
(A) An application for a license covering
more than one category of specific license shall be accompanied by the
prescribed fee for the highest category and 25% of the applicable prescribed
fee for each additional requested category.
(B) An application for a certificate of
registration covering more than one category shall be accompanied by the
prescribed fee for the highest category.
(C) No application will be accepted for
filing or processed prior to payment of the full amount specified.
(2) A nonrefundable fee, in
accordance with subsection (e) of this section shall be paid for each
radioactive material license and/or for each general license acknowledgement.
The fee shall be paid every two years based on the month listed as the
expiration month on the license or general license acknowledgement and shall be
paid in full on or before the last day of the expiration month. In the case of
a single license that authorizes more than one category of use, the fee shall
be the prescribed fee for the highest license category plus 25% of the
applicable prescribed fee for each additional license category
authorized.
(3) A nonrefundable
fee, in accordance with subsection (j) of this section, shall be paid for each
certificate of registration for radiation machines and/or services, or sources
of laser radiation. The fee shall be paid every two years based on the month
listed as the expiration month on the certificate of registration and shall be
paid in full on or before the last day of the expiration month. For
certificates of registration with no specified expiration date, payment shall
be paid in full on or before the due date stated on the invoice.
(4) In the case of a single certificate of
registration that authorizes more than one category of machine/type of use, the
category listed in subsection (j) of this section and assigned the higher fee
will be used.
(5) An additional
nonrefundable fee equal to 5% of the total fee for each specific license shall
be paid with the specified fee by each holder of a specific license, excluding
licensees that are authorized only for diagnostic nuclear medicine.
(A) The fees collected by the agency in
accordance with this paragraph shall be deposited to the credit of the agency's
Radiation and Perpetual Care Account.
(B) The agency shall collect the fees in
accordance with this paragraph so long as the sum of the balances of the
perpetual care accounts specified under Health and Safety Code, §
401.307,
does not exceed $100 million; and if the sum of such balances subsequently is
reduced to $50 million or less, the agency shall reinstitute assessment of the
fee until the sum of such balances reaches $100 million.
(6) Each application for reciprocal
recognition of an out-of-state license in accordance with §
289.252(s)
of this title, an out-of-state registration in accordance with §
289.226
of this title, or an out-of-state laser registration in accordance with §
289.301
of this title, shall be accompanied by the applicable fee, provided that no
such fee has been submitted within 24 months of the date of commencement of the
proposed activity.
(7) Each holder
of a fixed nuclear facility construction permit or operating license or an
operator of any other fixed nuclear facility shall submit an annual fee for
services received. This fee shall recover for the State of Texas the actual
expenses arising from environmental surveillance and emergency planning and
implementation activities. Payment shall be made within 90 days following the
date of invoice.
(8) Fee payments
shall be in cash or by check or money order made payable to the Department of
State Health Services. The payments may be made by personal delivery to the
central office, Radiation Control, Department of State Health Services, 1100
West 49th Street, Austin, Texas, or mailed to Radiation Control, Department of
State Health Services, P.O. Box 149347, MC 2003, Austin, Texas,
78714-9347.
(9) Any applicant
requesting authorization for any of the categories in subsection (e) of this
section for veterinary use will be assessed the fee for the corresponding
category.
(e) Schedule of fees for radioactive material licenses. The following schedule contains the fees for radioactive material licenses:
(f) Fee for evaluation of a sealed source and/or device.
(1) Each time a manufacturer submits a
request for evaluation of a unique sealed source, one of the following fees
shall be paid:
(A) for an initial evaluation,
a fee of $5,320; or
(B) for an
amendment requiring re-evaluation, a fee of $2,660.
(2) Each time a manufacturer submits a
request for evaluation of a unique device, one of the following fees shall be
paid:
(A) for an initial evaluation, a fee of
$10,650; or
(B) for an amendment
requiring re-evaluation, a fee of $5,330.
(3) A manufacturer shall pay a $1,000 record
maintenance fee, beginning one year after initial sealed source and device
authorization listing and every two years thereafter.
(4) No request for evaluation will be
processed prior to payment of the full amount specified.
(g) Fees for certification of mammography systems and mammography machines used for interventional breast radiography. No application will be accepted for filing or processed prior to payment of the full amount specified in paragraph (1) of this subsection.
(1) An application for certification of
mammography systems shall be accompanied by a nonrefundable fee of $2,010.
Additional mammography systems that have not been assigned a separate United
States Food and Drug Administration (FDA) identification number shall be
authorized on the same certification. A nonrefundable fee of $240 for each
additional mammography system on the same certification shall be included in
the nonrefundable application fee.
(2) The annual fee for mammography systems is
$2,010. A fee of $240 for each additional mammography system on the same
certification shall be included in the annual fee.
(3) Fees for mammography machines used for
interventional breast radiography shall be as follows:
(A) An application for certification of
machines used for interventional breast radiography shall be accompanied by a
nonrefundable fee of $490. A nonrefundable fee of $240 for each machine used
for interventional breast radiography on the same certification shall be
included in the nonrefundable application fee.
(B) The annual fee for machines used for
interventional breast radiography is $490. A fee of $240 for each additional
machine used for interventional breast radiography on the same certification
shall be included in the annual fee.
(h) Fees for accreditation of mammography facilities.
(1) Each application for
accreditation or re-accreditation of a mammography facility shall be
accompanied by a nonrefundable fee. No application will be accepted for filing
or processed prior to payment of the full amount specified in paragraph (2) of
this subsection.
(2) Fees for
accreditation of mammography facilities are as follows.
(A) The accreditation fee for the first
mammography machine is $1,025.
(B)
The accreditation fee for each additional mammography machine is
$610.
(C) The fee for re-evaluation
of clinical images due to failure during the accreditation process is $330 per
mammography machine.
(D) The fee
for re-evaluation of phantom images due to failure during the accreditation
process is $300 per machine.
(E)
The fee for an additional mammography review will be based on the number of
clinical image sets reviewed and the type of review.
(F) The fee for reinstatement of a
mammography machine is $610.
(G)
Each facility for which a targeted clinical image review is required will be
charged for actual expenses to the agency arising from the visit.
(H) The fee for the review of clinical images
for dual modality mammography machines, if utilized, is $330 for the
alternative modality.
(I) Each
facility for which an on-site visit due to three denials of accreditation is
required will be charged for actual expenses to the agency arising from such
visit.
(J) Payment of the fees in
subparagraphs (G) and (I) of this paragraph shall be made within 60 days
following the date of invoice.
(i) Fees for industrial radiographer certification and for radiographer certification examinations.
(1) The nonrefundable and non-transferable
application fee for examination shall be $120 and shall be submitted to the
agency with the application for examination.
(2) The nonrefundable application fee for
radiographer certification shall be $110 and shall be submitted to the agency
with the application for radiographer certification.
(j) Schedule of fees for certificates of registration for radiation machines, lasers, and services. The following schedule contains the fees for certificates of registration for radiation machines, lasers, and services. As of January 1, 2012, the fees for the dental radiographic only category and the veterinary category, as specified in the following schedule, are the applicable fees for those categories.
(k) Annual fees for environmental surveillance and emergency planning and implementation. Fees shall be set annually by the agency for each facility. Fees for fixed nuclear facilities shall be the actual expenses for environmental surveillance and emergency planning and implementation activities. Costs of activities benefiting more than one facility shall be prorated.
(l) Failure to pay prescribed fees.
(1) In any case where the
agency finds that an applicant for a license or certificate of registration has
failed to pay the fee prescribed in this section, the agency will not process
that application until such fee is paid.
(2) In any case where the agency finds that a
licensee or registrant has failed to pay a fee prescribed by this section by
the due date, the agency may implement compliance procedures as provided in
§
289.205
of this title (relating to Hearing and Enforcement Procedures).
(3) In any case where the agency finds that a
fixed nuclear facility has failed to pay fees for environmental surveillance or
emergency planning and implementation within 90 days following date of invoice,
the agency may issue an order to show cause why those services should not be
terminated.
(m) Electronic fee payments. Renewal payments may be processed through texas.gov or another electronic payment system specified by the agency. For all types of electronic fee payments, the agency will collect additional fees, in amounts determined by texas.gov to recover costs associated with electronic payment processing.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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