|(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 manufacture,
produce, 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) §289.255 of this title (relating to Radiation
Safety Requirements and Licensing and Registration Procedures for
(ii) §289.256 of this title (relating to Medical
and Veterinary Use of Radioactive Material);
(iii) §289.258 of this title (relating to Licensing
and Radiation Safety Requirements for Irradiators); and/or
(iv) §289.259 of this title (relating to Licensing
of Naturally Occurring Radioactive Material (NORM)); 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 manufactures, produces, receives,
possesses, uses, transfers, owns, or acquires radioactive materials
prior to receiving a license is subject to the requirements of this
(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 Materials);
(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 industrial radiographic operations
are subject to the requirements of §289.255 of this title.
(4) Licensees using radioactive material for medical
or veterinary use are subject to the requirements of §289.256
of this title.
(5) Licensees using sealed sources in irradiators are
subject to the requirements of §289.258 of this title.
(6) Licensees possessing or using naturally occurring
radioactive material are subject to the requirements of §289.259
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 conditions or 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 conditions or 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 the chief executive
officer or other individual delegated the authority to manage, direct,
or administer the licensee's activities.
(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
RC Form 252-1 (Business Information Form).
(6) Each applicant shall demonstrate to the agency
that the applicant is financially qualified to conduct the activity
requested for licensure, including any required decontamination, decommissioning,
reclamation, and disposal before the agency issues a license. Each
licensee shall demonstrate to the agency that it remains financially
qualified to conduct the licensed activity before a license is renewed.
Methods for demonstrating financial qualifications are specified in
subsection (jj)(8) of this section. The requirement for demonstration
of financial qualification is separate from the requirement specified
in subsection (gg) of this section for certain applicants or licensees
to provide financial assurance.
(7) If facility drawings submitted in conjunction with
the application for a license are prepared by a professional engineer
or engineering firm, those drawings shall be final and shall be signed,
sealed and dated in accordance with the requirements of the Texas
Board of Professional Engineers, Title 22, Texas Administrative Code
(TAC), Chapter 131.
(8) 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 agency 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, Chapter 2001.
(9) Except as provided in this paragraph, an application
for a specific license to use radioactive material in the form of
a sealed source or in a device that contains the sealed source shall:
(A) identify the source or device by manufacturer and
model number as registered in accordance with subsection (v) of this
section or with equivalent regulations of the United States Nuclear
Regulatory Commission (NRC) or any agreement state, or for a source
or a device containing radium-226 or accelerator-produced radioactive
material registered in accordance with subsection (v) of this section;
(B) contain the information specified in subsection
(v)(3) - (4) of this section.
(10) For sources or devices manufactured before October
23, 2012, that are not registered in accordance with subsection (v)
of this section or with equivalent regulations of the NRC or any agreement
state, and for which the applicant is unable to provide all categories
of information specified in subsection (v)(3) - (4) of this section,
the application shall include:
(A) all available information identified in subsection
(v)(3) - (4) of this section concerning the source, and, if applicable,
the device; and
(B) sufficient additional information to demonstrate
that there is reasonable assurance that the radiation safety properties
of the source or device are adequate to protect health and minimize
danger to life and property. Such information shall include:
(i) a description of the source or device;
(ii) a description of radiation safety features;
(iii) the intended use and associated operating experience;
(iv) the results of a recent leak test.
(11) For sealed sources and devices allowed to be distributed
without registration of safety information in accordance with subsection
(v)(8)(A) of this section, the applicant shall supply only the manufacturer,
model number, and radionuclide and quantity.
(12) If it is not feasible to identify each sealed
source and device individually, the applicant shall propose constraints
on the number and type of sealed sources and devices to be used and
the conditions under which they will be used, in lieu of identifying
each sealed source and device.
(13) Notwithstanding the provisions of §289.204(d)(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 (8) 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
(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 Title 1, TAC, Chapter 155, and the Formal Hearing Procedures, §§1.21,
1.23, 1.25, and 1.27 of this title.
(14) Applications for licenses may be denied for the
(A) any material false statement in the application
or any statement of fact required under provisions of the Texas Radiation
Control Act (Act);
(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;
(C) failure to clearly demonstrate how the requirements
in this chapter have been addressed.
(15) Action on a specific license application will
be considered abandoned if the applicant does not respond within 30
days from the date of a request for any information by the agency.
Abandonment of such actions does not provide an opportunity for a
hearing; however, the applicant retains the right to resubmit the
application in accordance with paragraphs (1) - (7) of this subsection.
(e) General requirements for the issuance of specific
licenses. A license application will be approved if the agency determines
(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, life, property, and the environment;
(2) the applicant's proposed equipment, facilities,
and procedures are adequate to minimize danger to occupational and
public health and safety, life, property, and the environment;
(3) the issuance of the license will not be inimical
to the health and safety of the public;
(4) the applicant satisfied 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 submitted adequate operating, safety,
and emergency procedures;
(8) the applicant's permanent facility is located in
Texas (if the applicant's permanent facility is not located in Texas,
reciprocal recognition shall be sought as required by subsection (ee)
of this section);