| (iv) the results of a recent leak test.
(12) 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.
(13) 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.
(14) 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 (9) 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 percent 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.
(15) Applications for licenses may be denied for the
following reasons:
(A) any materially 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 department to refuse to grant a license on an application;
or
(C) failure to clearly demonstrate how the requirements
in this chapter have been addressed.
(16) 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 department.
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) - (8) of this subsection.
(e) General requirements for the issuance of specific
licenses. A license application will be approved if the department
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, 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);
(9) the owner of the property is aware that radioactive
material is stored or used on the property, if the proposed facility
is not owned by the applicant. The applicant shall provide a written
statement from the owner, or from the owner's agent, indicating such.
This paragraph does not apply to property owned or held by a government
entity or to property on which radioactive material is used under
an authorization for temporary job site use;
(10) there is no reason to deny the license as specified
in subsections (d)(15) or (x)(9) of this section; and
(11) the applicant shall have a current registration
with the Secretary of State to conduct business in the state, unless
the applicant is exempt. All applicants using an assumed name in their
application shall file an assumed name certificate as required under
the Texas Business and Commerce Code, Chapter 71.
(f) RSO.
(1) An RSO shall be designated for every license issued
by the department. A single individual may be designated as RSO for
more than one license if authorized by the department.
(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) Every licensee shall establish in writing the authority,
duties, and responsibilities of the RSO and ensure that the RSO is
provided sufficient authority, organizational freedom, time, resources,
and management prerogative to perform the specific duties of the RSO
which include 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 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 department 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 department 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 transport containers;
(K) to ensure that inventories are performed in accordance
with the activities for which the license application is submitted;
(L) to perform a physical inventory of the radioactive
sealed sources authorized for use on the license every 6 months and
make, maintain, and retain records of the inventory of the radioactive
sealed sources authorized for use on the license every six months,
to include the following:
(i) isotope(s);
(ii) quantity(ies);
Cont'd... |
