| specified in their licenses; and
(i) the intended recipients are licensed in accordance
with subsection (h) of this section, §289.256(o) of this title,
or equivalent regulations of the NRC or any agreement state; or
(ii) the recipients are authorized for research and
development; or
(iii) the sources and devices are to be built to the
unique specifications of the particular recipient and contain no more
than 20 Ci (740 GBq) of tritium or 200 mCi (7.4 GBq) of any other
radionuclide.
(9) After the SS & D certificate of registration
is issued, the department may conduct an additional review as it determines
is necessary to ensure compliance with current regulatory standards.
In conducting its review, the department will complete its evaluation
in accordance with criteria specified in this section. The department
may request such additional information as it considers necessary
to conduct its review and the SS & D certificate of registration
holder shall provide the information as requested.
(10) Inactivation of SS & D certificate(s) of registration.
(A) An SS & D certificate of registration holder
who no longer manufactures or initially transfers any of the sealed
source(s) or device(s) covered by a particular SS & D certificate
of registration issued by the department shall request inactivation
of the SS & D certificate of registration. Such a request shall
be made to the department by an appropriate method in accordance with §289.201(k)
of this title and shall normally be made no later than 2 years after
initial distribution of all of the source(s) or device(s) covered
by the SS & D certificate of registration has ceased. However,
if the SS & D certificate of registration holder determines that
an initial transfer was in fact the last initial transfer more than
2 years after that transfer, the SS & D certificate of registration
holder shall request inactivation of the SS & D certificate of
registration within 90 days of this determination and briefly describe
the circumstances of the delay.
(B) If a distribution license is to be terminated in
accordance with subsection (y) of this section, the licensee shall
request inactivation of its SS & D certificate of registration(s)
associated with that distribution license before the department will
terminate the license. Such a request for inactivation of the SS &
D certificate(s) of registration shall indicate that the license is
being terminated and include the associated specific license number.
(C) A specific license to manufacture or initially
transfer a source or device covered only by an inactivated SS &
D certificate of registration no longer authorizes the licensee to
initially transfer such sources or devices for use. Servicing of devices
shall be in accordance with any conditions in the SS & D certificate
of registration, including in the case of an inactive SS & D certificate
of registration.
(w) Issuance of specific licenses.
(1) When the department determines that an application
meets the requirements of the Act and the rules of the department,
the department will issue a specific license authorizing the proposed
activity in such form and containing the conditions and limitations
as the department deems appropriate or necessary.
(2) The department 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 the department deems appropriate or necessary in order to:
(A) minimize danger to occupational and public health
and safety and 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.
(3) The department may request, and the licensee shall
provide, additional information after the license has been issued
to enable the department to determine whether the license should be
modified in accordance with subsection (dd) of this section.
(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 department.
(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 department 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 department, and shall give its consent in
writing.
(3) An application for transfer of license shall include:
(A) the identity, technical and financial qualifications
of the proposed transferee; and
(B) financial assurance for decommissioning information
required by subsection (gg) of this section.
(4) Each person licensed by the department in accordance
with this section shall confine use and possession of the radioactive
material licensed to the locations and purposes authorized in the
license. Radioactive material shall not be used or stored in residential
locations unless specifically authorized by the department.
(5) The licensee shall notify the department, in writing
within 15 calendar days, of any of the following changes:
(A) name;
(B) mailing address; or
(C) RSO.
(6) Each licensee shall notify the department, in writing,
immediately following the filing of a voluntary or involuntary petition
for bankruptcy by the licensee or its parent company, if the parent
company is involved in the bankruptcy.
(7) The notification in paragraph (6) of this subsection
shall include:
(A) the bankruptcy court in which the petition for
bankruptcy was filed; and
(B) the date of the filing of the petition.
(8) A copy of the petition for bankruptcy shall be
submitted to the department along with the written notification.
(9) In making a determination whether to grant, deny,
amend, renew, revoke, suspend, or restrict a license, the department
may consider the technical competence and compliance history of an
applicant or holder of a license. After an opportunity for a hearing,
the department may deny an application for a license, an amendment
to a license, or renewal of a license if the applicant's compliance
history reveals that three or more department actions have been issued
against the applicant, within the previous six years, that assess
administrative or civil penalties against the applicant, or that revoke
or suspend the license.
(10) Each licensee preparing technetium-99m radiopharmaceuticals
from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82
generators shall test the generator eluates for molybdenum-99 breakthrough
or strontium-82 and strontium-85 contamination, respectively, in accordance
with §289.256 of this title.
(A) The licensee shall make, maintain, and retain a
record of the results of each test for inspection by the department
in accordance with subsection (mm) of this section.
(B) The licensee shall report the results of any test
that exceeds the permissible concentration listed in §289.256(ii)
of this title at the time of generator elution, in accordance with §289.256(xxx)
of this title.
(11) Licensees shall not hold radioactive waste, sources,
or devices not authorized for disposal by decay in storage, and that
are not in use for longer than 24 months following the last principal
activity use. Sources and devices kept in standby for future use may
be excluded from the 24-month time limit if the department approves
a plan for future use. A plan for an alternative disposal timeframe
may be submitted by the licensee if the 24-month time limit cannot
be met. Licensees shall submit plans to the department at least 30
days before the end of the 24 months of nonuse.
(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) Expiration of the specific license does not relieve
the licensee of the requirements of this chapter.
Cont'd... |
