Current through Register Vol. 43, No. 52, December 26, 2024
An application for a specific license to manufacture and
distribute one or more of the devices specified in
K.A.R.
28-35-178b shall not be approved unless the
applicant meets the requirements of subsections (a) and (b) of this regulation
in addition to meeting all of the additional applicable requirements specified
in these regulations.
(a) Each
applicant shall submit information about 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 the following conditions are met:
(1) The device can be safely operated by
individuals not having training in radiological protection;
(2) 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 individual will receive a dose in excess of 10 percent of the
limits specified in
K.A.R.
28-35-212a; and
(3) under accident conditions, including fire
and explosion, associated with handling, storage, and use of the device, it is
unlikely that any individual will receive an external radiation dose or dose
commitment in excess of the following organ doses:
| (A) Whole body; head and trunk; active blood-forming
organs; gonads; or lens of eye |
15 rems |
| (B) Hands and forearms; feet and ankles; localized areas
of skin averaged over areas no larger than 1 square centimeter |
200 rems |
| (C) Other organs |
50 rems. |
(b)
(1)
Each device shall bear a durable, legible, clearly visible label or labels that
contain, in clearly identified and separate statements, the following
information:
(A) Instructions and precautions
necessary to ensure safe installation, operation, and servicing of the device.
Operating and service manuals may be identified in the label and used to
provide this information;
(B)
specification of whether or not leak testing or testing of any on-off mechanism
and indicator is required. The information shall include the maximum allowable
time intervals between tests and shall identify the radioactive material by
isotope, quantity of radioactivity, and date that the quantity was determined;
and
(C) the information required in
one of the following statements, as appropriate, in the same or a substantially
similar form:
(i) "The receipt, possession,
use, and transfer of this device, model_, serial no._, are subject to a general
license or the equivalent and the regulations of the U.S. nuclear regulatory
commission or a state with which the U.S. nuclear regulatory commission has
entered into an agreement for the exercise of regulatory authority. This label
shall be maintained on the device in a legible condition. Removal of this label
is prohibited.
CAUTION-RADIOACTIVE MATERIAL
(Name of manufacturer or distributor)"; or
(ii) "The receipt, possession, use, and
transfer of this device, model_, serial no._, are subject to a general license
or the equivalent, and the regulations of a licensing state. This label shall
be maintained on the device in a legible condition. Removal of this label is
prohibited.
CAUTION-RADIOACTIVE MATERIAL
(Name of manufacturer or
distributor)"
(2) The model, serial number, and name of the
manufacturer or distributor may be omitted from the requirements specified in
paragraphs (b)(1)(C)(i) and (ii) if the information is elsewhere specified in
labeling affixed to the device.
(3)
Each device having a separate source housing that provides the primary
shielding for the source shall also bear, on the source housing, a durable
label containing the device model number and serial number, the isotope and
quantity, the words "Caution - Radioactive Material," the radiation symbol
described in part 4 of these regulations, and the name of the manufacturer or
initial distributor.
(4) Each
device containing at least 370 Mbq (10 mCi) of cesium-137, 3.7 Mbq (0.1 mCi) of
strontium-90, 37 Mbq (1 mCi) of americium-241 or any other transuranic element
based on the activity indicated on the label shall meet the following criteria:
(A)
(i)
Bear a permanent label affixed to the source housing if the source housing is
separable, including the words "Caution - Radioactive Material"; or
(ii) bear a permanent label affixed to the
device if the source housing is not separable, including the words "Caution -
Radioactive Material"; and
(B) if practicable, bear the radiation symbol
described in part 4 of these regulations.
(c) If the device is 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 the performance
characteristics of the device or of similar devices and by design features that
have a significant bearing on the probability or consequences of leakage of
radioactive material from the device or failure of the on-off mechanism and
indicator. In determining the acceptable interval for the test for leakage of
radioactive material, the applicant shall address the following in the
application:
(1) The primary containment of
the source capsule;
(2) protection
of the primary containment;
(3) the
methods of sealing the primary containment;
(4) the containment construction
materials;
(5) the form of
contained radioactive material;
(6)
the maximum temperature withstood during prototype tests;
(7) the maximum pressure withstood during
prototype tests;
(8) the maximum
quantity of contained radioactive material;
(9) the radiotoxicity of contained
radioactive material; and
(10) any
prior operating experience with identical devices or similarly designed and
constructed devices.
(d)
If the general licensee under
K.A.R.
28-35-178b, or under equivalent regulations
of an agreement state, is authorized to install the device, collect the sample
to be analyzed by a specific licensee for leakage of radioactive material,
service the device, test the on-off mechanism and indicator, or remove the
device, the applicant shall include in the application the written instructions
to be followed by the general licensee, the estimated calendar-quarter doses
associated with each operation, and the bases for the estimates. The submitted
information shall demonstrate that performance of the specified operations by
an individual untrained in radiological protection, in addition to other
handling, storage, and use of devices under the general license, is unlikely to
cause that individual to receive a dose in excess of 10 percent of the annual
limits specified in part 4 of these regulations.
(e) Each device shall be listed on the
nuclear regulatory commission's sealed source and device registry.
