Current through Register Vol. 43, No. 52, December 26, 2024
(a) An application for a specific license to
manufacture or initially transfer calibration or reference sources containing
americium-241 or radium-226 for distribution to persons generally licensed
under K.A.R. 28-35-178e shall not be approved unless the following requirements
are met:
(1) The applicant shall satisfy the
general requirements of part 3 of these regulations.
(2) The applicant shall submit sufficient
information regarding each type of calibration or reference source pertinent to
evaluation of the potential radiation exposure, including the following:
(A) Chemical and physical form and maximum
quantity of americium-241 or radium-226 in the source;
(B) details of construction and
design;
(C) details of the method
of incorporation and binding of the americium-241 or radium-226 in the
source;
(D) procedures for and
results of prototype testing of sources that are designed to contain more than
0.005 microcurie of americium-241 or radium-226, to demonstrate that the
americium-241 or radium-226 contained in each source will not be released or be
removed from the source under normal conditions of use;
(E) details of quality control procedures to
be followed in manufacture of the source;
(F) description of labeling to be affixed to
the source or the storage container for the source; and
(G) any additional information, including
experimental studies and tests, required by the department to facilitate a
determination of the safety of the source.
(3) Each source shall contain no more than 5
microcuries of americium-241 or radium-226. With respect to any type of source
containing more than 0.005 microcurie of americium-241 or radium-226, it shall
be determined by the secretary that the method of incorporation and binding of
more than 0.005 microcuries of the americium-241 or radium-226 in the source
prevents the release or removal of americium-241 or radium-226 from the source
under normal conditions of use and handling of the source.
(4) The applicant shall subject at least five
prototypes of each source that is designed to contain more than 0.185
kilobecquerel (0.005 microcurie) of americium-241 or radium-226 to the
following tests:
(A) Initial measurement. The
quantity of radioactive material deposited on the source shall be measured by
direct counting of the source.
(B)
Weathering test. Each source shall be subjected to tests that adequately take
into account the individual, aggregate, and cumulative effects of environmental
conditions, including physical handling, moisture, and water immersion,
expected in service that could adversely affect the effective containment or
binding of americium-241 or radium-226. Each source shall be inspected for
evidence of physical damage and for loss of americium-241 or radium-226 after
each stage of testing, using methods of inspection adequate for determining
compliance with the criteria specified in subsection (b).
(C) Wet wipe test. The entire radioactive
surface of the source shall be wiped with filter paper moistened with water,
with the application of moderate finger pressure. Removal of radioactive
material from the source shall be determined by measuring the radioactivity on
the filter paper after the paper has dried or by direct measurement of the
radioactivity on the source following the wet wipe.
(D) Water soak test. The source shall be
immersed in water at room temperature for 24 consecutive hours. The source
shall then be removed from the water. Removal of radioactive material from the
source shall be determined by direct measurement of the radioactivity on the
source after the source has dried or by measuring the radioactivity in the
residue obtained by evaporation of the water in which the source was
immersed.
(E) Dry wipe test. A dry
wipe test shall be performed on each source containing more than 3.7
kilobecquerels (0.1 microcurie) of americium-241 or radium-226 before
transferring the source to a general licensee under K.A.R. 28-35-178e or under
equivalent regulations of an agreement state. The dry wipe test shall be
performed by wiping the entire radioactive surface of the source with a filter
paper with the application of moderate finger pressure. The radioactivity on
the filter paper shall be measured using a method capable of detecting 0.185
kilobecquerel (0.005 microcurie) of americium-241 or radium-226. If a source
has been shown to be leaking or losing more than 0.185 kilobecquerel (0.005
microcurie) of americium-241 or radium-226 by any of the methods described in
this subsection, the source shall be rejected and shall not be transferred to a
general licensee under K.A.R. 28-35-178e or equivalent regulations of an
agreement state.
(F) Observations.
Removal of more than 0.005 microcurie of radioactivity in any test prescribed
by paragraph (a)(4) shall be cause for rejection of the source design. Results
of prototype tests submitted to the nuclear regulatory commission shall be
given in terms of radioactivity in microcuries and percent of removal from the
total amount of radioactive material deposited on the source.
(6) Each source or storage
container for the source shall have a label affixed that contains sufficient
information about safe use and storage of the source and includes the following
or an equivalent statement:
The receipt, possession, use and transfer of this source, Model
_____, Serial No. _____, are subject to a general
license and the regulations of the United States Nuclear
Regulatory Commission or of a State with which the commission has entered into
an agreement for the exercise of regulatory authority. Do not remove this
label.
CAUTIONx20AC;x201D;RADIOACTIVE MATERIALx20AC;x201D;THIS SOURCE
CONTAINS AMERICIUM-241 (or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF
THIS SOURCE.
(Name of manufacturer or initial transferor)."
(b) Each person licensed under
this regulation shall perform a dry wipe test upon each source containing more
than 3.7 kilobecquerels (0.1 microcurie) of americium-241 or radium-226 before
transferring the source to a general licensee in accordance with K.A.R.
28-35-178e or equivalent regulations of an agreement state or the nuclear
regulatory commission. This test shall be performed by wiping the entire
radioactive surface of the source with a filter paper with the application of
moderate finger pressure.
The radioactivity on the paper shall be measured by using
radiation detection instrumentation capable of detecting 0.185 kilobecquerel
(0.005 microcurie) of americium-241 or radium-226. If this test discloses more
than 0.185 kilobecquerel (0.005 microcurie) of radioactive material or if there
is evidence of any physical damage, the source shall be deemed to be leaking or
losing americium-241 or radium-226 and shall not be transferred to a general
licensee in accordance with K.A.R. 28-35-178e or equivalent regulations of an
agreement state or the nuclear regulatory commission.
