Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Manufacture or initial transfer of certain calibration sources.
An application for a specific license to manufacture or
initially transfer calibration and reference sources containing plutonium for
distribution to persons generally licensed under part 4731.0555 shall be
approved if:
A. the applicant
satisfies the general requirements of part 4731.0575;
B. the applicant submits sufficient
information regarding each type of calibration or reference source pertinent to
evaluation of the potential radiation exposure, including:
(1) chemical and physical form and maximum
quantity of plutonium in the source;
(2) details of construction and
design;
(3) details of the method
of incorporation and binding of the plutonium in the source;
(4) procedures for and results of prototype
testing of sources that are designed to contain more than 0.005 microcurie of
plutonium to demonstrate that the plutonium contained in each source will not
be released or be removed from the source under normal conditions of
use;
(5) details of quality control
procedures to be followed in manufacture of the source;
(6) a description of labeling to be affixed
to the source or the storage container for the source; and
(7) any additional information, including
experimental studies and tests, required by the commissioner to facilitate a
determination of the safety of the source;
C. each source contains no more than five
microcuries of plutonium;
D. the
commissioner determines, with respect to any type of source containing more
than 0.005 microcurie of plutonium that:
(1)
the method of incorporation and binding of the plutonium in the source is such
that the plutonium will not be released or be removed from the source under
normal conditions of use and handling of the source; and
(2) the source has been subjected to and has
satisfactorily passed the prototype tests prescribed by item E; and
E. for any type of source that is
designed to contain more than 0.005 microcurie of plutonium, the applicant has
conducted prototype tests, in the order listed, on each of five prototypes of
such source, which contains more than 0.005 microcurie of plutonium, as
follows:
(1) an initial measurement. The
quantity of radioactive material deposited on the source must be measured by
direct counting of the source;
(2)
a dry wipe test. The entire radioactive surface of the source must be wiped
with filter paper with the application of moderate finger pressure. Removal of
radioactive material from the source must be determined by measuring the
radioactivity on the filter paper or by direct measurement of the radioactivity
on the source following the dry wipe;
(3) a wet wipe test. The entire radioactive
surface of the source must be wiped with filter paper, moistened with water,
with the application of moderate finger pressure. Removal of radioactive
material from the source must be determined by measuring the radioactivity on
the filter paper after it has dried or by direct measurement of the
radioactivity on the source following the wet wipe;
(4) a water soak test. The source must be
immersed in water at room temperature for a period of 24 consecutive hours. The
source must then be removed from the water. Removal of radioactive material
from the source must be determined by direct measurement of the radioactivity
on the source after it has dried or by measuring the radioactivity in the
residue obtained by evaporation of the water in which the source was
immersed;
(5) a dry wipe test. On
completion of the preceding tests under subitems (1) to (4), the dry wipe test
described in subitem (2) must be repeated; and
(6) observations. Removal of more than 0.005
microcurie of radioactivity in any test prescribed by this item is cause for
rejection of the source design. Results of prototype tests submitted to the
commissioner must be given in terms of radioactivity in microcuries and percent
of removal from the total amount of radioactive material deposited on the
source.
Subp.
2.
Labeling.
A person licensed under this part must affix to each source
or storage container for the source a label that:
A. contains sufficient information relative
to safe use and storage of the source; and
B. includes the following statement or a
substantially similar statement containing the information called for:
"The receipt, possession, use, and transfer of this source,
Model ..., Serial No. ..., are subject to a general license and the regulations
of the Minnesota Department of Health, the Nuclear Regulatory Commission, or a
state with which the Nuclear Regulatory Commission has entered into an
agreement for the exercise of regulatory authority. Do not remove this
label.
CAUTION -- RADIOACTIVE MATERIAL -- THIS SOURCE
CONTAINS
PLUTONIUM. DO NOT TOUCH RADIOACTIVE PORTION OF
THIS SOURCE.
(Name of manufacturer or initial transferor)".
Subp. 3.
Test
before transfer.
A person licensed under this part must perform a dry wipe
test upon each source containing more than 0.1 microcurie of plutonium before
transferring the source to a general licensee under part 4731.0555. The test
must 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 must be measured by using radiation detection
instrumentation capable of detecting 0.005 microcurie of plutonium. If the test
discloses more than 0.005 microcurie of radioactive material, the source is
deemed to be leaking or losing plutonium and must not be transferred to a
general licensee under part 4731.0555.
