Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 35 - RADIATION › Section 28-35-181j - Specific licenses to manufacture and distribute calibration sources containing americium-241 or radium-226

Current through Register
			 Vol. 43, No. 28, July 11, 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)."