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 rule 3701:1-46-08 of the Administrative Code, will be approved if:
(A) The applicant satisfies the general requirements of rule 3701:1-40-15 of the Administrative Code;
(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 americium-241 or radium-226 in the source;
(2) Details of construction and design;
(3) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;
(4) Procedures for and results of prototype testing of sources, which are designed to contain more than one hundred eighty-five becquerels ( 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;
(5) Details of quality control procedures to be followed in manufacture of the source;
(6) Description of labeling to be affixed to the source or the storage container for the source;
(7) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the source.
(C) Each source will contain no more than one hundred eighty-five kilobecquerels (five microcuries) of americium-241 or radium-226.
(D) The director determines, with respect to any type of source containing more than one hundred eighty five-becquerels ( 0.005 microcurie) of americium-241, or radium-226 that:
(1) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 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 rule 3701:1-46-46 of the Administrative Code.