An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under rule 3701:1-46-07 of the Administrative Code, will be approved if:
(A) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;
(B) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:
(1) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;
(2) Details of construction and design;
(3) Details of the method of binding or containing the tritium or promethium-147;
(4) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;
(5) Any quality control procedures proposed as alternatives to those prescribed by rule 3701:1-46-35 of the Administrative Code; and
(6) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the device.
(C) Each device will contain no more than three hundred seventy gigabecquerels (ten curies) of tritium or 11.1 gigabecquerels (three hundred millicuries) of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed five microgray ( 0.5 millirad) per hour at ten centimeters from any surface when measured through fifty milligrams per square centimeter of absorber.
(D) The director determines that:
(1) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;
(2) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;
(3) The device is so designed that it cannot easily be disassembled; and
(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by rule 3701:1-46-45 of the Administrative Code.