3701:1-46-40 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.

An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under rule 3701:1-46-10 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 type of device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of strontium-90 in the device;

(2) Details of construction and design of the source of radiation and its shielding;

(3) Radiation profile of a prototype device;

(4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;

(5) Details of quality control procedures to be followed in manufacture of the device;

(6) Description of labeling to be affixed to the device;

(7) Instructions for handling and installation of the device;

(8) 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 1.85 megabecquerels (fifty microcuries) of strontium-90 in an insoluble form;

(D) Each device will bear durable, legible labeling which includes the radiation symbol prescribed by paragraph (A) of rule 3701:1-38-18 of the Administrative Code, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;

(E) The director determines that:

(1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of five millisieverts ( 0.5 rem) in a year under ordinary circumstances of use;

(3) The device is so designed that it cannot be easily disassembled;

(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by rule 3701:1-46-47 of the Administrative Code; and

(5) Quality control procedures have been established to satisfy the requirements of rule 3701:1-46-41 of the Administrative Code.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08