Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-46 - General Licenses and Licenses for Manufacturing and Distribution › Section 3701:1-46-30 - Radioactive material contained in devices for use under rule 3701:1-46-05 of the Administrative Code; requirements for license to manufacture, or initially transfer

Current through all regulations passed and filed through July 1, 2024
(A) An application for a specific license to
			 manufacture, or initially transfer devices containing radioactive material to
			 persons generally licensed under rule
			 3701:1-46-05
			 of the Administrative Code or equivalent regulations of the United States
			 nuclear regulatory commission or an agreement state will be approved if:
(1) The applicant satisfies the general
			 requirements of rule
			 3701:1-40-15
			 of the Administrative Code;
(2)
			 The applicant submits sufficient information relating to the design,
			 manufacture, prototype testing, quality control, labels, proposed uses,
			 installation, servicing, leak testing, operating and safety instructions, and
			 potential hazards of the device to provide reasonable assurance that:
(a) The device can be safely operated by
			 persons not having training in radiological protection;
(b) Under ordinary conditions of handling,
			 storage, and use of the device, the radioactive material contained in the
			 device will not be released or inadvertently removed from the device, and it is
			 unlikely that any person will receive in one year a dose in excess of ten per
			 cent of the annual limits specified in paragraph (A) of rule
			 3701:1-38-12
			 of the Administrative Code; and
(c) Under accident conditions (such as fire
			 and explosion) associated with handling, storage and use of the device, it is
			 unlikely that any person would receive an external radiation dose or dose
			 commitment in excess of the dose to the appropriate organ as specified in the
			 appendix A to this rule.
(3) Each device bears a durable, legible,
			 clearly visible label or labels approved by the director which contain in a
			 clearly identified and separate statement:
(a) Instructions and precautions necessary to
			 assure safe installation, operation, and servicing of the device (documents
			 such as operating and service manuals may be identified in the label and used
			 to provide this information);
(b)
			 The requirements, or lack of requirement, for leak testing, or for testing any
			 on-off mechanism and indicator, including the maximum time interval for such
			 testing, and the identification of radioactive material by radionuclide,
			 quantity of radioactivity, and date of determination of the quantity; and
(c) The information called for in
			 the following statement in the same or substantially similar form. Devices
			 licensed by the United States nuclear regulatory commission prior to January
			 19, 1975, may bear labels authorized by the regulations in effect on January 1,
			 1975. The receipt, possession, use, and transfer of this device model, serial
			 no., are subject to a general license or the equivalent and the regulations of
			 the United States nuclear regulatory commission or a state with which the
			 United States nuclear regulatory commission has entered into an agreement for
			 the exercise of regulatory authority. This label shall be maintained on the
			 device in a legible condition. Removal of this label is prohibited. The model,
			 serial number, and the name of the manufacturer, or initial transferor may be
			 omitted from this label provided the information is elsewhere specified in
			 labeling affixed to the device.
"CAUTION-RADIOACTIVE MATERIAL"
(Name of manufacturer, or initial transferor)
Devices licensed by the United States nuclear regulatory
				commission prior to January 19, 1975, may bear labels authorized by the
				regulations in effect on January 1, 1975.
The model, serial number, and the name of the manufacturer, or
				initial transferor may be omitted from this label provided the information is
				elsewhere specified in labeling affixed to the device.
(4) Each device having a separable
			 source housing that provides the primary shielding for the source also bears,
			 on the source housing, a durable label containing the device model number and
			 serial number, the radionuclide and quantity, the words, "Caution: Radioactive
			 Material," the radiation symbol described in paragraph (A) of rule
			 3701:1-38-18
			 of the Administrative Code, and the name of the manufacturer or initial
			 distributor.
(5) Each device
			 meeting the criteria of paragraph (C)(13)(a) of rule
			 3701:1-46-05
			 of the Administrative Code, bears a permanent (e.g., embossed, etched, stamped,
			 or engraved) label affixed to the source housing if separable, or the device if
			 the source housing is not separable, that includes the words, "Caution:
			 Radioactive Material," and, if practicable, the radiation symbol described in
			 paragraph (A) of rule
			 3701:1-38-18
			 of the Administrative Code.