South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part II - LICENSING OF RADIOACTIVE MATERIAL › Section 61-63.II.RHA 2.7 - Special Requirements for Issuance of Certain Specific Licenses for Radioactive Materials

Current through Register Vol. 48, No. 6, June 28, 2024
2.7.1 Licensing the Manufacture and the
				Distribution of Devices to Persons Generally Licensed under RHA 2.4.2.
2.7.1.1 An application for a specific license to
				manufacture or distribute devices containing radioactive material, excluding special
				nuclear material, to persons generally licensed under RHA 2.4.2 or equivalent
				regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a
				Licensing State will be approved if:
2.7.1.1.1 the
				applicant satisfies the general requirements of
				RHA 2.6;
2.7.1.1.2 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:
2.7.1.1.2.1 the device can be safely
				operated by persons not having training in radiological protection;
2.7.1.1.2.2 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 10% of the annual
				limits specified in RHA 3.5.1; and
2.7.1.1.2.3 under accident conditions (such as
				fire and explosion) associated with handling, storage, and the use of the device, it
				is unlikely that any person would receive an external radiation dose or dose
				commitment in excess of the following organ doses: Whole body: 15 rems head and
				trunk; active bloodforming organs; gonads; or lens of eye: Hands and forearms; 200
				rems feet and ankles; localized areas of skin averaged over areas no larger than 1
				square centimeter. Other organs 50 rems.
2.7.1.1.3 Each device bears a durable, legible,
				clearly visible label or labels approved by the Department, which contain in a
				clearly identified and separate statement:
2.7.1.1.3.1 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);
2.7.1.1.3.2 the
				requirement, 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 isotope, quantity of radioactivity,
				and date of determination of the quantity; and
2.7.1.1.3.3 The information called for in the
				following statement in the same or substantially similar form:
Receipt, possession, use, and transfer of this device
				  Model3*, Serial No 
				  3*, containing (Identity and quantity of
				  radioactive material) are subject to a general license or the equivalent and the
				  regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a
				  Licensing State. This label shall be maintained on the device in a legible
				  condition. Removal of this label is prohibited.
CAUTION-RADIOACTIVE MATERIAL
_______________________________________________
(Name of manufacturer or initial
				  transferor)3*
2.7.1.1.4 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
				isotope and quantity, the words, "Caution-Radioactive Material," the radiation
				symbol described in RHA 3.21, and the name of the manufacturer or initial
				distributor.
2.7.1.1.5 Each device
				meeting the criteria of RHA 2.4.2.3.11.1 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 RHA 3.21.
2.7.1.1.6 The device has
				been registered in the Sealed Source and Device Registry.