Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part III - Licensing of Radioactive Material › Article 4 - Specific Licenses › Section 12VAC5-481-480 - Special requirements for a specific license to manufacture, assemble, repair, or distribute commodities, products, or devices that contain radioactive material

Current through Register Vol. 40, No. 24, July 15, 2024
A.
					 Reserved.
B. Licensing the
					 distribution of radioactive material in exempt quantities. (Authority to
					 transfer possession or control by the manufacturer, processor, or producer of
					 any equipment, device, commodity, or other product containing radioactive
					 material whose subsequent possession, use, transfer, and disposal by all other
					 persons are exempted from regulatory requirements may be obtained only from the
					 Nuclear Regulatory Commission, Washington, DC 20555-0001.)
C. Licensing the manufacture or initial
					 transfer of devices to persons generally licensed under
					 12VAC5-481-430
					 B.
1. An application for a specific license
					 to manufacture or initially transfer devices containing radioactive material,
					 excluding special nuclear material, to persons generally licensed under
					 12VAC5-481-430
					 B or equivalent regulations of the NRC, or another Agreement state will be
					 approved if:
a. The applicant satisfies the
					 general requirements of
					 12VAC5-481-450;
b. 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:
(1) The
					 device can be safely operated by persons not having training in radiological
					 protection;
(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 any period
					 of one calendar quarter a dose in excess of 10% of the limits specified in
					 12VAC5-481-640;
					 and
(3) 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
					 12VAC5-481-3580,
					 Column IV;
c. Each
					 device bears a durable, legible, clearly visible label or labels approved by
					 the agency, which contain in a clearly identified and separate statement:
(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)
					 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
(3) The information called for in one of the
					 following statements, as appropriate, in the same or substantially similar
					 form:
(a) 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 Nuclear
					 Regulatory Commission or a state with which the 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.
CAUTION-RADIOACTIVE MATERIAL
____________________Name of manufacturer or initial
						transferor
(b) 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 a licensing state. This label shall be maintained on the device
					 in a legible condition. Removal of this label is prohibited. (The model, serial
					 number, and name of the manufacturer or distributor 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;
d. 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, and the words, "Caution Radioactive
					 Material," the radiation symbol described in
					 12VAC5-481-850,
					 and the name of the manufacturer or initial distributor;
e. Each device meeting the criteria of
					 12VAC5-481-430
					 B 4 m bears a permanent (e.g., embossed, etched, stamped, or engraved) label
					 affixed to the source housing if separate, 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
					 12VAC5-481-850;
					 and
f. The device has been
					 registered in the Sealed Source and Device Registry.