Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0235 - Requirements for License to Manufacture, or Initially Transfer Radioactive Material Contained in Devices Granted a General License Under OAR 333-102-0115

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An
			 application for a specific license to manufacture, or initially transfer
			 devices containing radioactive material, excluding special nuclear material, to
			 persons granted a general license by OAR 333-102-0115  or equivalent regulations
			 of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing
			 State will be approved if:
(a) The applicant
			 satisfies the general requirements of OAR 333-102-0200;
(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:
(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 percent of the annual limits specified in OAR
			 333-120-0100; 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 may receive an
			 external radiation dose or dose commitment in excess of the dose to the
			 appropriate organ as specified in Column IV of the table in  10 CFR Part 32.24 :
(i) Whole body, head and trunk, active
			 blood-forming organs, gonads, or lens of eye 150 mSv (15 rem);
(ii) Hands and forearms, feet and ankles,
			 localized areas of skin averaged over areas no larger than one square
			 centimeter two Sv (200 rem);
(iii)
			 Other organs 500 mSv (50 rem).
(c) Each device bears a durable, legible,
			 clearly visible label or labels approved by the Authority, 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 of 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
(C) The information called for in the
			 following statement in the same or substantially similar form:
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 U.S. Nuclear Regulatory Commission or of a State with
				which the U.S. Nuclear Regulatory Commission has entered into an agreement for
				the exercise of regulatory authority. This label must be maintained on the
				device in a legible condition. Removal of this label is prohibited.
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, the words, "Caution-Radioactive Material,"
			 the radiation symbol described in OAR 333-120-0400, and the name of the
			 manufacturer or initial distributor.
(E) Each device meeting the criteria of OAR
			 333-102-0115(9)(a), bears a permanent label, such as being embossed, etched,
			 stamped, or engraved, 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 OAR 333-120-0400.
(F)
			 The device has been registered in the Sealed Source and Device Registry