Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-235 - Radioactive materials - Specific licenses › FEES › Section 246-235-093 - Manufacture, assembly or distribution of devices under general license

Current through Register Vol. 24-14, July 15, 2024
(1) An application
				  for a specific license to manufacture or initially transfer or distribute
				  devices containing radioactive material, excluding special nuclear material, to
				  persons generally licensed under WAC
				  246-233-020
				  or equivalent regulations of the NRC or an agreement state will be approved if:
(a) The applicant satisfies the general
				  requirements of WAC
				  246-235-020;
(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:
(i) The
				  device can be safely operated by persons not having training in radiological
				  protection;
(ii) 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 percent of the limits specified in the table in WAC
				  246-221-010(1);
				  and
(iii) 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 following organ doses:
Whole body; head and trunk; active blood-forming organs;
					 gonads; or lens of eye. . . . 15 centigray (15 rem)
Hands and forearms; feet and ankles; localized areas of
					 skin averaged over areas no larger than one square centimeter .................
					 200 centigray (200 rem)
Other organs ................. 50 centigray (50 rem)
(c) Each device bears a
				  durable, legible, clearly visible label or labels approved by the department,
				  which contain in a clearly identified and separate statement:
(i) 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);
(ii) 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 nuclide, quantity of
				  radioactivity, and date of determination of the quantity; and
(iii) 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 ........ Name of manufacturer
				  or distributor, are subject to a general license or the equivalent, and the
				  regulations of the NRC or a state with which the NRC 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 distributor
(B) The receipt, possession, use and transfer
				  of this device, Model ....., Serial No ......... Name of manufacturer or
				  distributor, are subject to a general license or the equivalent, and the rules
				  of an agreement state. 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 distributor
(C) 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.
(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 nuclide and quantity, the words, "CAUTION -
				  RADIOACTIVE MATERIAL," the radiation symbol described in WAC
				  246-221-120,
				  and the name of the manufacturer or initial distributor;
(e) Each device meeting the criteria of WAC
				  246-233-020(3)(k),
				  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 WAC
				  246-221-120;
(f) The device has been registered in the
				  sealed source and device registry.