Nebraska Administrative Code › Topic - HEALTH AND HUMAN SERVICES SYSTEM › Title 180 - CONTROL OF RADIATION › Chapter 3 - LICENSING OF RADIOACTIVE MATERIAL › Section 180-3-014 - SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR, OR DISTRIBUTE COMMODITIES, PRODUCTS, OR DEVICES WHICH CONTAIN RADIOACTIVE MATERIAL

Current through June 17, 2024
This section addresses special requirements for a specific license to
	 manufacture, assemble, repair, or distribute commodities, products, or devices
	 which contain radioactive material.
014.01
RESERVED.
014.02
TRANSFER TO EXEMPT
  PERSONS.
No person may introduce radioactive material into a
  product or material knowing or having reason to believe that it will be
  transferred to persons exempt under 180 NAC
  3.004.01 or equivalent regulation
  of an Agreement State or U.S. Nuclear Regulatory Commission (NRC), other than
  according to a license issued under
  10
  CFR 32.11.
014.03
LICENSING THE
  INCORPORATION OF NATURALLY OCCURRING ACCELERATOR-PRODUCED RADIOACTIVE MATERIAL
  INTO GAS AND AEROSOL DETECTORS.
An applicant for a specific
  license authorizing the incorporation of NARM into gas and aerosol detectors to
  be distributed to persons exempt under 180 NAC
  3-004.03(C) must
  satisfy the requirements of
  10
  CFR 32.26. The maximum quantity of radium-226
  in each device must not exceed
  3.7 kBq (
  0.1
									µCi).
014.04
LICENSING THE MANUFACTURE
  AND DISTRIBUTION OF DEVICES TO PERSONS GENERALLY LICENSED UNDER 180 NAC
  3-008.04.
The
  following is applicable to licensing the manufacture and distribution of
  devices to person generally licensed under 180 NAC
  3-008.04.
014.04(A)
APPLICATION.
An applicant for a specific license to
  manufacture or distribute devices containing radioactive material, excluding
  special nuclear material, to persons generally licensed under 180 NAC
  3-008.04 or equivalent regulations
  of the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State must:
(i) Satisfy the general requirements of 180
  NAC
  3-011;
(ii) Submit 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 one year a dose in excess of 10% of
  the annual limits specified in 180 NAC
  4-005.01; 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 following organ doses:
Whole body; head and trunk; active blood-forming organs;
				gonads; or lens of eye
150 millisievert (mSv) (15 rems)
Hands and forearms; feet and ankles; localized areas of skin
				averaged over areas no larger than 1 square centimeter
2 sievert (Sv) (200 rems)
Other organs
500 millisievert (mSv) (50 rems)
(iii) Label each device so that each device
  bears a durable, legible, clearly visible label or labels approved by the
  Department, 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 or off mechanism, or both, 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 the following statement, as appropriate in the same or substantially similar
  form:
The receipt, possession, use, and transfer of this device Model
	 _______, Serial No. ______9, are subject to a general license or the equivalent
	 and the regulations of the U.S. Nuclear Regulatory Commission (NRC) or a state
	 with which the U.S. Nuclear Regulatory Commission (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
The model, serial number, and name of manufacturer or distributor may
	 be omitted from this label provided the information is elsewhere specified and
	 labeling affixed to the device;
(iv) Label 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 180 NAC
  4-033.01, and the name of the
  manufacturer or initial distributor;
(v) Label each device meeting the criteria of
  180 NAC
  3-008.04, (C)(xiii)(1) so that it
  bears a permanent, 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 180 NAC
  4-033.01; and
(vi) Register the device in the Sealed Source
  and Device Registry.