008.04(C)
GENERAL REQUIREMENTS. Any person who owns, receives,
acquires, possesses, uses, or transfers radioactive material in a device
according to the general license in 180 NAC 3-008.04(A) must meet the following
requirements.
008.04(C)(i)
LABELS. Assure that all labels affixed to the device at the time
of receipt, and bearing a statement that removal of the label is prohibited,
are maintained thereon and comply with all instructions and precautions
provided by such labels.
008.04(C)(ii)
LEAK
TESTS. Assure that the device is tested for leakage of radioactive
material and proper operation of the on or off mechanism, or both, and
indicator, if any, at no longer than six-month intervals or at such other
intervals as are specified in the label, however,
(1) Devices containing only krypton need not
be tested for leakage of radioactive material, and
(2) Devices containing only tritium or not
more than 3.7 MBq (100 µCi) of other beta or gamma emitting material or
0.37 MBq (10 µCi) of alpha emitting material and devices held in storage
in the original shipping container prior to initial installation need not be
tested for any purpose.
008.04(C)(iii)
LEAK TEST
FREQUENCY. Assure that the tests required by 180 NAC
3-008.04(C)(ii) and other testing, installation, servicing, and removal from
installation involving the radioactive materials, its shielding or containment,
are performed:
(1) According to the
instructions provided by the labels; or
(2) By a person holding an applicable
specific license from the Department, the U.S. Nuclear Regulatory Commission
(NRC), or an Agreement State to perform such activities.
008.04(C)(iv)
RECORDS. Maintain records showing compliance with the
requirements of 180 NAC 3-008.04(C)(ii) and (C)(iii). The records must show the
results of the tests. The records also must show the dates of performance of,
and the names of persons performing, testing, installation, servicing, and
removal from installation concerning the radioactive material, its shielding or
containment. The licensee must retain these records as follows:
(1) Each record of tests for leakage of
radioactive material required by 180 NAC 3-008.04, (C)(ii) must be retained for
three years after the next required leak test is performed or until the sealed
source is transferred or disposed of;
(2) Each record of tests of the on or off
mechanism, or both, and indicator required by 180 NAC 3-008.04, (C)(ii) must be
retained for three years after the next required test of the on or off
mechanism, or both and indicator is performed or until the sealed source is
transferred or disposed of; and
(3)
Each record which is required by 180 NAC 3-008.04, (C)(iii) must be retained
for a period of three years from the date of the recorded event or until the
device is transferred or disposed of.
008.04(C)(v)
SUSPEND
OPERATION. Immediately suspend operation of the device if there is
a failure of, or damage to, or any indication of a possible failure of or
damage to, the shielding of the radioactive material or the on or off
mechanism, or both, or indicator, or upon the detection of 185 Bq (
0.005µCi) or more removable radioactive material. The device may not be
operated until it has been repaired by the manufacturer or other person holding
a specific license to repair such devices that was issued by this Department,
the U.S. Nuclear Regulatory Commission (NRC) or by an Agreement State. The
device and any radioactive material from the device may only be disposed of by
transfer to a person authorized by a specific license to receive the
radioactive material in the device or as otherwise approved by the Department,
the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State. A report
containing a brief description of the event and the remedial action taken; and,
in the case of detection of 185 Bq ( 0.005µCi) or more removable
radioactive material or failure of or damage to a source likely to result in
contamination of the premises or the environs, a plan for ensuring that the
premises and environs are acceptable for unrestricted use, must be furnished to
the Department within 30 days. Under these circumstances, the criteria set out
in 180 NAC
4-016, "Radiological Criteria for
Unrestricted Use," may be applicable, as determined by the Department on a
case-by-case basis.
008.04(C)(vi)
ABANDONMENT. Not abandon the device containing
radioactive material.
008.04(C)(vii)
EXPORT. Not export the device containing radioactive
material other than as specified in 10 CFR 110.
008.04(C)(viii)
TRANSFER OF
DEVICES CONTAINING RADIOACTIVE MATERIAL. Transfer or dispose of
devices only as follows.
008.04(C)(viii)(1)
EXPORT. Transfer or dispose of the device containing
radioactive material only by export as provided by 180 NAC 3-008.04(C)(vii) by
transfer to another general licensee as authorized in paragraph 180 NAC
3-008.04(C)(ix), or to a person authorized to receive the device by a specific
license issued under 180 NAC 3, or 180 NAC 12 that authorized waste collection,
or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) or an
Agreement State, or as otherwise approved under 180 NAC
3-008.04(C)(viii).
008.04(C)(viii)(2)
REPORT.
Furnish a report to the Department within 30 days after the
transfer of a device to a specific licensee or export. The report must contain:
(a) The identification of the device by
manufacturer's (or initial transferor's) name, model number, and serial
number;
(b) The name, address, and
license number of the person receiving the device (license number not
applicable if exported); and
(c)
The date of the transfer.
008.04(C)(viii)(3)
APPROVAL. Obtain written Department approval before
transferring the device to any other specific licensee not specifically
identified in 180 NAC 3-008.04(C)(viii)(1). However a holder of a specific
license may transfer a device for possession and use under its own specific
license without prior approval, if, the holder:
(a) Verifies that the specific license
authorizes the possession and use, or applies for and obtains an amendment to
the license authorizing the possession and use;
(b) Removes, alters, covers, or clearly and
unambiguously augments the existing label otherwise required by 180 NAC
3-008.04(C)(i) so that the device is labeled in compliance with 180 NAC
4-036; however the manufacturer, model
number, and serial number must be retained;
(c) Obtains the manufacturer's or initial
transferor's information concerning maintenance that would be applicable under
the specific license (such as leak testing procedures); and
(d) Reports the transfer under paragraph 180
NAC 3-008.04(C)(viii)(2).
008.04(C)(ix)
TRANSFER TO
ANOTHER GENERAL LICENSEE. Transfer the device to another general
licensee only if:
(1) The device remains in
use at a particular location. In such case the transferor must give the
transferee a copy of 180 NAC 3-008.01,
3-030,
4-057, and 4058, and any safety
documents identified in the label of the device. Within 30 days of the
transfer, the transferor must report to the Department:
(a) The manufacturer's or initial
transferor's name;
(b) The model
number and the serial number of the device transferred;
(c) The transferee's name and mailing address
for the location of use; and
(d)
The name, title, and phone number of the responsible individual identified by
the transferee according to 180 NAC 3-008.04, (C)(xii). to have knowledge of
and authority to take actions to ensure compliance with the appropriate
regulations and requirements; or
(2) The device is held in storage by an
intermediate person in the original shipping container at its intended location
of use prior to initial use by a general licensee.
008.04(C)(x)
INCIDENTS, THEFT OR
LOSS. Comply with the provisions of 180 NAC
4-057 and
4-058 for reporting radiation
incidents, theft, or loss of licensed material, but will be exempt from the
other reporting requirements of 180 NAC 4 and 10.
008.04(C)(xi)
RESPOND TO REQUESTS
FOR INFORMATION. Respond to written requests from the Department
to provide information relating to the general license within 30 calendar days
of the date of the request, or other time specified in the request. If the
general licensee cannot provide the requested information within the allotted
time, it must, within the same time period, request a longer period to supply
information by submitting a letter to the Radioactive Material Program Manager,
Nebraska Department of Health and Human Services, 301 Centennial Mall South,
P.O. Box 95026, Lincoln, NE 68509-5026 and provide written justification as to
why it cannot comply.
008.04(C)(xii)
NAME AN INDIVIDUAL
RESPONSIBLE. Appoint an individual responsible for having
knowledge of the appropriate regulations and requirements and the authority for
taking required actions to comply with appropriate regulations and
requirements. The general licensee, through this individual, must ensure the
day-today compliance with appropriate regulations and requirements. This
appointment does not relieve the general licensee of any of its responsibility
in this regard.
008.04(C)(xiii)
REGISTER GENERAL LICENSE DEVICES. General license
devices must be registered as follows.
008.04(C)(xiii)(1)
INITIAL
REGISTRATION. Register, according to 180 NAC 3-008.04(C)(xiii)(2)
and (3), devices containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (
0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 3.7 MBq ( 0.1 mCi) of
radium-226, or 37 MBq (1 mCi) of americium-241 or any other transuranic, based
on the activity indicated on the label. Each address for a location of use, as
described in 180 NAC 3-008.04(C)(xiii)(3)(d) represents a separate general
licensee and requires a separate registration and fee.
008.04(C)(xiii)(2)
ANNUAL
REGISTRATION. If in possession of a device meeting the criteria of
180 NAC 3-008.04, (C)(xiii)(1), must register these devices annually with the
Department and must pay the fee required by 180 NAC 18. Registration must be
done by verifying, correcting, or adding to the information provided in a
request for registration received from the Department. The registration
information must be submitted to the Department within 30 days of the date of
the request for registration or as otherwise indicated in the request. In
addition, a general licensee holding devices that meet the criteria of 180 NAC
3-008.04, (C)(xiii)(1) is subject to the bankruptcy notification requirement in
180 NAC 3-017.05.
008.04(C)(xiii)(3)
REQUIRED
INFORMATION. In registering devices, the general licensee must
furnish the following information and any other information specifically
requested by the Department:
(a) Name and
mailing address of the general licensee.
(b) Information about each device: the
manufacturer, or initial transferor, model number, serial number, the
radionuclide and activity (as indicated on the label).
(c) Name, title, and telephone number of the
responsible person designated as a representative of the general licensee in
180 NAC 3-008.04(C)(xii).
(d)
Address or location at which the device or devices are used or stored. For
portable devices, the address of the primary place of storage.
(e) Certification by the responsible
representative of the general licensee that the information concerning the
device or devices has been verified through a physical inventory and checking
of label information.
(f)
Certification by the responsible representative of the general licensee that
they are aware of the requirements of the general license.
008.04(C)(xiii)(4)
TEMPORARY
DEVICES. Persons generally licensed by an Agreement State or the
U.S. Nuclear Regulatory Commission (NRC), with respect to devices meeting the
criteria in paragraph 180 NAC 3-008.04, (C)(xiii)(1) are not subject to
registration requirements if the devices are used in areas subject to
Department jurisdiction for a period less than 180 days in any calendar year.
The Department will not request registration information from such
licensees.
008.04(C)(xiv)
REPORT CHANGES.
Report changes to the mailing address for the location of use
(including change in name of general licensee) to the Radioactive Materials
Program Manager, Nebraska Department of Health and Human Services, 301
Centennial Mall South, P.O. Box 95026, Lincoln, NE 68509-5026 within 30 days of
the effective date of the change. For a portable device, a report of address
change is only required for a change in the device's primary place of
storage.
008.04(C)(xv)
UNUSED DEVICES. Not hold unused devices for longer than 2 years.
If devices with shutters are not being used, the shutter must be locked in the
closed position. The testing required by 180 NAC 3-008.04, (C)(ii) need not be
performed during the period of storage only. However, when devices are put back
into service or transferred to another person, and have not been tested within
the required test interval, they must be tested for leakage before use or
transfer and the shutter tested before use. Devices kept in standby for future
use are excluded from the two-year time limit if the general licensee performs
quarterly physical inventories of these devices while they are in
standby.