Certain detecting, measuring, gauging or
controlling devices and certain devices for producing light or an ionized
atmosphere.
(c) Persons who own, acquire, receive,
possess, use or transfer radioactive material in a device pursuant to the
general license contained in subparagraph (a) of this paragraph:
1. Shall assure that all labels affixed to
the device at the time of receipt and bearing the statement that removal of the
label is prohibited are maintained thereon and shall comply with all
instructions and precautions provided by such labels;
6 Different general licenses are
issued in this rule, each of which has its own specific conditions and
requirements.
7 Persons possessing radioactive
material in devices under the general license in this paragraph before October
2, 1978, may continue to possess, use or transfer that material in accordance
with the requirements in the 1972 edition of the regulations.
2. Shall assure that the device is tested for
leakage of radioactive material and proper operation of the on-off mechanism
and indicator, if any, at no longer than 6 month intervals or at such other
intervals as are specified in the label; however,
(i) Devices containing only krypton need not
be tested for leakage of radioactive material; and
(ii) Devices containing only tritium or not
more than 100 microcuries of other beta and/or gamma emitting material or 10
microcuries 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.
3.
Shall assure that the tests required by part 2 of this subparagraph and other
testing, installation, servicing and removal from installation involving the
radioactive material, its shielding or containment, are performed:
(i) In accordance with the instructions
provided by the labels, or
(ii) By
a person holding an applicable specific license issued by the Division, the
U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to
perform such activities.
4. Shall maintain records showing compliance
with the requirements of parts 2 and 3 of this subparagraph. The records shall
show the results of tests. The records also shall show the dates of performance
of and the names of persons performing testing, installation, servicing and
removal from installation of the radioactive material, its shielding or
containment. The licensee shall retain these records as follows:
(i) Each record of a test for leakage or
radioactive material required by part 2 of this subparagraph shall be retained
for 3 years after the next required leak test is performed or until the sealed
source is transferred or disposed of;
(ii) Each record of a test of the on-off
mechanism and indicator required by part 2 of this subparagraph shall be
retained for 3 years after the next required test of the on-off mechanism and
indicator is performed or until the sealed source is transferred or disposed
of; and
(iii) Each record that is
required by part 3 of this subparagraph shall be retained for 3 years from the
date of the recorded event or until the sealed source is transferred or
disposed of.
5. Shall
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-off mechanism or indicator, or upon the
detection of 0.005 microcurie (185 becquerel) or more removable radioactive
material. The device may not be operated until it has been repaired by the
manufacturer or other person holding an applicable specific license issued by
the Division, the U.S. Nuclear Regulatory Commission, an Agreement State or a
Licensing State to repair such devices. The device and any radioactive material
from the device may only be disposed of by transfer to a person holding an
applicable specific license to receive the radioactive material contained in
the device or as otherwise approved by the Division. The licensee shall within
30 days furnish to the Division at the address in Rule
0400-20-04-.07 a report
containing a brief description of the event and the remedial action taken. In
the case of detection of 0.005 microcurie or more removable radioactive
material or failure of or damage to a source likely to result in contamination
of the premises or the environs, the licensee shall within 30 days submit to
the Division at the address in Rule
0400-20-04-.07 a plan for
ensuring that the premises and environs are acceptable for unrestricted use.
Under these circumstances, the criteria set out in paragraph (2) of Rule
0400-20-10-.36, "Radiological
criteria for unrestricted use," may be applicable, as determined by the
Division on a case-by-case basis;
6. Shall not abandon the device containing
radioactive material;
7. Shall not
export the device containing radioactive material except in accordance with 10
CFR
110;
8. Shall:
(i) Transfer or dispose of the device
containing radioactive material only by export as provided by part 7 of this
subparagraph, by transfer to another general licensee as authorized in part 9
of this subparagraph, or to a person authorized to receive the device by a
specific license issued by the Division under this Chapter or an equivalent
license issued by the U.S. Nuclear Regulatory Commission or an Agreement State,
or as otherwise approved under subpart (iii) of this part.
(ii) Shall within 30 days after the transfer
of a device to a specific licensee or export furnish a report to the Division.
The report shall contain:
(I) The
identification of the device by manufacturer's (or initial transferor's) name,
model number and serial number;
(II) The name, address and license number of
the person receiving the device (license number not applicable if exported);
and
(III) The date of the
transfer.
(iii) Shall
obtain written Division approval before transferring the device to any other
specific licensee not specifically identified in subpart (i) of this part.
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:
(I) 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;
(II) Removes, alters, covers, or clearly and
unambiguously augments the existing label (otherwise required by part 1 of this
subparagraph) so that the device is labeled in compliance with Rule
0400-20-05-.113; however the
manufacturer, model number, and serial number must be retained;
(III) Obtains manufacturer's or initial
transferor's information concerning maintenance that would be applicable under
the specific license (such as leak testing procedures); and
(IV) Reports the transfer under subpart (ii)
of this part.
9. Shall transfer the device to another
general licensee only if:
(i) The device
remains in use at a particular location. In this case, the transferor shall
give the transferee a copy of this paragraph and any safety documents
identified in the label of the device. Within 30 days of the transfer, the
transferor shall report to the Division:
(I)
The manufacturer's (or initial transferor's) name;
(II) The model number and the serial number
of the device transferred;
(III)
The transferee's name and mailing address for the location of use;
and
(IV) The name, title and phone
number of the responsible individual identified by the transferee in accordance
with part 12 of this subparagraph to have knowledge of and authority to take
actions to ensure compliance with the appropriate regulations and requirements;
or
(ii) 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.
10. Shall
comply with the provisions of Rules
0400-20-05-.140 and
0400-20-05-.141 for reporting
radiation incidents, theft or loss of radioactive material;
11. Shall respond to written requests from
the Division 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 shall, within that same time period, request a
longer period to supply the information by submitting a letter to the Division
at the address in Rule
0400-20-04-.07 providing written
justification as to why it cannot comply;
12. Shall 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, shall ensure
the day-to-day compliance with appropriate regulations and requirements. This
appointment does not relieve the general licensee of any of its responsibility
in this regard;
13. Shall:
(i) Report these devices to the Division
annually. Reporting shall be done by verifying, correcting and/or adding to the
information provided in a request for a report received from the Division. The
report information shall be submitted to the Division within 30 days of the
date of the request or as otherwise indicated in the request.
(ii) In reporting devices, furnish the
following information and any other information specifically requested by the
Division:
(I) Name and mailing address of the
general licensee;
(II) Information
about each device: the manufacturer (or initial transferor), model number,
serial number, the radioisotope and activity (as indicated on the
label);
(III) Name, title and
telephone number of the responsible person designated as a representative of
the general licensee under part 12 of this subparagraph;
(IV) Address or location at which the
device(s) are used and/or stored. For portable devices, the address of the
primary place of storage. Each address for a location of use represents a
separate general license;
(V)
Certification by the responsible representative of the general licensee that
the information concerning the device(s) has been verified through a physical
inventory and checking of label information; and
(VI) Certification by the responsible
representative of the general licensee that they are aware of the requirements
of the general license.
14. Shall be subject to the bankruptcy
notification requirement in paragraph (7) of Rule
0400-20-10-.16 if holding
devices containing radioactive material that meet the following criteria, based
on the activity indicated on the label:
(i) At
least 10 mCi (370MBq) of cesium-137;
(ii) At least 0.1 mCi (3.7 MBq) of
strontium-90;
(iii) At least 1 mCi
(37 MBq) of cobalt-60;
(iv) At
least 1 mCi (37 MBq) of americium-241 or any other transuranic (i.e., element
with atomic number greater than uranium (92)); or
(v) At least 0.1 mCi (37 MBq) of
radium-226.
15. Persons
generally licensed by the U.S. Nuclear Regulatory Commission or an Agreement
State with respect to devices meeting the criteria in parts 13 and 14 of this
subparagraph are not subject to reporting requirements if the devices are used
in areas subject to the Division's jurisdiction for a period less than 180 days
in any calendar year. The Division will not request reporting information from
such licensees.
16. Shall report
changes to the mailing address for the location of use (including change in
name of general licensee) to the Division, at the address in Rule
0400-20-04-.07, 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;
17. Shall not hold devices
that are not in use for longer than 2 years. If devices with shutters are not
being used, the shutter shall be locked in the closed position. The testing
required by part 2 of this subparagraph 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 shall 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 2-year
time limit if the general licensee performs quarterly physical inventories of
these devices while they are in storage.