Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
License issued.
Commercial and industrial firms; research, educational, and
medical institutions; individuals in the conduct of their business; and state
or local government agencies are issued a general license to acquire, receive,
possess, use, or transfer, according to this part, radioactive material
contained in devices designed and manufactured for:
A. detecting, measuring, gauging, or
controlling thickness, density, level, interface location, radiation, leakage,
or qualitative or quantitative chemical composition; or
B. producing light or an ionized
atmosphere.
Subp. 2.
Applicability.
A. The general
license under subpart 1 applies only to radioactive material contained in
devices that have been manufactured or initially transferred and labeled
according to:
(1) a specific license issued
under part 4731.3330;
(2) an
equivalent specific license issued by the NRC or an agreement state;
or
(3) an equivalent specific
license issued by a state with provisions comparable to part
4731.3330.
B. The
devices must have been received from one of the specific licensees described in
item A or through a transfer made under subpart 3, item M.
Subp. 3.
Requirements.
A person who acquires, receives, possesses, uses, or
transfers radioactive material in a device according to the general license
issued under subpart 1 must:
A. ensure
that all labels that are affixed to the device at the time of receipt and that
bear a statement that removal of the label is prohibited are maintained on the
device and must comply with all instructions and precautions provided by the
labels;
B. ensure 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 six-month intervals
or at such other intervals as are specified in the label, except:
(1) devices containing only krypton need not
be tested for leakage of radioactive material;
(2) devices containing only tritium or not
more than 100 microcuries of other beta- or gamma-emitting material or ten
microcuries of alpha-emitting material need not be tested for any purpose;
and
(3) devices held in storage in
the original shipping container prior to initial installation need not be
tested for any purpose;
C. ensure that the tests under item B and
other testing, installation, servicing, and removal from installation involving
the radioactive material, its shielding, or its containment are performed:
(1) according to the instructions provided by
the labels; or
(2) by a person
holding a specific license issued under parts 4731.3000 to 4731.3175 or
4731.3300 to 4731.3400 or issued by the NRC or an agreement state to perform
such activities;
D.
maintain records showing compliance with items B and C. The records must
include:
(1) the results of the
tests;
(2) the dates the tests were
performed; and
(3) the names of
persons performing the tests, installation, servicing, and removal from
installation of radioactive material and its shielding or
containment;
E. retain
the records under item D as follows:
(1) each
record of a test for leakage or radioactive material required by item B 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 a test of the on-off
mechanism and indicator required by item B must be retained for three 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
(3) each record showing compliance with item
C must be retained for three years from the date of the recorded event or until
the device is transferred or disposed of;
F. 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 Bq) or
more removable radioactive material until the device has been repaired by the
manufacturer or other person holding a specific license issued under parts
4731.3000 to 4731.3175 or 4731.3300 to 4731.3400 or issued by the NRC or an
agreement state to repair the device. 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 contained in the device or
as otherwise approved by the commissioner;
G. within 30 days, furnish to the
commissioner a report containing a brief description of any event under item F
and the remedial actions taken and, in the case of detection of 0.005
microcurie or more of removable radioactive material or failure of or damage to
a source likely to result in contamination of the premises or environs, a plan
for ensuring that the premises and environs are acceptable for unrestricted
use. Under these circumstances, the criteria under part 4731.2100, subpart 2,
may be applicable, as determined by the commissioner on a case-by-case basis;
H. not abandon the device
containing radioactive material;
I.
not export the device containing radioactive material, except according to Code
of Federal Regulations, title 10, part 110;
J. transfer or dispose of the device
containing radioactive material only:
(1) by
export as provided in item I;
(2)
by transfer to another general licensee as authorized under item M;
(3) to a person authorized to receive the
device by a specific license issued under parts 4731.3000 to 4731.3175 or
4731.3300 to 4731.3400 or under equivalent regulations of the NRC or an
agreement state that authorizes waste collection; or
(4) as otherwise approved under item L;
K. within 30 days of a
transfer under item J, report to the commissioner:
(1) the identification of the device by
manufacturer's or initial transferor's name, model number, and serial
number;
(2) the name, address, and
license number of the person receiving the device. No license number is
required if the device is exported; and
(3) the date of the transfer;
L. obtain written approval from
the commissioner before transferring the device to another specific licensee
not specifically identified in item J; 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:
(1)
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;
(2) removes, alters,
covers, or clearly and unambiguously augments the existing label, otherwise
required by subpart 3, item A, so that the device is labeled in compliance with
part 4731.2330; however, the manufacturer, model number, and serial number must
be retained;
(3) 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
(4) reports the
transfer under item K;
M. transfer the device to another general
licensee only if:
(1) the device remains in
use at a particular location, in which case the transferor must give the
transferee a copy of this part and parts 4731.2600, 4731.2610, 4731.3115, and
4731.3200 and any safety documents identified in the label of the device.
Within 30 days of the transfer, the transferor must report to the commissioner:
(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 telephone number of the responsible individual identified
by the transferee under item P to have knowledge of and authority to take
actions to ensure compliance with the appropriate rules 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;
N. comply with
parts 4731.2600 and 4731.2610 for reporting radiation incidents, theft, and
loss of licensed material, but is exempt from the remainder of parts 4731.1000
to 4731.1090 and 4731.2000 to 4731.2950 and Code of Federal Regulations, title
10, part 21;
O. respond to written
requests from the commissioner 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, the general licensee must, within the
same time period, request a longer period to supply the information by
submitting a letter to the commissioner and provide written justification as to
why it cannot comply;
P. appoint an
individual responsible for having knowledge of the appropriate rules and
requirements and the authority for taking required actions to comply with
appropriate rules and requirements. The general licensee, through the appointed
individual, must ensure the day-to-day compliance with appropriate rules and
requirements. The appointment does not relieve the general licensee of any of
the general licensee's responsibility in this regard;
Q. report changes to the mailing address for
the location of use, including change in name of the general licensee, to the
commissioner within 30 days of the effective date of the change. For a portable
device, a report of address change is required only for a change in the
device's primary place of storage; and
R. not hold devices that are not in use for
more than two years. If a device with shutters is not being used, the shutters
must be locked in the closed position. The testing required under item B need
not be performed during the period of storage only. When a device is put back
into service or transferred to another person, and has not been tested within
the required test interval, the device must be tested for leakage before use or
transfer and the shutters must be 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.
Subp. 3a.
Registration of generally licensed devices.
A. A person to whom subpart 3 applies shall
register generally licensed devices according to items B and C. These devices
contain:
(1) at least ten millicuries (370
MBq) of cesium-137;
(2) at least
0.1 millicurie (3.7 MBq) of strontium-90;
(3) at least one millicurie (37 MBq) of
cobalt-60;
(4) at least 0.1
millicurie (3.7 MBq) of radium-226; or
(5) at least one millicurie (37 MBq) of
americium-241 or any other transuranic (any other element with an atomic number
greater than uranium-92) based on the activity indicated on the
label.
B. If in
possession of a device meeting the criteria of item A, a person to whom subpart
3 applies must register the device annually with the commissioner and pay the
fee required under
Minnesota Statutes, section
144.1205.
(1) Registration must be done by verifying,
correcting, or adding to the information provided in a request for registration
received from the commissioner. Registration information must be submitted to
the commissioner within 30 days of the date of the request for registration or
as otherwise indicated in the request.
(2) A general licensee holding devices
meeting the criteria of item A is subject to the bankruptcy notification
requirement under part 4731.3075, subpart 4. Each address for a location of use
under item C, subitem (4), represents a separate general license and requires a
separate registration and fee.
(3)
Persons generally licensed by the NRC or an agreement state with respect to
devices meeting the criteria in item A are not subject to registration under
this item if the devices are used in areas subject to the commissioner's
jurisdiction for a period of less than 180 days in any calendar year. The
commissioner shall not request registration information from such licensees.
C. In registering
devices under item B, a person to whom subpart 3 applies must furnish the
following information and any other information specifically requested by the
commissioner:
(1) name and mailing address of
the general licensee;
(2) the
following information about each device:
(a)
the manufacturer or initial transferor;
(c) the serial number; and
(d) the radioisotope and activity, as
indicated on the label;
(3) name, title, and telephone number of the
responsible person designated as a representative of the general licensee under
subpart 3, item P;
(4) address or
location at which each device is used or stored. For portable devices, the
address of the primary place of storage must be furnished;
(5) certification by the responsible
representative of the general licensee that the information concerning the
device has been verified through a physical inventory and checking of label
information; and
(6) certification
by the responsible representative of the general licensee that the responsible
representative is aware of the requirements of the general license.
Subp. 4.
Limitation.
The general license issued under subpart 1 does not authorize
the manufacture or import of devices containing radioactive material.