Subpart
1.
Approval criteria.
An application for a specific license to manufacture or
initially transfer devices containing radioactive material to a person
generally licensed under part 4731.3215 or equivalent regulations of the NRC or
an agreement state shall be approved if:
A. the applicant satisfies the general
requirements of part 4731.3070;
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:
(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 ten
percent of the annual limits under part 4731.2020, subpart 1; 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 dose to the appropriate organ as specified in part
4731.3325, Column IV;
C.
each device bears a durable, legible, clearly visible label or labels approved
by the commissioner, which contain in a clearly identified and separate
statement:
(1) instructions and precautions
necessary to ensure 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-off mechanism and indicator, including
the maximum time interval for the 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, in the same or substantially similar form:
"The receipt, possession, use, and transfer of this device,
Model ....., Serial No. ......, are subject to a general license or the
equivalent and the regulations of the Minnesota commissioner of health, the
Nuclear Regulatory Commission, or a state that has entered into an agreement
with the Nuclear Regulatory Commission 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 initial transferor)"
The model, serial number, and name of the manufacturer or
initial transferor may be omitted from the label if 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 isotope and quantity, the words "Caution-Radioactive
Material," the radiation symbol described in part 4731.2300, and the name of
the manufacturer or initial distributor;
E. each device meeting the criteria of part
4731.3215, subpart 3a, 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 part
4731.2300; and
F. the device has
been registered in the Sealed Source and Device Registry.
Subp. 2.
Additional requirements;
alternate testing intervals.
In the event the applicant desires that the device be
required to be tested at intervals longer than six months, for proper operation
of the on-off mechanism and indicator, if any, or for leakage of radioactive
material, or for both:
A. the
applicant must include in the application sufficient information to demonstrate
that the longer interval is justified:
(1) by
performance characteristics of the device or similar devices; and
(2) by design features that have a
significant bearing on the probability or consequences of leakage of
radioactive material from the device or failure of the on-off mechanism and
indicator; and
B. the
commissioner, in determining the acceptable interval for the test for leakage
of radioactive material, shall consider information that includes, but is not
limited to:
(1) primary containment (source
capsule);
(2) protection of primary
containment;
(3) method of sealing
containment;
(4) containment
construction materials;
(5) form of
contained radioactive material;
(6)
maximum temperature withstood during prototype tests;
(7) maximum pressure withstood during
prototype tests;
(8) maximum
quantity of contained radioactive material;
(9) radiotoxicity of contained radioactive
material; and
(10) operating
experience with identical devices or similarly designed and constructed
devices.
Subp.
3.
Additional requirements; general licensee
authority.
If the applicant desires that a general licensee under part
4731.3215 or under equivalent regulations of the NRC or an agreement state be
authorized to install the device, collect the sample to be analyzed by a
specific licensee for leakage of radioactive material, service the device, test
the on-off mechanism and indicator, or remove the device from installation, the
applicant must:
A. include in the
application written instructions to be followed by the general licensee, the
estimated calendar quarter doses associated with such activity, and the bases
for these estimates; and
B. submit
information to demonstrate that performance of the activity by an individual
untrained in radiological protection, in addition to other handling, storage,
and use of devices under the general license, is unlikely to cause the
individual to receive a dose in excess of ten percent of the annual limits
under part 4731.2020, subpart 1.
Subp. 4.
Transfer for use under general
license; requirements. If a device containing radioactive material is
to be transferred for use under a general license issued under part 4731.3215,
a person that is licensed under this part must provide the information
specified in this subpart to each person to whom a device is to be transferred.
The information must be provided before the device may be transferred. In case
of a transfer through an intermediate person, the information must also be
provided to the intended user before the initial transfer to the intermediate
person. The required information includes:
A.
a copy of the general license issued under part 4731.3215. If part 4731.3215,
subpart 3, items B to D, or 3a, do not apply to the particular device, those
items may be omitted;
B. a copy of
parts 4731.2600, 4731.2610, 4731.3115, and 4731.3200, item B;
C. a list of the services that can only be
performed by a specific licensee;
D. information on acceptable disposal
options, including estimated costs of disposal; and
E. an indication that the commissioner's
policy is to issue high civil penalties for improper
disposal.
Subp. 5.
Transfer for use under equivalent regulations; requirements.
If radioactive material is to be transferred in a device for
use under an equivalent general license of the NRC or an agreement state, a
person that is licensed under this part must provide the information specified
in this subpart to each person to whom a device is to be transferred. The
information must be provided before the device may be transferred. In the case
of a transfer through an intermediate person, the information must also be
provided to the intended user before initial transfer to the intermediate
person. The required information includes:
A. a copy of the NRC or agreement state
regulations equivalent to parts 4731.2600; 4731.2610; 4731.3115; 4731.3205; and
4731.3215, or a copy of parts 4731.2600; 4731.2610; 4731.3115; 4731.3205; and
4731.3215. If a copy of the commissioner's rules is provided to a prospective
general licensee in lieu of the NRC or agreement state regulations, the copy
must be accompanied by a note explaining that use of the device is regulated by
the NRC or agreement state. If certain subparts, items, or subitems do not
apply to the particular device, those subparts, items, and subitems may be
omitted;
B. a list of the services
that can only be performed by a specific licensee;
C. information on acceptable disposal
options, including estimated costs of disposal; and
D. the name or title, address, and telephone
number of the contact at the NRC or agreement state regulatory agency from
which additional information may be obtained.
Subp. 6.
Alternative methods.
A licensee may propose an alternative method of informing
customers, other than that specified under subparts 4 and 5, for approval by
the commissioner.
Subp. 7.
Labeling requirements.
A device that is transferred after February 19, 2002, must
meet the labeling requirements in subpart 1, items D and E.
Subp. 8.
Records upon
bankruptcy.
If a notification of bankruptcy is made under part 4731.3075,
subpart 4, or the license is to be terminated, a person licensed under this
part must provide, upon request, to the commissioner, the NRC, and any
appropriate agreement state, records of final disposition required under
subpart 11.
Subp. 9.
Report; transfer for use under general license.
A person licensed under this part to initially transfer
devices to generally licensed persons must report all transfers of devices to
persons for use under the general license in part 4731.3215 and all receipts of
devices from persons licensed under part 4731.3215 to the commissioner. The
report must be submitted on a quarterly basis on a transfers of industrial
devices report form prescribed by the commissioner or in a clear and legible
report containing all the data required by the form. The report must:
A. include:
(1) the identity of each general licensee by
name and mailing address for the location of use. If there is no mailing
address for the location of use, an alternate address for the general licensee
must be submitted along with information on the actual location of
use;
(2) the name, title, and
telephone number of the person identified by the general licensee as having
knowledge of and authority to take required actions to ensure compliance with
the appropriate rules and requirements;
(3) the date of transfer;
(4) the type, model number, and serial number
of the device transferred; and
(5)
the quantity and type of radioactive material in the device;
B. if one or more intermediate
persons will temporarily possess the device at the intended place of use before
its possession by the user, include the same information for both the intended
user and the intermediate person and clearly designate the intermediate
person;
C. for devices received
from a person generally licensed under part 4731.3215, include the identity of
the general licensee by name and address, the type, model number, and serial
number of the device received, the date of receipt, and, in the case of devices
not initially transferred by the reporting licensee, the name of the
manufacturer or initial transferor;
D. if the licensee makes changes to a device
possessed by a person generally licensed under part 4731.3215, such that the
label must be changed to update the required information, identify the general
licensee, the device, and the changes to information on the device
label;
E. cover each calendar
quarter, be filed within 30 days of the end of the calendar quarter, and
clearly indicate the period covered by the report;
F. clearly identify the specific licensee
submitting the report and include the license number of the specific licensee;
and
G. if no transfers have been
made to or from persons generally licensed under part 4731.3215 during the
reporting period, so indicate.
Subp.
10.
Report; transfer for use under equivalent
regulations.
A person licensed under this part to initially transfer
devices to generally licensed persons must report all transfers of devices to
persons for use under a general license issued by the NRC or an agreement state
under regulations that are equivalent to part 4731.3215, and all receipts of
devices from general licensees in the NRC's or agreement state's jurisdiction
to the NRC or the responsible agreement state agency. The report must be
submitted on a transfers of industrial devices report form prescribed by the
NRC or in a clear and legible report containing all of the data required by the
form. The report must:
A. include:
(1) the identity of each general licensee by
name and mailing address for the location of use. If there is no mailing
address for the location of use, an alternate address for the general licensee
must be submitted along with information on the actual location of
use;
(2) the name, title, and
telephone number of the person identified by the general licensee as having
knowledge of and authority to take required actions to ensure compliance with
the appropriate rules and requirements;
(3) the date of transfer;
(4) the type, model number, and serial number
of the device transferred; and
(5)
the quantity and type of radioactive material contained in the
device;
B. if one or
more intermediate persons will temporarily possess the device at the intended
place of use before its possession by the user, include the same information
for both the intended user and each intermediate person and clearly designate
the intermediate person;
C. for
devices received from a general licensee, include the identity of the general
licensee by name and address; the type, model number, and serial number of the
device received; the date of receipt; and in the case of devices not initially
transferred by the reporting licensee, the name of the manufacturer or initial
transferor;
D. if the licensee
makes changes to a device possessed by a general licensee, such that the label
must be changed to update required information, identify the general licensee,
the device, and the changes to information on the device label;
E. cover each calendar quarter, be filed
within 30 days of the end of the calendar quarter, and clearly indicate the
period covered by the report;
F.
clearly identify the specific licensee submitting the report and include the
license number of the specific licensee; and
G. upon request of the NRC or responsible
agreement state agency, include a statement that no transfers have been made to
or from a general licensee during the reporting period, if
applicable.
Subp. 11.
Record retention.
A person licensed under this part to initially transfer
devices to generally licensed persons must maintain all information concerning
transfers and receipts of devices that supports the reports required under
subparts 9 and 10. The records must be maintained for three years following the
date of the recorded event.
