Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Approval criteria.
An application for a specific license to manufacture,
assemble, repair, or initially transfer luminous safety devices containing
tritium or promethium-147 for use in aircraft, for distribution to persons
generally licensed under part 4731.3225, shall be approved if:
A. the applicant satisfies the general
requirements of part 4731.3070;
B.
the applicant submits sufficient information regarding each device pertinent to
evaluation of the potential radiation exposure, including:
(1) chemical and physical form and maximum
quantity of tritium or promethium-147 in each device;
(2) details of construction and
design;
(3) details of the method
of binding or containing the tritium or promethium-147;
(4) procedures for and results of prototype
testing to demonstrate that the tritium or promethium-147 will not be released
to the environment under the most severe conditions likely to be encountered in
normal use;
(5) quality assurance
procedures to be followed that are sufficient to ensure compliance with subpart
4; and
(6) any additional
information, including experimental studies and tests, required by the
commissioner to facilitate a determination of the safety of the
device;
C. each device
will contain no more than ten curies of tritium or 300 millicuries of
promethium-147. The levels of radiation from each device containing
promethium-147 will not exceed 0.5 millirad per hour at ten centimeters from
any surface when measured through 50 milligrams per square centimeter of
absorber;
D. the commissioner
determines that:
(1) the method of
incorporation and binding of the tritium or promethium-147 in the device is
such that the tritium or promethium-147 will not be released under the most
severe conditions that are likely to be encountered in normal use and handling
of the device;
(2) the tritium or
promethium-147 is incorporated or enclosed so as to preclude direct physical
contact by any person with it;
(3)
the device is so designed that it cannot easily be disassembled; and
(4) prototypes of the device have been
subjected to and have satisfactorily passed the tests under item E;
E. the applicant must subject at
least five prototypes of the device to tests as follows:
(1) the devices are subjected to tests that
adequately take into account the individual, aggregate, and cumulative effects
of environmental conditions expected in service that could adversely affect the
effective containment of tritium or promethium-147, such as temperature,
moisture, absolute pressure, water immersion, vibration, shock, and
weathering;
(2) the devices are
inspected for evidence of physical damage and for loss of tritium or
promethium-147, after each stage of testing, using methods of inspection
adequate for determining compliance with the criteria in subitem (3);
and
(3) device designs are rejected
for which the following has been detected for any unit:
(a) a leak resulting in a loss of 0.1 percent
or more of the original amount of tritium or promethium-147 from the
device;
(b) surface contamination
of tritium or promethium-147 on the device of more than 2,200 disintegrations
per minute per 100 square centimeters of surface area; or
(c) any other evidence of physical damage;
and
F. the
device has been registered in the Sealed Source and Device Registry.
Subp. 2.
Labeling
requirements.
A person licensed under this part to manufacture, assemble,
or initially transfer devices containing tritium or promethium-147 for
distribution to persons generally licensed under part 4731.3225 must, except as
provided in subpart 3, affix to each device a label containing:
A. the radiation symbol prescribed by part
4731.2300;
B. such other
information as may be required by the commissioner, including disposal
instructions when appropriate; and
C. the following or a substantially similar
statement that contains all of the information called for:
"The receipt, possession, use, and transfer of this device,
Model ..., Serial No. ..., containing ... (identity and quantity of radioactive
material) 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 with which the Nuclear Regulatory Commission has entered
into an agreement for the exercise of regulatory authority. Do not remove this
label.
CAUTION -- RADIOACTIVE MATERIAL
(Name of manufacturer, assembler, or initial
transferor)"
The model, serial number, and name of manufacturer,
assembler, or initial transferor may be omitted from the label if they are
elsewhere specified in the labeling affixed to the device.
Subp. 3.
Alternative
labeling.
If the commissioner determines that it is not feasible to
affix a label to the device containing all the information required under
subpart 2, the commissioner may waive those requirements and require in lieu
thereof that:
A. a label be affixed to
the device identifying:
(1) the manufacturer,
assembler, or initial transferor; and
(2) the type of radioactive material;
and
B. a leaflet bearing
the following information be enclosed in or accompany the container in which
the device is shipped:
(1) the name of the
manufacturer, assembler, or initial transferor;
(2) the type and quantity of radioactive
material;
(3) the model
number;
(4) a statement that the
receipt, possession, use, and transfer of the device are subject to a general
license or the equivalent and the rules of the commissioner, the NRC, or an
agreement state; and
(5) such other
information as may be required by the commissioner, including disposal
instructions when appropriate.
Subp. 4.
Quality assurance; transfer
prohibition.
A. A person licensed under
this part must visually inspect each device and must reject any that has an
observable physical defect that could adversely affect containment of the
tritium or promethium-147.
B. A
person licensed under this part must:
(1)
maintain quality assurance systems in the manufacture of the luminous safety
device in a manner sufficient to provide reasonable assurance that the
safety-related components of the distributed devices are capable of performing
their intended functions; and
(2)
subject inspection lots to acceptance sampling procedures, by procedures
specified in item C and in the license issued under this part, to provide at
least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0
percent will not be exceeded.
C. The licensee must subject each inspection
lot to:
(1) tests that adequately take into
account the individual, aggregate, and cumulative effects of environmental
conditions expected in service that could adversely affect the effective
containment of tritium or promethium-147, such as absolute pressure and water
immersion; and
(2) inspection for
evidence of physical damage, containment failure, or for loss of tritium or
promethium-147 after each stage of testing, using methods of inspection
adequate for applying the following criteria for defective:
(a) a leak resulting in a loss of 0.1 percent
or more of the original amount of tritium or promethium-147 from the
device;
(b) levels of radiation in
excess of 0.5 millirad (5 microgray) per hour at ten centimeters from any
surface when measured through 50 milligrams per square centimeter of absorber,
if the device contains promethium-147; and
(c) any other criteria specified in the
license issued under this part.
D. No person licensed under this part shall
transfer to persons generally licensed under part 4731.3225 or under an
equivalent general license of the NRC or an agreement state:
(1) any luminous safety device that has been
tested and found defective under a condition of a license issued under this
part, unless the defective luminous safety device has been repaired or
reworked, retested, and determined by an independent inspector to meet the
applicable acceptance criteria; or
(2) any luminous safety device contained
within any lot that has been sampled and rejected as a result of the procedures
in item B, subitem (2), unless:
(a) a
procedure for defining sub-lot size, independence, and additional testing
procedures is contained in the license issued under this part; and
(b) each individual sub-lot is sampled,
tested, and accepted in accordance with items B, subitem (2), and D, subitem
(2), unit (a), and any other criteria that may be required as a condition of
the license issued under this part.
Subp. 5.
Transfer reports.
A. A person licensed under this part must
file an annual report with the commissioner that covers the year ending June 30
and is filed within 30 days thereafter. If no transfers have been made to
persons generally licensed under part 4731.3225 during the reporting period,
the report must so indicate. The report must:
(1) state the total quantity of tritium or
promethium-147 transferred to persons generally licensed under part
4731.3225;
(2) identify each
general licensee by name;
(3) state
the kinds and numbers of luminous devices transferred; and
(4) specify the quantity of tritium or
promethium-147 in each kind of device.
B. A person licensed under this part must
report annually all transfers of devices to persons for use under a general
license in the NRC's or an agreement state's regulations that are equivalent to
part 4731.3225 to the NRC or responsible agreement state agency. If no
transfers have been made to the NRC or a particular agreement state during the
reporting period, this information must be reported to the NRC or responsible
agreement state agency upon request of the agency. The report must:
(1) state the total quantity of tritium of
promethium-147 transferred;
(2)
identify each general licensee by name;
(3) state the kinds and numbers of luminous
devices transferred; and
(4)
specify the quantity of tritium or promethium-147 in each kind of
device.