Mont. Admin. r. 37.14.542 - SPECIFIC LICENSES: SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR, OR DISTRIBUTE COMMODITIES, PRODUCTS, OR DEVICES WHICH CONTAIN RADIOACTIVE MATERIAL
(1)
(a) In addition to the requirements set forth
in ARM 37.14.521, a specific license
authorizing the introduction of radioactive material into a product or material
owned by or in the possession of the licensee or another to be transferred to
persons exempt under ARM
37.14.506(1) (b)
will be issued if:
(i) the applicant submits
a description of the product or material into which the radioactive material
will be introduced, intended use of the radioactive material and the product or
material into which it is introduced, method of introduction, initial
concentration of the radioactive material in the product or material, control
methods to assure that no more than the specified concentration is introduced
into the product or material, estimated time interval between introduction and
transfer of the product or material, and estimated concentration of the
radioactive material in the product or material at the time of transfer;
and
(ii) the applicant provides
reasonable assurance that the concentrations of radioactive material at the
time of transfer will not exceed the concentrations in Schedule A of this
subchapter, that reconcentrating of the radioactive material in concentrations
exceeding those in Schedule A is not likely, that use of lower concentrations
is not feasible, and that the product or material is not likely to be
incorporated in any food, beverage, cosmetic, drug or other commodity or
product designed for ingestion or inhalation by, or application to, a human
being.
(b) Each person
licensed under (1) shall file an annual report with the department which shall
identify the type and quantity of each product or material into which
radioactive material has been introduced during the reporting period; name and
address of the person who owned or possessed the product or material, into
which radioactive material has been introduced, at the time of introduction;
the type and quantity of radionuclide introduced into each such product or
material; and the initial concentrations of the radionuclide in the product or
material at time of transfer of the radioactive material by the licensee. If no
transfers of radioactive material have been made pursuant to (1) during the
reporting period, the report shall so indicate. The report shall cover the year
ending June 30, and shall be filed within 30 days thereafter.
(2) Authority to transfer
possession or control by the manufacturer, processor, or producer of any
equipment, device, commodity, or other product containing by-product material
whose subsequent possession, use, transfer, and disposal by all other persons
are exempted from regulatory requirements may be obtained only from the US
Nuclear Regulatory Commission, Washington, DC 20555.
(a) An application for a specific license to
distribute naturally-occurring and accelerator-produced radioactive materials
(NARM) to persons exempted from this subchapter pursuant to ARM
37.14.506(2)
will be approved if:
(i) the radioactive
material is not contained in any food, beverage, cosmetic, drug, or other
commodity designed for ingestion or inhalation by, or application to, a human
being;
(ii) the radioactive
material is in the form of processed chemical elements, compounds, or mixtures,
tissue samples, bioassay samples, counting standards, plated or encapsulated
sources, or similar substances, identified as radioactive and to be used for
its radioactive properties, but is not incorporated into any manufactured or
assembled commodity, product, or device intended for commercial distribution;
and
(iii) the applicant submits
copies of prototype labels and brochures and the department approves such
labels and brochures.
(b) The license issued under (a) above is
subject to the following conditions:
(i) No
more than 10 exempt quantities shall be sold or transferred in any single
transaction. However, an exempt quantity may be composed of fractional parts of
1 or more of the exempt quantity provided the sum of the fractions shall not
exceed unity.
(ii) Each exempt
quantity shall be separately and individually packaged. No more than 10 such
packaged exempt quantities shall be contained in any outer package for transfer
to persons exempt pursuant to ARM
37.14.506(2). The
outer package shall be such that the dose rate at the external surface of the
package does not exceed 0.5 millirem per hour.
(iii) The immediate container of each
quantity or separately packaged fractional quantity of radioactive material
shall bear a durable, legible label which:
(A) identifies the radionuclide and the
quantity of radioactivity, and
(B)
bears the words "Radioactive Material".
(iv) In addition to the labeling information
required by (iii) above, the label affixed to the immediate container, or an
accompanying brochure, shall:
(A) state that
the contents are exempt from licensing state requirements,
(B) bear the words "Radioactive Material--Not
for Human Use--Introduction into Foods, Beverages, Cosmetics, Drugs, or
Medicinals, or into Products Manufactured for Commercial Distribution is
Prohibited--Exempt Quantities should not be Combined", and
(C) set forth appropriate additional
radiation safety precautions and instructions relating to the handling, use,
storage, and disposal of the radioactive material.
(c) Each person licensed under (2)
shall maintain records identifying, by name and address, each person to whom
radioactive material is transferred for use under ARM
37.14.506(2) or
the equivalent regulations of a licensing state, and stating the kinds and
quantities of radioactive material transferred. An annual summary report
stating the total quantity of each radionuclide transferred under the specific
license shall be filed with the department. Each report shall cover the year
ending June 20, and shall be filed within 30 days thereafter. If no transfers
of radioactive material have been made pursuant to (2) during the reporting
period, the report shall so indicate.
(3) An application for a specific license
authorizing the incorporation of NARM into gas and aerosol detectors to be
distributed to persons exempt under ARM
37.14.506(3) (c)
will be approved if the application satisfies requirements equivalent to those
contained in 10 CFR Part 32, section 32.26.
(4)
(a) An
application for a specific license to manufacture or distribute devices
containing radioactive material, excluding special nuclear material, to persons
generally licensed under ARM
37.14.512(4) or
equivalent regulations of the US nuclear regulatory commission, an agreement
state or a licensing state will be approved if:
(i) the applicant satisfies the general
requirements of ARM 37.14.521;
(ii)
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:
(A) the device can be safely operated by
persons not having training in radiological protection,
(B) 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 any period of 1 calendar quarter a
dose in excess of 10% of the limits specified in the table in ARM
37.14.705(1),
and
(C) 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 addition dose
or dose commitment in excess of the following organ doses:
| Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye | 15 rams |
| Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter | 200 rams |
| Other organs | 50 rams |
(iii) each device bears a durable, legible,
clearly visible label or labels approved by the department, which contain in a
clearly identified and separate statement:
(A) instructions and precautions necessary to
assure 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),
(B)
the requirement, or lack of requirement, for leak testing, or for testing any
on/off mechanism and indicator, including the maximum time interval for such
testing, and the identification of radioactive material by isotope, quantity of
radioactivity, and date of determination of the quantity, and
(C) the information called for in 1 of the
following statements, as appropriate, in the same or substantially similar
form:
(I) 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 US nuclear
regulatory commission or a state with which the US nuclear regulatory
commission has entered into an agreement for the exercise of regulatory
authority. This label shall be maintained on the device in a legible condition.
Removal of this label is prohibited.
CAUTION--RADIOACTIVE MATERIAL
____________________
(Name of manufacturer or distributor)
(II) 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 a licensing state. This label shall be
maintained on the device in a legible condition. Removal of this label is
prohibited.
CAUTION--RADIOACTIVE MATERIAL
________________________
(Name of manufacturer or distributor)
(D) The model, serial number, and
name of the manufacturer or distributor may be omitted from the foregoing label
provided the information is elsewhere specified in labeling affixed to the
device.
(b)
In the event the applicant desires that the device be required to be tested at
intervals longer than 6 months, either for proper operation of the on/off
mechanism and indicator, if any, or for leakage of radioactive material or for
both, he shall include in his application sufficient information to demonstrate
that such longer interval is justified by performance characteristics of the
device or similar devices and by design features which 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. In
determining the acceptable interval for the test for leakage of radioactive
material, the department will consider information which includes, but is not
limited to:
(i) primary containment (source
capsule);
(ii) protection of
primary containment;
(iii) method
of sealing containment;
(iv)
containment construction material;
(v) form of contained radioactive
material;
(vi) maximum temperature
withstood during prototype tests;
(vii) maximum pressure withstood during
prototype tests;
(viii) maximum
quantity of contained radioactive material;
(ix) radiotoxicity of contained radioactive
material; and
(x) operating
experience with identical devices or similarly designed and constructed
devices.
(c) In the
event the applicant desires that the general license under ARM
37.14.512(4) or
under equivalent regulations of the US nuclear regulatory commission, an
agreement state or a licensing 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, he shall include in his
application written instructions to be followed by the general licensee,
estimated calendar quarter doses associated with such activity or activities,
and bases for such estimates. The submitted information shall demonstrate that
performance of such activity or activities 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 that individual to
receive a calendar quarter dose in excess of 10% of the limits specified in the
table in ARM
37.14.705(2).
(d) Each person licensed under (4) to
distribute devices to generally licensed persons shall:
(i) Furnish a copy of the general license
contained in ARM
37.14.512(4) to
each person to whom he directly or through an intermediate person transfers
radioactive material in a device for use pursuant to the general license
contained in ARM
37.14.512(4).
(ii) Furnish a copy of the general license
contained in the US nuclear regulatory commission's, agreement state's or
licensing state's regulation equivalent to ARM
37.14.512(4) or
alternatively, furnish a copy of the general license contained in ARM
37.14.512(4), to
each person to whom he directly or through an intermediate person transfers
radioactive material in a device for use pursuant to the general license of the
US nuclear regulatory commission, the agreement or the licensing state. If a
copy of the general license in ARM
37.14.512(4) is
furnished to such person, it shall be accompanied by a note explaining that the
use of the device is regulated by the US nuclear regulatory commission,
agreement state or licensing state under requirements substantially the same as
those in ARM
37.14.512(4).
(iii) Report to the department all transfers
of such devices to persons for use under the general license in ARM
37.14.512(4).
Such report shall identify each general licensee by name and address, an
individual by name and/or position who may constitute a point of contact
between the department and the general licensee, the type and model number of
device transferred, and the quantity and type of radioactive material contained
in the device. If 1 or more intermediate persons will temporarily possess the
device at the intended place of use prior to its possession by the user, the
report shall include identification of each intermediate person by name,
address, contact, and relationship to the intended user. If no transfers have
been made to persons generally licensed under ARM
37.14.512(4)
during the reporting period, the report shall so indicate. The report shall
cover each calendar quarter and shall be filed within 30 days
thereafter.
(iv) Reports to other
agencies include:
(A) Report to the US
nuclear regulatory commission all transfers of such devices to persons for use
under the US nuclear regulatory commission general license.
(B) Report to the responsible state agency
all transfers of devices manufactured and distributed pursuant to ARM
37.14.542(4) for
use under a general license in that state's regulations equivalent to ARM
37.14.512(4).
(C) Such reports shall identify each general
licensee by name and address, an individual by name and/or position who may
constitute a point of contact between the department and the general licensee,
the type and model of the device transferred, and the quantity and type of
radioactive material contained in the device. If 1 or more intermediate persons
will temporarily possess the device at the intended place of use prior to its
possession by the user, the report shall include identification of each
intermediate person by name, address, contact, and relationship to the intended
user. The report shall be submitted within 30 days after the end of each
calendar quarter in which such a device is transferred to the generally
licensed person.
(D) If no
transfers have been made to US nuclear regulatory commission licensees during
the reporting period, this information shall be reported to the US nuclear
regulatory commission.
(E) If no
transfers have been made to general licensees within a particular state during
the reporting period, this information shall be reported to the responsible
state agency upon request of the agency.
(5) An application for a specific
license to manufacture, assemble, or repair luminous safety devices containing
tritium or promethium-147 for use in aircraft, for distribution to persons
generally licensed under ARM
37.14.512(5) will
be approved subject to the following conditions:
(a) The applicant satisfies the general
requirements specified in ARM 37.14.521, and
(b) the applicant satisfies the requirements
of 10 CFR Part 32, sections 32.53, 32.54, 32.55, 32.56, 32.101, or their
equivalent.
(6) An
application for a specific license to manufacture calibration and reference
sources containing americium-241, plutonium or radium-226 to persons generally
licensed under ARM
37.14.512(7) will
be approved subject to the following conditions:
(a) The applicant satisfies the general
requirement of ARM
37.14.521 and
(7) In addition to requirements set forth in
ARM 37.14.521, a specific license authorizing the distribution of radioactive
material for use by physicians under the general license in ARM
37.14.512(8)
will be issued if:
(a) the applicant submits
evidence that the radioactive material is to be manufactured, labeled, and
packaged in accordance with a new drug application which the commissioner of
food and drugs, food and drug administration, has approved, or in accordance
with a license for a biologic product issued by the secretary, department of
health, education, and welfare; and
(b) one of the following statements, as
appropriate, or a substantially similar statement which contains the
information called for in 1 of the following statements, appears on the label
affixed to the container or appears in the leaflet or brochure which
accompanies the package:
(i) This radioactive
drug may be received, possessed, and used only by physicians licensed in the
practice of medicine. Its receipt, possession, use and transfer are subject to
the regulations and a general license or its equivalent of the US nuclear
regulatory commission or of a state with which the commission has entered into
an agreement for the exercise of regulatory authority.
___________________________________
(Name of manufacturer)
(ii) This radioactive drug may be received,
possessed, and used only by physicians licensed in the practice of medicine.
Its receipt, possession, use and transfer are subject to the regulations and a
general license or its equivalent of a licensing state.
___________________________________
(Name of manufacturer)
(8) An application for a specific
license to manufacture or distribute radioactive material for use under the
general license of ARM
37.14.512(9) will
be approved if:
(a) The applicant satisfies
the general requirements specified in ARM 37.14.521.
(b) The radioactive material is to be
prepared for distribution in prepackaged units of:
(i) Iodine-125 in units not exceeding 10
microcuries each.
(ii) Iodine-131
in units not exceeding 10 microcuries each.
(iii) Carbon-14 in units not exceeding 10
microcuries each.
(iv) Hydrogen-3
(tritium) in units not exceeding 50 microcuries each.
(v) Iron-59 in units not exceeding 20
microcuries each.
(vi) Cobalt-57 in
units not exceeding 10 microcuries each.
(vii) Selenium-75 in units not exceeding 10
microcuries each.
(viii) Mock
iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005
microcurie of americium-241 each.
(c) Each prepackaged unit bears a durable,
clearly visible label:
(i) identifying the
radioactive contents as to chemical form and radionuclide, and indicating that
the amount of radioactivity does not exceed 10 microcuries of iodine-125,
iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries of hydrogen-3
(tritium); 20 microcuries of iron-59; or mock iodine-125 in units not exceeding
0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each;
and
(ii) displaying the radiation
caution symbol described in ARM
37.14.725(1) (a)
and the words, "CAUTION--RADIOACTIVE MATERIAL", and "Not for Internal or
External Use in Humans or Animals".
(d) One of the following statements, as
appropriate, or a substantially similar statement which contains the
information called for in 1 of the following statements, appears on a label
affixed to each prepackaged unit or appears in a leaflet or brochure which
accompanies the package:
(i) This radioactive
material may be received, acquired, possessed, and used only by physicians,
clinical laboratories or hospitals and only for in vitro clinical or laboratory
tests not involving internal or external administration of the material, or the
radiation therefrom, to human beings or animals. Its receipt, acquisition,
possession, use, and transfer are subject to the regulations and a general
license of the US nuclear regulatory commission or of a state with which the
commission has entered into an agreement for the exercise of regulatory
authority.
_____________________________________
(Name of manufacturer)
(ii) This radioactive material may be
received, acquired, possessed, and used only by physicians, clinical
laboratories or hospitals and only for in vitro clinical or laboratory tests
not involving internal or external administration of the material, or the
radiation therefrom, to human beings or animals. Its receipt, acquisition,
possession, use, and transfer are subject to the regulations and a general
license of a licensing state.
______________________________________
(Name of manufacturer)
(e) The label affixed to the unit, or the
leaflet or brochure which accompanies the package, contains adequate
information as to the precautions to be observed in handling and storing such
radioactive material. In the case of the mock iodine-125 reference or
calibration source, the information accompanying the source must also contain
directions to the licensee regarding the waste disposal requirements set out in
ARM 37.14.740.
(9) An application for a specific license to
manufacture and distribute ice detection devices to persons generally licensed
under ARM 37.14.512(10)
will be approved subject to the following conditions:
(a) the applicant satisfies the general
requirements of ARM 37.14.521, and
(b) the criteria of 10 CFR Part 32, sections
32.61, 32.62, 32.103, are met.
(10) An application for a specific license to
manufacture and distribute radiopharmaceuticals containing radioactive material
for use by persons licensed pursuant to ARM
37.14.540(3) for
the uses listed in Group I, Group II, IV, or V of Schedule C of this subchapter
will be approved if:
(a) The applicant
satisfies the general requirements specified in ARM 37.14.521;
(b) The applicant submits evidence that:
(i) the radiopharmaceutical containing
radioactive material will be manufactured, labeled, and packaged in accordance
with the federal Food, Drug and Cosmetic Act or the Public Health Service Act,
such as a new drug application (NDA) approved by the food and drug
administration (FDA), a biologic product license issued by FDA or a "Notice of
claimed investigational exemption for a new drug" (IND) that has been accepted
by the FDA, or
(ii) the manufacture
and distribution of the radiopharmaceutical containing radioactive material is
not subject to the federal Food, Drug and Cosmetic Act and the Public Health
Service Act;
(c) The
applicant submits information on the radionuclide, chemical and physical form,
packaging including maximum activity per package, and shielding provided by the
packaging of the radioactive material which is appropriate for safe handling
and storage of radiopharmaceuticals by group licensees; and
(d)
(i) The
label affixed to each package of the radiopharmaceutical contains information
on the radionuclide, quantity, and date of assay and the label affixed to each
package, or the leaflet or brochure which accompanies each package, contains a
statement that the radiopharmaceutical is licensed by the department for
distribution to persons licensed pursuant to ARM
37.14.540(3) and
Schedule C, Group I, Group II, Group IV, and Group V of this subchapter, as
appropriate, or under equivalent licenses of the US nuclear regulatory
commission, an agreement state or a licensing state.
(ii) The labels, leaflets or brochures
required by (d) (i) above are in addition to the labeling required by the food
and drug administration (FDA) and they may be separate from or, with the
approval of FDA, may be combined with the labeling required by FDA.
(11) An application for
a specific license to manufacture and distribute generators or reagent kits
containing radioactive material for preparation of radiopharmaceuticals by
persons licensed pursuant to ARM
37.14.540(3) for
the uses listed in Group II of Schedule C of this subchapter will be approved
if:
(a) The applicant satisfies the general
requirements specified in ARM 37.14.521;
(b) the applicant submits evidence that:
(i) the generator or reagent kit is to be
manufactured, labeled and packaged in accordance with the federal Food, Drug
and Cosmetic Act or the Public Health Service Act, such as a new drug
application (NDA) approved by the food and drug administration (FDA), a
biologic product license issued by FDA, or a "Notice of claimed investigational
exemption for a new drug" (IND) that has been accepted by the FDA, or
(ii) the manufacture and distribution of the
generator or reagent kit are not subject to the federal Food, Drug and Cosmetic
Act and the Public Health Service Act;
(c) the applicant submits information on the
radionuclide, chemical and physical form, packaging including maximum activity
per package, and shielding provided by the packaging of the radioactive
material contained in the generator or the reagent kit;
(d) the label affixed to the generator or
reagent kit contains information on the radionuclide, quantity, and date of
assay; and
(e) the label affixed to
the generator or reagent kit, or the leaflet or brochure which accompanies the
generator or reagent kit, contains:
(i)
adequate information, from a radiation safety standpoint, on the procedures to
be followed and the equipment and shielding to be used in elating the generator
or processing radioactive material with the reagent kit, and
(ii) a statement that this generator or
reagent kit (as appropriate) is approved for use by persons licensed by the
department pursuant to ARM
37.14.540(3) and
Schedule C, Group III of this subchapter or under equivalent licenses of the US
nuclear regulatory commission, an agreement state or a licensing state. The
labels, leaflets or brochures required by (11) are in addition to the labeling
required by FDA and they may be separate from or, with the approval of FDA, may
be combined with the labeling required by FDA.
NOTE: Although the department does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have his reagent kits approved by the department for use by persons licensed pursuant to ARM 37.14.540(3) and Group III of Schedule C of this subchapter may submit the pertinent information specified in (11).
(12) An application for a specific license to
manufacture and distribute sources and devices containing radioactive material
to persons licensed pursuant to ARM
37.14.540(3) for
use as a calibration or reference source or for the uses listed in Group VI of
Schedule C of this subchapter will be approved if:
(a) The applicant satisfies the general
requirements in ARM 37.14.521.
(b)
The applicant submits sufficient information regarding each type of source or
device pertinent to an evaluation of its radiation safety, including:
(i) the radioactive material contained, its
chemical and physical form, and amount,
(ii) details of design and construction of
the source or device,
(iii)
procedures for, and results of, prototype tests to demonstrate that the source
or device will maintain its integrity under stresses likely to be encountered
in normal use and accidents,
(iv)
for devices containing radioactive material, the radiation profile of a
prototype device,
(v) details of
quality control procedures to assure that production sources and devices meet
the standards of the design and prototype tests,
(vi) procedures and standards for calibrating
sources and devices,
(vii) legend
and methods for labeling sources and devices as to their radioactive content,
and
(viii) instructions for
handling and storing the source or device from the radiation safety standpoint;
these instructions are to be included on a durable label attached to the source
or device or attached to a permanent storage container for the source or
device; provided, that instructions which are too lengthy for such label may be
summarized on the label and printed in detail on a brochure which is referenced
on the label.
(c) The
label affixed to the source or device, or to the permanent storage container
for the source or device, contains information on the radionuclide, quantity,
and date of assay, and a statement that the name of source or device is
licensed by the department for distribution to persons licensed pursuant to ARM
37.14.540(3) and
Schedule C, Group VI of this subchapter or under equivalent licenses of the US
nuclear regulatory commission, an agreement state or a licensing state,
provided, that such labeling for sources which do not require long term storage
(e.g., gold-198 seeds) may be on a leaflet or brochure which accompanies the
source.
(d) In the event the
applicant desires that the source or device be required to be tested for
leakage of radioactive material at intervals longer than 6 months, he shall
include in his application sufficient information to demonstrate that such
longer interval is justified by performance characteristics of the source or
device or similar sources or devices and by design features that have a
significant bearing on the probability or consequences of leakage of
radioactive material from the source.
(e) In determining the acceptable interval
for test of leakage of radioactive material, the department will consider
information that includes, but is not limited to:
(i) primary containment (source
capsule),
(ii) protection of
primary containment,
(iii) method
of sealing containment,
(iv)
containment construction materials,
(v) form of contained radioactive
material,
(vi) maximum temperature
withstood during prototype tests,
(vii) maximum pressure withstood during
prototype tests,
(viii) maximum
quantity of contained radioactive material,
(ix) radiotoxicity of contained radioactive
material, and
(x) operating
experience with identical sources or devices or similarly designed and
constructed sources or devices.
(13) Requirements for license to manufacture
and distribute industrial products containing depleted uranium for mass-volume
applications.
(a) An application for a
specific license to manufacture industrial products and devices containing
depleted uranium for use pursuant to ARM
37.14.511(4) or
equivalent regulations of the US nuclear regulatory commission or an agreement
state will be approved if:
(i) the applicant
satisfies the general requirements specified in ARM 37.14.521;
(ii) the applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control procedures, labeling or marking, proposed uses, and potential hazards
of the industrial product or device to provide reasonable assurance that
possession, use, or transfer of the depleted uranium in the product or device
is not likely to cause any individual to receive in any period of 1 calendar
quarter a radiation dose in excess of 10% of the limits specified in ARM
37.14.705(2);
and
(iii) the applicant submits
sufficient information regarding the industrial product or device and the
presence of depleted uranium for a mass-volume application in the product or
device to provide reasonable assurance that unique benefits will accrue to the
public because of the usefulness of the product or device.
(b) In the case of an industrial product or
device whose unique benefits are questionable, the department will approve an
application for a specific license under (13) only if the product or device is
found to combine a high degree of utility and low probability of uncontrolled
disposal and dispersal of significant quantities of depleted uranium into the
environment.
(c) The department may
deny any application for a specific license under (13) if the end use(s) of the
industrial product or device cannot be reasonably foreseen.
(d) Each person licensed pursuant to (a)
above shall:
(i) maintain the level of
quality control required by the license in the manufacture of the industrial
product or device, and in the installation of the depleted uranium into the
product or device;
(ii) label or
mark each unit to:
(A) identify the
manufacturer of the product or device and the number of the license under which
the product or device was manufactured, the fact that the product or device
contains depleted uranium, and the quantity of depleted uranium in each product
or device; and
(B) state that the
receipt, possession, use, and transfer of the product or device are subject to
a general license or the equivalent and the regulations of the US nuclear
regulatory commission or of an agreement state;
(iii) assure that the depleted uranium before
being installed in each product or device has been impressed with the following
legend clearly legible through any plating or other covering: "Depleted
Uranium";
(iv)
(A) furnish a copy of the general license
contained in ARM
37.14.511(4) and
a copy of department form MRH-12 to each person to whom he transfers depleted
uranium in a product or device for use pursuant to the general license
contained in ARM
37.14.511(4),
or
(B) furnish a copy of the
general license contained in the US nuclear regulatory commission's or
agreement state's regulation equivalent to ARM
37.14.511(4) and
a copy of the US nuclear regulatory commission's or agreement state's
certificate, or alternatively, furnish a copy of the general license contained
in ARM 37.14.511(4) and
a copy of department form MRH-12 to each person to whom he transfers depleted
uranium in a product or device for use pursuant to the general license of the
US nuclear regulatory commission or an agreement state, with a note explaining
that use of the product or device is regulated by the US nuclear regulatory
commission or an agreement state under requirements substantially the same as
those in ARM
37.14.511(4);
(v) report to the department all
transfers of industrial products or devices to persons for use under the
general license in ARM
37.14.511(4).
Such report shall identify each general licensee by name and address, an
individual by name and/or position who may constitute a point of contact
between the department and the general licensee, the type and model number of
device transferred, and the quantity of depleted uranium contained in the
product or device. The report shall be submitted within 30 days after the end
of each calendar quarter in which such a product or device is transferred to
the generally licensed person. If no transfers have been made to persons
generally licensed under ARM
37.14.511(4)
during the reporting period, the report shall so indicate;
(vi)
(A)
report to the US nuclear regulatory commission all transfers of industrial
products or devices to persons for use under the US nuclear regulatory
commission general license,
(B)
report to the responsible state agency all transfers of devices manufactured
and distributed pursuant to (13) for use under a general license in that
state's regulations equivalent to ARM
37.14.511(4),
(C) such report shall identify each general
licensee by name and address, an individual by name and/or position who may
constitute a point of contact between the agency and the general licensee, the
type and model number of the device transferred, and the quantity of depleted
uranium contained in the product or device. The report shall be submitted
within 30 days after the end of each calendar quarter in which such product or
device is transferred to the generally licensed person,
(D) if no transfers have been made to US
nuclear regulatory commission licensees during the reporting period, this
information shall be reported to the US nuclear regulatory
commission,
(E) if no transfers
have been made to general licensees within a particular agreement state during
the reporting period, this information shall be reported to the responsible
agreement state agency; and
(vii) keep records showing the name, address,
and point of contact for each general licensee to whom he transfers depleted
uranium in industrial products or devices for use pursuant to the general
license provided in ARM
37.14.511(4) or
equivalent regulations of the US nuclear regulatory commission or of an
agreement state. The records shall be maintained for a period of 2 years and
shall show the date of each transfer, the quantity of depleted uranium in each
product or device transferred, and compliance with the report requirements of
this subchapter.
Notes
Sec. 75-3-202, MCA; IMP, Sec. 75-3-202, MCA;
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