410 IAC 5-3-13 - Specific licenses to manufacture, repair, or distribute products containing radioactive materials
Authority: IC 16-41-35-26; IC 16-41-35-29
Affected: IC 16-41-35
Sec. 13.
(a)
Licensing the Introduction of Radioactive Material into Products in Exempt
Concentrations.
(1) In addition to the
requirements set forth in
410
IAC 5-3-10, 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
410 IAC
5-3-4(a)(1) 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,
410 IAC
5-3-26, that reconcentration 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.
(2) Each person licensed under 410 IAC
5-3-13(a) shall file an annual report with the board 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 410 IAC 5-3-13(a) 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.
(b) Licensing the Distribution of
Radioactive Material in Exempt Quantities.10/
(1) An application for a specific license to
distribute NARM to persons exempted from 410 IAC 5 pursuant to
410 IAC
5-3-4(b) 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 board approves such labels and
brochures.
(2) The
license issued under 410 IAC 5-3-13(b)(1) 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 one 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
410 IAC
5-3-4(b). 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 410 IAC 5-3-13(b)(2)(iii), 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.
(3)
Each person licensed under 410 IAC 5-3-13(b) shall maintain records
identifying, by name and address, each person to whom radioactive material is
transferred for use under
410 IAC
5-3-4 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
board. Each report shall cover the year ending June 30, and shall be filed
within thirty (30) days thereafter. If no transfers of radioactive material
have been made pursuant to 410 IAC 5-3-13(b) during the reporting period, the
report shall so indicate.
10/ Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
(c) Licensing the
Incorporation of Naturally-Occurring and Accelerator-Produced Radioactive
Material into Gas and Aerosol Detectors. An application for a specific license
authorizing the incorporation of NARM into gas and aerosol detectors to be
distributed to persons exempt under
410 IAC
5-3-4(c)(3) will be approved if the
application satisfies requirements equivalent to those contained in Section
32.26 of 10 CFR Part 32. The maximum quantity of radium-226 in each device
shall not exceed 0.1 microcurie.
(d) Licensing the Manufacture and
Distribution of Devices to Persons Generally Licensed Under
410
IAC 5-3-7(d).
(1) An application for a specific license to
manufacture or distribute devices containing radioactive material, excluding
special nuclear material, to persons generally licensed under
410
IAC 5-3-7(d) or equivalent
regulations of the U.S. Nuclear Regulatory Commission, an agreement state or a
licensing state will be approved if:
(i) The
applicant satisfies the general requirements of
410
IAC 5-3-10;
(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 one calendar quarter a dose in excess of 10 percent of the limits specified
in the table in
410
IAC 5-4-2(a); 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 radiation 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 rems
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 200 rems
Other organs 50 rems; and
(iii) Each device bears a durable, legible,
clearly visible label or labels approved by the board, 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 one of the
following statements, as appropriate, in the same or substantially similar
form:
(aa) The receipt, possession, use, and
transfer of this device, Model _____, Serial No. _____
11/, are subject to a general license or
the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or
a state with which the U.S. 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
(bb) The receipt, possession, use, and
transfer of this device, Model _____, Serial No. _____
11/, 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
(2) In the
event the applicant desires that the device be required to be tested at
intervals longer than six months, either for proper operation of the "on-off"
mechanism and indicator, if any, or for leakage of radioactive material or for
both, the applicant shall include in the 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 board will consider information which includes, but
is not limited to:
(i) Primary containment or
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 test;
(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.
(3) In the event
the applicant desires that the general licensee under
410
IAC 5-3-7(d), or under equivalent
regulations of the U.S. 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, the applicant shall include in the application written
instructions to be followed by the general licensee, estimated calendar quarter
doses associated with such activity or activities, and basis 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 percent of the limits specified in the table in
410
IAC 5-4-2(a).
(4) Each person licensed under 410 IAC
5-3-13(d) to distribute devices to generally licensed persons shall:
(i) Furnish a copy of the general license
contained in
410
IAC 5-3-7(d) 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
410
IAC 5-3-7(d);
(ii) Furnish a copy of the general license
contained in the U.S. Nuclear Regulatory Commission's, agreement state's or
licensing state's regulation equivalent to
410
IAC 5-3-7(d), or alternatively,
furnish a copy of the general license contained in
410
IAC 5-3-7(d) 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 U.S. Nuclear Regulatory
Commission, the agreement state or the licensing state. If a copy of the
general license in
410
IAC 5-3-7(d) is furnished to such a
person, it shall be accompanied by a note explaining that the use of the device
is regulated by the U.S. Nuclear Regulatory Commission, agreement state or
licensing state under requirements substantially the same as those in
410
IAC 5-3-7(d);
(iii) Report to the board all transfers of
such devices to persons for use under the general license in
410
IAC 5-3-7(d). 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 board 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 one 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 the
persons generally licensed under
410
IAC 5-3-7(d) 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) Furnish reports to other agencies:
(A) Report to the U.S. Nuclear Regulatory
Commission all transfers of such devices to persons for use under the U.S.
Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR Part
31;
(B) Report to the responsible
state agency all transfers of devices manufactured and distributed pursuant to
410 IAC 5-3-13(d) for use under a general license in that state's regulations
equivalent to
410
IAC 5-3-7(d);
(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 board 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 one 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 U.S. Nuclear Regulatory Commission licensees during
the reporting period, this information shall be reported to the U.S. 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 that agency.
(v) Keep records showing the name, address,
and the point of contact for each general licensee to whom he directly or
through an intermediate person transfers radioactive material in devices for
use pursuant to the general license provided in
410
IAC 5-3-7(d), or equivalent
regulations of the U.S. Nuclear Regulatory Commission, an agreement state or a
licensing state. The records should show the date of each transfer, the
radionuclide and the quantity of radioactivity in each device transferred, the
identity of any intermediate person and compliance with the report requirements
of 410 IAC 5-3-13(d)(4).
11/ The model, serial number, and name of manufacturer or distributor may be omitted from this label provided the information is elsewhere specified and labeling affixed to the device.
(e) Special
Requirements for the Manufacture, Assembly, or Repair of Luminous Safety
Devices for Use in Aircraft. 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
410
IAC 5-3-7(e) will be approved if:
(1) The applicant satisfies the general
requirements specified in
410
IAC 5-3-10, and
(2) The applicant satisfies the requirements
of Sections 32.53, 32.54, 32.55, 32.56, and 32.101 of 10 CFR Part 32 or their
equivalent.
(f) Special
Requirements for License to Manufacture Calibration Sources Containing
Americium-241, Plutonium, or Radium-226 for Distribution to Persons Generally
Licensed Under
410
IAC 5-3-7(g). An application for a
specific license to manufacture calibration and reference sources containing
americium-241, plutonium or radium-226 to persons generally licensed under
410
IAC 5-3-7(g) will be approved if:
(1) The applicant satisfies the general
requirement of
410
IAC 5-3-10, and
(g) Manufacture and Distribution of
Radioactive Material for Medical Use Under General License. In addition to
requirements set forth in
410
IAC 5-3-10, a specific license authorizing the
distribution of radioactive material for use by physicians under the general
license in
410
IAC 5-3-7(h) will be issued if:
(1) 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, U.S. Department of Health and Human
Services; and
(2) One of the
following statements, as appropriate, or a substantially similar statement
which contains the information called for in one 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 (to dispense drugs) 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 U.S. 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 (to dispense drugs) 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
(h) Manufacture and Distribution of
Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under
General License. An application for a specific license to manufacture or
distribute radioactive material for use under the general license of
410
IAC 5-3-7(i) will be approved if:
(1) The applicant satisfies the general
requirements specified in
410
IAC 5-3-10;
(2) The radioactive material is to be
prepared for distribution in prepackaged units of:
(i) Carbon-14 in units not exceeding 10
microcuries each;
(ii) Cobalt-57 in
units not exceeding 10 microcuries each;
(iii) Hydrogen-3 (tritium) in units not
exceeding 50 microcuries each;
(iv)
Iodine-125 in units not exceeding 10 microcuries each;
(v) Mock Iodine-125 in units not exceeding
0.05 microcurie of iodine-129 and 0.005 microcuries of americium-241
each;
(vi) Iodine-131 in units not
exceeding 10 microcuries each;
(vii) Iron-59 in units not exceeding 20
microcuries each;
(viii)
Selenium-75 in units not exceeding 10 microcuries each;
(3) 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, selenium-75, cobalt-57, or carbon-14; 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
410 IAC
5-4-11(a)(1) and the words,
"CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in
Humans or Animals."
(4)
One of the following statements, or a substantially similar statement which
contains the information called for in 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, veterinarians, 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 U.S. 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, veterinarians,
clinical laboratories or hospitals and only in 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
(5) 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
410 IAC
5-4-16.
(i) Licensing the Manufacture and
Distribution of Ice Detection Devices. An application for a specific license to
manufacture and distribute ice detection devices to persons generally licensed
under
410
IAC 5-3-10 will be approved if:
(1) The applicant satisfies the general
requirements of
410
IAC 5-3-10, and
(2) The criteria of Sections 32.61, 32.62,
and 32.103 of 10 CFR Part 32 are met.
(j) Manufacture and Distribution of
Radiopharmaceuticials [sic.] Containing Radioactive Material
for Medical Use Under Group Licenses. An application for a specific license to
manufacture and distribute radiopharmaceuticals containing radioactive material
for use by persons licensed pursuant to
410
IAC 5-3-11(c) for the uses listed in
Group I, Group II, IV, or V of Schedule C,
410 IAC
5-3-28, will be approved if:
(1) The applicant satisfies the general
requirements specified in
410
IAC 5-3-10;
(2) 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), 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;
(3) 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
(4)
(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 board for
distribution to persons licensed pursuant to
410
IAC 5-3-11(c) and Schedule C,
410 IAC
5-3-28, Group I, Group II, Group IV, and Group V, as
appropriate, or under equivalent licenses of the U.S. Nuclear Regulatory
Commission, an agreement state or a licensing state.
(ii) The labels, leaflets, or brochures
required by 410 IAC 5-3-13(j)(4)(i) are in addition to the labeling required by
the Food and Drug Administration and they may be separate from or, with the
approval of FDA, may be combined with the labeling required by FDA.
(k) Manufacture and
Distribution of Generators or Reagent Kits for Preparation of
Radiopharmaceuticals Containing Radioactive
Material.12/ 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
410
IAC 5-3-11(c) for the uses listed in
Group III of Schedule C,
410 IAC
5-3-28, will be approved if:
(1) The applicant satisfies the general
requirements specified in
410
IAC 5-3-10;
(2) 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 approved by the Food and Drug Administration or a "Notice of
Claimed Investigational Exemption for a New Drug" 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;
(3) 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 reagent
kit;
(4) The label affixed to the
generator or reagent kit contains information on the radionuclide, quantity,
and date of assay; and
(5) 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 eluting 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
board pursuant to
410
IAC 5-3-11(c) and Schedule C,
410 IAC
5-3-28, Group III or under equivalent licenses of the
U.S. Nuclear Regulatory Commission, an agreement state or a licensing state.
The labels, leaflets or brochures required by 410 IAC 5-3-13(k) 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.
12/ Although the board 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 board for use by persons
licensed pursuant to
410
IAC 5-3-11(c) and Group III of
Schedule C,
410 IAC
5-3-28, may submit the pertinent information specified
in 410 IAC 5-3-13(k).
(l) Manufacture and Distribution of Sources
or Devices Containing Radioactive Material for Medical Use. An application for
a specific license to manufacture and distribute sources and devices containing
radioactive material to persons licensed pursuant to
410
IAC 5-3-11(c) for use as a
calibration or reference source or for the uses listed in Group VI of Schedule
C,
410 IAC
5-3-28, will be approved if:
(1) The applicant satisfies the general
requirements in
410
IAC 5-3-10;
(2) 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) Instruction 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; and
(3) 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 board for distribution to persons licensed pursuant to
410
IAC 5-3-11(c) and Schedule C,
410 IAC
5-3-28, Group VI or under equivalent licenses of the
U.S. Nuclear Regulatory Commission, an agreement state or a licensing state,
provided, that such labeling for sources which do not require long term storage
may be on a leaflet or brochure which accompanies the source.
(4) 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 six 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; and
(5) In determining the
acceptable interval for test of leakage of radioactive material, the board will
consider information that includes, but is not limited to:
(i) Primary containment or 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.
(m) Requirements for License to Manufacture
and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume
Applications.
(1) An application for a
specific license to manufacture industrial products and devices containing
depleted uranium for use pursuant to
410 IAC
5-3-6(d) or equivalent regulations
of the U.S. Nuclear Regulatory Commission or an agreement state will be
approved if:
(i) The applicant satisfies the
general requirements specified in
410
IAC 5-3-10;
(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 one calendar
quarter a radiation dose in excess of 10 percent of the limits specified in
410
IAC 5-4-2(a); 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.
(2) In the case of an industrial product or
device whose unique benefits are questionable, the board will approve an
application for a specific license under 410 IAC 5-3-13(m) 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.
(3)
The board may deny any application for a specific license under 410 IAC
5-3-13(m) if the end use(s) of the industrial product or device cannot be
reasonably foreseen.
(4) Each
person licensed pursuant to 410 IAC 5-3-13(m)(1) 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 U.S. Nuclear Regulatory
Commission or 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
410 IAC
5-3-6(d) and a copy of board form
"W,"
410
IAC 5-3-32, to each person to whom he transfers
depleted uranium in a product or device for use pursuant to the general license
contained in
410 IAC
5-3-6(d); or
(B) Furnish a copy of the general license
contained in the U.S. Nuclear Regulatory Commission's or agreement state's
regulation equivalent to
410 IAC
5-3-6(d) and a copy of the U.S.
Nuclear Regulatory Commission's or agreement state's certificate; or
alternatively, furnish a copy of the general license contained in
410 IAC
5-3-6(d) and a copy of board form
"W,"
410
IAC 5-3-32, to each person to whom he transfers
depleted uranium in a product or device for use pursuant to the general license
of the U.S. Nuclear Regulatory Commission or an agreement state, with a note
explaining that use of the product or device is regulated by the U.S. Nuclear
Regulatory Commission or an agreement state under requirements substantially
the same as those in
410 IAC
5-3-6(d).
(v) Report to the board all transfers of
industrial products or devices to persons for use under the general license in
410 IAC
5-3-6(d). 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 board 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
410 IAC
5-3-6(d) during the reporting
period, the report shall so indicate;
(vi)
(A)
Report to the U.S. Nuclear Regulatory Commission all transfers of industrial
products or devices to persons for use under the U.S. Nuclear Regulatory
Commission general license in Section 40.25 of 10 CFR Part 40.
(B) Report to the responsible state agency
all transfers of devices manufactured and distributed pursuant to 410 IAC
5-3-13(m) for use under a general license in that state's regulations
equivalent to
410 IAC
5-3-6(d).
(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 U.S.
Nuclear Regulatory Commission licensees during the reporting period, this
information shall be reported to the U.S. 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 upon the request of that agency.
(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
410 IAC
5-3-6(d) or equivalent regulations
of the U.S. Nuclear Regulatory Commission or 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
section.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.