Ill. Admin. Code tit. 32, § 330.280 - Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices that Contain Radioactive Material
a)
Licensing the Introduction of Radioactive Material into Products in Exempt
Concentrations
1) In addition to the
requirements set forth in Section
330.250,
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
and the transfer of ownership or possession of the product or material
containing the radioactive material to persons exempted from this Part pursuant
to Section
330.30
or
330.40(a)
will be issued if:
A) The applicant submits:
i) a description of the product or material
into which the radioactive material will be introduced;
ii) intended use of the radioactive material
and the product or material into which it is introduced;
iii) method of introduction;
iv) initial concentration of the radioactive
material in the product or material;
v) control methods to assure that no more
than the specified concentration is introduced into the product or
material;
vi) estimated time
interval between introduction and transfer of the product or material;
and
vii) estimated concentration of
the radioactive material in the product or material at the time of transfer;
and
B) The applicant
provides reasonable assurance that the concentrations of radioactive material
at the time of transfer will not exceed the concentrations in Appendix A, that
reconcentration of the radioactive material in concentrations exceeding those
in Appendix 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 this subsection
(a) is required to maintain records of transfer of material and shall file a
report with the Agency that shall identify the following:
A) Type and quantity of each product or
material into which radioactive material has been introduced during the
reporting period;
B) 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;
C) The radionuclide,
activity and activity assay date of radioactive material introduced into each
product or material; and
D) The
initial concentrations of the radionuclide in the product or material at time
of transfer of the radioactive material by the licensee.
3) The licensee shall file the report within
30 days after any of the following events:
A)
5 years have passed since the preceding report was filed; or
B) The licensee has:
i) Filed an application for renewal of the
license under Section
330.320;
or
ii) Notified the Agency under
Section
330.325(c)
that the licensee has ended activities authorized under the license issued
under this subsection (a).
4) The report shall cover the period between
the filing of the preceding report and an occurrence specified in subsection
(a)(3). If no transfers of radioactive material have been made under this
subsection (a) during the reporting period, the report shall so
indicate.
5) The licensee shall
maintain the record of a transfer for a period of one year after the event has
been included in a report to the Agency.
6) No person may introduce radioactive
material into a product or material knowing or having reason to believe that it
will be transferred to persons exempt under Section
330.30
or
330.40(a)
or the equivalent regulations of NRC (10 CFR
30.14) or of an Agreement State, except in
accordance with a specific license issued under this subsection (a).
b) Licensing the Distribution of
Radioactive Material in Exempt Quantities
AGENCY NOTE: 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 DC 20555.
c)
Licensing the Incorporation of Naturally Occurring and Accelerator-Produced
Radioactive Material into Gas and Aerosol Detectors.
AGENCY NOTE: 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 DC 20555.
d)
Licensing the Manufacture and Distribution of Devices to Persons Generally
Licensed Under Section
330.220(a).
AGENCY NOTE: Subsection (p) describes requirements for radioactive material transfer reports and records.
1) An application for a specific license to
manufacture or distribute devices containing radioactive material, excluding
special nuclear material, to persons generally licensed under Section
330.220(a)
or equivalent regulations of NRC or an Agreement State will be approved if:
A) The applicant satisfies the general
requirements of Section 330.250.
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:
i) The device can be safely operated by
persons not having training in radiological protection;
ii) 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 10
percent of the annual limits specified in 32 Ill. Adm. Code
340.210(a);
and
iii) 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 ... 150 mSv (15 rem)
Hands and forearms; feet and ankles or localized areas of skin averaged over areas no larger than one square centimeter................................... 2 Sv (200 rem)
Other organs .......................................... 500 mSv (50 rem).
C)
Each device bears a durable, legible, clearly visible label or labels approved
by the Agency that contains in a clearly identified and separate statement:
i) Instructions and precautions necessary to
assure safe installation, operation and servicing of the device. Documents such
as operating and service manuals may be identified on the label and used to
provide this information;
ii) The
requirement, or lack of requirement, for testing for leakage or contamination,
or for testing any on-off mechanism and indicator, including the maximum time
interval for the testing, and the identification of radioactive material by
radionuclide, activity and activity assay date; and
iii) The information called for in one of the
following statements, as appropriate, 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 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.
OR
CAUTION - RADIOACTIVE MATERIAL
Name of Manufacturer or Distributor
AGENCY NOTE: The model, serial number and name of the manufacturer or distributor may be omitted from this label provided 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 displaying the
device model and serial number, the radionuclide and activity, the words
"Caution - Radioactive Material", the radiation symbol described in 32 Ill.
Adm. Code 340.Illustration A and the name of the manufacturer or
distributor.
E) Each device meeting
the criteria of
10
CFR 31.5(c)(13)(i) (73 Fed.
Reg. 42673, July 23, 2008) bears a permanent (e.g., 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 32
Ill. Adm. Code 340.Illustration A.
F) The device has been registered in the
Sealed Source and Device Registry in accordance with subsection
(m)(2).
2) Except as
provided in this subsection (d)(2), the interval between tests for proper
operation of the on-off mechanism and indicator, if any, shall not exceed six
months. The interval between tests for contamination of the device or for
leakage of radioactive material from the device or for both shall not exceed
three months for devices containing sources designed to emit alpha particles
and six months for all other devices. In the event the applicant desires that
the device be required to be tested at longer intervals, the applicant shall
include in the application sufficient information to demonstrate that those
longer intervals are justified. The information shall include a description of
the performance characteristics of the device or similar devices and of design
features that have a significant bearing on the probability or consequences of
contamination of the device or 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 or contamination of
the device, the Agency will consider information that includes, but is not
limited to:
A) Primary containment or source
capsule;
B) Protection of primary
containment;
C) Method of sealing
containment;
D) Containment
construction materials;
E) Form of
contained radioactive material;
F)
Maximum temperature withstood during prototype tests;
G) Maximum pressure withstood during
prototype tests;
H) Maximum
activity of contained radioactive material;
I) Radiotoxicity of contained radioactive
material; and
J) Operating
experience with identical devices or similarly designed and constructed
devices.
3) In the event
the applicant desires that the general licensee under Section
330.220(a),
or under equivalent regulations of NRC or an Agreement State, be authorized to
install the device, collect the sample to be analyzed by a specific licensee
for leakage of, or contamination by, 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 annual doses associated with the
activity or activities and bases for the estimates. The submitted information
shall demonstrate that performance of the 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 an annual dose in excess of 10 percent of the limits
specified in 32 Ill. Adm. Code
340.210(a).
4) A person licensed under this subsection
(d) to distribute devices to generally licensed persons shall provide the
information in this subsection (d)(4) to each person to whom a device is to be
transferred for possession and use under the general license in Section
330.220(a).
This information shall be provided before a device is transferred. In the case
of a transfer through an intermediate person, the information shall be provided
to the intended user prior to transfer to the intermediate person. The required
information is:
A) A copy of Section
330.220(a);
AGENCY NOTE: If certain provisions of Section 330.220(a) do not apply to a particular device, they may be omitted; e.g., tests for leakage or contamination or proper operation of an on-off mechanism and indicator.
C) A list of the services that may only be
performed by a specific licensee;
D) Information on acceptable disposal
options, including estimated costs of disposal; and
E) A statement of the Agency's policy to take
escalated enforcement action for improper disposal.
5) A person licensed under this subsection
(d) to distribute devices to generally licensed persons shall provide the
information in this subsection (d)(5) to each person to whom a device is to be
transferred for possession and use under a general license equivalent to
Section
330.220(a)
in the regulations of NRC or an Agreement State. This information shall be
provided before a device is transferred. In the case of a transfer through an
intermediate person, the information shall be provided to the intended user
prior to transfer to the intermediate person. The required information is:
A) A copy of the following regulations of NRC
or the equivalent regulations of an Agreement State. NRC regulations are
10
CFR 31.5 (73 Fed. Reg. 42673, July 23, 2008),
10 CFR 31.2
(65 Fed. Reg. 79187, December 18, 2000),
10 CFR
30.51 (61 Fed. Reg. 24673, May 16, 1996),
10 CFR
20.2201 (67 Fed. Reg. 3585, January 25, 2002)
and
10 CFR
20.2202 (63 Fed. Reg. 39483, July 23, 1998).
If NRC regulations are provided to a prospective general licensee in lieu of
applicable Agreement State regulations, they shall be accompanied by a note
explaining that use of the device is regulated by the Agreement State;
AGENCY NOTE: If certain provisions of the regulations do not apply to a particular device, they may be omitted; e.g., tests for leakage or contamination or proper operation of an on-off mechanism and indicator.
B) A list of the
services that may only be performed by a specific licensee;
C) Information on acceptable disposal
options, including estimated costs of disposal;
D) A statement of the policies of NRC and
most Agreement States to take escalated enforcement action for improper
disposal; and
E) The name or title,
address and phone number of the contact at NRC or Agreement State regulatory
agency from whom additional information may be obtained.
6) A person licensed under this subsection
(d) may propose, for approval by the Agency, an alternative method of informing
customers.
7) Each transferred
device shall meet the labeling requirements of subsections (d)(1)(C), (D) and
(E).
8) If a license is to be
terminated or if notification of bankruptcy is required by Section
330.310(j),
a person licensed under this subsection (d) shall, upon request, provide to the
Agency, NRC or an Agreement State the records of final disposition required by
subsection (p)(8).
e)
Special Requirements for the Manufacture, Assembly or Repair of Luminous Safety
Devices for Use in Aircraft
1) 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 Section
330.220(b)
will be approved if:
A) The applicant
satisfies the general requirements specified in Section 330.250; and
2) Each person
licensed under this subsection (e) shall file an annual report with the Agency
that shall state the total activity of tritium or promethium-147 transferred to
persons generally licensed under Section
330.220(b)
or equivalent regulations of NRC or an Agreement State. The report shall
identify each general licensee by name and address, state the kinds and numbers
of luminous devices transferred and specify the activity of tritium or
promethium-147 in each kind of device. Each report shall cover the year ending
June 30 and shall be filed within 30 days thereafter. If no transfers have been
made to a particular Agreement State during the reporting period, this
information must be reported to the responsible Agreement State agency upon
request of the Agency.
3) Each
person licensed under this subsection (e) shall also file an annual report with
the Director, Office of Nuclear Material Safety and Safeguards, ATTN: Document
Control Desk/GLTS, U.S. Nuclear Regulatory Commission, Washington DC 20555 by
the appropriate method listed in
10 CFR 30.6, which
must state the total quantity of tritium or promethium-147 transferred to
persons generally licensed under Section
330.220(b).
The report shall identify each general licensee by name, state the kinds and
numbers of luminous devices transferred, and specify the quantity of tritium or
promethium-147 in each kind of device. Each report shall cover the year ending
June 30 and shall be filed by July 30. If no transfers have been made to
persons generally licensed under Section
330.220(b)
during the reporting period, the report shall so indicate.
f) Special Requirements for License to
Manufacture Calibration Sources Containing Americium-241, Plutonium or
Radium-226 for Distribution to Persons Generally Licensed Under Section
330.220(d).
An application for a specific license to manufacture calibration and reference
sources containing americium-241, plutonium or radium-226 for distribution to
persons generally licensed under Section
330.220(d)
will be approved if:
1) The applicant
satisfies the general requirements of Section 330.250; and
2) The applicant satisfies the requirements
of
10
CFR 32.57 (77 Fed. Reg. 43693, July 25, 2012)
and
10
CFR 70.39 (43 Fed. Reg. 6925, February 17,
1978). The applicant shall also certify that it will satisfy, and subsequently
satisfies, the requirements of
10 CFR
32.58 and
32.59
(77 Fed. Reg. 43694, July 25, 2012).
g) 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 Section
330.220(e),
or equivalent regulations of NRC or an Agreement State, will be approved if:
1) The applicant satisfies the general
requirements specified in Section 330.250.
2) The radioactive material is to be prepared
for distribution in prepackaged units of:
A)
Carbon-14 in units not exceeding 370 kBq (10 µCi) each.
B) Cobalt-57 in units not exceeding 370 kBq
(10 µCi) each.
C) Hydrogen-3
(tritium) in units not exceeding
1.85
MBq (50 µCi) each.
D)
Iodine-125 in units not exceeding 370 kBq (10 µCi) each.
E) Mock iodine-125 in units not exceeding
1.85
kBq (50 nCi) of iodine-129 and 185 Bq (5 nCi) of americium-241 each.
F) Iodine-131 in units not exceeding 370 kBq
(10 µCi) each.
G) Iron-59 in
units not exceeding 740 kBq (20 µCi) each.
H) Selenium-75 in units not exceeding 370 kBq
(10 µCi) each.
3)
Each prepackaged unit bears a durable, clearly visible label:
A) Identifying the radioactive contents as to
chemical form and radionuclide, and indicating that the amount of radioactivity
does not exceed 370 kBq (10 µCi) of iodine-125, iodine-131, carbon-14,
cobalt-57 or selenium-75;
1.85
MBq (50 µCi) of hydrogen-3 (tritium); 740 kBq (20 µCi) of iron-59;
or mock iodine-125 in units not exceeding
1.85
kBq (50 nCi) of iodine-129 and 185 Bq (5 nCi) of americium-241 each;
and
B) Displaying the radiation
caution symbol described in 32 Ill. Adm. Code
340.910(a)
and the words "CAUTION - RADIOACTIVE MATERIAL" and "Not for Internal or
External Use in Humans or Animals".
4) The following statement, or a statement
that contains the information called for in the following statement, appears on
a label affixed to each prepackaged unit or appears in a leaflet or brochure
that accompanies the package:
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 NRC or of a state with which NRC has entered into an agreement for the exercise of regulatory authority.
5) The
label affixed to the unit, or the leaflet or brochure that accompanies the
package, contains information about the precautions to be followed in handling
and storing that radioactive material. In the case of the mock iodine-125
reference or calibration source, the manufacturer shall state in the directions
that this item shall be disposed of in compliance with 32 Ill. Adm. Code
340.1010(a)
or the equivalent regulations of NRC or an Agreement State.
h) 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 Section
330.220(f)
will be approved if:
1) The applicant
satisfies the general requirements of Section 330.250; and
i) Manufacture and Distribution of
Radiopharmaceuticals Containing Radioactive Material for Medical Use Under
Specific Licenses. An application for a specific license to manufacture and
distribute radiopharmaceuticals containing radioactive material for use by
persons licensed pursuant to Section
330.260(a),
(b) or (c) for the uses described in 32 Ill.
Adm. Code
335.3010,
335.4010
or
335.5010
will be approved if:
1) The applicant
satisfies the general requirements specified in Section 330.250;
2) The applicant submits information showing
that:
A) The radiopharmaceutical containing
radioactive material will be manufactured, labeled and packaged in accordance
with the Federal Food, Drug, and Cosmetic Act (21 USC
301) or the Public Health Service Act
(42
USC 201 et seq.); or
B) 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; maximum
activity per vial, syringe, generator or other container of the radioactive
drug; and the shielding provided by the packaging to show the packaging is
appropriate for safe handling and storage of radiopharmaceuticals by medical
use licensees; and
4) The label
affixed to each package of the radiopharmaceutical contains information on the
radionuclide, activity and activity assay date and the label affixed to each
package, or the leaflet or brochure that accompanies each package, contains a
statement that the radiopharmaceutical is licensed by the Agency for
distribution to persons licensed pursuant to Section
330.260(a),
(b) or (c) for radioactive material specified
in 32 Ill. Adm. Code 335.3010, 335.4010 or 335.5010, as appropriate, or under
equivalent licenses of NRC or an Agreement State. The labels, leaflets or
brochures required by this subsection (i) are in addition to the labeling
required by the FDA and may be separate from, or, with the approval of FDA, may
be combined with the labeling required by FDA.
j) Manufacture and Distribution of Generators
or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive
Material
AGENCY NOTE: Although the Agency does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of those 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 those reagent kits approved by the Agency for use by persons licensed pursuant to Section 330.260(a), (b) or (c) for generators or reagent kits specified in 32 Ill. Adm. Code 335.4010 may submit the pertinent information specified in this subsection (j).
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 Section 330.260(a), (b) or (c) for the uses specified in 32 Ill. Adm. Code 335.4010 will be approved if:
1) The applicant
satisfies the general requirements specified in Section 330.250;
2) The applicant submits evidence that:
A) 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; or
B) 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, activity and activity
assay date; and
5) The label
affixed to the generator or reagent kit, or the leaflet or brochure that
accompanies the generator or reagent kit, contains:
A) 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
B) A statement that the generator or reagent
kit, as appropriate, is approved for use by persons licensed by the Agency
pursuant to Section
330.260(a),
(b) or (c) and 32 Ill. Adm. Code
335.4010
or under equivalent licenses of NRC or an Agreement State. The labels, leaflets
or brochures required by this subsection (j) are in addition to the labeling
required by the FDA 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
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 Section
330.260(a)
or (b) for use as a calibration, transmission
or reference source in 32 Ill. Adm. Code
335.2040
or for the uses listed in 32 Ill. Adm. Code
335.2140,
335.6010,
335.7010
and
335.8010
will be approved if:
1) The applicant
satisfies the general requirements in Section 330.250;
2) The applicant submits sufficient
information regarding each type of source or device pertinent to an evaluation
of its radiation safety, including:
A) The
radioactive material contained and its chemical and physical form and
activity;
B) Details of design and
construction of the source or device;
C) 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;
D) For devices containing radioactive
material, the radiation profile of a prototype device;
E) Details of quality control procedures to
assure that production sources and devices meet the standards of the design and
prototype tests;
F) Procedures and
standards for calibrating sources and devices;
G) Legend and methods for labeling sources
and devices as to their radioactive content; and
H) Instructions for handling and storing
sources or devices from the radiation safety standpoint. These instructions
shall be included on a durable label attached to each source or device or
attached to a permanent storage container for the source or device; provided,
that instructions that are too lengthy for the label may be summarized on the
label and printed in detail on a brochure that is referenced on the
label;
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, activity and
activity assay date, radiation symbol and/or "CAUTION - RADIOACTIVE MATERIAL",
serial number, model, manufacturer name or logo, and a statement that the
source or device is licensed by the Agency for distribution to persons licensed
pursuant to Section
330.260(a),
(b) or (c) and 32 Ill. Adm. Code 335.2040,
335.2140, 335.6010, 335.7010 and 335.8010 or under equivalent licenses of NRC
or an Agreement State, provided that the labeling for sources that do not
require long-term storage may be on a leaflet or brochure that accompanies the
source;
4) In the event the
applicant desires that the source or device be required to be tested for
leakage of, or contamination by, radioactive material at intervals longer than
6 months, the applicant shall include in the application sufficient information
to demonstrate that the 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 radioactive contamination or leakage of radioactive material
from the source;
5) In determining
the acceptable interval for tests of leakage of, or contamination by,
radioactive material, the Agency will consider information that includes, but
is not limited to:
A) Primary containment or
source capsule;
B) Protection of
primary containment;
C) Method of
sealing containment;
D) Containment
construction materials;
E) Form of
contained radioactive material;
F)
Maximum temperature withstood during prototype tests;
G) Maximum pressure withstood during
prototype tests;
H) Maximum
activity of contained radioactive material;
I) Radiotoxicity of contained radioactive
material;
J) Operating experience
with identical sources or devices or similarly designed and constructed sources
or devices; and
K) Proposed use of
source; and
6) The
source or device has been registered in the Sealed Source and Device Registry
in accordance with subsection (m)(2).
l) Requirements for License to Manufacture
and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume
Applications. An application for a specific license to manufacture industrial
products and devices containing depleted uranium for use pursuant to Section
330.210(g)
or equivalent regulations of NRC or an Agreement State will be approved if:
1) The applicant satisfies the general
requirements specified in Section 330.250.
2) The applicant submits sufficient
information relating to the design (including blueprints), manufacture
(construction materials and methods), prototype testing (description of testing
that will be done and the acceptance criteria), quality control procedures,
labeling or marking, proposed uses and potential hazards of the industrial
product or device to assure that possession, use or transfer of the depleted
uranium in the product or device will not cause any individual to receive, in
any period of one year, a radiation dose in excess of 10 percent of the limits
specified in 32 Ill. Adm. Code
340.210(a).
3) The applicant submits information assuring
that the presence of depleted uranium for a mass-volume application in the
product or device will provide a unique benefit to the public, i.e., a benefit
that could not be achieved but for the use of depleted uranium. The applicant's
methods for use and handling of the product or device will not result in
uncontrolled disposal or dispersal of depleted uranium into the
environment.
4) The Agency will
deny any application for a specific license under this subsection (l) if the
end uses of the industrial product or device cannot be reasonably
foreseen.
5) Each person licensed
pursuant to this subsection (l) shall:
A)
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;
B) Label or mark each unit to:
i) 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 activity of depleted uranium in each product or device; and
ii) 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 NRC or an Agreement State;
C) 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";
D)
Furnish:
i) A copy of the general license
contained in Section
330.210(g)
and a copy of the form "Registration Certificate - Use of Depleted Uranium
Under General License", to each person to whom the licensee transfers depleted
uranium in a product or device for use pursuant to the general license
contained in Section
330.210(g);
or
ii) A copy of the general
license contained in NRC's or Agreement State's regulation equivalent to
Section
330.210(g)
and a copy of NRC's or Agreement State's certificate, or alternatively, furnish
a copy of the general license contained in Section
330.210(g)
and a copy of the form "Registration Certificate - Use of Depleted Uranium
Under General License", to each person to whom he or she transfers depleted
uranium in a product or device for use pursuant to the general license of NRC
or an Agreement State, with a note explaining that use of the product or device
is regulated by NRC or an Agreement State under requirements substantially the
same as those in Section
330.210(g);
E) Report to the Agency all
transfers of industrial products or devices to persons for use under the
general license in Section
330.210(g).
The 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
device transferred, and the activity 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 the product or device is transferred to the
generally licensed person. If no transfers have been made to persons generally
licensed under Section
330.210(g)
during the reporting period, the report shall so indicate;
F) File a report that identifies each general
licensee by name and address, an individual by name and/or position who
constitutes a point of contact between the Agency and the general licensee, the
type and model number of the device transferred, and the activity 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 the product or
device is transferred to the generally licensed person. The licensee shall
report:
i) To NRC, all transfers of industrial
products or devices to persons for use under NRC general license in
10
CFR 40.25;
ii) To the responsible state agency, all
transfers of devices manufactured and distributed pursuant to this subsection
(l) for use under a general license in that state's regulations equivalent to
Section
330.210(g);
iii) To NRC, if no transfers have been made
by the licensees during the reporting period;
iv) To the responsible Agreement State
agency, upon the request of that agency, if no transfers have been made to
general licensees within a particular Agreement State during the reporting
period; and
G) Keep
records showing the name, address and point of contact for each general
licensee to whom the licensee transfers depleted uranium in industrial products
or devices for use pursuant to the general license provided in Section
330.210(g)
or equivalent regulations of NRC or an Agreement State. The records shall be
maintained for a period of 2 years and shall show the date of each transfer,
the activity of depleted uranium in each product or device transferred, and
compliance with the report requirements of this subsection (l).
m) Special Requirements
for License to Manufacture or Initially Distribute Sealed Sources or Devices
Containing Sealed Sources
1) An application
for license to manufacture or initially distribute sealed sources or devices
containing sealed sources for initial transfer to persons having a specific
license to receive those sealed sources or devices will be approved subject to
the following conditions:
A) The applicant
satisfies the general requirements specified in Section 330.250;
B) The licensee subject to this subsection
(m) shall not transfer a sealed source or device containing a sealed source to
any person, except in accordance with the requirements of Section
330.400.
2) Any manufacturer or initial
distributor of a sealed source or device containing a sealed source may submit
a request to the Agency for evaluation of radiation safety information about
its product and for filing an evaluation sheet in the NRC "Registry of
Radioactive Sealed Sources and Devices".
3) The request for review of a sealed source
or a device must include sufficient information about the design, manufacture,
prototype testing, quality control program, labeling, proposed uses and leak
testing, and, for a device, the request must also include sufficient
information about installation, service and maintenance, operating and safety
instructions, and the device's potential hazards to provide reasonable
assurance that the radiation safety properties of the source or device are
adequate to protect health and minimize danger to life and property.
4) The Agency normally evaluates a sealed
source or a device using radiation safety criteria in accepted industry
standards. If these standards and criteria do not readily apply to a particular
case, the Agency formulates reasonable standards and criteria with the help of
the manufacturer or distributor. The Agency shall use criteria and standards
sufficient to ensure that the radiation safety properties of the device or
sealed source are adequate to protect health and minimize danger to life and
property. Other subsections of this Section have specific criteria that apply
to certain products.
5) After
completion of the evaluation, the Agency issues a certificate of registration
to the person making the request. The certificate of registration acknowledges
the availability of the submitted information for inclusion in an application
for a specific license proposing use of the product, or concerning use under an
exemption from licensing or general license, as applicable, for the category of
certificate.
6) The person
submitting the request for evaluation and registration of safety information
about the product shall manufacture and distribute the product in accordance
with:
A) The statements and representations,
including quality control program, contained in the request; and
B) The provisions of the registration
certificate.
7)
Authority to manufacture or initially distribute a sealed source or device to
specific licensees may be provided in the license without the issuance of a
certificate of registration in the following cases:
A) Calibration and reference sources
containing no more than:
i) 37 MBq (1 mCi),
for beta and/or gamma emitting radionuclides; or
ii)0.37 MBq (10 µCi), for alpha
emitting radionuclides; or
B) The intended recipients are qualified by
training and experience, and have sufficient facilities and equipment, to
safely use and handle the requested quantity of radioactive material in any
form, in the case of unregistered sources, or, for registered sealed sources
contained in unregistered devices, are qualified by training and experience and
have sufficient facilities and equipment, to safely use and handle the
requested quantity of radioactive material in unshielded form, as specified in
their licenses; and
i) The intended recipients
are licensed under Section
330.270
or comparable provisions of NRC or an Agreement State; or
ii) The recipients are authorized for
research and development; or
iii)
The sources and devices are to be built to the unique specifications of the
particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4
GBq (200 mCi) of any other radionuclide.
8) After the certificate is issued, the
Agency may conduct an additional review as it determines is necessary to ensure
compliance with current regulatory standards. In conducting its review, the
Agency will complete its evaluation in accordance with criteria specified in
this Section. The Agency may request such additional information as it
considers necessary to conduct its review and the certificate holder shall
provide the information requested.
9) A certificate holder who no longer
manufactures or initially transfers any of the sealed sources or devices
covered by a particular certificate issued by the Agency shall request
inactivation of the registration certificate. The request must be made to the
Agency by an appropriate method listed in 32 Ill. Adm. Code
310.110 and must
normally be made no later than two years after initial distribution of all the
sources or devices covered by the certificate has ceased. However, if the
certificate holder determines that an initial transfer was in fact the last
initial transfer more than 2 years after that transfer, the certificate holder
shall request inactivation of the certificate within 90 days after this
determination and briefly describe the circumstances of the delay.
10) If a distribution license is to be
terminated in accordance with Section 330.325, the licensee shall request
inactivation of its registration certificates associated with that distribution
license before the Agency will terminate the license. A request for
inactivation of certificates must indicate that the license is being terminated
and include the associated specific license number.
11) A specific license to manufacture or
initially transfer a source or device covered only by an inactivated
certificate no longer authorizes the licensee to initially transfer the sources
or devices for use. Servicing of devices must be in accordance with any
conditions in the certificate, including in the case of an inactive
certificate.
n)
Manufacture and Distribution of Radioactive Material for Medical Use Under
General License. A specific license authorizing the distribution of radioactive
materials for diagnostic medical use by a physician under a general license
shall be issued only if the applicant for the specific license satisfies the
requirements of Section
330.250
and:
1) The applicant submits evidence that
the radioactive material is to be manufactured, labeled and packaged in
accordance with an approval by the commissioner of Food and Drugs, U.S. Food
and Drug Administration, or in accordance with an approval for a biologic
product issued by the Secretary, U.S. Department of Health and Human Services;
and
2) The following statement, or
a statement that contains the information called for in the following
statement, appears on the label affixed to the container or appears in the
leaflet or brochure that accompanies the package:
This radiopharmaceutical 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 NRC or of a state with which NRC has entered into an agreement for the exercise of regulatory authority.
o)
Requirements for License to Initially Transfer Source Material for Use Under
the "Small Quantities of Source Material" General License
1) An application for a specific license to
initially transfer source material for use under Section
330.210
will be approved if:
A) The applicant
satisfies the general requirements specified in Section 330.250; and
B) The applicant submits adequate information
on the methods to be used for quality control, labeling and providing safety
instructions to recipients.
2) Each person licensed under this subsection
(o) shall label the immediate container of each quantity of source material
with the type and quantity of source material and the words "radioactive
material".
3) Each person licensed
under this subsection (o) shall ensure that the quantities and concentrations
of source material are as labeled and indicated in any transfer
records.
4) Each person licensed
under this subsection (o) shall provide the information specified in this
subsection (o)(4) to each person to whom source material is transferred for use
under Section 330.210. This information shall be transferred before the source
material is transferred for the first time in each calendar year to the
particular recipient. The required information includes:
A) A copy of Sections
330.210
and 330.400; and
B) Appropriate
radiation safety precautions and instructions relating to handling, use,
storage and disposal of the material.
5) Each person licensed under this subsection
(o) shall report transfers as follows:
A)
File a report with the Agency that includes the following information:
i) The name, address and license number of
the person who transferred the source material;
ii) For each general licensee under Section
330.210
to whom greater than 50 grams (0.11 pounds) of source material has been
transferred in a single calendar quarter, the name and address of the general
licensee to whom source material is distributed; a responsible agent, by name
and/or position and phone number, of the general licensee to whom the material
was sent; and the type, physical form and quantity of source material
transferred; and
iii) The total
quantity of each type and physical form of source material transferred in the
reporting period to all such generally licensed recipients.
B) File a report with each
responsible Agreement State or NRC, as appropriate, that identifies all
persons, operating under provisions equivalent to Section 330.210, to whom
greater than 50 grams (0.11 pounds) of source material has been transferred
within a single calendar quarter. The report shall include the following
information specific to those transfers made to the Agreement State or NRC
licensees:
i) The name, address and license
number of the person who transferred the source material;
ii) The name and address of the general
licensee to whom source material was distributed; a responsible agent, by name
and/or position and phone number, of the general licensee to whom the material
was sent; and the type, physical form and quantity of source material
transferred; and
iii) The total
quantity of each type and physical form of source material transferred in the
reporting period to all such generally licensed recipients within the Agreement
State or NRC jurisdictions.
C) Submit each report by January 31 of each
year covering all transfers for the previous calendar year. If no transfers
were made to persons generally licensed under Section 330.210, or equivalent
Agreement State or NRC provisions, during the current period, a report shall be
submitted to the Agency indicating so. If no transfers have been made to
general licensees in a particular Agreement State during the reporting period,
this information shall be reported to each responsible Agreement State agency
or NRC upon request.
6)
Each person licensed under this subsection (o) shall maintain all information
that supports the reports required by subsection (o)(5) concerning each
transfer to a general licensee for a period of one year after the event is
included in a report to the Agreement State agency or NRC.
p) Material Transfer Reports and Records
Each person licensed under subsection (d) to distribute devices to generally licensed persons shall comply with the requirements of this subsection (p).
1) The person
shall report:
A) To the Agency and to the
responsible regulatory agency all transfers of devices to persons for use under
the general license in Section
330.220(a)
or the equivalent regulations of NRC or an Agreement State;
B) To the Agency and to the responsible
regulatory agency all receipts of devices from persons generally licensed under
Section
330.220(a)
or the equivalent regulations of NRC or an Agreement State;
C) To the Agency if no transfers were made to
or from general licensees during the reporting period; and
D) To the responsible regulatory agency upon
the request of the agency if no transfers during the reporting period were made
to or from general licensees in the agency's area of jurisdiction.
2) The report shall be on NRC Form
653, "Transfers of Industrial Devices Report", or in a clear and legible format
containing all of the information required by the form. The report shall cover
each calendar quarter, shall be filed within 30 days after the end of the
calendar quarter, and shall clearly indicate the period covered.
3) For a transfer to a general licensee, the
report shall provide:
A) The identity of the
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 shall be submitted, along with information on the actual
location of use;
B) The name, title
and phone number of the individual identified by the general licensee as having
knowledge of and authority to take required actions to ensure compliance with
the appropriate regulations and requirements;
C) The date of transfer;
D) The type, model and serial number of the
device transferred; and
E) The
radionuclide and activity contained in the device.
4) If one or more intermediate persons will
temporarily possess a device at the intended place of use before its possession
by the user, the report shall include the same information for both the
intended user and each intermediate person and shall clearly designate all
intermediate persons.
5) For a
device received from a general licensee, the report shall provide the name and
address of the general licensee and the type, model and serial number of the
device and the date of receipt. For a device not initially transferred by the
reporting person, the report shall provide the name of the manufacturer or
distributor.
6) If the person makes
a change to a device possessed by a general licensee that necessitates a change
in the label, the report shall identify the general licensee, the device and
the changes to information on the device label.
7) The report shall clearly identify the
person licensed under subsection (d) that is furnishing the report and shall
include the person's specific license number.
8) The person shall maintain all information
concerning transfers and receipts of devices that supports the reports required
by this subsection (p). These records shall be maintained for 5 years following
the recorded event.
Notes
Amended at 35 Ill. Reg. 2931, effective February 7, 2011
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