TITLE 32: ENERGY
CHAPTER II: DEPARTMENT OF NUCLEAR SAFETY
SUBCHAPTER b: RADIATION PROTECTION
PART 330
LICENSING OF RADIOACTIVE MATERIAL
SUBPART A: GENERAL PROVISIONS
Section
330.10 Purpose and Scope
330.30 License Exemption - Source Material
330.40 License Exemption - Radioactive Materials Other Than Source
Material
SUBPART B: TYPES OF LICENSES
Section
330.200 Types of Licenses
330.210 General Licenses - Source Material
330.220 General Licenses - Radioactive Material Other Than Source Material
SUBPART C: SPECIFIC LICENSES
Section
330.240 Filing Application for Specific Licenses
330.250 General Requirements for the Issuance of Specific Licenses
330.260 Special Requirements for Issuance of Certain Specific Licenses
for Radioactive Materials
330.270 Special Requirements for Specific Licenses of Broad Scope
330.280 Special Requirements for a Specific License to Manufacture,
Assemble, Repair, or Distribute Commodities, Products, or
Devices which Contain Radioactive Material
330.300 Issuance of Specific Licenses
330.310 Specific Terms and Conditions of License
330.320 Expiration and Termination of Licenses
330.330 Renewal of Licenses
330.340 Amendment of Licenses at Request of Licensee
330.350 Department Action on Application to Renew or Amend
330.360 Persons Possessing a License for Source, Byproduct, or Special
Nuclear Material in Quantities Not Sufficient to Form a Critical
Mass on Effective Date of This Part
330.370 Persons Possessing Accelerator-Produced or Naturally-Occurring
Radioactive Material on Effective Date of This Part (Repealed)
330.400 Transfer of Material
330.500 Modification and Revocation of Licenses
330.900 Reciprocal Recognition of Licenses
SUBPART D: TRANSPORTATION (Repealed)
Section
330.1000 Transportation of Radioactive Materials (Repealed)
330.APPENDIX A EXEMPT CONCENTRATIONS
330.APPENDIX B EXEMPT QUANTITIES
330.APPENDIX C GROUPS OF MEDICAL USES OF RADIOACTIVE MATERIALS (Repealed)
330.TABLE A Group I (Repealed)
330.TABLE B Group II (Repealed)
330.TABLE C Group III (Repealed)
330.TABLE D Group IV (Repealed)
330.TABLE E Group V (Repealed)
330.TABLE F Group VI (Repealed)
330.APPENDIX D LIMITS FOR BROAD LICENSES (SECTION 330.270)
330.APPENDIX E Schedule E (Repealed)
330.APPENDIX F Schedule F (Repealed)
330.APPENDIX G FINANCIAL SURETY ARRANGEMENTS (SECTION 330.250(c)(1)(D))
330.APPENDIX H WORDING OF FINANCIAL SURETY ARRANGEMENTS (SECTION
330.250(c)(1)(E))
AUTHORITY: Implementing and authorized by the Radiation Protection Act of
1990 (Ill. Rev. Stat. 1990 Supp., ch. 111�, pars. 210-1 et seq.).
SOURCE: Filed April 20, 1974, by the Department of Public Health; transferred
to the Department of Nuclear Safety by P.A. 81-1516, effective December 3,
1980; amended at 5 Ill. Reg. 9586, effective September 10, 1981; codified at 7
Ill. Reg. 17492; recodified at 10 Ill. Reg. 11268; amended at 10 Ill. Reg.
17315, effective September 25, 1986; amended at 15 Ill. Reg. 10632, effective
July 15, 1991.
SUBPART A: GENERAL PROVISIONS
Section 330.10 Purpose and Scope
a) This Part provides for the licensing of radioactive material. No
person shall receive, possess, utilize, manufacture, distribute,
transfer, own, or acquire radioactive material or devices or
equipment utilizing or producing such materials except as
authorized in a specific or general license issued pursuant to
this Part or as otherwise provided in this Part.
b) In addition to the requirements of subsection (a), all licensees
are subject to the requirements of this Part, and 32 Ill. Adm.
Code 310, 320, 331, 340, 341 and 400. Licensees engaged in
industrial radiographic operations are subject to the requirements
of 32 Ill. Adm. Code 350. Licensees using radioactive material in
the healing arts are subject to the requirements of 32 Ill. Adm.
Code 335 and licensees engaged in wireline and subsurface tracer
studies are subject to the requirements of 32 Ill. Adm. Code 351.
The requirements of this Part do not apply to carriers. Carriers
are subject to the requirements of 32 Ill. Adm. Code 341.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.30 License Exemption - Source Material
a) Any person is exempt from this Part to the extent that such person
receives, possesses, uses, owns, or transfers source material in
any chemical mixture, compound, solution, or alloy in which the
source material is by weight less than 1/20 of 1 percent (0.05
percent) of the mixture, compound, solution, or alloy.
b) Any person is exempt from this Part to the extent that such person
receives, possesses, uses, or transfers unrefined and unprocessed
ore containing source material; provided that, except as
authorized in a specific license, such person shall not refine or
process such ore.
c) Any person is exempt from this Part to the extent that such person
receives, possesses, uses, or transfers:
1) Any quantities of thorium contained in:
A) Incandescent gas mantles,
B) Vacuum tubes,
C) Welding rods,
D) Electric lamps for illuminating purposes provided that
each lamp does not contain more than 50 milligrams of
thorium,
E) Germicidal lamps, sunlamps and lamps for outdoor or
industrial lighting provided that each lamp does not
contain more than 2 grams of thorium,
F) Rare earth metals and compounds, mixtures and products
containing not more than 0.25 percent by weight
thorium, uranium, or any combination of these, or
G) Personnel neutron dosimeters, provided that each
dosimeter does not contain more than 50 milligrams of
thorium.
2) Source material contained in the following products:
A) Glazed ceramic tableware, provided that the glaze
contains not more than 20 percent by weight source
material,
B) Piezoelectric ceramic containing not more than 2
percent by weight source material,
C) Glassware containing not more than 10 percent by
weight source material, but not including commercially
manufactured glass brick, pane glass, ceramic tile, or
other glass or ceramic used in construction, and
D) Glass enamel or glass enamel frit containing not more
than 10 percent by weight source material imported or
ordered for importation into the United States, or
initially distributed by manufacturers in the United
States, before July 25, 1983.
3) Photographic film, negatives and prints containing uranium
or thorium.
4) Any finished product or part fabricated of, or containing,
tungsten-thorium or magnesium-thorium alloys, provided that
the thorium content of the alloy does not exceed 4 percent
by weight and that this exemption shall not be deemed to
authorize the chemical, physical, or metallurgical treatment
or processing of any such product or part.
5) Uranium contained in counterweights installed in aircraft,
rockets, projectiles and missiles, or stored or handled in
connection with installation or removal of such counter-
weights, provided that:
A) The counterweights are manufactured in accordance with
a specific license issued by the U.S. Nuclear
Regulatory Commission or the Atomic Energy Commission
authorizing distribution by the licensee pursuant to
10 CFR 40.13(c)(5)(i), as in effect on June 30, 1969,
B) Each counterweight has been impressed with the
following legend clearly legible through any plating
or other covering: "DEPLETED URANIUM",
AGENCY NOTE: The requirement specified in subsection
(c)(5)(B) does not need to be met by counterweights
manufactured prior to December 31, 1969; provided that
such counterweights were manufactured under a specific
license issued by the Atomic Energy Commission and
were impressed with the legend, "CAUTION - RADIOACTIVE
MATERIAL - URANIUM", as previously required by 10 CFR
40.13(c)(5)(ii), as in effect June 30, 1969, exclusive
of subsequent amendments or additions. A copy of this
rule is available for public inspection at the
Department of Nuclear Safety (Department).
C) Each counterweight is durably and legibly labeled or
marked with the identification of the manufacturer and
the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED",
and
AGENCY NOTE: The requirement specified in subsection
(c)(5)(C) does not need to be met by counterweights
manufactured prior to December 31, 1969; provided that
such counterweights were manufactured under a specific
license issued by the Atomic Energy Commission and
were impressed with the legend, "CAUTION - RADIOACTIVE
MATERIAL - URANIUM", as previously required by 10 CFR
40.13(c)(5)(ii), as in effect June 30, 1969, exclusive
of subsequent amendments or additions. A copy of this
rule is available for public inspection at the
Department.
D) This exemption shall not be deemed to authorize the
chemical, physical, or metallurgical treatment or
processing of any such counterweights other than
repair or restoration of any plating or covering.
6) Natural or depleted uranium metal used as shielding
constituting part of any shipping container, provided that:
A) The shipping container is conspicuously and legibly
impressed with the legend, "CAUTION- RADIOACTIVE
SHIELDING-URANIUM"; and
B) The uranium metal is encased in mild steel or equally
fire resistant metal of minimum wall thickness of one-
eighth inch (3.2mm).
7) Thorium contained in finished optical lenses, provided that
each lens does not contain more than 30 percent by weight of
thorium, and that this exemption shall not be deemed to
authorize either:
A) The shaping, grinding, or polishing of such lens or
manufacturing processes other than the assembly of
such lens into optical systems and devices without any
alteration of the lens, or
B) The receipt, possession, use, or transfer of thorium
contained in contact lenses, or in spectacles, or in
eyepieces in binoculars or other optical instruments.
8) Uranium contained in detector heads for use in fire
detection units, provided that each detector head contains
not more than 0.005 microcurie of uranium; or
9) Thorium contained in any finished aircraft engine part
containing nickel-thoria alloy, provided that:
A) The thorium is dispersed in the nickel-thoria alloy in
the form of finely divided thoria (thorium dioxide),
and
B) The thorium content in the nickel-thoria alloy does
not exceed 4 percent by weight.
d) The exemptions in subsection (c) do not authorize the manufacture
of any of the products described.
e) Any licensee is exempt from the requirements of this Part to the
extent that its activities are subject to the requirements of 32
Ill. Adm. Code 601, except as specifically provided for in 32 Ill.
Adm. Code 601.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.40 License Exemption - Radioactive Materials Other Than Source
Materials
a) Exempt Concentrations.
1) Except as provided in Section 330.40(a)(2), any person is
exempt from this Part to the extent that such person
receives, possesses, uses, transfers, owns, or acquires
products containing radioactive material introduced in
concentrations not in excess of those listed in Appendix A
of this Part. This Section shall not be deemed to authorize
the import of radioactive materials or products containing
radioactive materials.
2) 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 330.40(a)(1)
or equivalent regulations of the U.S. Nuclear Regulatory
Commission (10 CFR 30.14 revised as of January 1, 1985,
exclusive of any subsequent amendments or editions), any
Agreement State or Licensing State, except in accordance
with a specific license issued pursuant to Section
330.280(a) or the general license provided in Section
330.900.
b) Exempt Quantities.
1) Except as provided in Section 330.40(b)(2) and (3), any
person is exempt from this Part to the extent that such
person receives, possesses, uses, transfers, owns, or
acquires radioactive material in individual quantities each
of which does not exceed the applicable quantity set forth
in Appendix B of this Part.
2) This paragraph (Section 330.40(b)) does not authorize the
production, packaging or repackaging of radioactive material
for purposes of commercial distribution, or the
incorporation of radioactive material into products intended
for commercial distribution.
3) No person may, for purposes of commercial distribution,
transfer radioactive material in the individual quantities
set forth in Appendix B of this Part, knowing or having
reason to believe that such quantities of radioactive
material will be transferred to persons exempt under Section
330.40(b) or equivalent regulations of the United States
Nuclear Regulatory Commission, any Agreement State or
Licensing State, except in accordance with a specific
license issued by the U.S. Nuclear Regulatory Commission
pursuant to Section 32.18 of 10 CFR 32 or by the Department
pursuant to Section 330.280(b) which license states that the
radioactive material may be transferred by the licensee to
persons exempt under Section 330.40(b) or the equivalent
regulations of the U.S. Nuclear Regulatory Commission, an
Agreement State or Licensing State.
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, D.C. 20555.
c) Exempt Items.
1) Certain Items Containing Radioactive Material. Except for
persons who apply radioactive material to, or persons who
incorporate radioactive material into the following products
or persons who initially transfer for sale or distribution
the following products, any person is exempt from this Part
to the extent that he receives, possesses, uses, transfers,
owns, or acquires the following products:
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, D.C. 20555.
A) Timepieces or hands or dials containing not more than
the following specified quantities of radioactive
material and not exceeding the following specified
radiation dose rate:
i) 25 millicuries (925 MBq) of tritium per
timepiece;
ii) 5 millicuries (185 MBq) of tritium per hand;
iii) 15 millicuries (555 MBq) of tritium per dial
(bezels when used shall be considered as part
of the dial);
iv) 100 microcuries (3.7 MBq) of promethium-147 per
watch or 200 microcuries (7.4 MBq) of
promethium-147 per any other timepiece;
v) 20 microcuries (0.74 MBq) of promethium-147 per
watch hand or 40 microcuries (1.48 MBq) of
promethium-147 per other timepiece hand;
vi) 60 microcuries (2.22 MBq) of promethium-147 per
watch dial or 120 microcuries (4.44 MBq) of
promethium-147 per other timepiece dial (bezels
when used shall be considered as part of the
dial);
vii) The radiation dose rate from hands and dials
containing promethium-147 will not exceed, when
measured through 50 milligrams per square
centimeter of absorber: for wrist watches, 0.1
millirad (1 uGy) per hour at 10 centimeters from
any surface; for pocket watches, 0.1 millirad (1
uGy) per hour at 1 centimeter from any surface;
for any other timepiece, 0.2 millirad (2 uGy)
per hour at 10 centimeters from any surface; or
viii) one microcurie (37 kBq) of radium-226 per
timepiece in timepieces acquired prior to May 1,
1974.
B) Lock illuminators containing not more than 15
millicuries (555 MBq) of tritium or not more than 2
millicuries (74 MBq) of promethium-147 installed in
automobile locks. The radiation dose rate from each
lock illuminator containing promethium-147 will not
exceed 1 millirad (10 uGy) per hour at 1 centimeter
from any surface when measured through 50 milligrams
per square centimeter of absorber.
C) Precision balances containing not more than 1
millicurie (37 MBq) of tritium per balance or not more
than 0.5 millicurie (18.5 MBq) of tritium per balance
part.
D) Automobile shift quadrants containing not more than
25 millicuries (925 MBq) of tritium.
E) Marine compasses containing not more than 750
millicuries (27.8 GBq) of tritium gas and other marine
navigational instruments containing not more than 250
millicuries (9.25 GBq) of tritium gas.
F) Thermostat dials and pointers containing not more than
25 millicuries (925 MBq) of tritium per thermostat.
G) Electron tubes; provided that each tube does not
contain more than one of the following specified
quantities of radioactive material:
i) 150 millicuries (5.55 GBq) of tritium per
microwave receiver protector tube or 10
millicuries (370 MBq) of tritium per any other
electron tube;
ii) 1 microcurie (37 kBq) of cobalt-60;
iii) 5 microcuries (185 kBq) of nickel-63;
iv) 30 microcuries (1.11 MBq) of krypton-85;
v) 5 microcuries (185 kBq) of cesium-137; or
vi) 30 microcuries (1.11 MBq) of promethium-147.
and provided further, that the radiation dose rate
from each electron tube containing radioactive
material will not exceed 1 millirad (10 uGy) per hour
at 1 centimeter from any surface when measured through
7 milligrams per square centimeter of absorber.
AGENCY NOTE: For purposes of Section 330.40(c)(1)(G),
"electron tubes" include spark gap tubes, power tubes,
gas tubes including glow lamps, receiving tubes,
microwave tubes, indicator tubes, pick-up tubes,
radiation detection tubes, and any other completely
sealed tube that is designed to conduct or control
electrical currents.
H) Ionizing radiation measuring instruments containing,
for purposes of internal calibration or
standardization, one or more sources of radioactive
material, provided that:
i) Each source contains no more than one exempt
quantity set forth in Appendix B of this Part;
and
ii) Each instrument contains no more than 10 exempt
quantities. For purposes of this requirement,
an instrument's source(s) may contain either one
or different types of radionuclides and an
individual exempt quantity may be composed of
fractional parts of one or more of the exempt
quantities in Appendix B of this Part, provided
that the sum of such fractions shall not exceed
unity.
AGENCY NOTE: For purposes of Section 330.40(c)(1)(H),
0.05 microcurie (1.85 kBq) of americium-241 is
considered an exempt quantity.
I) Spark gap irradiators containing not more than 1
microcurie (37 kBq) of cobalt-60 per spark gap
irradiator for use in electrically-ignited fuel oil
burners having a firing rate of at least 3 gallons
(11.4 l) per hour.
A) Tritium, Krypton-85, or Promethium-147. Except for
persons who manufacture, process, or produce self-
luminous products containing tritium, krypton-85, or
promethium-147, any person is exempt from this Part to
the extent that such person receives, possesses, uses,
transfers, owns, or acquires tritium, krypton-85, or
promethium-147 in self-luminous products manufactured,
processed, produced, imported, or transferred in
accordance with a specific license issued by the U.S.
Nuclear Regulatory Commission pursuant to Section
32.22 of 10 CFR 32, which license authorizes the
transfer of the product to persons who are exempt from
regulatory requirements. The exemption in
Section 330.40(c)(2) does not apply to tritium,
krypton-85, or promethium-147 used in products for
frivolous purposes or in toys or adornments. The U.
S. Nuclear Regulatory Commission shall make this
determination of exemption.
B) Radium-226. Any person is exempt from this Part to
the extent that such person receives, possesses, uses,
transfers, or owns articles containing less than 0.1
microcurie (3.7 kBq) of radium-226 which were acquired
prior to May 1, 1974.
3) Gas and Aerosol Detectors Containing Radioactive Material.
A) Except for persons who manufacture, process, produce,
or initially transfer for sale and distribution gas
and aerosol detectors containing radioactive material,
any person is exempt from 32 Ill. Adm. Code 320, 330,
331, 340, 350, 351, 370, 400 and 601 to the extent
that such person receives, possesses, uses, transfers,
owns, or acquires radioactive material in gas and
aerosol detectors designed to protect life or property
from fires and airborne hazards provided that
detectors containing radioactive material shall have
been manufactured, imported, or initially transferred
in accordance with a specific license issued by the
U.S. Nuclear Regulatory Commission pursuant to Section
32.26 of 10 CFR 32; or a Licensing State pursuant to
Section 330.280(c), which authorizes the transfer of
the detectors to persons who are exempt from
regulatory requirements.
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, D.C. 20555.
B) Gas and aerosol detectors previously manufactured and
distributed to general licensees in accordance with a
specific license issued by an Agreement State shall be
considered exempt under Section 330.40(c)(3)(a),
provided that the device is labeled in accordance with
the specific license authorizing distribution of the
generally licensed device, and provided further that
they meet the requirements of Section 330.280(c).
C) Gas and aerosol detectors containing naturally-
occurring or accelerator-produced radioactive material
(NARM) previously manufactured and distributed in
accordance with a specific license issued by a
Licensing State shall be considered exempt under
Section 330.40(c)(3)(a), provided that the device is
labeled in accordance with the specific license
authorizing distribution, and provided further that
they meet the requirements of Section 330.280(c).
4) Resins Containing Scandium-46 and Designed for Sand
Consolidation in Oil Wells. Any person is exempt from this
Part to the extent that such person receives, possesses,
uses, transfers, owns, or acquires synthetic plastic resins
containing scandium-46 which are designed for sand
consolidation in oil wells. Such resins shall have been
manufactured or imported in accordance with a specific
license issued by the U.S. Nuclear Regulatory Commission, or
shall have been manufactured in accordance with the
specifications contained in a specific license issued by the
Department or any Agreement State to the manufacturer of
such resins pursuant to licensing requirements equivalent to
those in Section 32.17 of 10 CFR 32, revised as of January
1, 1985, of the regulations of the U.S. Nuclear Regulatory
Commission. This exemption does not authorize the
manufacture of any resins containing scandium-46.
AGENCY NOTE: Licensing requirements contained in subsequent
amendments or editions of 10 CFR 32 are not incorporated
into this rule. A copy of 10 CFR 32 is available for public
inspection at the Department of Nuclear Safety.
(Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986)
SUBPART B: TYPES OF LICENSES
Section 330.200 Types of Licenses
Licenses for radioactive materials are of two types: general and specific.
a) "General license" means a license, set forth in this Part and 32
Ill. Adm. Code 341, which is effective without the filing of an
application to transfer, acquire, own, possess, or use quantities
of, or devices or equipment utilizing radioactive material (Ill.
Rev. Stat. 1990 Supp., ch. 111�, par. 210-4(d)), although the
filing of a certificate with the Department may be required by the
particular general license. The general licensee is subject to
all other applicable portions of 32 Ill. Adm. Code: Chapter II and
any limitations of the general license.
b) "Specific license" means a license, as set forth in this Part,
issued after application to use, manufacture, produce, transfer,
receive, acquire, own, or possess quantities of, or devices or
equipment utilizing radioactive material (Ill. Rev. Stat. 1990
Supp., ch. 111�, par. 210-4(m)). The licensee is subject to all
applicable portions of 32 Ill. Adm. Code: Chapter II as well as
any limitations specified in the licensing document.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.210 General Licenses - Source Material
a) A general license is hereby issued authorizing commercial and
industrial firms, research, educational, and medical institutions,
and State and local government agencies to use and transfer not
more than 15 pounds (6.82 kg) of source material at any one time
for research, development, educational, commercial, or operational
purposes. A person authorized to use or transfer source material,
pursuant to this general license, may not receive more than a
total of 150 pounds (68.2 kg) of source material in any one
calendar year.
b) Persons who receive, possess, use, or transfer source material
pursuant to the general license issued in Section 330.210(a) are
exempt from the provisions of 32 Ill. Adm. Code 340 and 400 to the
extent that such receipt, possession, use, or transfer is within
the terms of such general license; provided, however, that this
exemption shall not be deemed to apply to any such person who is
also in possession of source material under a specific license
issued pursuant to this Part.
c) A general license is hereby issued authorizing the receipt of
title to source material without regard to quantity. This general
license does not authorize any person to receive, possess, use, or
transfer source material.
d) Depleted Uranium in Industrial Products and Devices.
1) A general license is hereby issued to receive, acquire,
possess, use, or transfer, in accordance with the provisions
of Section 330.210(d)(2), (3), (4), and (5), depleted
uranium contained in industrial products or devices for the
purpose of providing a concentrated mass in a small volume
of the product or device.
2) The general license in Section 330.210(d)(1) applies only to
industrial products or devices which have been manufactured
either in accordance with a specific license issued to the
manufacturer of the products or devices pursuant to Section
330.280(m) or in accordance with a specific license issued
to the manufacturer by the U.S. Nuclear Regulatory
Commission or an Agreement State which authorizes
manufacture of the products or devices for distribution to
persons generally licensed by the U.S. Nuclear Regulatory
Commission or an Agreement State.
3) Persons who receive, acquire, possess, or use depleted
uranium pursuant to the general license established by
Section 330.210(d)(1) shall:
A) file the form, "Registration Certificate - Use of
Depleted Uranium Under General License," with the
Department. The form shall be submitted within 30
days after the first receipt or acquisition of such
depleted uranium. The registrant shall furnish on the
form "Registration Certificate - Use of Depleted
Uranium Under General License," the following
information:
i) name and address of the registrant;
ii) a statement that the registrant has developed
and will maintain procedures designed to
establish physical control over the depleted
uranium described in Section 330.210(d)(1) and
designed to prevent transfer of such depleted
uranium in any form, including metal scrap, to
persons not authorized to receive the depleted
uranium; and
iii) name and/or title, address, and telephone number
of the individual duly authorized to act for and
on behalf of the registrant in supervising the
procedures identified in Section
330.210(d)(3)(A)(ii).
B) report in writing to the Department any changes in
information furnished by him in the form,
"Registration Certificate - Use of Depleted Uranium
Under General License." The report shall be submitted
within 30 days after the effective date of such
change.
4) A person who receives, acquires, possesses, or uses depleted
uranium pursuant to the general license established by
Section 330.210(d)(1):
A) shall not introduce such depleted uranium, in any
form, into a chemical, physical, or metallurgical
treatment or process, except a treatment or process
for repair or restoration of any plating or other
covering of the depleted uranium;
B) shall not abandon such depleted uranium;
C) shall transfer or dispose of such depleted uranium
only by transfer in accordance with the provisions of
Section 330.400. In the case where the transferee
receives the depleted uranium pursuant to the general
license established by Section 330.210(d)(1), the
transferor shall furnish the transferee a copy of this
Part and a copy of the form, "Registration Certificate
- Use of Depleted Uranium Under General License". In
the case where the transferee receives the depleted
uranium pursuant to a general license contained in the
U.S. Nuclear Regulatory Commission's regulation, (10
CFR 40.25(a) revised as of July 1, 1985, exclusive of
any subsequent amendments or editions) or Agreement
State's regulation equivalent to Section
330.210(d)(1), the transferor shall furnish the
transferee a copy of this Part and a copy of the form,
"Registration Certificate - Use of Depleted Uranium
Under General License", accompanied by a note
explaining that use of the product or device is
regulated by the U.S. Nuclear Regulatory Commission or
Agreement State under requirements substantially the
same as those in this Part;
D) within 30 days of any transfer, shall report in
writing to the Department the name and address of the
person receiving the depleted uranium pursuant to such
transfer; and
E) shall not export such depleted uranium except in
accordance with a license issued by the U.S. Nuclear
Regulatory Commission pursuant to 10 CFR 110.
5) Any person receiving, acquiring, possessing, using, or
transferring depleted uranium pursuant to the general
license established by Section 330.210(d)(1) is exempt from
the requirements of 32 Ill. Adm. Code 340 and 400 with
respect to the depleted uranium covered by that general
license.
(Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.220 General Licenses - Radioactive Material Other Than Source
Material
a) Certain Devices and Equipment. A general license is hereby issued
to transfer, receive, acquire, own, possess and use radioactive
material incorporated in the following devices or equipment which
have been manufactured, tested and labeled by the manufacturer in
accordance with a specific license issued to the manufacturer by
the U.S. Nuclear Regulatory Commission for use pursuant to Section
31.3 of 10 CFR 31. This general license is subject to the
provisions of 32 Ill. Adm. Code 310.40 through 310.90, 340, 341,
400, and Sections 330.40(a)(2), 330.310, 330.400, and 330.500 of
this Part.
AGENCY NOTE: Attention is directed particularly to the provisions
of 32 Ill. Adm. Code 340 which relate to the labeling of
containers.
1) Static Elimination Device. Devices designed for use as
static eliminators which contain, as a sealed source or
sources, radioactive material consisting of a total of not
more than 500 microcuries (18.5 MBq) of polonium-210 per
device.
2) Ion Generating Tube. Devices designed for ionization of air
which contain, as a sealed source or sources, radioactive
material consisting of a total of not more than 500
microcuries (18.5 MBq) of polonium-210 per device or a total
of not more than 50 millicuries (1.85 GBq) of hydrogen-3
(tritium) per device.
b) Certain Measuring, Gauging or Controlling Devices.
1) A general license is hereby issued to commercial and
industrial firms and to research, educational, and medical
institutions, individuals in the conduct of their business
and State or local government agencies to own, receive,
acquire, possess, use, or transfer in accordance with the
provisions of subsection (b)(2), (3) and (4), radioactive
material, excluding special nuclear material, contained in
devices designed and manufactured for the purpose of
detecting, measuring, gauging, or controlling thickness,
density, level, interface location, radiation, leakage, or
qualitative or quantitative chemical composition, or for
producing light or an ionized atmosphere.
2) The general license in subsection (b)(1) applies only to
radioactive material contained in devices which have been
manufactured and labeled in accordance with the specifica-
tions contained in a specific license issued by the
Department pursuant to Section 330.280(d) or in accordance
with the specifications contained in a specific license
issued by the U.S. Nuclear Regulatory Commission, an
Agreement State, or a Licensing State, which authorizes
distribution of devices to persons generally licensed by the
U.S. Nuclear Regulatory Commission, an Agreement State, or a
Licensing State.
AGENCY NOTE: Regulations under the Federal Food, Drug and
Cosmetic Act authorizing the use of radioactive control
devices in food production require certain additional
labeling thereon which is found in 21 CFR 179.21.
3) Any person who owns, receives, acquires, possesses, uses, or
transfers radioactive material in a device pursuant to the
general license in subsection (b)(1):
A) Shall assure that all labels affixed to the device at
the time of receipt, and bearing a statement that
removal of the label is prohibited, are maintained
thereon and shall comply with all instructions and
precautions provided by such labels;
B) Shall assure that the device is tested for leakage of
radioactive material and proper operation of the "on-
off" mechanism and indicator, if any, at no longer
than 6-month intervals or at such other intervals as
are specified in the label; however,
i) Devices containing only krypton need not be
tested for leakage of radioactive material, and
ii) Devices containing only tritium or not more than
100 microcuries (3.7 MBq) of other beta and/or
gamma emitting material or 10 microcuries (0.37
MBq) of alpha emitting material and devices held
in storage in the original shipping container
prior to initial installation need not be tested
for any purpose;
C) Shall assure that testing (including testing required
by subsection (b)(3)(B)), installation, servicing and
removal from installation involving the radioactive
material, its shielding or containment, are performed:
i) In accordance with the instructions provided by
the labels, or
ii) By a person holding an applicable specific
license from the Department, the U.S. Nuclear
Regulatory Commission, an Agreement State, or a
Licensing State to perform such activities;
D) Shall maintain records showing compliance with the
requirements of subsections (b)(3)(B) and (3)(C). The
records shall show the results of tests concerning the
installation, leakage testing, servicing and removal
of radioactive material, its shielding or containment.
The records also shall show the dates of performance
of, and the names of persons performing these tests.
Records of tests for leakage of radioactive material
required by subsection (b)(3)(B) shall be maintained
for 1 year after the next required leak test is
performed or until the sealed source is transferred or
disposed of. Records of tests of the "on-off"
mechanism and indicator required by subsection
(b)(3)(B) shall be maintained for 1 year after the
next required test of the "on-off" mechanism and
indicator is performed or until the sealed source is
transferred or disposed of. Records which are
required by subsection (b)(3)(C), other than records
of tests for leakage of radioactive material, shall be
maintained for a period of 2 years from the date of
the recorded event or until the device is transferred
or disposed of;
E) Upon the occurrence of a failure of or damage to, or
any indication of a possible failure of or damage to,
the shielding of the radioactive material or the "on-
off" mechanism or indicator, or upon the detection of
0.005 microcurie (185 Bq) or more removable radio-
active material, shall immediately suspend operation
of the device until it has been repaired by the
manufacturer or other person holding an applicable
specific license from the Department, the U.S. Nuclear
Regulatory Commission, an Agreement State, or a
Licensing State to repair such devices, or disposed of
by transfer to a person authorized by an applicable
specific license to receive the radioactive material
contained in the device and, within 30 days, furnish
to the Department a report containing a brief descrip-
tion of the event and the remedial action taken;
F) Shall not abandon the device containing radioactive
material;
G) Except as provided in subsection (b)(3)(H), shall
transfer or dispose of the device containing
radioactive material only by transfer to a specific
licensee of the Department, the U.S. Nuclear
Regulatory Commission, an Agreement State, or a
Licensing State whose specific license authorizes him
to receive the device and within 30 days after
transfer of a device to a specific licensee shall
furnish to the Department a report containing
identification of the device by manufacturer's name
and model number and the name and address of the
person receiving the device. No report is required if
the device is transferred to the specific licensee in
order to obtain a replacement device;
H) Shall transfer the device to another general licensee
only:
i) Where the device remains in use at a particular
location. In such case the transferor shall
give the transferee a copy of subsection (b) and
any safety documents identified in the label on
the device and within 30 days of the transfer,
report to the Department the manufacturer's name
and model number of device transferred, the name
and address of the transferee and the name
and/or position of an individual who may
constitute a point of contact between the
Department and the transferee; or
ii) Where the device is held in storage in the
original shipping container at its intended
location of use prior to initial use by a
general licensee;
I) Shall comply with the provisions of 32 Ill. Adm. Code
340.4020 and 340.4030 for reporting radiation
incidents, theft, or loss of licensed material, but
shall be exempt from the other requirements of 32 Ill.
Adm. Code 340 and 400.
4) The general license in subsection (b)(1) does not authorize
the manufacture of devices containing radioactive material.
5) The general license provided in subsection (b)(1) is subject
to the provisions of 32 Ill. Adm. Code 310.40 through
310.90, 341 and Sections 330.310, 330.400 and 330.500 of
this Part.
c) Luminous Safety Devices for Aircraft.
1) A general license is hereby issued to own, receive, acquire,
possess and use tritium or promethium-147 contained in
luminous safety devices for use in aircraft, provided:
A) Each device contains not more than 10 curies (370 GBq)
of tritium or 300 millicuries (11.1 GBq) of
promethium-147; and
B) Each device has been manufactured, assembled, or
imported in accordance with a specific license issued
by the U.S. Nuclear Regulatory Commission, or each
device has been manufactured or assembled in
accordance with the specifications contained in a
specific license issued by the Department or any
Agreement State to the manufacturer or assembler of
such device pursuant to licensing requirements
equivalent to those in Section 32.53 of 10 CFR 32,
revised as of January 1, 1990, exclusive of any
subsequent amendments or editions. A copy of 10 CFR
32 is available for public inspection at the
Department of Nuclear Safety.
2) Persons who own, receive, acquire, possess, or use luminous
safety devices pursuant to the general license in subsection
(c)(1) are exempt from the requirements of 32 Ill. Adm. Code
340 and 400, except that they shall comply with the
provisions of 32 Ill. Adm. Code 340.4020 and 340.4030.
3) This general license does not authorize the manufacture,
assembly, or repair of luminous safety devices containing
tritium or promethium-147.
4) This general license does not authorize the ownership,
receipt, acquisition, possession, or use of promethium-147
contained in instrument dials.
5) This general license is subject to the provisions of 32 Ill.
Adm. Code 310.40 through 310.90, 341 and Sections 330.310,
330.400 and 330.500 of this Part.
d) Ownership of Radioactive Material. A general license is hereby
issued to own radioactive material without regard to quantity.
Notwithstanding any other provisions of this Part, this general
license does not authorize the manufacture, production, transfer,
receipt, possession, or use of radioactive material.
e) Calibration and References Sources.
1) A general license is hereby issued to those persons listed
below to own, receive, acquire, possess, use and transfer,
in accordance with the provisions of subsections (e)(4) and
(5), americium-241 in the form of calibration or reference
sources:
A) Any person who holds a specific license issued by the
Department which authorizes him to receive, possess,
use and transfer radioactive material; and
B) Any person who holds a specific license issued by the
U.S. Nuclear Regulatory Commission which authorizes
him to receive, possess, use and transfer special
nuclear material.
2) A general license is hereby issued to own, receive, possess,
use and transfer plutonium in the form of calibration or
reference sources in accordance with the provisions of
subsections (e)(4) and (5) to any person who holds a
specific license issued by the Department which authorizes
him to receive, possess, use and transfer radioactive
material.
3) A general license is hereby issued to own, receive, possess,
use and transfer radium-226 in the form of calibration or
reference sources in accordance with the provisions of
subsections (e)(4) and (5) to any person who holds a
specific license issued by the Department which authorizes
him to receive, possess, use and transfer radioactive
material.
4) The general licenses in subsections (e)(1), (2) and (3)
apply only to calibration or reference sources which have
been manufactured in accordance with the specifications
contained in a specific license issued to the manufacturer
or importer of the sources by the U.S. Nuclear Regulatory
Commission pursuant to Section 32.57 of 10 CFR 32 or Section
70.39 of 10 CFR 70, revised as of January 1, 1990, or which
have been manufactured in accordance with the specifications
contained in a specific license issued by the Department,
any Agreement State, or Licensing State pursuant to
licensing requirements equivalent to those contained in
Section 32.57 of 10 CFR 32 or Section 70.39 of 10 CFR 70,
revised as of January 1, 1990, exclusive of subsequent
amendments or additions. Licensing requirements contained
in subsequent amendments or editions of 10 CFR 32 or 10 CFR
70 are not incorporated into this Part. Copies of 10 CFR 32
and 10 CFR 70 are available for public inspection at the
Department of Nuclear Safety.
5) The general licenses provided in subsections (e)(1), (2) and
(3) are subject to the provisions of 32 Ill. Adm. Code
310.40 through 310.90, 340, 341, 400 and Sections 330.310,
330.400 and 330.500 of this Part. In addition, persons who
own, receive, acquire, possess, use, or transfer one or more
calibration or reference sources pursuant to these general
licenses:
A) Shall not possess at any one time, at any one location
of storage or use, more than 5 microcuries (185 kBq)
of americium-241, 5 microcuries (185 kBq) of
plutonium, or 5 microcuries (185 kBq) of radium-226 in
such sources;
B) Shall not receive, possess, use, or transfer such
source unless the source, or the storage container,
bears a label which includes one of the following
statements, as appropriate, or a statement which
contains the information called for in one of the
following statements, as appropriate:
i) The receipt, possession, use and transfer of
this source, Model , Serial No. ,
are subject to a general license and the
regulations 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. Do not remove
this label.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE
CONTAINS (AMERICIUM-241) (PLUTONIUM). DO NOT
TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
Name of Manufacturer or Importer
AGENCY NOTE: Showing only the name of the
appropriate material.
ii) The receipt, possession, use and transfer of
this source, Model , Serial No. ,
are subject to a general license and the
regulations of a Licensing State. Do not remove
this label.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE
CONTAINS RADIUM-226. DO NOT TOUCH RADIOACTIVE
PORTION OF THIS SOURCE.
Name of Manufacturer or Importer
C) Shall not transfer, abandon, or dispose of such source
except by transfer to a person authorized by a license
from the Department, the U.S. Nuclear Regulatory
Commission, an Agreement State, or a Licensing State
to receive the source;
D) Shall store such source, except when the source is
being used, in a closed container adequately designed
and constructed to contain americium-241, plutonium,
or radium-226 which might otherwise escape during
storage; and
E) Shall not use such source for any purpose other than
the calibration of radiation detectors or the
standardization of other sources.
6) These general licenses do not authorize the manufacture of
calibration or reference sources containing americium-241,
plutonium, or radium-226.
f) General License for Use of Radioactive Material for Certain In
Vitro Clinical or Laboratory Testing.
AGENCY NOTE: The New Drug provisions of the Federal Food, Drug
and Cosmetic Act also govern the availability and use of any
specific diagnostic drugs in interstate commerce.
1) A general license is hereby issued to any physician,
veterinarian, clinical laboratory, or hospital to receive,
acquire, possess, transfer, or use, for any of the following
stated tests, in accordance with the provisions of
subsections (f)(2), (3), (4), (5) and (6), the following
radioactive materials in prepackaged units for use in in
vitro clinical or laboratory tests not involving internal or
external administration of radioactive material, or the
radiation therefrom, to human beings or animals:
A) Carbon-14, in units not exceeding 10 microcuries (370
kBq) each.
B) Cobalt-57, in units not exceeding 10 microcuries (370
kBq) each.
C) Hydrogen-3 (tritium), in units not exceeding 50
microcuries (1.85 MBq) each.
D) Iodine-125, in units not exceeding 10 microcuries (370
kBq) each.
E) Mock Iodine-125 reference or calibration sources, in
units not exceeding 0.05 microcurie (1.85 kBq) of
iodine-129 and 0.005 microcurie (185 Bq) of americium-
241 each.
F) Iodine-131, in units not exceeding 10 microcuries (370
kBq) each.
G) Iron-59, in units not exceeding 20 microcuries (740
kBq) each.
H) Selenium-75, in units not exceeding 10 microcuries
(370 kBq) each.
2) No person shall receive, acquire, possess, use, or transfer
radioactive material pursuant to the general license
established by subsection (f)(1) until he has:
A) Filed Department Form KLM.006, "Certificate - In Vitro
Testing with Radioactive Material Under General
License", with the Department and received from the
Department a validated copy of Department Form KLM.006
with certification number assigned.
B) The physician, veterinarian, clinical laboratory, or
hospital requesting general licensure pursuant to
subsection (f)(2)(A) shall furnish on Department Form
KLM.006 the following information and such other
information as may be required by that form:
i) Name and address of the physician, veterinarian,
clinical laboratory, or hospital;
ii) The location of use; and
iii) A statement that the physician, veterinarian,
clinical laboratory, or hospital has appropriate
radiation measuring instruments to carry out in
vitro clinical or laboratory tests with
radioactive material as authorized under the
general license in subsection (f)(1) and that
such tests will be performed only by personnel
competent in the use of such instruments and in
the handling of the radioactive material.
3) A person who receives, acquires, possesses, or uses
radioactive material pursuant to the general license
established by subsection (f)(1) shall comply with the
following:
A) The general licensee shall not possess at any one
time, pursuant to the general license in subsection
(f)(1), at any one location of storage, or use a total
amount of iodine-125, iodine-131, selenium-75, iron-59
and/or cobalt-57 in excess of 200 microcuries (7.4
MBq).
B) The general licensee shall store the radioactive
material, until used, in the original shipping
container or in a container providing equivalent
radiation protection.
C) The general licensee shall use the radioactive
material only for the uses authorized by subsection
(f)(1).
D) The general licensee shall not transfer the
radioactive material to a person who is not authorized
to receive it pursuant to a license issued by the
Department, the U.S. Nuclear Regulatory Commission,
any Agreement State, or Licensing State, nor transfer
the radioactive material in any manner other than in
the unopened, labeled shipping container as received
from the supplier.
E) The general licensee shall dispose of the mock iodine-
125 reference or calibration sources described in
subsection (f)(1)(E) as required by 32 Ill. Adm. Code
340.3010.
4) The general licensee shall not receive, acquire, possess, or
use radioactive material pursuant to subsection (f)(1):
A) Except as prepackaged units which are labeled in
accordance with the provisions of an applicable
specific license issued pursuant to Section 330.280(g)
or in accordance with the provisions of a specific
license issued by the U.S. Nuclear Regulatory
Commission, any Agreement State, or Licensing State
which authorizes the manufacture and distribution of
iodine-125, iodine-131, carbon-14, hydrogen-3
(tritium), iron-59, selenium-75, cobalt-57, or mock
iodine-125 to persons generally licensed under
subsection (f) or its equivalent, and
B) Unless one of the following statements, as
appropriate, or a statement which contains the
information called for in one 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 shall 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 shall 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 a Licensing State.
Name of Manufacturer
5) The physician, veterinarian, clinical laboratory, or
hospital possessing or using radioactive material under the
general license of subsection (f)(1) shall report in writing
to the Department, any changes in the information furnished
by him in the "Certificate - In Vitro Testing with
Radioactive Material Under General License", Department Form
KLM.006. The report shall be furnished within 30 days after
the effective date of such change.
6) Any person using radioactive material pursuant to the
general license of subsection (f)(1) is exempt from the
requirements of 32 Ill. Adm. Code 340 and 400 with respect
to radioactive material covered by that general license,
except that such persons shall comply with the provisions of
32 Ill. Adm. Code 340.3010. In addition, persons using mock
iodine-125 described in subsection (f)(1)(E) shall also
comply with the provisions of 32 Ill. Adm. Code 340.4020 and
340.4030.
g) Ice Detection Devices.
1) A general license is hereby issued to own, receive, acquire,
possess, use and transfer strontium-90 contained in ice
detection devices, provided each device contains not more
than 50 microcuries (1.85 MBq) of strontium-90 and each
device has been manufactured or initially transferred in
accordance with a specific license issued by the U.S.
Nuclear Regulatory Commission or each device has been
manufactured or initially transferred in accordance with the
specifications contained in a specific license issued by the
Department or an Agreement State to the manufacturer of such
device pursuant to licensing requirements equivalent to
those in Section 32.61 of 10 CFR 32.
2) Persons who own, receive, acquire, possess, use, or transfer
strontium-90 contained in ice detection devices pursuant to
the general license in subsection (g)(1):
A) Shall, upon occurrence of visually observable damage,
such as a bend or crack or discoloration from
overheating to the device, discontinue use of the
device until it has been inspected, tested for leakage
and repaired by a person holding a specific license
from the U.S. Nuclear Regulatory Commission or an
Agreement State to manufacture or service such
devices; or shall dispose of the device pursuant to
the provisions of 32 Ill. Adm. Code 340.3010;
B) Shall assure that all labels affixed to the device at
the time of receipt, and which bear a statement which
prohibits removal of the labels, are maintained
thereon; and
C) Are exempt from the requirements of 32 Ill. Adm. Code
340 and 400 except that such persons shall comply with
the provisions of 32 Ill. Adm. Code 340.3010, 340.4020
and 340.4030.
3) This general license does not authorize the manufacture,
assembly, disassembly, or repair of strontium-90 in ice
detection devices.
4) This general license is subject to the provisions of 32 Ill.
Adm. Code 310.40 through 310.90, 341 and Sections 330.310,
330.400 and 330.500 of this Part.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
SUBPART C: SPECIFIC LICENSES
Section 330.240 Filing Application for Specific Licenses
a) Applications for specific licenses shall be filed in duplicate on
forms prescribed by the Department.
b) The Department may at any time after the filing of the original
application, and before the expiration of the license, require
further statements in order to enable the Department to determine
whether the application should be granted or denied or whether an
existing license should be modified or revoked.
c) Each application shall be signed by the applicant or licensee or a
person duly authorized to act for and on his behalf.
d) An application may include a request for a license authorizing one
or more activities. The Department will not grant the request if
the proposed activities are not under the control of the same
facility, administrator and radiation safety officer. In
addition, when evaluating the request, the Department will
consider complexity, similarity and proximity of the proposed
activities.
e) In the application, the applicant may incorporate by reference
information contained in previous applications, statements, or
reports filed with the Department provided such references are
clear and specific.
f) Public inspection of applications and other documents submitted to
the Department pursuant to this Section shall be in accordance
with 2 Ill. Adm. Code 1076 and the requirements of the Freedom of
Information Act (Ill. Rev. Stat. 1989, ch. 116, par. 201 et seq.).
g) An application for a specific license to authorize receipt,
possession, or use of radioactive material in the form of a sealed
source or in a device that contains a sealed source must either:
1) Identify the sealed source or device that contains a sealed
source by manufacturer and model number as filed in an
evaluation sheet in the U.S. Department of Health and Human
Services "Radioactive Material Reference Manual" or in the
U.S. Nuclear Regulatory Commission "Registry of Radioactive
Sealed Sources and Devices"; or
2) Contain the information identified in Section 330.280(m).
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.250 General Requirements for the Issuance of Specific Licenses
a) A license application will be approved only if the Department
determines that:
1) The applicant is qualified by reason of training and
experience to use the material in question for the purpose
requested in accordance with this Part in such a manner as
to minimize danger to public health and safety or property;
2) The applicant's proposed equipment, facilities and
procedures are adequate to minimize danger to public health
and safety or property;
3) The issuance of the license will not be inimical to the
health and safety of the public; and
4) The applicant satisfies any applicable special requirements
in Sections 330.260, 330.270, or 330.280.
b) Environmental Report, Commencement of Construction.
1) In the case of an application for a license to receive and
possess radioactive material for commercial waste disposal
by land burial, or for the conduct of any other activity
which the Department determines will significantly affect
the quality of the environment, a license application must
be reviewed and approved by the Department before
commencement of construction of the plant or facility in
which the activity will be conducted. Issuance of the
license shall be based upon a consideration by the
Department of the environmental, economic, technical and
other benefits in comparison with the environmental costs
and available alternatives, and a determination that the
action called for is the issuance of the proposed license,
with any appropriate conditions to protect environmental
values;
2) Commencement of construction prior to such conclusion shall
be grounds for denial of a license to receive and possess
radioactive material in such plant or facility. As used in
this paragraph the term "commencement of construction" means
any clearing of land, excavation, or other substantial
action that would adversely affect the environment of a
site. The term does not mean site exploration, necessary
borings to determine foundation conditions, or other
preconstruction monitoring or testing to establish
background information related to the suitability of the
site or the protection of environmental values.
c) Financial Surety Arrangements for Reclaiming Sites. For purposes
of this subsection, "reclaiming" shall mean returning property to
a condition or state such that the property no longer presents a
public health or safety hazard or threat to the environment.
1) Unless exempted by subsection (c)(4) or (c)(5), issuance or
amendment of a license shall be dependent upon satisfactory
financial surety arrangements to ensure the protection of
the public health and safety in the event of abandonment,
default, or other inability of the licensee to meet the
requirements of the Act, this Part, 32 Ill. Adm. Code:
Chapter II, Subparts b and d. Self insurance, or any
arrangement which essentially constitutes self insurance,
will not satisfy the surety requirements since such
arrangement provides no further assurance than being without
insurance. Determination of satisfactory surety
arrangements shall be subject to the following conditions:
A) Financial surety arrangements for site reclamation may
consist of surety bonds, certificates of deposit,
deposits of government securities, letters of credit,
insurance policies, or any combination of the above
for the categories of licenses listed in subsection
(c)(3). The amount of funds to be ensured by such
surety arrangements shall be based on Department-
approved reclaiming cost estimates for disposal of all
radioactive material authorized under the license,
including removal of all radioactive contamination
caused by authorized material to a level in
conformance with 32 Ill. Adm. Code 340.Appendix C.
The Department shall consider the following in
approving the cost estimate of the financial surety
requirements for each individual applicant or
licensee:
i) The probable extent of contamination through the
use or possession of radioactive material at the
facility or site and the probable cost of
removal of such contamination to a level in con-
formance with 32 Ill. Adm. Code 340.Appendix C.
This consideration shall encompass probable
contaminating events associated with licensee's
methods or modes of operation and shall be based
on factors such as quantities, half-lives,
radiation hazards and toxicities, and chemical
and physical forms;
ii) The extent of possible off-site property damage
caused by operation of the facility or site;
iii) The cost of removal and disposal of sources of
radiation, which are or would be generated,
stored, processed, or otherwise present at the
licensed facility or site; and
iv) The costs involved in reclaiming the property on
which the facility or site is located, and all
other properties contaminated by radioactive
material authorized under the license.
B) The financial surety arrangements shall be filed with
and maintained by the Chief, Division of Radioactive
Materials of the Department (hereafter referred to as
the Division Chief) in a dollar amount greater than or
equal to the amount approved by the Department and
determined necessary to provide for the protection of
public health and safety in accordance with subsection
(c)(1)(A).
i) A licensee or applicant shall submit a cost
estimate for approval by the Department in
accordance with subsection (c)(1)(A).
ii) The licensee's surety arrangements may be
reviewed annually by the Department and be
adjusted to recognize any increases or decreases
resulting from inflation or deflation, changes
in engineering plans, activities performed and
any other condition affecting costs for
reclaiming to ensure that sufficient surety is
retained to cover liability which remains until
license termination.
iii) When a change in activities not requiring a
license amendment would raise the cost estimate
for reclaiming to an amount greater than the
amount of financial surety currently filed with
the Division Chief, the licensee shall, within
sixty (60) days after the increase, file
additional financial surety at least equal to
this increase.
iv) When a license amendment would raise the cost
estimate for reclaiming to an amount greater
than the amount of financial surety currently
filed with the Division Chief, the amendment
shall not be issued until the required surety
arrangements are established.
v) When the current reclaiming cost estimate
decreases, upon the written request of the
licensee, and provided that the decrease is
verified by the Division Chief, the Division
Chief shall reduce the amount of financial
surety required for the facility to the amount
of the current reclaiming cost estimate. Upon
such occurrence, the Division Chief shall,
considering the financial surety arrangements on
file, either cause to be released to the
licensee collateral which has been deposited
equal to this reduction or allow the licensee to
substitute for the arrangements on file new
arrangements in the reduced amount.
vi) The term of the surety arrangement shall be for
the period from issuance of the license until
termination of the license by the Department in
accordance with Section 330.320.
vii) Upon termination of the license, the Division
Chief will release all surety amounts not
previously forfeited by the licensee.
C) The Director:
i) May order that any financial surety filed by a
licensee pursuant to subsection (c) be forfeited
to the State if the Director determines that the
licensee has failed to perform reclaiming to
assure health and safety from radiation hazards
and comply with other license requirements or
orders pertaining to reclaiming. Such
forfeiture action shall follow the procedures
provided in 32 Ill. Adm. Code 200.
ii) Shall, upon the date of issuance of the final
order described in subsection (c)(1)(C)(i),
notify the Attorney General who shall collect
the forfeiture if voluntary payment is not made
within thirty (30) days of the date of issuance
of the final order.
iii) Shall deposit all funds from forfeited financial
sureties in a temporary, locally-held trust fund
to be administered by the Department for site
reclaiming.
D) The licensee or applicant must choose from the
financial surety arrangements specified in Appendix G
of this Part.
E) The wording of the financial surety may be identical
to the wording of the corresponding arrangement in
Appendix H of this Part and must contain provisions
described in Appendix G of this Part.
F) Use of Multiple Financial Surety Arrangements. The
licensee or applicant may utilize more than one
financial surety arrangement per facility to satisfy
the requirement specified in subsection (c)(1). These
arrangements are limited to bonds supported by letters
of credit, insurance and securities. The arrangement
must be as specified in Appendix G of this Part,
except that it is the combination of arrangements,
rather than the single arrangement, which must provide
financial surety for the necessary amount.
G) Use of Financial Surety Arrangement for Multiple
Facilities and/or Multiple Licensees at a Facility.
The licensee or applicant may use a financial surety
arrangement specified in Appendix G of this Part to
meet the requirements of subsection (c)(1) for more
than one license he holds, or more than one facility
he owns, or operates in Illinois. The arrangement
submitted to the Division Chief shall include a list
indicating, for each facility, the license number(s),
name(s), address(es) and amount(s) of funds for
reclaiming assured by the arrangement. The amount of
funds available through the arrangement shall not be
less than the sum of the sureties that would be
available if a separate arrangement had been filed and
maintained for each license or facility. If more than
one license exists for a facility, the amount of funds
for each license shall be specified.
H) Substitution of Alternate Financial Surety
Arrangements. The licensee may substitute alternate
financial surety arrangements specified in Appendix G
of this Part meeting the requirements of subsection
(c)(1) for the financial surety already filed with the
Department for the facility. However, the existing
arrangements shall not be released by the Division
Chief until the substitute financial surety
arrangements have been received and approved.
I) Any applicant or licensee who fulfills the
requirements of subsection (c)(1) by obtaining a
surety bond, letter of credit, or insurance policy,
will be deemed to be without the required financial
surety in the event of bankruptcy of the issuing
institution, or a suspension, or revocation of the
authority of the institution issuing the surety bond,
letter of credit, or insurance policy to issue such
instruments. The applicant or licensee must establish
other Department-approved financial surety within
thirty (30) days after such an event.
2) The arrangements required in subsection (c)(1) shall be
established prior to issuance or amendment of the license to
assure that sufficient funds will be available for
reclaiming;
3) The following specific licensees are required to make
financial surety arrangements:
A) Major processors as defined in 32 Ill. Adm. Code
310.20;
B) Waste handling licensees as defined in 32 Ill. Adm.
Code 310.20;
C) Wet source storage irradiators;
D) Ore processors which produce source material tailings
or sludge;
E) Possessors of source material tailings or sludge;
F) Persons who use particle accelerators to manufacture
radionuclides for distribution to other licensees or
customers;
G) Former U.S. Atomic Energy Commission or U.S. Nuclear
Regulatory Commission licensed facilities that were
licensed pursuant to 10 CFR 50, exclusive of
subsequent amendments or additions unless exempted by
subsection (c)(4).
4) The following persons are exempt from the requirements of
subsection (c)(1):
A) All State, local, or other government agencies, unless
they are subject to subsection (c)(3)(A) or (c)(3)(B);
AGENCY NOTE: For purposes of subsection (c),
"government agencies" shall not include federal or
state contractors, non-governmental recipients of
government grants, or non-governmental medical
institutions.
B) All educational institutions; and
AGENCY NOTE: An educational institution is a non-
profit organization which has as its primary purpose
the advancement of knowledge in one or more specific
fields and which is accredited by the North Central
Association of Colleges and Schools.
C) Persons authorized to possess only those radioactive
materials with half-lives of sixty-five (65) days or
less.
5) Unless also described in subsection (c)(3), the following
persons are exempt from the requirements of subsection
(c)(1):
A) Persons licensed to manufacture or possess, but not
distribute, radioactive material for medical purposes,
including veterinary medicine;
B) Persons licensed to perform industrial radiography;
C) Persons licensed to perform wireline service
operations and subsurface tracer studies;
D) Persons licensed to distribute radiopharmaceuticals,
generators, or reagent kits as a nuclear pharmacy;
E) Persons licensed to distribute, without processing,
radioactive material or products containing
radioactive material;
F) Persons licensed to possess irradiators, other than
wet source storage irradiators;
G) Persons licensed to possess source material (depleted
uranium) for shielding purposes;
H) Persons licensed to possess radioactive material for
use in analytical instruments; and
I) Persons licensed to possess radioactive material in
gauges or other measuring systems.
d) Long-Term Care Requirements.
1) A license application will be approved only if the
Department determines that a long-term care fund for
monitoring and maintenance has been established by the waste
handling licensee prior to the issuance of the license; or
2) The waste handling applicants may choose, at the time of the
licensure, to provide a financial surety arrangement in lieu
of a long-term care fund.
AGENCY NOTE: Long-term care funding may also be required
for former U.S. Atomic Energy Commission or U.S. Nuclear
Regulatory Commission licensed facilities, or persons whose
activities cause situations that significantly affect the
public health and safety, or the environment by reason of
exposure to radiation or radioactive materials.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.260 Special Requirements for Issuance of Certain Specific
Licenses for Radioactive Materials
a) Specific Licenses to Institutions for Human Use of Radioactive
Material. A specific license for human use of radioactive
material in institutions shall be issued only if the applicant has
met the requirements of 32 Ill. Adm. Code 335 and the requirements
set forth in Section 330.250.
b) Specific Licenses to Individual Physicians for Human Use of
Radioactive Material. An application by an individual physician
or group of physicians for a specific license for human use of
radioactive material shall be approved only if:
1) The applicant satisfies the general requirements specified
in Section 330.250;
2) The application is for use in the applicant's practice in an
office outside a medical institution; and
3) The applicant has met the requirements of 32 Ill. Adm. Code
335.
c) Specific Licenses for Pharmacies Using Radioactive Material. In
addition to the requirements set forth in Section 330.250, a
specific license for a pharmacy shall meet the following
additional requirements:
1) Radiopharmaceuticals dispensed and/or distributed for human
use shall be either:
A) Repackaged from prepared radiopharmaceuticals
i) that are the subject of a U.S. Food and Drug
Administration (FDA) approved "New Drug
Application" (NDA), or
ii) for which the FDA has accepted an
"Investigational New Drug Application" (IND), or
B) Prepared from generators and reagent kits that are the
subject of an FDA-approved NDA or for which the FDA
has accepted an IND.
2) Prepared radiopharmaceuticals for which FDA has accepted an
IND and radiopharmaceuticals prepared from generators or
reagent kits for which the FDA has accepted an IND shall be
dispensed and/or distributed:
A) In accordance with the directions provided by the
sponsor of the IND, and
B) Only to physicians who have been accepted by the
sponsor of the IND to participate in clinical
evaluation of the drug.
3) The licensee shall inform in writing each physician who
participates in an IND evaluation that the physician is
responsible to the sponsor of the IND for use of the drug in
accordance with protocols established by the sponsor and for
reporting to the sponsor the clinical information obtained
through use of the drug.
4) The licensee shall procure biological products labeled with
radionuclides or kits used to prepare such products from a
supplier who holds an unsuspended or unrevoked license
issued by either the U.S. Department of Health, Education
and Welfare or the U.S. Department of Health and Human
Services to propagate, manufacture, prepare, label, or
distribute the products.
5) The licensee shall perform radiometric tests for molybdenum
breakthrough upon each elution of a molybdenum-99/tech-
netium-99m generator in accordance with the requirements of
32 Ill. Adm. Code 335.4020.
6) The licensee shall procure all radioactive drugs from a
supplier who manufactures or repackages the product under
appropriate pharmaceutical controls related to assay,
identity, quality, purity, sterility and non-pyrogenicity.
7) The licensee shall dispense radioactive drugs only under the
prescription of a specifically licensed physician who is
authorized to possess and use the radioactive drugs or of a
physician authorized under the provisions of a broad
radioactive material license. The licensee shall maintain a
copy of the radioactive material license of each customer
physician and shall verify that the physician is authorized
to receive the prescribed radiopharmaceutical prior to
transferring the radiopharmaceutical.
8) The licensee may distribute in vitro test kits to customers
but shall neither remove any package insert nor violate the
packaging.
9) The licensee shall subject each batch of sulfur colloid to
microscopic tests for particle size and chromatographic
tests for free pertechnetate, and shall maintain records of
such tests for inspection by the Department. Preparations
which contain particles one micron or larger in diameter,
have more than 10% free pertechnetate, or appear flocculent
or aggregated shall not be dispensed to customers.
10) The licensee shall report to the Department, within ten days
of occurrence, any irregularities pertaining to identifica-
tion, labeling, quality, or assay of any radioactive drug
received under the authority of this license.
d) Use of Sealed Sources in Industrial Radiography. In addition to
the requirements set forth in Section 330.250, a specific license
for use of sealed sources in industrial radiography will be issued
if:
1) The applicant will have an adequate program for training
radiographers and radiographer's assistants and submits to
the Department a schedule or description of such program
which specifies the:
A) Initial training;
B) Periodic training;
C) On-the-job training;
D) Means to be used by the licensee to determine the
radiographer's knowledge and understanding of and
ability to comply with the conditions of the license,
the provisions of this Part and 32 Ill. Adm. Code 310,
320, 340, 341, 350 and 400 and the operating and
emergency procedures of the applicant; and
E) Means to be used by the licensee to determine the
radiographer's assistants' knowledge and understanding
of and ability to comply with the operating and
emergency procedures of the applicant.
2) The applicant has established and submits to the Department
satisfactory written operating and emergency procedures
described in 32 Ill. Adm. Code 350.2020;
3) The applicant will have an internal inspection system to
assure that the requirements of 32 Ill. Adm. Code 310, 320,
340, 341, 350, 400 and this Part, license provisions, and
the applicant's operating and emergency procedures are
followed by radiographers and radiographer's assistants; the
inspection system shall include the performance of internal
inspections at intervals not to exceed 3 months and the
retention of records of such inspections for 2 years. The
inspection records shall contain the date, name of the
person performing the inspection, inspection findings and a
description of any corrective action taken;
4) The applicant submits to the Department a description of the
overall organizational structure pertaining to the
industrial radiography program, including specified
delegations of authority and responsibility for operation of
the program;
5) The applicant who desires to conduct his own leak tests has
established adequate procedures to be followed in testing
sealed sources for possible leakage and contamination and
submits to the Department a description of such procedures,
including:
A) Instrumentation to be used;
B) Method of performing tests; and
C) Pertinent experience of the individual who will
perform the test;
6) The licensee shall conduct a program for inspection and
maintenance of radiographic exposure devices and storage
containers to assure proper functioning of components
important to safety.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.270 Special Requirements for Specific Licenses of Broad Scope
This Section prescribes requirements for the issuance of specific licenses of
broad scope for radioactive material and certain regulations governing holders
of such licenses.
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, D.C.
20555.
a) The different types of broad scope licenses are set forth below:
1) A "Type A specific license of broad scope" is a specific
license authorizing receipt, acquisition, ownership,
possession, use and transfer of any chemical or physical
form of the radioactive material specified in the license,
but not exceeding quantities specified in the license, for
any authorized purpose. The quantities specified are
usually in the multicurie range.
2) A "Type B specific license of broad scope" is a specific
license authorizing receipt, acquisition, ownership,
possession, use and transfer of any chemical or physical
form of radioactive material specified in Appendix D of this
Part, for any authorized purpose. The possession limit for
a Type B license of broad scope, if only one radionuclide is
possessed thereunder, is the quantity specified for that
radionuclide in Appendix D, Column I. If two or more
radionuclides are possessed thereunder, the possession limit
for each is determined as follows: For each radionuclide,
determine the ratio of the quantity possessed to the
applicable quantity specified in Appendix D, Column I, for
that radionuclide. The sum of the ratios for all
radionuclides possessed under the license shall not exceed
unity.
3) A "Type C specific license of broad scope" is a specific
license authorizing receipt, acquisition, ownership,
possession, use and transfer of any chemical or physical
form of radioactive material specified in Appendix D of this
Part, for any authorized purpose. The possession limit for
a Type C license of broad scope, if only one radionuclide is
possessed thereunder, is the quantity specified for that
radionuclide in Appendix D, Column II. If two or more
radionuclides are possessed thereunder, the possession limit
is determined for each as follows: For each radionuclide,
determine the ratio of the quantity possessed to the
applicable quantity specified in Appendix D, Column II, for
that radionuclide. The sum of the ratios for all radio-
nuclides possessed under the license shall not exceed unity.
b) An application for a Type A specific license of broad scope will
be approved if:
1) The applicant satisfies the general requirements specified
in Section 330.250;
2) The applicant has engaged in a reasonable number of
activities involving the use of radioactive material; and
3) The applicant has established administrative controls and
provisions relating to organization and management,
procedures, record keeping, material control and accounting
and management review that are necessary to assure safe
operations, including:
A) The establishment of a radiation safety committee
composed of such persons as a radiation safety
officer, a representative of management and persons
trained and experienced in the safe use of radioactive
material;
B) The appointment of a radiation safety officer who is
qualified by training and experience in radiation
protection, and who is available for advice and
assistance on radiation safety matters; and
C) The establishment of appropriate administrative
procedures to assure:
i) Control of procurement and use of radioactive
material;
ii) Completion of safety evaluations of proposed
uses of radioactive material which take into
consideration such matters as the adequacy of
facilities and equipment, training and
experience of the user and the operating or
handling procedures; and
iii) Review, approval and recording by the radiation
safety committee of safety evaluations of
proposed uses prepared in accordance with
subsection (b)(3)(C)(ii) prior to use of the
radioactive material.
c) An application for a Type B specific license of broad scope will
be approved if:
1) The applicant satisfies the general requirements specified
in Section 330.250; and
2) The applicant has established administrative controls and
provisions relating to organization and management,
procedures, record keeping, material control and accounting
and management review that are necessary to assure safe
operations, including:
A) The appointment of a radiation safety officer who is
qualified by training and experience in radiation
protection, and who is available for advice and
assistance on radiation safety matters; and
B) The establishment of appropriate administrative
procedures to assure:
i) Control of procurement and use of radioactive
material;
ii) Completion of safety evaluations of proposed
uses of radioactive material which take into
consideration such matters as the adequacy of
facilities and equipment, training and
experience of the user and the operating or
handling procedures; and
iii) Review, approval and recording by the radiation
safety officer of safety evaluations of proposed
uses prepared in accordance with subsection
(c)(2)(B)(ii) prior to use of the radioactive
material.
d) An application for a Type C specific license of broad scope will
be approved if:
1) The applicant satisfies the general requirements specified
in Section 330.250;
2) The applicant submits a statement that radioactive material
will be used only by, or under the direct supervision of,
individuals who have received:
A) A college degree at the bachelor level, or equivalent
training and experience, in the physical, or
biological sciences, or in engineering; and
B) At least 40 hours of training and experience in the
safe handling of radioactive material, and in the
characteristics of ionizing radiation, units of
radiation dose and quantities, radiation detection
instrumentation and biological hazards of exposure to
radiation pertinent to the type and forms of
radioactive material to be used; and
3) The applicant has established administrative controls and
provisions relating to procurement of radioactive material,
procedures, record keeping, material control and accounting
and management review necessary to assure safe operations.
e) Specific licenses of broad scope are subject to the following
conditions:
1) Unless specifically authorized, persons licensed pursuant to
this Section shall not:
A) Conduct tracer studies in the environment involving
direct release of radioactive material;
B) Receive, acquire, own, possess, use, or transfer
devices containing 100,000 curies (3.7 PBq) or more of
radioactive material in sealed sources used for
irradiation of materials;
C) Conduct activities for which a specific license issued
by the Department under Sections 330.260 or 330.280 is
required; or
D) Add or cause the addition of radioactive material to
any food, beverage, cosmetic, drug, or other product
designed for ingestion or inhalation by, or
application to, a human being.
2) Each Type A specific license of broad scope issued under
this Part shall be subject to the condition that radioactive
material possessed under the license may only be used by, or
under the direct supervision of, individuals approved by the
licensee's radiation safety committee.
3) Each Type B specific license of broad scope issued under
this Part shall be subject to the condition that radioactive
material possessed under the license may only be used by, or
under the direct supervision of, individuals approved by the
licensee's radiation safety officer.
4) Each Type C specific license of broad scope issued under
this Part shall be subject to the condition that radioactive
material possessed under the license may only be used by, or
under the direct supervision of, individuals who satisfy the
requirements of subsection (d).
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.280 Special Requirements for a Specific License to Manufacture,
Assemble, Repair, or Distribute Commodities, Products, or Devices which
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 Sections 330.30 or
330.40(a) will be issued if:
A) 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
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 of this Part, 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 subsection (a) is required to
maintain records of transfer of material and shall file a
report with the Department which 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 type and quantity of radionuclide 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 following:
A) Five years after filing the preceding report; or
B) Filing an application for renewal of the license under
Section 330.330; or
C) Notifying the Department under Section 330.310(d) of
the licensee's decision to permanently discontinue
activities authorized under the license issued under
subsection (a).
4) The report must cover the period between the filing of the
preceding report and the occurrence specified in subsection
(3) (A), (B) and (C) of this Section. If no transfers of
radioactive material have been made under 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 Department.
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, D.C.
20555.
1) An application for a specific license to distribute NARM to
persons exempted from this Part pursuant to Section
330.40(b) will be approved if:
A) 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;
B) 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
C) The applicant submits copies of prototype labels and
brochures and the Department approves such labels and
brochures.
2) The license issued under subsection (b)(1) is subject to the
following conditions:
A) 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 quantities provided the sum
of the fractions shall not exceed unity.
B) 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
Section 330.40(b). The outer package shall be such
that the dose rate at the external surface of the
package does not exceed 0.5 millirem (5 uSv) per hour.
C) The immediate container of each quantity or separately
packaged fractional quantity of radioactive material
shall bear a durable, legible label which:
i) Identifies the radionuclide and the quantity of
radioactivity, and
ii) Bears the words "Radioactive Material".
D) In addition to the labeling information required by
subsection (b)(2)(C), the label affixed to the
immediate container, or an accompanying brochure,
shall:
i) State that the contents are exempt from
Licensing State requirements,
ii) 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
iii) 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 subsection (b) is required to
maintain records and file reports as follows:
A) Records of transfer of material identifying, by name
and address, each person to whom radioactive material
is transferred for use under Section 330.40(b) or the
equivalent regulations of an Agreement State, or
Licensing State and stating the kinds and quantities
of radioactive material transferred. The licensee
shall maintain the record of a transfer for a period
of one year after the event is included in a summary
report to the Department.
B) The licensee shall file a summary report stating the
total quantity of each radioisotope transferred under
the specific license with the Department.
C) The licensee shall file the summary report within 30
days following:
i) Five years after filing the preceding report; or
ii) Filing an application for renewal of the license
under Section 330.330; or
iii) Notifying the Department under Section
330.310(a) of the licensee's decision to
permanently discontinue activities authorized
under the license issued under subsection (b).
D) The report must cover the period between the filing of
the preceding report and the occurrences specified in
subsections (C)(i), (ii), or (iii) of this Section.
If no transfers of radioactive material have been made
under subsection (b) during the reporting period, the
report must so indicate.
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 Section 330.40(c)(3) will be
approved if the application satisfies requirements equivalent to
those contained in Section 32.26 of 10 CFR 32, revised as of
January 1, 1990. The maximum quantity of radium-226 in each
device shall not exceed 0.1 microcurie (3.7 kBq).
AGENCY NOTE: Licensing requirements contained in subsequent
amendments or editions of 10 CFR 32 are not incorporated into this
Part. A copy of 10 CFR 32 is available for public inspection at
the Department of Nuclear Safety.
d) Licensing the Manufacture and Distribution of Devices to Persons
Generally Licensed Under Section 330.220(b).
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(b) or equivalent regulations
of the U.S. Nuclear Regulatory Commission, an Agreement
State, or a Licensing 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 any
period of 1 calendar quarter a dose in excess of
10 percent of the limits specified in the table
in 32 Ill. Adm. Code 340.2010(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 ............. 15
rems (150 mSv)
Hands and forearms; feet and ankles; localized
areas of skin averaged over areas no larger than
1 square centimeter ........................ 200
rems (2 Sv)
Other organs ................ 50 rems (500 mSv);
and
C) Each device bears a durable, legible, clearly visible
label or labels approved by the Department, which
contain 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 in the label
and used to provide this information,
ii) 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
iii) The information called for in one of the
following statements, as appropriate, in the
same or substantially similar form:
Devices Containing Radioactive Material Other
Than Naturally Occurring Radioactive Material
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.
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.
Devices Containing Naturally-Occurring
Radioactive Material
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
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.
2) 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, 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 Department will consider information which
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 quantity 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(b) 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 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 percent of
the limits specified in the table in 32 Ill. Adm. Code
340.2010(a).
4) Each person licensed under subsection (d) to distribute
devices to generally licensed persons shall:
A) Furnish a copy of the general license contained in
Section 330.220(b) 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 Section 330.220(b);
B) 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
Section 330.220 (b), or alternatively, furnish a copy
of the general license contained in Section 330.220(b)
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 Section 330.220(b) 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 Section 330.220(b);
C) Report to the Department all transfers of such devices
to persons for use under the general license in
Section 330.220(b). 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 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 persons
generally licensed under Section 330.220(b) during the
reporting period, the report shall so indicate. The
report shall cover each calendar quarter and shall be
filed within 30 days thereafter;
D) Furnish reports to other agencies.
i) 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 31.
ii) Report to the responsible State agency all
transfers of devices manufactured and
distributed pursuant to subsection (d) for use
under a general license in that State's
regulations equivalent to Section 330.220(b).
iii) 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 agency 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.
iv) 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.
v) 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; and
E) 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 Section 330.220(b), or
equivalent regulations of the U.S. Nuclear Regulatory
Commission, an Agreement State, or a Licensing State.
The records shall 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
subsection (d)(4). The records required by this
paragraph shall be maintained for a period of five
years from the date of the recorded event.
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(c) will be approved if:
A) The applicant satisfies the general requirements
specified in Section 330.250; and
B) The applicant satisfies the requirements of Sections
32.53, 32.54, 32.55, and 32.101 of 10 CFR 32, revised
as of January 1, 1990, exclusive of subsequent
amendments or editions, or their equivalent. A copy
of 10 CFR 32 is available for public inspection at the
Department of Nuclear Safety.
2) Each person licensed under this subsection shall file an
annual report with the Department which shall state the
total quantity of tritium or promethium-147 transferred to
persons generally licensed under Section 330.220(c) or
equivalent regulations of the U.S. Nuclear Regulatory
Commission 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
quantity of tritium or promethium-147 in each kind of
device. Each report shall cover the year ending June 30 and
shall be filed within thirty (30) days thereafter.
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(e). 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(e) 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, 10
CFR 70.39 and certifies that he will satisfy, and
subsequently satisfies, the requirements of 10 CFR 32.58, 10
CFR 32.59 and 10 CFR 32.102, revised as of January 1, 1990,
exclusive of subsequent amendments or editions.
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(f), or equivalent regulations of an Agreement State, a
Licensing State, or the U.S. Nuclear Regulatory Commission, 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 10 microcuries (370
kBq) each.
B) Cobalt-57 in units not exceeding 10 microcuries (370
kBq) each.
C) Hydrogen-3 (tritium) in units not exceeding 50
microcuries (1.85 MBq) each.
D) Iodine-125 in units not exceeding 10 microcuries (370
kBq) each.
E) Mock Iodine-125 in units not exceeding 0.05 microcurie
(1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq)
of americium-241 each.
F) Iodine-131 in units not exceeding 10 microcuries (370
kBq) each.
G) Iron-59 in units not exceeding 20 microcuries (740
kBq) each.
H) Selenium-75 in units not exceeding 10 microcuries (370
kBq) 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 10 microcuries (370
kBq) of iodine-125, iodine-131, carbon-14, cobalt-57,
or selenium-75; 50 microcuries (1.85 MBq) of hydrogen-
3 (tritium); 20 microcuries (740 kBq) of iron-59; or
mock iodine-125 in units not exceeding 0.05 microcurie
(1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq)
of americium-241 each; and
B) Displaying the radiation caution symbol described in
32 Ill. Adm. Code 340.2030(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, as appropriate, or a
statement which contains the information called for in one
of the following statements, appears on a label affixed to
each prepackaged unit or appears in a leaflet or brochure
which accompanies the package:
A) 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
B) 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 a Licensing State.
Name of Manufacturer
5) The label affixed to the unit, or the leaflet or brochure
which accompanies the package, contains information about
the precautions to be followed in handling and storing such
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 340.3010.
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(g) will be approved if:
1) The applicant satisfies the general requirements of Section
330.250; and
2) The criteria of Section 32.61, 32.62, and 32.103 of 10 CFR
32, as in effect January 1, 1990, exclusive of subsequent
amendments or editions, are met.
AGENCY NOTE: A copy of 10 CFR 32 is available for public
inspection at the Department.
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) for the uses
listed 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 or the Public Health Service Act, such as
a New Drug Application (NDA) approved by the Food and
Drug Administration (FDA), or an "Investigational New
Drug Application" (IND) that has been accepted by the
FDA; 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, 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
specific licensees; and
4) 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
Section 330.260(a) for radioactive material specified in 32
Ill. Adm. Code 335.3010, 335.4010, or 335.5010, as
appropriate, 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 this subsection are in addition to the labeling
required by the Food and Drug Administration (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 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
such reagent kits approved by the Department for use by persons
licensed pursuant to Section 330.260(a) for generators or reagent
kits specified in 32 Ill. Adm. Code 335.4010 may submit the
pertinent information specified in this subsection. 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) 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, such as a New Drug Application (NDA)
approved by the Food and Drug Administration (FDA), or
an "Investigational New Drug Application" (IND) that
has been accepted by the FDA, 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, 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:
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 this generator or reagent kit, as
appropriate, is approved for use by persons licensed
by the Department pursuant to Section 330.260(a) and
32 Ill. Adm. Code 335.4010 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 this subsection 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.
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) for use as a calibration or reference source
or for the uses listed in 32 Ill. Adm. Code 335.7010 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, its chemical and
physical form, and amount;
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 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;
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 source or device is
licensed by the Department for distribution to persons
licensed pursuant to Section 330.260(a) and 32 Ill. Adm.
Code 335.7010 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 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; and
5) In determining the acceptable interval for test of leakage
of radioactive material, the Department 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 quantity of contained radioactive material;
I) Radiotoxicity of contained radioactive material; and
J) Operating experience with identical sources or devices
or similarly designed and constructed sources or
devices.
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(d) or equivalent regulations of the U.S.
Nuclear Regulatory Commission 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 1 calendar quarter a
radiation dose in excess of 10 percent of the limits
specified in 32 Ill. Adm. Code 340.1010(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 benefits to the
public, i.e., a benefit which 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 Department will deny any application for a specific
license under this subsection if the end use(s) of the
industrial product or device cannot be reasonably foreseen.
5) Each person licensed pursuant to subsection (l)(1) 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 quantity 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 the U.S. Nuclear Regulatory
Commission 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(d) and a copy of the form,
"Registration Certificate - Use of Depleted
Uranium Under General License", to each person
to whom he transfers depleted uranium in a
product or device for use pursuant to the
general license contained in Section 330.210(d);
or
ii) A copy of the general license contained in the
U.S. Nuclear Regulatory Commission's or
Agreement State's regulation equivalent to
Section 330.210(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 Section
330.210(d) and a copy of the form, "Registration
Certificate - Use of Depleted Uranium Under
General License", 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 Section 330.210(d);
E) Report to the Department all transfers of industrial
products or devices to persons for use under the
general license in Section 330.210(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 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 thirty (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 Section 330.210(d)
during the reporting period, the report shall so
indicate;
F) File a report which 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
quantity of depleted uranium contained in the product
or device. The report shall be submitted within
thirty (30) days after the end of each calendar
quarter in which such product or device is transferred
to the generally licensed person. The licensee shall
report:
i) 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 40;
ii) To the responsible State agency all transfers of
devices manufactured and distributed pursuant to
subsection (l) for use under a general license
in that State's regulations equivalent to
Section 330.210(d);
iii) To the U.S. Nuclear Regulatory Commission 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 he transfers
depleted uranium in industrial products or devices for
use pursuant to the general license provided in
Section 330.210(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.
m) Special Requirements for License to Manufacture, Import, or
Initially Distribute Sealed Sources or Devices Containing Sealed
Sources to Persons having a Specific License.
1) An application for license to manufacture, import, or
initially distribute sealed sources or devices containing
sealed sources for initial transfer to persons having a
specific license to receive such 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 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, importer, or initial distributor of a
sealed source or device containing a sealed source whose
product is intended for use under a specific license may
submit a request to the Department for evaluation of
radiation safety information about its product and for
filing an evaluation sheet in the U.S. Department of Health
and Human Services "Radioactive Material Reference Manual"
or in the U.S. Nuclear Regulatory Commission "Registry of
Radioactive Sealed Sources and Devices".
A) A request for evaluation of a sealed source or device
containing a sealed source must be submitted in
duplicate and shall include information required by
subsections (m)(2)(B) or (C), as applicable,
demonstrating that the radiation safety properties of
such source or device will not endanger public health
and safety or property.
B) A request for evaluation of a sealed source must
include the following radiation safety information:
i) Proposed uses for the sealed source;
ii) Chemical and physical form and maximum quantity
of radioactive material in the sealed source;
iii) Details of design of the sealed source,
radiation and its shielding including
blueprints, engineering drawings or annotated
drawings;
iv) Details of construction of the sealed source
including a description of materials used in
construction;
v) Radiation profile of a prototype sealed source;
vi) Procedures for and results of prototype testing;
vii) Details of quality control procedures to be
followed in manufacture;
viii) A description or facsimile of labeling to be
affixed to the sealed source;
ix) Leak testing procedures; and
x) Any additional information, including
experimental studies and tests, required by the
Department to facilitate a determination of the
safety of the sealed source, as required by
Section 330.250.
C) A request for evaluation of a device containing a
sealed source must include the following radiation
safety information:
i) Proposed uses for the device;
ii) Manufacturer, model number, chemical and
physical form and maximum quantity of
radioactivity in the sealed source or sources to
be used in the device;
iii) Details of design of the sealed source,
including blueprints, engineering drawings or
annotated drawings;
iv) Details of construction of the sealed source
including a description of materials used in
construction;
v) Radiation profile of a prototype device;
vi) Procedures for and results of prototype testing;
vii) Details of quality control procedures to be
followed in manufacture;
viii) A description or facsimile of labeling to be
affixed to the device;
ix) Leak testing procedures;
x) A description of potential hazards in
installation, service, maintenance, handling,
use and operation of the device;
xi) Information about installation, service and
maintenance procedures;
xii) Handling, operating and safety instructions; and
xiii) Any additional information, including
experimental studies and tests, required by the
Department to facilitate a determination of the
safety of the device as required by Section
330.250.
D) When evaluating a sealed source or device, the
Department will apply the radiation safety criteria
described in subsection 32.210(d) of 10 CFR 32,
revised as of January 1, 1990, exclusive of subsequent
amendments or editions. A copy of 10 CFR 32 is
available for public inspection at the Department.
E) The person submitting a request for evaluation of a
product shall manufacture and distribute the product
in accordance with:
i) The statements and representations, including
the quality control program, described in the
request; and
ii) The provisions of the evaluation sheet prepared
by the Department and submitted to the U.S.
Department of Health and Human Services, for
filing in the "Radioactive Material Reference
Manual" or in the U.S. Nuclear Regulatory
Commission, for filing in the "Registry of
Radioactive Sealed Sources and Devices".
n) Manufacture and Distribution of Radioactive Material for Medical
Use Under General License. A specific license authorizing the
distribution of radioactive material 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 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
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:
A) 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
B) 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
(Source: Amended at 15 Ill. Reg.10632, effective July 15, 1991)
Section 330.300 Issuance of Specific Licenses
a) Upon a determination that an application meets the requirements of
the Act and the regulations of the Department, the Department will
issue a specific license authorizing the proposed activity in such
form and containing such conditions and limitations as it deems
appropriate or necessary.
b) The Department may incorporate in any license at the time of
issuance, or thereafter by appropriate rule, regulation, or order,
such additional requirements and conditions with respect to the
licensee's receipt, possession, use, and transfer of radioactive
material subject to this Part as it deems appropriate or necessary
in order to:
1) minimize danger to public health and safety or property;
2) require such reports and the keeping of such records, and to
provide for such inspections of activities under the license
as may be appropriate or necessary; and
3) prevent loss or theft of material subject to this Part.
(Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.310 Specific Terms and Conditions of License
a) Each license issued pursuant to this Part shall be subject to all
applicable provisions, of the Radiation Protection Act of 1990
(The Act) (Ill. Rev. Stat. 1990 Supp., ch. 111�, par. 210-1 et
seq.), now or hereafter in effect, and to all applicable rules,
regulations, and orders of the Department.
b) No license issued or granted under this Part and no right to
possess or utilize radioactive material granted by any license
issued pursuant to this Part shall be transferred, assigned, or in
any manner disposed of, either voluntarily or involuntarily,
directly or indirectly, through transfer of control of any license
to any person unless the Department shall, after securing full
information find that the transfer is in accordance with the
provisions of the Act, and shall give its consent in writing.
c) Each person licensed by the Department pursuant to this Part shall
confine use and possession of the material licensed to the
locations and purposes authorized in the license.
d) Each licensee shall notify the Department in writing prior to
commencing activities to reclaim the licensed facility.
e) Notification of Bankruptcy.
1) Each licensee shall notify the Department, in writing,
immediately following the filing of a voluntary or
involuntary petition for bankruptcy under any Chapter of
Title 11 (Bankruptcy) of the United States Code by or
against;
A) The licensee;
B) An entity (as that term is defined in 11 U.S.C.
101(14)) controlling the licensee or listing the
license or licensee as property of the estate; or
C) An affiliate (as that term is defined in 11 U.S.C.
101(2)) of the licensee.
2) This notification must indicate:
A) The bankruptcy court in which the petition for
bankruptcy was filed; and
B) The date of the filing of the petition.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.320 Expiration and Termination of Licenses
a) Except as provided in Section 330.330(b), the authority to engage
in licensed activities as specified in the specific license shall
expire at the end of the specified day in the month and year
stated therein. Any expiration date on a specific license applies
only to the authority to engage in licensed activities.
Expiration of a specific license shall not relieve the licensee of
responsibility for decommissioning his facility and terminating
the specific license.
b) Each licensee shall notify the Department immediately, in writing,
and request termination of the license when the licensee decides
to terminate all activities involving radioactive materials
authorized under the license. This notification and request for
termination shall include the documents required by subsection (d)
and shall otherwise substantiate that the licensee has met all of
the requirements in subsection (d).
c) No less than 30 days before the expiration date specified in the
license, the licensee shall either:
1) submit an application for license renewal under Section
330.330; or
2) notify the Department, in writing, if the licensee decides
not to renew the license. The licensee requesting
termination of a license shall comply with the requirements
of subsection (d).
d) Termination of Licenses.
1) If a licensee does not submit an application for license
renewal under Section 330.330, the licensee shall, on or
before the expiration date specified in the license:
A) terminate use of radioactive material;
B) remove radioactive contamination to the level outlined
in 32 Ill. Adm. Code 340.Appendix C, to the extent
practicable;
C) properly dispose of radioactive material;
D) submit a completed Department Form KLM.007; and
E) submit a radiation survey report to confirm the
absence of radioactive materials or to establish the
levels of residual radioactive contamination, unless
the licensee demonstrates the absence of residual
radioactive contamination in some other manner. The
licensee shall, as applicable:
i) report levels of radiation in units of microrads
per hour of beta and gamma radiation at 1 centi-
meter and gamma radiation at 1 meter from sur-
faces and report levels of radioactivity in
units of transformations per minute (or micro-
curies) per 100 square centimeters removable and
fixed on surfaces; microcuries per milliliter in
water, and picocuries per gram in contaminated
solids such as soils or concrete; and
ii) specify the instrumentation used and certify
that each instrument was properly calibrated and
tested.
2) If no residual radioactive contamination attributable to
activities conducted under the license is detected, the
licensee shall submit a certification that no detectable
radioactive contamination was found. The Department will
notify the licensee, in writing, of the termination of the
license.
3) If detectable levels or residual radioactive contamination
attributable to activities conducted under the license are
found:
A) the license continues in effect beyond the expiration
date, if necessary, with respect to possession of
residual radioactive material present as contamination
until the Department notifies the licensee in writing
that the license is terminated. During this time the
licensee is subject to the provisions of subsection
(e).
B) in addition to the information submitted under
subsections (d)(1)(D) and (E), the licensee shall
submit a plan for decontamination, if required, as
regards residual radioactive contamination remaining
at the time the license expires.
e) Each licensee who possesses residual radioactive material under
subsection (d)(3), following the expiration date specified in the
license, shall:
1) limit actions involving radioactive material to those
related to decontamination and other activities related to
preparation for release for unrestricted use; and
2) continue to control entry to restricted areas until they are
suitable for release for unrestricted use and the Department
notifies the licensee in writing that the license is
terminated.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.330 Renewal of Licenses
a) Applications for renewal of specific licenses shall be filed in
accordance with Section 330.240.
b) In any case in which a licensee, not less than 30 days prior to
expiration of his existing license, has filed an application in
proper form for renewal or for a new license authorizing the same
activities, such existing license shall not expire until final
action has been taken by the Department.
(Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.340 Amendment of Licenses at Request of Licensee
Applications for amendment of a license shall be filed in accordance with
Section 330.240 and shall specify the purpose for which the licensee desires
the license to be amended and the grounds for such amendment. The Department
shall not issue amendments to licenses that were issued before June 1, 1987,
for naturally occurring or accelerator produced radioactive material to
authorize use, possession, or receipt of source, byproduct, or special nuclear
material.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.350 Department Action on Application to Renew and Amend
In considering an application by a licensee to renew or amend the license, the
Department will apply the criteria set forth in Sections 330.250, 330.260,
330.270 or 330.280 as applicable.
(Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.360 Persons Possessing a License for Source, Byproduct, or
Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass
on Effective Date of This Part
Any person who, on the effective date of this Part, possesses a general or
specific license for source, byproduct, or special nuclear material in
quantities not sufficient to form a critical mass, issued by the U.S. Nuclear
Regulatory Commission, shall be deemed to possess a like license issued under
this Part and the Act. Such license shall expire on the date of expiration
specified in the U.S. Nuclear Regulatory Commission license.
(Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.370 Persons Possessing Accelerator-Produced or Naturally-
Occurring Radioactive Material on Effective Date of This Part (Repealed)
(Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.400 Transfer of Material
a) No licensee shall transfer radioactive material except as
authorized pursuant to this Section.
b) Except as otherwise provided in his license and subject to the
provisions of subsections (c) and (d), any licensee may transfer
radioactive material:
1) To the Department;
AGENCY NOTE: A licensee may transfer material to the
Department only after receiving prior approval from the
Department.
2) To the U.S. Department of Energy;
3) To any person exempt from the regulations in this Part to
the extent permitted under such exemption;
4) To any person authorized to receive such material under
terms of a general license or its equivalent, or a specific
license or equivalent licensing document, issued by the
Department, the U.S. Nuclear Regulatory Commission, an
Agreement State, or any Licensing State, or to any person
otherwise authorized to receive such material by the Federal
Government or any agency thereof, the Department, an
Agreement State, or a Licensing State; or
5) As otherwise authorized by the Department in writing.
c) Before transferring radioactive material to a specific licensee of
the Department, or to a general licensee who is required to
register with the Department, the U.S. Nuclear Regulatory
Commission, an Agreement State, or a Licensing State prior to
receipt of the radioactive material, the licensee transferring the
material shall verify that the transferee's license authorizes the
receipt of the type, form, and quantity of radioactive material to
be transferred.
d) Any of the following methods for the verification required by
subsection (c) is acceptable:
1) The transferor may possess a current copy of the
transferee's specific license or registration certificate
authorizing the transferee to receive the type, form and
quantity of radioactive material to be transferred;
2) The transferor may possess a written certification by the
transferee that the transferee is authorized by license or
registration certificate to receive the type, form and
quantity of radioactive material to be transferred,
specifying the license or registration certificate number,
issuing agency and expiration date;
3) For emergency shipments, the transferor may accept oral
certification by the transferee that the transferee is
authorized by license or registration certificate to receive
the type, form and quantity of radioactive material to be
transferred, specifying the license or registration
certificate number, issuing agency and expiration date;
provided, that the oral certification is confirmed in
writing within 10 days;
4) The transferor may obtain other information compiled by a
reporting service from official records of the Department,
the U.S. Nuclear Regulatory Commission, an Agreement State,
or a Licensing State regarding the identity of licensees and
the scope and expiration dates of licenses and registration;
or
5) When none of the methods of verification described in
subsections (d)(1) through (4) are readily available or when
a transferor desires to verify that information received by
one of such methods is correct or up-to-date, the transferor
may obtain and record confirmation from the Department, the
U.S. Nuclear Regulatory Commission, an Agreement State, or a
Licensing State that the transferee is licensed to receive
the radioactive material.
e) Shipment and transport of radioactive material shall be in
accordance with the provisions of 32 Ill. Adm. Code 341.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.500 Modification and Revocation of Licenses
a) The terms and conditions of all licenses shall be subject to
amendment, revision, or modification or the license may be
suspended or revoked by reason of amendments to the Act, or by
reason of rules, regulations, and orders issued by the Department
in accordance with 32 Ill. Adm. Code 200.
b) In accordance with 32 Ill. Adm. Code 200, any license may be
revoked, suspended, or modified, in whole or in part, for any
material false statement in the application or any statement of
fact required under provisions of the Act, or because of
conditions revealed by such application or statement of fact or
any report, record, or inspection or other means which would
warrant the Department to refuse to grant a license on an original
application, or for violation of, or failure to observe any of the
terms and conditions of the Act, or of the license, or of any
rule, regulation, or order of the Department.
c) Except in cases of willfulness or those in which the public
health, interest, or safety requires otherwise, no license shall
be modified, suspended, or revoked unless, prior to the
institution of proceedings therefor, facts or conduct which may
warrant such action shall have been called to the attention of the
licensee in writing and the licensee shall have been accorded an
opportunity to demonstrate or achieve compliance with all lawful
requirements.
(Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.900 Reciprocal Recognition of Licenses
a) Licenses of Byproduct, Source, and Special Nuclear Material in
Quantities Not Sufficient to Form a Critical Mass.
1) Subject to this Part, any person who holds a specific
license from the U.S. Nuclear Regulatory Commission or an
Agreement State, and issued by the agency having
jurisdiction where the licensee maintains an office for
directing the licensed activity and at which radiation
safety records are normally maintained, is hereby granted a
general license to conduct the activities authorized in such
licensing document within this State for a period not in
excess of 180 days in any 12 month period, provided that:
A) A current copy of the licensing document is on file
with the Department and the activities authorized by
such document are not limited to specified
installations or locations;
B) The out-of-state licensee notifies the Department by
telephone, telegraph, or letter prior to engaging in
such activities. Such notification shall indicate the
location, period, and type of proposed possession and
use within the State. If initial notification was by
telephone, the out-of-state licensee shall submit to
the Department within ten (10) days following such
telephone notification a telegram or letter which
contains the above information. Upon receipt from the
out-of-state licensee of a written request which
contains a schedule of activities to be conducted
within Illinois, the Department will waive the
requirement for additional notifications during the
remainder of the calendar year following the receipt
of the initial notification from a person engaging in
activities under the general license provided in
subsection (a)(1);
C) The out-of-state licensee complies with 32 Ill. Adm.
Code: Chapter II and with all the terms and conditions
of the licensing document, except any such terms and
conditions which may be inconsistent with 32 Ill. Adm.
Code: Chapter II;
D) The out-of-state licensee supplies such other
information as the Department may request; and
E) The out-of-state licensee shall not transfer or
dispose of radioactive material possessed or used
under the general license provided in subsection
(a)(1) except by transfer to a person:
i) Specifically licensed by the Department or by
the U.S. Nuclear Regulatory Commission to
receive such material, or
ii) Exempt from the requirements for a license for
such material under Section 330.40(a).
2) Notwithstanding the provisions of subsection (a)(1), any
person who holds a specific license issued by the U.S.
Nuclear Regulatory Commission or an Agreement State
authorizing the holder to manufacture, transfer, install, or
service a device described in Section 330.220(b)(1) within
areas subject to the jurisdiction of the licensing body is
hereby granted a general license to install, transfer,
demonstrate, or service such a device in this State provided
that:
A) Such person shall file a report with the Department
within thirty (30) days after the end of each calendar
quarter in which any device is transferred to or
installed in this State. Each such report shall
identify each general licensee to whom such device is
transferred by name and address, the type of device
transferred, and the quantity and type of radioactive
material contained in the device;
B) The device has been manufactured, labeled, installed
and serviced in accordance with applicable provisions
of the specific license issued to such person by the
U.S. Nuclear Regulatory Commission or an Agreement
State;
C) Such person shall assure that any labels required to
be affixed to the device under regulations of the
authority which licensed manufacture of the device
bear a statement that "Removal of this label is
prohibited"; and
D) The holder of the specific license shall furnish to
each general licensee to whom he transfers such device
or on whose premises he installs such device a copy of
the general license contained in Section 330.220(b) or
in equivalent regulations of the agency having
jurisdiction over the manufacture and distribution of
the device.
3) The Department may withdraw, limit, or qualify its
acceptance of any specific license or equivalent licensing
document issued by a Licensing State, or any product
distributed pursuant to such licensing document, if the
Department determines that had the individual been licensed
in Illinois by the Department, the license would have been
subject to action under Section 330.500 or 32 Ill. Adm. Code
310.90.
b) Licenses of Naturally Occurring and Accelerator-Produced
Radioactive Material.
1) Subject to this Part, any person who holds a specific
license from a Licensing State, and issued by the agency
having jurisdiction where the licensee maintains an office
for directing the licensed activity and at which radiation
safety records are normally maintained, is hereby granted a
general license to conduct the activities authorized in such
licensing document within this State for a period not in
excess of 180 days in any 12 month period, provided that:
A) A current copy of the licensing document is on file
with the Department and the activities authorized by
such document are not limited to specified
installations or locations;
B) The out-of-state licensee notifies the Department by
telephone, telegraph, or letter prior to engaging in
such activities. Such notification shall indicate the
location, period, and type of proposed possession and
use within the State. If initial notification was by
telephone, the out-of-state licensee shall submit to
the Department within ten (10) days following such
telephone notification a telegram or letter which
contains the above information. Upon receipt from the
out-of-state licensee of a written request which
contains a schedule of activities to be conducted
within Illinois, the Department will waive the
requirement for additional notifications during the
remainder of the calendar year following the receipt
of the initial notification from a person engaging in
activities under the general license provided in
subsection (a)(1);
C) The out-of-state licensee complies with 32 Ill. Adm.
Code: Chapter II and with all the terms and conditions
of the licensing document, except any such terms and
conditions which may be inconsistent with 32 Ill. Adm.
Code: Chapter II;
D) The out-of-state licensee supplies any other
information necessary to show compliance with 32 Ill.
Adm. Code: Chapter II; and
E) The out-of-state licensee shall not transfer or
dispose of radioactive material possessed or used
under the general license provided in subsection
(b)(1) except by transfer to a person:
i) Specifically licensed by the Department or by
another Licensing State to receive such
material, or
ii) Exempt from the requirements for a license for
such material under Section 330.40.
2) Notwithstanding the provisions of subsection (b)(1), any
person who holds a specific license issued by a Licensing
State authorizing the holder to manufacture, transfer,
install, or service a device described in Section 330.220
(b)(1) within areas subject to the jurisdiction of the
licensing body is hereby granted a general license to
install, transfer, demonstrate, or service such a device in
this State provided that:
A) Such person shall file a report with the Department
within thirty (30) days after the end of each calendar
quarter in which any device is transferred to or
installed in this State. Each such report shall
identify each general licensee to whom such device is
transferred by name and address, the type of device
transferred and the quantity and type of radioactive
material contained in the device;
B) The device has been manufactured, labeled, installed
and serviced in accordance with applicable provisions
of the specific license issued to such person by a
Licensing State;
C) Such person shall assure that any labels required to
be affixed to the device under regulations of the
authority which licensed manufacture of the device
bear a statement that "Removal of this label is
prohibited"; and
D) The holder of the specific license shall furnish to
each general licensee to whom he transfers such device
or on whose premises he installs such a copy of the
general license contained in Section 330.220(b) or in
equivalent regulations of the agency having
jurisdiction over the manufacture and distribution of
the device.
3) The Department may withdraw, limit, or qualify its
acceptance of any specific license or equivalent licensing
document issued by a Licensing State, or any product
distributed pursuant to such licensing document, if the
Department determines that had the out-of-state licensee
been licensed by Illinois, the licensee's license would have
been subject to action under Section 330.500 or 32 Ill. Adm.
Code 310.90.
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
SUBPART D: TRANSPORTATION (Repealed)
Section 330.1000 Transportation of Radioactive Material (Repealed)
(Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.APPENDIX A Exempt Concentrations
Column II
Column I Liquid and
Gas Con- Solid Con-
Element (atomic centration centration
number) Isotope uCi/ml 1 uCi/ml 2
Iron (26) Fe-55 8XlO-3
Fe-59 6XlO-4 Column II
Column I Liquid and
Gas Con- Solid Con-
Element (atomic centration centration
number) Isotope uCi/ml 1 uCi/ml 2
Beta- and/or
gamma-emitting
radioactive material
not listed above with
half-life of less than
3 years. lXlO-10 1X10-6
1 Values are given in Column I only for those materials normally used as
gases.
2 uCi/g for solids.
NOTE 1: Many radioisotopes transform into isotopes which are also radio-
active. In expressing the concentrations in Appendix A of this
Part, the activity stated is that of the parent isotope and takes
into account the daughters.
NOTE 2: For purposes of Section 330.40 where there is involved a combination
of isotopes, the limit for the combination should be derived as
follows: Determine for each isotope in the product the ratio
between the radioactivity concentration present in the product and
the exempt radioactivity concentration established in Appendix A for
the specific isotope when not in combination. The sum of such
ratios may not exceed "1".
EXAMPLE:
Concentration of Isotope A in Product +
Exempt Concentration of Isotope A
Concentration of Isotope B in Product is less
Exempt Concentration of Isotope B than or
equal to 1
NOTE 3: To convert uCi/ml to SI units of megabecquerels per liter, multiply
the above values by 37.
EXAMPLE: Zirconium (40) Zr-97 (2xlO-4 uCi/ml multiplied by 37 is
equivalent to 74 x 10-4 MBq/l).
(Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986)
SECTION 330.APPENDIX B EXEMPT QUANTITIES
Any radioactive material
other than source material,
special nuclear material,
or alpha emitting radio-
active material not listed
above. 0.1 0.001
NOTE 1: To convert curies (Ci) to SI units of gigabecquerels (GBq),
multiply the above values by 37.
EXAMPLE: Zirconium-97 (Col. II) (0.01 Ci multiplied by 37 is
equivalent to 0.37 GBq)
(Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991)
Section 330.APPENDIX E Schedule E, Unimportant Quantities of Source Material
(Repealed)
(Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.APPENDIX F Schedule F, Certain Items Containing Byproduct
Material (Repealed)
(Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986)
Section 330.APPENDIX G FINANCIAL SURETY ARRANGEMENTS (SECTION 330.250
(c)(1)(D))
a) Surety Bond - If an applicant or licensee elects to satisfy the
requirements of Section 330.250(c)(1) by filing a surety bond,
that bond shall conform to the following requirements:
1) The surety company issuing the bond must, at a minimum, be
among those listed as acceptable sureties or reinsurers on
federal bonds in Circular 570 of the U.S. Department of
Treasury, entitled "Surety Companies Acceptable On Federal
Bonds", 52 Fed. Reg. 24601, revised as of July 1, 1987. A
copy of this document is available for inspection at the
Department of Nuclear Safety;
2) The wording of the surety bond must contain the provisions
specified in subsection (1) of Appendix H of this Part.
Additional conditions may be agreed to between the applicant
or licensee and the surety company so long as no requirement
of this Part nor other required provision is avoided or
altered;
3) The surety bond guarantees that:
A) Funds will be available to perform reclaiming in
accordance with 32 Ill. Adm. Code 340.Appendix C to
assure health and safety from radiation hazards and
other requirements of the license for the facility
whenever required by the Department;
B) Surety waives notification of amendments to licenses,
applicable laws, statutes, rules and regulations and
agrees that no such amendment shall in any way
alleviate its obligation on the bond; and
C) The licensee will provide alternate financial surety
as specified in Section 330.250(c)(1) and obtain the
Division Chief's written approval of the assurance
provided within ninety (90) days of receipt by both
the licensee and the Division Chief of a notice of
cancellation of the bond from the surety;
4) Under the terms of the bond the surety shall become liable
on the bond obligation when the licensee fails to perform as
guaranteed by the bond. Following a determination by the
Division Chief that the licensee has failed to so perform,
under the terms of the bond the surety shall perform
reclaiming to the satisfaction of the State as guaranteed by
the bond or shall forfeit the amount of the penal sum, as
provided in Section 330.250(c)(1)(C);
5) The penal sum of the bond shall be in an amount at least
adequate to provide the necessary financial surety;
6) Under the terms of the bond, the surety may cancel the bond
by sending notice of cancellation by certified mail return
receipt requested to the licensee and to the Division Chief.
Cancellation shall not occur, however, during the 180 days
beginning on the date of receipt of the notice of
cancellation by both the licensee and the Division Chief, as
evidenced by the return receipts;
7) The surety shall not be liable for the deficiency in the
performance of reclaiming after the Division Chief has
determined satisfactory reclaiming has occurred;
8) Licensee may terminate the bond by sending written notice to
the surety, provided, however, that no such notice shall
become effective until the surety receives written
authorization from the Division Chief for the termination of
the bond.
b) Personal Bond Supported by a Letter of Credit. If an applicant or
licensee elects to satisfy the surety requirements of Section
330.250(c)(1) by filing his personal performance guarantee
accompanied by collateral in the form of an irrevocable standby
letter of credit, he must guarantee funds to perform reclaiming in
accordance with 32 Ill. Adm. Code 340.Appendix C for protection of
health and safety and other requirements of the license for the
facility. In addition, the irrevocable standby letter of credit
supporting this guarantee must conform to the following
requirements:
1) The institution issuing the letter of credit must be an
entity which has the authority to issue letters of credit
and whose letter of credit operations are regulated and
examined by a Federal or Illinois agency;
2) The wording of the letter of credit must contain the
provisions specified in subsection (a)(2) of Appendix H of
this Part. Additional conditions may be agreed to between
the applicant or licensee and the issuing institution so
long as no requirement of this Part nor required provision
is avoided or altered;
3) The letter of credit must be accompanied by a letter from
the licensee referring to the letter of credit by number,
issuing institution and date and providing the following
information: the radioactive material license number(s),
name(s) and address(es) of the facility(ies) and the amount
of funds for each license assured for reclaiming of the
facility(ies) by the letter of credit;
4) The letter of credit must be irrevocable and issued for a
period of at least one year. The letter of credit shall
provide that the expiration date shall be automatically
extended for a period of at least one year unless, at least
180 days before the current expiration date, the issuing
institution notifies both the licensee and the Division
Chief by certified mail of a decision not to extend the
expiration date. Under the terms of a letter of credit, the
180 days will begin on the date when both the licensee and
the Division Chief have received the notice, as evidenced by
the return receipts;
5) The letter of credit must be issued in an amount at least
adequate to provide the necessary financial surety; and
6) The Director may draw on the letter of credit upon
forfeiture as provided in Section 330.250(c)(1)(C). The
Director shall also draw on the letter of credit if the
licensee does not establish alternate financial surety as
specified in this Part and obtain written approval of such
alternate assurance from the Division Chief within ninety
(90) days after receipt by both the licensee and the
Division Chief of a notice from the issuing institution that
it has decided not to extend the letter of credit beyond the
current expiration date. The Division Chief shall delay the
drawing if the issuing institution grants an extension of
the term of the credit. During the last thirty (30) days of
any extension, the Director will draw on the letter of
credit if the licensee has failed to provide alternate
financial surety as specified in subsection 330.250(c)(1)
and obtain written approval of such surety from the Division
Chief.
c) Personal Bond Supported by Insurance. If an applicant or licensee
elects to satisfy the surety requirements of Section 330.250(c)(1)
by filing his personal performance guarantee accompanied by
collateral in the form of an insurance policy, he must guarantee
funds sufficient to perform reclaiming in accordance with 32 Ill.
Adm. Code 340.Appendix C for protection of health and safety and
other requirements of the licensee for the facility. In addition,
the insurance policy supporting this guarantee must conform to the
following requirements:
1) The insurer must be licensed to transact the business of
insurance or be eligible to provide insurance as an excess
or surplus lines insurer;
2) The insurance policy shall be accompanied by a certificate
of insurance in which the wording contains the provisions
specified in subsection (3) of Appendix H of this Part.
Additional conditions may be agreed to between the applicant
or licensee and the insurer so long as no requirement of
this Part nor required provision is avoided or altered;
3) The insurance policy must be for a face amount at least
adequate to provide the necessary financial surety. The
term "face amount" means the total amount the insurer is
obligated to pay under the policy. Actual payments by the
insurer shall not change the face amount, although the
insurer's future liability shall be lowered by the amount of
the payments;
4) The insurance policy must guarantee that funds will be
available for reclaiming the facility whenever reclaiming is
necessary as determined by the Division Chief;
5) Upon forfeiture of financial surety as provided in Section
330.250(c)(1)(C), the Director shall direct the insurer to
pay the full face amount to the State as specified in
Section 330.250(c)(1)(C);
6) The licensee shall maintain the policy in full force and
effect until license termination or substitution of
alternate financial surety as specified in Section
330.250(c)(1). Failure to pay the premium without
substitution of alternate financial surety as specified in
Section 330.250(c)(1) shall constitute a violation of this
Part. Such violation shall be considered to begin upon
receipt by the Division Chief of a notice of future
cancellation, termination, or failure to renew due to
nonpayment of the premium, rather than upon the date of
expiration;
7) The policy shall provide that the insurer shall not cancel,
terminate or fail to renew the policy except for failure to
pay the premium. The automatic renewal of the policy must,
at a minimum, provide the insured with the option of renewal
at the face amount of the expiring policy. If there is a
failure to pay the premium, the insurer may elect to cancel,
terminate or fail to renew the policy by sending notice by
certified mail to the licensee and the Division Chief.
Cancellation, termination or failure to renew shall not
occur, however, during the 180 days beginning with the date
of receipt of the notice by both the Division Chief and the
licensee, as evidenced by the return receipts.
Cancellation, termination or failure to renew shall not
occur and the policy shall remain in full force and effect
in the event that on or before the date of expiration:
A) The Division Chief considers the facility abandoned;
B) The license is terminated or revoked or renewal is
denied;
C) Closure is ordered by the Director or a court of
competent jurisdiction;
D) The licensee is named as debtor in a voluntary or
involuntary proceeding under Title 11, U.S. Code
(Bankruptcy); or
E) The premium due is paid.
8) Commencing on the date that liability to make payments
pursuant to the policy accrues, the insurer will thereafter
annually increase the face amount of the policy. Such
increase must be equivalent to the face amount of the
policy, less any payments made, multiplied by an amount
equivalent to 85 percent of the most recent investment rate
or of the equivalent coupon-issue yield announced by the
U.S. Treasury for 26-week Treasury securities; and
9) Any provision of the policy inconsistent with any or all
regulations in this Part will be deemed to be amended to
eliminate such inconsistency.
d) Personal Bond Supported by Securities. If an applicant or
licensee elects to satisfy the surety requirements of Section
330.250(c)(1) by filing his personal performance guarantee
accompanied by collateral in the form of securities, he must
guarantee sufficient funds to perform reclaiming in accordance
with 32 Ill. Adm. Code 340.Appendix C for protection of health and
safety and other requirements of the license(s) for the
facility(ies). In addition, the securities supporting this
guarantee must be fully registered as to principal and interest in
such manner as to identify the State and the Department as holder
of such collateral and also identifying that person filing such
collateral. The securities shall be accompanied by a certificate
whose wording contains the provisions specified in subsection (4)
of Appendix H, identifying the State and the Department as holder
of such collateral and to also identify that person filing such
collateral. These securities must have a current market value at
least adequate to provide the necessary financial surety and must
be included among the following types:
1) Negotiable United States Treasury securities assigned
irrevocably to the State; or
2) Negotiable general obligation municipal or corporate bonds
which have at least an "A" rating by Moody's and/or Standard
and Poor's rating services and which are assigned
irrevocably to the State.
e) Personal Bond Supported by Certificate of Deposit. If an
applicant or licensee elects to satisfy the surety requirements of
Section 330.250(c)(1) by filing his personal performance guarantee
accompanied by a Certificate of Deposit in an amount at least
adequate to provide necessary financial surety, the irrevocable
certificate of deposit supporting this guarantee must conform to
the following requirements:
1) The institution issuing the certificate of deposit must be
an entity which has the authority to issue certificates of
deposit and whose certificate of deposit operations are
regulated and examined by a Federal or State agency;
2) The certificate of deposit must be accompanied by a letter
from the licensee referring to the certificate of deposit by
number, issuing institution and date and providing the
following information:
A) The radioactive material license number(s), name(s)
and address(es) of the facility(ies) and the amount of
funds assured for reclaiming of the facility(ies) by
the certificate of deposit. Such certificate of
deposit must also include a statement signed by an
officer of the issuing financial institution which
waives all rights of lien which the institution has or
might have against the certificate;
B) This letter must contain the applicable provisions
specified in subsection (5) of Appendix H of this
Part. Additional provisions may be agreed to between
the applicant or licensee and the issuing institution
so long as no requirement of this Part or required
provision is avoided or altered;
3) The certificate of deposit must be assigned irrevocably to
the State and issued for a period of at least one year. The
certificate of deposit must provide that the expiration date
will be automatically extended for a period of at least one
year unless, at least 180 days before the current expiration
date, the issuing institution notifies both the licensee and
the Division Chief by certified mail of a decision not to
extend the expiration date. Under the terms of the
certificate of deposit, the 180 days will begin on the date
when both the licensee and the Division Chief have received
the notice, as evidenced by the return receipts; and
4) The Director may draw on the certificate of deposit upon
forfeiture as provided in Section 330.250(c)(1)(C). The
Director will also draw on the certificate of deposit if the
licensee does not establish alternate financial surety as
specified in this Part and obtain written approval of such
alternate assurance from the Division Chief within ninety
(90) days after receipt by both the licensee and the
Division Chief of a notice from the issuing institution that
it has decided not to extend the certificate of deposit
beyond the current expiration date. The Director may delay
the drawing if the issuing institution grants an extension
of the term of the certificate of deposit. During the last
thirty (30) days of any such extension, the Director will
draw on the certificate of deposit if the licensee has
failed to provide alternate financial surety as specified in
this Part and obtain written approval of such surety from
the Division Chief.
(Source: Added at 15 Ill. Reg. 10632, effective July 15, 1991)
SECTION 330.APPENDIX H - WORDING OF FINANCIAL SURETY ARRANGEMENTS
(SECTION 330.250(c)(1)(E))
1) A surety bond guaranteeing funds for reclaiming as specified in
subsection (a) of Appendix G of this Part must contain the
following provisions except that the instructions in parentheses
are to be replaced with the relevant information and the
parentheses deleted:
SURETY BOND
Date bond executed:
Effective date:
Principal: (legal name and business address of applicant or
licensee)
Type of organization: (insert "individual," "joint
venture," "partnership" or "corporation")
State of incorporation:
Surety(ies): (Name(s) and business address(es))
License Number(s), name, address and reclaiming cost for
each facility guaranteed by this bond:
Total penal sum of bond: $
Surety's bond number:
KNOW ALL PERSONS BY THESE PRESENTS, That we, the Principal
and Surety(ies) hereto are firmly bound to the Illinois
Department of Nuclear Safety, 1035 Outer Park Drive,
Springfield, Illinois 62704, (hereinafter called
Department), in the above penal sum for the payment of which
we bind ourselves, our heirs, executors, administrators,
successors and assigns jointly and severally; provided that,
where the Surety(ies) are corporations acting as co-
sureties, we, the Sureties, bind ourselves in such sum
"jointly and severally" only for the purpose of allowing a
joint action or actions against any or all of us, and for
all other purposes each Surety binds itself, jointly and
severally with the Principal, for the payment of such sum
only as is set forth opposite the name of such Surety, but
if no limit of liability is indicated, the limit of
liability shall be the full amount of the penal sum.
WHEREAS said Principal is required, under the
Radiation Protection Act, as amended, to have a license in
order to receive, possess, store and use radioactive
material at the facility identified above, and
WHEREAS said Principal is required to provide
financial assurance for reclaiming as a condition of the
license;
NOW, THEREFORE, the conditions of this obligation are
such that if the Principal shall faithfully perform
reclaiming, whenever required to do so, of each facility for
which this bond guarantees funds for reclaiming, to the
satisfaction of the Director, Illinois Department of Nuclear
Safety, in accordance with acceptable practices for
protection of health and safety pursuant to all applicable
laws, statutes, rules and regulations, as such laws,
statutes, rules and regulations may be amended.
OR, if the Principal shall provide alternate financial
assurance as specified in Section 330.250(c)(1)(H), and
obtain the written approval of such assurance from the
Chief, Division of Radioactive Materials (hereinafter called
the Division Chief), within ninety (90) days after the date
notice of cancellation is received by both the Principal and
the Division Chief from the Surety(ies), then this
obligation shall be null and void; otherwise, it is to
remain in full force and effect.
The Surety(ies) shall become liable on this bond
obligation only when the Principal has failed to fulfill the
conditions described above.
Upon notification by the Division Chief that the
Principal has been found in violation of the reclaiming
requirements of the Department, for a facility for which
this bond guarantees funds for performance of reclaiming,
the Surety(ies) shall forfeit the reclaiming cost amount
guaranteed for the facility to the Department as directed by
the Director.
Upon notification by the Division Chief that the
Principal has failed to provide alternate financial
assurance as specified in Section 330.250(c)(1)(H), and
obtain written approval of such assurance from the Division
Chief during the thirty (30) days following receipt by both
the Principal and the Director of a notice of cancellation
of the bond, the Surety(ies) shall forfeit funds in the
amount guaranteed for the facility(ies) to the Department as
directed by the Director.
The Surety(ies) hereby waive(s) notification of amendments
to licenses, applicable laws, statutes, rules and
regulations and agree(s) that no such amendment shall in any
way alleviate its (their) obligation on this bond.
The liability of the Surety(ies) shall not be discharged by
any payment or succession of payments hereunder, unless and
until such payment or payments shall amount in the aggregate
to the penal sum of the bond, but in no event shall the
obligation of the Surety(ies) hereunder exceed the amount of
said penal sum.
The Surety(ies) may cancel the bond by sending notice of
cancellation by certified mail to the applicant or licensee
and to the Division Chief; provided, however, that
cancellation shall not occur during the 180 days beginning
on the date of receipt of the notice of cancellation by both
the Principal and the Division Chief, as evidenced by the
return receipts.
The Principal may terminate this bond by sending written
notice to the Surety(ies); provided, however, that no such
notice shall become effective until the Surety(ies)
receive(s) written authorization for termination of the bond
by the Division Chief.
IN WITNESS WHEREOF, the Principal and Surety(ies) have
executed this SURETY BOND and have affixed their seals on
the date set forth above.
The persons whose signatures appear below hereby certify
that they are authorized to execute this surety bond on
behalf of the Principal and Surety(ies).
(For every co-surety, provide signature(s), corporate seal
and other information in the same manner as for the Surety
above.)
Bond premium: $
2) A letter of credit, as specified in subsection (b) of Appendix G
of this Part, must contain the following provisions except that
instructions in parentheses are to be replaced with the relevant
information and the parentheses deleted:
IRREVOCABLE STANDBY LETTER OF CREDIT
Chief Date:
Division of Radioactive Materials
Illinois Department of Nuclear Safety
Dear Sir or Madam:
We hereby establish our Irrevocable Standby Letter of Credit No.
_______ in your favor, at the request and for the account of
(applicant's or licensee's name and address) up to the aggregate
amount of (in words) U.S. dollars $ , available upon
presentation of:
A) your sight draft, bearing reference to this letter of
credit No. _______, and
B) your signed statement reading as follows: "I certify
that the amount of the draft is payable pursuant to
regulations issued under authority of the Illinois
Radiation Protection Act, as amended."
This letter of credit is effective as of (date) and shall expire
on (date at least 1 year later), but such expiration date shall be
automatically extended for a period of (at least 1 year) on (date)
and on each successive expiration date, unless, at least 180 days
before the current expiration date, we notify both you and
(applicant's or licensee's name) by certified mail that we have
decided not to extend this letter of credit beyond the current
expiration date. In the event you are so notified, any unused
portion of the credit shall be available upon presentation of your
sight draft for 180 days after the date of receipt by both you and
(licensee's name), as shown on the signed return receipts.
Whenever this letter of credit is drawn on, under and in
compliance with the terms of this credit, we shall duly honor such
draft upon presentation to us, and we shall forfeit the amount of
the draft to the State of Illinois in accordance with your
instructions.
(Signature(s) and title(s) of official(s) of issuing institution)
(Date)
This credit is subject to (the most recent edition of the Uniform
Customs and Practice for Documentary Credits, published by the
International Chamber of Commerce, or the Uniform Commercial
Code).
3) A certificate of insurance, as specified in subsection (c) of
Appendix G of this Part, must contain the following provisions
except that instructions in parentheses are to be replaced with
the relevant information and the parentheses deleted:
CERTIFICATE OF INSURANCE FOR RECLAIMING
Name and Address of Insurer
(herein called the "Insurer"):
Name and Address of Insured
(herein called the "Insured"):
Facilities Covered: (List for each facility: The License Number,
name, address and the amount of insurance for reclaiming (these
amounts for all facilities covered must total the face amount
shown below)).
Face Amount:
Policy Number:
Effective Date:
The Insurer hereby certifies that it has issued to the Insured the
policy of insurance identified above to provide financial surety for
reclaiming the facilities identified above. The Insurer further
warrants that such policy conforms in all respects with the require-
ments of subsection (c) of Appendix G of this Part, as applicable and
as such regulations were constituted on the date shown immediately
below. It is agreed that any provision of the policy inconsistent
with such regulation is hereby amended to eliminate such
inconsistency.
Whenever requested by the Chief, Division of Radioactive materials,
Illinois Department of Nuclear Safety, the Insurer agrees to furnish
to the Chief, Division of Radioactive Materials, a duplicate original
of the policy listed above, including all endorsements thereon.
(Authorized signature for Insurer)
(Name of person signing)
(Title of person signing)
Signature of witness or notary:
(Date)
4) A personal bond supported by securities, as specified in subsection
(d) of Appendix G of this Part, must be accompanied by a document
which contains the following provisions except that the instructions
in parentheses are to be replaced with relevant information and the
parentheses deleted:
ASSIGNMENT OF SECURITIES
Pursuant to 32 Ill. Adm. Code 330.250(c), (licensee or
applicant's name) hereby transfers ( Dollars)
($ ) in negotiable United States Treasury Securities unto
Illinois Department of Nuclear Safety, including interest which
thereby accrues, represented by Certificate No. ( ), herewith
and does hereby agree that such securities shall be used for purposes
of ensuring reclamation of ( name of facility ) site.
5) A certificate of deposit, as specified in subsection (e) of Appendix
G of this Part, must contain the following provisions except that
instructions in parentheses are to be replaced with the relevant
information and the parentheses deleted:
Name and address of Bank
Certificate of Deposit , 19
No. $
(Licensee name and address) has deposited not subject to check (
) Dollars ($ ) payable to the order of
Illinois Department of Nuclear Safety, Chief, Division of Radioactive
Materials, ( ) days after notice in writing of intended with-
drawal shall have been given to the bank and upon surrender of this
certificate properly endorsed, with interest as herein provided.
This certificate shall be automatically renewed at maturity for
successive periods of 1 year each. The bank reserves the right not
to renew this certificate at the expiration of any 1 year's period
upon mailing to the payee, at least 180 days prior to the expiration
date, a notice of its election not to renew the certificate.
(Cashier)
Dated , 19 .
(Licensee or Applicant)
Signature Guaranteed
By:
(Title)
ASSIGNMENT OF CORPORATE OR MUNICIPAL BOND
Pursuant to 32 Ill. Adm. Code 330.250(c), (licensee or
applicant's name) hereby transfers to Illinois Department of Nuclear
Safety bonds of the (Corporation or Municipality's name) for (
) Dollars ($ ), No. ( ) herewith standing
in the name of the undersigned on the books of said (Corporation or
Municipality) and does hereby agree that such bonds shall be used for
purposes of ensuring reclaiming of ( name of facility ) site.
Dated , 19 .
(Licensee or Applicant)
Signature Guaranteed
By:
(Title)
(Source: Added at 15 Ill. Reg. 10632, effective July 15, 1991)