Ga. Comp. R. & Regs. R. 391-3-17-.02 - Licensing of Radioactive Material
(1)
Purpose and Scope.
(a) This Rule,
391-3-17-.02, provides for the
licensing of radioactive material. No person shall receive, possess, use,
transfer, own, or acquire radioactive material except as authorized in a
specific or general license issued pursuant to this Rule or as otherwise
provided in this Chapter. However, nothing in this Rule shall apply to any
person to the extent such person is subject to regulation by the U.S. Nuclear
Regulatory Commission.
(b) In
addition to the requirements of this Rule, all licensees are subject to the
requirements of Rules
.01,
.03,
.06,
.07,
.10, and
.11 of this Chapter. Licensees
engaged in industrial radiographic operations are subject to the requirements
of Rule .04 of this
Chapter. Licensees using radioactive material in the healing arts are also
subject to the requirements of Rule
.05 of this Chapter. Licensees
engaged in the extrusion, mining, storage, beneficiating, processing, use,
transfer, or disposal of NORM in such a manner as to alter the chemical
properties or physical state of the NORM or its potential exposure pathways to
humans are also subject to the requirements of Rule
.08 of this Chapter. Licensees
using irradiators whose dose rate exceeds 500 rads (5 Grays) per hour at one
meter from the radioactive sealed sources are also subject to the requirements
of Rule .09 of this
Chapter.
Note: All numbered and lettered references within this Rule refer to parts of this Rule, unless stated otherwise.
(2)
Exemptions/Source
Material.
(a) Any person is exempt from
this Rule 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 one percent (0.05
percent) of the mixture, compound, solution, or alloy.
(b) Any person is exempt from this Rule 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 Rule to the extent that such person receives, possesses, uses, or
transfers:
1. Any quantities of thorium
contained in:
(i) Incandescent gas
mantles,
(ii) Vacuum
tubes,
(iii) Welding
rods,
(iv) Electric lamps for
illuminating purposes provided that each lamp does not contain more than 50
milligrams of thorium,
(v)
Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting
provided that each lamp does not contain more than two grams of
thorium,
(vi) 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
(vii) Personnel neutron dosimeters, provided
that each dosimeter does not contain more than 50 milligrams of
thorium;
2. Source
material contained in the following products:
(i) Glazed ceramic tableware manufactured
before August 27, 2013, provided that the glaze contains not more than 20
percent by weight source material,
(ii) Glassware containing not more than ten
percent by weight source material, but not including commercially manufactured
glass brick, pane glass, ceramic tile, or other glass or ceramic used in
construction,
(iii) Glassware
containing not more than 2 percent by weight source material, or for glassware
manufactured before August 27, 2013, 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, or
(iv) Piezoelectric ceramic containing not
more than two percent by weight source material;
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 four 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 counterweights, provided that:
(i) Each such counterweight has been
impressed with the following legend clearly legible through any plating or
other covering: "DEPLETED URANIUM",
(ii) Each counterweight is durably and
legibly labeled or marked with the identification of the manufacturer and the
statement: "UNAUTHORIZED ALTERATIONS PROHIBITED", and
(iii) 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
other covering;
Note: The requirements specified in (2)(c)5.(i) and (ii) need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights are impressed with the legend: "CAUTION - RADIOACTIVE MATERIAL - URANIUM".
6. Natural or depleted uranium metal used as
shielding constituting part of any shipping container which is conspicuously
and legibly impressed with the legend: "CAUTION - RADIOACTIVE SHIELDING -
URANIUM" and the uranium metal is encased in mild steel or equally
fire-resistant metal of minimum wall thickness of 1/8 inch (3.2 mm);
7. Thorium or uranium contained in or on
finished optical lenses and mirrors, provided that each lens or mirror does not
contain more than 10 percent by weight thorium or uranium or, for lenses
manufactured before August 27, 2013, 30 percent by weight of thorium; and that
this exemption contained in this subparagraph (c) does not authorize either:
(i) The shaping, grinding, or polishing of
such lens or mirror or manufacturing processes other than the assembly of such
lens or mirror into optical systems and devices without any alteration of the
lens or mirror; or
(ii) The
receipt, possession, use, or transfer of uranium or thorium contained in
contact lenses, 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:
(i) The thorium is dispersed in the
nickel-thoria alloy in the form of finely divided thoria (thorium dioxide),
and
(ii) The thorium content in the
nickel-thoria alloy does not exceed four percent by weight.
10. No person may initially
transfer for sale or distribution a product containing source material to
persons exempt under this subparagraph (c), or equivalent regulations of an
Agreement State or the U.S. Nuclear Regulatory Commission, unless authorized by
a license issued under 10
CFR 40.52 to initially transfer such products
for sale or distribution.
(i) Persons
initially distributing source material in products covered by the exemptions in
this subparagraph (c) before August 27, 2013, without specific authorization
may continue such distribution for 1 year beyond this date. Initial
distribution may also be continued until the Commission takes final action on a
pending application for license or license amendment to specifically authorize
distribution submitted no later than 1 year beyond this date.
(ii) Persons authorized to manufacture,
process, or produce these materials or products containing source material by
an Agreement State, and persons who import finished products or parts, for sale
or distribution must be authorized by a license issued under
10 CFR
40.52 for distribution only and are exempt
from the requirements of 10 CFR 19 and 20, and
10 CFR
40.32(b) and (c).
(d) The exemptions in
paragraph (2)(c) do not authorize the manufacture of any of the products
described.
(3)
Exemptions/Radioactive Material Other Than Source Material.
(a) Exempt Concentrations.
1. Except as provided in (3)(a)3. and 4., any
person is exempt from this Chapter to the extent that such person receives,
possesses, uses, transfers, owns, or acquires products containing radioactive
material in concentrations not in excess of those listed in (21)(a), Schedule
A.
2. This section shall not be
deemed to authorize the import of radioactive material or products containing
radioactive material.
3. A
manufacturer, processor, or producer of a product or material is exempt from
the requirements of this Rule to the extent that this person transfers products
containing radioactive material in concentrations not in excess of those listed
in (21)(a), Schedule A and introduced into the product or material by a
licensee holding a specific license issued by the Director expressly
authorizing such introduction. This exemption does not apply to the transfer of
radioactive material contained in any food, beverage, cosmetic, drug, or other
commodity or product designed for ingestion or inhalation by, or application
to, a human being.
4. 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 (3)(a) or
equivalent Regulations of the U.S. Nuclear Regulatory Commission or any
Agreement State, except in accordance with a specific license issued pursuant
to 10 CFR
32.11.
(b) Exempt Quantities.
1. Except as provided in (3)(b)3. through 5.,
any person is exempt from this Chapter 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 (21)(b), Schedule B.
2.
Any person, who possesses radioactive material received or acquired before
September 25, 1971, under the general license then provided in
10 CFR
31.4, or similar general license of an
Agreement State, is exempt from the requirements of this Chapter to the extent
that this person possesses, uses, transfers, or owns byproduct
material.
3. Paragraph (3)(b) does
not authorize the production, packaging, repackaging, or transfer of
radioactive material for purposes of commercial distribution, or the
incorporation of radioactive material into products intended for commercial
distribution.
4. No person may, for
purposes of commercial distribution, transfer radioactive material in the
individual quantities set forth in (21)(b), Schedule B, knowing or having
reason to believe that such quantities of radioactive material will be
transferred to persons exempt under (3)(b) or equivalent regulations of the
U.S. Nuclear Regulatory Commission or any Agreement State, except in accordance
with a specific license issued by the U.S. Nuclear Regulatory Commission
pursuant to Section 32.18 of 10 CFR, Part 32, or by the Director pursuant to
(11)(b) which license states that the radioactive material may be transferred
by the licensee to persons exempt under (3)(b) or the equivalent regulations of
the U.S. Nuclear Regulatory Commission or an Agreement State.
5. No person may, for purposes of producing
an increased radiation level, combine quantities of byproduct material covered
by this exemption so that the aggregate quantity exceeds the limits set forth
in (21)(b), Schedule B, except for radioactive material combined within a
device placed in use before May 3, 1999, or as otherwise permitted by this
Chapter.
(c) Exempt
Items.
1. Certain Items Containing Radioactive
Material. Except for persons who apply radioactive material to, or who
incorporate radioactive material into, the following products, or persons who
initially transfer for sale or distribution the following products containing
radioactive material, any person is exempt from the requirements for a license
set forth in this Chapter to the extent that he receives, possesses, uses,
transfers, owns, or acquires the following products:
Note: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing radioactive 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.
(i)
Timepieces or hands or dials containing not more than the following specified
quantities of radioactive material and not exceeding the following specified
radiation dose rates:
(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 levels of
radiation from hands and dials containing promethium-147 will not exceed, when
measured through 50 milligrams per square centimeter of absorber:
I. For wrist watches, 0.1 millirad (1
µGy) per hour at ten centimeters from any surface.
II. For pocket watches, 0.1 millirad (1
µGy) per hour at one centimeter from any surface.
III. For any other timepiece, 0.2 millirad (2
µGy) per hour at ten centimeters from any surface.
(VIII) One microcurie (37 kBq) of radium-226
per timepiece in intact timepieces manufactured prior to November 30,
2007.
(ii) Static
elimination devices which contain, as a sealed source or sources, byproduct
material consisting of a total of not more than 18.5 MBq (500 µCi) of
polonium-210 per device.
(iii) Ion
generating tubes designed for ionization of air that contain, as a sealed
source or sources, byproduct material consisting of a total of not more than
18.5 MBq (500 µCi) of polonium-210 per device or of a total of not more
than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.
(iv) Such devices authorized before October
23, 2012, for use under the general license then provided in Section 31.3 of 10
CFR, Part 31 and equivalent regulations of Agreement States and manufactured,
tested, and labeled by the manufacturer in accordance with the specifications
contained in a specific license issued by the Director.
(v) Precision balances containing not more
than one millicurie (37 MBq) of tritium per balance or not more than 0.5
millicurie (18.5 MBq) of tritium per balance part manufactured before December
17, 2007.
(vi) [Reserved]
(vii) 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
manufactured before December 17, 2007.
(viii) [Reserved]
(ix) Ionization chamber smoke detectors
containing not more than 1 microcurie (µCi) of americium-241 per detector
in the form of a foil and designed to protect life and property from
fires.
(x) Electron tubes, provided
that the levels of radiation from each electron tube containing radioactive
material will not exceed one millirad (10 µGy) per hour at one centimeter
from any surface when measured through seven milligrams per square centimeter
of absorber. Provided also, 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 ten 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.
(VI) 30 microcuries (1.11 MBq) of
promethium-147.
NOTE: For the purpose of .02(3)(c)1.(x), "Electron tubes" includes 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.
(xi) 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 (21)(b), Schedule B;
(II) Each instrument contains no more than
ten 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 specified in (21)(b), Schedule B, provided that the
sum of such fractions shall not exceed unity; and
(III) For purposes of .02(3)(c)1.(xi), 0.05
microcurie (1.85 kBq) of americium-241 is considered an exempt quantity under
(21)(b), Schedule B.
(xii) [Reserved]
(xiii) Any person who desires to apply
byproduct material to, or to incorporate byproduct material into, the products
exempted in 3(c)1., or who desires to initially transfer for sale or
distribution such products containing radioactive material, should apply for a
specific license with the U.S. Nuclear Regulatory Commission pursuant to
Section 32.14 of 10 CFR, Part 32, which license states that the product may be
distributed by the licensee to persons exempt under (3)(c)1., or the equivalent
regulations of the U.S. Nuclear Regulatory Commission or an Agreement
State.
2. Self-Luminous
Products Containing Radioactive Material.
(i)
Tritium, krypton-85, or promethium-147. Except for persons who manufacture,
process, produce, or initially transfer for sale or distribution self-luminous
products containing tritium, krypton-85, or promethium-147, any person is
exempt from the requirements for a license set forth in this Chapter 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, or initially transferred in accordance with a specific
license issued by the U.S. Nuclear Regulatory Commission pursuant to Section
32.22 of 10 CFR, Part 32, which license authorizes the initial transfer of the
product to persons who are exempt from regulatory requirements. This exemption
does not apply to tritium, krypton-85, or promethium-147 used in products for
frivolous purposes or in toys or adornments.
(ii) Radium-226. Any person is exempt from
this Chapter 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 that were acquired prior to July 12, 1982.
(iii) Any person who desires to manufacture,
process, or produce, or initially transfer for sale or distribution
self-luminous products containing tritium, krypton-85, or promethium-147 for
use under paragraph
.02(3)(c)2.(i)
should apply for a license with the U.S. Nuclear Regulatory Commission pursuant
to Section 32.22 of 10 CFR Part 32 and apply to the U.S. Nuclear Regulatory
Commission for a certificate of registration in accordance with Section 32.210
of 10 CFR Part 32.
3. Gas
and Aerosol Detectors Containing Radioactive Material.
(i) Except for persons who manufacture,
process, produce, or initially transfer for sale or distribution gas and
aerosol detectors containing radioactive material, any person is exempt from
the requirements for a license set forth in this Chapter to the extent that
such person receives, possesses, uses, transfers, owns, or acquires radioactive
material in gas and aerosol detectors designed to protect health, safety, or
property provided that detectors containing radioactive material shall have
been manufactured, processed, produced, 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, Part 32. This exemption also covers gas
and aerosol detectors manufactured or distributed before November 30, 2007, in
accordance with a specific license issued by a State under comparable
provisions to Section 32.26 of 10 CFR, Part 32 authorizing distribution to
persons exempt from regulatory requirements.
(ii) Gas and aerosol detectors containing
naturally-occurring and accelerator-produced radioactive material (NARM)
previously manufactured and distributed to general licensees in accordance with
a specific license issued by an Agreement State shall be considered exempt
under (3)(c)3.(i), 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
10 CFR
32.26.
(iii) Gas and aerosol detectors containing
NARM previously manufactured and distributed in accordance with a specific
license issued by the U.S. Nuclear Regulatory Commission or another Agreement
State shall be considered exempt under (3)(c)3.(i), provided that the device is
labeled in accordance with the specific license authorizing distribution, and
provided further that they meet the requirements of
10 CFR
32.26.
(iv) Any person who desires to manufacture,
process, or produce gas and aerosol detectors containing radioactive material,
or to initially transfer such products for use under .02(3)(c)3.(i) should
apply for a license with the U.S. Nuclear Regulatory Commission pursuant to
Section 32.26 of 10 CFR Part 32 and apply to the U.S. Nuclear Regulatory
Commission for a certificate of registration in accordance with Section 32.210
of 10 CFR, Part 32.
4.
Radioactive drug: Capsules containing carbon-14 urea for "in vivo" diagnostic
use for humans.
(i) Except as provided in
.02(3)(c)4.(ii) and .02(3)(c)4.(iii), any person is exempt from the
requirements for a license set forth in O.C.G.A. Section
31-13-5(a)(9) (Georgia Radiation Control
Act) and from the regulations in this Chapter
provided that such person receives, possesses, uses, transfers, owns, or
acquires capsules containing one µCi (37 kBq) carbon-14 urea (allowing
for nominal variation that may occur during the manufacturing process) each,
for "in vivo" diagnostic use for humans.
(ii) Any person who desires to use the
capsules for research involving human subjects shall apply for and receive a
specific license pursuant to Rule
.02 and Rule
.05 of this chapter.
(iii) Any person who desires to manufacture,
prepare, process, produce, package, repackage, or transfer for commercial
distribution such capsules shall apply for and receive a specific license
pursuant to Rule
.02 of this chapter.
(iv) Nothing in .02(3)(c)4. relieves persons
from complying with applicable FDA, other Federal, and State requirements
governing receipt, administration, and use of drugs.
5. Except for persons who manufacture,
process, produce, or initially transfer for sale or distribution industrial
devices containing byproduct material 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 an ionized atmosphere, any person is exempt from
the requirements for a license set forth in this Chapter to the extent that
such person receives, possesses, uses, transfers, owns, or acquires byproduct
material, in these certain detecting, measuring, gauging, or controlling
devices and certain devices for producing an ionized atmosphere, and
manufactured, processed, produced, or initially transferred in accordance with
a specific license issued under Section 32.30 of 10 CFR Part 32, which license
authorizes the initial transfer of the device for use under this section. This
exemption does not cover sources not incorporated into a device, such as
calibration and reference sources.
6. Any person who desires to manufacture,
process, produce, or initially transfer for sale or distribution industrial
devices containing byproduct material for use under .02(3)(c)5. should apply
for a license to the U.S. Nuclear Regulatory Commission pursuant to Section
32.30 of 10 CFR Part 32 and to the U.S. Nuclear Regulatory Commission for a
certificate of registration in accordance with §32.210 of 10 CFR, Part
32.
(4)
Types of Licenses. Licenses for radioactive materials are of two
types: general and specific.
(a) General
licenses provided in this Rule are effective without the filing of applications
with the Division or the issuance of licensing documents to the particular
persons, although the filing of a certificate with the Division may be required
by the particular general license. The general licensee is subject to all other
applicable portions of this Chapter and any limitations of the general
license.
(b) Specific licenses
require the submission of an application to the Division and the issuance of a
licensing document by the Director to a named person. The licensee is subject
to all applicable portions of this Chapter as well as any limitations specified
in the licensing document.
(5)
General Licenses - Source
Material.
(a) A general license is
hereby issued authorizing persons to hold bare title to source material without
regard to quantity. This general license does not authorize any person to
receive, possess, use, or transfer source material.
(b) A general license is hereby issued
authorizing commercial and industrial firms; research, educational, and medical
institutions; and Federal, State and local government agencies to receive,
possess, use, and transfer uranium and thorium, in their natural isotopic
concentrations and in the form of depleted uranium, for research, development,
educational, commercial, or operational purposes in the following forms and
quantities:
1. No more than 1.5 kg (3.3 lb) of
uranium and thorium in dispersible forms (e.g., gaseous, liquid, powder, etc.)
at any one time. Any material processed by the general licensee that alters the
chemical or physical form of the material containing source material must be
accounted for as a dispersible form. A person authorized to possess, use, and
transfer source material under this subparagraph may not receive more than a
total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year.
Persons possessing source material in excess of these limits as of August 27,
2013, may continue to possess up to 7 kg (15.4 lb) of uranium and thorium at
any one time for one year beyond this date, or until the Nuclear Regulatory
Commission takes final action on a pending application submitted on or August
27, 2014, for a specific license for such material; and receive up to 70 kg
(154 lb) of uranium or thorium in any one calendar year until December 31,
2014, or until the Nuclear Regulatory Commission takes final action on a
pending application submitted on or before August 27, 2014, for a specific
license for such material; and
2.
No more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time.
A person authorized to possess, use, and transfer source material under this
subparagraph may not receive more than a total of 70 kg (154 lb) of uranium and
thorium in any one calendar year. A person may not alter the chemical or
physical form of the source material possessed under this subparagraph unless
it is accounted for under the limits of subparagraph (b)(1) of this section;
or
3. No more than 7 kg (15.4 lb)
of uranium, removed during the treatment of drinking water, at any one time. A
person may not remove more than 70 kg (154 lb) of uranium from drinking water
during a calendar year under this subparagraph; or
4. No more than 7 kg (15.4 lb) of uranium and
thorium at laboratories for the purpose of determining the concentration of
uranium and thorium contained within the material being analyzed at any one
time. A person authorized to possess, use, and transfer source material under
this subparagraph may not receive more than a total of 70 kg (154 lb) of source
material in any one calendar year.
(c) Any person who receives, possesses, uses,
or transfers source material in accordance with the general license in
subparagraph (b) of this section.
1. Is
prohibited from administering source material, or the radiation there from,
either externally or internally, to human beings except as may be authorized by
the NRC in a specific license.
2.
Shall not abandon such source material. Source material may be disposed of as
follows:
(i) A cumulative total of 0.5 kg (1.1
lb) of source material in a solid, non-dispersible form may be transferred each
calendar year, by a person authorized to receive, possess, use, and transfer
source material under this general license to persons receiving the material
for permanent disposal. The recipient of source material transferred under the
provisions of this subparagraph (c) is exempt from the requirements to obtain a
license under paragraph (5) to the extent the source material is permanently
disposed. This provision does not apply to any person who is in possession of
source material under a specific license issued under
391-3-17-.02(7)
through 391-3-17-.02(13);
or
(ii) In accordance with
391-3-17-.03(13)
of this Chapter.
3. Is
subject to the provisions of
391-3-17-.03(13)
of this Chapter.
4. Is subject to
the provisions in
391-3-17-.01(4), (5), (6) and
(8),
391-3-17-.02(13), (18) and
(19), and
391-3-17-.03(14) and
(15).
5. Shall not export such source material
except in accordance with 10 CFR Part 110.
(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 (5)(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 (5)(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 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 (5)(d)1. shall:
(i) File
Division form "Registration Certificate - Use of Depleted Uranium Under General
License" with the Division. 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 the following information and such other information as may
be required by that form:
(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 (5)(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
(5)(d)3.(i)(II); and
(ii)
Report in writing to the Division any changes in information furnished by him
in Division 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 (5)(d)1:
(i) 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;
(ii) Shall not abandon such depleted
uranium;
(iii) Shall transfer or
dispose of such depleted uranium only by transfer in accordance with the
provisions of (19). In the case where the transferee receives the depleted
uranium pursuant to the general license established by (5)(d)1., the transferor
shall furnish the transferee a copy of this Regulation and a copy of Division
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 or Agreement State's regulation equivalent to (5)(d)1., the
transferor shall furnish the transferee a copy of this Regulation and a copy of
Division 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 Regulation;
(iv) Shall report in writing to the Division
the name and address of the person receiving the depleted uranium pursuant to
such transfer within 30 days of any transfer.
(e) Any person who receives, possesses, uses,
or transfers source material in accordance with subparagraph (b) of this
section shall conduct activities so as to minimize contamination of the
facility and the environment. When activities involving such source material
are permanently ceased at any site, if evidence of significant contamination is
identified, the general licensee shall notify the Division about such
contamination and may consult with the Division as to the appropriateness of
sampling and restoration activities to ensure that any contamination or
residual source material remaining at the site where source material was used
under this general license is not likely to result in exposures that exceed the
limits in 10 CFR
20.1402.
(f) Any person who receives, possesses, uses,
or transfers source material in accordance with the general license granted in
subparagraph (b) of this section is exempt from the provisions of
391-3-17-.03 and
391-3-17-.07 to the extent that
such receipt, possession, use, and transfer are within the terms of this
general license, except that such person shall comply with the provisions of
391-3-17-.03(7)(b)
and 391-3-17-.03(13)(a)
to the extent necessary to meet the provisions of subparagraphs (c)(2) and (e)
of this section. However, this exemption does not apply to any person who also
holds a specific license issued under this Chapter.
(g) No person may initially transfer or
distribute source material to persons generally licensed under subparagraph (b)
of this section, or equivalent regulations of an Agreement State or NRC, unless
authorized by a specific license issued in accordance with
391-3-17-.02(5)(h),
10 CFR
40.54, or equivalent provisions of an
Agreement State. This prohibition does not apply to analytical laboratories
returning processed samples to the client who initially provided the
sample.
(h) An application for a
specific license to initially transfer source material for use under
391-3-17-.02 will be approved if:
1. The applicant satisfies the general
requirements specified in this Chapter; and
2. The applicant submits adequate information
on, and the Division approves the methods to be used for quality control,
labeling, and providing safety instructions to recipients.
(i) Each person licensed under
391-3-17-.02 shall label the
immediate container of each quantity of source material with the type of source
material and quantity of material and the words, "radioactive
material."
(j) Each person licensed
under 391-3-17-.02
shall ensure that the quantities and concentrations of source material are as
labeled and indicated in any transfer records.
(k) Each person licensed under
391-3-17-.02 shall report transfers
as follows:
1. File a report with the
Division. The report shall include the following information:
(i) The name, address, and license number of
the person who transferred the source material;
(ii) For each general licensee under
391-3-17-.02,
10 CFR
40.22 and equivalent Agreement State
regulations or provisions to whom greater than 50 grams (0.11 lb) of source
material has been transferred in a single calendar quarter, the name and
address of the general licensee to whom source material is distributed; a
responsible agent, by name and/or position and phone number, of the general
licensee to whom the material was sent; and the type, physical form, and
quantity of source material transferred; and
(iii) The total quantity of each type and
physical form of source material transferred in the reporting period to all
such generally licensed recipients.
2. File a report with each responsible
Agreement State agency or NRC that identifies all persons, operating under
provisions equivalent to this Chapter, to whom greater than 50 grams (0.11 lb)
of source material has been transferred within a single calendar quarter. The
report shall include the following information specific to those transfers made
to the Agreement State or NRC being reported to:
(i) The name, address, and license number of
the person who transferred the source material; and
(ii) The name and address of the general
licensee to whom source material was distributed; a responsible agent, by name
and/or position and phone number, of the general licensee to whom the material
was sent; and the type, physical form, and quantity of source material
transferred.
(iii) The total
quantity of each type and physical form of source material transferred in the
reporting period to all such generally licensed recipients within the Agreement
State or NRC.
3. Submit
each report by January 31 of each year covering all transfers for the previous
calendar year. If no transfers were made to persons generally licensed under 10
CFR Part 40.22 or equivalent Agreement State or NRC provisions during the
current period, a report shall be submitted indicating so. If no transfers have
been made to general licensees in a particular Agreement State or falling under
the jurisdiction of the NRC, during the reporting period, this information
shall be reported to the NRC or responsible Agreement State agency upon request
of the agency or NRC.
(l)
Each person licensed under
391-3-17-.02 shall maintain all
information that supports the reports required by this subparagraph concerning
each transfer to a general licensee for a period of 1 year after the event is
included in a report to the Division, Commission or to an Agreement State
agency.
(m) Each person licensed
under 391-3-17-.02(5)(h)
shall provide the information specified in this paragraph to each person to
whom source material is transferred for use under
391-3-17-.02(5)(b).
This information must be transferred before the source material is transferred
for the first time in each calendar year to the particular recipient. The
required information includes:
1. A copy of
391-3-17-.02(5)(b)
and .02(19) or relevant equivalent regulations of the NRC or an Agreement
State.
2. Appropriate radiation
safety precautions and instructions relating to handling, use, storage, and
disposal of the material.
(6)
General Licenses - Radioactive
Materials Other Than Source Material. Each general license issued under
(6) has its own specific conditions and requirements.
(a) Ownership of Radioactive Material. A
general license is hereby issued to own radioactive material without regard to
quantity. Notwithstanding any other provisions of this Rule, this general
license does not authorize the manufacture, production, transfer, receipt,
possession, or use of radioactive material.
(b) [Reserved]
(c) Certain Detecting, Measuring, Gauging, or
Controlling Devices and Certain Devices for Producing Light or an Ionizing
Atmosphere.
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 (6)(c)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 (6)(c)1. applies only to radioactive material contained in
devices which have been manufactured or initially transferred and labeled in
accordance with the specifications contained:
(i) in a specific license issued by the
Director pursuant to (11)(d); or
(ii) in accordance with the specifications
contained in a specific license issued by the U.S. Nuclear Regulatory
Commission or an Agreement State, which authorizes distribution of devices to
persons generally licensed by the U.S. Nuclear Regulatory Commission or an
Agreement State.
The devices must have been received from one of the specific licensees described in (i) or (ii) above or through a transfer made under (6)(c)3.(viii).
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 Section 179.21 of the Code of Federal Regulations, Title 21.
3. Any person who owns, receives, acquires,
possesses, uses, or transfers radioactive material in a device pursuant to the
general license in (6)(c)1.:
(i) 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;
(ii) 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 six-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 ten 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;
(iii) Shall assure that the tests required by
(6)(c)3.(ii) and other testing, 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 Director, the U.S. Nuclear Regulatory Commission or
an Agreement State to perform such activities;
(iv) Shall maintain records showing
compliance with the requirements of (6)(c)3.(ii) and (iii). The records shall
show the results of tests. The records also shall show the dates of performance
of, and the names of persons performing, testing, installation, servicing, and
removal from installation concerning the radioactive material, its shielding,
or containment. Records of tests for leakage of radioactive material required
by (6)(c)3.(ii) shall be maintained for three years after the next required
leak test is performed. Records of tests of the on/off mechanism and indicator
required by (6)(c)3.(ii) shall be maintained for three years after the next
required test of the on/off mechanism and indicator is performed. Records which
are required by (6)(c)3.(iii) shall be maintained for three years. In case of
transfer or disposal, records required by this paragraph (iv) shall be
maintained for three years after the transfer or disposal.
(v) Shall, 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 radioactive
material, immediately suspend operation of the device. The device may not be
operated until it has been repaired by the manufacturer or other person holding
an applicable specific license from the Director, the U.S. Nuclear Regulatory
Commission or an Agreement State to repair such devices. The device and any
radioactive material from the device may only be disposed of by transfer to a
person authorized by an applicable specific license to receive the radioactive
material contained in the device or as otherwise approved by the Division. A
report containing a brief description of the event and the remedial action
taken; and, in the case of detection of 0.005 microcurie (185 Bq) or more of
removable radioactive material, or failure or damage to a source likely to
result in contamination of the premises or environs, a plan for ensuring that
the premises and environs are acceptable for unrestricted use, must be
furnished to the Division within 30 days. Under these circumstances, the
criteria set out in Rule
.03(7)(b)"Radiological
requirements for unrestricted use" may be applicable, as determined by the
Division on a case-by-case basis;
(vi) Shall not abandon the device containing
radioactive material;
(vii)
(I) Shall transfer or dispose of the device
containing radioactive material only by export as provided in (6)(c)3.(xiv), by
transfer to another general licensee as specified in (6)(c)3.(viii) or
equivalent regulations of the NRC or another Agreement State, by transfer to a
specific licensee of the Director, the U.S. Nuclear Regulatory Commission or an
Agreement State whose specific license authorizes him to receive the device or
authorizes him to collect waste, or as otherwise approved under
(6)(c)(3)(vii)(III).
(II) Within 30
days after transfer of a device to a specific licensee or export, the licensee
shall furnish to the Division a report containing identification of the device
by manufacturer's (or initial transferor's) name, model number, serial number,
the name and address and license number (license number not applicable if
exported) of the person receiving the device and the date of
transfer;
(III) If transfer is to
any other licensee not identified in (vii)(I), the licensee shall obtain
written approval from the Division before transferring the device to any other
person; however, a holder of a specific license may transfer a device for
possession and use under its own specific license without prior approval, if,
the holder:
I. Verifies that the specific
license authorizes the possession and use, or applies for and obtains an
amendment to the license authorizing the possession and use;
II. Removes, alters, covers, or clearly and
unambiguously augments the existing label (otherwise required by Rule
.02(6)(c)3.(i) so
that the device is labeled in compliance with Rule
.03(12)(d);
however the manufacturer, model number, and serial number must be
retained;
III. Obtains the
manufacturer's or initial transferor's information concerning maintenance that
would be applicable under the specific license (such as leak testing
procedures); and
IV. Reports the
transfer under Rule
.02(6)(c)3.(vii)
(viii) 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 this Regulation and any safety documents identified in the label on the
device. Within 30 days of the transfer, report to the Division the
manufacturer's (or initial transferor's) name, model number, serial number of
the device transferred, the name and mailing address for place of use of the
transferee, and the name, title and telephone number of a person identified by
the transferee as the individual responsible for having knowledge of and
authority to take actions to ensure compliance with the appropriate regulations
and requirements; or
(II) Where the
device is held in storage by an intermediate person in the original shipping
container at its intended location of use prior to initial use by a general
licensee;
(ix) Shall
comply with the provisions of Rule
.03(15) of this
Chapter for reporting radiation incidents, or the theft or loss of licensed
material, but shall be exempt from the other requirements contained in Rules
.03 and
.07 of this Chapter;
(x) Shall appoint an individual responsible
for having knowledge of the appropriate regulations and requirements and the
authority for taking required actions to comply with appropriate regulations
and requirements. The general licensee, through this individual, shall ensure
the day-to-day compliance with appropriate regulations and requirements. This
appointment does not relieve the general licensee of any of its responsibility
in this regard;
(xi)
(I) Shall register, in accordance with
paragraphs (6)(c)3.(xi)(II) and (III), devices containing at least 10 mCi (370
Mbq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, 1 mCi (37 MBq) of
cobalt-60, 0.1 mCi (3.7 MBq) of radium 226, or 1 mCi (37 MBq) of americium-241
or any other transuranic [i.e., element with atomic number greater than uranium
(92)], based on the activity indicated on the label. Each address for a
location of use, as described under paragraph 3.(xi)(III)IV. of this section,
represents a separate general licensee and requires a separate
registration.
(II) If in possession
of a device meeting the criteria of paragraph (6)(c)3.(xi)(I), shall register
these devices annually with the Division. Registration must be done by
verifying, correcting, and/or adding to the information provided in a request
for registration received from the Division. The registration information must
be submitted to the Division within 30 days of the date of the request for
registration or as otherwise indicated in the request. In addition, a general
licensee holding devices meeting the criteria of (6)(c)3.(xi)(I) is subject to
the bankruptcy notification requirement in (13)(e) of this rule.
(III) In registering devices, the general
licensee shall furnish the following information and any other information
specifically requested by the Division;
I.
Name and mailing address of the general licensee.
II. Information about each device: the
manufacturer (or initial transferor), model number, serial number, the
radioisotope and activity (as indicated on the label).
III. Name, title, and telephone number of the
responsible person designated as a representative of the general licensee under
(6)(c)3.(x).
IV. Address or
location at which the device(s) are used and/or stored.
V. Certification by the responsible
representative of the general licensee that the information concerning the
device(s) has been verified through a physical inventory and checking of label
information.
VI. Certification by
the responsible representative of the general licensee that they are aware of
the requirements of the general license.
(IV) Persons generally licensed by the NRC or
an Agreement State are not eligible for reciprocity.
(xii) Shall report changes to the mailing
address for the location of use (including change in name of general licensee)
to the Division within 30 days of the effective date of the change;
(xiii) May not hold devices that are not in
use for longer than two years. If devices with shutters are not being used, the
shutter must be locked in the closed position. The testing required by
(6)(c)3.(ii) need not be performed during the period of storage only. However,
when devices are put back into service or transferred to another person, and
have not been tested within the required test interval, they must be tested for
leakage before use or transfer and the shutter tested before use. Devices kept
in standby for future use are excluded from the two-year time limit if the
general licensee performs quarterly physical inventories of these devices while
they are in standby.
(xiv) Shall
not export the device containing byproduct material except in accordance with
the requirements of 10 CFR Part 110.
(xv) Shall respond to written requests from
the Program to provide information relating to the general license within 30
calendar days of the date of the request, or other time specified in the
request. If the general licensee cannot provide the requested information
within the allotted time, it shall, within that same time period, request a
longer period to supply the information by providing the Program a written
justification for the request.
4. The general license in (6)(c)1. does not
authorize the manufacture or import of devices containing radioactive
material.
(d) 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:
(i) Each device contains not more than ten
Curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium-147;
and
(ii) 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 Director 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, Part 32, of the regulations of
the U.S. Nuclear Regulatory Commission.
2. Persons who own, receive, acquire,
possess, or use luminous safety devices pursuant to the general license in
(6)(d) are exempt from the requirements of Rules
.03 and
.07 of this Chapter, except that
they shall comply with the provisions of Rule
.03(15) of this
Chapter.
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.
(e) 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
imported in accordance with a specific license issued by the U.S. Nuclear
Regulatory Commission or each device has been manufactured in accordance with
the specifications contained in a specific license issued by the Director or
any Agreement State to the manufacturer of such device pursuant to licensing
requirements equivalent to those in Section 32.61 of 10 CFR, Part 32, of the
regulations of the U.S. Nuclear Regulatory Commission.
2. Persons who own, receive, acquire,
possess, use, or transfer strontium-90 contained in ice-detection devices
pursuant to the general license in (6)(e)1.:
(i) 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 or equivalent
licensing document 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 Rule
.03(13) of this
Chapter;
(ii) Shall assure that all
labels affixed to the device at the time of receipt and which bear a statement
that prohibits removal of the labels are maintained thereon; and
3. This
general license does not authorize the manufacture, assembly, disassembly, or
repair of strontium-90 in ice-detection devices.
(f) Calibration and Reference
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 (6)(f)4. and 5.,
americium-241 in the form of calibration or reference sources:
(i) Any person who holds a specific license
issued by the Director which authorizes him to receive, possess, use, and
transfer radioactive material; and
(ii) 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 (6)(f)4.
and 5. to any person who holds a specific license issued by the Director 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
(6)(f)4. and 5. to any person who holds a specific license issued by the
Director which authorizes him to receive, possess, use, and transfer
radioactive material.
4. The
general licenses in (6)(f)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, Part 32, or Section 70.39 of 10 CFR, Part 70, or which have been
manufactured in accordance with the specifications contained in a specific
license issued to the manufacturer by the Director or any Agreement State
pursuant to licensing requirements equivalent to those contained in Section
32.57 of 10 CFR, Part 32, or Section 70.39 of 10 CFR, Part 70, of the
regulations of the U.S. Nuclear Regulatory Commission.
5. The general licenses provided in (6)(f)1.,
2., and 3. are subject to the provisions of paragraphs (13), (18), and (19) of
this Rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule
.01, and of Rules
.03,
.06, and
.07 of this Chapter. In addition,
persons who own, receive, acquire, possess, use, or transfer one or more
calibration or reference sources pursuant to these general licenses:
(i) Shall not possess at any one time, at any
one location of storage or use, more than five microcuries (185 kBq) of
americium-241, five microcuries (185 kBq) of plutonium, or five microcuries
(185 kBq) of radium-226 in such sources;
(ii) Shall not receive, possess, use, or
transfer such source unless the source, or the storage container, bears a label
that includes the following statement, or a substantially similar statement
that contains the information called for, 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 U.S. Nuclear Regulatory 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)
*Note: Showing only the name of the appropriate material, i.e., either plutonium or americium.
(iii) Shall not transfer, abandon, or dispose
of such source except by transfer to a person authorized by a license from the
Director, the U.S. Nuclear Regulatory Commission or an Agreement State to
receive the source;
(iv) 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
(v) 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.
(g) General License for Use of
Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.
Note: The new drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specified diagnostic drugs in interstate commerce.
1. A
general license is hereby issued to any physician, veterinarian in the practice
of veterinary medicine, clinical laboratory, or hospital to receive, acquire,
possess, transfer, or use, for any of the following radioactive material, in
accordance with the provisions of (6)(g) 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:
(i) Iodine-125, in units not exceeding ten
microcuries (370 kBq) each.
(ii)
Iodine-131, in units not exceeding ten microcuries (370 kBq) each.
(iii) Carbon-14, in units not exceeding ten
microcuries (370 kBq) each.
(iv)
Hydrogen-3 (tritium), in units not exceeding 50 microcuries (1.85 MBq)
each.
(v) Iron-59, in units not
exceeding 20 microcuries (740 kBq) each.
(vi) Cobalt-57, in units not exceeding ten
microcuries (370 kBq) each.
(vii)
Selenium-75, in units not exceeding ten microcuries (370 kBq) each.
(viii) 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.
2. No person shall receive,
acquire, possess, use, or transfer radioactive material pursuant to the general
license established by (6)(g)1. until he has filed Division form, "Certificate
- In-Vitro Testing with Radioactive Material Under General License" with the
Division and received from the Division a validated copy of this form with
certification number assigned or until he has been authorized pursuant to
(9)(e)3. to use radioactive material under the general license in (6)(g). The
physician, veterinarian in the practice of veterinary medicine, clinical
laboratory, or hospital shall furnish on the form the following information and
such other information as may be required by that form:
(i) Name and address of the physician,
veterinarian in the practice of veterinary medicine, clinical laboratory, or
hospital;
(ii) The location of use;
and
(iii) A statement that the
physician, veterinarian in the practice of veterinary medicine, 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 (6)(g)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 (6)(g)1. shall comply with the following:
(i) The general licensee shall not possess at
any one time, pursuant to the general license in (6)(g)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).
(ii) The general licensee shall store the
radioactive material, until used, in the original shipping container or in a
container providing the equivalent amount of radiation protection.
(iii) The general licensee shall use the
radioactive material only as authorized by (6)(g)1.
(iv) 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 Director, the U.S. Nuclear Regulatory
Commission or any Agreement State, nor transfer the radioactive material in any
manner other than in the unopened, labeled shipping container as received from
the supplier.
(v) The general
licensee shall dispose of the Mock Iodine-125 reference or calibration sources
described in (6)(g)1.(viii) as required by Rule
.03(13) of this
Chapter.
4. The general
licensee shall not receive, acquire, possess, or use radioactive material
pursuant to (6)(g)1.:
(i) Except as
prepackaged units which are labeled in accordance with the provisions of an
applicable specific license issued pursuant to (11)(g) or in accordance with
the provisions of a specific license issued by the U.S. Nuclear Regulatory
Commission or any Agreement 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 (6)(g) or its equivalent, and
(ii) Unless the following statement, or a
statement which contains the information called for, 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 in the practice of veterinary medicine, 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)
5. The physician, veterinarian in the
practice of veterinary medicine, clinical laboratory, or hospital possessing or
using radioactive material under the general license of (6)(g)1. shall report
in writing to the Division any changes in the information furnished by him in
the "Certificate - In Vitro Testing with Radioactive Material Under General
License". 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 (6)(g)1. is exempt from
the requirements of Rules
.03 and
.07 of this Chapter with respect to
radioactive material covered by that general license, except that such persons
using the Mock Iodine-125 described in (6)(g)1.(viii) shall comply with the
provisions of (13) and (15) of Rule
.03 of this Chapter.
(7)
Filing
Application for Specific Licenses.
(a)
Applications for specific licenses shall be filed on forms supplied by the
Georgia Department of Natural Resources, Environmental Protection Division,
Radioactive Materials Program, 4244 International Parkway, Suite 120, Atlanta,
Georgia, 30354, or current mailing address. The application shall set forth all
applicable information called for by the form.
(b) The Division 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 Director to determine whether
the application should be granted or denied or whether a license should be
modified or revoked.
(c) Each
application shall be signed by the applicant or person duly authorized to act
for and on his behalf.
(d) An
application for a license may include a request for a license authorizing one
or more activities.
(e) In his
application, the applicant may incorporate, by reference, information contained
in previous applications, statements, or reports filed with the Division,
provided that such references are clear and specific by page, paragraph, and
date.
(f) Applications and
documents submitted to the Division may be made available for public inspection
except those documents described in Rule
.01(5)(c) which
may be withheld from public inspection or discovery.
(g) The Division may verify information
contained in applications and secure additional information deemed necessary to
make a reasonable determination as to whether to issue a license and whether
special conditions should be attached thereto by visiting the facility or
location where radioactive materials would be possessed, or used, and by
discussing details of proposed possession or use of the radioactive materials
with the applicant or the applicant's designated representatives.
(h) Emergency Plan for Large Quantity Users.
1. Each application to possess radioactive
materials in unsealed form, on foils or plated sources, or sealed in glass in
excess of the quantities specified in (21)(e), Schedule E, must contain either:
(i) An evaluation showing that the maximum
dose to a person offsite due to a release of radioactive materials would not
exceed one rem (.01 Sv) effective dose equivalent or five rems (.05 Sv) to the
thyroid; or
(ii) An emergency plan
for responding to a release of radioactive material.
2. One or more of the following factors may
be used to support an evaluation submitted under (7)(h)1.(i):
(i) The radioactive material is physically
separated so that only a portion could be involved in an accident;
(ii) All or part of the radioactive material
is not subject to release during an accident because of the way it is stored or
packaged;
(iii) The release
fraction in the respirable size range would be lower than the release fraction
shown in (21)(e), Schedule E, due to the chemical or physical form of the
material;
(iv) The solubility of
the radioactive material would reduce the dose received;
(v) Facility design or engineered safety
features in the facility would cause the release fraction to be lower than
shown in (21)(e), Schedule E;
(vi)
Operating restrictions or procedures would prevent a release fraction as large
as that shown in (21)(e), Schedule E; or
(vii) Other factors appropriate for the
specific facility.
3. An
emergency plan for responding to a release of radioactive material submitted
under (7)(h)1.(ii) must include the following information:
(i) Facility description - a brief
description of the licensee's facility and the area near the site.
(ii) Types of accidents - an identification
of each type of radioactive materials accident for which protective actions may
be needed.
(iii) Classification of
accidents - a classification system for classifying accidents as alerts or site
area emergencies.
(iv) Detection of
accidents - identification of the means of detecting each type of accident in a
timely manner.
(v) Mitigation of
consequences - a brief description of the means and equipment for mitigating
the consequences of each type of accident, including those provided to protect
workers on site, and a description of the program for maintaining the
equipment.
(vi) Assessment of
releases - a brief description of the methods and equipment to assess releases
of radioactive materials.
(vii)
Responsibilities - a brief description of the responsibilities of licensee
personnel should an accident occur, including identification of personnel
responsible for promptly notifying offsite response organizations and the
Division; also responsibilities for developing, maintaining, and updating the
plan.
(viii) Notification and
coordination - a commitment to and a brief description of the means to promptly
notify offsite response organizations and request offsite assistance, including
medical assistance for the treatment of contaminated injured onsite workers
when appropriate. A control point must be established to prevent spreading of
contamination during recovery activities. The notification and coordination
must be planned so that unavailability of some personnel, parts of the
facility, and some equipment will not prevent the notification and
coordination. The licensee shall also commit to notify the Division immediately
after notification of the appropriate offsite response organizations and not
later than one hour after the licensee declares an emergency.
Note: This Chapter does not supersede or release licensees from complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L-99-499 or other State or Federal reporting requirements.
(ix)
Information to be communicated - a brief description of the types of
information on facility status, radioactive releases, and recommended
protective actions, if necessary, to be given to offsite response organizations
and to the Division.
(x) Training -
a brief description of the frequency, performance objectives, and plans for the
training that the licensee will provide workers on how to respond to an
emergency, including any special instruction and orientation tours the licensee
would offer to fire, police, medical, and other emergency personnel. The
training shall familiarize personnel with site-specific emergency procedures.
Also, the training shall thoroughly prepare site personnel for their
responsibilities in the event of accident scenarios postulated as most probable
for the specific site, including the use of team training for such
scenarios.
(xi) Safe shutdown - a
brief description of the means of restoring the facility to a safe condition
after an accident.
(xii) Exercises
- provisions for conducting quarterly communications checks with offsite
response organizations and biennial onsite exercises to test response to
simulated emergencies. Quarterly communications checks with offsite response
organizations must include the check and update of all necessary telephone
numbers. The licensee shall invite offsite response organizations to
participate in the biennial exercises. Participation of offsite response
organizations in biennial exercises, although recommended, is not required.
Exercises must use accident scenarios postulated as most probable for the
specific site, and the scenarios shall not be known to most exercise
participants. The licensee shall critique each exercise using individuals not
having direct implementation responsibility for the plan. Critiques of
exercises must evaluate the appropriateness of the plan, emergency procedures,
facilities, equipment, training of personnel, and the overall effectiveness of
the response. These exercises must be documented and deficiencies found by the
critiques must be corrected.
(xiii)
Hazardous chemicals - a certification that the applicant has met its
responsibilities under the Emergency Planning and Community Right-to-Know Act
of 1986, Title III, Pub. L.99-499, if applicable to the applicant's activities
at the proposed place of use of the radioactive material.
4. The licensee shall allow the offsite
response organizations expected to respond in case of an accident 60 days to
comment on the licensee's emergency plan before submitting it to the Division.
The licensee shall provide any comments received within the 60 days to the
Division with the emergency plan.
(i) Except as provided in paragraphs 2., 3.
and 4. of this section, an application for a specific license to use
radioactive material in the form of a sealed source or in a device that
contains the sealed source must:
1. Identify
the source or device by manufacturer and model number as registered with the
Nuclear Regulatory Commission, an Agreement State, or for a source or a device
containing radium-226 or accelerator produced radioactive material with a State
under provisions comparable to Section 32.210 of 10 CFR Part 32.
2. For sources or devices manufactured before
October 23, 2012, that are not registered with the Commission under Section
32.210 of 10 CFR, Part 32 or with an Agreement State, and for which the
applicant is unable to provide all categories of information specified in
Section 32.210(c) of 10 CFR, Part 32, the application must include:
(i) All available information identified in
Section 32.210(c) of 10 CFR, Part 32 concerning the source, and, if applicable,
the device; and
(ii) Sufficient
additional information to demonstrate that there is reasonable assurance that
the radiation safety properties of the source or device are adequate to protect
health and minimize danger to life and property. Such information must include
a description of the source or device, a description of radiation safety
features, the intended use and associated operating experience, and the results
of a recent leak test.
3.
For sealed sources and devices allowed to be distributed without registration
of safety information in accordance with Section 32.210(g)(1) of 10 CFR, Part
32, the applicant may supply only the manufacturer, model number, and
radionuclide and quantity.
4. If it
is not feasible to identify each sealed source and device individually, the
applicant may propose constraints on the number and type of sealed sources and
devices to be used and the conditions under which they will be used, in lieu of
identifying each sealed source and device.
(j) An application from a medical facility,
educational institution, or Federal facility to produce Positron Emission
Tomography (PET) radioactive drugs for noncommercial transfer to licensees in
its consortium authorized for medical use under Rule
.05 or equivalent Nuclear
Regulatory Commission or Agreement State requirements shall include:
1. A request for authorization for the
production of PET radionuclides or evidence of an existing license issued under
Rule .02, Nuclear
Regulatory Commission or of this chapter or Agreement State requirements for a
PET radionuclide production facility within its consortium from which it
receives PET radionuclides.
2.
Evidence that the applicant is qualified to produce radioactive drugs for
medical use by meeting one of the criteria in .02(11)(i)2. of this
Rule.
3. Identification of
individual(s) authorized to prepare the PET radioactive drugs if the applicant
is a pharmacy, and documentation that each individual meets the requirements of
an authorized nuclear pharmacist as specified in .02(11)(i)5. of this
Rule.
4. Information identified in
Rule .02(11)(i)3. of
this Rule on the PET drugs to be noncommercially transferred to members of its
consortium.
(8)
General Requirements for the Issuance of Specific Licenses. A
license application will be approved if the Division determines the following:
(a) That the applicant is qualified by reason
of training and experience to use the material in question for the purpose
requested in accordance with this Chapter in such a manner as to minimize
danger to public health and safety or property;
(b) That the applicant's proposed equipment,
facilities, and procedures are adequate to minimize danger to public health and
safety or property;
(c) That the
issuance of the license will not be inimical to the health and safety of the
public; and
(d) That the applicant
satisfies any applicable special requirements in (9), (10), and (11).
(e) Bonding Requirements.
1. Pursuant to Georgia Laws 1979, pp. 1059,
1060, a specific license will be issued to a Major Processor as defined in Rule
.01(2) of this
Chapter only if the applicant has posted a surety bond with, and made payable
to, the Director, Environmental Protection Division, Department of Natural
Resources, to ensure the protection of the public health and safety in the
event of abandonment, insolvency, or other inability of the licensee to meet
the requirements of the Act and this Chapter.
(i) The bond provided shall be not less than
$100,000.00, nor more than $5,000,000.00.
(ii) The exact amount of the bond shall be
determined by the Director, Environmental Protection Division, and shall be
based on the probable extent of contamination, the amount of possible property
damage, the costs of removal and disposal of sources of radiation used by the
licensee, and the costs of reclamation of the property in the event of
abandonment, insolvency, or other inability of the licensee to meet the
requirements of the Act and this Chapter, including performing such services to
the satisfaction of the Division.
2. Persons licensed at the time the bonding
requirements of this Chapter became effective, and upon notice by the Division,
must, within a period of 90 days following such notice, provide the bond
required by (8)(e)1. as a condition for continuation of the license.
(f) Environmental Report,
Commencement of Construction. In the case of an application for a license to
receive and possess radioactive material for the conduct of any activity which
the Division determines will significantly affect the quality of the
environment, commencement of construction of the plant or facility in which the
activity will be conducted shall not begin until the Director has concluded,
after weighing the environmental, economic, technical, and other benefits
against environmental costs and considering available alternatives, that the
action called for is the issuance of the proposed license, with any appropriate
conditions to protect environmental values. 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.
(g) Financial assurance and record-keeping
for decommissioning.
1. The following are
required to furnish financial assurance and record-keeping for decommissioning:
(i) Each applicant for a specific license
authorizing the possession and use of unsealed radioactive material of
half-life greater than 120 days and in quantities exceeding
105 times the applicable quantities set forth in
Schedule F shall submit a decommissioning funding plan as described in
subparagraphs (8)(g)5 and (8)(g)6. The decommissioning funding plan must also
be submitted when a combination of isotopes is involved if R divided by
105 is greater than 1 (unity Rule), where R is
defined here as the sum of the ratios of the quantity of each isotope to the
applicable value in Schedule F.
(ii) Each applicant for a specific license
authorizing the possession and use of sealed sources or plated foils of
half-life greater than 120 days and in quantities exceeding
1012 times the applicable quantities set forth in
Schedule F shall submit a decommissioning funding plan as described in
subparagraphs (8)(g)5 and (8)(g)6. The decommissioning funding plan must also
be submitted when a combination of isotopes is involved if R divided by
1012 is greater than 1 (unity Rule), where R is
defined here as the sum of the ratios of the quantity of each isotope to the
applicable value in Schedule F.
2. Each applicant for a specific license
authorizing the possession and use of radioactive material of half-life greater
than 120 days and in quantities specified in subparagraphs (8)(g)4. shall
either:
(i) Submit a decommissioning funding
plan as described in subparagraphs (8)(g)5 and (8)(g)6.; or
(ii) Submit a certification that financial
assurance for decommissioning has been provided in the amount prescribed by
(8)(g)4. using one of the methods described in (8)(g)7. For an applicant, this
certification may state that the appropriate assurance will be obtained after
the application has been approved and the license issued but prior to the
receipt of licensed material. As part of the certification, a copy of the
financial instrument obtained to satisfy the requirements of (8)(g)7. is to be
submitted to the Division. If the applicant defers execution of the financial
instrument until after the license has been issued, a signed original of the
financial instrument obtained to satisfy the requirements (8)(g)7. must be
submitted to the Division before the receipt of licensed material. If the
applicant does not defer execution of the financial instrument, the applicant
shall submit to the Division, as part of the certification a signed original of
the financial instrument obtained to satisfy the requirements of
(8)(g)7.
3.
(i) Each holder of a specific license issued
on or after January 1, 1993, which is of a type described in (8)(g)1. or 2.
shall provide financial assurance for decommissioning in accordance with the
criteria set forth in this Rule.
(ii) Each holder of a specific license issued
before January 1, 1993, which is of a type described in (8)(g)1. shall submit,
on or before January 1, 1993, a decommissioning funding plan or a certification
of financial assurance for decommissioning in an amount at least equal to
$1,125,000 in accordance with the criteria set forth in this Rule. If the
licensee submits the certification of financial assurance rather than a
decommissioning funding plan at this time, the licensee shall include a
decommissioning funding plan in any application for license renewal.
(iii) Each holder of a specific license
issued before January 1, 1993, and of a type described in (8)(g)2. shall
submit, on or before January 1, 1993, a certification of financial assurance
for decommissioning or a decommissioning funding plan in accordance with the
criteria set forth in this .02(8)(g).
(iv) Waste collectors and waste processors
shall provide financial assurance in an amount based on a decommissioning
funding plan as described in subparagraphs .02(8)(g)5 and (8)(g)6. The
decommissioning funding plan must also include the cost of disposal of the
maximum amount (curies) of radioactive material permitted by the license, and
the cost of disposal of the maximum quantity, by volume, of radioactive
material that could be present at the licensee's facility at any time, in
addition to the cost to remediate the licensee's site to meet the license
termination requirements in .02(18).
4. Table of required amounts of financial
assurance for decommissioning by quantity of material.
Greater than 104 but less than or equal to 105 times the applicable quantities of Schedule F in unsealed form. (For a combination of isotopes, if R, as defined in (8)(g), divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1): $1,125,000
Greater than 103 but less than or equal to 104 times the applicable quantities of Schedule F in unsealed form. (For a combination of isotopes, if R, as defined in (8)(g), divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1): $225,000
Greater than 1010 times the applicable quantities of Schedule F in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in (8)(g), divided by 1010 is greater than 1): $113,000
5. Each decommissioning funding plan must be
submitted for review and approval and must contain
(i) A detailed cost estimate for
decommissioning, in an amount reflecting:
(I)
The cost of an independent contractor to perform all decommissioning
activities;
(II) The cost of
meeting the .03(7)(b) criteria for unrestricted use, provided that, if the
applicant or licensee can demonstrate its ability to meet the provisions of
.03(7)(c), the cost estimate may be based on meeting the .03(7)(c)
criteria;
(III) The volume of
onsite subsurface material containing residual radioactivity that will require
remediation to meet the criteria for license termination; and
(IV) An adequate contingency
factor.
(ii)
Identification of and justification for using the key assumptions contained in
the DCE;
(iii) A description of the
method of assuring funds for decommissioning from subparagraph 7 of this
section, including means for adjusting cost estimates and associated funding
levels periodically over the life of the facility;
(iv) A certification by the licensee that
financial assurance for decommissioning has been provided in the amount of the
cost estimate for decommissioning; and
(v) A signed original of the financial
instrument obtained to satisfy the requirements of subparagraph 7 of this
section (unless a previously submitted and accepted financial instrument
continues to cover the cost estimate for decommissioning).
6. At the time of license renewal and at
intervals not to exceed 3 years, the decommissioning funding plan must be
resubmitted with adjustments as necessary to account for changes in costs and
the extent of contamination. If the amount of financial assurance will be
adjusted downward, this cannot be done until the updated decommissioning
funding plan is approved. The decommissioning funding plan must update the
information submitted with the original or prior approved plan, and must
specifically consider the effect of the following events on decommissioning
costs:
(i) Spills of radioactive material
producing additional residual radioactivity in onsite subsurface
material;
(ii) Waste inventory
increasing above the amount previously estimated;
(iii) Waste disposal costs increasing above
the amount previously estimated;
(iv) Facility modifications;
(v) Changes in authorized possession
limits;
(vi) Actual remediation
costs that exceed the previous cost estimate;
(vii) Onsite disposal; and
(viii) Use of a settling pond.
7. Financial assurance for
decommissioning must be provided by one or more of the following methods:
(i) Prepayment. Prepayment is the deposit
prior to the start of operation into an account segregated from licensee assets
and outside the licensee's administrative control of cash or liquid assets such
that the amount of funds would be sufficient to pay decommissioning costs.
Prepayment may be in the form of a trust, escrow account, government fund,
certificate of deposit, or deposit of government securities.
(ii) A surety method, insurance, or other
guarantee method. These methods guarantee that decommissioning costs will be
paid. A surety method may be in the form of a surety bond, letter of credit, or
line of credit. A parent company guarantee of funds for decommissioning costs
based on a financial test may be used if the guarantee and test are as
contained in (21)(d) Schedule D. A parent company guarantee may not be used in
combination with other financial methods to satisfy the requirements of this
section. For commercial corporations that issue bonds, a guarantee of funds by
the applicant or licensee for decommissioning costs based on a financial test
may be used if the guarantee and test are as contained in (21)(g) Schedule G.
For commercial companies that do not issue bonds, a guarantee of funds by the
applicant or licensee for decommissioning: costs may be used if the guarantee
and test are as contained in (21)(d) Schedule D. For nonprofit entities, such
as colleges, universities, and nonprofit hospitals, a guarantee of funds by the
applicant or licensee may be used if the guarantee and test are as contained in
(21)(h) Schedule H. A guarantee by the applicant or licensee may not be used in
combination with any other financial methods used to satisfy the requirements
of this section or in any situation where the applicant or licensee has a
parent company holding majority control of the voting stock of the company. Any
surety method or insurance used to provide financial assurance for
decommissioning must contain the following conditions:
(I) The surety method or insurance must be
open-ended or, if written for a specified term, such as five years, must be
renewed automatically, unless 90 days or more prior to the renewal date the
issuer notifies the Division, the beneficiary, and the licensee of its
intention not to renew. The surety method or insurance must also provide that
the full face amount be paid to the beneficiary automatically prior to the
expiration without proof of forfeiture if the licensee fails to provide a
replacement acceptable to the Division within 30 days after receipt of
notification of cancellation.
(II)
The surety method or insurance must be payable to a trust established for
decommissioning costs. The trustee and trust must be acceptable to the
Division. An acceptable trustee includes an appropriate State or Federal
government agency or an entity which has the authority to act as a trustee and
whose trust operations are regulated and examined by a Federal or State
agency.
(III) The surety method or
insurance must remain in effect until the Director has terminated the
license.
(iii) An
external sinking fund in which deposits are made at least annually, coupled
with a surety method or insurance, the value of which may decrease by the
amount being accumulated in the sinking fund. An external sinking fund is a
fund established and maintained by setting aside funds periodically in an
account segregated from licensee assets and outside the licensee's
administrative control in which the total amount of funds would be sufficient
to pay decommissioning costs at the time termination of operation is expected.
An external sinking fund may be in the form of a trust, escrow account,
government fund, certificate of deposit, or deposit of government securities.
The surety or insurance provisions must be as stated in (8)(g)2.
(iv) In the case of Federal, State, or local
government licensees, a statement of intent containing a cost estimate for
decommissioning or an amount based on the Table in (8)(g)4., and indicating
that funds for decommissioning will be obtained when necessary.
8. Each person licensed under this
Chapter shall keep records of information important to the safe and effective
decommissioning of the facility in an identified location until the site is
released for unrestricted use by the Division. Before licensed activities are
transferred or assigned in accordance with .02(13)(b), licensees shall transfer
all records described in (7)(i) through (iv) to the new licensee. In this case,
the new licensee will be responsible for maintaining these records until the
license is terminated. If records of relevant information to the
decommissioning of a facility are kept for other purposes, references to these
records and their locations may be used. Information the Division considers
important to decommissioning consists of:
(i)
Records of spills or other unusual occurrences involving the spread of
contamination in and around the facility, equipment, or site. These records may
be limited to instances when contamination remains after any cleanup procedures
or when there is reasonable likelihood that contaminants may have spread to
inaccessible areas as in the case of possible seepage into porous materials
such as concrete. These records must include any known information on
identification of involved nuclides, quantities, forms, and
concentrations.
(ii) As-built
drawings and modifications of structures and equipment in restricted areas
where radioactive materials are used and/or stored, and of locations of
possible inaccessible contamination such as buried pipes which may be subject
to contamination. If required drawings are referenced, each relevant document
need not be indexed individually. If drawings are not available, the licensee
shall substitute appropriate records of available information concerning these
areas and locations.
(iii) Except
for areas containing only sealed sources (provided the sources have not leaked
or no contamination remains after any leak) or radioactive materials having
only half-lives of less than 65 days, or depleted uranium used only for
shielding or as penetrators in unused munitions, a list contained in a single
document and updated every two years, of the following:
(I) All areas designated and formerly
designated as restricted areas as defined under Rule
391-3-17-.01(2);
(II) All areas outside of restricted areas
that require documentation under (8)(g)8.(i);
(III) All areas outside of restricted areas
where current and previous wastes have been buried as documented under Rule
.03(14)(i) of this
Chapter; and
(IV) All areas outside
of restricted areas that contain materials such that, if the license expired,
the licensee would be required to either decontaminate the area to unrestricted
release levels or apply for approval for disposal under Rule
.03(13)(b) of this
Chapter.
(iv) Records of
the cost estimate performed for the decommissioning funding plan or of the
amount certified for decommissioning, and records of the funding method used
for assuring funds if either a funding plan or certification is used.
9. Teletherapy licensees are
exempted from decommissioning financial assurance requirements for possession
of licensed material in sealed sources in quantities greater than
1010 times the applicable quantities of Schedule F
of this rule, for the purpose of source changes only. This exemption is granted
for no more than 30 days for any one source change.
(h) Expiration and termination of licenses
and decommissioning of sites and separate buildings or outdoor areas.
1. Each specific license continues in effect,
beyond the expiration date if necessary, with respect to possession of
radioactive material until the Director notifies the licensee in writing that
the license is terminated. During this time, the licensee shall:
(i) Limit actions involving radioactive
material to those related to decommissioning; and
(ii) Continue to control entry to restricted
areas until they are suitable for release in accordance with Division
requirements.
2. Within
60 days of the occurrence of any of the following, each licensee shall provide
notification to the Division in writing of such occurrence, and either begin
decommissioning its site, or any separate building or outdoor area that
contains residual radioactivity so that the building or outdoor area is
suitable for release in accordance with Division requirements, or submit within
12 months of notification a decommissioning plan, if required by (8)(h)5.(i),
and begin decommissioning upon approval of that plan if:
(i) The license has expired pursuant to (14)
or (18)(c); or
(ii) The licensee
has decided to permanently cease principal activities, as defined in this part,
at the entire site or in any separate building or outdoor area that contains
residual radioactivity such that the building or outdoor area is unsuitable for
release in accordance with Division requirements; or
(iii) No principal activities under the
license have been conducted for a period of 24 months; or
(iv) No principal activities have been
conducted for a period of 24 months in any separate building or outdoor area
that contains residual radioactivity such that the building or outdoor area is
unsuitable for release in accordance with Division requirements.
3. Coincident with the
notification required by (8)(h)2., the licensee shall maintain in effect all
decommissioning financial assurances established by the licensee pursuant to
(8)(g) in conjunction with a license issuance or renewal or as required by this
section. The amount of the financial assurance must be increased or may be
decreased, as appropriate, to cover the detailed cost estimate for
decommissioning established pursuant to (8)(h)5.(iv)(V).
(i) Any licensee who has not provided
financial assurance to cover the detailed cost estimate submitted with the
decommissioning plan shall do so when this rule becomes effective.
(ii) Following approval of the
decommissioning plan, a licensee may reduce the amount of the financial
assurance as decommissioning proceeds and radiological contamination is reduced
at the site with the approval of the Director.
4. The Division may grant a request to extend
the time periods in (8)(h)2. if the Division determines that this relief is not
detrimental to the public health and safety and is otherwise in the public
interest. The request must be submitted no later than 30 days before
notification pursuant to (8)(h)2. The schedule for decommissioning set forth in
(8)(h)2. may not commence until the Director has made a determination on the
request.
5.
(i) A decommissioning plan must be submitted
if required by license condition or if the procedures and activities necessary
to carry out decommissioning of the site or separate building or outdoor area
have not been previously approved by the Division and these procedures could
increase potential health and safety impacts to workers or to the public, such
as in any of the following cases:
(I)
Procedures would involve techniques not applied routinely during cleanup or
maintenance operations;
(II)
Workers would be entering areas not normally occupied where surface
contamination and radiation levels are significantly higher than routinely
encountered during operation;
(III)
Procedures could result in significantly greater airborne concentrations of
radioactive materials than are present during operation or;
(IV) Procedures could result in significantly
greater releases of radioactive material to the environment than those
associated with operation.
(ii) The Division may approve an alternate
schedule for submittal of a decommissioning plan required pursuant to (8)(h)2.
if the Division determines that the alternative schedule is necessary to the
effective conduct of decommissioning operations and presents no undue risk from
radiation to the public health and safety and is otherwise in the public
interest.
(iii) Procedures such as
those listed in (8)(h)5.(i) with potential health and safety impacts may not be
carried out prior to approval of the decommissioning plan.
(iv) The proposed decommissioning plan for
the site or separate building or outdoor area must include:
(I) A description of the conditions of the
site or separate building or outdoor area sufficient to evaluate the
acceptability of the plan;
(II) A
description of planned decommissioning activities;
(III) A description of methods used to ensure
protection of workers and the environment against radiation hazards during
decommissioning;
(IV) A description
of the planned final radiation survey; and
(V) An updated detailed cost estimate for
decommissioning, comparison of that estimate with present funds set aside for
decommissioning, and a plan for assuring the availability of adequate funds for
completion of decommissioning.
(VI)
For decommissioning plans calling for completion of decommissioning later than
24 months after plan approval, the plan shall include a justification for the
delay based on the criteria in (8)(h)7.
(v) The proposed decommissioning plan will be
approved by the Division if the information therein demonstrates that the
decommissioning will be completed as soon as practicable and that the health
and safety of workers and the public will be adequately protected.
6.
(i) Except as provided in (8)(h)7., licensees
shall complete decommissioning of the site or separate building or outdoor area
as soon as practical but no later than 24 months following the initiation of
decommissioning.
(ii) Except as
provided in (8)(h)7. when decommissioning involves the entire site, the
licensee shall request license termination as soon as practical but no later
than 24 months following the initiation of decommissioning.
7. The Division may approve a
request for an alternative schedule for completion of decommissioning of the
site or separate building or outdoor area, and license termination if
appropriate, if the Division determines that the alternative is warranted by
consideration for the following:
(i) Whether
it is technically feasible to complete decommissioning within the allotted
24-month period;
(ii) Whether
sufficient waste disposal capacity is available to allow completion of
decommissioning within the allotted 24-month period;
(iii) Whether a significant volume reduction
in wastes requiring disposal will be achieved by allowing short-lived
radionuclides to decay;
(iv)
Whether a significant reduction in radiation exposure to workers can be
achieved by allowing short-lived radionuclides to decay; and
(v) Other site-specific factors which the
Division may consider appropriate on a case-by-case basis, such as the
regulatory requirements of other government agencies, lawsuits, ground-water
treatment activities, monitored natural ground-water restoration, actions that
could result in more environmental harm than deferred cleanup, and other
factors beyond the control of the licensee.
8. As the final step in decommissioning, the
licensee shall follow the requirements of Rule
.02(18)(d).
(9)
Special Requirements for
Issuance of Certain Specific Licenses for Radioactive Material.
(a) Use of Sealed Sources in Industrial
Radiography. In addition to the requirements set forth in (8), a specific
license for the use of sealed sources in industrial radiography will be issued
if the licensee meets all of the requirements of Rule
.04 of this Chapter.
(b) Human Use of Radioactive Materials in
Institutions. In addition to the requirements set forth in (8), a specific
license for the human use of radioactive material in an institution will be
issued only if the licensee also meets all of the requirements of Rule
.05 of this Chapter.
(c) Specific Licenses to Individual
Physicians for Human Use of Radioactive Material.
1. An application by an individual physician
or group of physicians for a specific license for human use of radioactive
material will be approved if:
(i) The
applicant satisfies the general requirements specified in (8), and all of the
requirements of Rule
.05 of this Chapter;
(ii) The application is for use in the
applicant's practice in an office outside a medical institution;
(iii) The applicant has access to a hospital
possessing adequate facilities to hospitalize and monitor the applicant's
radioactive patients whenever it is advisable; and
(iv) The applicant has extensive experience
in the proposed use, the handling and administration of radionuclides, and
where applicable, the clinical management of radioactive patients.
2. The Director will not approve
an application by an individual physician or group of physicians for a specific
license to receive, possess, or use radioactive material on the premises of a
medical institution unless:
(i) The use of
radioactive material is limited to:
(I) The
administration of radiopharmaceuticals for diagnostic or therapeutic
purposes;
(II) The performance of
diagnostic studies on patients to whom a radiopharmaceutical has been
administered;
(III) The performance
of in vitro diagnostic studies; or
(IV) The calibration and quality control
checks of radioactive assay instrumentation, radiation safety instrumentation,
and diagnostic instrumentation;
(ii) The physician brings the radioactive
material with him and removes the radioactive material when he departs (The
institution cannot receive, possess, or store radioactive material other than
the amount of material remaining in the patient.); and
(iii) The medical institution does not hold a
radioactive material license under (9)(b).
(d) Human Use of Sealed Sources Containing
Radioactive Material. In addition to the requirements set forth in (8), a
specific license for the human use of sealed sources containing radioactive
material will be issued only if the applicant, or, if the application is made
by an institution, the individual user is a physician and either:
1. Has specialized training in the
therapeutic use of the sealed source considered (e.g., teletherapy unit, beta
applicator), or has experience equivalent to such training; or
2. Has specialized training in the diagnostic
use of the sealed source considered (e.g., bone mineral analyzer) or has
experience equivalent to such training.
(e) Specific Licenses for Certain Medical
Uses of Radioactive Material.
1. Subject to
the provisions of (9)(e)2. and 3., an application for a specific license
pursuant to (9)(b), (c), or (d), for any medical use or uses of radioactive
material specified in Rule
.05 of this Chapter, will be
approved if:
(i) The applicant satisfies the
requirements of (9)(b), (c), or (d);
(ii) The applicant, or the physician
designated in the application as the individual user, has adequate clinical
experience in the types of uses specified in the application;
(iii) The applicant, or the physicians and
all other personnel who will be involved in the preparation and use of the
radioactive material, has adequate training and experience in the handling of
radioactive material appropriate to his participation in the uses specified in
the application;
(iv) The
applicant's radiation detection and measuring instrumentation is adequate for
conducting the procedures involved in the uses specified in the
application;
(v) The applicant's
radiation safety operating procedures are adequate for handling and disposal of
the radioactive material involved in the uses specified in the application;
and
(vi) For uses regulated by
Rules .05(41) and
(44) of this Chapter, any licensee using
radioactive material for clinical procedures other than those specified in the
product labeling (package insert) shall comply with the product labeling
regarding:
(I) Chemical and physical
form,
(II) Route of administration,
and
(III) Dosage range.
2. Any licensee who is
authorized to use radioactive material pursuant to (9)(e) and to Rule
.05 of this Chapter is subject to
the following conditions:
(i) For paragraphs
(41), (44), and (48) of Rule
.05 of this Chapter, no licensee
shall receive, possess, or use radioactive material except as a
radiopharmaceutical manufactured in the form to be administered to the patient,
and labeled, packaged, and distributed in accordance with a specific license
issued by the Director pursuant to (11)(i), a specific license issued by the
U.S. Nuclear Regulatory Commission pursuant to Section 32.72 of 10 CFR, Part
32, or a specific license issued by an Agreement State pursuant to equivalent
regulations.
(ii) For Rule
391-3-17-.05(44),
no licensee shall receive, possess, or use generators or reagent kits
containing radioactive material or shall use reagent kits that do not contain
radioactive material to prepare radiopharmaceuticals containing radioactive
material, except:
(I) Reagent kits not
containing radioactive material that are approved by the Division, the U.S.
Nuclear Regulatory Commission or an Agreement State for use by persons licensed
pursuant to (9)(d) and to Rule
.05 of this Chapter or
(II) Generators or reagent kits containing
radioactive material that are manufactured, labeled, packaged, and distributed
in accordance with a specific license issued by the Director pursuant to
(11)(i), a specific license issued by the U.S. Nuclear Regulatory Commission
pursuant to Section 32.73 of 10 CFR, Part 32, or a specific license issued by
an Agreement State pursuant to equivalent regulations; and
(iii) For Brachytherapy, regulated by Rule
.05 of this Chapter, no licensee
shall receive, possess, or use radioactive material except as contained in a
source or device that has been manufactured, labeled, packaged, and distributed
in accordance with a specific license issued by the Director pursuant to
(11)(j), a specific license issued by the U.S. Nuclear Regulatory Commission
pursuant to Section 32.74 of 10 CFR, Part 32, or a specific license issued to
the manufacturer by an Agreement State pursuant to equivalent
regulations.
3. Any
licensee who is licensed pursuant to (9) for one or more of the medical uses
regulated by Rule
.05 of this Chapter also is
authorized to use radioactive material under the general license in (6)(g) for
in vitro uses without filing the Certificate as required by (6)(g)2, provided
that the licensee is subject to the other provisions of (6)(g).
(f) Use of Naturally-Occurring
Radioactive Material (NORM). In addition to the requirements set forth in (8),
a specific license for the use of NORM will be issued if the licensee meets all
of the requirements of Rule
.08 of this Chapter.
(g) Use of Sealed Sources in Irradiators. In
addition to the requirements set forth in (8), a specific license for the use
of sealed sources in large irradiators will be issued if the licensee meets all
of the requirements of Rule
.09 of this Chapter.
(10)
Special Requirements
for Specific Licenses of Broad Scope. These requirements are for the
issuance of non-medical specific licenses of broad scope for radioactive
material ("broad licenses") and contain certain regulations governing holders
of such licenses. (The issuance of medical specific licenses of broad scope is
addressed in (9).)
Nota Bene: See Note, in (3)(c)1.
(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 (21)(c), Schedule C, for any authorized purpose. The possession
limit for a Type B broad license, if only one radionuclide is possessed
thereunder, is the quantity specified for that radionuclide in (21)(c),
Schedule C, 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 (21)(c), Schedule C, 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 (21)(c), Schedule C, for any authorized
purpose. The possession limit for a Type C broad license, if only one
radionuclide is possessed thereunder, is the quantity specified for that
radionuclide in (21)(c), Schedule C, 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 (21)(c), Schedule C, Column II, for
that radionuclide. The sum of the ratios for all radionuclides 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 (8);
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:
(i) 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;
(ii)
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
(iii) 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, the 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 (10)(b)3.(iii)(II) prior to the 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 (8);
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:
(i) 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
(ii) 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, the 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 (10)(c)2.(ii)(II)
prior to the 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 (8);
2.
The applicant submits a statement that radioactive material will be used only
by, or under the direct supervision of, individuals who have received:
(i) A college degree at the bachelor level,
or equivalent training and experience, in the physical or biological sciences
or in engineering, and
(ii) 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 appropriate 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 non-medical licenses of broad
scope are subject to the following conditions:
1. Unless specifically authorized, persons
licensed pursuant to (10) shall not:
(i)
Conduct tracer studies in the environment involving direct release of
radioactive material;
(ii) 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;
(iii) Conduct activities
for which a specific license issued by the Division under (9) or (11) is
required; or
(iv) 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 (10) 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 (10) 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 (10) 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
(10)(d).
(11)
Special Requirements for a Specific License to Manufacture, Assemble,
Repair, or Distribute Commodities, Products, or Devices which Contain
Radioactive Material.
(a)
[Reserved]
(b) Licensing the
Distribution of Naturally-Occurring and Accelerator-Produced Radioactive
Material (NARM) in Exempt Quantities.
Nota Bene: See Note, in (3)(c)1.
1. An application for a specific license to
distribute NARM to persons exempted from this Chapter pursuant to (3)(b) will
be approved if:
(i) The radioactive material
is not contained in any food, beverage, cosmetic, drug, or other commodity
designed for ingestion or inhalation by, or application to, a human
being;
(ii) The radioactive
material is in the form of processed chemical elements, compounds, mixtures,
tissue samples, bioassay samples, counting standards, plated or encapsulated
sources, or similar substances identified as radioactive and to be used for its
radioactive properties, but is not incorporated into any manufactured or
assembled commodity, product, or device intended for commercial distribution;
and
(iii) The applicant submits
copies of prototype labels and brochures and the Division approves such labels
and brochures.
2. The
license issued under (11)(b)1. is subject to the following conditions:
(i) No more than ten 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.
(ii) Each exempt quantity shall be separately
and individually packaged. No more than ten such packaged exempt quantities
shall be contained in any outer package for transfer to persons exempt pursuant
to (3)(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 µSv) per
hour.
(iii) The immediate container
of each quantity or separately- packaged fractional quantity of radioactive
material shall bear a durable and legible label which:
(I) Identifies the radionuclide and the
quantity of radioactivity, and
(II)
Bears the words "Radioactive Material".
(iv) In addition to the labeling information
required by (11)(b)2.(iii), the label affixed to the immediate container, or an
accompanying brochure, shall:
(I) State that
the contents are exempt from applicable U.S. Nuclear Regulatory Commission or
Agreement 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 (11)(b) shall maintain records identifying, by name
and address, each person to whom radioactive material is transferred for use
under (3)(b) or the equivalent regulations of the U.S. Nuclear Regulatory
Commission or another Agreement State, and stating the kinds and quantities of
radioactive material transferred. An annual summary report stating the total
quantity of each radionuclide transferred under the specific license shall be
filed with the Division. Each report shall cover the year ending June 30, and
shall be filed within 30 days thereafter. If no transfers of radioactive
material have been made pursuant to (11)(b) during the reporting period, the
report shall so indicate.
(c) [Reserved]
(d) Licensing the Manufacture and Initial
Transfer of Devices to Persons Generally Licensed Under (6)(c).
1. An application for a specific license to
initially transfer devices containing radioactive material to persons generally
licensed under (6)(c) or equivalent regulations of the U.S. Nuclear Regulatory
Commission or an Agreement State will be approved if:
(i) The applicant satisfies the general
requirements of (8);
(ii) The
applicant submits sufficient information relating to the design, manufacture,
prototype testing, quality control, labels, proposed uses, installation,
servicing, leak testing, operating and safety instructions, and potential
hazards of the device to provide reasonable assurance that:
(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 one year a dose in
excess of ten percent of the annual limits specified in Rule
.03(5)(a)1. of
this Chapter, 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:
I. Whole body; head and trunk; active
blood-forming organs; gonads; or lens of eye 15 rem (150 mSv);
II. Hands and forearms; feet and ankles;
localized areas of skin averaged over areas no larger than one square
centimeter 200 rem (2 Sv);
III.
Other Organs 50 rem (500 mSv); and
(iii) Each device bears a durable, legible,
and clearly visible label or labels approved by the Division, 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 the
following statement, in the same or substantially similar form:
I. The receipt, possession, use, and transfer
of this device, Model ____, Serial No.____, are subject to a general license or
the equivalent and to the regulations of the U.S. Nuclear Regulatory Commission
or of 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 INITIAL TRANSFEROR)
Note: The model, serial number, and name of the manufacturer or distributor may be omitted from the appropriate label provided the information is elsewhere specified in labeling affixed to the device. Devices distributed pursuant to Regulations equivalent to (11)(d) prior to January 1, 1981, may bear labels authorized by the Regulations in effect on January 1, 1980. Devices distributed on or after January 1, 1981, including devices redistributed upon radioactive sources exchange, shall bear labels authorized in (11)(d).
(iv) Each device having a separable source
housing that provides the primary shielding for the source also bears, on the
source housing, a durable label containing the device model number and serial
number, the isotope and quantity, the words, "Caution-Radioactive Material,"
the radiation symbol described in Rule
.03(12), and the
name of the manufacturer or initial distributor.
(v) Each device meeting the criteria of
(6)(c)3.(xii), bears a permanent (e.g., embossed, etched, stamped, or engraved)
label affixed to the source housing if separable, or the device if the source
housing is not separable, that includes the words, "Caution-Radioactive
Material," and, if practical, the radiation symbol described in Rule
.03(12).
(vi) The device has been registered in the
Sealed Source and Device Registry.
2. In the event the applicant desires that
the device be tested at intervals longer than six months, either for proper
operation of the on/off mechanism and indicator, if any, or for leakage of
radioactive material, or for both, the applicant shall include in his
application sufficient information to demonstrate that such longer interval is
justified by performance characteristics of the device or similar devices and
by design features which have a significant bearing on the probability or
consequences of leakage of radioactive material from the device or failure of
the on/off mechanism and indicator. In determining the acceptable interval for
the test for leakage of radioactive material, the Division will consider
information that includes, but is not limited to:
(i) Primary containment (source
capsule);
(ii) Protection of
primary containment;
(iii) Method
of sealing containment;
(iv)
Containment construction materials;
(v) Form of contained radioactive
material;
(vi) Maximum temperature
withstood during prototype tests;
(vii) Maximum pressure withstood during
prototype tests;
(viii) Maximum
quantity of contained radioactive material;
(ix) Radiotoxicity of contained radioactive
material; and
(x) Operating
experience with identical devices or similarly designed and constructed
devices.
3. In the event
the applicant desires that the general licensee under (6)(c), or under
equivalent regulations of the U.S. Nuclear Regulatory Commission or an
Agreement 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 his application written
instructions to be followed by the general licensee, estimated calendar quarter
doses associated with such activity or activities, and the basis for such
estimates. The submitted information shall demonstrate that the 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 dose in
excess of ten percent of the annual limits specified in Rule
.03(5)(a)1. of
this Chapter.
4. Each person
licensed under (11)(d) shall provide the information specified in (11)(d)4.(i)
to each generally licensed recipient to whom a device is to be transferred.
This information must be provided before the device may be transferred. In the
case of a transfer through an intermediate person, the information must also be
provided to the intended user prior to initial transfer to the intermediate
person.
(i) The required information includes:
(I) A copy of the general license contained
in (6)(c); if (6)(c)3.(ii) through (iv) or (6)(c)3.(xii) do not apply to the
particular device, these rules may be omitted.
(II) A copy of Rule
.01(4), (5), (6), (7), (8), (9) and
(10), Rule
.02(13), (18), and
(19), Rule
.03(15)(a) and (b)
and Rule .06;
(III) A list of the services that can only be
performed by a specific licensee;
(IV) Information on acceptable disposal
options including estimated costs of disposal; and
(V) An indication that improper disposal can
result in high civil penalties.
(ii) If a device containing radioactive
material is to be transferred for use under a general license contained in the
U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent
to (6)(c), the licensee shall provide the information specified in
(11)(d)4.(ii) to each person to whom a device is to be transferred. This
information must be provided before the device may be transferred. In the case
of a transfer through an intermediate person, the information must also be
provided to the intended user prior to initial transfer to the intermediate
person. The required information includes:
(I)
A copy of this equivalent regulation or, alternatively, furnish a copy of the
general license contained in (6)(c) 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
or the Agreement State. In the case of a transfer through an intermediate
person, the information must also be provided to the intended user prior to
initial transfer to the intermediate person. If a copy of the general license
in (6)(c) 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 or the Agreement State under requirements substantially
the same as those in (6)(c); if certain paragraphs of the regulations do not
apply to the particular device, those paragraphs may be omitted;
(II) A list of the services that can only be
performed by a specific licensee;
(III) Information on acceptable disposal
options including estimated costs of disposal;
(IV) An indication that improper disposal can
result in high civil penalties; and
(V) The name or title, address, and telephone
number of the contact at the appropriate NRC Regional Office or Agreement State
from which additional information may be obtained.
(iii) An alternative approach to informing
customers may be proposed by the licensee for approval by the
Division.
5. Each device
that is transferred after January 1, 2003, must meet the labeling requirements
of (11)(d)1.(iii) through (v).
6.
If a notification of bankruptcy has been made under (13)(e) or the license is
to be terminated, each person licensed under (11)(d) shall provide, upon
request, to the Division and as appropriate to any Agreement State or the NRC,
records of final disposition required under (11)(d)4.(viii).
7. The licensee shall report to the Division
all transfers of such devices to persons for use under the general license in
(6)(c) and report all receipts of such devices from persons licensed under
(6)(c).
(i) Such report shall identify each
general licensee by the following:
(I) The
name and mailing address for the location of use; if there is no mailing
address for the location of use, an alternate address for the general licensee
shall be submitted along with information on the actual location of
use;
(II) The name, title, and
telephone number of the person identified by the general licensee as having
knowledge of and authority to take required actions to ensure compliance with
the appropriate regulations and requirements;
(III) The date of the transfer;
(IV) The type, model number, and serial
number of the device transferred; and
(V) The quantity and type of radioactive
material contained in the device.
(ii) 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 the same information for both
the intended user and each intermediate person, and clearly designate the
intermediate person(s).
(iii) For
devices received from a (6)(c) general licensee, the report must include the
identity of the general licensee by name and address, the type, model number,
and serial number of the device received, the date of receipt, and, in the case
of devices not initially transferred by the reporting licensee, the name of the
manufacturer or initial transferor.
(iv) If the licensee makes changes to a
device possessed by a (6)(c) general licensee, such that the label must be
changed to update required information, the report must identify the general
licensee, the device, and the changes to information on the device
label.
(v) The report must cover
each calendar quarter, must be filed within 30 days of the end of the calendar
quarter, and must clearly indicate the period covered by the report.
(vi) The report must clearly identify the
specific licensee submitting the report and include the license number of the
specific licensee.
(vii) If no
transfers have been made to or from persons generally licensed under (6)(c)
during the reporting period, the report shall so indicate.
8. The licensee shall furnish reports to
other agencies as follows:
(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, Part 31 and all receipts of devices from U.S. Nuclear
Regulatory Commission Section 31.5 general licensees;
(ii) Report to the responsible state agency
all transfers of devices manufactured and distributed pursuant to (11)(d) for
use under a general license in that state's regulations equivalent to (6)(c)
and all receipts of devices from general licensees in the state agency's
jurisdiction;
(iii) The reports
identified in 8.(i) and 8.(ii) shall identify each general licensee by the
following:
(I) The name and mailing address
for the location of use; if there is no mailing address for the location of
use, an alternate address for the general licensee shall be submitted along
with information on the actual location of use.
(II) The name, title and telephone number the
person identified by the general licensee as having knowledge of and authority
to take required actions to ensure compliance with the appropriate regulations
and requirements;
(III) The date of
the transfer;
(IV) The type, model,
and serial number of the device transferred; and
(V) The quantity and type of radioactive
material contained in the device.
(iv) 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 the same information for both
the intended user and each intermediate person, and clearly designate the
intermediate person(s).
(v) For
devices received from a (6)(c) general licensee, the report must include the
identity of the general licensee by name and address, the type, model number,
and serial number of the device received, the date of receipt, and, in the case
of devices not initially transferred by the reporting licensee, the name of the
manufacturer or initial transferor.
(vi) If the licensee makes changes to a
device possessed by a general licensee, such that the label must be changed to
update required information, the report must identify the general licensee, the
device, and the changes to information on the device label.
(vii) The report must cover each calendar
quarter, must be filed within 30 days of the end of the calendar quarter, and
must clearly indicate the period covered by the report.
(viii) The report must clearly identify the
specific licensee submitting the report and must include the license number of
the specific licensee.
(ix) If no
transfers have been made to U.S. Nuclear Regulatory Commission licensees during
the reporting period, report this information to the U.S. Nuclear Regulatory
Commission; and
(x) If no transfers
have been made to general licensees within a particular state during the
reporting period, report this information to the responsible state agency upon
request of that agency.
9. Each person licensed under (11)(d) to
distribute devices to generally licensed persons shall maintain all information
concerning transfers and receipts of devices that supports the reports required
by (11)(d)4. These records shall be maintained for a period of three years
following the date of the recorded event.
(e) Special Requirements for the Manufacture,
Assembly, or Repair of Luminous Safety Devices for Use in Aircraft. An
application for a specific license to manufacture, assemble, repair, or
initially transfer luminous safety devices containing tritium or promethium-147
for use in aircraft, and for distribution to persons generally licensed under
(6)(d), will be approved subject to the following conditions:
1. The applicant satisfies the general
requirements specified in (8), and
2. The applicant satisfies the requirements
of Sections 32.53, 32.54, 32.55, and 32.56 of 10 CFR, Part 32, or their
equivalent.
(f) Special
Requirements for License to Manufacture or Initially Transfer Calibration
Sources Containing Americium-241, Plutonium, or Radium-226 for Distribution to
Persons Generally Licensed Under (6)(f). An application for a specific license
to manufacture or initially transfer calibration and reference sources
containing americium-241, plutonium, or radium-226 to persons generally
licensed under (6)(f) will be approved subject to the following conditions:
1. The applicant satisfies the general
requirement of (8), and
(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 (6)(g) will be approved subject to the following
conditions:
1. The applicant satisfies the
general requirements specified in (8);
2. The radioactive material is to be prepared
for distribution in prepackaged units of:
(i)
Iodine-125 in units not exceeding ten microcuries (370 kBq) each,
(ii) Iodine-131 in units not exceeding ten
microcuries (370 kBq) each,
(iii)
Carbon-14 in units not exceeding ten microcuries (370 kBq) each,
(iv) Hydrogen-3 (tritium) in units not
exceeding 50 microcuries (1.85 MBq) each,
(v) Iron-59 in units not exceeding 20
microcuries (740 kBq) each,
(vi)
Cobalt-57 in units not exceeding ten microcuries (370 kBq) each,
(vii) Selenium-75 in units not exceeding ten
microcuries (370 kBq) each,
(viii)
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;
3. Each prepackaged unit bears a durable and
clearly visible label:
(i) Identifying the
radioactive contents as to chemical form and radionuclide, and indicating that
the amount of radioactivity does not exceed ten 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
(ii) Displaying the radiation caution symbol
described in Rule
391-3-17-.03, of this Chapter, and
the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External
Use in Humans or Animals";
4. The following statement, as appropriate,
or a substantially similar statement which contains the information called for
in the following statement, appears on a label affixed to each prepackaged unit
or appears in a leaflet or brochure which accompanies the package:
(i) This radioactive material may be
received, acquired, possessed, and used only by physicians, veterinarians in
the practice of veterinary medicine, 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 of and a general license of the U.S. Nuclear
Regulatory Commission or of a State with which the U.S. Nuclear Regulatory
Commission has entered into an agreement for the exercise of regulatory
authority.
___________________________________
(NAME OF MANUFACTURER)
and
5. The label affixed to the unit, or the
leaflet or brochure, which accompanies the package, contains adequate
information as to the precautions to be observed in handling and storing such
radioactive material. In the case of the Mock Iodine-125 reference or
calibration source, the information accompanying the source must also contain
directions to the licensee regarding the waste disposal requirements set out in
Rule .03(13) of this
Chapter.
(h) Licensing
the Manufacture and Distribution of Ice-Detection Devices. An application for a
specific license to manufacture and initially transfer ice-detection devices to
persons generally licensed under (6)(e) will be approved subject to the
following conditions:
1. The applicant
satisfies the general requirements of (8), and
2. The criteria of Sections 32.61 and 32.62
of 10 CFR, Part 32, are met.
(i) Manufacture, Preparation, or Transfer,
for Commercial Distribution of Pharmaceuticals Containing Radioactive Material
for Medical Use. An application for a specific license to manufacture, prepare,
or transfer for commercial distribution pharmaceuticals containing radioactive
material for use by persons licensed pursuant to (9) for the uses listed in
(41), (44), and (48) of Rule
.05 of this Chapter will be
approved subject to the following conditions:
1. The applicant satisfies the general
requirements specified in (8);
2.
The applicant submits evidence that the applicant is at least one of the
following:
(i) Registered or licensed with
the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug
establishment that engages in the manufacture, preparation, propagation,
compounding, or processing of a drug under
21 CFR
207.17(a);
(ii) Registered or licensed with a State
Agency as a drug manufacturer;
(iii) Licensed as a pharmacy by the Georgia
State Board of Pharmacy;
(iv)
Operating as a nuclear pharmacy within a Federal medical institution;
or
(v) A Positron Emission
Tomography (PET) drug production facility registered with a State
agency.
3. The applicant
submits information on the radionuclide, chemical and physical form, packaging
including maximum activity per vial, syringe, generator, or other container of
the radiopharmaceutical, and shielding provided by the packaging to show it is
appropriate for safe handling and storage of radiopharmaceuticals by licensees;
and
4. The applicant commits to the
following labeling requirements:
(i) A label
is affixed to each transport radiation shield, whether it is constructed of
lead, glass, plastic, or other material, of a radiopharmaceutical to be
transferred for commercial distribution. The label must include the radiation
symbol and words "Caution, Radioactive Material" or "Danger Radioactive
Material"; the name of the radiopharmaceutical or its abbreviation, and
quantity of radioactivity at a specified date and time. For
radiopharmaceuticals with a half-life greater than 100 days, the time may be
omitted.
(ii) A label is affixed to
each syringe, vial, or other container used to hold a radiopharmaceutical to be
transferred for commercial distribution. The label must include the words
"Caution, Radioactive Material" or "Danger Radioactive Material" and an
identifier that ensures that the syringe, vial, or other container can be
correlated with the information on the transport radiation shield label,
leaflet, or brochure.
5.
A licensee described by (11)(i)2.(iii) or (iv):
(i) May prepare radiopharmaceuticals for
medical use, as defined in Rule
.05(2)(s) provided
that the radiopharmaceutical is prepared by either an authorized nuclear
pharmacist, as specified in (ii) and (iv) or an individual under the
supervision of an authorized nuclear pharmacist as specified in Rule
.05(18)(b).
(ii) May allow a pharmacist to work as an
authorized nuclear pharmacist if this individual:
(I) Qualifies as an authorized nuclear
pharmacist as defined in .05(2)(e),
(II) Meets the requirements specified in Rule
.05(24)(b) and
.05(27) and the
licensee has received an approved license amendment identifying this individual
as an authorized nuclear pharmacist, or has notified the Division in accordance
with Rule
.05(11),
or
(III) Is designated as an
authorized nuclear pharmacist in accordance with (iv).
(iii) The actions authorized in (i) and (ii)
are permitted not withstanding more restrictive language in license
conditions.
(iv) May designate a
nuclear pharmacist in accordance with Rule
.05(26) as an
authorized nuclear pharmacist if the individual is identified as of December
31, 1996, as an "authorized user" on a license issued by the Director, the NRC,
or an Agreement State, under this rule or equivalent requirements, or if the
individual was a nuclear pharmacist preparing only radiopharmaceuticals
containing accelerator produced radioactive material and the individual
practiced at a Government Agency or Federally recognized Indian Tribe before
November 30, 2007 or at all other pharmacies before August 8, 2009, or an
earlier date as noticed by the NRC.
(v) Shall provide to the Division a copy of
each individual's certification by a specialty board whose certification
process has been recognized by the Commission or an Agreement State as
specified in
391-3-17-.05(24),
or a Division, NRC, or Agreement State issued license, or permit issued by a
licensee of broad scope, or documentation that only accelerator-produced
radioactive materials were used in the practice of nuclear pharmacy at a
Government agency or Federally recognized Indian Tribe before November 30, 2007
or at all other locations of use before August 8, 2009, or an earlier date as
noticed by the NRC, and a copy of the individual's license to practice pharmacy
in the State of Georgia issued by the Secretary of State's office, no later
than 30 days after the date that the licensee allows pursuant to (ii) and
(iii), the individual to work as an authorized nuclear pharmacist.
6. A licensee shall possess and
use instrumentation to measure the radioactivity of radiopharmaceuticals. The
licensee shall measure, by direct measurements or by combination of
measurements and calculations, the amount of radioactivity in dosages of
alpha-, beta-, or photon-emitting radiopharmaceuticals prior to transfer for
commercial distribution. In addition, the licensee shall:
(i) Perform test before initial use,
periodically, and following repair, on each instrument for accuracy, linearity,
and geometry dependence, as appropriate for the use of the instrument; and make
adjustments when necessary; and
(ii) Check each instrument for constancy and
proper operation at the beginning of each day of use.
7. A licensee shall satisfy the labeling
requirements in subparagraph (11)(i)4.
8. Nothing in this subparagraph relieves the
licensee from complying with applicable FDA, other Federal, or other State
requirements governing radiopharmaceuticals.
(j) 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 Rule
.05 of this chapter for use as a
calibration, transmission, or reference source or for medical uses regulated by
Rule .05(55), (65), or
(67) of this Chapter will be approved subject
to the following conditions:
1. The applicant
satisfies the general requirements of (8);
2. The applicant submits sufficient
information regarding each type of source or device pertinent to an evaluation
of its radiation safety, including:
(i) The
radioactive material contained, its chemical and physical form, and
amount,
(ii) Details of design and
construction of the source or device,
(iii) Procedures for, and results of,
prototype tests to demonstrate that the source or device will maintain its
integrity under stresses likely to be encountered in normal use and
accidents,
(iv) For devices
containing radioactive material, the radiation profile of a prototype
device,
(v) Details of quality
control procedures to assure that production sources and devices meet the
standards of the design and prototype tests,
(vi) Procedures and standards for calibrating
sources and devices,
(vii) Legend
and methods for labeling sources and devices as to their radioactive content,
and
(viii) 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. Instructions which are too lengthy for such label may be summarized on
the label and printed in detail on a brochure that is referenced on the
label.)
3. The label
affixed to the source or device, or to the permanent storage container for the
source or device, contains information on the radionuclide, quantity, and date
of assay, and a statement that the source or device is licensed by the Director
for distribution to persons licensed pursuant to (9) and to Rule
.05(55), (65), or
(67) of this Chapter or under equivalent
licenses of the U.S. Nuclear Regulatory Commission or an Agreement
State;
4. The source or device has
been registered in the Sealed Source and Device Registry;
5. In the event the applicant desires that
the source or device be required to be tested for leakage of radioactive
material at intervals longer than six months, he shall include in his
application sufficient information to demonstrate that such longer interval is
justified by performance characteristics of the source or device or similar
sources or devices and by design features that have a significant bearing on
the probability or consequences of leakage of radioactive material from the
source;
6. In determining the
acceptable interval for test of leakage of radioactive material, the Division
will consider information that includes, but is not limited to, that which is
listed in (11)(d)2.
(k)
Requirements for License to Manufacture and Distribute Industrial Products
Containing Depleted Uranium for Mass-Volume Applications.
1. An application for a specific license to
manufacture industrial products and devices containing depleted uranium for use
pursuant to (5)(d) or equivalent regulations of the U.S. Nuclear Regulatory
Commission or an Agreement State will be approved subject to the following
conditions:
(i) The applicant satisfies the
general requirements specified in (8);
(ii) The applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control procedures, labeling or marking, proposed uses, and potential hazards
of the industrial product or device to provide reasonable assurance that
possession, use, or transfer of the depleted uranium in the product or device
is not likely to cause any individual to receive in any period of 1 year a
radiation dose in excess of ten percent of the annual limits specified in Rule
.03(5)(a)1. of
this Chapter; and
(iii) The
applicant submits sufficient information regarding the industrial product or
device and the presence of depleted uranium for a mass-volume application in
the product or device to provide reasonable assurance that unique benefits will
accrue to the public because of the usefulness of the product or
device.
2. In the case of
an industrial product or device whose unique benefits are questionable, the
Director will approve an application for a specific license under (11)(k) only
if the product or device is found to combine a high degree of utility and low
probability of uncontrolled disposal and dispersal of significant quantities of
depleted uranium into the environment.
3. The Director may deny any application for
a specific license under (11)(k) if the end use(s) of the industrial product or
device cannot be reasonably foreseen.
4. Each person licensed pursuant to (11)(k)1.
shall:
(i) Maintain the level of quality
control required by the license in the manufacture of the industrial product or
device and in the installation of the depleted uranium into the product or
device;
(ii) Label or mark each
unit to:
(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 to the regulations of the U.S. Nuclear Regulatory
Commission or an Agreement State;
(iii) Assure that the depleted uranium before
being installed in each product or device has been impressed with the following
legend clearly legible through any plating or other covering: "Depleted
Uranium";
(iv) Furnish a copy of
the general license contained in:
(I) (5)(d)
and a copy of Division 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
(5)(d), or
(II) The U.S. Nuclear
Regulatory Commission's or Agreement State's regulation equivalent to (5)(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 (5)(d) and a copy of Division 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 (5)(d);
(v) Report to the Division all transfers of
industrial products or devices to persons for use under the general license in
(5)(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 Division and the general licensee, the type and model number of
device transferred, and the quantity of depleted uranium contained in the
product or device. The report shall be submitted within 30 days after the end
of each calendar quarter in which such a product or device is transferred to
the generally licensed person. If no transfers have been made to persons
generally licensed under (5)(d) during the reporting period, the report shall
so indicate;
(vi) Report to other
agencies as follows:
(I) To the U.S. Nuclear
Regulatory Commission all transfers of industrial products or devices to
persons for use under the U.S. Regulatory Commission general license in Section
40.25 of 10 CFR, Part 40 ;
(II) To
the responsible state agency all transfers of devices manufactured and
distributed pursuant to 10
CFR 32.210 for use under a general license in
that state's regulations equivalent to (5)(d);
(III) Have such reports identify each general
licensee by name and address, an individual by name and/or position who may
constitute a point of contact between the agency and the general licensee, the
type and model number of the device transferred, and the quantity of depleted
uranium contained in the product or device. The report shall be submitted
within 30 days after the end of each calendar quarter in which such product or
device is transferred to the generally licensed person;
(IV) If no transfers have been made to U.S.
Nuclear Regulatory Commission licensees during the reporting period, report
this information to the U.S. Nuclear Regulatory Commission; and
(V) If no transfers have been made to general
licensees within a particular Agreement State during the reporting period,
report this information to the responsible Agreement State agency upon the
request of that agency; and
(vii) Keep records showing the name, address,
and point of contact for each general licensee to whom he transfers depleted
uranium in industrial products or devices for use pursuant to the general
license provided in (5)(d) or equivalent regulations of the U.S. Nuclear
Regulatory Commission or an Agreement State. The records shall be maintained
for a period of two 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 (11).
(l) [Reserved]
(12)
Issuance of Specific
Licenses.
(a) Upon a determination that
an application meets the requirements of the Act and the Rules of the Division,
the Director may issue a specific license authorizing the proposed activity in
such form and containing such conditions and limitations as it deems
appropriate or necessary to effectuate the purposes of the Act.
(b) The Director may incorporate in any
license at the time of issuance, or thereafter, such additional requirements
and conditions, as authorized by the Act or Rules, or Order, with respect to
the licensee's receipt, possession, use, and transfer of radioactive material
subject to this Chapter as 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 necessary to effectuate the purposes of the
Act; and
3. Prevent loss or theft
of material subject to this Rule.
(13)
Specific Terms and Conditions of
Licenses.
(a) Each license issued
pursuant to this Rule shall be subject to all the provisions of the Act, and to
all Rules of the Division and Orders of the Director.
(b) No license issued or granted under this
Rule and no right to possess or utilize radioactive material granted by any
license issued pursuant to this Rule 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
Division, after securing full information, finds that the transfer is in
accordance with the provisions of the Act, and gives its consent in writing.
1. An application for transfer of license
must include:
(i) The identity, technical and
financial qualification of the proposed transferee; and
(ii) Financial assurance for decommissioning
information required by .02(8)(g).
(c) Each person licensed by the Director
pursuant to this Rule shall confine use and possession of the material licensed
to the locations and purposes authorized in the license.
(d) Each licensee shall notify the Division
in writing immediately and request termination of his license when the licensee
decides to terminate all activities involving radioactive materials authorized
under the license. This notification and request for termination must include
the information specified in (18)(d).
(e) Each general licensee required to
register by (6)(c)3.(xi) and each specific licensee shall notify the Division
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:
1. The
licensee;
2. An entity (as that
term is defined in 11 U.S.C.
101(15)) controlling the
licensee or listing the license or licensee as property of the estate;
or
3. An affiliate (as that term is
defined in 11 U.S.C.
101(2)) of the
licensee.
(f) The
notification specified in (13)(e) shall indicate the bankruptcy court in which
the petition for bankruptcy was filed and the date of the filing of the
petition.
(g) Security requirements
for portable gauges. Each portable gauge licensee shall use a minimum of two
independent physical controls that form tangible barriers to secure portable
gauges from unauthorized removal, whenever portable gauges are not under the
control and constant surveillance of the licensee.
(h) Each licensee preparing technetium-99m
radiopharmaceuticals from molybdenum-99/technetium-99m generators or
rubidium-82 from strontium-82/rubidium-82 generators shall test the generator
eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85
contamination, respectively, in accordance with Rule
.05(45)(a)(b) and
(c). The licensee shall record the results of
each test and retain each record for 3 years after the record is made. The
licensee shall report the results of any test that exceeds the permissible
concentration listed in
391-3-17-.05(45)
at the time of generator elution, in accordance with
391-3-17-.05(120).
(i) Authorization under .02(7)(j) to produce
Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer
to medical use licensees in its consortium does not relieve the licensee from
complying with applicable FDA, other Federal, and State requirements governing
radioactive drugs.
1. Each licensee authorized
under .02(7)(j) to produce PET radioactive drugs for noncommercial transfer to
medical use licensees in its consortium shall:
(i) Satisfy the labeling requirements in
.02(11)(i)4. of this Rule for each PET radioactive drug transport radiation
shield and each syringe, vial, or other container used to hold a PET
radioactive drug intended for noncommercial distribution to members of its
consortium.
(ii) Possess and use
instrumentation to measure the radioactivity of the PET radioactive drugs
intended for noncommercial distribution to members of its consortium and meet
the procedural, radioactivity measurement, instrument test, instrument check,
and instrument adjustment requirements in .02(11)(i)6. of this Rule.
2. A licensee that is a pharmacy
authorized under .02(7)(j) to produce PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium shall require that any
individual that prepares PET radioactive drugs shall be:
(i) an authorized nuclear pharmacist that
meets the requirements in .02(11)(i)5. of this Rule, or
(ii) an individual under the supervision of
an authorized nuclear pharmacist as specified in Rule
.05(18).
3. A pharmacy, authorized under
.02(7)(j) to produce PET radioactive drugs for noncommercial transfer to
medical use licensees in its consortium that allows an individual to work as an
authorized nuclear pharmacist, shall meet the requirements of .02(11)(i)5.(v)
of this Rule.
(14)
Expiration of Licenses.
Except as provided in (15)(b), each specific license shall expire at the end of
the day, in the month and year stated therein.
(15)
Renewal of Licenses.
(a) No less than 30 days before the
expiration date specified in a specific license, the licensee shall either:
1. Submit an application for license renewal
filed in accordance with (7), or
2.
Notify the Division in writing in accordance with (13)(d) and (15)(c) if the
licensee decides not to renew the license.
(b) In any case in which a licensee, not less
than 30 days prior to the 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 the application
has been finally determined by the Division.
(c) If a licensee does not submit an
application for license renewal on or before the expiration date specified in
the license, then the licensee shall, on or before that expiration date:
1. Terminate the use of radioactive
material,
2. Remove radioactive
contamination to the extent practicable,
3. Properly dispose of the radioactive
material, and
4. Submit the
information specified in (18)(d).
(16)
Amendment of Licenses at Request
of Licensee. Applications for amendment of a license shall be filed in
accordance with (7) and shall specify the respects in which the licensee
desires the license to be amended and the grounds for such amendment.
(17)
Action on Applications to Renew or
Amend. In considering an application by a licensee to renew or amend the
license, the Director will apply the criteria set forth in (8), (9), (10), or
(11), as applicable.
(18)
Modification, Revocation, and Termination 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,
and Orders issued by the Director.
(b) 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 of
this Rule, 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 Director 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, of the license, or of any Rule or Order of the Director.
(c) Each specific license revoked by the
Director expires at the end of the day on the date of the Director's final
determination to revoke the license, or on the expiration date stated in the
determination, or as otherwise provided by Order of the Director.
(d) The Director may terminate a specific
license upon request submitted by the licensee to the Division in writing
provided the following:
1. The licensee
certifies the disposition of all licensed material, including accumulated
wastes, by submitting a completed "Request to Terminate Radioactive Materials
License" form or equivalent information; and
2. The licensee conducts a radiation survey
of the premises where the licensed activities were carried out and submits a
report of the results of the survey unless the licensee demonstrates that the
premises are suitable for release in accordance with the requirements for
decommissioning in Rule
.03(7). As
appropriate, the licensee shall:
(i) Report
levels of gamma radiation in units of microroentgen (millisieverts) per hour at
one meter from surfaces, and report levels of radioactivity, including alpha
and beta, in units of disintegrations per minute or microcuries
(megabecquerels) per 100 square centimeters - removable and fixed - for
surfaces, microcuries (megabecquerels) per milliliter for water, and picocuries
(becquerels) per gram for solids such as soils or concrete; and
(ii) Specify the survey instrument(s) used
and certify that each instrument is properly calibrated and tested.
3. If detectable levels of
residual radioactive contamination are found, the license continues to be in
effect, even beyond the expiration date if necessary, with respect to
possession of residual radioactive material as contamination until the Division
notifies the licensee in writing that the license is terminated. Each licensee
who possesses residual radioactive material under this paragraph shall initiate
decommissioning activities as required by (8)(h).
4. If no residual radioactive contamination
is detected, the licensee shall submit a certification that no detectable
radioactive contamination was found. If the information submitted is found to
be adequate, the Director will notify the licensee in writing that the license
is terminated.
(e)
Specific licenses, including expired licenses, will be terminated by written
notice to the licensee when the Director determines that:
1. Radioactive material has been properly
disposed;
2. Reasonable effort has
been made to eliminate residual radioactive contamination, if present;
and
3.
(i) A radiation survey has been performed
which demonstrates that the premises are suitable for release in accordance
with Division requirements for decommissioning in Rule
.03(7);
or
(ii) Other information submitted
by the licensee is sufficient to demonstrate that the premises are suitable for
release in accordance with Division requirements for decommissioning in Rule
.03(7).
4. Prior to license termination,
each licensee authorized to possess radioactive material with a half-life
greater than 120 days, in an unsealed form, shall forward the following records
to the Division:
(i) Records of disposal of
licensed material made under Rule
.03(13)(b)
(including burials authorized before January 28, 1982), .03(13)(c), .03(13)(d),
.03(13)(e); and
(ii) Records
required by Rule
.03(14)(c)2.(iv).
5. If licensed activities are
transferred or assigned in accordance with Rule
.02(13)(b), each
licensee authorized to possess radioactive material, with a half-life greater
than 120 days, in an unsealed form, shall transfer the following records to the
new licensee and the new licensee will be responsible for maintaining these
records until the license is terminated:
(i)
Records of disposal of licensed material made under Rule
.03(13)(b)
(including burials authorized before January 28, 1982), .03(13)(c), .03(13)(d),
.03(13)(e); and
(ii) Records
required by Rule
.03(14)(c)2.(iv).
6. Prior to license termination,
each licensee shall forward the records required by Rule
.02(8)(g)8. to the
Division.
(19)
Transfer of Material.
(a)
Authorization for Transfer. No licensee shall transfer radioactive material
except as authorized pursuant to (19)(b).
(b) Condition of Transfer. Any licensee may
transfer radioactive material, subject to acceptance by the transferee, to:
1. The Division, after receiving prior
approval from the Division;
2. The
United States Department of Energy or any successor thereto;
3. Any person exempt from this Rule to the
extent permitted under such exemption;
4. Any person licensed to receive such
material under terms of a general license or its equivalent, or specific
license or equivalent licensing document issued by the Director, the U.S.
Nuclear Regulatory Commission or any Agreement State, to any person otherwise
authorized to receive such material by the Federal Government or any agency
thereof, the Division or any Agreement State; or
5. Any person authorized by the Division in
writing.
(c) Before
transferring radioactive material to a specific licensee of the Director, the
U.S. Nuclear Regulatory Commission or an Agreement State or to a general
licensee who is required to register with the Division, the U.S. Nuclear
Regulatory Commission or an Agreement 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) The following methods for the
verification required by (19)(c) are acceptable:
1. The transferor may possess, and read, a
current copy of the transferee's specific license or registration
certificate.
2. The transferor may
have in his possession 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 ten
days.
4. The transferor may obtain
other sources of information compiled by a reporting service from official
records of the Division, the U.S. Nuclear Regulatory Commission or the
licensing agency of an Agreement State regarding the identity of licensees and
the scope and expiration date of licenses and registration.
5. When none of the methods of verification
described in paragraphs (19)(d)1., 2., 3., and 4. is 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 Division, the U.S. Nuclear Regulatory Commission or the licensing
agency of an Agreement State that the transferee is licensed to receive the
radioactive material.
(e)
Preparation for shipment and transport of radioactive material shall be in
accordance with the provisions of Rule
.06 of this Chapter.
(f) Each person who receives source or
byproduct material pursuant to a license issued pursuant to the regulations in
Rule 391-3-17-.02
shall keep records showing the receipt, transfer, and disposal of this source
or byproduct material as specified in
10 CFR
40.61.
(20)
Reciprocity.
(a) Persons licensed by other Agencies.
Subject to the provisions of this Chapter, any person who holds a specific
license from the U.S. Nuclear Regulatory Commission or any Agreement State,
other than this 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, except in areas of exclusive federal jurisdiction, for a period not
in excess of 180 days in any calendar year provided that:
1. The licensing document does not limit the
activity authorized by such document to specified installations or
locations;
2. The out-of-state
licensee notifies the Division in writing at least three days prior to engaging
in such activity. Such notification shall indicate the location, period, and
type of proposed possession and use within the State, and shall be accompanied
by a copy of the pertinent licensing document. If, for a specific case, the
3-day period would impose an undue hardship on the out-of-state licensee, he
may, upon application to the Division, obtain permission to proceed
sooner;
3. The out-of-state
licensee complies with all applicable Rules of the Division, and with all the
terms and conditions of his licensing document except any such terms and
conditions that may be inconsistent with applicable Rules of the
Division;
4. Provided further that
the Division may require the out-of-state licensee to supply such other
information as the Division may reasonably request; and
5. The out-of-state licensee shall not
transfer or dispose of radioactive material possessed or used under the general
license provided in (20)(a) except by transfer to a person who is:
(i) Specifically licensed by the Director or
the U.S. Nuclear Regulatory Commission to receive such material; or
(ii) Exempt from the requirements for a
license for such material under (3)(a).
(b) Notwithstanding the provisions of
(20)(a), 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 (6)(c)1.
within areas subject to the jurisdiction of the licensing body is hereby
granted a general license to install, transfer, demonstrate, or service such
device in this State provided that:
1. Such
person shall file a report with the Division within 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
a device is transferred by name and address, the type of device transferred,
and the quantity and type of radioactive material contained in the
device;
2. 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;
3. Such person shall assure that any labels
required to be affixed to the device under regulations of the authority which
licensed the manufacturing of the device bear a statement that "Removal of This
Label is Prohibited"; and
4. The
holder of the specific license shall furnish to each general licensee to whom
he transfers such a device or on whose premises he installs such a device a
copy of the general license contained in (6)(c).
(c) The Division may withdraw, limit, or
qualify its acceptance of any specific license or equivalent licensing document
issued by another agency, or any product distributed pursuant to such licensing
document, upon determining that such action is necessary in order to prevent
undue hazard to public health and safety, to property, or to the
environment.
(21)
Schedules.
(a) Schedule A.
SCHEDULE A
EXEMPT CONCENTRATIONS
|
Exempt Concentrations Element (Atomic Number) |
Schedule A Isotope |
Column I Gas Concentration (µCi/mL)
|
Column II Liquid and Solid Concentration (µCi/mL)
|
|
Antimony (51) |
Sb 122 |
3 x 10-4 |
|
|
Sb 124 |
2 x 10-4 |
||
|
Sb 125 |
1 x 10-3 |
||
|
Argon (18) |
Ar 37 |
1 x 10-3 |
|
|
Ar 41 |
4 x 10-7 |
||
|
Arsenic (33) |
As 73 |
5 x 10-3 |
|
|
As 74 |
5 x 10-4 |
||
|
As 76 |
2 x 10-4 |
||
|
As 77 |
8 x 10-4 |
||
|
Barium (56) |
Ba 131 |
2 x 10-3 |
|
|
Ba 140 |
3 x 10-4 |
||
|
Beryllium (4) |
Be 7 |
2 x 10-2 |
|
|
Bismuth (83) |
Bi 206 |
4 x 10-4 |
|
|
Bromine (35) |
Br 82 |
4 x 10-7 |
3 x 10-3 |
|
Cadmium (48) |
Cd 109 |
2 x 10-3 |
|
|
Cd 115m |
3 x 10-4 |
||
|
Cd 115 |
3 x 10-4 |
||
|
Calcium (20) |
Ca 45 |
9 x 10-5 |
|
|
Ca 47 |
5 x 10-4 |
||
|
Carbon (6) |
C 14 |
1 x 10-6 |
8 x 10-3 |
|
Cerium (58) |
Ce 141 |
9 x 10-4 |
|
|
Ce 143 |
4 x 10-4 |
||
|
Ce 144 |
1 x 10-4 |
||
|
Cesium (55) |
Cs 131 |
2 x 10-2 |
|
|
Cs 134m |
6 x 10-2 |
||
|
Cs 134 |
9 x 10-5 |
||
|
Chlorine (17) |
Cl 38 |
9 x 10-7 |
4 x 10-3 |
|
Chromium (24) |
Cr 51 |
2 x 10-2 |
|
|
Cobalt (27) |
Co 57 |
5 x 10-3 |
|
|
Co 60 |
5 x 10-4 |
||
|
Copper (29) |
Cu 64 |
3 x 10-3 |
|
|
Dysprosium (66) |
Dy 165 |
4 x 10-3 |
|
|
Dy 166 |
4 x 10-4 |
||
|
Erbium (68) |
Er 169 |
9 x 10-4 |
|
|
Er 171 |
1 x 10-3 |
||
|
Europium (63) (T0.5 = 9.2 h) |
Eu 152 |
6 x 10-4 |
|
|
Eu 155 |
2 x 10-3 |
||
|
Fluorine (9) |
F 18 |
2 x 10-6 |
8 x 10-3 |
|
Gadolinium (64) |
Gd 153 |
2 x 10-3 |
|
|
Gd 159 |
8 x 10-4 |
||
|
Gallium (31) |
Ga 72 |
4 x 10-4 |
|
|
Germanium (32) |
Ge 71 |
2 x 10-2 |
|
|
Gold (79) |
Au 196 |
2 x 10-3 |
|
|
Au 198 |
5 x 10-4 |
||
|
Au 199 |
2 x 10-3 |
||
|
Hafnium (72) |
Hf 181 |
7 x 10-4 |
|
|
Hydrogen (1) |
H 3 |
5 x 10-6 |
3 x 10-2 |
|
Indium (49) |
In 113m |
1 x 10-2 |
|
|
In 114m |
2 x 10-4 |
||
|
Iodine (53) |
I 126 |
3 x 10-9 |
2 x 10-5 |
|
I 131 |
3 x 10-9 |
2 x 10-5 |
|
|
I 132 |
8 x 10-8 |
6 x 10-4 |
|
|
I 133 |
1 x 10-8 |
7 x 10-5 |
|
|
I 134 |
2 x 10-7 |
1 x 10-3 |
|
|
Iridium (77) |
Ir 190 |
2 x 10-3 |
|
|
Ir 192 |
4 x 10-4 |
||
|
Ir 194 |
3 x 10-4 |
||
|
Iron (26) |
Fe 55 |
8 x 10-3 |
|
|
Fe 59 |
6 x 10-4 |
||
|
Krypton (36) |
Kr 85m |
1 x 10-6 |
|
|
Kr 85 |
3 x 10-6 |
||
|
Lanthanum (57) |
La 140 |
2 x 10-4 |
|
|
Lead (82) |
Pb 203 |
4 x 10-3 |
|
|
Lutetium (71) |
Lu 177 |
1 x 10-3 |
|
|
Manganese (25) |
Mn 52 |
3 x 10-4 |
|
|
Mn 54 |
1 x 10-3 |
||
|
Mn 56 |
1 x 10-3 |
||
|
Mercury (80) |
Hg 197m |
2 x 10-3 |
|
|
Hg 197 |
3 x 10-3 |
||
|
Hg 203 |
2 x 10-4 |
||
|
Molybdenum (42) |
Mo 99 |
2 x 10-3 |
|
|
Neodymium (60) |
Nd 147 |
6 x 10-4 |
|
|
Nd 149 |
3 x 10-3 |
||
|
Nickel (28) |
Ni 65 |
1 x 10-3 |
|
|
Niobium (columbium) (41) |
Nb 95 |
1 x 10-3 |
|
|
Nb 97 |
9 x 10-3 |
||
|
Osmium (76) |
Os 185 |
7 x 10-4 |
|
|
Os 191m |
3 x 10-2 |
||
|
Os 191 |
2 x 10-3 |
||
|
Os 193 |
6 x 10-4 |
||
|
Palladium (46) |
Pd 103 |
3 x 10-3 |
|
|
Pd 109 |
9 x 10-4 |
||
|
Phosphorus (15) |
P 32 |
2 x 10-4 |
|
|
Platinum (78) |
Pt 191 |
1 x 10-3 |
|
|
Pt 193m |
1 x 10-2 |
||
|
Pt 197m |
1 x 10-2 |
||
|
Pt 197 |
1 x 10-3 |
||
|
Polonium (84) |
Po 210 |
7 x 10-6 |
|
|
Potassium (19) |
K 42 |
3 x 10-3 |
|
|
Praseodymium (59) |
Pr 142 |
3 x 10-4 |
|
|
Pr 143 |
5 x 10-4 |
||
|
Promethium (61) |
Pm 147 |
2 x 10-3 |
|
|
Pm 149 |
4 x 10-4 |
||
|
Radium (88) |
Ra 226 |
1 x 10-7 |
|
|
Ra 228 |
3 x 10-7 |
||
|
Rhenium (75) |
Re 183 |
6 x 10-3 |
|
|
Re 186 |
9 x 10-4 |
||
|
Re 188 |
6 x 10-4 |
||
|
Rhodium (45) |
Rh 103m |
1 x 10-1 |
|
|
Rubidium (37) |
Rb 86 |
7 x 10-4 |
|
|
Ruthenium (44) |
Ru 97 |
4 x 10-3 |
|
|
Ru 103 |
8 x 10-4 |
||
|
Ru 105 |
1 x 10-3 |
||
|
Ru 106 |
1 x 10-4 |
||
|
Samarium (62) |
Sm 153 |
8 x 10-4 |
|
|
Scandium (21) |
Sc 46 |
4 x 10-4 |
|
|
Sc 47 |
9 x 10-4 |
||
|
Sc 48 |
3 x 10-3 |
||
|
Selenium (34) |
Se 75 |
3 x 10-3 |
|
|
Silicon (14) |
Si 31 |
9 x 10-3 |
|
|
Silver (47) |
Ag 105 |
1 x 10-3 |
|
|
Ag 110m |
3 x 10-4 |
||
|
Ag 111 |
4 x 10-4 |
||
|
Sodium (11) |
Na 24 |
2 x 10-3 |
|
|
Strontium (38) |
Sr 85 |
1 x 10-3 |
|
|
Sr 89 |
1 x 10-4 |
||
|
Sr 91 |
7 x 10-4 |
||
|
Sr 92 |
7 x 10-4 |
||
|
Sulfur (16) |
S 35 |
9 x 10-8 |
6 x 10-4 |
|
Tantalum (73) |
Ta 182 |
4 x 10-4 |
|
|
Technetium (43) |
Tc 96m |
1 x 10-1 |
|
|
Tc 96 |
1 x 10-3 |
||
|
Tellurium (52) |
Te 125m |
2 x 10-3 |
|
|
Te 127m |
6 x 10-4 |
||
|
Te 127 |
3 x 10-3 |
||
|
Te 129m |
3 x 10-4 |
||
|
Te 131m |
6 x 10-4 |
||
|
Te 132 |
3 x 10-4 |
||
|
Terbium (65) |
Tb 160 |
4 x 10-4 |
|
|
Thallium (81) |
Tl 200 |
4 x 10-3 |
|
|
Tl 201 |
3 x 10-3 |
||
|
Tl 202 |
1 x 10-3 |
||
|
Tl 204 |
1 x 10-3 |
||
|
Thulium (69) |
Tm 170 |
5 x 10-4 |
|
|
Tin (50) |
Sn 113 |
9 x 10-4 |
|
|
Sn 125 |
2 x 10-4 |
||
|
Tungsten (wolfram) (74) |
W 181 |
4 x 10-3 |
|
|
W 187 |
7 x 10-4 |
||
|
Vanadium (23) |
V 48 |
3 x 10-4 |
|
|
Xenon (54) |
Xe 131m |
4 x 10-6 |
|
|
Xe 133 |
3 x 10-6 |
||
|
Xe 135 |
1 x 10-6 |
||
|
Ytterbium (70) |
Yb 175 |
1 x 10-3 |
|
|
Yttrium (39) |
Y 90 |
2 x 10-4 |
|
|
Y 91m |
3 x 10-2 |
||
|
Y 91 |
3 x 10-4 |
||
|
Y 92 |
6 x 10-4 |
||
|
Y 93 |
3 x 10-4 |
||
|
Zinc (30) |
Zn 65 |
1 x 10-3 |
|
|
Zn 69m |
7 x 10-4 |
||
|
Zn 69 |
2 x 10-2 |
||
|
Zirconium (40) |
Zr 95 |
6 x 10-4 |
|
|
Zr 97 |
2 x 10-4 |
||
|
Beta- and/or gamma-emitting radioactive material not listed above with half-life less than three years |
1 x 10-10 |
1 x 10-6 |
Note: Many radioisotopes disintegrate into isotopes that are also radioactive. In expressing the concentrations in Schedule A, the activity stated is that of the parent isotope and takes into account the daughters. For purposes of (3)(a) 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 concentration present in the product and the exempt concentration established in Schedule A for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e., unity).
Click here to view image
(b)
Schedule B.
SCHEDULE B
EXEMPT QUANTITIES
|
Schedule B - Exempt Quantities Radioactive Material |
Exempt Quantity (Microcuries) |
|
Antimony-122 (Sb 122) |
100 |
|
Antimony-124 (Sb 124) |
10 |
|
Antimony-125 (Sb 125) |
10 |
|
Arsenic-73 (As 73) |
100 |
|
Arsenic-74 (As 74) |
10 |
|
Arsenic-76 (As 76) |
10 |
|
Arsenic-77 (As 77) |
100 |
|
Barium-131 (Ba 131) |
10 |
|
Barium-133 (Ba 133) |
10 |
|
Barium-140 (Ba 140) |
10 |
|
Bismuth-210 (Bi 210) |
1 |
|
Bromine-82 (Br 82) |
10 |
|
Cadmium-109 (Cd 109) |
10 |
|
Cadmium-115m (Cd 115m) |
10 |
|
Cadmium-115 (Cd 115) |
100 |
|
Calcium-45 (Ca 45) |
10 |
|
Calcium-47 (Ca 47) |
10 |
|
Carbon-14 (C 14) |
100 |
|
Cerium-141 (Ce 141) |
100 |
|
Cerium-143 (Ce 143) |
100 |
|
Cerium-144 (Ce 144) |
1 |
|
Cesium-129 (Cs 129) |
100 |
|
Cesium-131 (Cs 131) |
1,000 |
|
Cesium-134m (Cs 134m) |
100 |
|
Cesium-134 (Cs 134) |
1 |
|
Cesium-135 (Cs 135) |
10 |
|
Cesium-136 (Cs 136) |
10 |
|
Cesium-137 (Cs 137) |
10 |
|
Chlorine-36 (Cl 36) |
10 |
|
Chlorine-38 (Cl 38) |
10 |
|
Chromium-51 (Cr 51) |
1,000 |
|
Cobalt-57 (Co 57) |
100 |
|
Cobalt-58m (Co 58m) |
10 |
|
Cobalt-58 (Co 58) |
10 |
|
Cobalt-60 (Co 60) |
1 |
|
Copper-64 (Cu 64) |
100 |
|
Dysprosium-165 (Dy 165) |
10 |
|
Dysprosium-166 (Dy 166) |
100 |
|
Erbium-169 (Er 169) |
100 |
|
Erbium-171 (Er 171) |
100 |
|
Europium-152 (Eu 152) 9.2h |
100 |
|
Europium-152 (Eu 152) 13 yr |
1 |
|
Europium-154 (Eu 154) |
1 |
|
Europium-155 (Eu 155) |
10 |
|
Fluorine-18 (F 18) |
1,000 |
|
Gadolinium-153 (Gd 153) |
10 |
|
Gadolinium-159 (Gd 159) |
100 |
|
Gallium-67 (Ga 67) |
100 |
|
Gallium-72 (Ga 72) |
10 |
|
Germanium-68 (Ge 68) |
10 |
|
Germanium-71 (Ge 71) |
100 |
|
Gold-195 (Au 195) |
10 |
|
Gold-198 (Au 198) |
100 |
|
Gold-199 (Au 199) |
100 |
|
Hafnium-181 (Hf 181) |
10 |
|
Holmium-166 (Ho 166) |
100 |
|
Hydrogen-3 (H 3) |
1,000 |
|
Indium-111 (In 111) |
100 |
|
Indium-113m (In 113m) |
100 |
|
Indium-114m (In 114m) |
10 |
|
Indium-115m (In 115m) |
100 |
|
Indium-115 (In 115) |
10 |
|
Iodine-123 (I 123) |
100 |
|
Iodine-125 (I 125) |
1 |
|
Iodine-126 (I 126) |
1 |
|
Iodine-129 (I 129) |
0.1 |
|
Iodine-131 (I 131) |
1 |
|
Iodine-132 (I 132) |
10 |
|
Iodine-133 (I 133) |
1 |
|
Iodine-134 (I 134) |
10 |
|
Iodine-135 (I 135) |
10 |
|
Iridium-192 (Ir 192) |
10 |
|
Iridium-194 (Ir 194) |
100 |
|
Iron-52 (Fe 52) |
10 |
|
Iron-55 (Fe 55) |
100 |
|
Iron-59 (Fe 59) |
10 |
|
Krypton-85 (Kr 85) |
100 |
|
Krypton-87 (Kr 87) |
10 |
|
Lanthanum-140 (La 140) |
10 |
|
Lutetium-177 (Lu 177) |
100 |
|
Manganese-52 (Mn 52) |
10 |
|
Manganese-54 (Mn 54) |
10 |
|
Manganese-56 (Mn 56) |
10 |
|
Mercury-197m (Hg 197m) |
100 |
|
Mercury-197 (Hg 197) |
100 |
|
Mercury-203 (Hg 203) |
10 |
|
Molybdenum-99 (Mo 99) |
100 |
|
Neodymium-147 (Nd 147) |
100 |
|
Neodymium-149 (Nd 149) |
100 |
|
Nickel-59 (Ni 59) |
100 |
|
Nickel-63 (Ni 63) |
10 |
|
Nickel-65 (Ni 65) |
100 |
|
Niobium-93m (Nb 93m) |
10 |
|
Niobium-95 (Nb 95) |
10 |
|
Niobium-97 (Nb 97) |
10 |
|
Osmium-185 (Os 185) |
10 |
|
Osmium-191m (Os 191m) |
100 |
|
Osmium-191 (Os 191) |
100 |
|
Osmium-193 (Os 193) |
100 |
|
Palladium-103 (Pd 103) |
100 |
|
Palladium-109 (Pd 109) |
100 |
|
Phosphorus-32 (P 32) |
10 |
|
Platinum-191 (Pt 191) |
100 |
|
Platinum-193m (Pt 193m) |
100 |
|
Platinum-193 (Pt 193) |
100 |
|
Platinum-197m (Pt 197m) |
100 |
|
Platinum-197 (Pt 197) |
100 |
|
Polonium-210 (Po 210) |
0.1 |
|
Potassium-42 (K 42) |
10 |
|
Potassium-43 (K 43) |
10 |
|
Praseodymium-142 (Pr 142) |
100 |
|
Praseodymium-143 (Pr 143) |
100 |
|
Promethium-147 (Pm 147) |
10 |
|
Promethium-149 (Pm 149) |
10 |
|
Rhenium-186 (Re 186) |
100 |
|
Rhenium-188 (Re 188) |
100 |
|
Rhodium-103m (Rh 103m) |
100 |
|
Rhodium-105 (Rh 105) |
100 |
|
Rubidium-81 (Rb 81) |
10 |
|
Rubidium-86 (Rb 86) |
10 |
|
Rubidium-87 (Rb 87) |
10 |
|
Ruthenium-97 (Ru 97) |
100 |
|
Ruthenium-103 (Ru 103) |
10 |
|
Ruthenium-105 (Ru 105) |
10 |
|
Ruthenium-106 (Ru 106) |
1 |
|
Samarium-151 (Sm 151) |
10 |
|
Samarium-153 (Sm 153) |
100 |
|
Scandium-46 (Sc 46) |
10 |
|
Scandium-47 (Sc 47) |
100 |
|
Scandium-48 (Sc 48) |
10 |
|
Selenium-75 (Se 75) |
10 |
|
Silicon-31 (Si 31) |
100 |
|
Silver-105 (Ag 105) |
10 |
|
Silver-110m (Ag 110m) |
1 |
|
Silver-111 (Ag 111) |
100 |
|
Sodium-22 (Na 22) |
10 |
|
Sodium-24 (Na 24) |
10 |
|
Strontium-85 (Sr 85) |
10 |
|
Strontium-89 (Sr 89) |
1 |
|
Strontium-90 (Sr 90) |
0.1 |
|
Strontium-91 (Sr 91) |
10 |
|
Strontium-92 (Sr 92) |
10 |
|
Sulphur-35 (S 35) |
100 |
|
Tantalum-182 (Ta 182) |
10 |
|
Technetium-96 (Tc 96) |
10 |
|
Technetium-97m (Tc 97m) |
100 |
|
Technetium-97 (Tc 97) |
100 |
|
Technetium-99m (Tc 99m) |
100 |
|
Technetium-99 (Tc 99) |
10 |
|
Tellurium-125m (Te 125m) |
10 |
|
Tellurium-127m (Te 127m) |
10 |
|
Tellurium-127 (Te 127) |
100 |
|
Tellurium-129m (Te 129m) |
10 |
|
Tellurium-129 (Te 129) |
100 |
|
Tellurium-131m (Te 131m) |
10 |
|
Tellurium-132 (Te 132) |
10 |
|
Terbium-160 (Tb 160) |
10 |
|
Thallium-200 (Tl 200) |
100 |
|
Thallium-201 (Tl 201) |
100 |
|
Thallium-202 (Tl 202) |
100 |
|
Thallium-204 (Tl 204) |
10 |
|
Thulium-170 (Tm 170) |
10 |
|
Thulium-171 (Tm 171) |
10 |
|
Tin 113-(Sn 113) |
10 |
|
Tin 125-(Sn 125) |
10 |
|
Tungsten-181 (W 181) |
10 |
|
Tungsten-185 (W 185) |
10 |
|
Tungsten-187 (W 187) |
100 |
|
Vanadium-48 (V 48) |
10 |
|
Xenon-131m (Xe 131m) |
1,000 |
|
Xenon-133 (Xe 133) |
100 |
|
Xenon-135 (Xe 135) |
100 |
|
Ytterbium-175 (Yb 175) |
100 |
|
Yttrium-87 (Y 87) |
10 |
|
Yttrium-88 (Y 88) |
10 |
|
Yttrium-90 (Y 90) |
10 |
|
Yttrium-91 (Y 91) |
10 |
|
Yttrium-92 (Y 92) |
100 |
|
Yttrium-93 (Y 93) |
100 |
|
Zinc-65 (Zn 65) |
10 |
|
Zinc-69m (Zn 69m) |
100 |
|
Zinc-69 (Zn 69) |
1,000 |
|
Zirconium-93 (Zr 93) |
10 |
|
Zirconium-95 (Zr 95) |
10 |
|
Zirconium-97 (Zr 97) |
10 |
|
Any radioactive material not listed above other than alpha- emitting radioactive material |
0.1 |
(c)
Schedule C.
SCHEDULE C
LIMITS FOR BROAD LICENSES
|
Schedule C - Limits For Broad Licenses Radioactive Materials |
Column I (Curies) |
Column II (Curies) |
|
Antimony-122 (Sb 122) |
1 |
0.01 |
|
Antimony-124 (Sb 124) |
1 |
0.01 |
|
Antimony-125 (Sb 125) |
1 |
0.01 |
|
Arsenic-73 (As 73) |
10 |
0.1 |
|
Arsenic-74 (As 74) |
1 |
0.01 |
|
Arsenic-76 (As 76) |
1 |
0.01 |
|
Arsenic-77 (As 77) |
10 |
0.1 |
|
Barium-131 (Ba 131) |
10 |
0.1 |
|
Barium-140 (Ba 140) |
1 |
0.01 |
|
Beryllium-7 (Be 7) |
10 |
0.1 |
|
Bismuth-210 (Bi 210) |
0.1 |
0.001 |
|
Bromine-82 (Br 82) |
10 |
0.1 |
|
Cadmium-109 (Cd 109) |
1 |
0.01 |
|
Cadmium-115m (Cd 115m) |
1 |
0.01 |
|
Cadmium-115 (Cd 115) |
10 |
0.1 |
|
Calcium-45 (Ca 45) |
1 |
0.01 |
|
Calcium-47 (Ca 47) |
10 |
0.1 |
|
Carbon-14 (C 14) |
100 |
1.0 |
|
Cerium-141 (Ce 141) |
10 |
0.1 |
|
Cerium-143 (Ce 143) |
10 |
0.1 |
|
Cerium-144 (Ce 144) |
0.1 |
0.001 |
|
Cesium-131 (Cs 131) |
100 |
1.0 |
|
Cesium-134m (Cs 134m) |
100 |
1.0 |
|
Cesium-134 (Cs 134) |
0.1 |
0.001 |
|
Cesium-135 (Cs 135) |
1 |
0.01 |
|
Cesium-136 (Cs 136) |
10 |
0.1 |
|
Cesium-137 (Cs 137) |
0.1 |
0.001 |
|
Chlorine-36 (Cl 36) |
0.01 |
0.001 |
|
Chlorine-38 (Cl 38) |
100 |
1.0 |
|
Chromium-51 (Cr 51) |
100 |
1.0 |
|
Cobalt-57 (Co 57) |
10 |
0.1 |
|
Cobalt-58m (Co 58m) |
100 |
1.0 |
|
Cobalt-58 (Co 58) |
1 |
0.01 |
|
Cobalt-60 (Co 60) |
0.1 |
0.001 |
|
Copper-64 (Cu 64) |
10 |
0.1 |
|
Dysprosium-165 (Dy 165) |
100 |
1.0 |
|
Dysprosium-166 (Dy 166) |
10 |
0.1 |
|
Erbium-169 (Er 169) |
10 |
0.1 |
|
Erbium-171 (Er 171) |
10 |
0.1 |
|
Europium-152 (Eu 152) 9.2h |
10 |
0.1 |
|
Europium-152 (Eu 152) 13 yr |
0.1 |
0.001 |
|
Europium-154 (Eu 154) |
0.1 |
0.001 |
|
Europium-155 (Eu 155) |
1 |
0.01 |
|
Fluorine-18 (F 18) |
100 |
1.0 |
|
Gadolinium-153 (Gd 153) |
1 |
0.01 |
|
Gadolinium-159 (Gd 159) |
10 |
0.1 |
|
Gallium-72 (Ga 72) |
10 |
0.1 |
|
Germanium-71 (Ge 71) |
100 |
1.0 |
|
Gold-198 (Au 198) |
10 |
0.1 |
|
Gold-199 (Au 199) |
10 |
0.1 |
|
Hafnium-181 (Hf 181) |
1 |
0.01 |
|
Holmium-166 (Ho 166) |
10 |
0.1 |
|
Hydrogen-3 (H 3) |
100 |
1.0 |
|
Indium-113m (In 113m) |
100 |
1.0 |
|
Indium-114m (In 114m) |
1 |
0.01 |
|
Indium-115m (In 115m) |
100 |
1.0 |
|
Indium-115 (In 115) |
1 |
0.01 |
|
Iodine-125 (I 125) |
0.1 |
0.001 |
|
Iodine-126 (I 126) |
0.1 |
0.001 |
|
Iodine-129 (I 129) |
0.1 |
0.001 |
|
Iodine-131 (I 131) |
0.1 |
0.001 |
|
Iodine-132 (I 132) |
10 |
0.1 |
|
Iodine-133 (I 133) |
1 |
0.01 |
|
Iodine-134 (I 134) |
10 |
0.1 |
|
Iodine-135 (I 135) |
1 |
0.01 |
|
Iridium-192 (Ir 192) |
1 |
0.01 |
|
Iridium-194 (Ir 194) |
10 |
0.1 |
|
Iron-55 (Fe 55) |
10 |
0.1 |
|
Iron-59 (Fe 59) |
1 |
0.01 |
|
Krypton-85 (Kr 85) |
100 |
1.0 |
|
Krypton-87 (Kr 87) |
10 |
0.1 |
|
Lanthanum-140 (La 140) |
1 |
0.01 |
|
Lutetium-177 (Lu 177) |
10 |
0.1 |
|
Manganese-52 (Mn 52) |
1 |
0.01 |
|
Manganese-54 (Mn 54) |
1 |
0.01 |
|
Manganese-56 (Mn 56) |
10 |
0.1 |
|
Mercury-197m (Hg 197m) |
10 |
0.1 |
|
Mercury-197 (Hg 197) |
10 |
0.1 |
|
Mercury-203 (Hg 203) |
1 |
0.01 |
|
Molybdenum-99 (Mo 99) |
10 |
0.1 |
|
Neodymium-147 (Nd 147) |
10 |
0.1 |
|
Neodymium-149 (Nd 149) |
10 |
0.1 |
|
Nickel-59 (Ni 59) |
10 |
0.1 |
|
Nickel-63 (Ni 63) |
1 |
0.01 |
|
Nickel-65 (Ni 65) |
10 |
0.1 |
|
Niobium-93m (Nb 93m) |
1 |
0.01 |
|
Niobium-95 (Nb 95) |
1 |
0.01 |
|
Niobium-97 (Nb 97) |
100 |
1.0 |
|
Osmium-185 (Os 185) |
1 |
0.01 |
|
Osmium-191m (Os 191m) |
100 |
1.0 |
|
Osmium-191 (Os 191) |
10 |
0.1 |
|
Osmium-193 (Os 193) |
10 |
0.1 |
|
Palladium-103 (Pd 103) |
10 |
0.1 |
|
Palladium-109 (Pd 109) |
10 |
0.1 |
|
Phosphorus-32 (P 32) |
1 |
0.01 |
|
Platinum-191 (Pt 191) |
10 |
0.1 |
|
Platinum-193m (Pt 193m) |
100 |
1.0 |
|
Platinum-193 (Pt 193) |
10 |
0.1 |
|
Platinum-197m (Pt 197m) |
100 |
1.0 |
|
Platinum-197 (Pt 197) |
10 |
0.1 |
|
Polonium-210 (Po 210) |
0.01 |
0.0001 |
|
Potassium-42 (K 42) |
1 |
0.01 |
|
Praseodymium-142 (Pr 142) |
10 |
0.1 |
|
Praseodymium-143 (Pr 143) |
10 |
0.1 |
|
Promethium-147 (Pm 147) |
1 |
0.01 |
|
Promethium-149 (Pm 149) |
10 |
0.1 |
|
Radium-226 |
0.01 |
0.0001 |
|
Rhenium-186 (Re 186) |
10 |
0.1 |
|
Rhenium-188 (Re 188) |
10 |
0.1 |
|
Rhodium-103m (Rh 103m) |
1,000 |
0 |
|
Rhodium-105 (Rh 105) |
10 |
0.1 |
|
Rubidium-86 (Rb 86) |
1 |
0.01 |
|
Rubidium-87 (Rb 87) |
1 |
0.01 |
|
Ruthenium-97 (Ru 97) |
100 |
1.0 |
|
Ruthenium-103 (Ru 103) |
1 |
0.01 |
|
Ruthenium-105 (Ru 105) |
10 |
0.1 |
|
Ruthenium-106 (Ru 106) |
0.1 |
0.001 |
|
Samarium-151 (Sm 151) |
1 |
0.01 |
|
Samarium-153 (Sm 153) |
10 |
0.1 |
|
Scandium-46 (Sc 46) |
1 |
0.01 |
|
Scandium-47 (Sc 47) |
10 |
0.1 |
|
Scandium-48 (Sc 48) |
1 |
0.01 |
|
Selenium-75 (Se 75) |
1 |
0.01 |
|
Silicon-31 (Si 31) |
10 |
0.1 |
|
Silver-105 (Ag 105) |
1 |
0.01 |
|
Silver-110m (Ag 110m) |
0.1 |
0.001 |
|
Silver-111 (Ag 111) |
10 |
0.1 |
|
Sodium-22 (Na 22) |
0.1 |
0.001 |
|
Sodium-24 (Na 24) |
1 |
0.01 |
|
Strontium-85m (Sr 85m) |
1,000 |
10.0 |
|
Strontium-85 (Sr 85) |
1 |
0.01 |
|
Strontium-89 (Sr 89) |
1 |
0.01 |
|
Strontium-90 (Sr 90) |
0.01 |
0.0001 |
|
Strontium-91 (Sr 91) |
10 |
0.1 |
|
Strontium-92 (Sr 92) |
10 |
0.1 |
|
Sulphur-35 (S 35) |
10 |
0.1 |
|
Tantalum-182 (Ta 182) |
1 |
0.01 |
|
Technetium-96 (Tc 96) |
10 |
0.1 |
|
Technetium-97m (Tc 97m) |
10 |
0.1 |
|
Technetium-97 (Tc 97) |
10 |
0.1 |
|
Technetium-99m (Tc 99m) |
100 |
1.0 |
|
Technetium-99 (Tc 99) |
1 |
0.01 |
|
Tellurium-125m (Te 125m) |
1 |
0.01 |
|
Tellurium-127m (Te 127m) |
1 |
0.01 |
|
Tellurium-127 (Te 127) |
10 |
0.1 |
|
Tellurium-129m (Te 129m) |
1 |
0.01 |
|
Tellurium-129 (Te 129) |
100 |
1.0 |
|
Tellurium-131m (Te 131m) |
10 |
0.1 |
|
Tellurium-132 (Te 132) |
1 |
0.01 |
|
Terbium-160 (Tb 160) |
1 |
0.01 |
|
Thallium-200 (Tl 200) |
10 |
0.1 |
|
Thallium-201 (Tl 201) |
10 |
0.1 |
|
Thallium-202 (Tl 202) |
10 |
0.1 |
|
Thallium-204 (Tl 204) |
1 |
0.01 |
|
Thulium-170 (Tm 170) |
1 |
0.01 |
|
Thulium-171 (Tm 171) |
1 |
0.01 |
|
Tin 113-(Sn 113) |
1 |
0.01 |
|
Tin 125-(Sn 125) |
1 |
0.01 |
|
Tungsten-181 (W 181) |
1 |
0.01 |
|
Tungsten-185 (W 185) |
1 |
0.01 |
|
Tungsten-187 (W 187) |
10 |
0.1 |
|
Vanadium-48 (V 48) |
1 |
0.01 |
|
Xenon-131m (Xe 131m) |
1,000 |
0 |
|
Xenon-133 (Xe 133) |
100 |
1.0 |
|
Xenon-135 (Xe 135) |
100 |
1.0 |
|
Ytterbium-175 (Yb 175) |
10 |
0.1 |
|
Yttrium-90 (Y 90) |
1 |
0.1 |
|
Yttrium-91 (Y 91) |
1 |
0.1 |
|
Yttrium-92 (Y 92) |
10 |
0.1 |
|
Yttrium-93 (Y 93) |
1 |
0.01 |
|
Zinc-65 (Zn 65) |
1 |
0.01 |
|
Zinc-69m (Zn 69m) |
10 |
0.1 |
|
Zinc-69 (Zn 69) |
100 |
1.0 |
|
Zirconium-93 (Zr 93) |
1 |
0.01 |
|
Zirconium-95 (Zr 95) |
1 |
0.01 |
|
Zirconium-97 (Zr 97) |
1 |
0.01 |
|
Any radioactive material other than source material, or alpha-emitting radioactive material not listed above. |
0.1 |
0.001 |
(d)
Schedule D. Criteria Relating to Use of Financial Tests and Parent Company
Guarantees for Providing Reasonable Assurance of Funds for Decommissioning.
1. Introduction. An applicant or licensee may
provide reasonable assurance of the availability of funds for decommissioning
based on obtaining a parent company guarantee that funds will be available for
decommissioning costs and on a demonstration that the parent company passes a
financial test. This schedule establishes criteria for passing the financial
test and for obtaining the parent company guarantee.
2. Financial Test. To pass the financial
test, the parent company must meet the criteria of either (21)(d)2.(i) or
(21)(d)2.(ii) as follows:
(i) The parent
company must have:
(I) Two of the following
three ratios: a ratio of total liabilities to net worth less than 2.0; a ratio
of the sum of net income plus depreciation, depletion, and amortization to
total liabilities greater than 0.1; and a ratio of current assets to current
liabilities greater than 1.5;
(II)
Net working capital and tangible net worth each at least six times the current
decommissioning cost estimates (or prescribed amount if a certification is
used);
(III) Tangible net worth of
at least $10 million; and
(IV)
Assets located in the United States amounting to at least 90 percent of total
assets or at least six times the current decommissioning cost estimates (or
prescribed amount if a certification is used).
(ii) The parent company must have:
(I) A current rating for its most recent bond
issuance of AAA, AA, A, or BBB as issued by Standard and Poor's or Aaa, Aa, A,
or Baa as issued by Moody's;
(II)
Tangible net worth each at least six times the current decommissioning cost
estimates for the total of all facilities or parts thereof (or prescribed
amount if a certification is used);
(III) Tangible net worth of at least $10
million; and
(IV) Assets located in
the United States amounting to at least 90 percent of total assets or at least
six times the current decommissioning cost estimates for the total of all
facilities or parts thereof (or prescribed amount if a certification is
used).
(iii) The parent
company's independent certified public accountant must have compared the data
used by the parent company in the financial test, which is derived from the
independently-audited, year-end financial statements for the latest fiscal
year, with the amounts in such financial statement. In connection with that
procedure the licensee shall inform the Director and Division within 90 days of
any matters coming to the auditor's attention that cause the auditor to believe
that the data specified in the financial test should be adjusted and that the
company no longer passes the test.
(iv) After the initial financial test, the
parent company must repeat the passage of the test within 120 days after the
close of each succeeding fiscal year. If the parent company no longer meets the
requirements, as appropriate, of either (21)(d)2.(i) or (21)(d)2.(ii), the
licensee must send notice to the Director and Division of intent to establish
alternate financial assurance as specified in the Division's Rules. The notice
must be sent by certified mail within 90 days after the end of the fiscal year
for which the year-end financial data show that the parent company no longer
meets the financial test requirements. The licensee must provide alternate
financial assurance within 120 days after the end of such fiscal
year.
3. Parent Company
Guarantee. The terms of a parent company guarantee which an applicant or
licensee obtains must provide that:
(i) The
parent company guarantee shall remain in force unless the guarantor sends
notice of cancellation by certified mail to the licensee and the Director and
Division. Cancellation may not occur, however, during the 120 days beginning on
the date of receipt of the notice of cancellation by both the licensee and the
Director, as evidenced by the return receipts;
(ii) If the licensee fails to provide
alternate financial assurance as specified in the Division's Rules within 90
days after receipt by the licensee and the Director and Division of a notice of
cancellation of the parent company guarantee from the guarantor, the guarantor
shall provide such alternative financial assurance in the name of the
licensee;
(iii) The parent company
guarantee and financial test provisions must remain in effect until the
Department has terminated the license; and
(iv) If a trust is established for
decommissioning costs, the trustee and trust must be acceptable to the
Department. An acceptable trustee includes an appropriate State or Federal
government agency or an entity which has the authority to act as a trustee and
whose trust operations are regulated and examined by a Federal or State
agency.
(e)
Schedule E.
SCHEDULE E
QUANTITIES OF RADIOACTIVE MATERIALS REQUIRING CONSIDERATION OF THE NEED FOR AN EMERGENCY PLAN FOR RESPONDING TO A RELEASE
|
Schedule E - Emergency Plan For Responding to a Release Radioactive Material
|
Release Fraction |
Quantity (Curies) |
|
Actinium-228 |
0.001 |
4,000 |
|
Americium-241 |
0.001 |
2 |
|
Americium-242 |
0.001 |
2 |
|
Americium-243 |
0.001 |
2 |
|
Antimony-124 |
0.01 |
4,000 |
|
Antimony-126 |
0.01 |
6,000 |
|
Barium-133 |
0.01 |
10,000 |
|
Barium-140 |
0.01 |
30,000 |
|
Bismuth-207 |
0.01 |
5,000 |
|
Bismuth-210 |
0.01 |
600 |
|
Cadmium-109 |
0.01 |
1,000 |
|
Cadmium-113 |
0.01 |
80 |
|
Calcium-45 |
0.01 |
20,000 |
|
Californium-252 |
0.001 |
9 (20 mg) |
|
Carbon-14 (Non Carbon dioxide) |
0.01 |
50,000 |
|
Cerium-141 |
0.01 |
10,000 |
|
Cerium-144 |
0.01 |
300 |
|
Cesium-134 |
0.01 |
2,000 |
|
Cesium-137 |
0.01 |
3,000 |
|
Chlorine-36 |
0.5 |
100 |
|
Chromium-51 |
0.01 |
300,000 |
|
Cobalt-60 |
0.001 |
5,000 |
|
Copper-64 |
0.01 |
200,000 |
|
Curium-242 |
0.001 |
60 |
|
Curium-243 |
0.001 |
3 |
|
Curium-244 |
0.001 |
4 |
|
Curium-245 |
0.001 |
2 |
|
Europium-152 |
0.01 |
500 |
|
Europium-154 |
0.01 |
400 |
|
Europium-155 |
0.01 |
3,000 |
|
Germanium-68 |
0.01 |
2,000 |
|
Gadolinium-153 |
0.01 |
5,000 |
|
Gold-198 |
0.01 |
30,000 |
|
Hafnium-172 |
0.01 |
400 |
|
Hafnium-181 |
0.01 |
7,000 |
|
Holmium-166m |
0.01 |
100 |
|
Hydrogen-3 |
0.5 |
20,000 |
|
Iodine-125 |
0.5 |
10 |
|
Iodine-131 |
0.5 |
10 |
|
Indium-114m |
0.01 |
1,000 |
|
Iridium-192 |
0.001 |
40,000 |
|
Iron-55 |
0.01 |
40,000 |
|
Iron-59 |
0.01 |
7,000 |
|
Krypton-85 |
1.0 |
6,000,000 |
|
Lead-210 |
0.01 |
8 |
|
Manganese-56 |
0.01 |
60,000 |
|
Mercury-203 |
0.01 |
10,000 |
|
Molybdenum-99 |
0.01 |
30,000 |
|
Neptunium-237 |
0.001 |
2 |
|
Nickel-63 |
0.01 |
20,000 |
|
Niobium-94 |
0.01 |
300 |
|
Phosphorus-32 |
0.5 |
100 |
|
Phosphorus-33 |
0.5 |
1,000 |
|
Polonium-210 |
0.01 |
10 |
|
Potassium-42 |
0.01 |
9,000 |
|
Promethium-145 |
0.01 |
4,000 |
|
Promethium-147 |
0.01 |
4,000 |
|
Radium-226 |
0.001 |
100 |
|
Ruthenium-106 |
0.01 |
200 |
|
Samarium-151 |
0.01 |
4,000 |
|
Scandium-46 |
0.01 |
3,000 |
|
Selenium-75 |
0.01 |
10,000 |
|
Silver-110m |
0.01 |
1,000 |
|
Sodium-22 |
0.01 |
9,000 |
|
Sodium-24 |
0.01 |
10,000 |
|
Strontium-89 |
0.01 |
3,000 |
|
Strontium-90 |
0.01 |
90 |
|
Sulfur-35 |
0.5 |
900 |
|
Technetium-99 |
0.01 |
10,000 |
|
Technetium-99m |
0.01 |
400,000 |
|
Tellurium-127m |
0.01 |
5,000 |
|
Tellurium-129m |
0.01 |
5,000 |
|
Terbium-160 |
0.01 |
4,000 |
|
Thulium-170 |
0.01 |
4,000 |
|
Tin-13 |
0.01 |
10,000 |
|
Tin-123 |
0.01 |
3,000 |
|
Tin-126 |
0.01 |
1,000 |
|
Titanium-44 |
0.01 |
100 |
|
Vanadium-48 |
0.01 |
7,000 |
|
Xenon-133 |
1.0 |
900,000 |
|
Yttrium-91 |
0.01 |
2,000 |
|
Zinc-65 |
0.01 |
5,000 |
|
Zirconium-93 |
0.01 |
400 |
|
Zirconium-95 |
0.01 |
5,000 |
|
Any other beta-/gamma-emitter |
0.01 |
10,000 |
|
Mixed fission products |
0.01 |
1,000 |
|
Mixed Corrosion Products |
0.01 |
10,000 |
|
Contaminated equipment, beta/gamma |
0.001 |
10,000 |
|
Irradiated material, any form other than solid noncombustible |
0.01 |
1,000 |
|
Irradiated material, solid noncombustible |
0.001 |
10,000 |
|
Mixed radioactive waste, beta/gamma |
0.01 |
1,000 |
|
Packaged mixed waste, beta/gamma |
0.001 |
10,000 |
|
Any other alpha-emitter |
0.001 |
2 |
|
Contaminated equipment, alpha |
0.0001 |
20 |
|
Packaged waste, alpha |
0.0001 |
20 |
(f)
Schedule F
SCHEDULE F
QUANTITIES FOR USE WITH DECOMMISSIONING
|
Schedule F - Quantities for Use With Decommissioning Radioactive Material |
Quantity (Microcurie
|
|
Americium-241 |
0.01 |
|
Antimony-122 |
100 |
|
Antimony-124 |
10 |
|
Antimony-125 |
10 |
|
Arsenic-73 |
100 |
|
Arsenic-74 |
10 |
|
Arsenic-76 |
10 |
|
Arsenic-77 |
100 |
|
Barium-131 |
10 |
|
Barium-133 |
10 |
|
Barium-140 |
10 |
|
Bismuth-210 |
1 |
|
Bromine-82 |
10 |
|
Cadmium-109 |
10 |
|
Cadmium-115m |
10 |
|
Cadmium-115 |
100 |
|
Calcium-45 |
10 |
|
Calcium-47 |
10 |
|
Carbon-14 |
100 |
|
Cerium-141 |
100 |
|
Cerium-143 |
100 |
|
Cerium-144 |
1 |
|
Cesium-131 |
1,000 |
|
Cesium-134m |
100 |
|
Cesium-134 |
1 |
|
Cesium-135 |
10 |
|
Cesium-136 |
10 |
|
Cesium-137 |
10 |
|
Chlorine-36 |
10 |
|
Chlorine-38 |
10 |
|
Chromium-51 |
1,000 |
|
Cobalt-58m |
10 |
|
Cobalt-58 |
10 |
|
Cobalt-60 |
1 |
|
Copper-64 |
100 |
|
Dysprosium-165 |
10 |
|
Dysprosium-166 |
100 |
|
Erbium-169 |
100 |
|
Erbium-171 |
100 |
|
Europium-152 (9.2 h) |
100 |
|
Europium-152 (13 yr) |
1 |
|
Europium-154 |
1 |
|
Europium-155 |
10 |
|
Florine-18 |
1,000 |
|
Gadolinium-153 |
10 |
|
Gadolinium-159 |
100 |
|
Gallium-72 |
10 |
|
Germanium-71 |
0 |
|
Hafnium-181 |
10 |
|
Holmium-166 |
100 |
|
Hydrogen-3 |
1,000 |
|
Indium-113m |
100 |
|
Indium-114m |
10 |
|
Indium-115m |
100 |
|
Indium-115 |
10 |
|
Iodine-125 |
1 |
|
Iodine-126 |
1 |
|
Iodine-129 |
0.1 |
|
Iodine-131 |
1 |
|
Iodine-132 |
10 |
|
Iodine-133 |
1 |
|
Iodine-134 |
10 |
|
Iodine-135 |
10 |
|
Iridium-192 |
10 |
|
Iridium-194 |
100 |
|
Iron-55 |
100 |
|
Iron-59 |
10 |
|
Krypton-85 |
100 |
|
Krypton-87 |
10 |
|
Lanthanum-140 |
10 |
|
Lutetium-177 |
100 |
|
Manganese-52 |
10 |
|
Manganese-54 |
10 |
|
Manganese-56 |
10 |
|
Mercury-197m |
100 |
|
Mercury-197 |
100 |
|
Mercury-203 |
10 |
|
Molybdenum-99 |
100 |
|
Neodymium-147 |
100 |
|
Neodymium-149 |
100 |
|
Nickel-59 |
100 |
|
Nickel-63 |
10 |
|
Nickel-65 |
100 |
|
Niobium-93m |
10 |
|
Niobium-95 |
10 |
|
Niobium-97 |
10 |
|
Osmium-185 |
10 |
|
Osmium-191m |
100 |
|
Osmium-191 |
100 |
|
Osmium-193 |
100 |
|
Palladium-103 |
100 |
|
Palladium-109 |
100 |
|
Phosphorus-32 |
10 |
|
Platinum-191 |
100 |
|
Platinum-193m |
100 |
|
Platinum-193 |
100 |
|
Platinum-197m |
100 |
|
Platinum-197 |
100 |
|
Plutonium-239 |
0.01 |
|
Polonium-210 |
0.1 |
|
Potassium-42 |
10 |
|
Praseodymium-142 |
100 |
|
Praseodymium-143 |
100 |
|
Promethium-147 |
10 |
|
Promethium-149 |
10 |
|
Radium-226 |
0.01 |
|
Rhenium-186 |
100 |
|
Rhenium-188 |
100 |
|
Rhodium-103m |
100 |
|
Rhodium-105 |
100 |
|
Rubidium-86 |
10 |
|
Rubidium-87 |
10 |
|
Ruthenium-97 |
100 |
|
Ruthenium-103 |
10 |
|
Ruthenium-105 |
10 |
|
Ruthenium-106 |
1 |
|
Samarium-151 |
10 |
|
Samarium-153 |
100 |
|
Scandium-46 |
10 |
|
Scandium-47 |
100 |
|
Scandium-48 |
10 |
|
Selenium-75 |
10 |
|
Silicon-31 |
100 |
|
Silver-105 |
10 |
|
Silver-110m |
1 |
|
Silver-111 |
100 |
|
Sodium-22 |
1 |
|
Sodium-24 |
10 |
|
Strontium-85 |
10 |
|
Strontium-89 |
1 |
|
Strontium-90 |
0.1 |
|
Strontium-91 |
10 |
|
Strontium-92 |
10 |
|
Sulfur-35 |
100 |
|
Tantalum-182 |
10 |
|
Technetium-96 |
10 |
|
Technetium-97m |
100 |
|
Technetium-97 |
100 |
|
Technetium-99m |
100 |
|
Technetium-99 |
10 |
|
Tellurium-125m |
10 |
|
Tellurium-127m |
10 |
|
Tellurium-127 |
100 |
|
Tellurium-129m |
10 |
|
Tellurium-129 |
100 |
|
Tellurium-131m |
10 |
|
Tellurium-132 |
10 |
|
Terbium-160 |
10 |
|
Thallium-200 |
100 |
|
Thallium-201 |
100 |
|
Thallium-202 |
100 |
|
Thallium-204 |
10 |
|
Thorium (natural) |
100 |
|
Thulium-170 |
10 |
|
Thulium-171 |
10 |
|
Tin-113 |
10 |
|
Tin-125 |
10 |
|
Tungsten-181 |
10 |
|
Tungsten-185 |
10 |
|
Tungsten-187 |
100 |
|
Uranium (natural) |
100 |
|
Uranium-233 |
0.01 |
|
Uranium-234 |
0.01 |
|
Uranium-235 |
0.01 |
|
Vanadium-48 |
10 |
|
Xenon-131m |
1,000 |
|
Xenon-133 |
100 |
|
Xenon-135 |
100 |
|
Ytterbium-175 |
100 |
|
Yttrium-90 |
10 |
|
Yttrium-91 |
10 |
|
Yttrium-92 |
100 |
|
Yttrium-93 |
100 |
|
Zinc-65 |
10 |
|
Zinc-69m |
100 |
|
Zinc-69 |
1,000 |
|
Zirconium-93 |
10 |
|
Zirconium-95 |
10 |
|
Zirconium-97 |
10 |
|
Any alpha emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition. |
0.01 |
|
Any radionuclide other than alpha emitting radionuclides, not listed above or mixtures of beta emitters of unknown composition. |
0.10 |
(g)
Schedule G. Criteria Relating to Use of Financial Tests and Self Guarantees for
Providing Reasonable Assurance of Funds for Decommissioning.
1. Introduction
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of (21)(g)2. The terms of the self-guarantee are in (21)(g)3. This schedule establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.
2.
Financial Test
(i) To pass the financial test,
a company must meet all of the following criteria:
(I) Tangible net worth at least ten times the
total current decommissioning cost estimate for the total of all facilities or
parts thereof (or the current amount required if certification is used) for all
decommissioning activities for which the company is responsible as
self-guaranteeing licensee.
(II)
Assets located in the United States amounting to at least 90 percent of total
decommissioning cost estimate for the total of all facilities or parts thereof
(or the current amount required if certification is used) for all
decommissioning activities for which the company is responsible as
self-guaranteeing licensee.
(III) A
current rating for its most recent bond issuance of AAA, AA, or A as issued by
Standard and Poors (S&P), or Aaa, Aa, or A as issued by Moodys.
(ii) To pass the financial test, a
company must meet all of the following additional requirements:
(I) The company must have at least one class
of equity securities registered under the Security Exchange Act of
1934.
(II) The company's
independent certified public accountant must have compared the data used by the
company in the financial test, which is derived from the independently audited,
year-end financial statements for the latest fiscal year, with the amounts in
such financial statement. In connection with that procedure, the licensee shall
inform the Director and Division within 90 days of any matters coming to the
attention of the auditor that cause the auditor to believe that the data
specified in the financial test should be adjusted and that the company no
longer passes the test.
(III) After
the initial financial test, the company must repeat passage of the test within
90 days after the close of each succeeding fiscal year.
(iii) If the licensee no longer meets the
requirements of (21)(g)2.(i), the licensee must send immediate notice to the
Director and Division of its intent to establish alternate financial assurance
as specified in the Division's Rules within 120 days of such notice.
3. Company Self-Guarantee
The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
(i) The
guarantee will remain in force unless the licensee sends notice of cancellation
by certified mail to the Director and Division. Cancellation may not occur,
however, during the 120 days beginning on the date of receipt of the notice of
cancellation by the Director, as evidence by the return receipt.
(ii) The licensee shall provide alternative
financial assurance as specified in the Division's Rules within 90 days
following receipt by the Director of a notice of cancellation of the
guarantee.
(iii) The guarantee and
financial test provisions must remain in effect until the Director has
terminated the license or until another financial assurance method acceptable
to the Director has been put in effect by the licensee.
(iv) The licensee will promptly forward to
the Department, the Division and the licensee's independent auditor all reports
covering the latest fiscal year filed by the licensee with the Securities and
Exchange Commission pursuant to the requirements of Section 13 of the
Securities and Exchange Act of 1934.
(v) If, at any time, the licensee's most
recent bond issuance ceases to be rated in any category of "A" or above by
either Standard and Poors or Moodys, the licensee will provide notice in
writing of such fact to the Director and Division within 20 days after
publication of the change by the rating service. If the licensee's most recent
bond issuance ceases to be rated in any category of A or above by both Standard
and Poors and Moodys, the licensee no longer meets the requirements of
(21)(g)2.(i).
(vi) The applicant or
licensee must provide to the Director and Division a written guarantee (a
written commitment by a corporate officer) which states that the licensee will
fund and carry out the required decommissioning activities or, upon issuance of
an order by the Director, the licensee will set up and fund a trust in the
amount of the current cost estimates for decommissioning.
(h) Schedule H. Criteria Relating
to Use of Financial Tests and Self-Guarantee For Providing Reasonable Assurance
of Funds For Decommissioning by Nonprofit Colleges, Universities, and
Hospitals.
1. Introduction
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the applicant or licensee passes the financial test of (h)2. The terms of the self-guarantee are in (h)3. This schedule establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.
2.
Financial Test
(i) For colleges and
universities, to pass the financial test a college or university must meet
either the criteria in (h)2.(i)(I) or the criteria in (h)2.(i)(II).
(I) For applicants or licensees that issue
bonds, a current rating for its most recent uninsured, uncollateralized, and
unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors
(S&P) or Aaa, Aa, or A as issued by Moodys.
(II) For applicants or licensees that do not
issue bonds, unrestricted endowment consisting of assets located in the United
States of at least $50 million, or at least 30 times the total current
decommissioning cost estimate (or the current amount required if certification
is used), whichever is greater, for all decommissioning activities for which
the college or university is responsible as a self-guaranteeing
licensee.
(ii) For
hospitals, to pass the financial test a hospital must meet either the criteria
in (h)2.(ii)(I) or the criteria in (h)2.(ii)(II):
(I) For applicants or licensees that issue
bonds, a current rating for its most recent uninsured, uncollateralized, and
unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors
(S&P) or Aaa, Aa, or A as issued by Moodys.
(II) For applicants or licensees that do not
issue bonds, all the following tests must be met:
I. (Total Revenues less total expenditures)
divided by total revenues must be equal to or greater than 0.04.
II. Long term debt divided by net fixed
assets must be less than or equal to 0.67.
III. (Current assets and depreciation fund)
divided by current liabilities must be greater than or equal to 2.55.
IV. Operating revenues must be at least 100
times the total current decommissioning cost estimate (or the current amount
required if certification is used) for all decommissioning activities for which
the hospital is responsible as a self-guaranteeing license.
(iii) In addition, to
pass the financial test, a licensee must meet all the following requirements:
(I) The licensee's independent certified
public accountant must have compared the data used by the licensee in the
financial test, which is required to be derived from the independently audited
year-end financial statements, based on United States generally accepted
accounting practices, for the latest fiscal year, with the amounts in such
financial statement. In connection with that procedure, the licensee shall
inform the Director and Division within 90 days of any matters coming to the
attention of the auditor that cause the auditor to believe that the data
specified in the financial test should be adjusted and that the licensee no
longer passes the test.
(II) After
the initial financial test, the licensee must repeat passage of the test within
90 days after the close of each succeeding fiscal year.
(III) If the licensee no longer meets the
requirements of (h)1., the licensee must send notice to the Director and
Division of its intent to establish alternative financial assurance as
specified in Division's Rules. The notice must be sent by certified mail,
return receipt requested, within 90 days after the end of the fiscal year for
which the year-end financial data show that the licensee no longer meets the
financial test requirements. The licensee must provide alternate financial
assurance within 120 days after the end of such fiscal year.
3. Self-Guarantee
The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
(i) The
guarantee shall remain in force unless the licensee sends notice of
cancellation by certified mail, and/or return receipt requested, to the
Director and Division. Cancellation may not occur unless an alternative
financial assurance mechanism is in place.
(ii) The licensee shall provide alternative
financial assurance as specified in the Division's Rules within 90 days
following receipt by the Director of a notice of cancellation of the
guarantee.
(iii) The guarantee and
financial test provisions must remain in effect until the Director has
terminated the license or until another financial assurance method acceptable
to the Director has been put in effect by the licensee.
(iv) The applicant or licensee must provide
to the Director and Division a written guarantee (a written commitment by a
corporate officer or officer of the institution) which states that the licensee
will fund and carry out the required decommissioning activities or, upon
issuance of an order by the Director, the licensee will set up and fund a trust
in the amount of the current cost estimates for decommissioning.
(v) If, at any time, the licensee's most
recent bond issuance ceases to be rated in any category of "A" or above by
either Standard and Poors or Moodys, the licensee shall provide notice in
writing of such fact to the Director and Division within 20 days after
publication of the change by the rating service.
Notes
Values are given only for those materials normally used as gases.
µCi/gm for solids.
For combinations of radioactive materials listed above, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Schedule E exceeds one.
Waste packaged in Type B containers does not require an emergency plan.
To convert µCi to kBq, multiply the µCi value by 37.
Based on alpha disintegration rate of Th-232, Th-230 and their daughter products.
Based on alpha disintegration rate of U-238, U-234, and U-235.
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