Sec. 7.
General Licenses*-Radioactive Material Other Than Source
Material.
(a) Certain Devices and
Equipment. A general license is hereby issued to transfer, receive, acquire,
own, possess and use radioactive material incorporated in the following devices
or equipment which have been manufactured, tested, and labeled by the
manufacturer in accordance with a specific license issued to the manufacturer
by the U.S. Nuclear Regulatory Commission for use pursuant to Section 31.3 of
10 CFR Part
31. This general license is subject to the provisions of
410 IAC 5-1-4
through
410 IAC 5-1-9,
410 IAC
5-3-4(a)(2),
410 IAC
5-3-15,
410 IAC
5-3-22,
410
IAC 5-3-23,
410 IAC
5-3-25, 410 IAC
5-4,
4/ and
410 IAC
5-10.
*Different general licenses are issued in this section, each
of which has its own specific conditions and requirements.
4/ Attention is directed
particularly to the provisions of 410 IAC 5-4 which relates to the labeling of
containers.
(1) Static Elimination
Device. Devices designed for use as static eliminators which contain, as a
sealed source or sources, radioactive material consisting of a total of not
more than 500 microcuries of polonium-210 per device or a total of not more
than 50 millicuries of hydrogen-3 (tritium) per device.
(2) Ion Generating Tube. Devices designed for
ionization of air which contain, as a sealed source or sources, radioactive
material consisting of a total of not more than 500 microcuries of polonium-210
per device or a total of not more than 50 millicuries of hydrogen-3 (tritium)
per device.
(d) Certain Measuring, Gauging or Controlling
Devices.
(1) A general license is hereby
issued to commercial and industrial firms and to research, educational and
medical institutions, individuals in the conduct of their business, and state
or local government agencies to own, receive, acquire, possess, use or transfer
in accordance with the provisions of 410 IAC
5-3-7(d)(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 410 IAC
5-3-7(d)(1) applies only to radioactive material
contained in devices which have been manufactured and labeled in accordance
with the specifications contained in a specific license issued by the board
pursuant to
410
IAC 5-3-13(d) or in accordance with
the specifications contained in a specific license issued by the U.S. Nuclear
Regulatory Commission, an agreement state or a licensing state, which
authorizes distribution of devices to persons generally licensed by the U.S.
Nuclear Regulatory Commission, an agreement state or a licensing
state.
5/
5/ Regulations under the Federal
Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices
in food production require certain additional labeling thereon which is found
in 21 CFR 179.21.
(3) Any
person who owns, receives, acquires, possesses, uses or transfers radioactive
material in a device pursuant to the general license in 410 IAC
5-3-7(d)(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 on the label; however,
(A) Devices containing only krypton need not
be tested for leakage of radioactive material, and
(B) Devices containing only tritium or not
more than 100 microcuries of other beta and/or gamma emitting material or 10
microcuries 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 other testing, installation, servicing and removal from
installation involving the radioactive material, its shielding or containment,
are performed:
(A) In accordance with the
instructions provided by the labels; or
(B) By a person holding an applicable
specific license from the board, the U.S. Nuclear Regulatory Commission, an
agreement state or a licensing state to perform such activities;
(iv) Shall maintain records
showing compliance with the requirements of 410 IAC
5-3-7(d)(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 410 IAC
5-3-7(d)(3)(ii) shall be
maintained for 1 year after the next required leak test is performed or until
the sealed source is transferred or disposed of. Records of tests of the on/off
mechanism and indicator required by 410 IAC
5-3-7(d)(3)(ii) shall be maintained
for 1 year after the next required test of the on/off mechanism and indicator
is performed or until the sealed source is transferred or disposed of. Records
which are required by 410 IAC
5-3-7(d)(3)(iii) shall be maintained for a period
of 2 years from the date of the recorded event or until the device is
transferred or disposed of;
(v)
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 or
more removable radioactive material, shall immediately suspend operation of the
device until it has been repaired by the manufacturer or other person holding
an applicable specific license from the board, the U.S. Nuclear Regulatory
Commission, an agreement state or a licensing state to repair such devices, or
disposed of by transfer to a person authorized by an applicable specific
license to receive the radioactive material contained in the device and, within
30 days, furnish to the board a report containing a brief description of the
event and the remedial action taken;
(vi) Shall not abandon the device containing
radioactive material;
(vii) Except
as provided in 410 IAC
5-3-7(d)(3)(viii), shall transfer or dispose of the
device containing radioactive material only by transfer to a specific licensee
of the board, the U.S. Nuclear Regulatory Commission, an agreement state or a
licensing state whose specific license authorizes him to receive the device and
within 30 days after transfer of a device to a specific licensee shall furnish
to the board a report containing identification of the device by manufacturer's
name and model number and the name and address of the person receiving the
device. No report is required if the device is transferred to the specific
licensee in order to obtain a replacement device;
(viii) Shall transfer the device to another
general licensee only:
(A) Where the device
remains in use at a particular location. In such case the transferor shall give
the transferee a copy of 410 IAC
5 and any safety documents identified in the
label on the device and within 30 days of the transfer, report to the board the
manufacturer's name and model number of device transferred, the name and
address of the transferee, and the name and/or position of an individual who
may constitute a point of contact between the board and the transferee;
or
(B) Where the device is held in
storage in the original shipping container at its intended location of use
prior to initial use by a general licensee; and
(ix) Shall comply with the provisions of
410 IAC
5-4-22 and
410 IAC 5-4-23
for reporting radiation incidents, theft, or loss of licensed material, but
shall be exempt from the other requirements of 410 IAC
5-4 and
410 IAC
5-10.
(4) The general
license in 410 IAC
5-3-7(d)(1) does not authorize the manufacture of devices
containing radioactive material.
(e) 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 10
curies of tritium or 300 millicuries 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 board 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.
(2) Persons who own, receive, acquire,
possess or use luminous safety devices pursuant to the general license in 410
IAC
5-3-7(e)(1) are exempt from the requirements of 410 IAC
5-4 and
410 IAC
5-10 except that they shall comply with the provisions of
410 IAC
5-4-22 and
410 IAC
5-4-23.
(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.
(f) Ownership of Radioactive Material. A
general license is hereby issued to own radioactive material without regard to
quantity. Notwithstanding any other provisions of 410 IAC
5-3, this general
license does not authorize the manufacture, production, transfer, receipt,
possession or use of radioactive material.
(g) 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 410 IAC
5-3-7(g)(4) and (5), americium-241
in the form of calibration or reference sources:
(i) Any person who holds a specific license
issued by the board 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 410 IAC
5-3-7(g)(4) and (5) to any person who holds a
specific license issued by the board 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 410 IAC
5-3-7(g)(4)
and (5) to any person who holds a specific license issued by the board which
authorizes him to receive, possess, use and transfer radioactive
material.
(4) The general licenses
in 410 IAC
5-3-7(g)(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 board, any agreement state or
licensing 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.
(5) The general licenses
provided in 410 IAC
5-3-7(g)(1), (2) and (3) are subject to the provisions of
410 IAC 5-1-4
through
410 IAC 5-1-9,
410 IAC
5-3-15,
410 IAC
5-3-22,
410
IAC 5-3-23, and
410 IAC
5-3-25 and 410 IAC
5-4, and
410 IAC 5-10. 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 5 microcuries of americium-241, 5
microcuries of plutonium or 5 microcuries 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 which includes the following statements as
appropriate, or a substantially similar statement which contains the
information called for in one of the following statements, as appropriate:
(A) The receipt, possession, use and transfer
of this source, Model _____, Serial No. _____, are subject to a general license
and the regulations of the U.S. Nuclear Regulatory Commission or of a state
with which the commission has entered into an agreement for the exercise of
regulatory authority. Do not remove this label. CAUTION-RADIOACTIVE
MATERIAL-THIS SOURCE CONTAINS (AMERICIUM-241).
(PLUTONIUM)6/ DO NOT TOUCH
RADIOACTIVE PORTION OF THIS SOURCE.
_____________________________
Name of manufacturer or importer
6/ Showing only the name of the
appropriate material.
(B)
The receipt, possession, use and transfer of this source, Model _____, Serial
No. _____, are subject to a general license and the regulations of a licensing
state. Do not remove this label.
CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS RADIUM-226.
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
_____________________________
Name of manufacturer or importer
(iii) Shall not transfer, abandon or dispose
of such source except by transfer to a person authorized by a license from the
board, the U.S. Nuclear Regulatory Commission, an agreement state, or licensing
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.
(h) Medical Diagnostic
Uses
7/8/
7/
410
IAC 5-3-13 requires manufacturers of
radiopharmaceuticals which are under the general license in this paragraph to
affix a certain identifying label to the container or in the leaflet or
brochure which accompanies the radiopharmaceutical.
8/ The New Drug provisions of the
Federal Food, Drug, and Cosmetic Act also govern the availability and use of
any specific diagnostic drugs in interstate commerce.
(1) A general license is hereby issued to any
physician to receive, possess, transfer or use radioactive material set forth
below for the stated diagnostic uses, provided, however, that the use is in
accordance with the provision of 410 IAC
5-3-7(h)(2), (3), and (4), the
radioactive material is in the form of capsules, disposable syringes or other
prepackaged individual doses; and the radioactive material has been
manufactured in accordance with a specific license issued by the board pursuant
to
410
IAC 5-3-13(g), or by the U.S. Nuclear
Regulatory Commission, any agreement state or a licensing state pursuant to
equivalent rules authorizing distribution to persons generally licensed
pursuant to 410 IAC
5-3-7(h) or its equivalent.
(i) Chromium-51 as sodium radiochromate for
determination of red blood cell volumes and studies of red blood cell survival
time;
(ii) Cobalt-57 for the
measurement of intestinal absorption of cyanocobalamin;
(iii) Cobalt-58 for the measurement of
intestinal absorption of cyanocobalamin;
(iv) Cobalt-60 for the measurement of
intestinal absorption of cyanocobalamin;
(v) Iodine-125 as iodinated human serum
albumin (IHSA) for determinations of blood and blood plasma volume;
(vi) Iodine-131 as sodium iodide for
measurement of thyroid uptake; and
(vii) Iodine-131 as iodinated human serum
albumin (IHSA) for determinations of blood and blood plasma volume;
(2) No physician shall receive,
possess, use or transfer radioactive material pursuant to the general license
established by 410 IAC
5-3-7(h)(1) until he has filed board form "U,"
410
IAC 5-3-30, "Certificate-Medical Use of Radioactive
Material Under General License" with the board and received from the board a
validated copy of the board form "U,"
410
IAC 5-3-30, with certification number assigned. The
generally licensed physician shall furnish on board form "U,"
410
IAC 5-3-30, the following information and such other
information as may be required by that form:
(i) name and address of the generally
licensed physician;
(ii) a
statement that the generally licensed physician is a duly licensed physician
(authorized to dispense drugs) in the practice of medicine in Indiana;
and
(iii) a statement that the
generally licensed physician has appropriate radiation measuring instruments to
carry out the diagnostic procedures for which he proposes to use radioactive
material under the general license of 410 IAC
5-3-7(h) and that he is competent
in the use of such instruments.
(3) A physician who receives, possesses, or
uses a pharmaceutical containing radioactive material pursuant to the general
license established by 410 IAC
5-3-7(h)(1) shall comply with the following:
(i) he shall not possess at any one time,
pursuant to the general license in 410 IAC
5-3-7(h)(1) more than:
(A) 200 microcuries of iodine-131,
(B) 200 microcuries of iodine-125,
(C) 5 microcuries of cobalt-57,
(D) 5 microcuries of cobalt-58,
(E) 5 microcuries of cobalt-60, and
(F) 200 microcuries of chromium-51;
(ii) he shall store the
pharmaceutical until administered in the original shipping container, or a
container providing equivalent radiation protection;
(iii) he shall use the pharmaceutical only
for the uses authorized by 410 IAC
5-3-7(h)(1);
(iv) he shall not administer the
pharmaceutical to a woman with confirmed pregnancy or to a person under 18
years of age; and
(v) he shall not
transfer the radioactive material to a person who is not authorized to receive
it pursuant to a license issued by the board, the U.S. Nuclear Regulatory
Commission, any agreement state or licensing state, or in any manner other than
in the unopened, labeled shipping container as received from the supplier,
except by administering it to a patient.
(4) The generally licensed physician
possessing or using radioactive material under the general license of 410 IAC
5-3-7(h)(1) shall report in duplicate to the board, any changes in the
information furnished by him in the "Certificate-Medical Use of Radioactive
Material Under General License," board form "U." The report shall be submitted
within 30 days after the effective date of such change.
(5) Any person using radioactive material
pursuant to the general license of 410 IAC
5-3-7(h)(1) is exempt from the
requirements of 410 IAC
5-4 and
410 IAC 5-10 with respect to the radioactive
material covered by the general license.
(i) General License for Use of Radioactive
Material for Certain In Vitro Clinical or Laboratory
Testing.
8/
8/ The New Drug provisions of the
Federal Food, Drug, and Cosmetic Act also govern the availability and use of
any specific diagnostic drugs in interstate commerce.
(1) A general license is hereby issued to any
physician, veterinarian, clinical laboratory or hospital to receive, acquire,
possess, transfer or use, for any of the following stated tests, in accordance
with the provisions of 410 IAC
5-3-7(i)(2), (3), (4), (5), and (6), the
following radioactive materials in prepackaged units for use 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) Carbon-14, in units not exceeding 10
microcuries each;
(ii) Cobalt-57,
in units not exceeding 10 microcuries each;
(iii) Hydrogen-3 (tritium), in units not
exceeding 50 microcuries each;
(iv)
Iodine-125, in units not exceeding 10 microcuries each;
(v) Mock Iodine-125 reference or calibration
sources, in units not exceeding 0.05 microcurie iodine-129 and 0.005 microcurie
of americium-241 each;
(vi)
Iodine-131, in units not exceeding 10 microcuries each;
(vii) Iron-59, in units not exceeding 20
microcuries each;
(viii)
Selenium-75, in units not exceeding 10 microcuries each;
(2) No person shall receive, acquire,
possess, use or transfer radioactive material pursuant to the general license
established by 410 IAC
5-3-7(i)(1) until he has filed board form "V,"
410
IAC 5-3-31, "Certificate-In Vitro Testing with
Radioactive Material Under General License," with the board and received from
the board a validated copy of board form "V" with certification number
assigned, or until he has been authorized pursuant to
410
IAC 5-3-11(c)(3) to use radioactive
material under the general license in 410 IAC
5-3-7(i). The physician,
veterinarian, clinical laboratory or hospital shall furnish on board form "V"
the following information and such other information as may be required by that
form:
(i) name and address of the physician,
veterinarian, clinical laboratory or hospital;
(ii) the location of use; and
(iii) a statement that the physician,
veterinarian, clinical laboratory or hospital has appropriate radiation
measuring instruments to carry out in vitro clinical or laboratory tests with
radioactive material as authorized under the general license in 410 IAC
5-3-7(i)(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 410 IAC
5-3-7(i)(1) shall comply with the
following:
(i) the general licensee shall not
possess at any one time, pursuant to the general license in 410 IAC
5-3-7(i)(1)
at any one location of storage or use, a total amount of iodine-125,
iodine-131, iron-59, selenium-75, and/or cobalt-57 in excess of 200
microcuries;
(ii) the general
licensee shall store the radioactive material, until used, in the original
shipping container or in a container providing equivalent radiation
protection;
(iii) the general
licensee shall use the radioactive material only for the uses authorized by 410
IAC
5-3-7(i)(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 board, the U.S.
Nuclear Regulatory Commission, any agreement state or licensing state, nor
transfer the radioactive material in any manner other than in the unopened,
labeled shipping container as received from the supplier;
(v) the general licensee shall dispose of the
Mock Iodine-125 reference or calibration sources described in 410 IAC
5-3-7(i)(1)(viii) as required by
410 IAC
5-4-16.
(4) The general licensee shall not receive,
acquire, possess or use radioactive material pursuant to 410 IAC
5-3-7(i)(1):
(i) Except as prepackaged units which are
labeled in accordance with the provisions of an applicable specific license
issued pursuant to
410
IAC 5-3-13(h), or in accordance with
the provisions of a specific license issued by the U.S. Nuclear Regulatory
Commission, any agreement state or licensing state which authorizes the
manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3
(tritium), iron-59, selenium-75, cobalt-57, or Mock Iodine-125 to persons
generally licensed under 410 IAC
5-3-7(i) or its equivalent; and
(ii) Unless one of the following statements,
as appropriate, or a substantially similar statement which contains the
information called for in one of the following statements, appears on a label
affixed to each prepackaged unit or appears in a leaflet or brochure which
accompanies the package:
(A) This radioactive
material may be received, acquired, possessed and used only by physicians,
veterinarians, clinical laboratories or hospitals and only for in vitro
clinical or laboratory tests not involving internal or external administration
of the material, or the radiation therefrom, to human beings or animals. Its
receipt, acquisition, possession, use and transfer are subject to the
regulations and a general license of the U.S. Nuclear Regulatory Commission or
of a state with which the commission has entered into an agreement for the
exercise of regulatory authority. _________________________________
Name of manufacturer
(B) This radioactive material shall be
received, acquired, possessed and used only by physicians, veterinarians,
clinical laboratories or hospitals and only for in vitro clinical or laboratory
tests not involving internal or external administration of the material, or the
radiation therefrom, to human beings or animals. Its receipt, acquisition,
possession, use and transfer are subject to the regulations and a general
license of a licensing state. _________________________________
Name of manufacturer
(5) The physician, veterinarian, clinical
laboratory or hospital possessing or using radioactive material under the
general license of 410 IAC
5-3-7(i)(1) shall report in writing to the board,
any changes in the information furnished by him in the "Certificate-In Vitro
Testing with Radioactive Material Under General License," board form "V,"
410
IAC 5-3-31. 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 410 IAC
5-3-7(i)(1) is exempt from the
requirements of 410 IAC
5-4 and
410 IAC 5-10 with respect to radioactive
material covered by that general license, except, that such persons using the
Mock Iodine-125 described in 410 IAC
5-3-7(i)(1)(viii) shall comply with the
provisions of
410 IAC
5-4-16,
410 IAC
5-4-22, and
410 IAC
5-4-23.
(j) 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
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 board or an agreement state to
the manufacturer of such device pursuant to licensing requirements equivalent
to those in Section 32.61 of 10 CFR Part
32.
(2) Persons who own, receive, acquire,
possess, use, or transfer strontium-90 contained in ice detection devices
pursuant to the general license in 410 IAC
5-3-7(j)(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 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
410 IAC
5-4-16;
(ii) Shall assure that all labels affixed to
the device at the time of receipt, and which bear a statement which prohibits
removal of the labels, are maintained thereon; and
(3) This general license does not authorize
the manufacture, assembly, disassembly or repair of strontium-90 in ice
detection devices.