(1) A general license is hereby issued to
transfer, receive, acquire, 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 US nuclear regulatory commission for use pursuant to 10 CFR
Part
31, section 31.3. This general license is subject to the provisions of ARM
37.14.107,
37.14.108,
37.14.115,
37.14.116,
37.14.506(1) (b),
37.14.526,
37.14.547,
37.14.550,
37.14.552, and Title 37, chapter
14, subchapters 7 and 17.
(a) 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.
(b) 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.
(4)
(a) 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 receive, acquire, possess, use, or transfer in
accordance with the provisions of (b) through (d) below, 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.
(b) The general
license in (a) above 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 department pursuant to ARM
37.14.542(4) or
in accordance with the specifications contained in a specific license issued by
the US nuclear regulatory commission, an agreement state or a licensing state,
which authorizes distribution of devices to persons generally licensed by the
US nuclear regulatory commission, an agreement state or a licensing
state.
(c) Any person who receives,
acquires, possesses, uses, or transfers radioactive material in a device
pursuant to the general license in (a) above:
(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 6-month intervals or at such
other intervals as are specified in 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 the tests required by (ii) above and other testing,
installation, servicing, and removal from installation involving the
radioactive materials, 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 department, the US
nuclear regulatory commission, an agreement state or a licensing state to
perform such activities;
(iv) shall maintain records showing
compliance with the requirements of (ii) and (iii) above. 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, installing, servicing, and
removing from installation concerning the radioactive material, its shielding
or containment. Records of tests for leakage of radioactive material required
by (ii) above 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 (ii) above 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 (iii) above 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 department, the US nuclear regulatory
commission, an agreement state or a licensing state to repair such devices, or
disposed of by transfer to a person authorized by an applicable specific
license to receive the radioactive material contained in the device and, within
30 days, furnish to the department a report containing a brief description of
the event and the remedial action taken;
(vi) shall not abandon the device containing
radioactive material;
(vii) except
as provided in (viii) below, shall transfer or dispose of the device containing
radioactive material only by transfer to a specific licensee of the department,
the US nuclear regulatory commission, an agreement state, or a licensing state
whose specific license authorizes him to receive the device and within 30 days
after transfer of a device to a specific licensee shall furnish to the
department a report containing identification of the device by manufacturer's
name and model number and the name and address of the person receiving the
device. No report is required if the device is transferred to the specific
licensee in order to obtain a replacement device;
(viii) shall transfer the device to another
general licensee:
(A) where the device
remains in use at a particular location. In such case the transferor shall give
the transferee a copy of this rule and any safety documents identified in the
label on the device and within 30 days of the transfer, report to the
department the manufacturer's name and model number of device transferred, the
name and address of the transferee, and the name and/or position of an
individual who may constitute a point of contact between the department and the
transferee; or
(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 ARM
37.14.751 and
37.14.755, for reporting radiation
incidents, theft, or loss of licensed material, but shall be exempt from the
other requirements of ARM Title 37, chapter 14, subchapters 7 and 17.
(d) The general license in (a)
above does not authorize the manufacture of devices containing radioactive
material.
(5)
(a) A general license is hereby issued to
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 US
nuclear regulatory commission, or each device has been manufactured or
assembled in accordance with the specifications contained in a specific license
issued by the department or any agreement state to the manufacturer or
assembler of such device.
(b) Persons who receive, acquire, possess, or
use luminous safety devices pursuant to the general license in (a) above are
exempt from the requirements of ARM Title 37, chapter 17, subchapters 7 and 17,
except that they shall comply with the provisions of ARM
37.14.751 and 37.14.755.
(c) This general license does not authorize
the manufacture, assembly, or repair of luminous safety devices containing
tritium or promethium-147.
(d) This
general license does not authorize the ownership, receipt, acquisition,
possession or use of promethium-147 contained in instrument dials.
(6) A general license is hereby issued to own
radioactive material without regard to quantity. Notwithstanding any other
provisions of this subchapter, this general license does not authorize the
manufacture, production, transfer, receipt, possession or use of radioactive
material.
(7)
(a) A general license is hereby issued to
those persons listed below to receive, acquire, possess, use, and transfer, in
accordance with the provisions of (d) and (e) below, americium-241 in the form
of calibration or reference sources:
(i) any
person who holds a specific license issued by the department which authorizes
him to receive, possess, use, and transfer radioactive material; and
(ii) any person who holds a specific license
issued by the US nuclear regulatory commission which authorizes him to receive,
possess, use, and transfer special nuclear material.
(b) A general license is hereby issued to
receive, possess, use, and transfer plutonium in the form of calibration or
reference sources in accordance with the provisions of (d) and (e) below to any
person who holds a specific license issued by the department which authorizes
him to receive, possess, use, and transfer radioactive material.
(c) A general license is hereby issued to
receive, possess, use, and transfer radium-226 in the form of calibration or
reference sources in accordance with the provisions of (d) and (e) below to any
person who holds a specific license issued by the department which authorizes
him to receive, possess, use, and transfer radioactive material.
(d) The general licenses in (a), (b) and (c)
above 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 US nuclear
regulatory commission or which have been manufactured in accordance with the
specification contained in a specific license issued to the manufacturer by the
department, any agreement state or licensing state.
(e) The general licenses provided in (a),
(b), and (c) above are subject to the provisions of ARM
37.14.107,
37.14.108,
37.14.115,
37.14.116,
37.14.526,
37.14.547,
37.14.550,
37.14.552, and Title 37,
chapter 14, subchapters 7 and 17. In addition, persons who receive, acquire,
possess, use, or transfer 1 or more calibration or reference sources pursuant
to these general licenses:
(i) shall not
possess at any 1 time, at any 1 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 1 of the following
statements, as appropriate, or a substantially similar statement which contains
the information called for in 1 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 US 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 or PLUTONIUM--show only the name of the appropriate
material.) DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
_______________________________
Name of manufacturer of importer
(B) The receipt, possession, use and transfer
of this source, Model_________, Serial No._________, are subject to a general
license and the regulations of any 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
department, the US nuclear regulatory commission, an agreement state or a
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.
(f) These general licenses do not authorize
the manufacture of calibration or reference sources containing americium-241,
plutonium, or radium-226.
(8)
(a) 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
(b), (c) and (d) below, 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 department pursuant to ARM
37.14.542(7), or
by the US nuclear regulatory commission, any agreement state or a licensing
state pursuant to equivalent regulations authorizing distribution to persons
generally licensed pursuant to (8) or its equivalent:
(i) iodine-131 as sodium iodide
(Na131I) for measurement of thyroid
uptake;
(ii) iodine-131 as
iodinated human serum albumin (IHSA) for determinations of blood and blood
plasma volume;
(iii) iodine-125 as
iodinated human serum albumin (IHSA) for determinations of blood and blood
plasma volume;
(v) cobalt-58 for the measurement of
intestinal absorption of cyanocobalamin ;
(vi) cobalt-60 for the measurement of
intestinal absorption of cyanocobalamin ; and
(vii) chromium-51 as sodium radiochromate for
determination of red blood cell volumes and studies of red blood cell survival
time.
(b) No physician
shall receive, possess, use, or transfer radioactive material pursuant to the
general license established by (a) above until he has filed department form
MRH-10, "Certificate--Medical Use of Radioactive Material Under General
License" with the department and received from the department a validated copy
of the department form MRH-10 with certification number assigned. The generally
licensed physician shall furnish on department form MRH-10 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 Montana;
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 this (8) and that he is competent in the
use of such instruments.
(c) A physician who receives, possesses, or
uses a pharmaceutical containing radioactive material pursuant to the general
license established by (a) above shall comply with the following:
(i) He shall not possess at any 1 time,
pursuant to the general license in (a) above 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 in the original shipping container, or a container providing
equivalent radiation protection until administered;
(iii) he shall use the pharmaceutical only
for the uses authorized by (a) above;
(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 department, the US 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.
(d) The generally licensed physician
possessing or using radioactive material under the general license of (a) above
shall report in duplicate to the department, any changes in the information
furnished by him in the "Certificate--Medical Use of Radioactive Material Under
General License", department form MRH-10. The report shall be submitted within
30 days after the effective date of such change.
(e) Any person using radioactive material
pursuant to the general license of (a) above is exempt from the requirements of
ARM Title 37, chapter 14, subchapters 7 and 17, with respect to the radioactive
material covered by the general license.
(9)
(a) A
general license is hereby issued to any physician, clinical laboratory or
hospital to receive, acquire, possess, transfer, or use, for any of the
following stated tests, in accordance with the provisions of (b) through (f)
below, the following radioactive materials in prepackaged units:
(i) Iodine-125, in units not exceeding 10
microcuries each 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.
(ii) Iodine-131, in units not exceeding 10
microcuries each 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.
(iii) Carbon-14, in units not exceeding 10
microcuries each 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.
(iv) Hydrogen-3 (tritium), in units not
exceeding 50 microcuries each 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.
(v) Iron-59, in units not exceeding 20
microcuries each 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.
(vi) Cobalt-57, in units not exceeding 10
microcuries each 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.
(vii) Selenium-75, in units not to exceed 10
microcuries each 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.
(viii) Mock Iodine-125 reference or
calibration sources, in units not exceeding 0.05 microcurie of iodine-129 and
0.005 microcurie of americium-241 each 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.
(b) No person
shall receive, acquire, possess, use or transfer radioactive material pursuant
to the general license established by (a) above until he has filed department
form MRH-11, "Certificate--In Vitro Testing with Radioactive Material Under
General License", with the department and received from the department a
validated copy of department form MRH-11 with certification number assigned, or
until he has been authorized pursuant to ARM
37.14.540(3) (c)
to use radioactive material under the general license in (9). The physician,
clinical laboratory or hospital shall furnish on department form MRH-11 the
following information and such other information as may be required by that
form:
(i) name and address of the physician,
clinical laboratory or hospital;
(ii) the location of use; and
(iii) a statement that the physician,
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 (a) above 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.
(c) A person who receives, acquires,
possesses or uses radioactive material pursuant to the general license
established by (a) above shall comply with the following:
(i) The general licensee shall not possess at
any 1 time, pursuant to the general license in (a) above, at any 1 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.
(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 (a) above.
(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 department, the US 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 (a) (viii) above
as required by ARM
37.14.740.
(d) The general licensee shall not receive,
acquire, possess, or use radioactive material pursuant to (a) above:
(i) Except as prepackaged units which are
labeled in accordance with the provisions of an applicable specific license
issued pursuant to ARM
37.14.542(8) in
accordance with the provisions of a specific license issued by the US 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 (9) or its equivalent, and
(ii) unless 1 of the following statements, as
appropriate, or a substantially similar statement which contains the
information called for in 1 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 shall be received, acquired, possessed, and used only by physicians,
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 US 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, 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
(e) The physician, clinical laboratory or
hospital possessing or using radioactive material under the general license of
(a) above shall report in writing to the department, any changes in the
information furnished by him in the "Certificate--In Vitro Testing with
Radioactive Material Under General License", department form MRH-11. The report
shall be furnished within 30 days after the effective date of such
change.
(f) Any person using
radioactive material pursuant to the general license of (a) above is exempt
from the requirements of ARM Title 37, chapter 14, subchapters 7 and 17, with
respect to radioactive material covered by that general license, except that
such persons using the mock iodine-125 described in (a) (viii) above shall
comply with the provisions of ARM
37.14.740,
37.14.751, and
37.14.755.
(10)
(a) A general license is hereby issued to
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 US nuclear regulatory commission or each
device has been manufactured in accordance with the specifications contained in
a specific license issued by the department or any agreement state to the
manufacturer of such device.
(b)
Persons who receive, acquire, possess, use, or transfer strontium-90 contained
in ice detection devices pursuant to the general license in (a) above:
(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 US
nuclear regulatory commission or an agreement state to manufacture or service
such devices; or shall dispose of the device pursuant to the provisions of ARM
37.14.740.
(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
(iii) are exempt from the
requirements of ARM Title 37, chapter 14, subchapters 7 and 17, except that
such persons shall comply with the provisions of ARM
37.14.740,
37.14.751, and
37.14.755.
(c) This
general license does not authorize the manufacture, assembly, disassembly or
repair of strontium-90 in ice detection devices.