| (ii) A general license is issued to any private carrier
to transport radioactive material, provided the transportation is
in accordance with the applicable requirements, appropriate to the
mode of transport, of the DOT insofar as such requirements relate
to the loading and storage of packages, placarding of the transporting
vehicle, and incident reporting. Any notification of incidents referred
to in those requirements shall be filed with the DOT, and with the
agency in accordance with §289.202(ww) - (yy) of this title.
(G) General license for the use of radioactive material
for certain in vitro clinical or laboratory
testing, not to include research and development. (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.)
(i) A general license is 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
clauses (ii) - (iii) of this subparagraph, the following radioactive
materials in prepackaged units:
(I) iodine-125, in units not exceeding 10 µCi
(0.37 MBq) each for use in in vitro clinical
or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or
animals;
(II) iodine-131, in units not exceeding 10 µCi
(0.37 MBq) each for use in in vitro clinical
or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or
animals;
(III) carbon-14, in units not exceeding 10 µCi
(0.37 MBq) each for use in in vitro clinical
or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or
animals;
(IV) hydrogen-3 (tritium), in units not exceeding 50 µCi
(1.85 MBq) each for use in in vitro clinical
or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or
animals;
(V) iron-59, in units not exceeding 20 µCi (0.74
MBq) each for use in in vitro clinical
or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or
animals;
(VI) selenium-75, in units not to exceed 10 µCi
(0.37 MBq) each for use in in vitro clinical
or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or
animals;
(VII) mock iodine-125 reference or calibration sources,
in units not exceeding 0.05 µCi (1850 Bq) of iodine-129 and
0.005 µCi 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 humans or animals; or
(VIII) cobalt-57, in units not exceeding 10 µCi
(0.37 MBq) each for use in in vitro clinical
or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to humans or
animals.
(ii) A person who receives, acquires, possesses, or
uses radioactive material in accordance with the general license in
clause (i) of this subparagraph shall comply with the following.
(I) The general licensee shall not possess at any one
time, 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 µCi
(7.4 MBq).
(II) The general licensee shall store the radioactive
material in the original shipping container or in a container providing
equivalent radiation protection and meeting the requirements of §289.202(cc)
of this title until used.
(III) The general licensee shall use the radioactive
material only for the uses authorized by clause (i) of this subparagraph.
(IV) The general licensee shall not transfer the radioactive
material to a person who is not authorized to receive it in accordance
with a specific license issued by the agency, the NRC, 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 clause (i)(VII)
of this subparagraph as required by §289.202(ff) of this title.
(iii) The general licensee shall not receive, acquire,
possess, or use radioactive material in accordance with the general
license in clause (i) of this subparagraph:
(I) except as prepackaged units that are labeled in
accordance with the provisions of an applicable specific license issued
in accordance with §289.252(p) of this title or in accordance
with the requirements of a specific license issued by the NRC or any
agreement state that 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 general licensees in
accordance with this subparagraph or its equivalent; and
(II) unless one of the statements in the following
figures, as appropriate, or a substantially similar statement that
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 that accompanies the package:
(-a-) option 1, as appropriate:
Attached Graphic
(-b-) option 2, as appropriate:
Attached Graphic
(iv) No person shall receive, acquire, possess, use,
or transfer radioactive material in accordance with the general license
in clause (i) of this subparagraph until that person has filed an
application for registration on a form prescribed by the agency and
has received from the agency a notification of receipt with an assigned
registration number. The applicant shall submit the following information
and any other information as may be required by the agency:
(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 in accordance with clause (i) of
this subparagraph, 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.
(H) General license for certain detecting, measuring,
gauging, or controlling devices and certain devices for producing
light or an ionized atmosphere.
(i) A general license is 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 clauses (ii) - (iv) of this subparagraph, radioactive
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.
(ii) The general license in clause (i) of this subparagraph
applies only to radioactive material contained in devices that have
been manufactured or initially transferred and labeled in accordance
with the specifications contained in:
(I) a specific license issued by the agency in accordance
with §289.252(l) of this title;
(II) a specific license issued by the NRC or any agreement
state that authorizes distribution of devices to persons generally
licensed by the NRC or any agreement state; or
(III) an equivalent specific license issued by a state
with provisions comparable to §289.252(l) of this title.
(iii) The devices must have been received from a specific
licensee described in clause (ii) of this subparagraph or through
a transfer made in accordance with clause (iv)(XII) of this subparagraph.
(iv) Any person who receives, acquires, possesses,
uses, or transfers radioactive material in a device in accordance
with the general license in this subparagraph shall do the following:
(I) 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 on the device and are clearly visible
and legible. The general licensee shall comply with all instructions
and precautions provided by such labels;
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