| any other completely sealed tube designed to control electrical
currents):
(-a-) 150 mCi (5.55 GBq) of tritium per microwave receiver
protector tube or 10 mCi (0.37 GBq) of tritium per any other electron
tube;
(-b-) 1 µCi (0.037 MBq) of cobalt-60;
(-c-) 5 µCi (0.185 GBq) of nickel-63;
(-d-) 30 µCi (1.11 GBq) of krypton-85;
(-e-) 5 µCi (0.185 GBq) of cesium-137; or
(-f-) 30 µCi (1.11 GBq) of promethium-147;
(VIII) ionizing radiation measuring instruments containing,
for purposes of internal calibration or standardization, a source
of radioactive material not exceeding:
(-a-) the applicable quantity set forth in subsection
(l)(2) of this section or 0.05 µCi (1.85 kilobecquerels (kBq))
of americium-241; and
(-b-) each instrument contains no more than 10 exempt
quantities. For purposes of this subclause, an instrument's source(s)
shall contain either one type or different types of radionuclides
and an individual exempt quantity shall be composed of fractional
parts of one or more of the exempt quantities in accordance with subsection
(l)(2) of this section, provided that the sum of such fractions shall
not exceed unity.
(IX) ionization chamber smoke detectors containing
not more than 1 µCi (37 kBq) of americium-241 per detector in
the form of a foil and designed to protect life and property from
fires.
(ii) Authority to transfer possession or control by
the manufacturer, processor, or producer of any equipment, device,
commodity, or other product containing source material or byproduct
material whose subsequent possession, use, transfer, and disposal
by all other persons are exempted from regulatory requirements may
be obtained only from the United States Nuclear Regulatory Commission,
Washington, DC 20555.
(iii) Any person who desires to apply radioactive material
to, or to incorporate radioactive material into, the products exempted
in clause (i) of this subparagraph, or who desires to initially transfer
for sale or distribution such products containing radioactive material,
shall apply for a specific license issued by the NRC in accordance
with Title 10, CFR, §32.14, which license states that the product
may be distributed by the licensee to persons exempt from the regulations
pursuant to clause (i) of this subparagraph.
(B) Self-luminous products containing tritium, krypton-85,
or promethium-147.
(i) Except for persons who manufacture, process, or
produce, or initially transfer for sale or distribution self-luminous
products containing tritium, krypton-85, or promethium-147, and except
as provided in clause (iii) of this subparagraph, any person is exempt
from this chapter if that 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 NRC in accordance
with Title 10, CFR, §32.22, which authorizes the initial transfer
of the product to persons who are exempt from regulatory requirements.
(ii) 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 clause (i) of this subparagraph, should apply for:
(I) a specific license to be issued by the NRC in accordance
with Title 10, CFR, §32.22; and
(II) a certificate of registration to be issued by
the NRC in accordance with Title 10, CFR, §32.210.
(iii) The exemption in clause (i) of this subparagraph
does not apply to tritium, krypton-85, or promethium-147 used in products
for frivolous purposes or in toys or adornments.
(C) 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 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.
(I) Detectors containing radioactive material shall
have been manufactured, processed, produced, or initially transferred
in accordance with a specific license issued by the NRC in accordance
with Title 10, CFR, §32.26.
(II) The specific license issued by the NRC in accordance
with Title 10, CFR, §32.26, authorizes the initial transfer of
the product for use to persons who are exempt from regulatory requirements.
(III) This exemption also covers gas and aerosol detectors
manufactured or distributed before November 30, 2007 in accordance
with a specific license issued in accordance with §289.252 of
this title or under comparable provisions to Title 10, CFR, §32.26
authorizing distribution to persons exempt from regulatory requirements.
(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 this clause,
shall apply for:
(-a-) a specific license to be issued by the NRC in
accordance with Title 10, CFR, §32.26; and
(-b-) a certificate of registration to be issued by
the NRC in accordance with Title 10, CFR, §32.210.
(ii) Authority to transfer possession or control by
the manufacturer, processor, or producer of any equipment, device,
commodity, or other product containing source material or byproduct
material whose subsequent possession, use, transfer, and disposal
by all other persons are exempted from regulatory requirements may
be obtained only from the United States Nuclear Regulatory Commission,
Washington, DC 20555.
(iii) Gas and aerosol detectors previously manufactured
and distributed to general licensees in accordance with a specific
license issued by any agreement state shall be considered exempt in
accordance with clause (i) of this subparagraph, provided that the
devices are labeled in accordance with the specific license authorizing
distribution of the generally licensed device, and provided further
that they meet the requirements of §289.252 of this title.
(D) Certain industrial devices. Except for persons
who manufacture, process, produce, or initially transfer for sale
or distribution industrial devices containing radioactive 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 of this chapter to the extent that such person receives,
possesses, uses, transfers, owns, or acquires radioactive material,
in these certain detecting, measuring, gauging, or controlling devices
and certain devices for producing an ionized atmosphere.
(i) Devices containing radioactive material shall have
been manufactured, processed, produced, or initially transferred in
accordance with a specific license issued under Title 10, CFR, §32.30.
(ii) The specific license issued by the NRC in accordance
with Title 10, CFR, §32.30, authorizes the initial transfer of
the device for use under Title 10, CFR, §32.30.
(iii) This exemption does not cover sources not incorporated
into a device, such as calibration and reference sources.
(iv) Any person who desires to manufacture, process,
produce, or initially transfer for sale or distribution industrial
devices containing radioactive material for use under this subparagraph,
shall apply for:
(I) a license to be issued by the NRC under Title 10,
CFR, §32.30; and
(II) a certificate of registration to be issued by
the NRC in accordance with Title 10, CFR, §32.210.
(4) Exemption for capsules containing carbon-14 urea
for "in vivo" diagnostic use in humans.
(A) Except as provided in subparagraphs (B) and (C)
of this paragraph, a person is exempt from the requirements of this
section and §289.256 of this title provided that such person
receives, possesses, uses, transfers, owns, or acquires capsules containing
1 µCi (37 kBq) or less of carbon-14 urea each (allowing for
nominal variation that may occur during the manufacturing process),
for "in vivo" diagnostic use in humans.
(B) A person desiring to use the capsules for research
involving human subjects shall apply for and receive a specific license
in accordance with §289.256 of this title.
(C) A person desiring to manufacture, prepare, process,
produce, package, repackage, or transfer for commercial distribution
such capsules shall apply for and receive a specific license in accordance
with Title 10, CFR, §32.21.
Cont'd... |
