| (A) Persons initially distributing source material
in products covered by the exemptions in subsection (d)(3) of this
section 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 agency 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.
(B) Persons authorized by the agency, the NRC, or any
agreement state to manufacture, process, or produce these materials
or products containing source material, and persons who import finished
products or parts, for sale or distribution must be authorized by
a license issued under Title 10, CFR, §40.52, for distribution
only. These persons are exempt from the requirements of §289.202
(relating to Standards for Protection Against Radiation from Radioactive
Materials), §289.203 (relating to Notices, Instructions, and
Reports to Workers; Inspections), and §289.252(e)(1) and (2)
of this title.
(e) Exemptions for radioactive material other than
source material.
(1) Exempt concentrations.
(A) Except as provided in subparagraph (B) of this
paragraph, any person is exempt from this section and §289.252
of this title if that person receives, possesses, uses, transfers,
or acquires products or materials containing radioactive material
in concentrations not in excess of those listed in subsection (l)(1)
of this section.
(B) No person may introduce radioactive material into
a product or material, including waste, knowing or having reason to
believe that it will be transferred to persons exempt in accordance
with subparagraph (A) of this paragraph or equivalent regulations
of the NRC or any agreement state, except in accordance with a specific
license issued under §289.252(i) of this title.
(C) A manufacturer, processor, or producer of a product
or material is exempt from the requirements for a license, as specified
in §289.252 of this title, if the manufacturer, processor, or
producer transfers radioactive material contained in a product or
material that does not exceed the concentrations specified in subsection
(l)(1) of this section, and that has been introduced into the product
or material by a licensee holding a specific license issued by the
NRC that expressly authorizes such introduction. The exemption specified
in this subparagraph 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.
(2) Exempt quantities.
(A) Except as provided in subparagraphs (C), (D), and
(F) of this paragraph, any person is exempt from these rules if that
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 subsection (l)(2) of this section.
(B) Any person who possesses radioactive material received
or acquired, prior to September 25, 1971, in accordance with the general
license provided in subsection (f)(4)(A) of this section is exempt
from the requirements for a license set forth in §289.252 of
this title if that person possesses, uses, transfers, or owns such
radioactive material.
(C) This paragraph does not authorize the production,
packaging, or repackaging or transfer of radioactive material for
purposes of commercial distribution, or the incorporation of radioactive
material into products intended for commercial distribution.
(D) No person may, for purposes of commercial distribution,
transfer radioactive material in quantities greater than the individual
quantities set forth in subsection (l)(2) of this section, knowing
or having reason to believe that such quantities of radioactive material
will be transferred to persons exempt under this paragraph or equivalent
regulations of the NRC or any agreement state, except in accordance
with a specific license issued by the NRC in accordance with Title
10, CFR, §32.18 or by the agency in accordance with §289.252(j)
of this title, which states that the radioactive material may be transferred
by the licensee to persons exempt in accordance with this paragraph
or the equivalent regulations of the NRC or any agreement state.
(E) The schedule of quantities set forth in subsection
(l)(2) of this section applies only to radioactive materials distributed
as exempt quantities under a specific license issued by the agency,
the NRC, or any agreement state. Subsection (l)(2) of this section
does not apply to radioactive materials that have decayed from quantities
not originally exempt and does not make such material, or the sources
or devices in which the material is contained exempt from the licensing
requirements in this section or §289.252 of this title.
(F) No person may, for purposes of producing an increased
radiation level, combine quantities of radioactive material covered
by this exemption so that the aggregate quantity exceeds the limits
set forth in subsection (l)(2) of this section, except for radioactive
material combined within a device placed in use before May 3, 1999,
or as otherwise permitted by the requirements in this title.
(3) Exempt items.
(A) Certain items containing radioactive material.
(i) Except for persons who apply radioactive material
to, or persons 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 this chapter if that person receives, possesses, uses,
transfers, or acquires the following products:
(I) timepieces, hands, or dials containing not more
than the following specified quantities of radioactive material and
not exceeding the following specified levels of radiation:
(-a-) 25 millicuries (mCi) (925 megabecquerels (MBq))
of tritium per timepiece;
(-b-) 5 mCi (185 MBq) of tritium per hand;
(-c-) 15 mCi (555 MBq) of tritium per dial (bezels
when used shall be considered as part of the dial);
(-d-) 100 µCi (3.7 MBq) of promethium-147 per
watch or 200 µCi (7.4 MBq) of promethium-147 per any other timepiece;
(-e-) 20 µCi (0.74 MBq) of promethium-147 per
watch hand or 40 µCi (1.48 MBq) of promethium-147 per other
timepiece hand;
(-f-) 60 µCi (2.22 MBq) of promethium-147 per
watch dial or 120 µCi (4.44 MBq) of promethium-147 per other
timepiece dial (bezels when used shall be considered as part of the
dial);
(-g-) the levels of radiation from hands and dials
containing promethium-147 will not exceed, when measured through 50
milligrams per square centimeter (mg/cm2) of absorber:
(-1-) for wrist watches, 0.1 millirad per hour (mrad/hr)
at 10 centimeters (cm) from any surface;
(-2-) for pocket watches, 0.1 mrad/hr at 1 cm from
any surface; and
(-3-) for any other timepiece, 0.2 mrad/hr at 10 cm
from any surface; or
(-h-) 1 µCi (0.037 MBq) 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, radioactive material consisting of a total
of not more than 500 µCi (18.5 MBq) of polonium-210 per device;
(III) ion generating tubes designed for ionization
of air that contain, as a sealed source or sources, radioactive material
consisting of a total of not more than 500 µCi (18.5 MBq) of
polonium-210 per device or of a total of not more than 50 mCi (1.85
gigabecquerels (GBq)) of hydrogen-3 (tritium) per device;
(IV) such devices authorized before October 23, 2012,
for use under a general license issued under this section or equivalent
regulations of the NRC or any agreement state and manufactured, tested,
and labeled by the manufacturer in accordance with the specifications
contained in a specific license issued by the NRC;
(V) balances of precision containing not more than
1 mCi (37 MBq) of tritium per balance or not more than 0.5 mCi (18.5
MBq) of tritium per balance part manufactured before December 17,
2007;
(VI) marine compasses containing not more than 750
mCi (27.75 MBq) of tritium gas and other marine navigational instruments
containing not more than 250 mCi (9.25 GBq) of tritium gas manufactured
before December 17, 2007;
(VII) electron tubes, provided that each tube does
not contain more than one of the following specified quantities of
radioactive material and that the levels of radiation from each electron
tube containing radioactive material do not exceed 1 mrad/hr at 1
cm from any surface when measured through 7 mg/cm2 of absorber (For
purposes of this clause, "electron tubes" include spark gap tubes,
power tubes, gas tubes including glow lamps, receiving tubes, microwave
tubes, indicator tubes, pick-up tubes, radiation detection tubes,
and Cont'd... |
