Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter F - LICENSE REGULATIONS
Section 289.251 - Exemptions, General Licenses, and General License Acknowledgements
Universal Citation: 25 TX Admin Code ยง 289.251
Current through Reg. 49, No. 38; September 20, 2024
(a) Purpose. This section provides for exemptions to licensing requirements, general licensing of radioactive material, and acknowledgement of general licenses.
(b) Scope. Except as otherwise authorized, no person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized in a general license or general license acknowledgement issued in accordance with this section, or in a specific license issued in accordance with § 289.252 of this title (relating to Licensing of Radioactive Material), § 289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), § 289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material), § 289.258 of this title (relating to Licensing and Radiation Safety Requirements for Irradiators), or § 289.259 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM).
(c) Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise.
(1) General license--An authorization in
accordance with this section that grants authority to a person for certain
activities involving radioactive material, and is effective without the filing
of applications with the agency or the issuance of licensing documents to the
particular persons. The general licensee is subject to all other applicable
portions of this chapter and any limitations of the general license.
(2) General license acknowledgement--A
written recognition of a general license issued in accordance with this
section. The issuance of a general license acknowledgement requires the
submission of an application to the agency. A written acknowledgement of a
general license granted in accordance with this section is issued by the
agency. The holder of a general license acknowledgement is subject to all other
applicable portions of this chapter as well as any conditions specified in the
acknowledgement document.
(d) Exemptions for source material.
(1) Any person is exempt from this section
and §
289.252
of this title if that person receives, possesses, uses, or transfers source
material in any chemical mixture, compound, solution, or alloy in which the
source material is by weight less than 1/20 of 1.0% (0.05%) of the mixture,
compound, solution, or alloy.
(2)
Any person is exempt from this section and §
289.252
of this title if that person receives, possesses, uses, or transfers unrefined
and unprocessed ore containing source material; provided that, except as
authorized in a specific license, such person shall not refine or process such
ore. This exemption does not apply to the mining of ore containing source
material.
(3) Any person is exempt
from this section and §
289.252
of this title to the extent that such person receives, possesses, uses, or
transfers:
(A) any quantities of thorium
contained in:
(i) incandescent gas
mantles;
(ii) vacuum
tubes;
(iii) welding
rods;
(iv) electric lamps for
illuminating purposes provided that each lamp does not contain more than 50
milligrams (mg) of thorium;
(v)
germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting
provided that each lamp does not contain more than two grams of
thorium;
(vi) rare earth metals and
compounds, mixtures, and products containing not more than 0.25% by weight
thorium, uranium, or any combination of these; or
(vii) personnel neutron dosimeters, provided
that each dosimeter does not contain more than 50 mg of thorium;
(B) source material contained in
the following products:
(i) glazed ceramic
tableware manufactured before August 27, 2013, provided that the glaze contains
not more than 20% by weight source material;
(ii) glassware containing not more than 2% by
weight source material or, for glassware manufactured before August 27, 2013,
10% by weight source material; but not including commercially manufactured
glass brick, pane glass, ceramic tile, or other glass or ceramic used in
construction;
(iii) glass enamel or
glass enamel frit containing not more than 10% by weight source material
imported or ordered for importation into the United States, or initially
distributed by manufacturers in the United States, before July 25, 1983;
or
(iv) piezoelectric ceramic
containing not more than 2.0% by weight source material;
(C) photographic film, negatives, and prints
containing uranium or thorium;
(D)
any finished product or part fabricated of, or containing, metal-thorium
alloys, provided that the thorium content of the alloy does not exceed 4% by
weight and that the exemption contained in this subparagraph shall not be
deemed to authorize the chemical, physical, or metallurgical treatment or
processing of any such product or part;
(E) uranium contained in counterweights
installed in aircraft, rockets, projectiles, and missiles, or stored or handled
in connection with installation or removal of such counterweights, provided
that:
(i) each counterweight has been
impressed with the following legend clearly legible through any plating or
other covering: "DEPLETED URANIUM" (The requirements specified in this clause
need not be met by counterweights manufactured prior to December 31, 1969,
provided that such counterweights were manufactured under a specific license
issued by the Atomic Energy Commission and were impressed with the legend,
"CAUTION - RADIOACTIVE MATERIAL - URANIUM," required at that time);
(ii) each counterweight is durably and
legibly labeled or marked with the identification of the manufacturer and the
statement: "UNAUTHORIZED ALTERATIONS PROHIBITED" (The requirements specified in
this clause need not be met by counterweights manufactured prior to December
31, 1969, provided that such counterweights were manufactured under a specific
license issued by the Atomic Energy Commission and were impressed with the
legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM" required at that time);
and
(iii) the exemption contained
in this subparagraph shall not be deemed to authorize the chemical, physical,
or metallurgical treatment or processing of any such counterweights other than
repair or restoration of any plating or other covering;
(F) natural or depleted uranium used as
shielding constituting part of any shipping container, provided that:
(i) the shipping container is conspicuously
and legibly impressed with the legend "CAUTION - RADIOACTIVE SHIELDING -
URANIUM;" and
(ii) the uranium
metal is encased in a one-eighth inch minimum wall thickness of mild steel or
equally fire resistant material;
(G) thorium or uranium contained in or on
finished optical lenses and mirrors, provided that each lens or mirror does not
contain more than 10% by weight of thorium or uranium or, for lenses
manufactured before August 27, 2013, 30% by weight of thorium; and that the
exemption contained in this subparagraph shall not be deemed to authorize
either:
(i) the shaping, grinding, or
polishing of such lens or mirror or manufacturing processes other than the
assembly of such lens or mirror into optical systems and devices without any
alteration of the lens or mirror; or
(ii) the receipt, possession, use, or
transfer of uranium or thorium contained in contact lenses, or in spectacles,
or in eyepieces in binoculars or in other optical instruments;
(H) uranium contained in detector
heads for use in fire detection units, provided that each detector head
contains not more than 0.005 microcurie (µCi) (185 becquerels (Bq)) of
uranium; or
(I) thorium contained
in any finished aircraft engine part containing nickel-thoria alloy, provided
that:
(i) the thorium is dispersed in the
nickel-thoria alloy in the form of finely divided thoria (thorium dioxide);
and
(ii) the thorium content in the
nickel-thoria alloy does not exceed 4.0% by weight.
(4) The exemptions in subsection
(d)(3) of this section do not authorize the manufacture of any of the products
described.
(5) No person may
initially transfer for sale or distribution a product containing source
material to persons exempt under subsection (d)(3) of this section, Title 10,
CFR, §40.13(c), or equivalent regulations of an agreement state, unless
authorized by a license issued under Title 10, CFR, §40.52, to initially
transfer such products for sale or distribution.
(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 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-)
0 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) 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.
(D) Nothing in this subsection relieves a
person from complying with applicable requirements of the United States Food
and Drug Administration (FDA) and other federal and state requirements
governing the receipt, administration, and use of drugs.
(f) General licenses. In addition to the requirements of this section, all general licenses, unless otherwise specified, are subject to the requirements of § 289.201 of this title (relating to General Provisions for Radioactive Material), § 289.202(ww) and (xx) of this title, § 289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), § 289.205 of this title (relating to Hearing and Enforcement Procedures), and § 289.257 of this title (relating to Packaging and Transportation of Radioactive Material).
(1) Compliance history. In making
a determination whether to revoke, suspend, or restrict a general license, the
agency may consider the technical competence and compliance history of a
general licensee. After an opportunity for a hearing, the agency may revoke,
suspend, or restrict a general license if the general licensee's compliance
history reveals that at least 3 agency actions have been issued against the
general licensee, within the previous 6 years, that assess administrative or
civil penalties against the general licensee, or that revoke or suspend the
general license.
(2) Modification,
suspension, and revocation of a general license.
(A) The terms and conditions of all general
licenses shall be subject to revision or modification.
(B) A general license may be suspended or
revoked by reason of amendments to the Texas Radiation Control Act (Act),
Health and Safety Code, Chapter 401, by reason of rules in this chapter, or
orders issued by the agency.
(C)
Any general license may be revoked, suspended, or modified, in whole or in
part, for any of the following:
(i) any
material false statement in the application for a general license
acknowledgement or any statement of fact required in accordance with provisions
of the Act;
(ii) conditions
revealed by such application or statement of fact or any report, record, or
inspection, or other means that would warrant the agency to refuse to grant a
general license on an original application;
(iii) violation of, or failure to observe,
any of the terms and conditions of the Act, this chapter, or of the general
license, or order of the agency; or
(iv) existing conditions that constitute a
substantial threat to the public health or safety or the environment.
(D) Except in cases in which the
occupational and public health, or safety requires otherwise, no general
license shall be suspended or revoked unless, prior to the institution of
proceedings therefore, facts or conduct that may warrant such action shall have
been called to the attention of the holder of the general license in writing
and the holder of the general license shall have been afforded an opportunity
to demonstrate compliance with all lawful requirements.
(E) Each general license revoked by the
agency expires at the end of the day on the date of the agency's final
determination to revoke the general license, or on the revocation date stated
in the determination, or as otherwise provided by agency order.
(3) General licenses for source
material.
(A) General license for small
quantities of source material.
(i) A general
license is hereby issued authorizing commercial and industrial firms, research,
educational and medical institutions, and federal, state and local government
agencies to receive, possess, use, and transfer uranium and thorium, in their
natural isotopic concentrations and in the form of depleted uranium, for
research, development, educational, commercial, or operational purposes in the
following forms and quantities:
(I) no more
than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g.,
gaseous, liquid, powder, etc.) at any one time.
(-a-) Any material processed by the general
licensee that alters the chemical or physical form of the material containing
source material must be accounted for as a dispersible form.
(-b-) A person authorized to possess, use,
and transfer source material as specified in this clause may not receive more
than a total of 7 kg (15.4 lb) of uranium and thorium in any 1 calendar
year.
(-c-) Persons possessing
source material in excess of these limits as of August 27, 2013, may continue
to possess up to 7 kg (15.4 lb) of uranium and thorium at any one time until
the NRC takes final action on any pending application submitted on or before
August 27, 2014, for a specific license for such material; and may receive up
to 70 kg (154 lb) of uranium or thorium in any one calendar year until the NRC
takes final action on a pending application submitted on or before August 27,
2014, for a specific license for such material; and
(II) no more than a total of 7 kg (15.4 lb)
of uranium and thorium at any one time.
(-a-)
A person authorized to possess, use, and transfer source material as specified
in this clause may not receive more than a total of 70 kg (154 lb) of uranium
and thorium in any 1 calendar year.
(-b-) A person may not alter the chemical or
physical form of the source material possessed as specified in this clause
unless it is accounted for in accordance with the limits of clause (i)(I) of
this subparagraph; or
(III) no more than 7 kg (15.4 lb) of uranium,
removed during the treatment of drinking water, at any one time. A person may
not remove more than 70 kg (154 lb) of uranium from drinking water during a
calendar year under this clause; or
(IV) no more than 7 kg (15.4 lb) of uranium
and thorium at laboratories for the purpose of determining the concentration of
uranium and thorium contained within the material being analyzed at any one
time. A person authorized to possess, use, and transfer source material as
specified in this clause may not receive more than a total of 70 kg (154 lb) of
source material in any 1 calendar year.
(ii) Any person who receives, possesses,
uses, or transfers source material in accordance with the general license in
clause (i) of this subparagraph:
(I) is
prohibited from administering source material, or the radiation therefrom,
either externally or internally, to human beings except as may be authorized by
the agency in a specific license;
(II) shall not abandon such source material.
Source material may be disposed of as follows:
(-a-) a cumulative total of 0.5 kg (1.1 lb)
of source material in a solid, non-dispersible form may be transferred each
calendar year, by a person authorized to receive, possess, use, and transfer
source material in accordance with the general license to persons receiving the
material for permanent disposal. The recipient of source material transferred
in accordance with this item is exempt from the requirements to obtain a
license as specified in subsection (f)(3) of this section to the extent the
source material is permanently disposed. This provision does not apply to any
person who is in possession of source material under a specific license issued
under §
289.252
of this title; or
(-b-) in
accordance with §
289.202(ff)
of this title;
(III) is
subject to the regulations in subsection (f)(2), (h)(2), and (i) of this
section and §§289.201(a), (b), (d) - (f), (i), (k), and (l); 289.202
(vv), (xx)(6) - (8) and (vv); 289.203(g)(3); 289.252(a), (w)(2), (x)(1) - (4),
and (cc); and 289.257(b)(1) of this title; and
(IV) shall not export such source material
except in accordance with Title 10, CFR, Part 110.
(iii) Any person who receives, possesses,
uses, or transfers source material in accordance with clause (i) of this
subparagraph shall conduct activities so as to minimize contamination of the
facility and the environment. When activities involving such source material
are permanently ceased at any site, if evidence of significant contamination is
identified, the general licensee shall notify the agency about such
contamination and may consult with the agency as to the appropriateness of
sampling and restoration activities to ensure that any contamination or
residual source material remaining at the site where source material was used
in accordance with this general license is not likely to result in exposures
that exceed the limits in §
289.202(ddd)(2)
of this title.
(iv) Any person who
receives, possesses, uses, or transfers source material in accordance with the
general license granted in clause (i) of this subparagraph is exempt from the
regulations in §§
289.201,
289.202,
and
289.203
of this title to the extent that such receipt, possession, use, and transfer
are within the terms of this general license, except that such person shall
comply with the regulations of §
289.202(ff)
and (ddd)(2)(A) of this title to the extent
necessary to meet the requirements of clauses (ii)(II) and (iii) of this
subparagraph. However, this exemption does not apply to any person who also
holds a specific license issued under §
289.252
of this title.
(v) No person may
initially transfer or distribute source material to persons generally licensed
as specified in clause (i)(I) or (II) of this subparagraph, or equivalent
regulations of any agreement state, unless authorized by a specific license
issued in accordance with §
289.252(cc)(6)(A)
of this title or equivalent regulations of the NRC or any agreement state. This
prohibition does not apply to analytical laboratories returning processed
samples to the client who initially provided the sample. Initial distribution
of source material to persons generally licensed by clause (i) of this
subparagraph may be continued until the NRC takes final action on a pending
application for license or license amendment to specifically authorize
distribution submitted on or before August 27, 2014.
(B) A general license is issued to own source
material without regard to quantity. This general license does not authorize
any person to receive, possess, use or transfer source material.
(C) A general license is issued to mine,
transport, and transfer ores containing source material without regard to
quantity. In addition to the provisions of subsection (f) of this section,
persons who mine, transport, and transfer ores containing source material in
accordance with this section shall comply with the provisions of §
289.202(n)
and (ff) of this title.
(D) A general license is issued to receive,
acquire, possess, use, or transfer depleted uranium contained in products or
devices for the purpose of providing shielding, including beam shaping and
collimation, in accordance with clauses (i) - (iv) of this subparagraph.
(i) The general license in this paragraph
applies only to products or devices that have been manufactured either in
accordance with a specific license issued by the agency to the manufacturer of
the products or devices in accordance with §
289.252(s)
of this title or in accordance with a specific license issued to the
manufacturer by another agreement state or the NRC that authorizes manufacture
of the products or devices for distribution to persons generally licensed by
another agreement state or the NRC.
(ii) Persons who receive, acquire, possess,
or use depleted uranium in accordance with the general license in this
paragraph shall notify the agency within 30 days after the first receipt of
acquisition of such depleted uranium. The general licensee shall furnish the
following information and such other information as may be required by the
agency:
(I) name and address of the general
licensee;
(II) a statement that the
general licensee has developed and will maintain procedures designed to
establish physical control over the depleted uranium in accordance with this
paragraph and designed to prevent transfer of such depleted uranium in any
form, including metal scrap, to persons not authorized to receive the depleted
uranium; and
(III) name and/or
title, address, and telephone number of the individual duly authorized to act
for and on behalf of the general licensee in supervising the procedures
identified in clause (ii) of this subparagraph.
(iii) The general licensee possessing or
using depleted uranium in accordance with the general license in this paragraph
shall report in writing to the agency any changes in information furnished by
the general licensee. The report shall be submitted within 30 days after the
effective date of such change.
(iv)
A person who receives, acquires, possesses, or uses depleted uranium in
accordance with the general license in this paragraph:
(I) shall not introduce such depleted
uranium, in any form, into a chemical, physical, or metallurgical treatment or
process, except a treatment or process for repair or restoration of any plating
or other covering of the depleted uranium;
(II) shall not abandon such depleted
uranium;
(III) shall transfer or
dispose of such depleted uranium only in accordance with the provisions of
§
289.252(cc)
of this title. In the case where the transferee receives the depleted uranium
in accordance with the general license in this paragraph or equivalent rule of
the NRC or an agreement state, the transferor shall furnish the transferee a
copy of this paragraph;
(IV) within
30 days of transfer, shall report in writing to the agency the name and address
of the person receiving the depleted uranium in accordance with such transfer;
and
(V) shall not export such
depleted uranium except in accordance with a license issued by the NRC in
accordance with Title 10, CFR, Part 110.
(v) Any person receiving, acquiring,
possessing, using, or transferring depleted uranium in accordance with the
general license in this paragraph is exempt from the requirements of §
289.202
of this title and §
289.203
of this title with respect to the depleted uranium covered by that general
license.
(4)
General licenses for radioactive material other than source material.
(A) General licenses for static elimination
devices and ion generating tubes. A general license is issued to transfer,
receive, acquire, possess, and use radioactive material incorporated in the
devices or equipment specified in the following clauses (i) and (ii) of this
paragraph that have been manufactured, tested, and labeled by the manufacturer
in accordance with a specific license issued to the manufacturer by the NRC. In
addition to the provisions of subsection (f) of this section, this general
license is subject to the provisions of subsection (e)(1)(B) of this section
and §
289.252(cc)
of this title:
(i) static elimination devices
designed for use as static eliminators that contain, as a sealed source or
sources, radioactive material totaling not more than 500 µCi (18.5 MBq)
of polonium-210 per device; or
(ii)
ion generating tubes designed for ionization of air that contain, as a sealed
source or sources, radioactive material totaling not more than 500 µCi
(18.5 MBq) of polonium-210 per device or a total of not more than 50 mCi (1.85
GBq) of tritium per device.
(B) General license for luminous safety
devices for aircraft.
(i) A general license
is 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 (Ci) (370 GBq) of tritium or 300 mCi (11.1 GBq) of promethium-147;
and
(II) each device has been
manufactured, assembled, or initially transferred in accordance with a specific
license issued by the NRC, or each device has been manufactured or assembled in
accordance with the specifications contained in a specific license issued by
the agency or any agreement state that authorizes the manufacture or assembly
of the device to persons generally licensed by the agency or an agreement
state.
(ii) The general
license in clause (i) of this subparagraph does not authorize the manufacture,
assembly, or repair of luminous safety devices containing tritium or
promethium-147.
(iii) The general
license in clause (i) of this subparagraph does not authorize the receipt,
acquisition, possession, or use of tritium or promethium-147 contained in
instrument dials.
(C)
General license for ownership of radioactive material. A general license is
issued to own radioactive material without regard to quantity. Notwithstanding
any other provisions of this section, this general license does not authorize
the manufacture, production, transfer, receipt, possession, or use of
radioactive material.
(D) General
license for calibration, stabilization, and reference sources.
(i) A general license is issued to own,
receive, acquire, possess, use, and transfer, in accordance with the provisions
of clauses (ii) and (iii) of this subparagraph, americium-241, plutonium,
and/or radium-226, in the form of calibration, stabilization, or reference
sources to any person who holds a specific license issued by the:
(I) agency that authorizes that person to
receive, possess, use, and transfer radioactive material; and
(II) NRC that authorizes that person to
receive, possess, use, and transfer radioactive material.
(ii) The general license in clause (i) of
this subparagraph applies only to calibration, stabilization, or reference
sources that have been manufactured or initially transferred in accordance with
the specifications contained in a specific license issued to the manufacturer
or importer of the sources by the NRC in accordance with Title 10, CFR,
§32.57 or Title 10, CFR, §70.39 or that have been manufactured or
initially transferred in accordance with the authorizations contained in a
specific license issued to the manufacturer by the agency or any agreement
state, in accordance with licensing requirements equivalent to those contained
in Title 10, CFR, §32.57 or Title 10, CFR, §70.39.
(iii) Persons who own, receive, acquire,
possess, use, or transfer one or more calibration or reference sources in
accordance with these general licenses:
(I)
shall not possess at any one time, at any one location of storage or use, more
than 5 µCi (185 kBq) each of americium-241, plutonium-238, plutonium-239,
and 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
that includes the following statements, or a substantially similar statement
that contains the information in the following statements:
(-a-) option 1, as appropriate:
(-b-)
option 2, as appropriate:
(III) shall not
transfer, abandon, or dispose of such source except by transfer to a person
authorized by a specific license from the agency, the NRC, or any agreement
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-238, plutonium-239, or radium-226 that 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.
(iv) The general license in subparagraph (A)
of this paragraph does not authorize the manufacture of calibration or
reference sources containing americium-241, plutonium-238, plutonium-239, or
radium-226.
(E) General
license for ice detection devices.
(i) A
general license is issued to own, receive, acquire, possess, use, and transfer
strontium-90 contained in ice detection devices, provided each device contains
not more than 50 µCi (1.85 MBq) of strontium-90 and each device has been
manufactured or initially transferred in accordance with a specific license
issued by the NRC or each device has been manufactured in accordance with the
authorizations contained in a specific license issued by the agency or any
agreement state to the manufacturer of such device in accordance with licensing
requirements equivalent to those in Title 10, CFR, §32.61.
(ii) Persons who receive, acquire, possess,
use, or transfer strontium-90 contained in ice detection devices in accordance
with the general license in clause (i) of this paragraph shall do the
following:
(I) upon occurrence of visually
observable damage, such as 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 NRC
or an agreement state to manufacture or service such devices; or dispose of the
device by transfer to a person authorized by a specific license from the
agency, the NRC, or an agreement state; and
(II) assure that all labels affixed to the
device at the time of receipt, and which bear a statement prohibiting removal
of the labels, are maintained on the device.
(iii) The general license in subparagraph (A)
of this paragraph does not authorize the manufacture, assembly, disassembly, or
repair of strontium-90 in ice detection devices.
(F) General license for intrastate
transportation of radioactive material.
(i) A
general license is issued to any common or contract carrier to transport and
store radioactive material in the regular course of their carriage for another
or storage incident to transport, provided the transportation and storage is in
accordance with the applicable requirements of §
289.257
of this title 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 agency and the United States Department of Transportation (DOT). Persons
who transport and store radioactive material in accordance with the general
license in this paragraph are exempt from the requirements of §
289.202
and §
289.203
of this title except for §289.202(ww) - (yy) of this title.
(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:
(-b-)
option 2, as appropriate:
(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(1)
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(1)
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;
(II)
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 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 µCi (3.7 MBq) of other beta and/or gamma emitting material
or 10 µCi (0.37 MBq) 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) assure that the tests required by
subclause (II) of this clause and other testing, installation, servicing, and
removal from location of installation involving the radioactive materials, its
shielding or containment, are performed:
(-a-) in accordance with the instructions
provided by the labels;
(-b-) in
accordance with written instructions provided by the manufacturer as specified
in §
289.252(l)(3)
of this title; or
(-c-) by a person
holding a specific license from the agency, the NRC, or any agreement state to
perform such activities;
(IV) maintain records for inspection by the
agency documenting compliance with the requirements of subclauses (II) and
(III) of this clause. The records shall include the test results. The records
also shall identify the device tested by manufacturer, model and serial number
of the device, serial number of the sealed source, and show the dates of
performance of and the names of persons performing testing, installation,
servicing, and removal from location of installation, of the radioactive
material, its shielding or containment. Retention shall be as follows:
(-a-) records for tests for leakage of
radioactive material required by subclause (II) of this clause shall be kept
for 3 years after the next required leak test is performed or until the sealed
source is transferred or disposed of;
(-b-) records of the test of the on-off
mechanism and indicator required by subclause (II) of this clause shall be kept
for 3 years after the next required test of the on-off mechanism and indicator
is performed or until the sealed source is transferred or disposed of;
and
(-c-) records of the testing,
installation (removal of the manufacturer's lock and initial alignment of the
radiation beam), servicing, and removal from location of installation involving
the radioactive materials, its shielding or containment required by subclause
(III) of this clause shall be kept for 3 years from the date of the recorded
event or until the device is transferred or disposed of;
(V) maintain assignment records (utilization
records) for portable or mobile devices for inspection by the agency at the
location listed in the general license acknowledgement in accordance with
subsection (g) of this section. These records shall include:
(-a-) a unique identification (for example,
serial number) of each portable or mobile device;
(-b-) the location(s) where each portable or
mobile device is assigned; and
(-c-) the date(s) each portable or mobile
device is assigned to the location(s) in accordance with item (-b-) of this
subclause;
(VI) have a
copy of the appropriate operating and instruction manual at each temporary site
for agency inspection;
(VII)
immediately suspend operation of the device if there is 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 185 Bq (0.005 µCi) or more of removable radioactive
material. The device shall not be operated until it has been repaired by the
manufacturer or other person holding a specific license from the agency, the
NRC, or any agreement state to repair such devices. The device and any
radioactive material from the device may only be disposed of by transfer to a
person authorized by a specific license to receive the radioactive material in
the device. A report, prepared in accordance with §
289.202(xx)
and (yy) of this title, containing a brief
description of the event and the remedial action taken and in the case of
detection of 185 Bq (0.005 µCi) or more removable radioactive material or
failure of, or damage to a source likely to result in contamination of the
premises or the environs, a plan for ensuring that the premises and environs
are acceptable for unrestricted use shall be furnished to the agency within 30
days. Under these circumstances, the requirements in §
289.202(ddd)
of this title may be applicable, as determined by the agency on a case-by-case
basis;
(VIII) not abandon the
device containing radioactive material;
(IX) transfer or dispose of the device
containing radioactive material only by export in accordance with Title 10,
CFR, Part 110, by transfer to another general licensee as authorized in
subclauses (XII) and (XVI) of this clause or to a person authorized to receive
the device by a specific license issued by the agency in accordance with §
289.252(l)
of this title, or an equivalent specific license issued by the NRC or any
agreement state, or as otherwise approved under subclause (XI) of this
clause;
(X) furnish a report to the
agency within 30 days after the transfer or export of a device to a specific
licensee. The report must contain the following:
(-a-) identification of the device by
manufacturer's (or initial transferor's) name, model and serial
number;
(-b-) name, address, and
license number of the person receiving the device; and
(-c-) date of the transfer;
(XI) obtain written agency
approval before transferring the device to any other specific licensee not
specifically identified in subclause (IX) of this clause; however, a holder of
a specific license may transfer a device for possession and use in accordance
with its own specific license without prior approval, if, the holder:
(-a-) verifies that the specific license
authorizes the possession and use, or applies for and obtains an amendment to
the license authorizing the possession and use;
(-b-) removes, alters, covers, or clearly and
unambiguously augments the existing label (otherwise required by clause (iv)(I)
of this subparagraph) so that the device is labeled in compliance with §
289.202(cc)
of this title; however the manufacturer, model number, and serial number must
be retained;
(-c-) obtains the
manufacturer's or initial transferor's information concerning maintenance that
would be applicable under the specific license (such as leak testing
procedures); and
(-d-) reports the
transfer as specified in subclause (X) of this clause;
(XII) transfer the device to another general
licensee only if:
(-a-) the device remains in
use at a particular location. In such case, the transferor shall give the
transferee a copy of this section and any safety documents identified in the
label on the device. Within 30 days of the transfer, the transferor shall
report the following to the agency:
(-1-)
manufacturer's (or initial transferor's) name;
(-2-) model and serial number of the device
transferred;
(-3-) transferee's
name and mailing address for the location of use; and
(-4-) name, title, and phone number of the
responsible individual identified by the transferee in accordance with
subclause (XIII) of this clause to have knowledge of and authority to take
actions to ensure compliance with the appropriate regulations and requirements;
or
(-b-) the device is
held in storage by an intermediate person in the original shipping container at
its intended location of use prior to initial use by a general
licensee;
(XIII) appoint
an individual responsible for having knowledge of the appropriate agency
requirements and the authority for taking required actions to comply with
appropriate agency requirements. The general licensee, through this individual,
shall ensure the day-to-day compliance with appropriate agency requirements.
This appointment does not relieve the general licensee of any of its
responsibility in this regard;
(XIV) report changes to the mailing address
for the location of use (including change in name of general licensee) to the
agency within 30 days of the effective date of the change. If it is a portable
device, a report of address change is only required for a change in the
device's primary place of storage;
(XV) not hold devices that are not in use for
longer than 24 months following the last principal activity use.
(-a-) If devices with shutters are not being
used, the shutter shall be locked in the closed position. The testing required
by clause (iv) of this subparagraph need not be performed during the period of
storage only. However, when devices are put back into service or transferred to
another person, and have not been tested within the required test interval,
they shall be tested for leakage before use or transfer and the shutter tested
before use.
(-b-) Devices kept in
standby for future use are excluded from the 24-month time limit if the agency
approves a plan for future use submitted by the licensee. Licensees shall
submit plans at least 30 days prior to the end of the 24 months of
nonuse.
(-c-) The general licensee
shall perform quarterly physical inventories of these devices while they are in
standby. The licensee shall make, maintain, and retain for intervals of 5
years, records of the quarterly physical inventories for inspection by the
agency;
(XVI) not export
the device containing radioactive material except in accordance with Title 10,
CFR, Part 110;
(XVII) comply with
the provisions of §
289.202(ww)
and (xx) of this title for reporting
radiation incidents, theft or loss of licensed material, but shall be exempt
from the other requirements of §
289.202
and §
289.203
of this title;
(XVIII) respond to
written requests from the agency to provide information relating to the general
license within 30 calendar days of the date of the request, or other time
specified in the request. If the general licensee cannot provide the requested
information within the allotted time, it shall, within that same time period,
request a longer period to supply the information by providing the agency a
written justification for the request; and
(XIX) assure that the device is used in
accordance with information contained in the device safety
evaluation.
(I) The general license in subparagraph (H)
of this paragraph does not authorize the manufacture or import of devices
containing radioactive material.
(J) The written instructions specified in
subparagraph (H)(iv)(III)(-a-) and (-b-) of this paragraph shall be followed
while performing the testing and the written instructions in subparagraph
(H)(iv)(III)(-b-) of this paragraph shall be maintained for inspection by the
agency.
(K) General license for
certain items and self-luminous products containing radium-226.
(i) A general license is hereby issued to any
person to acquire, receive, possess, use, or transfer radium-226 contained in
the following products manufactured prior to November 30, 2007.
(I) Antiquities originally intended for use
by the general public. For purposes of this subclause, antiquities are products
distributed for use by the general public in the late 19th and early 20th
centuries; such as radium emanator jars, revigators, radium water jars, radon
generators, refrigerator cards, radium bath salts, and healing pads.
(II) Intact timepieces containing greater
than 1 µCi (0.037 MBq), nonintact timepieces, and timepiece hands and
dials no longer installed in timepieces.
(III) Luminous items installed in air,
marine, or land vehicles.
(IV) All
other luminous products, provided that no more than 100 items are used or
stored at the same location at any one time.
(V) Small radium sources containing no more
than 1 µCi (0.037 MBq) of radium 226. For the purposes of this paragraph,
"small radium sources" means discrete survey instrument check sources, sources
contained in radiation measuring instruments, sources used in educational
demonstrations (such as cloud chambers and spinthariscopes), electron tubes,
lightning rods, ionization sources, static eliminators, or as designated by the
NRC.
(ii) Persons who
acquire, receive, possess, use, or transfer byproduct material under the
general license issued in clause (i) of this subparagraph are exempt from the
provisions of §§
289.201,
289.202,
289.203,
and
289.252
of this title, to the extent that the receipt, possession, use, or transfer of
byproduct material is within the terms of the general license; provided,
however, that this exemption shall not be deemed to apply to any such person
specifically licensed under §
289.252
of this title.
(iii) Any person who
acquires, receives, possesses, uses, or transfers radioactive material in
accordance with this subparagraph shall do the following.
(I) Provide to the agency within 30 days of
any indication of possible damage to the product that could result in a loss of
the radioactive material. The report should include a brief description of the
event, and the remedial action taken.
(II) Not abandon products containing
radium-226.
(-a-) The product, and any
radioactive material from the product, may only be disposed of according to
§
289.202
of this title or as otherwise approved by the agency.
(-b-) The product, and any radioactive
material from the product, may be transferred to a person authorized by a
specific license to receive the radium-226 or as otherwise approved by the
agency.
(III) The general
license in this subparagraph does not authorize the manufacture, assembly,
disassembly, repair, or import of products containing radium-226, except that
timepieces may be disassembled and repaired provided that paint containing
radium-226 is not applied or removed.
(IV) Not export products containing
radium-226 except in accordance with or equivalent regulations of the NRC Title
10, CFR, §110.
(V) Dispose of
products containing radium-226 at a disposal facility authorized to dispose of
radioactive material in accordance with any federal or state solid or hazardous
waste law, including the Solid Waste Disposal Act, as authorized under the
Energy Policy Act of 2005, by transfer to a person authorized to receive
radium-226 by a specific license issued under this section, or under equivalent
regulations of the NRC, or any agreement state.
(VI) Respond to written requests from the
agency, the NRC, or any agreement state to provide information relating to the
general license within 30 calendar days of the date of the request, or other
time specified in the request. If the general licensee cannot provide the
requested information within the allotted time, it shall, within that same time
period, request a longer period to supply the information by providing the
agency, the NRC, or any agreement state a written justification for the
request.
(g) General license acknowledgements for radioactive material other than source material. In addition to the requirements of this section, all general license acknowledgement holders, unless otherwise specified, are subject to the requirements of §§289.201, 289.202(ww) and (xx), 289.204, 289.205, and 289.257 of this title.
(1) Persons possessing a general
license for devices in accordance with subsection (f)(4)(H) of this section and
being in the possession of radioactive material in devices containing at least
370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1
mCi) of cobalt-60, 3.7 MBq (0.1 mCi) of radium-226, 37 MBq (1 mCi) of
americium-241, or any transuranic (for example, element with atomic number
greater than uranium (92)), based on the activity indicated on the label on the
device, shall file an application for acknowledgement within 30 days of
receipt, acquisition, or possession of such a device. The application shall be
on a form prescribed by the agency to include the following information and any
other information specifically requested by the agency:
(A) name and mailing address of the general
licensee;
(B) information about
each device to include the manufacturer (or initial transferor), model number,
and serial number of the device, and the radioisotope and activity (as
indicated on the label), and serial number of the source;
(C) name, title, and telephone number of the
responsible person designated as a representative of the general licensee in
accordance with subsection (f)(4)(H)(iv)(XIII) of this section;
(D) address or location at which the
device(s) are used and/or stored. For portable devices, the address of the
primary place of storage;
(E)
certification by the responsible representative of the general licensee that
the information concerning the device(s) has been verified through a physical
inventory and checking of label information;
(F) certification by the responsible
representative of the general licensee that they are aware of the requirements
of this section; and
(G) a
completed RC Form 252-1, Business Information Form and the applicable fee as
required by §
289.204
of this title.
(2)
Persons generally licensed by the agency, the NRC, or any agreement state with
respect to devices meeting the criteria in paragraph (1) of this subsection,
are not subject to the requirements of paragraph (1) of this subsection if the
devices are used in areas subject to agency jurisdiction for a period less than
180 days in any calendar year.
(3)
Persons possessing a device meeting the criteria of paragraph (1) of this
subsection shall respond annually to the General License Acknowledgement Self
Evaluation Form provided by the agency. The form shall be completed in
accordance with the instructions contained in the form. The completed form
shall be submitted to the agency within 30 days of receipt.
(4) Each address for a location of use, as
described under paragraph (1)(D) of this subsection, represents a separate
general licensee and requires a separate registration and
fee.
(h) Issuance of general license acknowledgements.
(1) When
the agency determines that an application meets the requirements of the Act and
the rules of the agency, the agency may issue a general license acknowledgement
recognizing the general license authorizing the activity in such form and
containing the conditions and limitations as it deems appropriate or
necessary.
(2) The agency may
incorporate in any general license acknowledgement at the time of issuance, or
thereafter by amendment, additional requirements and conditions with respect to
the licensee's receipt, possession, use, and transfer of radioactive material
subject to this section as the agency deems appropriate or necessary in order
to:
(A) minimize danger to occupational and
public health and safety or the environment;
(B) require reports and the keeping of
records, and to provide for inspections of activities in accordance with the
license as may be appropriate or necessary; and
(C) prevent loss or theft of material subject
to this section.
(3) The
agency may request, and the licensee shall provide, additional information
after the general license acknowledgement has been issued to enable the agency
to determine whether the general license acknowledgement should be modified in
accordance with subsection (k) of this section.
(i) Specific terms and conditions.
(1) Each general license acknowledgement
issued in accordance with this section shall be subject to the applicable
provisions of the Act, now or hereafter in effect, and to the applicable rules
and orders of the agency.
(2) Each
person holding a general license acknowledgement issued by the agency in
accordance with this section shall confine use and possession of the devices
and radioactive material identified in the general license acknowledgement to
the locations specified in the general license acknowledgement. Radioactive
material shall not be used or stored in residential locations unless authorized
by the agency. Each person holding a general license acknowledgement issued by
the agency shall obtain prior approval from the agency before storing or using
radioactive material in an area not previously authorized in the general
license acknowledgement.
(3) Each
holder of a general license acknowledgement shall notify the agency, in
writing, immediately following the filing of a voluntary or involuntary
petition for bankruptcy by the general license acknowledgement holder or its
parent company.
(4) The
notification in paragraph (3) of this subsection shall include:
(A) the bankruptcy court in which the
petition for bankruptcy was filed; and
(B) the date of the filing of the
petition.
(5) A copy of
the "Petition for Bankruptcy" shall be submitted to the agency with the written
notification.
(j) Termination of general license acknowledgements.
(1) Each holder of a general license
acknowledgement shall notify the agency immediately, in writing, and request
termination of the general license acknowledgement when the holder of the
general license acknowledgement decides to terminate all activities involving
materials specified in the general license acknowledgement.
(2) Each holder of a general license
acknowledgement shall, no less than 30 days before vacating or relinquishing
possession of control of premises that have been used as a place of storage or
use of radioactive material as a result of general licensed activities, notify
the agency in writing of intent to vacate and do the following:
(A) terminate use of radioactive
material;
(B) dispose of
radioactive material in accordance with this section and/or §
289.202(ff)
of this title; and
(C) pay any
outstanding fees in accordance with §
289.204
of this title.
(k) Amendment of general license acknowledgements.
(1) The holder of the
general license acknowledgement required by subsection (g)(1) of this section
shall report in writing to the agency any changes in information furnished by
the holder of the general license acknowledgement. The report shall be
submitted within 30 days after the effective date of such change.
(2) Applications for amendments of a general
license acknowledgement shall be filed in accordance with subsection (g)(1)(A)
- (F) of this section, as applicable, and shall specify the respects in which
the holder of a general license acknowledgement desires a general license
acknowledgement to be amended.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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