| (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 Cont'd... |
