| (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) Cont'd... |
