| (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:
Attached Graphic
(-b-) option 2, as appropriate:
Attached Graphic
(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(l) 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(l) 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;
Cont'd... |
