| (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 Cont'd... |
