| (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.
Cont'd... |
