Certain detecting, measuring, gauging or
controlling devices and certain devices for producing light or an ionized
atmosphere.*
NOTE: *Persons possessing radioactive material in devices
under a general license in R313-21-22(4) before January 15, 1975, may continue
to possess, use, or transfer that material in accordance with the labeling
requirements of R313-21-22(4) in effect on January 14, 1975.
(c) Any person who owns, acquires, receives,
possesses, uses or transfers radioactive material in a device pursuant to the
general license in R313-21-22(4)(a):
(i)
shall 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
thereon and shall comply with all instructions and precautions provided by the
labels;
(ii) shall 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 six-month
intervals or at other intervals as are 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 3.7 megabecquerel (100 uCi) of other beta, gamma, or both, emitting
material or 0.37 megabecquerel (10 uCi) 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) shall assure that other testing,
installation, servicing, and removal from installation involving the
radioactive materials, its shielding or containment, are performed:
(A) in accordance with the instructions
provided by the labels; or
(B) by a
person holding a specific license pursuant to R313-22 or from the Nuclear
Regulatory Commission, an Agreement State, or a Licensing State to perform such
activities;
(iv) shall
maintain records showing compliance with the requirements of
R313-21-22(4)(c)(ii) and (iii). The records shall show the results of tests.
The records also shall show the dates of performance of, and the names of
persons performing, testing, installation, servicing, and removal from the
installation the radioactive material and its shielding or containment. The
licensee shall retain these records as follows:
(A) Each record of a test for leakage of
radioactive material required by R313-21-22(4)(c)(ii) shall be retained for
three years after the next required leak test is performed or until the sealed
source is transferred or disposed of;
(B) Each record of a test of the on-off
mechanism and indicator required by R313-21-22(4)(c)(ii) shall be retained for
three 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;
(C) Each record that is
required by R313-21-22(4)(c)(iii) shall be retained for three years from the
date of the recorded event or until the device is transferred or disposed
of;
(v) shall
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 becquerel (0.005 uCi) or more removable radioactive material.
The device may not be operated until it has been repaired by the manufacturer
or other person holding a specific license to repair the device that was issued
by the Director, the Nuclear Regulatory Commission, an Agreement State, or a
Licensing State. 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 or as otherwise approved by the
Director, the Nuclear Regulatory Commission, an Agreement State, or a Licensing
State. A report containing a brief description of the event and the remedial
action taken; and, in the case of detection of 185 becquerel (0.005 uCi) 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, must be
furnished to the Director within 30 days. Under these circumstances, the
criteria set out in
R313-15-402
may be applicable, as determined by the Director on a case-by-case
basis;
(vi) shall not abandon the
device containing radioactive material;
(vii) shall not export the device containing
radioactive materials except in accordance with 10 CFR
110;
(viii)
(A)
shall transfer or dispose of the device containing radioactive material only by
export as provided by R313-21-22(4)(c) (vii), by transfer to another general
licensee as authorized in R313-21-22(4)(c)(ix), to a person authorized to
receive the device by a specific license issued under R313-22, to an authorized
waste collector under R313-25, or equivalent regulations of the Nuclear
Regulatory Commission, an Agreement State, or a Licensing State , or as
otherwise approved under R313-21-22(4)(c)(viii)(C);
(B) shall furnish a report to the Director
within 30 days after transfer of a device to a specific licensee or export. The
report must contain:
(I) the identification
of the device by manufacturer's or initial transferor's name, model number, and
serial number;
(II) the name,
address, and license number of the person receiving the device, the license
number is not applicable if exported; and
(III) the date of the transfer;
(C) shall obtain written approval
from the Director before transferring the device to any other specific licensee
not specifically identified in R313-21-22(4)(c)(viii)(A); however, a holder of
a specific license may transfer a device for possession and use under its own
specific license without prior approval, if the holder:
(I) 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;
(II) removes, alters, covers, or clearly and
unambiguously augments the existing label (otherwise required by
R313-21-22(4)(c)(i)) so that the device is labeled in compliance with
R313-15-904;
however, the manufacturer, model number, and serial number must be
retained;
(III) 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
(IV) reports the
transfer under R313-21-22(4)(c)(viii)(B);
(ix) shall transfer the device to another
general licensee only if:
(A) the device
remains in use at a particular location. In this case, the transferor shall
give the transferee a copy of R313-21-22(4),
R313-12-51,
R313-15-1201,
and
R313-15-1202,
and any safety documents identified in the label of the device. Within 30 days
of the transfer, the transferor shall report to the Director:
(I) the manufacturer's or initial
transferor's name;
(II) the model
number and serial number of the device transferred;
(III) the transferee's name and mailing
address for the location of use; and
(IV) the name, title, and phone number of the
responsible individual identified by the transferee in accordance with
R313-21-22(4)(c)(xii) 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;
(x) shall
comply with the provisions of
R313-15-1201
and
R313-15-1202
for reporting radiation incidents, theft or loss of licensed material, but
shall be exempt from the other requirements of R313-15 and R313-18;
(xi) shall respond to written requests from
the Director 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 submitting a letter to the Director
and provide written justification as to why it cannot comply;
(xii) shall appoint an individual responsible
for having knowledge of the appropriate regulations and requirements and the
authority for taking required actions to comply with appropriate regulations
and requirements. The general licensee, through this individual, shall ensure
the day-to-day compliance with appropriate regulations and requirements. This
appointment does not relieve the general licensee of any of its responsibility
in this regard;
(xiii)
(A) shall register, in accordance with
R313-21-22(4)(c) (xiii)(B) and (C), devices containing at least 370
megabecquerel (ten mCi) of cesium-137, 3.7 megabecquerel (0.1 mCi) of
strontium-90, 37 megabecquerel (one mCi) of cobalt-60, 3.7 megabecquerel (0.1
mCi) of radium-226, or 37 megabecquerel (one mCi) of americium-241 or any other
transuranic, (elements with atomic number greater than uranium-92), based on
the activity indicated on the label. Each address for a location of use, as
described under R313-21-22(4)(c)(xiii)(C)(IV) represents a separate general
licensee and requires a separate registration and fee;
(B) if in possession of a device meeting the
criteria of R313-21-22(4)(c)(xiii)(A), shall register these devices annually
with the Director and shall pay the fee required by R313-70. Registration shall
include verifying, correcting, or adding, as appropriate, to the information
provided in a request for registration received from the Director. The
registration information must be submitted to the Director within 30 days of
the date of the request for registration or as otherwise indicated in the
request. In addition, a general licensee holding devices meeting the criteria
of R313-21-22(4)(c)(xiii)(A) is subject to the bankruptcy notification
requirement in
R313-19-34(5) and
(6);
(C) in registering devices, the general
licensee shall furnish the following information and any other information
specifically requested by the Director:
(I)
name and mailing address of the general licensee;
(II) information about each device: the
manufacturer or initial transferor, model number, serial number, the
radioisotope and activity as indicated on the label;
(III) name, title, and telephone number of
the responsible person designated as a representative of the general licensee
under R313-21-22(4)(c)(xii);
(IV)
address or location at which the device(s) are used, stored, or both. For
portable devices, the address of the primary place of storage;
(V) certification by the responsible
representative of the general licensee that the information concerning the
device(s) has been verified through a physical inventory and checking of label
information; and
(VI) certification
by the responsible representative of the general licensee that they are aware
of the requirements of the general license; and
(D) persons generally licensed by the Nuclear
Regulatory Commission, an Agreement State, or Licensing State with respect to
devices meeting the criteria in R313-21-22(4)(c)(xiii)(A) are not subject to
registration requirements if the devices are used in areas subject to Division
jurisdiction for a period less than 180 days in any calendar year. The Director
will not request registration information from such licensees;
(xiv) shall report changes to the
mailing address for the location of use, including changes in the name of a
general licensee, to the Director within 30 days of the effective date of the
change. For a portable device, a report of address change is only required for
a change in the device's primary place of storage; and
(xv) may not hold devices that are not in use
for longer than 2 years. If devices with shutters are not being used, the
shutter must be locked in the closed position. The testing required by
R313-21-22(4) (c)(ii) 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 must
be tested for leakage before use or transfer and the shutter tested before use.
Devices kept in standby for future use are excluded from the two-year time
limit if the general licensee performs quarterly physical inventories of these
devices while they are in standby.