C. Certain measuring,
gauging or controlling devices
(1) A general
license is hereby 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 own, receive, acquire,
possess, use or transfer in accordance with the provision of C.6.C(2), (3),
(4), radioactive material, excluding special nuclear 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.
(2) The general license in C.6.C(1) applies
only to radioactive material contained in devices, which have been manufactured
and labeled in accordance with the specifications contained in a specific
license issued by the Agency pursuant to C.11.D or in accordance with the
specifications contained in a specific license issued by the U.S. Nuclear
Regulatory Commission or an Agreement State, which authorizes distribution of
devices to persons generally licensed by the U.S. Nuclear Regulatory Commission
or an Agreement State. Regulations under the Federal Food, Drug, and Cosmetic
Act authorizing the use of radioactive control devices in food production
require certain additional labeling thereon which is found in Section 179.21 of
the Code of Federal Regulations, Title 21. The devices must have been received
from one of the specific licensees described in C.6.C(2) or through a transfer
under C.6.C(3)(i)
(3) Any person
who owns, receives, acquires, possesses, uses, or transfers radioactive
material in a device pursuant to the general license in C.6.C(1) shall file
Agency Form HHE 861, Registration Certificate - Use of Fixed Measuring, Gauging
or Controlling Devices, Agency Form HHE 862, Registration Certificate - Use of
Portable Measuring, Gauging or Controlling Devices or Agency Form HHE 864,
Registration Certificate for use of Static Eliminators, Electron Capture
Devices, Gas Chromatographs, or Other Devices which Contain Radioactive
Material Under a General License with the Agency. The form shall be submitted
within 30 days after the first receipt or acquisition of such device or 30 days
after the effective date of this rule for devices acquired prior to the
effective date. The general licensee shall furnish such information as may be
required by that form as well as the annual fee referenced in Appendix A of
this Part and:
(a) 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 such labels;
(b) 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
such other intervals as are specified in the label, however,
(i) Devices containing only krypton need not
be tested for leakage of radioactive material, and
(ii) Devices containing only tritium or not
more than 100 microcuries (3.7 MBq) of other beta and/or gamma emitting
material or 10 microcuries (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;
(c) Shall assure that the tests required by
C.6.C(3)(b) and other testing, installation, servicing, and removal from
installation involving the radioactive materials, its shielding or containment,
are performed:
(i) in accordance with the
instructions provided by the labels, or
(ii) by a person holding an applicable
specific license from the Agency, the U.S. Nuclear Regulatory Commission or an
Agreement State to perform such activities;
(d) Shall maintain records showing compliance
with the requirements of C.6.C(3)(b) and c. 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
installation concerning the radioactive material, its shielding or containment.
Records of tests for leakage of radioactive material required by C.6.C(3)(b)
shall be maintained for three years after the next required leak test is
performed or until the sealed source is transferred or disposed. Records of
tests of the on/off mechanism and indicator required by C.6.C(3)(b) shall be
maintained 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. Records which are required by C.6.C(3)(c) shall be maintained for a
period of three years from the date of the recorded event or until the device
is transferred or disposed;
(e)
Upon the occurrence of 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 0.005 microcurie
(185 Bq) or more removable radioactive material, shall immediately suspend
operation of the device until it has been repaired by the manufacturer or other
person holding an applicable specific license from the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State to repair such devices, or disposed
of by transfer to a person authorized by an applicable specific license to
receive the radioactive material contained in the device and, within 30 days,
furnish to the Agency a report containing a brief description of the event and
the remedial action taken, and, in the case of detection of 0.005 microcurie 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 Agency;
(f) Shall
not abandon the device containing radioactive material;
(g) Shall not export the device containing
radioactive material except in accordance with 10 CFR Part 110 ;
(h)
(i)
Shall transfer or dispose of the device containing radioactive material only by
export as provided by paragraph (g) of this section, by transfer to another
general licensee as authorized in paragraph (i) of this section, or to a person
authorized to receive the device by a specific license issued under Part C,
that authorizes possession, use, waste collection, or equivalent regulations of
an Agreement State, or as otherwise approved under paragraph (h)(iii) of this
section.
(ii) Shall, within 30 days
after the transfer of a device to a specific licensee or export, furnish a
report to the Manager, Radiation Control Program. The report must contain:
(a) The identification of the device by
manufacturer's (or initial transferor's) name, model number, and serial
number;
(b) The name, address, and
license number of the person receiving the device (license number not
applicable if exported); and
(c)
The date of the transfer.
(iii) Shall obtain written Agency approval
before transferring the device to any other specific licensee not specifically
identified in paragraph (h)(i) of this section; 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:
(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 paragraph (a)
of this section) so that the device is labeled in compliance with Part D.1904;
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 under paragraph (h)(ii) of this section.
(i) Shall transfer the device to
another general licensee only:
(a) Where the
device remains in use at a particular location. In such case the transferor
shall give the transferee a copy of this Section, a copy of Sections
10 CFR
31.2, C.25, D.2201, D.2202, and any safety
documents identified in the label on the device and within 30 days of the
transfer, report to the Agency: the manufacturer's (or initial transferor's)
name and model and serial number of device transferred, the name, address for
the location of use of the transferee, and the name and/or position of an
individual who may constitute a point of contact between the Agency and the
transferee; or
(b) Where the device
is held in storage in the original shipping container at its intended location
of use prior to initial use by a general licensee;
(j) Shall comply with the provisions of
D.2201. and D.2202. of this rule for reporting radiation incidents, theft, or
loss of licensed material, but shall be exempt from the other requirements of
Parts D and J of this rule;
(k)
Shall 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
submitting a letter to the Radiation Control Program and provide written
justification as to why it cannot comply.
(l) 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.
(m)
(i) Shall register, in accordance with
C.6.C.(3)(m)(ii) and (iii), devices containing at least 370 MBq (10 mCi) of
cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt- 60,
3.7 megabecquerels (0.1 millicurie) of radium-226, or 37 MBq (1 mCi) of
americium-241 or any other transuranic ((i)e., element 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 paragraph
C.6.C.(3)(m)(iii)(d), represents a separate general licensee and requires a
separate registration and fee.
(ii)
If in possession of a device meeting the criteria of C.6.C(3)(m)(i), shall
register these devices annually with the Agency and shall pay the required fee.
Registration must be done by verifying, correcting and/or adding to the
information provided in a request for registration received from the Agency.
The registration information must be submitted to the Agency within 30 days of
the date of the request for registration or as otherwise indicated in the
request. In addition, a general license holding devices meeting the criteria of
C.6.C.(3)(m)(i) is subject to bankruptcy notification requirement in Part
C.
(iii) In registering devices,
shall furnish the following information and any other information specifically
requested by the Agency:
(a) Name and mailing
address of the general licensee.
(b) Information about each device: the
manufacturer (or initial transferor), model number, serial number, the
radioisotope and activity (as indicated on the label).
(c) Name, title, and telephone number of the
responsible person designated as a representative of the general licensee under
paragraph C.6.C(3)(l). of this section.
(d) Address or location at which the
device(s) are used and/or stored. For portable devices, the address of the
primary place of storage.
(e)
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.
(f) Certification by the responsible
representative of the general licensee that they are aware of the requirements
of the general license.
(iv) Persons generally licensed by an
Agreement State with respect to devices meeting the criteria in paragraph
C.6.C.(3)(m)(i) this section are not subject to registration requirements if
the devices are used in areas subject to Agency jurisdiction for a period fewer
than 180 days in any calendar year. The Agency will not request registration
information from such licensees.
(n) Shall report changes to the mailing
address for the location of use (including change in name of general licensee)
to the Radiation Control Program Manager 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.
(o) Shall not hold devices that are not in
use for longer than two years. If devices with shutters are not being used, the
shutter must be locked in the closed position. The testing required by
C.6.C(3)(c) 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.
(4)
The general license in C.6.C(1) does not authorize the manufacture of devices
containing radioactive material.
(5) The general license provided in C.6.C(1)
is subject to the provisions of A.4 through A.9., C.14., C.21., C.22. and Part
L of this rule.