WAC 246-233-020
General license -- Certain measuring,
gauging or controlling devices. (1) A general license is
hereby issued to commercial and industrial firms and research,
educational and medical institutions, individuals in the
conduct of their business, and state or local government
agencies to own, acquire, receive, possess, use or transfer,
in accordance with the provisions of subsections (2), (3), and
(4) of this section, 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 subsection (1) of this section
applies only to radioactive material contained in devices
which have been manufactured or initially transferred and
labeled in accordance with the specifications contained in a
specific license issued by the department pursuant to WAC 246-235-093 or in accordance with the Nuclear Regulatory
Commission, an agreement state or a licensing state, which
authorizes distribution or transfer of devices to persons
generally licensed by the United States Nuclear Regulatory
Commission, an agreement state or licensing state**. The
devices shall have been received from one of the specific
licensees described in this subsection or through a transfer
made under subsection (3)(h) of this section.
*Note:
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 21 CFR Part 179.
(3) Any person who owns, acquires, receives, possesses,
uses or transfers radioactive material in a device pursuant to
the general license in subsection (1) of this section:
(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 of other beta and/or gamma emitting material or 10
microcuries of alpha emitting material need not be tested for
any purpose. Devices held in storage in the original shipping
container prior to initial installation need not be tested
until immediately prior to use;
(c) Shall assure that the tests required by (b) of this
subsection and other testing, installing, servicing, and
removing 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 a specific license from the
department or from the United States Nuclear Regulatory
Commission or from any agreement state or from a licensing
state to perform such activities;
(d) Shall maintain records showing compliance with the
requirements of (b) and (c) of this subsection. The records
shall show the results of tests. The records also shall show
the dates of performance and the names of persons performing,
testing, installing, servicing, and removing from installation
concerning the radioactive material, its shielding or
containment. Records of tests for leakage of radioactive
material required by (b) of this subsection shall be
maintained for three years after the next required leak test
is performed or the sealed source is transferred or disposed. Records of tests of the on/off mechanism and indicator
required by (b) of this subsection shall be maintained for
three years after the next required test of the on/off
mechanism and indicator is performed or the sealed source is
transferred or disposed. Records of other testing,
installation, servicing, and removal from installation
required by (c) of this subsection 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 microcuries or
more removable radioactive material, shall immediately suspend
operation of the device until it has been repaired by the
manufacturer or other person holding a specific license from
the department, the United States Nuclear Regulatory
Commission, or from an agreement state or a licensing state to
repair such devices, or disposed by transfer to a person
authorized by a specific license to receive the radioactive
material contained in the device and, within thirty days,
furnish to the department a written report containing a brief
description of the event and the remedial action taken; and,
in the case of detection of 0.005 microcuries or more of
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 (see WAC 246-246-020);
(f) Shall not abandon the device containing radioactive
material;
(g) Except as provided in (h) of this subsection, shall
transfer or dispose the device containing radioactive material
only by transfer to a person holding a specific license of the
department, the United States Nuclear Regulatory Commission,
or an agreement state, or a licensing state whose specific
license authorizes the person to receive the device and within
thirty days after transfer of a device to a specific licensee
shall furnish to the department a report containing
identification of the device by manufacturer's (or initial
transferor's) name, model number, and serial number; the name,
address, and license number of the person receiving the
device, and the date of transfer. Prior written approval from
the department is required before transferring the device to
any other specific licensee not specifically identified in
this subsection;
(h) Shall transfer the device to another general licensee
only:
(i) 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 WAC 246-221-240,
246-221-250, 246-232-050, and 246-232-060, and any safety
documents identified in the label of the device and within
thirty days of the transfer, report to the department the
manufacturer's (or transferor's) name, model number, and
serial number of device transferred, the transferee's name and
mailing address for the location of use, and the name, title,
and phone number of the responsible individual identified by
the transferee in accordance with (j) of this subsection to
have knowledge of and authority to take actions to ensure
compliance with the appropriate regulations and requirements;
or
(ii) 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;
(i) Shall comply with the provisions of WAC 246-221-240
and 246-221-250 for reporting radiation incidents, theft or
loss of licensed material, but shall be exempt from the other
requirements of chapters 246-221 and 246-222 WAC;
(j) 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;
(k)(i) Shall register, in accordance with (k)(i) and
(iii) of this subsection, 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, 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 (k)(iii)(D) of this subsection, represents a separate
general licensee and requires a separate registration and fee;
(ii) If in possession of a device meeting the criteria of
(k)(i) of this subsection, shall register these devices
annually with the department and shall pay the fee required by
WAC 246-254-090. Registration must be done by verifying,
correcting, and/or adding to the information provided in a
request for registration received from the department. The
registration information must be submitted to the department
within thirty 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
(k)(i) of this subsection is subject to the bankruptcy
notification requirement in WAC 246-232-050;
(iii) In registering devices, the general licensee shall
furnish the following information and any other information
specifically requested by the department:
(A) Name and mailing address of the general licensee;
(B) Information about each device: The manufacturer (or
initial transferor), model number, serial number, the
radionuclide 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 (j) of this subsection;
(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 the U.S. Nuclear
Regulatory Commission, or an agreement state with respect to
devices meeting the criteria in (k)(i) of this subsection are
not subject to registration requirements if the devices are
used in areas subject to Washington state jurisdiction for a
period less than one hundred eighty days in any calendar year.
The department will not request registration information from
such licensees;
(l) Shall report changes to the mailing address for the
location of use (including change in name of general licensee)
to the department within thirty 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;
(m) 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 (b) of this subsection 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 subsection (1) of this section
does not authorize the manufacture, import or export of
devices containing radioactive material.