Current through Register Vol. 24-18, September 15, 2024
(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 federal, state,
or local government agencies to 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
an equivalent specific license issued by the department, NRC, or an agreement
state, which authorizes distribution or transfer of devices to persons
generally licensed by the department, NRC, or an agreement state**. The devices
must 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 C.F.R. Part 179 . |
(3)
Any person who 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 3.7 megabecquerels (100 microcuries) of other beta or gamma emitting
material or 370 kilobecquerels (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
material, 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 issued by the department, the NRC or an
agreement state to perform such activities;
(d) Shall maintain records showing compliance
with the requirements of (b) and (c) of this subsection. The records must show
the results of tests. The records also must show the dates of performance and
the names of persons performing, testing, installing, servicing, and removing
from installation radioactive material and its shielding or containment.
Records of tests for leakage of radioactive material required by (b) of this
subsection must be retained 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 must
be retained 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 must be retained for a period
of three years from the date of the recorded event or until the device is
transferred or disposed;
(e) 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 becquerels (0.005 microcurie) 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 issued by the
department, the NRC or an agreement 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 or as otherwise approved by the
department. Within thirty days, the licensee must send the department a written
report containing a brief description of the event and the remedial action
taken; and, in the case of detection of 185 becquerels (0.005 microcurie) 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)
(i)
Shall not abandon the device containing radioactive material;
(ii) Shall not export the device containing
radioactive material except in accordance with the provisions of
10 C.F.R.
110 ;
(g) Except as provided in (h) of this
subsection, must transfer or dispose of the device containing radioactive
material only by transfer to a person with a specific license issued by the
department, the NRC, or an agreement state, which authorizes the person to
receive the device. Within thirty days after export or transfer of a device to
a specific licensee, the general licensee must send a report to the department,
containing the identity of the device and manufacturer (or initial transferor),
model number, serial number, the nuclide(s), and activity of radioactive
material contained in the devices; 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; however, a
specific licensee may transfer a device for possession and use under its own
specific license without prior approval, if the specific licensee:
(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, so that the device is labeled in
compliance with WAC
246-221-120(9);
however, the manufacturer, model number, and serial number must be
retained;
(iii) Obtains the
manufacturer's or initial transferor's maintenance information applicable under
the specific license (such as leak test procedures); and
(iv) Reports the transfer under WAC
246-233-020(3)(g);
(h) Shall transfer the device to
another general licensee only if:
(i) 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 by the label of the device. Within thirty days of the
transfer, the transferor shall report to the department: The name of the
manufacturer (or initial transferor), model number, serial number, and the
source, nuclide(s), and original activity contained in the device(s)
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 action to ensure compliance with the appropriate
regulations and requirements; or
(ii) 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;
(i) Shall comply with the provisions of WAC
246-221-240 and
246-221-250 for reporting
radiation incidents, or theft or loss of radioactive material, but shall be
exempt from 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 responsibility in this
regard;
(k)
(i) Shall register, in accordance with
(k)(ii) and (iii) of this subsection, devices containing at least 370
megabecquer-els (10 millicuries) of Cesium-137, 3.7 megabecquerels (0.1
millicurie of Strontium-90, 3.7 megabecquerels (100 microcuries) of Radium-226,
37 megabecquerels (1 millicu-rie) of Cobalt-60, or 37 megabecquerels (1
millicurie) 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, 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) When registering devices, the general
licensee shall provide 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
radionu-clide 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 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 verification 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) WAC
246-232-040, Reciprocal
recognition of licenses describes how persons licensed by the NRC or an
agreement state may obtain approval to work in Washington;
(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
subsection (3)(b) of this section 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;
(n) Must respond to written requests from the
department to provide information relating to the general license within thirty
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 the same time period, request a
longer period to supply the information by providing a written justification
for the extension request.
(4) The general license in subsection (1) of
this section does not authorize the manufacture, import, or export of devices
containing radioactive material. A person must not export the device containing
radioactive material except in accordance with NRC's regulations, including 10
C.F.R. Part 110, and in accordance with other applicable federal, state, and
local regulations including, but not limited to, the U.S. Department of
Commerce, U.S. Department of Revenue, U.S. Department of Transportation, and
any other applicable jurisdiction for each export.
(5) The general license provided in this
subsection is subject to the provisions of WAC
246-220-020,
246-220-030,
246-220-040,
246-220-060,
246-220-070,
246-220-100,
246-221-240,
246-221-250,
246-232-050,
246-232-060,
246-232-070,
246-232-080, and
246-232-090.
Statutory Authority:
RCW
70.98.050 and
70.98.080. 09-06-003, §
246-233-020, filed 2/18/09, effective 3/21/09. Statutory Authority:
RCW
70.98.050. 04-04-055, § 246-233-020,
filed 1/30/04, effective 3/1/04; 98-13-037, § 246-233-020, filed 6/8/98,
effective 7/9/98. Statutory Authority:
RCW
70.98.050 and
70.98.080. 91-15-112 (Order 184),
§ 246-233-020, filed 7/24/91, effective 8/24/91. Statutory Authority:
RCW
43.70.040. 91-02-049 (Order 121), recodified
as § 246-233-020, filed 12/27/90, effective 1/31/91. Statutory Authority:
RCW
70.98.080. 87-01-031 (Order 2450), §
402-21-050, filed 12/11/86; 83-19-050 (Order 2026), § 402-21-050, filed
9/16/83. Statutory Authority:
RCW
70.98.050. 81-01-011 (Order 1570), §
402-21-050, filed 12/8/80. Statutory Authority:
RCW
70.98.080. 79-12-073 (Order 1459), §
402-21-050, filed 11/30/79, effective 1/1/80. Formerly WAC
402-20-040.
