Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-233 - Radioactive materials-General licenses › Section 246-233-020 - Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere

Current through Register Vol. 24-14, July 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.