Wash. Admin. Code § 246-233-020

Current through Register Vol. 24-21, November 1, 2024

Section 246-233-020 - Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere

(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.

Wash. Admin. Code § 246-233-020

Amended by WSR 13-24-025, filed 11/22/13, effective 12/23/2013

Amended by WSR 16-13-054, Filed 6/10/2016, effective 7/11/2016

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.