Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0115 - General Licenses - Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices

Current through Register Vol. 63, No. 7, July 1, 2024
(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 provisions of OAR 333-103-0015  and sections (2), (3) and
			 (4) of this rule, 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 section (1) of
			 this rule applies only to radioactive material contained in devices that have
			 been manufactured or initially transferred and labeled in accordance with the
			 specifications contained in a specific license issued by the Authority pursuant
			 to OAR 333-102-0200  or in accordance with the specifications contained in a
			 specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement
			 State, or a Licensing State, that authorizes distribution of devices to persons
			 generally licensed by the U.S. Nuclear Regulatory Commission, an Agreement
			 State or a Licensing State.
(3) The
			 devices must have been received from one of the specific licensees described in
			 section (2) of this rule or through a transfer made in accordance with
			 subsection (4)(i) of this rule.
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
				21
				CFR 179.21.
(4) Any person who owns, receives, acquires,
			 possesses, uses or transfers radioactive material in a device pursuant to the
			 general license in section (1) of this rule:
(a) Must 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 must comply with all
			 instructions and precautions provided by such labels;
(b) Must 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:
(A) Devices containing only krypton need not
			 be tested for leakage of radioactive material; and
(B) Devices containing only tritium or not
			 more than 100 microcuries (3.7 MBq) of other beta 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) Must assure that tests required in
			 subsection (4)(b) of this rule and other testing, installation servicing and
			 removing from installation involving the radioactive materials, its shielding
			 or containment, are performed:
(A) In
			 accordance with the instructions provided by the labels; or
(B) By a person holding an applicable
			 specific license from the Authority, the U.S. Nuclear Regulatory Commission, an
			 Agreement State or a Licensing State to perform such activities.
(d) Must maintain records showing
			 compliance with the requirements of subsections (4)(b) and (4)(c) of this rule.
			 The records must show the results of tests. The records also must 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. The licensee must retain these records
			 as follows:
(A) Records of tests for leakage
			 of radioactive material required by subsection (4)(b) of this rule must be
			 maintained as required in OAR 333-100-0057.
(B) Records of tests of the on-off mechanism
			 and indicator required by subsection (4)(b) of this rule must be maintained as
			 required in OAR 333-100-0057.
(C)
			 Records which are required by subsection (4)(c) of this rule must be maintained
			 as required in OAR 333-100-0057.
(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 of removable
			 radioactive material, the licensee must immediately suspend operation of the
			 device until it has been repaired by the manufacturer or other person holding
			 an applicable specific license from the Authority, the U.S. Nuclear Regulatory
			 Commission, an Agreement State or a Licensing State to repair such devices. The
			 device and any radioactive material from the device may only be disposed of by
			 transfer to a person authorized by a specific license to receive the
			 radioactive material in the device or as otherwise approved by the Authority. 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 submitted to
			 the Authority within 30 days. Under these circumstances, the criteria set out
			 in OAR 333-120-0190, as determined by the Authority, on a case-by-case
			 basis;
(f) Must not abandon the
			 device containing radioactive material;
(g) Except as provided in subsection (4)(i)
			 of this rule, must transfer or dispose of the device containing radioactive
			 material only by export as provided by subsection (4)(l) of this rule, by
			 transfer to another general licensee as authorized in subsection (4)(i) of this
			 rule, or by transfer to a specific licensee of the Authority, the U.S. Nuclear
			 Regulatory Commission, an Agreement State or a Licensing State whose specific
			 license authorizes the individual to receive the device; and
(A) Must furnish to the Authority, within 30
			 days after transfer of a device to a specific licensee or export, a report
			 containing identification of the device by manufacturer's name, model number,
			 serial number, the date of transfer, and the name, address and license number
			 of the person receiving the device;
(B) The general licensee must obtain written
			 Authority approval before transferring the device to any other specific
			 licensee not specifically identified in subsection (4)(g) of this
			 rule.
(h) 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
			 authorized 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 so that the device is labeled in
			 compliance with OAR 333-120-0430, however the manufacturer model and serial
			 numbers must be retained;
(C)
			 Obtains manufacturer's or initial transferor's information concerning
			 maintenance that are applicable under the specific license (such as leak
			 testing procedures); and
(D)
			 Reports the transfer under OAR 333-102-0115(4)(g)(A).
(i) Must transfer the device to another
			 general licensee only:
(A) Where the device
			 remains in use at a particular location. In such case the transferor must give
			 the transferee a copy of this rule and any safety documents identified in the
			 label on the device and within 30 days of the transfer, report to the Authority
			 the manufacturer's (or initial transferor's) name, model number, serial number
			 of the device transferred, the date of transfer, the name and address of the
			 transferee and the location of use, and the name, title and phone number of the
			 individual who is a point of contact between the Authority and the transferee.
			 This individual must have the knowledge and authority to take actions to ensure
			 compliance with the appropriate rules and requirements concerning the
			 possession and use of these devices; 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) Must comply with the provisions of OAR
			 333-120-0700  and 333-120-0710  for reporting radiation incidents, theft or loss
			 of licensed material but shall be exempt from the other requirements of
			 divisions 111 and 120 of this chapter;
(k) Must submit the required Authority form
			 and receive from the Authority a validated registration certificate
			 acknowledging the general license and verifying that all provisions of these
			 rules have been met. The form must be submitted within 30 days after the first
			 receipt or acquisition of such device. The general licensee must develop and
			 maintain procedures designed to establish physical control over the device as
			 described in this rule and designed to prevent transfer of such devices in any
			 form, including metal scrap, to persons not authorized to receive the
			 devices.
(l) Shall not export a
			 device containing radioactive material except in accordance with 10 CFR Part
			 110.