Oregon Oregon Health Authority, Public Health Division

Rule Rule 333-102-0340
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reciprocal Recognition of Licenses


(1)

Subject to these rules, any person who holds a specific license from the U.S. Nuclear Regulatory Commission, an Agreement State, or a licensing state, and issued by the Authority having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this state for a period not in excess of 180 consecutive days in any calendar year, provided that:

(a)

The licensing document does not limit the activity authorized by such document to specified installations or locations;

(b)

The out-of-state licensee has notified the Authority using the Notification of Entry to Perform Activities Under Oregon Reciprocity Application form at least three days prior to engaging in such activity and has paid the applicable registration fee pursuant to OAR 333-103-0030 (Reciprocal Recognition Fee). Such notification shall indicate the location, period and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the three-day period imposes an undue hardship on the out-of-state licensee, the licensee may, upon application to the Authority, obtain permission to proceed sooner. The Authority may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license granted by subsection (1)(a) of this rule;

(c)

The out-of-state licensee complies with all applicable rules of the Authority and with all the terms and conditions of the licensing document, except any such terms and conditions that may be inconsistent with applicable rules of the Authority or laws of the State of Oregon;

(d)

The out-of-state licensee supplies such other information as the Authority may request; and

(e)

The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in subsection (1)(a) of this rule except by transfer to a person:

(A)

Specifically licensed by the Authority or by the U.S. Nuclear Regulatory Commission to receive such material; or

(B)

Exempt from the requirements for a license for such material under OAR 333-102-0010 (Exemptions — Radioactive Material Other than Source Material: Exempt Concentrations)(2).

(2)

Notwithstanding the provisions of section (1) of this rule, any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission, pursuant to 10 CFR 31.6 or equivalent regulations of an Agreement State, authorizing the holder of the license to manufacture, transfer, install or service a device described in OAR 333-102-0115 (General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices)(1) within the State of Oregon is hereby granted a general license to install, transfer, demonstrate or service such a device in this state provided that:

(a)

Such person shall register the general license pursuant to OAR 333-101-0007 (Application for General License Registration for Radioactive Materials Gauges, In Vitro Testing, Source Material, Reference and Calibration Sources, and Reciprocal Recognition of Specific Radioactive Materials License);

(b)

File a report with the Authority within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred and the quantity and type of radioactive material contained in the device;

(c)

Ensure that the device has been manufactured, labeled, installed and serviced in accordance with applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission or an Agreement State;

(d)

Ensure that any labels required to be affixed to the device under rules of the licensing authority also include the statement “Removal of this label is prohibited”; and

(e)

The holder of the specific license shall furnish to each general licensee to whom such device is transferred, or on whose premises such a device is installed, a copy of the general license contained in OAR 333-102-0115 (General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices) or in equivalent rules of the Authority having jurisdiction over the manufacture and distribution of the device.

(3)

The Authority may withdraw, limit or qualify its acceptance of any specific license or equivalent licensing document issued by the U.S. Nuclear Regulatory Commission or an Agreement State, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property. The Authority may deny the licensee to perform activities under Oregon reciprocity.

(4)

The out-of-state licensee shall at all times during work at any work location within the state have available the pertinent licensing document, the applicable sections of the State of Oregon radiation regulations, a complete source inventory, pertinent U.S. Department of Transportation documentation, leak test records, instrument calibration records, personnel training records, and necessary documentation required by applicable special requirements of these regulations.

(5)

While working in Oregon, the out-of-state licensee shall notify the Authority (in writing, indicating date and court) immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of Title 11 (bankruptcy) of the United States code by or against:

(a)

The licensee;

(b)

An entity (as that term is defined in II U.S.C 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or

(c)

An affiliate (as that term is defined in II U.S.C. 101(2)) of the license.

(6)

If multiple work crews or persons work concurrently at more than one work location under a general license granted pursuant to this rule, each day worked at each location shall count toward the limit of 180 consecutive days in a calendar year.

(7)

Each general licensee granted authorization to conduct activities within the State of Oregon pursuant to this rule, based upon an acceptable licensing document, will receive acknowledgment from the Authority. This acknowledgment shall be kept at the site of use.

(8)

Each general licensee granted authorization to conduct activities within the State of Oregon pursuant to this rule based upon an acceptable licensing document is subject to the reciprocity fee and may be inspected by the Authority. The fee for the general license granting reciprocity shall:

(a)

Be charged as provided by division 103 of this chapter; and

(b)

Shall not be charged more often than once during each calendar year.

(9)

Each general licensee operating within the state under reciprocity in areas of exclusive federal jurisdiction shall comply with the applicable provisions of 10 CFR 150.20.
Source

Last accessed
Jun. 8, 2021