OAR 333-102-0305
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specific Terms and Conditions of License

(1) Each license issued pursuant to the rules in this division and divisions 103, 105, 113, 115, 116, 117, 120, 121 and 124 of this chapter are subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations and orders of the Authority.
(2) No license issued or granted pursuant to the rules in this division and divisions 103, 105, 113, 115, 116, 117, 120 and 121 of this chapter nor any right may be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Authority, after securing full information, shall find that the transfer is in accordance with the provisions of the Act, and shall give its consent in writing.
(3) An application for transfer of license must include:
(a) The identity, technical and financial qualification of the proposed transferee; and
(b) Financial assurance for decommissioning as required by 10 CFR Parts 30.35, 40.36, 40.46, 70.25, or 70.36.
(4) Each person licensed by the Authority pursuant to the rules in this division and divisions 103, 105, 113, 115, 116, 117, 120 and 121 of this chapter must confine the use and possession of the radioactive material to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the rules in this division and divisions 105, 113, 115, 116, 117, and 121 of this chapter shall carry with it the right to receive, acquire, own, use and possess radioactive material. Preparation for shipment and transport of radioactive material must be in accordance with the provisions of division 118 of this chapter.
(5) Each license issued pursuant to the rules in this division and divisions 105, 113, 115, 116, 117, and 121 of this chapter shall be deemed to contain the provisions set forth by the Authority, whether or not these provisions are expressly set forth in the license.
(6) The Authority may incorporate, in any license issued pursuant to the rules in this division and divisions 103, 105, 113, 115, 116, 117, 120 and 121 of this chapter, at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee’s receipt, possession, use and transfer of radioactive material as it deems appropriate or necessary in order to:
(a) Protect health or to minimize danger to life or property;
(b) Protect restricted data; and
(c) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.
(7) Licensees required to submit emergency plans by OAR 333-102-0190 (General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses)(10) must follow the emergency plan approved by the Authority. The licensee may change the approved plan without Authority approval only if the changes do not decrease the effectiveness of the plan. The licensee must furnish the change to the Authority and to affected offsite response organizations within six months after the change is made. Proposed changes that decrease, or potentially decrease, the effectiveness of the approved emergency plan may not be implemented without prior application to and prior approval by the Authority.
(8) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators must test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85, respectively, in accordance with OAR 333-116-0330 (Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentration). The licensee must record the results of each test and retain each record for three years after the record is made.
(9)(a) Each general licensee subject to the registration requirement in 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) and each specific licensee must notify the Authority in writing 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 11 U.S.C. 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or
(C) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.
(b) This notification must indicate:
(A) The bankruptcy court in which the petition for bankruptcy was filed; and
(B) The date of the filing of the petition.
(10) Sealed sources or detector cells containing licensed material must not be opened or sources removed from source holders or detector cells by the licensee.
(11) No licensee may acquire licensed radioactive material in a sealed source or in a device that contains a sealed source unless the source or device has been registered with the U.S. Nuclear Regulatory Commission under 10 CFR 32.210 or with an Agreement State.
(12) Any sealed source fabricated by a licensee must be registered, inspected, and tested for construction defects, leakage, and contamination prior to any use or transfer as a sealed source in accordance with requirements in 10 CFR 32.210.
(13) Each licensee must conduct a physical inventory at intervals not to exceed six months to account for all radioactive material received and possessed by licensee. Inventories must include the types and quantities of radioactive material, location of materials, date of receipt, and the date of the inventory; and for sealed sources, the inventory must include the types and quantities of sealed sources, sealed source manufacturer, model number, serial number, date of receipt, condition of sealed sources, and the date of the inventory. Records of the inventories required by this section must be kept until inspection by the Authority.
(14) Each licensee must transport radioactive material or deliver radioactive material to a carrier for transport in accordance with the provisions of Parts 170 through 189 of Title 49, Code of Federal Regulations and in accordance with division 118 of this chapter, “Transportation of Radioactive Material.”
(15) Each licensee possessing a device licensed pursuant to OAR 333-103-0010 (Annual Fee for Specific Licenses)(2)(h) must perform an inspection of all devices at intervals not to exceed six months. Inspections must include condition of labeling and posting of each radiation device, and corrective actions taken if any; condition of shutter operation, if applicable, of each device, and corrective actions taken if any; and location of each device. Records of the inspections required by this section must be kept until inspection by the Authority.
(16) No licensee may open or remove radioactive material from sealed sources or detector cells containing licensed radiation sources.
(17) No person may repair, modify, dismantle, or effect any change in licensed devices or radiation sources, nor modify nor alter labels affixed to licensed devices by the manufacturer
(18) Installation, initial radiation survey, relocation, removal from service, maintenance, and repair of fixed gauging devices containing radioactive sealed sources, and installation, replacement, and disposal of sealed sources must be performed only by persons specifically authorized by the Authority, the U.S. Nuclear Regulatory Commission, or another Agreement state to perform such services. Records of all surveys must be maintained for inspection by the Radiation Protection Services section.
(19) If the licensee has previously determined that monitoring for internal exposure pursuant to OAR 333-120-0130 (Radiation Dose Limits: Determination of Internal Exposure), 333-120-0210 (Surveys and Monitoring: Conditions Requiring Individual Monitoring of External and Internal Occupational Dose), or 333-120-0320 (Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas: Use of Individual Respiratory Protection Equipment) is required, the data and results of this evaluation must be placed in the worker’s exposure records and included the worker’s Oregon Form Z report.
(20) Testing for leakage or contamination of sealed sources must be in accordance with requirements in OAR 333-120-0460 (Precautionary Procedures: Testing for Leakage or Contamination of Sealed Sources). In the absence of a certificate from a transferor indicating that a test has been made within six months prior to the transfer, a sealed source or detector cell received from another person must not be put into use until tested.
(21) Detector cells must be used only in conjunction with a properly operating temperature control mechanism that prevents foil temperatures from exceeding manufacturer’s specifications. Exhaust from detector cells must be vented to keep exposures to personnel and the public as low as reasonably achievable pursuant to OAR 333-120-0180 (Radiation Dose Limits: Dose Limits for Individual Members of the Public).
(22) Licensees who possess sealed sources used for testing at field sites must possess at such locations transport documents, a current copy of the specific radioactive materials license, specific license validation certificates, the current leak test certificate, and the licensee’s operating and emergency procedures. Licensed materials stored in an unrestricted area must be secured from unauthorized removal from the place of storage in accordance with provisions of OAR 333-120-0250 (Storage and Control of Licensed Material: Security of Stored Material) and 333-120-0260 (Storage and Control of Licensed Material: Control of Material Not in Storage).
(23) Any specific licensee is authorized to receive, possess, use, transfer, and import up to 999 kilograms of uranium contained as shielding for specific licensed radioactive material authorized by license.
(24) A licensee may store, pursuant to OAR 333-120-0500 (Waste Disposal: General Requirements), radioactive waste for decay in storage before disposal in accordance with OAR 333-116-0290 (Decay-In-Storage).
(25) Licensed materials in an unrestricted area and not in storage must be tended under the constant surveillance and immediate control of the licensee.
(26) Except as otherwise specified in a radioactive materials license, the licensee must have available and follow the instructions contained in the manufacturer’s instruction manual for the chromatography device.
(27) In lieu of using the conventional radiation caution colors (magenta or purple on yellow background) as provided in OAR 333-120-0400 (Precautionary Procedures: Caution Signs)(2), the licensee is hereby authorized to label detector cells and cell baths, containing licensed radioactive material and used in gas chromatography devices, with conspicuously etched or stamped radiation caution symbols without a color requirement.
(28) If a radiography licensee plans to use, during normal industrial radiographic operations subject to division 105 of this chapter, two or more exposure devices at one jobsite, the licensee must require at least one Radiographer or Radiographer Instructor authorized user for each exposure device, and the total number of authorized personnel (radiographers and assistant radiographers) at the temporary jobsite must not be less than n+1 where n=the number of cameras.
(29) Security requirements for portable devices containing licensed radioactive materials. Each portable device containing licensed radioactive materials must be secured using a minimum of two independent physical controls that form two separate tangible barriers to prevent unauthorized removal or use, whenever the portable device is not under the direct control and constant surveillance of the licensee.
(30) Authorization under OAR 333-102-0190 (General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses)(10)(c)(N) to produce Positron Emission Tomography (PET) radiopharmaceutical drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other federal, and state requirements governing radiopharmaceutical drugs.
(31) Each licensee authorized under OAR 333-102-0190 (General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses)(10)(c)(N) to produce PET radiopharmaceutical drugs for noncommercial transfer to medical use licensees in its consortium shall:
(a) Satisfy the labeling requirements in OAR 333-102-0285 (Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture, Preparation, or Transfer for Commercial Distribution of Radiopharmaceutical Drugs Containing Byproduct Material for Medical Use Under Division 116)(1)(d) for each PET radiopharmaceutical drug transport radiation shield and each syringe, vial, or other container used to hold a PET radiopharmaceutical drug intended for noncommercial distribution to members of its consortium.
(b) Possess and use instrumentation to measure the radioactivity of the PET radiopharmaceutical drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in OAR 333-102-0285 (Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture, Preparation, or Transfer for Commercial Distribution of Radiopharmaceutical Drugs Containing Byproduct Material for Medical Use Under Division 116)(3).
(32) A licensee that is a pharmacy authorized under OAR 333-102-0190 (General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses)(10)(c)(N) to produce PET radiopharmaceutical drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radiopharmaceutical drugs shall be:
(a) An authorized nuclear pharmacist who meets the requirements in OAR 333-116-0910 (Training for an Authorized Nuclear Pharmacist); or
(b) An individual under the supervision of an authorized nuclear pharmacist as specified in OAR 333-116-0100 (Supervision).
(33) A pharmacy, authorized under OAR 333-102-0190 (General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses)(10)(c)(N) to produce PET radiopharmaceutical drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of OAR 333-116-0910 (Training for an Authorized Nuclear Pharmacist).

Source: Rule 333-102-0305 — Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specific Terms and Conditions of License, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-102-0305.

333‑102‑0001
Purpose and Scope 333‑102‑0005
Exemptions: Unimportant Quantities of Source Material 333‑102‑0010
Exemptions — Radioactive Material Other than Source Material: Exempt Concentrations 333‑102‑0015
Exemptions: Certain Items Containing Radioactive Material 333‑102‑0025
Exemptions: Gas and Aerosol Detectors Containing Byproduct Material 333‑102‑0030
Exemptions: Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147 333‑102‑0032
Exemptions: Self Luminous Products and Sources Containing Radium-226 333‑102‑0033
Exemptions: Certain Industrial Devices 333‑102‑0035
Exemptions: Exempt Quantities 333‑102‑0040
Exemptions: In Vivo Testing in Humans for H. Pylori Using Carbon-14 Labeled Urea 333‑102‑0075
Licenses: Types of Licenses 333‑102‑0101
General Licenses — Small Quantities of Source Material 333‑102‑0102
General Licenses — Requirements for License to Initially Transfer Source Material for Use Under the Small Quantities of Source Materials General License 333‑102‑0104
General Licenses — Conditions of Licenses to Initially Transfer Source Material for Use Under the ’Small Quantities of Source Material’ General License: Quality Control, Labeling, Safety Instructions, and Records and Reports 333‑102‑0106
General Licenses — Depleted Uranium in Industrial Products and Devices 333‑102‑0110
General Licenses — Radioactive Material Other than Source Material: Luminous Safety Devices for Aircraft 333‑102‑0115
General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices 333‑102‑0120
General Licenses — Radioactive Material Other than Source Material: Ownership of Radioactive Material 333‑102‑0125
General Licenses — Radioactive Material Other than Source Material: Calibration and Reference Sources 333‑102‑0130
General Licenses — Radioactive Material Other than Source Material: General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing 333‑102‑0135
General Licenses — Radioactive Material Other than Source Material: Ice Detection Devices 333‑102‑0190
General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses 333‑102‑0200
General Licenses — Radioactive Material Other than Source Material: General Requirements for the Issuance of Specific Licenses 333‑102‑0203
General Licenses — Radioactive Material Other than Source Material: Definitions 333‑102‑0235
General Licenses — Radioactive Material Other than Source Material: Requirements for License to Manufacture, or Initially Transfer Radioactive Material Contained in Devices Granted a General License Under OAR 333-102-0115 333‑102‑0245
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Introduction of Radioactive Material in Exempt Concentrations into Products or Materials, and Transfer of Ownership or Possession: Requirements for License 333‑102‑0247
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Records and Material Transfer Reports 333‑102‑0250
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under a General License 333‑102‑0255
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Distribution of Radioactive Material in Exempt Quantities 333‑102‑0260
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors 333‑102‑0265
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Special Requirements for the Manufacture, Assembly or Repair of Luminous Safety Devices for Use in Aircraft 333‑102‑0270
Special Requirements for License to Manufacture Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Granted a General License by OAR 333-102-0125 333‑102‑0275
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Manufacture and Distribution of Ice Detection Devices 333‑102‑0285
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture, Preparation, or Transfer for Commercial Distribution of Radiopharmaceutical Drugs Containing Byproduct Material for Medical Use Under Division 116 333‑102‑0290
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use 333‑102‑0293
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications 333‑102‑0297
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Sealed Source or Device Evaluation 333‑102‑0300
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Issuance of Specific Licenses 333‑102‑0305
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specific Terms and Conditions of License 333‑102‑0310
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas 333‑102‑0315
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Application for Renewal of Licenses 333‑102‑0320
Amendment of Licenses at Request of Licensee 333‑102‑0325
Authority Action on Applications to Renew and Amend 333‑102‑0327
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specifically Licensed Items — Registration of Product Information 333‑102‑0330
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Transfer of Material 333‑102‑0335
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Modification, Revocation and Termination of Licenses 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 333‑102‑0345
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Special Procedures in Regulatory Review 333‑102‑0350
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reporting Requirements 333‑102‑0355
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Records 333‑102‑0360
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Right to Cause the Withholding or Recall of Byproduct Material 333‑102‑0365
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Third Party Method 333‑102‑0900
Transport: Special Requirements for Specific Licenses of Broad Scope 333‑102‑0910
Transport: Specific Terms and Conditions for Broad Licenses
Last Updated

Jun. 8, 2021

Rule 333-102-0305’s source at or​.us