OAR 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


If the applicant consents, the Authority may enter into third party agreements for the applicant to engage and pay for the services of a third party contractor to prepare an environmental impact analysis required by OAR 333-102-0190 (General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses) and/or to furnish an opinion of independent experts, satisfactory to the Authority, in respect to the completeness and adequacy of any information or data furnished by the applicant and on any aspect of the applicant’s project or effects thereof.

(1)

When the license applicant pays for a third party agreement, the monies paid for the consultant must not be considered as specific license fees, pursuant to OAR 333-103-0010 (Annual Fee for Specific Licenses) of this chapter.

(2)

In proceeding under the third party agreement, the Authority shall carry out the following practices:

(a)

Such contractor shall be chosen solely by the Authority.

(b)

The Authority shall manage the contract.

(c)

The consultant must be selected based on the consultant’s ability and relevant and applicable work experience and an absence of conflict of interest. Third party contractors shall be required to execute a disclosure statement showing that they have no financial or other conflicting interest in the outcome of the project.

(d)

The Authority shall specify the information to be developed and supervise the gathering, analysis and presentation of the information. The Authority shall have sole authority for approval and modification of the statement, analysis, and conclusions included in third party’s report.

(e)

The Authority has the single right of refusal of the final application and the Authority is not obligated to approve the application or issue a license.

Source: Rule 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, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-102-0365.

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 333-102-0365’s source at or​.us