OAR 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

(1)

An application for a specific license to distribute NARM to persons exempted from these rules pursuant to OAR 333-102-0035 (Exemptions: Exempt Quantities) will be approved if:

(a)

The radioactive material is not contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion or inhalation by, or application to, a human being;

(b)

The radioactive material is in the form of processed chemical elements, compounds or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product or device intended for commercial distribution; and

(c)

The applicant submits copies of prototype labels and brochures and the Authority approves such labels and brochures.

(2)

The license issued under this rule is subject to the following conditions:

(a)

No more than ten exempt quantities may be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions must not exceed unity;

(b)

Each exempt quantity must be separately and individually packaged. No more than ten such packaged exempt quantities must be contained in any outer package for transfer to persons exempt pursuant to OAR 333-102-0035 (Exemptions: Exempt Quantities). The outer package must be such that the dose rate at the external surface of the package does not exceed 0.5 millirem (5 microSv) per hour;

(c)

The immediate container of each quantity or separately packaged fractional quantity of radioactive material must bear a durable, legible label which:

(A)

Identifies the radionuclide and the quantity of radioactivity; and

(B)

Bears the words Radioactive Material.

(d)

In addition to the labeling information required by subsection (2)(c) of this rule, the label affixed to the immediate container, or an accompanying brochure, must:

(A)

State that the contents are exempt from Licensing State requirements;

(B)

Bear the words, Radioactive Material — Not for Human Use — Introduction into Foods, Beverages, Cosmetics, Drugs or Medicinals or into Products Manufactured for Commercial Distribution is Prohibited — Exempt Quantities Should Not Be Combined; and

(C)

Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.

(3)

Each person licensed under this rule must maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under OAR 333-102-0035 (Exemptions: Exempt Quantities) or the equivalent rules of any Agreement State or Licensing State and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license must be filed with the Authority. Each report must cover the year ending June 30, and must be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to this rule during the reporting period, the report must so indicate.
NOTE: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

Source: Rule 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, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-102-0255.

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 333-102-0255’s source at or​.us