reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0101 - General Licenses - Small Quantities of Source Material

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A general
			 license is hereby issued authorizing commercial and industrial firms, research,
			 educational and medical institutions, and state and local government agencies
			 to use and transfer uranium and thorium, in their natural isotopic
			 concentrations and in the form of depleted uranium, for research, development,
			 educational, commercial, or operations purposes in the following forms and
			 quantities:
(a) No more than 1.5 kg (3.3 lb)
			 of uranium and thorium in dispersible forms such as gaseous, liquid, or powder,
			 at any one time. Any material processed by the general licensee that alters the
			 chemical or physical form of the material containing source material must be
			 accounted for as a dispersible form. A person authorized to possess, use, and
			 transfer source material under this paragraph may not receive more than a total
			 of 7 kg (15.4 lb) of uranium and thorium in any one calendar year. Persons
			 possessing source material in excess of these limits as of August 27, 2013, may
			 continue to possess up to 7 kg (15.4 lb) of uranium and thorium at any one time
			 for one year beyond this date, or until the Authority takes final action on a
			 pending application submitted on or before August 27, 2014, for a specific
			 license for such material; and receive up to 70 kg (154 lb) of uranium or
			 thorium in any one calendar year until December 31, 2014, or until the
			 Authority takes final action on a pending application submitted on or before
			 August 27, 2014, for a specific license for such material; and
(b) No more than a total of 7 kg (15.4 lb) of
			 uranium and thorium at any one time. A person authorized to possess, use, and
			 transfer source material under this section may not receive more than a total
			 of 70 kg (154 lb) of uranium and thorium in any one calendar year. A person may
			 not alter the chemical or physical form of the source material possessed under
			 this section unless it is accounted for under the limits of subsection (1)(a)
			 of this rule; or
(c) No more than
			 7 kg (15.4 lb) of uranium, removed during the treatment of drinking water, at
			 any one time. A person may not remove more than 70 kg (154 lb) of uranium from
			 drinking water during a calendar year under this section; or
(d) No more than 7 kg (15.4 lb) of uranium
			 and thorium at laboratories for the purpose of determining the concentration of
			 uranium and thorium contained within the material being analyzed at any one
			 time. A person authorized to possess, use, and transfer source material under
			 this section may not receive more than a total of 70 kg (154 lb) of source
			 material in any one calendar year.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0102 - Requirements for License to Initially Transfer Source Material for Use Under the Small Quantities of Source Materials General License

Current through Register Vol. 63, No. 7, July 1, 2024
An application for a specific license to initially transfer
				source material for use under OAR 333-102-0101, or equivalent regulations of
				the U.S. Nuclear Regulatory Commission or an Agreement State shall be approved
				if:
(1) The applicant satisfies the
			 general requirements specified in OAR 333-102-0200; and
(2) The applicant submits adequate
			 information on, and the Authority approves the methods to be used for quality
			 control, labeling, and providing safety instructions to recipients.
Stat. Auth.: ORS
				  453.635
Stats. Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0104 - 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

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Each person licensed under OAR
			 333-102-0102  shall label the immediate container of each quantity of source
			 material with the type of source material and quantity of material and the
			 words "radioactive material".
(2)
			 Each person licensed under OAR 333-102-0102  shall ensure that the quantities
			 and concentrations of source material are as labeled and indicated in any
			 transfer records.
(3) Each person
			 licensed under OAR 333-102-0102  shall provide the information specified in this
			 rule to each person to whom source material is transferred for use under OAR
			 333-102-0101, equivalent provisions in Agreement State or the U.S. Nuclear
			 Regulatory Commission's regulations. This information must be transferred
			 before the source material is transferred for the first time in each calendar
			 year to the particular recipient. The required information includes:
(a) A copy of OAR 333-102-0101  and OAR
			 333-102-0330, or relevant equivalent regulations of the Agreement State or the
			 U.S. Nuclear Regulatory Commission; and
(b) Appropriate radiation safety precautions
			 and instructions relating to handling, use, storage, and disposal of the
			 material.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0106 - General Licenses - Depleted Uranium in Industrial Products and Devices

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A general
			 license is hereby granted to receive, acquire, possess, use or transfer, in
			 accordance with the provisions of sections (2), (3), (4) and (5), depleted
			 uranium contained in industrial products or devices for the purpose of
			 providing a concentrated mass in a small volume of the product or device.
(2) The general license in section
			 (1) of this rule applies only to industrial products or devices that have been
			 manufactured either in accordance with a specific license issued to the
			 manufacturer of the products or devices pursuant to OAR 333-102-0235  or in
			 accordance with a specific license issued to the manufacturer by the U.S.
			 Nuclear Regulatory Commission or an Agreement State that authorizes manufacture
			 of the products or devices for distribution to persons granted a general
			 license by the U.S. Nuclear Regulatory Commission or an Agreement State.
(3) Persons who receive, acquire,
			 possess or use depleted uranium pursuant to the general license established by
			 section (1) of this rule must apply for registration of the general license
			 pursuant to OAR 333-101-0007, and submit the required fee pursuant to
			 333-103-0015. Applicants will receive a validation certificate from the
			 Authority. Application for registration must be submitted within 30 days after
			 the first receipt or acquisition of such depleted uranium.
(a) The general licensee must provide the
			 following information in accordance with the registration application required
			 by OAR 333-101-0007  and such other information as may be required by that form:
(A) Name and address of the general licensee;
(B) A statement that the general
			 licensee has developed and will maintain procedures designed to establish
			 physical control over the depleted uranium described in section (1) of this
			 rule and designed to prevent transfer of such depleted uranium in any form,
			 including metal scrap, to persons not authorized to receive the depleted
			 uranium; and
(C) Name and title,
			 address, and telephone number of the individual duly authorized to act for and
			 on behalf of the general licensee in supervising the procedures identified in
			 subsection (3)(b) of this rule.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0110 - Luminous Safety Devices for Aircraft

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A general license is hereby granted to
			 own, receive, acquire, possess and use tritium or promethium-147 contained in
			 luminous safety devices for use in aircraft, provided:
(a) Each device contains not more than 370
			 GBq (10 curies) of tritium or 11.1 GBq (300 millicuries) of promethium-147;
			 and
(b) Each device has been
			 manufactured, assembled or imported in accordance with a specific license
			 issued by the U.S. Nuclear Regulatory Commission, or each device has been
			 manufactured or assembled in accordance with the specifications contained in a
			 specific license issued by the Authority or any Agreement State to the
			 manufacturer or assembler of such device pursuant to licensing requirements
			 equivalent to those in  10 CFR Part 32.53.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0120 - Ownership of Radioactive Material

Current through Register Vol. 63, No. 7, July 1, 2024
A general license is hereby granted to own radioactive material
				without regard to quantity. Notwithstanding any other provisions of this
				division, this general license does not authorize the manufacture, production,
				transfer, receipt, possession or use of radioactive material.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0125 - Calibration and Reference Sources

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A general license is hereby granted to
			 those persons listed in subsections (1)(a) and (1)(b) of this rule to own,
			 receive, acquire, possess, use, and transfer, in accordance with the provisions
			 of sections (4) and (5) of this rule, americium-241, plutonium, or radium-226,
			 in the form of calibration or reference sources:
(a) Any person who holds a specific license
			 issued by the Authority that authorizes receipt, possession, use, and transfer
			 of radioactive material; and
(b)
			 Any person who holds a specific license issued by the U.S. Nuclear Regulatory
			 Commission that authorizes receipt, possession, use, and transfer of special
			 nuclear material.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0130 - General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 general license is hereby granted to any physician, veterinarian, clinical
			 laboratory, or hospital to receive, acquire, possess, transfer or use, for any
			 of the following stated tests, in accordance with sections (2), (3), (4), (5)
			 and (6) of this rule, the following radioactive materials in prepackaged units
			 for use in In Vitro clinical or laboratory tests not involving internal or
			 external administration of radioactive material, or the radiation therefrom, to
			 human beings or animals:
(a) Iodine-125 in
			 units not exceeding ten microcuries (370 kBq) each for use in in vitro clinical
			 or laboratory tests not involving internal or external administration of
			 radioactive material, or the radiation therefrom, to human beings or
			 animals;
(b) Iodine-131, in units
			 not exceeding ten microcuries (370 kBq) each for use in in vitro clinical or
			 laboratory tests not involving internal or external administration of byproduct
			 material, or the radiation therefrom, to human beings or animals;
(c) Carbon-14, in units not exceeding ten
			 microcuries (370 kBq) each for use in in vitro clinical or laboratory tests not
			 involving internal or external administration of byproduct material, or the
			 radiation therefrom, to human beings or animals;
(d) Hydrogen-3 (tritium) in units not
			 exceeding 50 microcuries (1.85 MBq) each for use in in vitro clinical or
			 laboratory tests not involving internal or external administration of
			 radioactive material, or the radiation therefrom, to human beings or
			 animals;
(e) Iron-59 in units not
			 exceeding 20 microcuries (740 kBq) each for use in in vitro clinical or
			 laboratory tests not involving internal or external administration of
			 radioactive material, or the radiation therefrom, to human beings or
			 animals;
(f) Selenium-75, in units
			 not exceeding ten microcuries (370 kBq) each for use in in vitro clinical or
			 laboratory tests not involving internal or external administration of byproduct
			 material, or the radiation therefrom, to human beings or animals;
(g) Mock iodine-125 reference or calibration
			 sources, in units not exceeding 0.05 microcuries (1.85 kBq) of iodine-129 and
			 0.005 microcuries (185 Bq) of americium-241 each for use in in vitro clinical
			 or laboratory tests not involving internal or external administration of
			 radioactive material, or the radiation therefrom, to human beings or
			 animals.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0135 - Ice Detection Devices

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 general license is hereby issued to own, receive, acquire, possess, use and
			 transfer strontium-90 contained in ice detection devices, provided each device
			 contains not more than 50 microcuries (1.85 MBq) of strontium-90 and each
			 device has been manufactured or imported in accordance with a specific license
			 issued by the U.S. Nuclear Regulatory Commission or each device has been
			 manufactured in accordance with the specifications contained in a specific
			 license issued by the Authority or an Agreement State to the manufacturer of
			 such device pursuant to licensing requirements equivalent to those in section
			 32.61 of  10 CFR Part 32.
(2)
			 Persons who own, receive, acquire, possess, use or transfer strontium-90
			 contained in ice detection devices pursuant to the general license granted by
			 section (1) of this rule:
(a) Must, upon
			 occurrence of visually observable damage, such as a bend or crack or
			 discoloration from overheating to the device, discontinue use of the device
			 until it has been inspected, tested for leakage and repaired by a person
			 holding a specific license from the Authority, the U.S. Nuclear Regulatory
			 Commission or any other Agreement State to manufacture or service such devices;
			 or shall dispose of the device pursuant to the provisions of OAR
			 333-120-0500;
(b) Must assure that all labels affixed to
			 the device at the time of receipt, and which bear a statement which prohibits
			 removal of the labels, are maintained thereon; and
(c) Are exempt from the requirements of
			 divisions 111 and 120 of this chapter except that such persons must comply with
			 the provisions of OAR
			 333-120-0500,
			 333-120-0700,
			 and
			 333-120-0710.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0200 - General Licenses-Radioactive Material Other than Source Material: General Requirements for the Issuance of Specific Licenses

Current through Register Vol. 63, No. 7, July 1, 2024
An application for a specific license, will be approved
				if:
(1) The application is for a
			 purpose authorized by the Act;
(2)
			 The applicant is qualified by training and experience to use the material for
			 the purpose requested in such manner as to protect health and minimize danger
			 to life or property;
(3) The
			 applicant's proposed equipment and facilities are adequate to protect health
			 and minimize danger to life or property;
(4) The applicant satisfies any applicable
			 special requirements contained in divisions 102, 105, 113, 115, 116, 117, or
			 121 of this chapter; and
(5) In the
			 case of an application for a license to receive and possess radioactive
			 material for the conduct of any activity which the Authority determines will
			 significantly affect the quality of the environment, the Authority Manager or
			 designee, before commencement of construction of the plant or facility in which
			 the activity will be conducted, on the basis of information filed and
			 evaluations made pursuant to Subpart A of Part 51 of 10 CFR, has concluded,
			 after weighing the environmental, economic, technical, and other benefits
			 against environmental costs and considering available alternatives, that the
			 action called for is the issuance of the proposed license, with any appropriate
			 conditions to protect environmental values. Commencement of construction prior
			 to such conclusion must be grounds for denial of a license to receive and
			 possess byproduct material in such plant or facility. As used in this rule, the
			 term "commencement of construction" means any clearing of land, excavation, or
			 other substantial action that can adversely affect the environment of a site.
			 The term does not mean site exploration, necessary roads for site exploration,
			 borings to determine foundation conditions, or other preconstruction monitoring
			 or testing to establish background information related to the suitability of
			 the site or the protection of environmental values. Upon a determination that
			 an application meets the requirements of the Act, and the rules of the
			 Authority, the Authority will issue a specific license authorizing the
			 possession and use of radioactive material ("Radioactive Materials
			 License'').
(6) Financial assurance
			 and recordkeeping for decommissioning meeting the specific requirements listed
			 below:
(a)
									10 CFR
			 30.35 and
			 30.36
			 for radioactive material that is not source or special nuclear material;
			 or
(b)
									10 CFR
			 40.36 for source material; or
(c)
									10 CFR
			 70.25 for special nuclear
			 material.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0247 - Records and Material Transfer Reports

Current through Register Vol. 63, No. 7, July 1, 2024
Each person licensed under OAR
				333-102-0235 to initially transfer devices to generally licensed persons must comply with
				the requirements of this rule.
(1) The
			 licensee must report on a quarterly basis all transfers of devices to persons
			 for use under the general license in OAR
			 333-102-0115  and all receipts of devices from persons licensed under
			 333-102-0115  to the Authority.
(a) The required
			 information for transfers to general licensees includes:
(A) The identity of each general licensee by
			 name and mailing address for the location of use. If there is no mailing
			 address for the location of use, an alternate address for the general licensee
			 must be submitted along with information on the actual location of
			 use;
(B) The name, title, and phone
			 number of the person identified by the general licensee as having knowledge of
			 and authority to take required actions to ensure compliance with the
			 appropriate regulations and requirements;
(C) The date of transfer;
(D) The type, model number, and serial number
			 of the device transferred; and
(E)
			 The quantity and type of byproduct material contained in the device.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0250 - Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under a General License

Current through Register Vol. 63, No. 7, July 1, 2024
An application for a specific license to manufacture or
				distribute radioactive material for use under the general license specified in
				OAR
				333-102-0130 or equivalent may be approved if:
(1)
			 The applicant satisfies the general requirements specified in OAR
			 333-102-0200.
(2) The radioactive material is to be
			 prepared for distribution in prepackaged units of:
(a) Carbon-14 in units not exceeding ten
			 microcuries (370 kBq) each;
(b)
			 Cobalt-57 in units not exceeding ten microcuries (370 kBq) each;
(c) Hydrogen-3 (tritium) in units not
			 exceeding 50 microcuries (1.85 MBq) each;
(d) Iodine-125 in units not exceeding ten
			 microcuries (370 kBq) each;
(e)
			 Mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129
			 and 0.005 microcurie (185 Bq) of americium-241 each;
(f) Iodine-131 in units not exceeding ten
			 microcuries (370 kBq) each;
(g)
			 Iron-59 in units not exceeding 20 microcuries (740 kBq) each;
(h) Selenium-75 in units not exceeding ten
			 microcuries (370 kBq) each;
(i)
			 Cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries)
			 each.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0255 - Licensing the Distribution of Radioactive Material in Exempt Quantities

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An application
			 for a specific license to distribute NARM to persons exempted from these rules
			 pursuant to OAR
			 333-102-0035  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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0260 - Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors

Current through Register Vol. 63, No. 7, July 1, 2024
An application for a specific license authorizing the
				incorporation of NARM into gas and aerosol detectors to be distributed to
				persons exempt under OAR
				333-102-0025 will be approved if the application satisfies requirements equivalent to those
				contained in section 32.26 of  10 CFR Part 32 . The maximum quantity of
				radium-226 in each device must not exceed 0.1 microcurie (3.7
				kBq).
Publications: Publications referenced are available from the
				  agency.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0265 - Special Requirements for the Manufacture, Assembly or Repair of Luminous Safety Devices for Use in Aircraft

Current through Register Vol. 63, No. 7, July 1, 2024
An application for a specific license to manufacture, assemble
				or repair luminous safety devices containing tritium or promethium-147 for use
				in aircraft, for distribution to persons granted a general license by OAR
				333-102-0110 will be approved if:
(1) The applicant
			 satisfies the general requirements specified in OAR
			 333-102-0200;
			 and
(2) The applicant satisfies the
			 requirements of sections 32.53, 32.54, 32.55, 32.56, 32.101, and 32.110 of  10
			 CFR Part 32  or their equivalent.
Publications: Publications referenced are available from the
				  agency.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 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

Current through Register Vol. 63, No. 7, July 1, 2024
An application for a specific license to manufacture
				calibration and reference sources containing americium-241, plutonium or
				radium-226 to persons granted a general license by OAR
				333-102-0125 will be approved if:
(1) The applicant
			 satisfies the general requirement of OAR
			 333-102-0200;
			 and
(2) The applicant satisfies the
			 requirements of sections 32.57, 32.58, 32.59, and 32.102 of  10 CFR Part 32 and section 70.39  of  10 CFR Part 70  or their equivalent.
Publications: Publications referenced are available from the
				  agency.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0275 - Licensing the Manufacture and Distribution of Ice Detection Devices

Current through Register Vol. 63, No. 7, July 1, 2024
An application for a specific license to manufacture and
				distribute ice detection devices to persons granted a general license by OAR
				333-102-0135 will be approved if:
(1) The applicant
			 satisfies the general requirements of OAR
			 333-102-0200;
(2) The criteria of sections 32.61, 32.62,
			 32.103, and 32.110 of  10 CFR Part 32  are met.
Publications: Publications referenced are available from the
				  agency.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 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

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An
			 application for a specific license to manufacture, prepare, or transfer for
			 commercial distribution radiopharmaceutical drugs containing radioactive
			 material for use by persons authorized pursuant to division 116 of this chapter
			 may be approved if:
(a) The applicant
			 satisfies the general requirements specified in OAR 333-102-0200;
(b) The applicant submits evidence that the
			 applicant is at least one of the following:
(A) Registered or licensed with the U.S. Food
			 and Drug Administration (FDA) as the owner or operator of a drug establishment
			 that engages in the manufacture, preparation, propagation, compounding, or
			 processing of a drug under  21 CFR 207.20(a);
(B) Registered or licensed with a state
			 agency as a drug manufacturer;
(C)
			 Licensed as a pharmacy by a state Board of Pharmacy;
(D) Operating as a nuclear pharmacy within a
			 federal medical institution; or
(E)
			 A Positron Emission Tomography (PET) drug production facility registered with a
			 state agency.
(c) The
			 applicant submits information on the radionuclide, chemical and physical form;
			 the maximum activity per vial, syringe, generator, or other container of the
			 radiopharmaceutical drug; and the shielding provided by the packaging to show
			 it is appropriate for the safe handling and storage of the radiopharmaceutical
			 drugs by medical use licensees; and
(d) The applicant commits to the following
			 labeling requirements:
(A) A label is affixed
			 to each transport radiation shield, whether it is constructed of lead, glass,
			 plastic, or other material, of a radiopharmaceutical drug to be transferred for
			 commercial distribution. The label must include the radiation symbol and the
			 words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL; the name
			 of the radiopharmaceutical drug or its abbreviation; and the quantity of
			 radioactivity at a specified date and time. For radiopharmaceutical drugs with
			 a half-life greater than 100 days, the time may be omitted.
(B) A label is affixed to each syringe, vial,
			 or other container used to hold a radiopharmaceutical drug to be transferred
			 for commercial distribution. The label must include the radiation symbol and
			 the words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL and an
			 identifier that ensures that the syringe, vial, or other container can be
			 correlated with the information on the transport radiation shield
			 label.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0290 - Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An
			 application for a specific license to manufacture and distribute sources and
			 devices containing byproduct material to persons licensed pursuant to division
			 116 of this chapter for use as a calibration, transmission, or reference
			 source, or for the uses listed in OAR 333-116-0400, 333-116-0420, 333-116-0480  and 333-116-0485  will be approved if:
(a) The
			 applicant satisfies the general requirements in OAR 333-102-0200.
(b) The applicant submits sufficient
			 information regarding each type of source or device pertinent to an evaluation
			 of its radiation safety, including:
(A) The
			 radioactive material contained, its chemical and physical form and amount;
(B) Details of design and
			 construction of the source or device;
(C) Procedures for, and results of, prototype
			 tests to demonstrate that the source or device will maintain its integrity
			 under stresses likely to be encountered in normal use and accidents;
(D) For devices containing radioactive
			 material, the radiation profile of a prototype device;
(E) Details of quality control procedures to
			 assure that production sources and devices meet the standards of the design and
			 prototype tests;
(F) Procedures
			 and standards for calibrating sources and devices;
(G) Legend and methods for labeling sources
			 and devices as to their radioactive content; and
(H) Instructions for handling and storing the
			 source or device from the radiation safety standpoint; these instructions are
			 to be included on a durable label attached to the source or device or attached
			 to a permanent storage container for the source or device. Provided, that
			 instructions that are too lengthy for such a label may be summarized on the
			 label and printed in detail on a brochure that is referenced on the label.
(c) The label affixed
			 to the source or device, or to the permanent storage container for the source
			 or device, contains information on the radionuclide, quantity, date of assay
			 and a statement that the U.S. Nuclear Regulatory Commission has approved
			 distribution of the (name of source or device) to persons licensed to use
			 radioactive material identified in OAR 333-116-0190, 333-116-0400, or
			 333-116-0420, as appropriate, and to persons who hold an equivalent license
			 issued by an Agreement State or the US Nuclear Regulatory Commission. However,
			 labels worded in accordance with requirements that were in place on March 30,
			 1987 may be used until March 30, 1989.
(d) The source or device has been registered
			 in the Sealed Source and Device Registry.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0293 - Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An application for a specific license to
			 manufacture industrial products or devices containing depleted uranium for use
			 pursuant to OAR 333-102-0106  or equivalent regulations of the U.S. Nuclear
			 Regulatory Commission or an Agreement State will be approved if:
(a) The applicant satisfies the general
			 requirements specified in OAR 333-102-0200;
(b) The applicant submits sufficient
			 information relating to the design, manufacture, prototype testing, quality
			 control procedures, labeling or marking, proposed uses and potential hazards of
			 the industrial product or device to provide reasonable assurance that
			 possession, use or transfer of the depleted uranium in the product or device is
			 not likely to cause any individual to receive in any period of one calendar
			 quarter a radiation dose in excess of ten percent of the limits specified in
			 OAR 333-120-0100; and
(c) The
			 applicant submits sufficient information regarding the industrial product or
			 device and the presence of depleted uranium for a mass-volume application in
			 the product or device to provide reasonable assurance that unique benefits will
			 accrue to the public because of the usefulness of the product or device.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0297 - Sealed Source or Device Evaluation

Current through Register Vol. 63, No. 7, July 1, 2024
No sealed source or device containing radioactive material may
				be authorized on a specific license or general license until radiation safety
				information for that sealed source or device has been evaluated by the U.S.
				Nuclear Regulatory Commission, an Agreement State, or a Licensing
				State.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0300 - Issuance of Specific Licenses

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Upon a determination that an application meets the requirements of the Act and
			 these rules, the Authority shall issue a specific license authorizing the
			 proposed activity in such form and containing such conditions and limitations
			 as it deems appropriate or necessary.
(2) The Authority may incorporate in any
			 license 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
			 subject to this division as it deems appropriate or necessary in order to:
(a) Minimize danger to public health and
			 safety or property;
(b) Require
			 such reports and the keeping of such records and to provide for such
			 inspections of activities under the license as may be appropriate or necessary;
			 and
(c) Prevent loss or theft of
			 material subject to this division.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0305 - Specific Terms and Conditions of License

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0310 - Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
(a) Except as provided in subsection (1)(b)
			 of this rule, each specific license must expire at the end of the day on the
			 expiration date stated in the license unless the licensee has filed an
			 application for renewal under OAR 333-102-0315  before the expiration date
			 stated in the existing license (or, for those licenses subject to subsection
			 (1)(b) of this rule, before the deemed expiration date in that section). If an
			 application for renewal has been filed before the expiration date stated in the
			 existing license (or, for those licenses subject to subsection (2)(a) of this
			 rule, before the deemed expiration date in that section), the existing license
			 expires at the end of the day on which the Authority makes a final
			 determination to deny the renewal application or, if the determination states
			 an expiration date, the expiration date stated in the determination.
(b) Each specific license that has an
			 expiration date after July 1, 1995, and is not one of the licenses described in
			 subsection (1)(c) of this rule, shall be deemed to have an expiration date that
			 is five years after the expiration date stated in the current
			 license.
(c) The following specific
			 licenses are not subject to, or otherwise affected by, the provisions of
			 subsection (1)(b) of this rule:
(A) Specific
			 licenses for which, on February 15, 1996, an evaluation or an emergency plan is
			 required in accordance with OAR 333-102-0190(10);
(B) Specific licenses whose holders are
			 subject to the financial assurance requirements specified in OAR
			 333-102-0200(6), and on February 15, 1996, the holders either:
(i) Have not submitted a decommissioning
			 funding plan or certification of financial assurance for decommissioning;
			 or
(ii) Have not received written
			 notice that the decommissioning funding plan or certification of financial
			 assurance for decommissioning is acceptable;
(C) Specific licenses who need an
			 environmental assessment or environmental impact statement pursuant to OAR
			 333-102-0200(5);
(D) Specific
			 licenses whose holders have not had at least one Authority inspection of
			 licensed activities before February 15, 1996;
(E) Specific licenses whose holders, as the
			 result of the most recent Authority inspection of licensed activities conducted
			 before February 15, 1996, have been:
(i) Cited
			 for a serious health and safety noncompliance;
(ii) Subject to an Order issued by the
			 Authority; or
(iii) Subject to a
			 Confirmatory Action Letter issued by the Authority.
(F) Specific licenses with expiration dates
			 before July 1, 1995, for which the holders have submitted applications for
			 renewal under OAR 333-102-0315.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0315 - Application for Renewal of Licenses

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Application for renewal of a specific
			 license must be filed in accordance with OAR
			 333-102-0190.
(2) In any case in which a licensee, not less
			 than 30 days prior to expiration of the existing license, has filed an
			 application in proper form for renewal or for a new license authorizing the
			 same activities, such existing license shall not expire until final action by
			 the Authority.
(3) Unless otherwise
			 specified, specific licenses shall expire after five years.
(4) The Authority shall require reapplication
			 when the license expires.
(5) The
			 Authority may grant, upon written request from a licensee, extension of the
			 license expiration date up to five years from the original expiration date.
			 Notwithstanding any licensee request, the Authority is not required, and may
			 deny, any license extension, based on review of licensed activities.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0320 - Amendment of Licenses at Request of Licensee

Current through Register Vol. 63, No. 7, July 1, 2024
Application for amendment of a license must be filed in
				accordance with OAR
				333-102-0190 and must specify the respects in which the licensee desires the license to be
				amended and the grounds for such amendment.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0325 - Agency Action on Applications to Renew and Amend

Current through Register Vol. 63, No. 7, July 1, 2024
In considering an application by a licensee to renew or amend
				the license, the Authority will apply the criteria set forth in OAR
				333-102-0200 through 0290, as applicable.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0327 - Specifically Licensed Items - Registration of Product Information

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Any
			 manufacturer or initial distributor of a sealed source or device containing a
			 sealed source whose product is intended for use under a specific license may
			 submit a request to the U.S. Nuclear Regulatory Commission, Office of Nuclear
			 Material Safety and Safeguards for evaluation of radiation safety information
			 about its product and for its registration.
(2) The request for review must be made in
			 duplicate and sent to the Director, Office of Nuclear Material Safety and
			 Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
NOTE:
The U.S. Nuclear Regulatory Commission
				charges a fee for processing a sealed source or device evaluation request.
				Contact the U.S. Nuclear Regulatory Commission directly for current fee
				structure.
(3) The request
			 for review of a sealed source or a device must include sufficient information
			 about the design, manufacture, prototype testing, quality control program,
			 labeling, proposed uses and leak testing and, for a device, the request must
			 also include sufficient information about installation, service and
			 maintenance, operating and safety instructions, and its potential hazards, to
			 provide reasonable assurance that the radiation safety properties of the source
			 or device are adequate to protect health and minimize danger to life and
			 property.
(4) The U.S. Nuclear
			 Regulatory Commission normally evaluates a sealed source or a device using
			 radiation safety criteria in accepted industry standards. The U.S. Nuclear
			 Regulatory Commission uses criteria and standards sufficient to ensure that the
			 radiation safety properties of the device or sealed source are adequate to
			 protect health and minimize danger to life and property.
(5) After completion of the evaluation, the
			 U.S. Nuclear Regulatory Commission, issues a certificate of registration to the
			 person making the request. The certificate of registration acknowledges the
			 availability of the submitted information for inclusion in an application for a
			 specific license proposing use of the product.
(6) The person submitting the request for
			 evaluation and registration of safety information about the product shall
			 manufacture and distribute the product in accordance with:
(a) The statements and representations,
			 including quality control program, contained in the request; and
(b) The provisions of the registration
			 certificate.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0330 - Transfer of Material

Current through Register Vol. 63, No. 7, July 1, 2024
(1) No
			 licensee may transfer radioactive material except as authorized pursuant to
			 this rule.
(2) Except as otherwise
			 provided in the license and subject to the provisions of sections (3) and (4)
			 of this rule, any licensee may transfer radioactive material:
(a) To the Authority;
NOTE:
A licensee may transfer radioactive material
				to the Authority only after receiving prior approval in writing from the
				Authority.
(b) To the U.S.
			 Department of Energy;
(c) To any
			 person exempt from the rules in this division to the extent permitted under
			 such exemption;
(d) To any person
			 authorized to receive such material under terms of a general license or its
			 equivalent, or a specific license or equivalent licensing document, issued by
			 the Authority, the U.S. Nuclear Regulatory Commission, any Agreement State or
			 any Licensing State, or to any person otherwise authorized to receive such
			 material by the Federal Government or any agency thereof, the Authority, an
			 Agreement State or a Licensing State; or
(e) As otherwise authorized by the Authority
			 in writing.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0335 - Modification, Revocation and Termination of Licenses

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The terms and conditions of each license
			 issued pursuant to the rules in this division and divisions 105, 113, 115, 116,
			 117, and 121 of this chapter shall be subject to amendment, revision or
			 modification or by reason of amendments to the Act, or by reason of rules,
			 regulations and orders issued in accordance with the terms of the Act by the
			 Authority.
(2) Any license may be
			 revoked, suspended or modified, in whole or in part, for any material false
			 statement in the application or any statement of fact required under section
			 182 of the Act, or because of conditions revealed by such application or
			 statement of fact or any report, record or inspection or other means that would
			 warrant the Authority to refuse to grant a license on an original application,
			 or for violation of, or failure to observe any of the terms and conditions of
			 the Act or of any rule, regulation or order of the US Nuclear Regulatory
			 Commission or the Authority.
(3)
			 Except in cases of willfulness or those in which the public health, interest or
			 safety requires otherwise, no license shall be modified, suspended or revoked
			 unless, prior to the institution of proceedings therefore, facts or conduct
			 which may warrant such action shall have been called to the attention of the
			 licensee in writing and the licensee shall have been accorded an opportunity to
			 demonstrate or achieve compliance with all lawful requirements.
(4) The Authority may terminate a specific
			 license upon request submitted by the licensee to the Authority in
			 writing.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807