Oregon Administrative Code

333-116-0585 Additional Technical Requirements for Mobile Remote Afterloader Units (1) A licensee providing mobile remote afterloader service must: (a) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and (b) Ac…

333-116-0587 Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units (1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit: (a) Monthly; (b) Before …

333-116-0590 Radiation Surveys Therapeutic Treatment Units (1) In addition to the survey requirement in OAR 333-120-0200, a person licensed under this rule must make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main sour…

333-116-0600 Safety Checks and Five-year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units (1) A licensee must have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement to assure proper functionin…

333-116-0605 Therapy-Related Computer Systems The licensee must perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing mu…

333-116-0610 Modification of Teletherapy Unit or Room Before Beginning a Treatment Program (1) If the survey required by OAR 333-116-0590 indicates that any individual member of the public is likely to receive a dose in excess of the limits specified in 333-120-0180, before begin…

333-116-0620 Reports of Teletherapy Surveys, Checks, Tests and Measurements A licensee must furnish a copy of the records required in OAR 333-116-0590, 333-116-0600, 333-116-0610 and the output from the teletherapy source expressed as rem (Sv) per hour at one meter from the sourc…

333-116-0640 Radiation Safety Officer and Associate Radiation Safety Officer Training and Experience Requirements Except as provided in OAR 333-116-0740, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer or an individual assi…

333-116-0650 Training for Experienced Radiation Safety Officer An individual identified as a Radiation Safety Officer on an Agency, Agreement State, Licensing State or U.S. Nuclear Regulatory Commission license on July 1, 2006 who oversees only the use of radioactive material for…

333-116-0660 Training for Uptake, Dilution or Excretion Studies Except as provided in OAR 333-116-0740, the licensee shall require the authorized user of a radiopharmaceutical listed in OAR 333-116-0300 to be a physician who: (1) Is certified by a medical specialty board whose ce…

333-116-0670 Training for Imaging and Localization Studies Except as provided in OAR 333-116-0740, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under OAR 333-116-0320 to be a physician who: (1) Is certified by a medical spec…

333-116-0680 Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required Except as provided in OAR 333-116-0740, the licensee must require an authorized user of unsealed byproduct material for the uses authorized under OAR 333-116-0360 to be a physic…

333-116-0683 Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 Gigabecquerels (33 millicuries) Except as provided in OAR 333-116-0740, the licensee shall require an authorized user for the oral admin…

333-116-0687 Training for Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater than 1.22 Gigabecquerels (33 millicuries) Except as provided in OAR 333-116-0740, the licensee must require an authorized user for the oral administration of s…

333-116-0690 Training for Use of Manual Brachytherapy Source Except as provided in OAR 333-116-0740, the licensee must require the authorized user using manual brachytherapy sources specified in OAR 333-116-0420 for therapy to be a physician who: (1) Is certified by a medical spe…

333-116-0700 Training for Ophthalmic Use of Strontium-90 Except as provided in OAR 333-116-0740, the licensee must require the authorized user using only strontium-90 for ophthalmic radiotherapy to be a physician who: (1) Is an authorized user under OAR 333-116-0690 or equivalent…

333-116-0710 Training for Use of Sealed Sources for Diagnosis Except as provided in OAR 333-116-0740 the licensee must require the authorized user using a sealed source in a device specified in OAR 333-116-0400 to be a physician, dentist or podiatrist who: (1) Is certified by a s…

333-116-0715 Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive Except as provided in OAR 333-116-0740, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a phys…

333-116-0720 Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units Except as provided in OAR 333-116-0740, the licensee must require the authorized user of a sealed source specified in OAR 333-116-0480 to be a physician who: (1…

333-116-0730 Training for Teletherapy or Brachytherapy Physicist The licensee must require the teletherapy physicist to: (1) Be certified by the American Board of Radiology in: (a) Therapeutic radiological physics; or (b) Roentgen ray and gamma ray physics; or (c) X-ray and radiu…

333-116-0740 Training for Experienced Authorized User, Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Nuclear Pharmacist or Authorized Nuclear Pharmacist (1) An individual identified on a U.S. Nuclear Regulatory Commission or an Agreemen…

333-116-0750 Physician Training in a Three Month Program A physician who, before July 1, 1984, began a three month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program is exempted from th…

333-116-0760 Recentness of Training The training and experience specified in OAR 333-116-0640 through 333-116-0730 and 333-116-0905 through 333-116-0910 must have been obtained within the seven years preceding the date of application or the individual must have had continuing edu…

333-116-0800 Licensing and Registration of Positron Emission Tomography (PET) Facilities (1) Each component of a PET facility (accelerator, radiopharmacy, and clinic) must be separately licensed pursuant to OAR 333-101-0005, 333-102-0200, 333-103-0005 or 333-103-0010. (2) The lic…

333-116-0810 Supervision of PET Facilities (1) Management must ensure that there is a qualified Radiation Safety Officer (RSO) who must oversee the radiation safety aspects of the PET facility and be responsible for radiation safety of the accelerator facility, pharmacy, and PET …

333-116-0820 Other Applicable Requirements (1) The licensee must ensure that any radiopharmaceutical for which an Investigational New Drug (IND) status does not exist, or which must be used for research purposes in humans, is reviewed by an Institutional Review Board (IRB) or Hum…

333-116-0830 Accelerator Facility Requirements ((1) Accelerators must meet all requirements of division 333-109. Shielded-room accelerators must be equipped with interlocks and personnel control; self-shielded accelerators must be shielded such that personnel access is prevented …

333-116-0840 Safety Considerations and Quality Management for PET Facilities (1) The licensee must establish and implement a Quality Management program pursuant to OAR 333-116-0125 for PET products, as well as other production and calibration products. (2) PET instrumentation and…

333-116-0850 Radiopharmacy and Radiochemical Production (1) All preparations used in humans must meet the Oregon State Board of Pharmacy standards, as well as applicable federal Food and Drug Administration (FDA) requirements. (a) All research products to be used in humans must b…

333-116-0870 Rubidium-82 Generator Rubidium-82 generators require quality assurance procedures for equipment, patient injection, waiting area, imaging, and post-imaging care. There also must be a procedure for spills, and a handling procedure for liquid quality assurance sources …

333-116-0880 Training and Experience for PET, PET/CT and SPECT/CT Personnel (1) Pharmacy or chemistry personnel must have 40 extra hours above Nuclear Pharmacy requirements and 40 hours specific to PET. The 40 hours can be divided equally between didactic and practical applicatio…

333-116-0905 Training for Authorized Medical Physicist Except as provided in OAR 333-116-0740, the licensee shall require the authorized medical physicist to be an individual who: (1) Is certified by a specialty board whose certification process has been recognized by the U.S. Nu…

333-116-0910 Training for an Authorized Nuclear Pharmacist Except as provided in OAR 333-116-0740, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who: (1) Is certified by a specialty board whose certification process has been recognized by the U.S…

333-116-1000 Report and Notification of a Medical Event (1) A licensee must report any medical event, except for an event that results from patient intervention, in which: (a) The administration of byproduct material or radiation from byproduct material, except permanent implant …

333-116-1011 Report and Notification for an Eluate Exceeding Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations (1) The licensee shall notify the Authority by telephone at 1-800-452-0311 and request for Radiation Protection Services to call. In addition, the…

333-116-1015 Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child (1) A licensee must report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct …

333-116-1030 Report Of A Leaking Source A licensee must file a report with the Authority within five days if a leak test required by OAR 333-116-0200 reveals the presence of 185 Bq (0.005 uCi) or more of removable contamination. The written report must include: (1) The model numb…

333-117-0010 Purpose This division establishes radiation protection standards for the possession, use, transfer and disposal of naturally occurring radioactive materials (NORM) not subject to regulation under the Atomic Energy Act of 1954, as amended. Statutory/Other Authority: O…

333-117-0020 Scope (1) These rules apply to any person who engages in the extraction, mining, beneficiating, processing, use, transfer or disposal of NORM in such a manner as to technologically alter the natural sources of radiation or their potential exposure pathways to humans.…

333-117-0030 Definitions As used in this division, the following definitions apply: (1) “Beneficial Attribute” or “Beneficial to the Product” means that the radioactivity of the product is necessary to the use of the product. (2) “Beneficiating” means the processing of materials …

333-117-0040 Exemptions (1) Persons who receive, possess, use, process, transfer, distribute and dispose of NORM are exempt from the requirements of these Rules if: The materials contain or are contaminated at concentrations less than five picocuries per gram (185 Bq/kg) of radiu…

333-117-0050 Effective Date The provision and requirements of this division shall take effect January 1990 and shall apply to all facilities or sites owned or controlled by a person on that date. Products distributed and disposals made prior to that date are not subject to the pr…

333-117-0100 General License (1) A general license is hereby issued to mine, extract, receive, possess, own, use, process and dispose of NORM not exempted in OAR 333-117-0040 without regard to quantity. This general license does not authorize the manufacturing or distribution of …

333-117-0110 Protection of Workers During Operations Each person subject to the general license in OAR 333-117-0100 shall conduct operations in compliance with the standards for radiation protection set out in division 111 and division 120, except for releases of radioactivity in…

333-117-0120 Protection of the General Population from Releases of Radioactivity Concentrations of radioactive material which may be released to the general environment in groundwater, surface water, air, soil, plants and animals shall not result in an annual dose above backgroun…

333-117-0130 Disposal and Transfer of Waste for Disposal Each person subject to the general license in OAR 333-117-0100 shall manage and dispose of wastes containing NORM in accordance with the applicable requirements of the U.S. Environmental Protection Agency for disposal of su…

333-117-0200 Specific License (1) Unless otherwise exempted under the provisions of division 102 of the Rules, the manufacturing and distribution of any material or product containing NORM shall be specifically licensed pursuant to the requirements of this division or pursuant to…

333-117-0210 Filing Application for Specific Licenses (1) Applications for specific licenses shall be filed in a manner and on a form prescribed by the Agency. (2) The Agency may at any time after the filing of the original application, and before the expiration of the license, r…

333-117-0220 Requirements for the Issuance of Specific Licenses (1) A license application will be approved if the Agency determines that: (a) The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance wi…

333-117-0230 Safety Criteria An applicant for a license under OAR 333-117-0220(3) shall demonstrate that the product is designed and will be manufactured so that: (1) In normal use and disposal it is unlikely that the external radiation dose in any one year, or the dose commitmen…