Oregon Administrative Code

333-113-0105 Equipment Control: Storage Precautions (1) Each source of radiation, except accelerators, must be provided with a storage and/or transport container. The container must be provided with a lock, or tamper seal for calibration sources, to prevent unauthorized removal o…

333-113-0110 Equipment Control: Transport Precautions (1) The licensee may not transport licensed material unless the material is packaged, labeled, marked, and accompanied with appropriate shipping papers in accordance with rules set out in 49 CFR Parts 171 to 178. (2) Security …

333-113-0115 Equipment Control: Radiation Survey Instruments (1) The licensee or registrant must maintain sufficient calibrated and operable radiation survey instruments, capable of detecting beta and gamma radiation, at each field station and temporary jobsite to make physical r…

333-113-0120 Equipment Control: Leak Testing of Sealed Sources (1) Testing and Record Keeping Requirements. Each licensee using sealed sources of radioactive material must have the sources tested for leakage at intervals not to exceed six months. Records of leak test results must…

333-113-0125 Equipment Control: Physical Inventory Each licensee or registrant must conduct a semiannual physical inventory to account for all sources of radiation. Records of inventories must be maintained in accordance with 333-100-0057 and must include the quantities and kinds…

333-113-0130 Equipment Control: Utilization Records Each licensee or registrant must be maintained in accordance with 333-100-0057 showing the following information for each source of radiation: (1) Make, model number and a serial number or a description of each source of radiati…

333-113-0135 Equipment Control: Design, Performance and Certification Criteria for Sealed Sources (1) Each sealed source, except those containing radioactive material in gaseous form, used in well logging operations and manufactured after May 1, 1983 must be certified by the manu…

333-113-0140 Equipment Control: Labeling (1) Each source, source holder or logging tool containing radioactive material must bear a durable, legible and clearly visible marking or label, which has, as a minimum, the standard radiation caution symbol specified in 333-120-0400, wit…

333-113-0145 Equipment Control: Inspection and Maintenance (1) Each licensee or registrant must conduct, at intervals not to exceed six months, a visual check of source holders, logging tools, source handling tools, storage containers, transport containers and injection tools to …

333-113-0150 Equipment Control: Use of a Sealed Source in a Well without a Surface Casing The licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the sourc…

333-113-0201 Requirements for Personnel Safety: Training Requirements (1) No licensee or registrant shall permit any individual to act as a logging supervisor as defined in this division until such individual has: (a) Received, in a course recognized by the Authority, the U.S. Nu…

333-113-0203 Requirements for Personnel Safety: Subjects to be Included in Training Courses for Logging Supervisors (1) Fundamentals of radiation safety: (a) Characteristics of radiation; (b) Units of radiation dose and quantity of radioactivity; (c) Significance of radiation dos…

333-113-0205 Requirements for Personnel Safety: Operating and Emergency Procedures The licensee's or registrant's operating and emergency procedures must include instructions in at least the following: (1) Handling and use of sources of radiation to be employed so that: (a) No in…

333-113-0210 Requirements for Personnel Safety: Personnel Monitoring (1) The licensee must not permit an individual to act as a logging supervisor or logging assistant unless that person wears a personnel dosimeter at all times during the handling of licensed radioactive material…

333-113-0301 Precautionary Procedures in Logging and Subsurface Tracer Studies: Security (1) A logging supervisor must be physically present at a temporary jobsite whenever licensed materials are being handled or are not stored and locked in a vehicle or storage place. The loggin…

333-113-0305 Precautionary Procedures in Logging and Subsurface Tracer Studies: Handling Tools The licensee must provide and require the use of tools that will assure remote handling of sealed sources other than low activity calibration sources. Statutory/Other Authority: ORS 453…

333-113-0310 Precautionary Procedures in Logging and Subsurface Tracer Studies: Subsurface Tracer Studies (1) Protective gloves and other appropriate protective clothing and equipment must be used by all personnel handling radioactive tracer material. Precautions must be taken to…

333-113-0315 Precautionary Procedures in Logging and Subsurface Tracer Studies: Particle Accelerators No licensee or registrant shall permit above-ground testing of particle accelerators, designed for use in well-logging, which results in the production of radiation, except in ar…

333-113-0325 Precautionary Procedures in Logging and Subsurface Tracer Studies: Energy Compensation Source The licensee may use an Energy Compensation Source (ECS) which is contained within a logging tool, or other tool components, only if the ECS contains quantities of licensed …

333-113-0335 Precautionary Procedures in Logging and Subsurface Tracer Studies: Tritium Neutron Generator Target Source (1) Use of a tritium neutron generator target source, containing quantities not exceeding 1,110 GBq (30 curies) and in a well with a surface casing to protect f…

333-113-0401 Radiation Surveys (1) Radiation surveys must be made and recorded for each area where radioactive materials are used and stored. (2) Radiation surveys must be made and recorded before transport for the radiation levels in all occupied positions and on the exterior of…

333-113-0403 Radiation Surveys and Records: Radioactive Contamination Control (1) If the licensee detects evidence that a sealed source has ruptured or licensed materials have caused contamination, the licensee must initiate immediately the emergency procedures required by 333-11…

333-113-0405 Radiation Surveys and Records: Documents and Records Required at Field Stations Each licensee or registrant must maintain, for inspection by the Authority, the following documents and records for the specific devices and sources used at the field station: (1) Appropr…

333-113-0410 Radiation Surveys and Records: Documents and Records Required at Temporary Jobsites Each licensee or registrant conducting operations at a temporary jobsite must have the following documents and records available at that site for inspection by the Authority: (1) Oper…

333-113-0501 Notification of Incidents, Abandonment and Lost Sources (1) Notification of incidents and sources lost in other than well logging operations must be made in accordance with appropriate provisions of division 120 of these rules. (2) Whenever a sealed source or device …

333-114-0001 General The purpose of these rules is to insure that the response to a radioactive material accident be both swift and appropriate to minimize damage to any person, property, domestic animals, wildlife or the environment. Statutory/Other Authority: ORS 453.635 Statut…

333-114-0005 Definitions For the purposes of ORS 469.611 and these rules: (1) “Certified Training” means radiological safety training in which performance has been demonstrated through the satisfactory completion of an authorized exam. (2) “Authorized Exam” means an exam, either …

333-114-0010 Training In order to receive certification in radiological safety training from the Oregon State Public Health Division a person must satisfactorily complete the authorized exam administered by an authorized Public Health Division representative. A county will receiv…

333-114-0015 Radioactive/Hazardous Materials Emergency Response Exercise This is defined as a practice response to an accident involving radioactive or other hazardous materials. The exercise should involve all organizations that would normally be present in a real incident, incl…

333-116-0010 Purpose and Scope This division contains the requirements and provisions for the production, preparation, compounding and use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material in Oregon. These requirements …

333-116-0020 Definitions As used in this division, the following definitions apply: (1) "Address of use" means the building or buildings identified on the license as the location(s) where radioactive material may be received, used, or stored. (2) "Area of use" means location(s) a…

333-116-0025 FDA, Other Federal, and State Requirements Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radiopharmaceutical drugs or devices. Statutory/Other Authority: ORS 453.635 Statutes/Other Imple…

333-116-0027 Implementation (1) A licensee must implement the provisions in division 333-116 no later June 15, 2006. (2) When a requirement in division 333-116 differs from the requirement in an existing license condition, the more restrictive requirement must govern until there …

333-116-0030 License Required (1) No person shall manufacture, produce, acquire, receive, possess, use or transfer radioactive material for medical use except in accordance with a specific or general license issued pursuant to this division or as otherwise provided in this divisi…

333-116-0035 Application for License, Amendment, or Renewal (1) An application must be signed by the management of the facility. (2) An application for a license for medical use of radioactive material as described in OAR 333-116-0300, 333-116-0320, 333-116-0360, 333-116-0400, 33…

333-116-0040 License Amendments A licensee must apply for and must receive a license amendment: (1) Before receiving or using radioactive material for a method or type of medical use not permitted by the license issued under this division; (2) Before permitting anyone to work as …

333-116-0045 Provisions for Research Involving Human Subjects. (1) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified in, and for the uses authorized by its license. (2) If the research is conducted, funded, support…

333-116-0050 Notifications (1) A licensee shall provide the Authority, no later than 30 days after the date that the licensee permits an individual to work under the provisions of OAR 333-116-0040 as an authorized user, authorized medical physicist, ophthalmic physicist, or autho…

333-116-0055 Exemptions Regarding Type A Specific Licenses of Broad Scope A licensee possessing a Type A specific license of broad scope for medical use is exempt from: (1) The provisions of OAR 333-116-0040(2); (2) The provisions of OAR 333-116-0040(7) regarding additions to or …

333-116-0057 License Issuance (1) The Authority must issue a license for the medical use of radioactive material if: (a) The applicant has filed a "Radioactive Materials License Application: Medical" in accordance with the instructions in OAR 333-116-0035; (b) The applicant has p…

333-116-0059 Specific Exemptions The Authority may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in this division as it determines are authorized by law and will not endanger life or property or the common defens…

333-116-0090 Authority and Responsibilities for the Radiation Protection Program (1) In addition to the radiation protection program requirements of OAR 333-120-0020, a licensee's management must approve in writing: (a) Requests for a license application, renewal, or amendment be…

333-116-0100 Supervision (1) A licensee who permits the receipt, possession, use or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by OAR 333-116-0030 must: (a) In addition to the requirements in OAR 333-111-0010, instruct…

333-116-0105 Written Directives (1) A written directive must be prepared, dated and signed by an authorized user prior to administration of I-131 sodium iodide greater than 1.11 Megabecquerels (MBq) (30 microcuries (uCi)), or any therapeutic dosage of a radiopharmaceutical, or an…

333-116-0107 Procedures for Administrations Requiring a Written Directive (1) For any administration requiring a written directive, the licensee must develop, implement, and maintain written procedures to provide high confidence that: (a) The patient's or human research subject's…

333-116-0110 Visiting Authorized User (1) A licensee may permit any visiting authorized user to use licensed material for medical use under the terms of the licensee's license for 60 days each year if: (a) The visiting authorized user has the prior written permission of the licen…

333-116-0120 Mobile Nuclear Medicine Service Administrative Requirements (1) The Authority will only license mobile nuclear medicine services in accordance with OAR 333-116-0300, 333-116-0320, and 333-116-0400 of this division and 333-102-0130. (2) Mobile nuclear medicine service…

333-116-0123 Radiation Safety Program Changes (1) A licensee may revise its radiation protection program without Authority approval if: (a) The revision does not require a license amendment under OAR 333-116-0040; (b) The revision is in compliance with the regulations and the lic…

333-116-0125 Quality Management Program (1) Each applicant or licensee under this division, as applicable, must establish and maintain a written quality management program to provide high confidence that radioactive material or radiation from radioactive material will be administ…

333-116-0140 Suppliers A licensee may use for medical use only: (1) Radioactive material manufactured, produced, labeled, prepared, compounded, packaged and distributed in accordance with a license issued pursuant to these rules or the equivalent rules of another Agreement State,…