justicedao/ipfs_state_laws huggingface dataset:
333-123-0135 Superficial Electronic Brachytherapy: Activation of the Superficial Electronic Brachytherapy X-ray Tube (1) A superficial electronic brachytherapy machine may only be activated by a superficial electronic brachytherapy operator. (2) An authorized user must provide personal supervision of the superficial electronic brachytherapy operator during the patient’s initial treatment when activating the X-ray tube and direct supervision of the superficial electronic brachytherapy operator for all subsequent treatments. (3) A qualified medical physicist must be a part of all initial patient planning and provide general supervision (be available for direct communication either in person, telephone, or other electronic means) during the patient’s treatments. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 72-2020, adopt filed 10/09/2020, effective 10/09/2020
333-123-0145 Superficial Electronic Brachytherapy: Calibration, Acceptance Testing and Commissioning (1) Full calibration, acceptance testing and commissioning must be performed by, or under the direct supervision of a qualified medical physicist. (2) Acceptance testing and commissioning shall be performed in accordance with industry standards of practice and the manufacturer’s specifications. Acceptance testing and commissioning shall be conducted before the first patient treatment following installation or re-installation of the superficial electronic brachytherapy device. (3) Full calibration must include all applicable parameters in accordance with industry standards of practice and implement all of the manufacturer’s specifications to determine that all parameters of the superficial brachytherapy device are within acceptable limits. Full calibration must be completed: (a) Before the first medical use after installation or reinstallation; (b) Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent from the value obtained at the last full calibration and the difference cannot be reconciled. Superficial brachytherapy device with multi-energy or multi-mode capabilities must only require measurements for those modes or energies that are not within their acceptable range; (c) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes and energies, measurements must be performed on the effected mode and energy that is in most frequent clinical use at the facility; (d) At intervals not exceeding 12 months, although it shall not be necessary to complete all elements of a full calibration at the same time, all applicable parameters (for all energies) shall be completed. (4) The registrant must maintain a record of each full calibration for the duration of the registration. The record must include: (a) The date of the calibration; (b) The manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the X-ray tube; (c) The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and (d) The signature of the qualified medical physicist responsible for performing the calibration. (5) Calibration records must be maintained in accordance with OAR 333-100-0057 for the duration of the registration. The record must include: (a) The date of the calibration; (b) The manufacturer's name, model number and serial number for the superficial brachytherapy device; (c) The model numbers and serial numbers of the instruments used to calibrate the superficial brachytherapy device; and (d) The signature of the qualified medical physicist responsible for performing or overseeing the calibration. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 72-2020, adopt filed 10/09/2020, effective 10/09/2020
333-123-0155 Superficial Electronic Brachytherapy: Operating Procedures (1) Only individuals approved by the authorized user, Radiation Safety Officer, or qualified medical physicist shall be present in the treatment room during treatment. (2) The superficial electronic brachytherapy device shall be inoperable. (3) Prior to administration of radiation treatments, the patient’s identity shall be verified by at least two methods. (4) If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used. (5) Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include: (a) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and (b) The names and telephone numbers of the authorized user, the qualified medical physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally. (6) A copy of the current operating and emergency procedures shall be physically located at the superficial brachytherapy device control console. For control consoles that are integral to the superficial electronic brachytherapy device, the required procedures shall be kept where the operator is located during superficial electronic brachytherapy device operation. (7) Instructions shall be posted at the superficial electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the qualified medical physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally. (8) The authorized user shall be notified immediately if the patient receiving superficial brachytherapy treatment has a medical emergency, suffers injury or dies. A Radiation Safety Officer or designee shall be notified by the device operator or authorized user as soon as possible if there is any radiation related injury to the patient. A Radiation Safety Officer or a qualified medical physicist shall inform the manufacturer and the Authority of the event. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 72-2020, adopt filed 10/09/2020, effective 10/09/2020
333-124-0001 Purpose and Scope The rules in this division establish civil penalties for failure to comply with the statutory and administrative rule requirements in divisions 100 through 123. Statutory/Other Authority: ORS 431.262, 431.950 & 453.771 Statutes/Other Implemented: ORS 431.262, 431.950 & 453.771 History: PH 4-2010, f. & cert. ef. 2-16-10
333-125-0005 Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material: Purpose and Scope (1) OAR 333-125-0005 through 333-125-0200 contains the physical protection program requirements for any licensees that possess an aggregated category 1 or category 2 quantity of radioactive material listed in Appendix A to 10 CFR Part 37. These requirements provide reasonable assurance of the security of category 1 or 2 quantities of radioactive material by protecting these materials from theft or diversion. Specific requirements for access to material, use of material, transfer of material, and transport of material are included. No provision of this division authorizes the possession of licensed material. (2) Background investigations, access control program and physical protection during use requirements apply to any person who possesses or uses at any site, an aggregated category 1 or category 2 quantity of radioactive material. (3) Physical protection in transit applies to any person who under the rules in this division: (a) Transports or delivers to a carrier for transport in a single shipment, a category 1 or category 2 quantity of radioactive material; or (b) Imports or exports a category 1 or category 2 quantity of radioactive materials. The rules that establish the physical protection program apply to the domestic portion of the transport. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0015 Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material: Specific Exemptions (1) A licensee that possesses radioactive waste that contains category 1 or category 2 of radioactive material is exempt from the requirements of OAR 333-125-0020 through OAR 333-125-0190. Except that any radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg (4,409 lbs) is not exempt from the requirements within this division. (2) The licensee shall implement the following requirements to secure the radioactive waste: (a) Use continuous physical barriers that allow access to the radioactive waste only through established access control points; (b) Use a locked door or gate with monitored alarm at the access control point; (c) Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred: (A) Immediately notify LLEA and request an emergency response upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste that contains category 1 or category 2 quantities of radioactive materials; and (B) As soon as reasonably possible, the licensee shall contact the Oregon Health Authority, Radiation Protection Services 24-hour response line at 1-800-425-0311. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0020 Background Investigations and Access Control Program: Personnel Access Authorization Requirements for Category 1 and 2 Quantities (1) Each licensee that possesses an aggregated quantity of radioactive materials at or above the category 2 threshold shall establish, implement, and maintain an access authorization program in accordance with OAR 333-125-0020 through 333-125-0095. (2) An applicant for a new license and each licensee that shall become newly subject upon application for modification of its license shall implement the requirements of OAR 333-125-0020 through 333-125-0095, as appropriate, before taking possession of an aggregated category 1 or category 2 of radioactive material. (3) Any licensee that has not previously implemented the Security Orders or has been subject to the provisions of OAR 333-125-0020 through 333-125-0095 shall implement the provisions of those rules before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold. (4) General performance objective. The licensee’s access authorization program must ensure that the individuals specified in section (5) of this rule are trustworthy and reliable. (5) Applicability. Licensees shall subject the following individuals to an access authorization program: (a) Any individual whose assigned duties require unescorted access to category 1 or category 2 quantities of radioactive material or to any device that contains the radioactive material; and (b) Reviewing officials. (6) Licensees need not subject the categories of individuals listed in OAR 333-125-0085 subsections (1)(a) through (m) to the investigation elements of the access authorization program. (7) Licensees shall approve for unescorted access to category 1 or category 2 quantities of radioactive material only those individuals with job duties that require unescorted access to category 1 or category 2 quantities of radioactive material. (8) Licensees may include individuals needing access to safeguards information-modified handling under 10 CFR Part 73 in the access authorization program under OAR 333-125-0020 through 333-125-0095. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0025 Background Investigations and Access Control Program: Access Authorization Program Requirements (1) Granting unescorted access authorization. Licensees shall implement the following requirements under OAR 333-125-0020 through 333-125-0095 for granting initial or reinstated unescorted access authorization: (a) Individuals who have been determined to be trustworthy and reliable, shall complete the security training required by OAR 333-125-0115 before being allowed unescorted access to category 1 or category 2 of radioactive material. (b) Reviewing officials shall be the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to category 1 or category 2 of radioactive material possessed by the licensee. (c) Each licensee shall name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee shall provide under oath or affirmation, a certification that the reviewing official is deemed trustworthy and reliable by the licensee. The licensee shall provide the oath or affirmation certifications to the Authority, attention: Radiation Protection Services, 800 NE Oregon Street, Suite 640, Portland, Oregon 97232. The fingerprints of the named reviewing official must be taken by a law enforcement agency, federal or state agencies that provide fingerprinting services to the public, or commercial fingerprinting services authorized by a state to take fingerprints. The licensee shall recertify that the reviewing official is deemed trustworthy and reliable every 10 years in accordance with OAR 333-125-0070. (2) Reviewing officials must be permitted to have unescorted access to category 1 or category 2 quantities of radioactive materials and access to the licensee’s safeguards information or safeguards information-modified handling, if the licensee possesses safeguards information or safeguards information-modified handling. (3) Reviewing officials cannot approve other individuals to act as reviewing officials. (4) A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if: (a) The individual has undergone a background investigation that included fingerprinting and an FBI criminal history records check and has been determined to be trustworthy and reliable by the licensee; or (b) The individual is subject to a category listed in OAR 333-125-0085. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 3-2023, amend filed 01/17/2023, effective 01/18/2023 PH 16-2019, amend filed 09/19/2019, effective 09/19/2019 PH 12-2017, amend filed 10/25/2017, effective 10/25/2017 PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0030 Background Investigations and Access Control Program: Informed Consent (1) Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. The consent must include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is developed during the background investigation. Licensees do not need to obtain signed consent from those individuals that meet the requirements of OAR 333-125-0065. A signed consent must be obtained prior to any reinvestigation. (2) The subject individual may withdraw his or her consent at any time. Licensees shall inform the individual that: (a) If an individual withdraws his or her consent, the licensee may not initiate any elements of the background investigation that were not in progress at the time the individual withdrew his or her consent; and (b) The withdrawal of consent for the background investigation is sufficient cause for denial or termination of unescorted access authorization. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0035 Background Investigations and Access Control Program: Personal History Disclosure Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee’s access authorization program for the reviewing official to make a determination of the individual’s trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by this division is sufficient cause for denial or termination of unescorted access. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0040 Background Investigations and Access Control Program: Background Investigations and Access Control Program: Determination Basis (1) The reviewing official shall determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual’s unescorted access authorization based on an evaluation of all of the information collected to meet the requirements within this division. (2) The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all of the information collected to meet the requirements of this division and determined that the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation. (3) The licensee shall document the basis for concluding whether or not there is reasonable assurance that an individual is trustworthy and reliable. (4) The reviewing official may terminate or administratively withdraw an individual’s unescorted access authorization based on information obtained after the background investigation has been completed and the individual had been granted unescorted access authorization. (5) Licensees shall maintain a list of persons currently approved for unescorted access authorization. When a licensee determines that a person no longer requires unescorted access or has become ineligible to meet access authorization requirements, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days, and take prompt measures to ensure that the individual is unable to have unescorted access to the material. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 4-2017, f. 1-26-17, cert. ef. 2-1-17 PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0045 Background Investigations and Access Control Program: Access Authorization Program Procedures Licensees shall develop, implement, and maintain written procedures for implementing the access authorization program. The procedures must include provisions for the notification of individuals who are denied unescorted access. The procedures must include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization. The procedures must contain a provision to ensure that the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0050 Background Investigations and Access Control Program: Right to Correct and Complete Information (1) Prior to any final adverse determination, licensees shall provide each individual subject to this division with the right to complete, correct, and explain information obtained as a result of the licensee’s background investigation. Confirmation of receipt by the individual of this notification must be maintained by the licensee for a period of one year from the date of the notification. (2) If an individual reviewing their criminal history record believes that it is incorrect or incomplete in any respect and wishes to change, correct, update, or explain anything in the record, the individual may initiate challenge procedures. (3) Challenge procedures include direct application by the individual challenging the record to the law enforcement agency that contributed the questioned information or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in 28 CFR 16.30 through 16.34. In the latter case, the Federal Bureau of Investigation (FBI) will forward the challenge to the agency that submitted the data, and will request that the agency verify or correct the challenged entry. Upon receipt of an official communication directly from the agency that contributed the original information, the FBI Identification Division makes any changes necessary in accordance with the information supplied by that agency. Licensees must provide at least 10 days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his or her review. The licensee may make a final adverse determination based upon the criminal history records only after receipt of the FBI’s confirmation or correction of the record. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0055 Background Investigations and Access Control Program: Records (1) The licensee shall retain documentation regarding the trustworthiness and reliability of individual employees for three years from the date the individual no longer requires unescorted access to category 1 or category 2 radioactive materials. (2) The licensee shall retain a copy of the current access authorization program procedures as a record for three years after the procedure is no longer needed. If any portion of the procedure is superseded, the licensee shall retain the superseded materials for three years after the records have been amended. (3) The licensee shall retain the list of persons approved for unescorted access authorization for three years after the list is superseded or replaced. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 19-2015, f. 9-30-15, cert. ef. 10-1-15
333-125-0065 Background Investigations and Access Control Program: Grandfathering (1) Individuals who have been determined to be trustworthy and reliable for unescorted access to category 1 or category 2 quantities of radioactive material under the Fingerprint Orders may continue to have unescorted access to category 1 and category 2 quantities of radioactive materials without further investigation. These individuals shall be subject to the reinvestigation requirement outlined in OAR 333-125-0070. (2) Individuals who have been determined to be trustworthy and reliable under the provisions of 10 CFR Part 73 or the security orders for access to safeguards information, safeguards information-modified handling, or risk-significant material, may have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. (3) The licensee shall document that the individual was determined to be trustworthy and reliable under the provisions of 10 CFR Parts 73 or a security order. Security order, in this context, refers to any order that was issued by the NRC that required fingerprints and an FBI criminal history records check for access to safeguards information, safeguards information-modified handling, or risk significant material such as special nuclear material or large quantities of uranium hexafluoride. These individuals shall be subject to the reinvestigation requirement per OAR 333-125-0070. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.635 History: PH 19-2015, f. 9-30-15, cert. ef. 10-1-15