justicedao/ipfs_state_laws huggingface dataset:
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) Appropriate license, certificate of registration or equivalent document(s); (2) Operating and emergency procedures; (3) Applicable rules; (4) Records of the latest survey instrument calibrations pursuant to OAR 333-113-0115; (5) Records of the latest leak test results pursuant to OAR 333-113-0120; (6) Records of quarterly inventories required pursuant to OAR 333-113-0125; (7) Utilization records required pursuant to OAR 333-113-0130; (8) Records of inspection and maintenance required pursuant to OAR 333-113-0145; (9) Survey records required pursuant to OAR 333-113-0401; and (10) Training records required pursuant to OAR 333-113-0201. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
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) Operating and emergency procedures; (2) Survey records required pursuant to OAR 333-113-0401 for the period of operation at the site; (3) Evidence of current calibration for the radiation survey instruments in use at the site; (4) When operating in the state under reciprocity, a copy of the appropriate license, certificate of registration or equivalent document(s); (5) Shipping papers for the transportation of radioactive material; (6) Copy of the license; (7) Current leak test; and (8) Validation certificate. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
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 Statutes/Other Implemented: ORS 453.605 - 453.755 History: HD 1-1991, f. & cert. ef. 1-8-91 HD 10-1987, f. & ef. 7-28-87
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 written or oral; or a performance demonstration that has been authorized by the Authority as adequate to demonstrate the competency of a particular skill level. Whenever possible authorized exams will be developed consistent with the programs and policies with the Oregon Department of Energy, Oregon Department of Environmental Quality, State Fire Accreditation Board, and the Board on Police Standards and Training. (3) “Skill Level” means: (a) “Radiological Monitor (RM)” means person who has demonstrated competency through the satisfactory completion of an authorized (RM) exam and therefore is qualified to be a member of a radiological response team. An RM must be recertified every four years; (b) “Regional Radiological Technical Assistant (RRTA)” means a person who has demonstrated competency through the satisfactory completion of an authorized RRTA exam. An RRTA is also qualified to instruct employees of emergency services agencies in the proper response to transportation accident involving radioactive materials. An RRTA must be recertified every two years; (c) “Radiological Officer (RO)” means a person who has demonstrated competency through the satisfactory completion of an authorized RO exam and therefore is qualified to advise a community before during and after a nuclear attack and/or incident. A RO must be recertified every three years; (d) “Radiological Monitor Instructor (RMI)” means a person who has demonstrated competency through the satisfactory completion of an authorized RMI exam and therefore is qualified to be an instructor of “Radiological Monitoring.” An RMI must be recertified every three years. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.775 History: HD 1-1991, f. & cert. ef. 1-8-91 HD 10-1987, f. & ef. 7-28-87
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 receive certification of training after it has qualified two Regional Radiological Technical Assistants, and completed a radioactive/hazardous materials emergency response exercise as defined in these rules. An “emergency services agency,” as defined in ORS 401.025, will receive certification of training after it has qualified one Radiological Monitor per duty shift. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.775 History: HD 1-1991, f. & cert. ef. 1-8-91 HD 10-1987, f. & ef. 7-28-87
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, including but not limited to: Firefighting, law enforcement, prehospital and hospital emergency medical care, highway maintenance and state technical support agencies. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.775 History: HD 1-1991, f. & cert. ef. 1-8-91 HD 10-1987, f. & ef. 7-28-87
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 and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this division are in addition to, and not in substitution for, others in these rules. The requirements and provisions of these rules apply to applicants and licensees subject to this division unless specifically exempted. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91
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 Implemented: ORS 453.605 - 453.807 History: PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 4-2007, f. & cert. ef. 3-1-07 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03
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 is a license amendment or license renewal. (3) Any existing license condition, not affected by a requirement in division 333-116, remains in effect until the license is amended or renewed. (4) If a license condition exempted a licensee from a provision of division 333-116 on June 15, 2006, it will continue to exempt a licensee from the corresponding provision in division 333-116. (5) If a license condition cites provisions in division 333-116 that will be deleted on June 15, 2006, then the license condition remains in effect until the license is amended or renewed to modify or remove the condition. (6) Licensees must continue to comply with any license condition that requires it to implement procedures required by OAR 333-116-0525, 333-116-0580, 333-116-0583, and 333-116-0587 until there is a license amendment or renewal that modifies the license condition. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06
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 division. (2) Unless prohibited by license condition, a specific license is not needed for an individual to: (a) Receive, possess, use or transfer radioactive material in accordance with the rules in this division under the supervision of an authorized user as provided in OAR 333-116-0100; or (b) Prepare unsealed byproduct material for medical use in accordance with the rules in this division under the supervision of an authorized nuclear pharmacist or authorized user as provided in OAR 333-116-0100. (3) Notwithstanding the above requirements, any licensee licensed pursuant to this rule also is authorized to use radioactive material under the general license in OAR 333-102-0130 for the specified in vitro uses without filing the form as required by 333-102-0130(2); the licensee is subject to the other provisions of 333-102-0130. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2007, f. & cert. ef. 3-1-07 HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91
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, 333-116-0420 and 333-116-0480 and medical use of byproduct material as described in OAR 333-116-0485 must be made by filing a "Radioactive Materials License Application: Medical." A request for a license amendment or renewal may be submitted in letter format. (3) Licensing of remote afterloaders as described in OAR 333-116-0480 requires a separate "Radioactive Materials License Application: The Medical License application must be completed and submitted to the Authority. A request for a license amendment or renewal may be submitted in letter format. (4) An application for a license for medical use of radioactive material as described in OAR 333-116-0800, Licensing and Registration of Positron Emission Tomography (PET) Facilities, must be made by filing a "Radioactive Materials License Application: Medical." (a) In addition to the information required in the "Radioactive Materials License Application: Medical," the application must also include information regarding any radiation safety aspects of the medical use of the radioactive material that is not addressed in this division, as well as any specific information necessary for: (A) Radiation safety precautions and instructions; (B) Training and experience of proposed users; (C) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and (D) Calibration, maintenance, and repair of equipment necessary for radiation safety. (b) The applicant of licensee must also provide any other information requested by the Authority in its review of the application. NOTE: An applicant that satisfies the requirements specified in OAR 333-102-0900 may apply for a Broad Scope A specific license. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 4-2010, f. & cert. ef. 2-16-10 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03
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 an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist under the license except: (a) For an authorized user; an individual who meets the requirements in OAR 333-116-0760, 333-116-0660, 333-116-0670, 333-116-0680, 333-116-0683, 333-116-0687, 333-116-0690, 333-116-0710 and 333-116-0720. (b) For an authorized nuclear pharmacist; an individual who meets the requirements in OAR 333-116-0910 and 333-116-0760. (c) For an authorized medical physicist; an individual who meets the requirements in OAR 333-116-0905 and 333-116-0760. (d) An individual identified as an authorized user, authorized nuclear pharmacist, ophthalmic physicist or an authorized medical physicist on a Nuclear Regulatory Commission or Agreement State license that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy. (3) Before changing the Radiation Safety Officer except as provided in OAR 333-116-0090; (4) Before permitting anyone to work as an Associate Radiation Safety Officer, or before the Radiation Safety Officer assigns duties and tasks to an Associate Radiation Safety Officer that differ from those for which this individual is authorized on the license; (5) Before receiving a sealed source from a different manufacturer or of a different model number than authorized by the license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license. (6) Before receiving radioactive material in excess of the amount authorized on the license; (7) Before adding to or changing the areas of use or mailing address identified on the license; and (8) Before revising procedures required by OAR 333-116-0495, 333-116-0580, 333-116-0583, and 333-116-0587 as applicable where such revision reduces radiation safety. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 4-2013, f. & cert. ef. 1-29-13 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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, supported, or regulated by a federal agency that has implemented the Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research: (a) Obtain review and approval of the research from an Institutional Review Board, as defined and described in the Federal Policy; and (b) Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject. (3) If the research is not conducted, funded, supported, or regulated by another federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, submit a license amendment request to the Authority and receive approval by amendment. The amendment request must include a written commitment that the licensee must, before conducting research; (a) Obtain review and approval of the research from an Institutional Review Board, as defined and described in the Federal Policy; and (b) Obtain informed consent, as defined and described in the Federal Policy, from the human research subject. (4) Nothing in this rule relieves licensees from complying with other requirements in this division. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06
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 changes in areas of use only at the addresses specified in the license; (3) The provisions of OAR 333-116-0050(1); (4) The provisions of OAR 333-116-0050(2)(a) for an authorized user, ophthalmic physicist or authorized nuclear pharmacist, and (5) The provisions of OAR 333-116-0140(1). Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03
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 paid any applicable fee as provided in division 103 of these rules; (c) The Authority finds the applicant equipped and committed to observe the safety standards established by the Authority in these rules for the protection of the public health and safety; and (d) The applicant meets the requirements of division 102 of these rules. (2) The Authority must issue a license for mobile services if the applicant: (a) Meets the requirements in section (1) of this rule; and (b) Assures that individuals or human research subjects to whom radiopharmaceuticals or radiation from implants will be administered may be released following treatment in accordance with OAR 333-116-0460. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03
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 defense and security and are otherwise in the public interest. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2007, f. & cert. ef. 3-1-07 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03
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 the supervised individual in the licensee's written radiation protection procedures, written directive procedures, the licensee's written quality management program, the Oregon Rules for the Control of Radiation and the license conditions appropriate to that individual's use of radioactive material; and (b) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures, written directive procedures, regulations of division 333-116, and license conditions with respect to the medical use of radioactive material. (2) A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by OAR 333-116-0030(3) must: (a) In addition to the requirements in OAR 333-111-0010, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's use of radioactive material; and (b) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, the written radiation protection procedures established by the licensee and division 333-116, and license conditions. (3) A licensee that permits supervised activities under sections (1) and (2) of this rule is responsible for the acts and omissions of the supervised individual. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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 identity is verified before each administration; and (b) Each administration is in accordance with the written directive. (2) The procedures required by section (1) of this rule must, at a minimum, address the following items applicable to the licensee's use of radioactive material: (a) Verifying the identity of the patient or human research subject; (b) Verifying that the specific details of the administration are in accordance with the written directive and, if applicable, the treatment plan; (c) Checking both manual and computer-generated dose calculations; (d) Verifying that any computer-generated dose calculations are correctly transferred into the console of therapeutic medical units authorized by OAR 333-116-0480 and 333-116-0485; (e) Determining if a medical event, as defined in OAR 333-116-1000 has occurred; and (f) Determining for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented. (3) The licensee must retain a copy of procedures in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 2-2026, minor correction filed 01/06/2026, effective 01/06/2026 PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03