justicedao/ipfs_state_laws huggingface dataset:
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 clinic. (a) In the case of separate licenses for different components in a PET facility, there must be a cooperative consortium of management and radiation safety personnel that acts as directors for the facility. (b) Management, whether singular or in consortium, must write a statement of authority and responsibility for all staff handling or controlling the production and use of PET isotopes. (2) The RSO must be assisted by personnel specifically trained and designated for the area of concern, whether accelerator operation, pharmaceutical production, or PET clinic. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 79-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2010, f. & cert. ef. 2-16-10 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1995, f. & cert. ef. 4-26-95
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 Human Subjects Review Board or Committee. The licensee must establish procedures, reviews, quality assurance, and emergency procedures for all procedures reviewed by the IRB. The IRB, the PET Radiation Safety Committee or subcommittee, and the PET or facility Radiation Safety Officer must review and approve any and all PET procedures, unless otherwise authorized in a radioactive materials license pursuant to OAR 333-102-0200. (2) Transfers of radioisotopes must be in accordance with requirements in OAR 333-102-0330. (3) PET facility radiation protection programs, occupational dose limits, radiation dose limits for the public, surveys and monitoring, restricted area control, storage of radioactive materials, internal exposure control, precautionary procedures, waste disposal, records, and reports must meet all applicable requirements of division 333-120. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 80-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1995, f. & cert. ef. 4-26-95
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 during operation. (2) Non-ionizing radiation must meet requirements of division 333-112. (3) Target maintenance and repair, contamination control, and emergency actions must be conducted pursuant to division 333-120. (4) There must be an Understanding of Transfer (UOT) when isotopes are transferred from one licensee or entity to another for processing, specifying at what point control is transferred to personnel handling radiochemical production or radiopharmacy operation. (5) Radiation surveys must be made prior to any accelerator operation or isotope production with a radiation survey instrument calibrated in accordance with requirements in OAR 333-116-0390. Periodic surveys must be done throughout times of operation to ensure that radiation levels meet all applicable requirements in division 333-120 (Radiation Protection Standards). (6) Ventilation controls must be implemented to ensure compliance with all applicable local, state, and federal requirements. Controls must include monitoring of stacks and computer modeling of air emissions to confirm compliance with standards. (7) Real-time (integrating) monitors must be used to confirm requirements in OAR 333-120-0100, 333-120-0160, 333-120-0170, and 333-120-0180. (8) Contamination wipes for radioactive material must be made pursuant to requirements in OAR 333-116-0250; (9) Dosimetry must address both gamma and beta doses in all areas of the facility. Licensees and registrants must monitor extremities to ensure compliance with OAR 333-120-0100. Bioassays, as defined in 333-100-0005, are not required, but there must be evaluation of internal exposures, pursuant to 333-120-0130, based on calculated releases and monitoring. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2018, minor correction filed 02/01/2018, effective 02/01/2018 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 1-1995, f. & cert. ef. 4-26-95
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 other equipment unique to the PET process must meet all applicable radiation protection standards pursuant to division 120 of these rules. (3) Area monitors must be visible and audible to accelerator operators. Monitors must be checked for proper operation daily. (4) Wasted targets must be treated as radioactive waste and must be properly dismantled, shielded, stored, and disposed. (5) Accelerator shielding design and safety must meet requirements of OAR 333-109-0025. (6) Shielding around guide-bends, targets, hot-cells, purification manifolds, etc. must ensure that limits in OAR 333-120-0180 and 333-120-0190 have been met in all areas of beam and nuclide production. (7) Security provisions for unauthorized access, janitorial services, maintenance, visitors, tours, and personnel-in-training must conform to requirements in OAR 333-120-0180, 333-120-0250 and 333-120-0260. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 82-2018, minor correction filed 02/01/2018, effective 02/01/2018 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 HD 1-1995, f. & cert. ef. 4-26-95
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 be reviewed and approved by the licensee's or consortium Institutional Review Board (IRB). (b) No research radiopharmaceutical must be used in a human being until its pyrogenicity and purity have been shown to meet applicable standards. (2) Pharmacy or chemistry personnel must work directly under the supervision of a physician who meets the training criteria in OAR 333-116-0670. (3) There must be no transfers between or among licensees unless there is a signed Memorandum or Understanding of Transfer. Such memorandum must preclude any transfers from one licensee entity to another if there is incomplete information, purity questions, or non-approval from the IRB. (4) There must be a detailed description of the shielding and operation of the "black box" (hot cell). (5) There must be operating and emergency, training, and survey procedures for ease of movement of the product within the pharmacy production area. Emergency procedures must address potential high dose rate emergencies such as stuck rabbit (transport container), pneumatic tube contamination, manifold leak or spill, hot cell emergency, or other incident. (6) Equipment and procedures must include: (a) Hood with continuous stack monitoring system and procedures to confirm air emission standards compliance; (b) Remote handling equipment for very high dose rates (all handling must be done remotely); (c) Dose calibration, system validation, and calibration standards, for all individual doses; (d) Ba-133 must not be used as a calibration source; (e) Dose calibrator linearity check using a positron emitter (beta shield must be evaluated to prevent interference with annihilation measurement); (f) Product delivery system design, shielding, carrier, and emergency procedures; (g) Leak tests (hermeticity) of delivery container; (h) Labeling requirements, transportation manifests, and packaging for outside deliveries; (i) Transportation requirements pursuant to division 333-118; (j) Inventory control, "cradle to grave" tracking, and communication with PET clinic; (k) Waste disposal procedures. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 83-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1995, f. & cert. ef. 4-26-95
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 for early model PET cameras. Dose calibration procedures are the same as in OAR 333-116-0850(6). Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 84-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 HD 1-1995, f. & cert. ef. 4-26-95
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 applications. (2) Technical personnel working under an authorized user must have basic radiation safety training, plus 40 additional hours specific to PET. (3) Positron Emission-Computed Tomography (PET/CT) or Single Photon Emission-Computed Tomography (SPECT/CT) systems must be operated by technologists licensed by the Oregon Board of Medical Imaging who are: (a) Any registered radiographer with the credential R.T. (R); (b) Registered radiation therapist with the credential R.T. (T); (c) Registered certified nuclear medicine technologist with the credentials R.T. (N); or (d) Certified Nuclear Medicine Technologist (CNMT) by the Nuclear Medicine Technologist Certification Board (NMTCB). (4) The individuals mentioned in section (3) of this rule must also have successfully completed appropriate additional education and training and demonstrated competency in the use and operation of PET/CT or SPECT/CT systems. (5)(a) Appropriate additional training is considered training that covers the topic areas outlined in the PET/CT curriculum developed by the Multi-Organizational Curriculum Project Group sponsored by the American Society of Radiologic Technologists and the Society of Nuclear Medicine Technologists, or equivalent training approved by the Authority; and (b) Includes the content specified in the PET/CT curriculum for the area(s) that the individual is not already trained or certified in; or (c) Individuals meeting the requirements of section (3) of this rule and who have successfully completed training that the Authority has evaluated and judged to be substantially equivalent to that specified in subsection (6)(a) of this rule. (6) An R.T. (N) or CNMT certified in Computed Tomography through the American Registry of Radiologic Technologists is considered to have met the training requirements in section (3) of this rule. (7) Technologists operating PET/CT or SPECT/CT systems must do so under the direction of an authorized user licensed to perform imaging and localization studies in accordance with OAR 333-116-0320. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 234-2018, amend filed 08/02/2018, effective 08/16/2018 PH 85-2018, minor correction filed 02/01/2018, effective 02/01/2018 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 5-2005, f. & cert. ef. 4-11-05 HD 1-1995, f. & cert. ef. 4-26-95
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 licensee must call the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in OAR 333-116-0330(1) at the time of generator elution. The telephone report to the Authority must include the manufacturer, model number, and serial number (or lot number) of the generator, the results of the measurement, the date of the measurement, whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken. (2) The licensee shall submit a written report to Radiation Protection Services, 800 NE Oregon Street, Suite 640, Portland Oregon, 97232 within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee’s equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee’s breakthrough determination; and the information in the telephone report as required by section (1) of this rule. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, adopt filed 11/19/2021, effective 11/23/2021
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 number and serial number of the leaking source, if assigned; (2) The radionuclide and its estimated activity; (3) The results of the test; (4) The date of the test; and (5) The action taken. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 91-2018, minor correction filed 02/01/2018, effective 02/01/2018 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
333-117-0010 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: ORS 453.605 - 453.775 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91
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. (2) The Rules in this division address the introduction of NORM into products in which neither the NORM nor the radiation emitted from the NORM is considered to be beneficial to the products. The manufacture and distribution of products containing NORM in which the NORM and/or its associated radiation(s) is considered to be a beneficial attribute are licensed under the provisions of division 102. (3) This division also addresses waste management and disposal standards which apply to both inactive and active sites and facilities. Statutory/Other Authority: ORS 453.605 - 453.745 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91
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 for the purpose of altering the chemical or physical properties to improve the quality, purity or assay grade of a desired product. (3) “General Environment” means the total terrestrial, atmospheric and aquatic environments outside sites within which any activity, operation or process authorized by a general or specific license issued under this Division is performed. (4) “Naturally Occurring Radioactive Material (NORM)” means any nuclide which is radioactive in its natural physical state (i.e., not man-made), but does not include source or special nuclear material. (5) “Working Level (WL)” means any combination of short-lived radon decay products in one liter of air that will result in the ultimate emission of alpha particles with a total energy of 130 billion electron volts. (2.1 x 10-8J). Statutory/Other Authority: ORS 453.605 - 453.745 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91
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 radium, 0.05 percent by weight of uranium or thorium or 150 picocuries per gram (5.55 kBq/kg) of any other NORM radionuclide, provided that these concentrations are not exceeded at any time. (2) Persons who receive products or materials containing NORM distributed in accordance with a specific license issued by the Agency pursuant to OAR 333-117-0220(2) or an equivalent license issued by another Licensing State are exempt from these rules. (3) The manufacturing, distribution, use and disposal of the following products/materials are exempt from the requirements of these rules: (a) Potassium and potassium compounds which have not been isotopically enriched in the radionuclide K-40; and (b) Brazil nuts. (4) The wholesale and retail distribution (including custom blending), possession and use of the following products/material are exempt from the requirements of these: (a) Phosphate and potash fertilizer; (b) Phosphogypsum for agricultural uses; and (c) Materials used for building construction if such materials contain NORM which has not been technologically enhanced. (5) The possession and use of natural gas and natural gas products as a fuel are exempt from the requirements of these rules. The distribution of natural gas and the manufacturing and distribution of natural gas products are exempt from the specific license requirements of this division but are subject to the general license requirements in OAR 333-117-0100 and 333-117-0130. Statutory/Other Authority: ORS 453.605 - 453.745 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91
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 provisions of this division. Statutory/Other Authority: ORS 453.605 - 453.745 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91
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 products containing NORM in concentrations greater than those specified in OAR 333-117-0040(1). (2) Facilities and equipment contaminated with NORM in excess of the levels set forth in Table 1 of this division shall not be released for unrestricted use. The decontamination or maintenance of such equipment and facilities shall only be performed by persons specifically licensed by the Agency or another Licensing State to conduct such work. Each general licensee shall establish written procedures for the evaluation (or screening) of equipment and components to ensure that the levels in Table 1 of this division are not exceeded. (3) No person shall transfer land for unrestricted use where the concentration of radium-226 or radium-228 in soil averaged over any 100 square meters exceeds the background level by more than: (a) Five pCi/gm, averaged over the first 15 cm of soil below the surface; and (b) Fifteen pCi/gm, averaged over 15 cm thick layers of soil more than 15 cm below the surface. (4) Equipment contaminated with NORM in excess of the levels set forth in Table 1 of this division may be released for maintenance and/or overhaul provided the recipient is specifically licensed to perform the activity on contaminated equipment. The decontamination or maintenance of equipment, facilities and land, as described in OAR 333-117-0200(2) shall only be performed by persons specifically licensed by the Agency or another Licensing State to conduct such work. [ED. NOTE: Tables referenced are available from the agency.] Statutory/Other Authority: ORS 453.605 - 453.745 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91
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 effluents, which shall be governed by 333-117-0120 and disposal, which shall be governed by 333-117-0130. Statutory/Other Authority: ORS 453.605 - 453.745 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91
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 background exceeding an equivalent of 25 millirem (0.25 mSv) to the whole body or 75 millirem (0.75 mSv) to the critical organ of any member of the public. Doses due to radon-220, radon-222 and their respective decay products, are excluded from these limits. Effort shall be made to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable. Statutory/Other Authority: ORS 453.605 - 453.745 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91
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 such wastes or in a manner equivalent to the requirements for uranium and thorium byproduct materials in 40 CFR 192 or shall transfer wastes for disposal to a land disposal facility licensed by the U.S. Nuclear Regulatory Commission or an Agreement State or a Licensing State. Records of disposal including manifests, shall be maintained pursuant to the provisions of division 120. Transfers of waste containing NORM for disposal shall be made only to a person specifically licensed to receive such waste. Statutory/Other Authority: ORS 453.605 - 453.745 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91