justicedao/ipfs_state_laws huggingface dataset:
333-121-0001 Purpose and Scope (1) This division contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive material in irradiators used to irradiate objects or materials using gamma radiation. This division also contains radiation safety requirements for operating irradiators. The requirements of this division are in addition to other requirements of these regulations. In particular, the provisions of divisions 100, 102, 120, and 111 of chapter 333 apply to applications and licenses subject to this division. Nothing in this division relieves the licensee from complying with other applicable federal, state and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities. (2) The regulations in this division apply to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rates exceed 5 grays (500 rads) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this division. (3) The regulations in this division do not apply to self-contained dry-source-storage irradiators in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel; medical radiology or teletherapy; radiography for the irradiation of materials for nondestructive testing purposes; gauging; or open-field, agricultural, irradiations. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 5-2005, f. & cert. ef. 4-11-05
333-121-0020 Application for a Specific License (1) Applications for specific licenses shall be filed on a form prescribed by the Authority and satisfy the general requirements specified in OAR 333-102-0200. (2) The Authority may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Authority to determine whether the application should be granted or denied or whether a license should be modified or revoked. (3) Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf. (4) An application for a license may include a request for a license authorizing one or more activities. (5) In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the Authority provided such references are clear and specific. (6) Applications and documents submitted to the Authority may be made available for public inspection except that the Authority may withhold any document or part thereof from public inspection if disclosure of its content is not required in the public interest and would adversely affect the interest of a person concerned. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 12-2006, f. & cert. ef. 6-16-06 PH 5-2005, f. & cert. ef. 4-11-05
333-121-0030 Specific Licenses for Irradiators The Authority will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this section. (1) The applicant must satisfy the general requirements specified in division 102 of these regulations and the requirements contained in this division. (2) The application must describe the training provided to irradiator operators including: (a) Classroom training; (b) On-the-job or simulator training; (c) Safety reviews; (d) Means employed by the applicant to test each operator's understanding of the Authority's regulations and licensing requirements and the irradiator operating, safety, and emergency procedures; and (e) Minimum training and experience of personnel who may provide training. (3) The application must include an outline of the written operating and emergency procedures listed in OAR 333-121-0310 that describes the radiation safety aspects of the procedures. (4) The application must describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have radiation safety responsibilities or authorities. In particular, the application must specify who, within the management structure, has the authority to stop unsafe operations. The application must also describe the training and experience required for the position of radiation safety officer. (5) The application must include a description of the access control systems required by OAR 333-121-0110 the radiation monitors required by 333-121-0140 the method of detecting leaking sources required by 333-121-0340 including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors. (6) If the applicant intends to perform leak testing, the applicant must establish procedures for performing leak testing of dry-source-storage sealed sources and submit a description of these procedures to the Authority. The description must include the: (a) Methods of collecting the leak test samples; (b) Qualifications of the individual who collects the samples; (c) Instruments to be used; and (d) Methods of analyzing the samples. (7) If licensee personnel are to load or unload sources, the applicant must describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading must be done by a person specifically authorized by the Authority, the Nuclear Regulatory Commission, an Agreement State, or a Licensing State to load or unload irradiator sources. (8) The applicant must describe the inspection and maintenance checks, including the frequency of the checks required by OAR 333-121-0350. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 PH 5-2005, f. & cert. ef. 4-11-05
333-121-0040 Start of Construction The applicant may not begin construction of a new irradiator prior to the submission to the Authority of both an application for a license for the irradiator and any fee required by the applicable state requirement or statute. As used in this division, the term "construction" includes the construction of any portion of the permanent irradiator structure on the site but does not include: engineering and design work, purchase of a site, site surveys or soil testing, site preparation, site excavation, construction of warehouse or auxiliary structures, and other similar tasks. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license with respect to the requirements of the appropriate state statute, rules, regulations, and orders issued under the appropriate state statute. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0050 Applications for Exemptions Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this division. The Authority will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that they are likely to provide an adequate level of safety for workers and the public. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0060 Request for Written Statements Each license is issued with the condition that the licensee will, at any time before expiration of the license, upon the Authority's request, submit a written statement to enable the Authority to determine whether the license should be modified, suspended, or revoked. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0100 Performance Criteria for Sealed Sources (1) Requirements for sealed sources installed after September 1, 2002: (a) Must have been evaluated in accordance with 10 CFR 32.210 or the equivalent state regulation; (b) Must be doubly encapsulated; (c) Must use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator; (d) Must be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the sources are for use in irradiator pools; and (e) In prototype testing of the sealed source, must have been leak tested and found leak-free after each of the tests described in OAR 333-121-0100(2) through 333-121-0100(7) of this rule. (2) Temperature. The test source must be held at -40oC for 20 minutes, 600oC for one hour, and then be subjected to thermal shock test with a temperature drop from 600oC to 20oC within 15 seconds. (3) Pressure. The test source must be twice subjected for at least five minutes to an absolute external pressure of 2 million newtons per square meter. (4) Impact. A 2 kilogram steel weight, 2.5 centimeters in diameter, must be dropped from a height of 1 meter onto the test source. (5) Vibration. The test source must be subjected three times for ten minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of five times the acceleration of gravity. In addition, each test source must be vibrated for 30 minutes at each resonant frequency found. (6) Puncture. A 50 gram weight and pin, 0.3 centimeter pin diameter, must be dropped from a height of 1 meter onto the test source. (7) Bend. If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source must be subjected to a force of 2000 newtons at its center equidistant from two support cylinders, the distance between which is ten times the minimum cross-sectional dimension of the source. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 PH 5-2005, f. & cert. ef. 4-11-05
333-121-0120 Shielding (1) The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 0.02 millisievert (2 mrem) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not to exceed 100 square centimeters having no linear dimension greater than 20 centimeters. Any area where the radiation dose rate exceeds 0.02 millisievert (2 mrem) per hour must be locked, roped off, or posted. (2) The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 0.02 millisievert (2 mrem) per hour when the sources are in the fully shielded position. (3) The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator when the source is shielded may not exceed 0.02 millisievert (2 mrem) per hour and at 5 centimeters from the shield may not exceed 0.2 millisievert (20 mrem) per hour. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0130 Fire Protection (1) The radiation room at a panoramic irradiator must have heat and smoke detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person who is prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected. (2) The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0140 Radiation Monitors (1) Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting an individual in the facility who is prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the requirements of this paragraph. (2) Underwater irradiators that are not in a shielded radiation room must have a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual who is prepared to respond promptly. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0150 Control of Source Movement (1) The mechanism that moves the sources of a panoramic irradiator must require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key. (2) The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in the fully shielded position, when they are in transit, and when the sources are exposed. (3) The control console of a panoramic irradiator must have a control that promptly returns the sources to the shielded position. (4) Each control for a panoramic irradiator must be clearly marked as to its function. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0160 Irradiator Pools (1) For licenses initially issued after April 11, 2005, irradiator pools must either: (a) Have a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool; or (b) Be constructed so that there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination. In either case, the licensee must have a method to safely store the sources during repairs of the pool. (2) For licenses initially issued after April 11, 2005, irradiator pools must have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons must have siphon breakers to prevent the siphoning of pool water. (3) A means must be provided to replenish water losses from the pool. (4) A visible indicator must be provided in a clearly observable location to indicate if the pool water level is below the normal low water level or above the normal high water level. (5) Irradiator pools must be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so that the sources can be seen clearly. (6) A physical barrier, such as a railing or cover, must be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations. (7) If long-handled tools or poles are used in irradiator pools, the radiation dose rate to the operator at the handling areas of the tools may not exceed 0.02 millisievert (2 mrem) per hour. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 PH 5-2005, f. & cert. ef. 4-11-05
333-121-0170 Source Rack Protection If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a carrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0180 Power Failures (1) If electrical power at a panoramic irradiator is lost for longer than ten seconds, the sources must automatically return to the shielded position. (2) The lock on the door of the radiation room of a panoramic irradiator must remain locked in the event of a power failure. (3) During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05
333-121-0310 Operating and Emergency Procedures (1) The licensee must have and follow written operating procedures for: (a) Operation of the irradiator, including entering and leaving the radiation room; (b) Use of personnel dosimeters; (c) Surveying the shielding of panoramic irradiators; (d) Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas; (e) Leak testing of sources; (f) Inspection and maintenance checks required by OAR 333-121-0350; (g) Loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and (h) Inspection of movable shielding required by OAR 333-121-0110(8), if applicable. (2) The licensee must have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for: (a) Sources stuck in the unshielded position; (b) Personnel overexposures; (c) A radiation alarm from the product exit portal monitor or pool monitor; (d) Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water; (e) A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool; (f) A prolonged loss of electrical power; (g) A fire alarm or explosion in the radiation room; (h) An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area; (i) Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and (j) The jamming of automatic conveyor systems. (3) The licensee may revise operating and emergency procedures without Authority approval only if all of the following conditions are met: (a) The revisions do not reduce the safety of the facility; (b) The revisions are consistent with the outline or summary of procedures submitted with the license application; (c) The revisions have been reviewed and approved by the radiation safety officer; and (d) The users or operators are instructed and tested on the revised procedures before they are put into use. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 PH 5-2005, f. & cert. ef. 4-11-05
333-121-0320 Personnel Monitoring (1) Irradiator operators must wear a personnel dosimeter while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter processor must be capable of detecting high energy photons in the normal and accident dose ranges, see OAR 333-120-0200(3). Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be replaced at least monthly, and all other personnel dosimeters must be processed at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent. (2) Other individuals who enter the radiation room of a panoramic irradiator must wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of the paragraph, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within ±20 percent of the true radiation dose. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 3-2023, amend filed 01/17/2023, effective 01/18/2023 PH 12-2006, f. & cert. ef. 6-16-06 PH 5-2005, f. & cert. ef. 4-11-05
333-121-0330 Radiation Surveys (1) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator must be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators must be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding must be performed at intervals not to exceed three years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates. (2) If the radiation levels specified in OAR 333-121-0120 are exceeded, the facility must be modified to comply with the requirements in OAR 333-121-0120. (3) Portable radiation survey meters must be calibrated at least annually to an accuracy of ±20% for the gamma energy of the sources in use. The calibration must be done at two points on each scale or, for digital instruments, at one point per decade over the range that will be used. Portable radiation survey meters must be of a type that does not saturate and read zero at high radiation dose rates. (4) Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in 10 CFR 20, Table II, Column 2 or Table III of Appendix B, "Annual Limits on Intake (ALIs) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sanitary Sewerage." (5) Before releasing resins for unrestricted use, they must be monitored before release in an area with a background level less than 0.5 microsievert (0.05 mrem) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used must be capable of detecting radiation levels of 0.5 microsievert (0.05 mrem) per hour. Statutory/Other Authority: ORS 453.675 Statutes/Other Implemented: ORS 453.675 History: PH 5-2005, f. & cert. ef. 4-11-05