justicedao/ipfs_state_laws huggingface dataset:
333-102-0275 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Manufacture and Distribution of Ice Detection Devices An application for a specific license to manufacture and distribute ice detection devices to persons granted a general license by OAR 333-102-0135 will be approved if: (1) The applicant satisfies the general requirements of OAR 333-102-0200; (2) The criteria of sections 32.61, 32.62, 32.103, and 32.110 of 10 CFR Part 32 are met. [Publications: Publications referenced are available from the agency.] Statutory/Other Authority: ORS 453.635 & 453.665 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 HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-102-0297 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Sealed Source or Device Evaluation No sealed source or device containing radioactive material may be authorized on a specific license or general license until radiation safety information for that sealed source or device has been evaluated by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. Statutory/Other Authority: ORS 453.635 & 453.665 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 1-1995, f. & cert. ef. 4-26-95
333-102-0300 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Issuance of Specific Licenses (1) Upon a determination that an application meets the requirements of the Act and these rules, the Authority shall issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary. (2) The Authority may incorporate in any license at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material subject to this division as it deems appropriate or necessary in order to: (a) Minimize danger to public health and safety or property; (b) Require such reports and the keeping of such records and to provide for such inspections of activities under the license as may be appropriate or necessary; and (c) Prevent loss or theft of material subject to this division. (3) Whenever the Authority denies an application for a new license or a license renewal, the Authority shall notify the applicant in writing stating the grounds for denial. Upon denial, the applicant may request a hearing pursuant to OAR 333-102-0345. Statutory/Other Authority: ORS 453.635 & 453.665 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 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 HD 4-1985, f. & ef. 3-20-85
333-102-0315 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Application for Renewal of Licenses (1) Application for renewal of a specific license must be filed in accordance with OAR 333-102-0190. (2) In any case in which a licensee, not less than 30 days prior to expiration of the existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until final action by the Authority. (3) Unless otherwise specified, specific licenses shall expire after five years. (4) The Authority shall require reapplication when the license expires. (5) The Authority may grant, upon written request from a licensee, extension of the license expiration date up to five years from the original expiration date. Notwithstanding any licensee request, the Authority is not required, and may deny, any license extension, based on review of licensed activities. Statutory/Other Authority: ORS 453.635 & 453.665 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 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-102-0320 Amendment of Licenses at Request of Licensee Application for amendment of a license must be filed in accordance with OAR 333-102-0190 and must specify the respects in which the licensee desires the license to be amended and the grounds for such amendment. Statutory/Other Authority: ORS 453.635 & 453.665 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 4-1985, f. & ef. 3-20-85
333-102-0325 Authority Action on Applications to Renew and Amend In considering an application by a licensee to renew or amend the license, the Authority will apply the criteria set forth in OAR 333-102-0200 through 0290, as applicable. Statutory/Other Authority: ORS 453.635 & 453.665 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2010, f. & cert. ef. 2-16-10 PH 4-2007, f. & cert. ef. 3-1-07 HD 15-1994, f. & cert. ef. 5-6-94 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-102-0327 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specifically Licensed Items — Registration of Product Information (1) Any manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to the U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards for evaluation of radiation safety information about its product and for its registration. (2) The request for review must be made in duplicate and sent to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. NOTE: The U.S. Nuclear Regulatory Commission charges a fee for processing a sealed source or device evaluation request. Contact the U.S. Nuclear Regulatory Commission directly for current fee structure. (3) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. (4) The U.S. Nuclear Regulatory Commission normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. The U.S. Nuclear Regulatory Commission uses criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. (5) After completion of the evaluation, the U.S. Nuclear Regulatory Commission, issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product. (6) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with: (a) The statements and representations, including quality control program, contained in the request; and (b) The provisions of the registration certificate. Statutory/Other Authority: ORS 453.635 & 453.665 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
333-102-0335 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Modification, Revocation and Termination of Licenses (1) The terms and conditions of each license issued pursuant to the rules in this division and divisions 105, 113, 115, 116, 117, and 121 of this chapter shall be subject to amendment, revision or modification or by reason of amendments to the Act, or by reason of rules, regulations and orders issued in accordance with the terms of the Act by the Authority. (2) Any license may be revoked, suspended or modified, in whole or in part, for any material false statement in the application or any statement of fact required under section 182 of the Act, or because of conditions revealed by such application or statement of fact or any report, record or inspection or other means that would warrant the Authority to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act or of any rule, regulation or order of the US Nuclear Regulatory Commission or the Authority. (3) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended or revoked unless, prior to the institution of proceedings therefore, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements. (4) The Authority may terminate a specific license upon request submitted by the licensee to the Authority in writing. Statutory/Other Authority: ORS 453.635 & 453.665 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 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 HD 4-1985, f. & ef. 3-20-85
333-102-0345 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Special Procedures in Regulatory Review (1) The provisions of ORS Chapter 183 governing contested cases are applicable in any case where the Authority proposes to refuse to issue, renew, modify, amend, revise, revoke or suspend a general or specific license or to find noncompliance with or to refuse to grant exemption from a regulation of the Authority. (2) In any case where the Authority proposes to grant, issue, renew, modify, amend or revise a general or specific license, or to find compliance or to grant exemption from a regulation of the Authority and the Assistant Director of the Public Health Division determines that such action would first merit public notice and opportunity for hearing, the following procedures shall be applicable: (a) Notice of the proposed action shall be published in the Secretary of State's bulletin or a newspaper of general circulation in the state, which notice shall provide that within 15 days of the day of publication of the notice, any person whose interest may be affected by the outcome of the proceeding, or who represents a public interest in the results of the proceeding, may file a petition to be made a party and given an opportunity for hearing in the matter. The notice of proposed action shall set forth: (A) The nature of the action proposed; (B) The manner in which and the location at which inspection may be made of the Authority records pertaining to the proposed action; and (C) A reference of the Authority's rules governing institution and conduct of hearings in radiation control proceedings. (b) If no request for hearing is filed within the time prescribed in the notice, the proposed action shall be taken; (c) If a hearing is requested, the person requesting to participate as a party must file a petition requesting party status and opportunity for hearing, setting forth the same information required of a person requesting party status in a contested case when the Authority has given notice that it intends to hold a contested case hearing pursuant to OAR 137-003-0005(6). The same procedures for determining party status under OAR 137-003-0005 shall be followed upon receipt of the petition; (d) If the Authority allows party status, it shall in the same order set the time for a contested case hearing and provide notice of the order to the petitioner and all parties; (e) A contested case shall proceed in accordance with the provisions of ORS Chapter 183 governing contested cases. Statutory/Other Authority: ORS 453.635 & 453.665 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 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-102-0360 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Right to Cause the Withholding or Recall of Byproduct Material The Authority may cause the withholding or recall of byproduct material from any licensee who is not equipped to observe or fails to observe such safety standards to protect health as may be established by the Authority, or who uses such materials in violation of law or regulation of the Authority, or in a manner other than as disclosed in the application therefore or approved by the Authority. Statutory/Other Authority: ORS 453.635 & 453.665 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
333-102-0365 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Third Party Method If the applicant consents, the Authority may enter into third party agreements for the applicant to engage and pay for the services of a third party contractor to prepare an environmental impact analysis required by OAR 333-102-0190 and/or to furnish an opinion of independent experts, satisfactory to the Authority, in respect to the completeness and adequacy of any information or data furnished by the applicant and on any aspect of the applicant's project or effects thereof. (1) When the license applicant pays for a third party agreement, the monies paid for the consultant must not be considered as specific license fees, pursuant to OAR 333-103-0010 of this chapter. (2) In proceeding under the third party agreement, the Authority shall carry out the following practices: (a) Such contractor shall be chosen solely by the Authority. (b) The Authority shall manage the contract. (c) The consultant must be selected based on the consultant's ability and relevant and applicable work experience and an absence of conflict of interest. Third party contractors shall be required to execute a disclosure statement showing that they have no financial or other conflicting interest in the outcome of the project. (d) The Authority shall specify the information to be developed and supervise the gathering, analysis and presentation of the information. The Authority shall have sole authority for approval and modification of the statement, analysis, and conclusions included in third party's report. (e) The Authority has the single right of refusal of the final application and the Authority is not obligated to approve the application or issue a license. Statutory/Other Authority: ORS 453.635 & 453.665 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
333-102-0910 Transport: Specific Terms and Conditions for Broad Licenses (1) No licensee may use radioactive material in or on human beings or in field applications where radioactive material is released except as specifically authorized by license. (2) Experimental animals administered radioactive materials or their products must not be used for human consumption. (3) Licensees must conduct a physical inventory every six months to account for all radioactive material received and possessed under the license. The records of the inventories must be maintained until inspection by the Radiation Protection Services Section, and must include the quantities and kinds of radioactive material, location of sealed sources and the date of the inventory. Statutory/Other Authority: ORS 453.635 & 453.665 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 1-1995, f. & cert. ef. 4-26-95
333-103-0001 Purpose and Scope (1) The rules in this division establish fees for sources of radiation and provide for their payment. Sources of radiation, as defined in OAR 333-100-0005, include, but are not limited to, radiation facilities, radiation machine tubes, radiation producing devices, radioactive material in sealed and unsealed form (normal form and special form), and radioactive material uses. (2) Except as otherwise specifically provided, the rules in this division apply as follows: (a) Radiation producing machines, radiation facility registration, radiation machine vendors and services, accredited hospital radiology inspectors, and non-ionizing sources of radiation are subject to OAR chapter 333, divisions 101, 105, 106, 108, 109, 111, 112, 115, 119, 122 or 123; (b) Radioactive materials pursuant to OAR chapter 333 divisions 102, 105, 110, 113, 115, 116, 117 or 121; (c) General licenses and registrations pursuant to divisions 101 and 102 of this chapter; (d) Microwave Oven Service Licensees; (e) Radiological Analyses; and (f) Tanning Device Registrations. Statutory/Other Authority: ORS 453.635 & 453.665 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 92-2021, amend filed 12/29/2021, effective 01/01/2022 PH 4-2010, f. & cert. ef. 2-16-10 PH 4-2007, f. & cert. ef. 3-1-07 PH 11-2006, f. & cert. ef. 6-16-06 DOA 13-2006, f.& cert. ef. 6-21-06 HD 3-1996, f. & cert. ef. 8-9-96 HD 4-1995, f. & cert. ef. 9-8-95 HD 2-1995(Temp), f. & cert. ef. 7-11-95
333-103-0003 Definitions As used in this division, the following definitions apply: (1) "Dental, academic or veterinary X-ray machine tube" means any X-ray machine tube designed and manufactured for dental diagnostics, research, and development, or used for the healing arts of animals. (2) "Hospital, radiologist, chiropractic, osteopathic or medical X-ray machine tube" means any X-ray tube used for the healing arts relating to diagnostic or therapy procedures within a fixed or mobile medical facility. (3) "License" ("Acknowledgment of Validation," "Validation Certificate," "Certificate of Validation") means the document issued that validates receipt of payment for a specific license or registration fee. (4) "Radiation Generating Device or Podiatry X-ray Machine tube" means radiation generating devices that produce X-rays used in the non-healing arts industries or X-ray machine tubes used for podiatry diagnostic practices. (5) "Registration Fee" means: (a) The fee paid to the Authority for registering Radiation Machine tube; (b) The fee paid to the Authority to validate a general license registration issued pursuant to OAR 333-102-0101, 333-102-0103, 333-102-0115, 333-102-0130 or 333-102-0340; (c) The fee paid to the Authority to register a tanning device pursuant to OAR 333-119-0020; or (d) The fee paid to the Authority to license a microwave oven service pursuant to OAR 333-112-0010. (6) "Specific License Fee" means: (a) The annual fee payable, to validate specific licenses for sources of radiation; or (b) The fee paid upon application to the Authority for an Oregon Radioactive Materials License to license specific licensed sources of radiation pursuant to OAR 333-103-0010; or (c) The fee paid to license additional sources of radiation pursuant to OAR 333-103-0010. (7) "Vendor License Fee" means: an annual fee paid pursuant to OAR 333-103-0055 for a license for a person to provide products or services listed in OAR 333-101-0020. Statutory/Other Authority: ORS 453.757 Statutes/Other Implemented: ORS 453.757 History: PH 92-2021, amend filed 12/29/2021, effective 01/01/2022 PH 24-2014, f. & cert. ef. 8-15-14 PH 20-2010, f. & cert. ef. 9-1-10 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 HD 3-1996, f. & cert. ef. 8-9-96 HD 4-1995, f. & cert. ef. 9-8-95 HD 2-1995(Temp), f. & cert. ef. 7-11-95
333-103-0005 Biennial Fee for Radiation Machine Tubes (1) For the purpose of this division, a radiation machine is defined under OAR 333-100-0005. (2) Each radiation machine tube shall be validated biennially by a radiation machine tube fee in the following amounts: (a) Hospital, radiologist, chiropractic, osteopathic or medical X-ray machine tube, $427; (b) Radiation generating device or podiatry X-ray machine tube, $285; (c) Dental, academic, or veterinary X-ray machine tubes, $210; (d) Computed tomography X-ray machine tube, $600. (e) Cone beam computed tomography X-ray machine tube, $210. (f) Mammography X-ray machine tube, $800; or (g) Therapy X-ray machine tube, $1,000; (3) The radiation machine tube fee shall be due and payable for each radiation machine tube on or before March 1 of each biennium. (4) A certificate of validation or acknowledgment of validation for the current biennium must be posted on or near the radiation machine by the registrant. (5) In any case in which a registrant has submitted the proper fee prior to the expiration of a validation certificate, such existing validation certificate shall not expire until the issuance of a new validation certificate for the current biennium. (6) Upon written request and approval by the Authority, fees for new licenses or additional machines shall be prorated on a biennial quarterly basis for the current biennium. Statutory/Other Authority: ORS 453.757 & 453.761 Statutes/Other Implemented: ORS 453.757 & 453.761 History: PH 92-2021, amend filed 12/29/2021, effective 01/01/2022 PH 19-2015, f. 9-30-15, cert. ef. 10-1-15 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 11-2006, f. & cert. ef. 6-16-06 HD 3-1996, f. & cert. ef. 8-9-96 HD 4-1995, f. & cert. ef. 9-8-95 HD 2-1995(Temp), f. & cert. ef. 7-11-95 HD 15-1994, f. & cert. ef. 5-6-94 HD 15-1991, f. & cert. ef. 10-1-91 HD 1-1991, f. & cert. ef. 1-8-91 HD 13-1988, f. 6-7-88, cert. ef. 7-1-88 HD 4-1985, f. & ef. 3-20-85