Or. Admin. R. 333-102-0235 - Requirements for License to Manufacture, or Initially Transfer Radioactive Material Contained in Devices Granted a General License Under OAR 333-102-0115

(1) An application for a specific license to manufacture, or initially transfer devices containing radioactive material, excluding special nuclear material, to persons granted a general license by OAR 333-102-0115 or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State will be approved if:
(a) The applicant satisfies the general requirements of OAR 333-102-0200;
(b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:
(A) The device can be safely operated by persons not having training in radiological protection;
(B) Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device; and it is unlikely that any person will receive in one year a dose in excess of ten percent of the annual limits specified in OAR 333-120-0100; and
(C) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person may receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in 10 CFR Part 32.24:
(i) Whole body, head and trunk, active blood-forming organs, gonads, or lens of eye 150 mSv (15 rem);
(ii) Hands and forearms, feet and ankles, localized areas of skin averaged over areas no larger than one square centimeter two Sv (200 rem);
(iii) Other organs 500 mSv (50 rem).
(c) Each device bears a durable, legible, clearly visible label or labels approved by the Authority, which contain in a clearly identified and separate statement:
(A) Instructions and precautions necessary to assure safe installation, operation and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);
(B) The requirements, or lack of requirement, for leak testing, or for testing of any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and
(C) The information called for in the following statement in the same or substantially similar form:

The receipt, possession, use and transfer of this device, Model _____, Serial No. _____, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or of a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label must be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION - RADIOACTIVE MATERIAL

_____________________________________________

(Name of manufacturer or initial transferor)

(D) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, "Caution-Radioactive Material," the radiation symbol described in OAR 333-120-0400, and the name of the manufacturer or initial distributor.
(E) Each device meeting the criteria of OAR 333-102-0115(9)(a), bears a permanent label, such as being embossed, etched, stamped, or engraved, affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, "Caution-Radioactive Material," and, if practicable, the radiation symbol described in OAR 333-120-0400.
(F) The device has been registered in the Sealed Source and Device Registry
(2) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or both, the applicant must include in this application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Authority will consider information that includes, but is not limited to:
(a) Primary containment (source capsule);
(b) Protection of primary containment;
(c) Method of sealing containment;
(d) Containment construction materials;
(e) Form of contained radioactive material;
(f) Maximum temperature withstood during prototype tests;
(g) Maximum pressure withstood during prototype tests;
(h) Maximum quantity of contained radioactive material;
(i) Radiotoxicity of contained radioactive material; and
(j) Operating experience with identical devices or similarly designed and constructed devices.
(3) In the event the applicant desires that the general licensee under OAR 333-102-0115, or under equivalent rules of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant must include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the bases for these estimates. The submitted information must demonstrate that performance of this activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of ten percent of the annual limits specified in OAR 333-120-0100.
(4) Prior to transfer of a device to a person granted a general license by OAR 333-102-0115(1), the licensee must:
(a) Furnish a copy of the general license contained in OAR 333-102-0115 to each person to whom the licensee directly, or through an intermediate person, transfers radioactive material in a device for use pursuant to the general license contained in 333-102-0115;
(b) Furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission, Agreement State or Licensing State's rules equivalent to OAR 333-102-0115. Alternatively, a copy of the general license contained in 333-102-0115 must be furnished to each person to whom directly, or through an intermediate person, is transfers radioactive material in a device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission, the Agreement State or the Licensing State. If a copy of the general license in 333-102-0115 is furnished to such person, it must be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State under requirements substantially the same as those in 333-102-0115;
(c) Report to the Authority all transfers of such devices to persons for use under the general license in OAR 333-102-0115. Such report must identify each general licensee by name and address, an individual by name or position who may constitute a point of contact between the Authority and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report must include identification of each intermediate person by name, address, contact and relationship to the intended user. If no transfers have been made to persons granted a general license by 333-102-0115 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days after the end of each quarter;
(d) Furnish reports to other agencies:
(A) Report to the U.S. Nuclear Regulatory Commission all transfers of such devices to persons for use under the U.S. Nuclear Regulatory Commission general license in section 31.5 of 10 CFR Part 31. Reports must be submitted on the NRC form "Transfers of Industrial Devices Report" or on a clear and legible report containing all of the data required by the form. The required information includes:
(i) The identity of each general licensee by name and address;
(ii) The name and phone number of the person designated by the general licensee to be responsible for ensuring compliance with the appropriate regulations and requirements;
(iii) The date of transfer;
(iv) The type, model number, and serial number of the device transferred; and
(v) The quantity and type of byproduct material contained in the device.
(B) If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediate person, and clearly designate that person as an intermediate person.
(C) If the device transferred replaced another returned by the general licensee, report also the type, model number, and serial number of the one returned.
(D) If no transfers have been made to persons generally licensed under 10 CFR 31.5 or OAR 333-102-0115 during the reporting period, the report must so indicate.
(E) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.
(F) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.
(e) Report to the responsible Agreement or Licensing State Authority all transfers of such devices to persons for use under a general license in an Agreement State's regulations equivalent to OAR 333-102-0115. Such reports must identify all of the information in 333-102-0235(4)(d) of this rule, including each general licensee by name and address, an individual by name or position who may constitute a point of contact between the Authority and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report must include identification of each intermediate person by name, address, contact and relationship to the intended user. The report must be submitted within 30 days after the end of each calendar quarter in which such device is transferred to the person granted a general license;
(f) If no transfers have been made to U.S. Nuclear Regulatory Commission's licensees during the reporting period, this information must be reported to the U.S. Nuclear Regulatory Commission;
(g) If no transfers have been made to persons granted a general license within a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State Agency upon request of the Authority;
(h) Keep records showing the name, address and the point of contact for each general licensee to whom directly, or through an intermediate person is transferred radioactive material in devices for use pursuant to the general license provided in OAR 333-102-0115 or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State. The records must show the date of each transfer, the isotope and the quantity of radioactive material in each device transferred, the identity of any intermediate person and compliance with the reporting requirements of subsection (4)(h) of this rule. Records required by this rule must be maintained for a period of three years following the estimated useful life of the device or the date of final disposition, if known;
(i) Furnish a list of the services that only can be performed by a specific licensee, and information on acceptable disposal options, including estimated costs of disposal, to each person to whom he directly, or through an intermediate person, transfers radioactive material in a device for use under the general license granted in OAR 333-102-0115;
(j) Furnish the name, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained. If a copy of the general license in OAR 333-102-0115 is furnished to such person, it must be accompanied by a note explaining that use of the device is regulated by the Agreement State.
(k) Label each device transferred if more than one year after the effective date of this rule in accordance with the labeling requirements in 10 CFR Part 32.51(a)(3) through (5).
(l) If a notification of bankruptcy has been made under 10 CFR Part 30.34(h) or the license is to be terminated, provide, upon request, to the NRC and to any appropriate Agreement State, records of final disposition required under 10 CFR Part 32.52(c).
(5) License Conditions.
(a) If a device containing radioactive material is to be transferred for use under the general license contained in OAR 333-102-0115, each person that is licensed under this rule must provide the information specified in this section to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:
(A) A copy of the general license contained in OAR 333-102-0115; if 333-102-0115(4)(b) through (d) or 333-102-0115(8) do not apply to the particular device, those sections may be omitted;
(C) A list of the services that can only be performed by a specific licensee;
(D) Information on acceptable disposal options including estimated costs of disposal; and
(b) If radioactive material is to be transferred in a device for use under an equivalent general license of an Agreement State, each person that is licensed under this rule must provide the information specified in this section to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:
(A) A copy of the Agreement State's regulations equivalent to OAR 333-102-0115, 333-100-0055, 333-100-0057, 333-120-0700 and 333-120-0710 or a copy of 10 CFR Secs. 31.5, 31.2, 30.51, 20.2201, and 20.2202. If a copy of the Nuclear Regulatory Commission regulations is provided to a prospective general licensee in lieu of the Agreement State's regulations, it must be accompanied by a note explaining that use of the device is regulated by the Agreement State. If certain sections of the regulations do not apply to the particular device, those sections may be omitted;
(B) A list of the services that can only be performed by a specific licensee;
(C) Information on acceptable disposal options including estimated costs of disposal; and
(D) The name or title, address, and phone number of the contact at the Agreement State regulatory agency or the Nuclear Regulatory Commission from which additional information may be obtained.

Notes

Or. Admin. R. 333-102-0235
HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 19-2015, f. 9-30-15, cert. ef. 10/1/2015

Publications: Publications referenced are available from the agency.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

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