6 Colo. Code Regs. § 1007-1-3.12

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1007-1-3.12 - Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices which Contain Radioactive Material

3.12.1 A licensee authorized to introduce radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under 3.3.1.1 shall meet the requirements of 10 CFR Part 32.11 and any other applicable NRC requirement.

3.12.2 No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempted pursuant to 3.3.2, under 10 CFR Part 30.14 or equivalent regulations of an Agreement State, except in accordance with a license issued under 10 CFR Part 32 .⁸

⁸ Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

3.12.2.3 Each person licensed under 3.12.2 shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under 3.3.2, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the Department. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to 3.12.2 during the reporting period, the report shall so indicate.

3.12.3Reserved.

3.12.4 Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed Under 3.6.4.

3.12.4.1 An application for a specific license to manufacture, or initially transfer devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 3.6.4 or equivalent regulations of NRC or an Agreement State will be approved if:

(1) The applicant satisfies the general requirements of 3.9;

(2) 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 any period of 1 calendar quarter a dose in excess of 10 percent of the limits specified in 4.6.1; 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 would receive an external radiation dose or dose commitment in excess of the following organ doses:

(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 1 square centimeter: 2 Sv (200 rem)

(iii) Other organs: 500 mSv (50 rem); and

(3) Each device bears a durable, legible, clearly visible label or labels approved by the Department, 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 requirement, or lack of requirement, for leak testing, or for testing 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 one of the following statements, as appropriate, in the same or substantially similar form:

(i) The receipt, possession, use, and transfer of this device, Model ___, Serial No. ___⁹, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION- RADIOACTIVE MATERIAL

________________________________

Name of manufacturer or distributor

⁹ The model, serial number, and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

(ii) The receipt, possession, use, and transfer of this device,

Model___, Serial No. ___¹⁰, are subject to a general license or the equivalent, and the radiation regulations. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION- RADIOACTIVE MATERIAL

________________________________

Name of manufacturer or distributor

¹⁰ The model, serial number, and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

(4) 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 prescribed in 4.27 and the name of the manufacturer or initial distributor.

(5) The device has been registered in the Sealed Source and Device Registry.

3.12.4.2 In the event the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which 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.

3.12.4.3 In determining the acceptable interval for the test for leakage of radioactive material, the Department will consider information which includes, but is not limited to:

(1) Primary containment or source capsule;

(2) Protection of primary containment;

(3) Method of sealing containment;

(4) Containment construction materials;

(5) Form of contained radioactive material;

(6) Maximum temperature withstood during prototype tests;

(7) Maximum pressure withstood during prototype tests;

(8) Maximum quantity of contained radioactive material;

(9) Radiotoxicity of contained radioactive material; and

(10) Operating experience with identical devices or similarly designed and constructed devices.

3.12.4.4 In the event the applicant desires that the general licensee under 3.6.4, or under equivalent regulations of NRC or an Agreement 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 shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates.

(1) The submitted information shall demonstrate that performance of such 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 calendar quarter dose in excess of 10 percent of the limits specified in 4.6.1.

3.12.4.5 Each person licensed under 3.12.4 to distribute devices to generally licensed person shall:

(1) Before a device is transferred, furnish information specified in this paragraph to each person to whom a device is to be transferred, or in the case of a transfer through an intermediate person, to the intended user prior to initial transfer to the intermediate person, including:

(a) A copy of the general license contained in 3.6.4 and a copy of the general license contained in the NRC or Agreement State regulation equivalent to 3.6.4;

(b) A copy of sections 3.6 and 4.40 through 4.52;

(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;

(e) An indication that federal policy is to issue high civil penalties for improper disposal; and

(f) The name or title, address, and phone number of the contact at the transferee's NRC or Agreement State location.

(2) Report to the Department all transfers of such devices to persons for use under the general license in 3.6.4 and all receipts of such devices.

(a) Such a report to the Department shall include:

(i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use;

(ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure 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 radioactive material contained in the device.

(b) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(c) For devices received from a 3.6.4 general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(d) If the licensee makes changes to a device possessed by a 3.6.4 general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(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.

(g) If no transfers have been made to or from persons generally licensed under 3.6.4 during the reporting period, the report must so indicate.

(3) Furnish clear and legible reports to other agencies, containing all of the data required by Form 653, "Transfers of Industrial Devices Report", including:

(a) Report the information specified in 3.12.4.5(2) to NRC for all transfers of such devices to persons for use under NRC general license in Section 31.5 of 10 CFR Part 31.

(b) Report the information specified in 3.12.4.5 (2) to the responsible State agency for all transfers of devices manufactured and distributed pursuant to 3.12.4 for use under a general license in that State's regulations equivalent to 3.6.4.

(4) Maintain all information concerning transfers and receipts of devices that supports the reports required by this section for a period of 3 years following the date of the recorded event.

3.12.5 Special Requirements for the Manufacture, Assembly, Repair or Initial Transfer of Luminous Safety Devices for Use in Aircraft.

3.12.5.1 An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 3.6.5 will be approved if:

(1) The applicant satisfies the general requirements specified in 3.9; and

(2) The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, and 32.56 of 10 CFR Part 32 , or their equivalent.

(3) The device has been registered in the Sealed Source and Device Registry.

3.12.6 Special Requirements for License to Manufacture or initially transfer Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Generally Licensed Under 3.6.7.

3.12.6.1 An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under 3.6.7 will be approved if:

(1) The applicant satisfies the general requirement of 3.9; and

(2) The applicant satisfies the requirements of Sections 32.57, 32.58, and 32.59 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent.

3.12.7 Reserved.

3.12.8 Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General License.

3.12.8.1 An application for a specific license to manufacture or distribute radioactive material for use under the general license of 3.6.9 will be approved if:

(1) The applicant satisfies the general requirements specified in 3.9.

(2) The radioactive material is to be prepared for distribution in prepackaged units of:

(a) Carbon-14 in units not exceeding 370 kBq (10 µCi) each.

(b) Cobalt-57 in units not exceeding 370 kBq (10 µCi) each.

(c) Hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 µCi) each.

(d) Iodine-125 in units not exceeding 370 kBq (10 µCi) each.

(e) Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 µCi) of iodine-129 and 185 kBq (0.005 µCi) of americium-241 each.

(f) Iodine-131 in units not exceeding 370 kBq (10 µCi) each.

(g) Iron-59 in units not exceeding 740 kBq (20 µCi) each.

(h) Selenium-75 in units not exceeding 370 kBq (10 µCi) each.

(3) Each prepackaged unit bears a durable, clearly visible label:

(a) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 370 kBq (10 µCi) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 MBq (50 µCi) of hydrogen-3 (tritium); 740 kBq (20 µCi) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 µCi) of iodine-129 and 185 Bq (0.005 µCi) of americium-241 each; and

(b) Displaying the radiation caution symbol described in 4.27.1 and the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals".

(4) One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

(a) This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of NRC or an Agreement State.

___________________________________

Name of manufacturer

(5) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in 4.33.

3.12.9 Licensing the Manufacture or initial transfer of Ice Detection Devices.

3.12.9.1 An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under 3.6.10 will be approved if:

(1) The applicant satisfies the general requirements of 3.9; and

(2) The criteria of Sections 32.61, and 32.62 of 10 CFR Part 32 are met.

(3) The device has been registered in the Sealed Source and Device Registry.

3.12.10 Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs for Medical Use.

3.12.10.1 An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized under Part 7 will be approved if:

(1) The applicant satisfies the general requirements specified in 3.9;

(2) The applicant submits evidence that the applicant is at least one of the following:

(a) Registered or licensed with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR Part 207.17(a);

(b) Registered or licensed with the State Board of Pharmacy as a drug manufacturer;

(c) Licensed as a pharmacy by the State Board of Pharmacy;

(d) Operating as a nuclear pharmacy within a Federal medical institution; or

(e) A Positron Emission Tomography (PET) drug production facility registered with the State Board of Pharmacy.

(3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for safe handling and storage of the radioactive drugs by medical use licensees; and

(4) The applicant has procedures which commit to the following labeling requirements:

(a) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material of a radioactive drug to be transferred for commercial distribution.

(i) The label must include the radiation symbol prescribed in 4.27 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time.

(ii) For radioactive drugs with a half-life greater than 100 days, the time may be omitted.

(b) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include:

(i) The radiation symbol prescribed in 4.27 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; and

(ii) An identifier that ensures that the syringe, vial or other container can be correlated with the information on the transport radiation shield label.

3.12.10.2 A licensee described by 3.12.10.1(2)(c) or 3.12.10.1(2)(d):

(1) May prepare radioactive drugs for medical use, as defined in Part 1, Section 1.2 and Part 7, provided that the radioactive drug is prepared by either:

(a) An authorized nuclear pharmacist, as specified in 3.12.10.2(2) or 3.12.10.2(4), or

(b) An individual under the direct supervision of an authorized nuclear pharmacist as specified in Part 7, Section 7.10;

(2) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(a) This individual qualifies as an Authorized Nuclear Pharmacist as defined in Part 7, Section 7.2;

(b) This individual meets the requirements specified in Part 7 Appendix 7C2 and Section 7.65, and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

(c) This individual is designated as an authorized nuclear pharmacist in accordance with 3.12.10.2(4).

(3) The actions authorized in 3.12.10.2(1) and 3.12.10.2(2) are permitted in spite of more restrictive language in license conditions.

(4) May designate a pharmacist (as defined in Part 7, Section 7.2) as an authorized nuclear pharmacist if:

(a) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

(b) The individual practiced at a pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC.

(5) Shall provide to the Department:

(a) A copy of each individual's certification by a specialty board whose certification process has been recognized by the NRC or an Agreement State as specified in Part 7, Appendix 7C1; or

(b) The Department, NRC or Agreement State license, or

(c) NRC master materials licensee permit, or

(d) The permit issued by a licensee or NRC master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist, or

(e) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; and

(f) A copy of the State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, under 3.12.10.2(2)(a) and 3.12.10.2(2)(c), the individual to work as an authorized nuclear pharmacist.

3.12.10.3 A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs.

(1) The licensee shall have procedures for use of the instrumentation.

(2) The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta- or photon-emitting radioactive drugs prior to transfer for commercial distribution.

(3) In addition, the licensee shall:

(a) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(b) Check each instrument for constancy and proper operation at the beginning of each day of use.

3.12.10.4 A licensee shall satisfy the labeling requirements in 3.12.10.1(4).

3.12.10.5 Nothing in this section relieves the licensee from complying with applicable FDA, Federal, and state requirements governing radioactive drugs.

3.12.11 Reserved.

3.12.12 Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use.

3.12.12.1 An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Part 7 for use as a calibration, transmission, or reference source or for the uses listed in Part 7, Sections 7.19, 7.40, 7.42, 7.48 and 7.62 will be approved if:

(1) The applicant satisfies the general requirements in 3.9 of this part;

(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(a) The radioactive material contained, its chemical and physical form, and amount,

(b) Details of design and construction of the source or device,

(c) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents,

(d) For devices containing radioactive material, the radiation profile of a prototype device,

(e) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,

(f) Procedures and standards for calibrating sources and devices,

(g) Legend and methods for labeling sources and devices as to their radioactive content, and

(h) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the Department for distribution to persons licensed pursuant to Part 7, Sections 7.40 and 7.42 or under equivalent licenses of NRC or an Agreement State, provided that such labeling for sources which do not require long term storage may be on a leaflet or brochure which accompanies the source;

(4) The source or device has been registered in the Sealed Source and Device Registry.

3.12.12.2 In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and

3.12.12.3 In determining the acceptable interval for test of leakage of radioactive material, the Department will consider information that includes, but is not limited to:

(1) Primary containment or source capsule,

(2) Protection of primary containment,

(3) Method of sealing containment,

(4) Containment construction materials,

(5) Form of contained radioactive material,

(6) Maximum temperature withstood during prototype tests,

(7) Maximum pressure withstood during prototype tests,

(8) Maximum quantity of contained radioactive material,

(9) Radiotoxicity of contained radioactive material, and

(10) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

3.12.13 Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications.

3.12.13.1 An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to 3.5.5 or equivalent regulations of NRC or an Agreement State will be approved if:

(1) The applicant satisfies the general requirements specified in 3.9;

(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of 1 calendar quarter a radiation dose in excess of 10 percent of the limits specified in 4.6.1; and

(3) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

3.12.13.2 In the case of an industrial product or device whose unique benefits are questionable, the Department will approve an application for a specific license under 3.12.13 only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

3.12.13.3 The Department may deny any application for a specific license under 3.12.13 if the end use(s) of the industrial product or device cannot be reasonably foreseen.

3.12.13.4 Each person licensed pursuant to 3.12.13.1 shall:

(1) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

(2) Label or mark each unit to:

(a) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

(b) State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of NRC or an Agreement State;

(3) Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";

(4) Furnish a copy of the general license:

(a) Contained in 3.5.5 and a copy of Department Form R-52 to each person to whom the specific licensee transfers depleted uranium in a product or device for use pursuant to the general license contained in 3.5.5, or

(b) Contained in an NRC or Agreement State regulation equivalent to 3.5.5 and a copy of an NRC or Agreement State certificate, or alternatively, furnish a copy of the general license contained in 3.5.5 and a copy of Department Form R-52 to each person to whom the specific licensee transfers depleted uranium in a product or device for use pursuant to the general license of NRC or an Agreement State, with a note explaining that use of the product or device is regulated by NRC or an Agreement State under requirements substantially the same as those in 3.5.5;

(5) Report to the Department all transfers of industrial products or devices to persons for use under the general license in 3.5.5.

(a) Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device.

(b) The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person.

(c) If no transfers have been made to persons generally licensed under 3.5.5 during the reporting period, the report shall so indicate;

(6) Report to NRC all transfers of industrial products or devices to persons for use under NRC general license in Section 40.25 of 10 CFR Part 40 .

(a) Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device.

(b) The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person.

(c) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to NRC;

(7) Report to the responsible State agency all transfers of devices manufactured and distributed pursuant to 3.12.13 for use under a general license in that State's regulations equivalent to 3.5.5,

(a) Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device.

(b) The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person.

(c) If no transfers have been made general licensees within a particular agreement state during the reporting period, this information shall be reported to the responsible Agreement State agency upon the request of that agency;

(8) Keep records showing the name, address, and point of contact for each general licensee to whom the specific licensee transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in 3.5.5 or equivalent regulations of NRC or an Agreement State.

(a) The records shall be maintained for a period of 2 years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this section.

3.12.14 Registration of Product Information.

3.12.14.1 Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the Department for evaluation of radiation safety information about its product and for the product registration.

3.12.14.2 The request for review must be sent to the Radiation Program Manager, Hazardous Materials and Waste Management Division, Colorado Department of Public Health and Environment, 4300 Cherry Creek Drive South, Denver, Colorado 80246-1530.

3.12.14.3 The request for review of a sealed source or 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.

3.12.14.4 The Department normally evaluates a sealed source or device using radiation safety criteria in accepted industry standards.

(1) If these standards and criteria do not readily apply to a particular case, the Department formulates reasonable standards and criteria with the help of the manufacturer or distributor.

(2) The Department shall use 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. Subpart A of 10 CFR Part 32 includes specific criteria that apply to certain exempt products and 3.12.4, 3.12.5, 3.12.6, 3.12.8, and 3.12.9 of this part includes specific criteria applicable to certain generally licensed devices. Sections 3.12.10 and 3.12.12 include specific provisions that apply to certain specifically licensed items.

3.12.14.5 After completion of the evaluation, the Department 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 specific license proposing use of the product or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

3.12.14.6 The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the certificate of registration.

3.12.14.7 Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(1) Calibration and reference sources containing no more than:

(a) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or

(b) 0.37 MBq (10 µCi), for alpha emitting radionuclides; or

(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(a) The intended recipients are licensed under 3.11 or comparable provisions of NRC or an Agreement State; or

(b) The recipients are authorized for research and development; or

(c) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.

3.12.14.8 After the certificate is issued, the Department may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Department will complete its evaluation in accordance with criteria specified in this section. The Department may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested.

3.12.15 Inactivation of certificates of registration of sealed sources and devices

3.12.15.1 A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the Department shall request inactivation of the registration certificate. Such a request must be made to the Department and must normally be made no later than two years after initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within 90 days of this determination and briefly describe the circumstances of the delay.

3.12.15.2 If a distribution license is to be terminated in accordance with 3.16 the licensee shall request inactivation of its registration certificates associated with that distribution license before the Department will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.

3.12.15.3 A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.

6 CCR 1007-1-3.12

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014

38 CR 02, January 25, 2015, effective 2/14/2015

38 CR 05, March 10, 2015, effective 3/30/2015

38 CR 12, June 25, 2015, effective 7/15/2015

38 CR 14, July 25, 2015, effective 8/14/2015

39 CR 02, January 25, 2016, effective 2/14/2016

39 CR 16, August 25, 2016, effective 9/14/2016

39 CR 22, November 25, 2016, effective 12/15/2016

40 CR 11, June 10, 2017, effective 6/30/2017

40 CR 20, October 25, 2017, effective 11/14/2017

42 CR 24, December 25, 2019, effective 1/14/2020

43 CR 14, July 25, 2020, effective 8/14/2020

43 CR 18, September 25, 2020, effective 10/15/2020

44 CR 11, June 10, 2021, effective 7/15/2021

44 CR 14, July 25, 2021, effective 8/14/2021

45 CR 22, November 25, 2022, effective 12/15/2022

46 CR 21, November 10, 2023, effective 12/15/2023