6 Colo. Code Regs. § 1007-1-3.6

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

Section 6 CCR 1007-1-3.6 - General Licenses[2] - Radioactive Material Other Than Source Material

² Different general licenses are issued in this section, each of which has its own specific conditions and requirements.

3.6.1 Reserved.

³ Reserved

3.6.2 Reserved.

3.6.3 Reserved.

3.6.4 Certain Measuring, Gauging or Controlling Devices.

3.6.4.1 A general license is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and State or local government agencies to receive, acquire, possess, use or transfer, in accordance with the provisions of 3.6.4.2, 3.6.4.3, and 3.6.4.4, radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

3.6.4.2 The general license in 3.6.4.1 applies only to radioactive material contained in devices which have been:

(1) Manufactured or initially transferred and labeled for distribution to persons generally licensed in accordance with the specifications contained in a specific license issued by:

(a) The Department pursuant to 3.12.4 or

(b) The NRC or an Agreement State⁴

⁴ Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in 21 CFR 179.21.

(2) Received from one of the specific licensees described in 3.6.4.2(1) or through a transfer made under 3.6.4.3(8).

3.6.4.3 Any person who owns, receives, acquires, possesses, uses, owns, or transfers radioactive material in a device pursuant to the general license in 3.6.4.1:

(1) Shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon and shall comply with all instructions and precautions provided by such labels;

(2) Shall assure that the device is tested for leakage of radioactive material and proper operation of the "on-off" mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified in the label, however;

(a) Devices containing only krypton need not be tested for leakage of radioactive material; and

(b) Devices containing only tritium or not more than 3.7 MBq (100 µCi) of other beta- and/or gamma-emitting material or 0.37 MBq (10 µCi) of alpha-emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose.

(3) Shall assure that the tests required by 3.6.4.3(2) of this section and other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are performed:

(a) In accordance with the instructions provided by the labels; or

(b) By a person holding an applicable specific license from the Department, NRC or an Agreement State to perform such activities;

(4) Shall maintain records showing compliance with the requirements of 3.6.4.3(2) and 3.6.4.3(3).

(a) The records shall show the results of tests.

(b) The records also shall show the dates of performance of, and the names of persons performing, testing, installation, servicing, and removal from installation concerning the radioactive material, its shielding or containment.

(c) Records of tests for leakage of radioactive material required by 3.6.4.3(2) shall be maintained for 3 years after the next required leak test is performed or until the sealed source is transferred or disposed of.

(d) Records of tests of the "on-off" mechanism and indicator required by 3.6.4.3(2) shall be maintained for 3 years after the next required test of the "on-off" mechanism and indicator is performed or until the sealed source is transferred or disposed of.

(e) Records which are required by 3.6.4.3(3) shall be maintained for a period of 3 years from the date of the recorded event or until the device is transferred or disposed of;

(5) Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the "on-off" mechanism or indicator, or upon the detection of 185 Bq (0.005 µCi) or more removable radioactive material, shall immediately suspend operation of the device and shall:

(a) Not operate the device until it has been repaired by the manufacturer or other person holding an applicable specific license from the Department, NRC or an Agreement State to repair such devices;

(b) Ensure that, if dispositioned, the device and any radioactive material from the device is disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device;

(c) Within 30 days, furnish to the Department a report containing a brief description of the event and the remedial action taken; and

(d) In the case of detection of 185 Bq (0.005 microcurie) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, furnish to the Director of the Hazardous Materials And Waste Management Division, within 30 days, a plan for ensuring that the premises and environs are acceptable for unrestricted use.

(i) Under these circumstances, the criteria set out in 4.61.2, "Radiological Criteria For Unrestricted Use," may be applicable, as determined by the division on a case by case basis;

(6) Shall not abandon the device containing radioactive material;

(7) Shall not export the device except in accordance with 10 CFR Part 110 and shall obtain written approval from NRC before transferring the device to any other specific licensee not specifically identified in 3.6.4.3(8);

(8) Except as provided in 3.6.4.3(9), shall transfer or dispose of the device containing radioactive material:

(a) Only by transfer to a specific licensee of the Department, NRC or an Agreement State whose specific license authorizes receipt of the device; and

(b) Within 30 days after transfer or export, shall furnish to the Department a report containing:

(i) Identification of the device by manufacturer's (or initial transferor's) name, model number and serial number;

(ii) The name, address and license number of the person receiving the device;

(iii) The date of the transfer;

(iv) The identity of the radionuclide(s) present and activity present, by assay or calculation;

(c) Shall obtain written Department approval before transferring the device to any other specific licensee not specifically identified in 3.6.4.3(8). However, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if, the holder:

(i) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

(ii) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by 3.6.4.3(1) of this part) so that the device is labeled in compliance with Part 4, Section 4.30; however the manufacturer, model number, and serial number must be retained;

(iii) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

(iv) Reports the transfer under 3.6.4.3(8)(b).

(9) Shall transfer the device to another general licensee only:

(a) Where the device remains in use at a particular location.

In such case the transferor shall give the transferee a copy of this regulation and any safety documents identified in the label on the device and within 30 days of the transfer, report to the Department the manufacturer's (or initial transferor's) name and model number and serial number of device transferred, the identity of the radionuclide(s) present and assayed or calculated activity present, the transferee's name and mailing address for the location of use, and the name, title, and phone number of the responsible individual identified by the transferee in accordance with 3.6.4.3(12) to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or

(b) Where the device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee; and

(10) Shall comply with the provisions of 4.51 and 4.52 for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of Parts 4 and 10;

(11) Shall respond to written requests from the Department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request.

(a) If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the director of the Hazardous Materials and Waste Management Division a written justification for the request;

(12) Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements.

(a) The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements; this appointment does not relieve the general licensee of any of its responsibility in this regard;

(13) Shall register each device annually in accordance with 3.6.4.3(13)(a) and 3.6.4.3(13)(b), and shall pay the fee required by Part 12, if in possession of a device containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 3.7 MBq (0.1 mCi) of radium-226, or 37 MBq (1 mCi) of americium 241 or any other transuranic (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label. Each address for a location of use, as described in 3.6.4.3(13)(b)(iv) of this section, represents a separate general licensee and requires a separate registration and fee.

(a) Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the Department.

(i) The registration information must be submitted to the Department within 30 days of the date of the request for registration or as otherwise indicated in the request.

(b) In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Department:

(i) Name and mailing address of the general licensee;

(ii) Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label);

(iii) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under 3.6.4.3(12);

(iv) Address or location at which the device(s) are used and/or stored; for portable devices, the address of the primary place of storage;

(v) Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information; and

(vi) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

(c) A general licensee holding devices meeting the criteria of 3.6.4.3(13) is subject to the bankruptcy notification requirement in 3.15.5.

(d) Persons generally licensed by an Agreement State with respect to devices meeting the criteria in paragraph 3.6.4.3(13) are not subject to U.S. Nuclear Regulatory Commission registration requirements if the devices are used in areas subject to NRC jurisdiction for a period less than 180 days in any calendar year. The Commission will not request registration information from such licensees.

(14) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the director of the hazardous materials and waste management division within 30 days of the effective date of the change.

(a) For a portable device, a report of address change is only required for a change in the device's primary place of storage.

(15) May not hold a device that is not in use for longer than 2 years.

(a) If a device with shutters is not being used, the shutter must be locked in the closed position.

(b) The testing required by 3.6.4.3(2) need not be performed during the period of storage only.

(c) However, when a device is put back into service or transferred to another person, and has not been tested within the required test interval, the device must be tested for leakage before use or transfer and the shutter tested before use.

(d) A device kept in standby for future use is excluded from the two-year time limit if the general licensee performs quarterly physical inventories of the device while the device is in standby.

3.6.4.4 The general license in 3.6.4.1 does not authorize the manufacture of devices containing radioactive material.

3.6.4.5 The general license provided in 3.6.4.1 is subject to the provisions of 1.4 through 1.9, 3.15, 3.22, 3.23 and Part 17.

3.6.5 Luminous Safety Devices for Aircraft.

3.6.5.1 A general license is hereby issued to receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided:

(1) Each device contains not more than 370 GBq (10 Ci) of tritium or 11.1 GBq (300 mCi) of promethium-147; and

(2) Each device has been manufactured, assembled or imported in accordance with a specific license issued by the NRC or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in Section 32.53 of 10 CFR Part 32.

3.6.5.2 Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general license in 3.6.5.1 are exempt from the requirements of Parts 4 and 10 except that they shall comply with the provisions of 4.51 and 4.52.

3.6.5.3 This general license does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium-147.

3.6.5.4 This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.

3.6.5.5 This general license is subject to the provisions of 1.4 through 1.9, 3.15, 3.22, 3.23, and Part 17.

3.6.6 Ownership of Radioactive Material.

3.6.6.1 A general license is hereby issued to own radioactive material without regard to quantity.

3.6.6.2 Notwithstanding any other provisions of this part, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.

3.6.7 Calibration and Reference Sources.

3.6.7.1 A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of 3.6.7.4 and 3.6.7.5, americium-241 in the form of calibration or reference sources:

(1) Any person who holds a specific license issued by the Department which authorizes receipt, possession, use, and transfer of radioactive material; and

(2) Any person who holds a specific license issued by the NRC which authorizes receipt, possession, use, and transfer of special nuclear material.

3.6.7.2 A general license is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of 3.6.7.4 and 3.6.7.5 to any person who holds a specific license issued by the Department which authorizes the licensee to receive, possess, use, and transfer radioactive material.

3.6.7.3 A general license is hereby issued to own, receive, possess, use, and transfer radium 226 in the form of calibration or reference sources in accordance with the provisions of 3.6.7.4 and 3.6.7.5 to any person who holds a specific license issued by the Department which authorizes the licensee to receive, possess, use, and transfer radioactive material.

3.6.7.4 The general licenses in 3.6.7.1, 3.6.7.2, and 3.6.7.3 apply only to calibration or reference sources which have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the NRC pursuant to Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the Department or any Agreement State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70.

3.6.7.5 The general licenses provided in 3.6.7.1, 3.6.7.2, and 3.6.7.3 are subject to the provisions of 1.4 through 1.9, 3.15, 3.22, 3.23 and 3.24, and Parts 4 and 10. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses, shall:

(1) Not possess at any one time, at any one location of storage or use, more than 185 kBq (5 µCi) of americium-241, 185 kBq (5 µCi) of plutonium, or 185 kBq (5 µCi) of radium-226 in such sources;

(2) Not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label which includes one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, as appropriate:

(a) The receipt, possession, use and transfer of this source, Model ___, Serial No.__ are subject to a general license and the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS (AMERICIUM-241) (PLUTONIUM) (RADIUM-226).⁵ DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

⁵ Showing only the name of the appropriate material.

______________________________________

Name of manufacturer or importer

(3) Not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the Department, NRC or an Agreement State to receive the source;

(4) Store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium, or radium-226 which might otherwise escape during storage; and

(5) Not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

3.6.7.6 These general licenses do not authorize the manufacture, import, or export of calibration or reference sources containing americium-241, plutonium or radium-226.

3.6.8 General license for certain items and self-luminous products containing radium-226.

3.6.8.1 A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with the provisions of 3.6.8.2 through 3.6.8.4., radium-226 contained in the following products manufactured prior to November 30, 2007.

(1) Antiquities originally intended for use by the general public.

For the purposes of 3.6.8.1(1), antiquities mean products originally intended for use by the general public and distributed in the late 19th and early 20th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads.

(2) Intact timepieces containing greater than 0.037 MBq (1 µCi), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.

(3) Luminous items installed in air, marine, or land vehicles.

(4) All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.

(5) Small radium sources containing no more than 0.037 MBq (1 µCi) of radium-226.

For the purposes of 3.6.8.1(5), ''small radium sources'' means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC.

3.6.8.2 Persons who acquire, receive, possess, use, or transfer radioactive material under the general license issued in 3.6.8.1 are exempt from the provisions of Parts 4 and 10 of these regulations, to the extent that the receipt, possession, use, or transfer of radioactive material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed under this Part.

3.6.8.3 Any person who acquires, receives, possesses, uses, or transfers radioactive material in accordance with the general license in 3.6.8.1 shall:

(1) Notify the Department should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event, and the remedial action taken, must be furnished to the Department within 30 days.

(2) Not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to Part 4, Section 4.39.2 of these regulations or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the NRC or an Agreement State.

(3) Not export products containing radium-226 except in accordance with 10 CFR Part 110.

(4) Dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued under this Part, or equivalent regulations of the NRC or an Agreement State, or as otherwise approved by the NRC or an Agreement State.

(5) Respond to written requests from the Department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Department, a written justification for the request.

3.6.8.4. The general license in 3.6.8.1 does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

3.6.9 General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.⁶

⁶ The New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.

3.6.9.1 A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of 3.6.9.2, 3.6.9.3, 3.6.9.4, 3.6.9.5, and 3.6.9.6, the following radioactive materials in prepackaged units for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:

(1) Carbon-14, in units not exceeding 370 kBq (10 µCi) each;

(2) Cobalt-57, in units not exceeding 370 kBq (10 µCi) each;

(3) Hydrogen-3 (tritium), in units not exceeding 1.85 MBq (50 µCi) each;

(4) Iodine-125, in units not exceeding 370 kBq (10 µCi) each;

(5) Mock Iodine-125 reference or calibration sources, in units not exceeding 1.85 kBq (0.05 µCi) of iodine-129 and 185 Bq (0.005 µCi) of americium-241 each;

(6) Iodine-131, in units not exceeding 370 kBq (10 µCi) each;

(7) Iron-59, in units not exceeding 740 kBq (20 µCi) each; or

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

3.6.9.2 No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by 3.6.9.1 until the person has filed Department Form R-27, "Certificate - In Vitro Testing with Radioactive Material Under General License", with the Department and received from the Department a validated copy of Department Form R-27 with certification number assigned. The physician, veterinarian, clinical laboratory or hospital shall furnish on Department Form R-27 the following information and such other information as may be required by that form:

(1) Name and address of the physician, veterinarian, clinical laboratory or hospital;

(2) The location of use; and

(3) A statement that the physician, veterinarian, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized under the general license in 3.6.9.1 and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.

3.6.9.3 A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by 3.6.9.1 shall comply with the following requirements.

(1) The general licensee shall not possess at any one time, pursuant to the general license in 3.6.9.1, at any one location of storage or use, a total amount of iodine 125, iodine 131, selenium 75, iron 59, and/or cobalt 57 in excess of 7.4 MBq (200 µCi).

(2) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(3) The general licensee shall use the radioactive material only for the uses authorized by 3.6.9.1.

(4) The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Department, NRC or any Agreement State nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

(5) The general licensee shall dispose of the Mock Iodine 125 reference or calibration sources described in 3.6.9.1(5) as required by 4.33.

3.6.9.4 The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to 3.6.9.1:

(1) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to 3.12.8 or in accordance with the provisions of a specific license issued by the NRC or any Agreement State which authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or Mock Iodine-125 to persons generally licensed under 3.6.9 or its equivalent; and

(2) Unless 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 shall 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 the U.S. Nuclear Regulatory Commission or an Agreement State.

______________________________________

Name of manufacturer

3.6.9.5 The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general license of 3.6.9.1 shall report in writing to the Department, any changes in the information previously furnished using the "Certificate - In Vitro Testing with Radioactive Material Under General License", Department Form R-27. The report shall be furnished within 30 days after the effective date of such change.

6 CCR 1007-1-3.6

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