Article 3. Licenses
12VAC5-481-410. Types of licenses.
Article 3
Licenses
A radioactive materials license will be one of the following:
1. A general license is provided by regulation, grants authority to a person for certain activities involving radioactive material, and is effective without the filing of an application with the agency or the issuance by the agency of licensing documents to the particular person; although, the filing of a certificate with the agency may be required by the particular general license. The general licensee is subject to all applicable parts of this chapter and any limitations of the general license.
2. A specific license requires the submission of an application to the agency and the issuance of a licensing document to a named person by the agency. A licensee is subject to all applicable parts of this chapter as well as any limitations specified in the licensing document.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-420. General licenses -- source material.
A. Small quantities of source material.
1. A general license is hereby issued authorizing commercial and industrial firms; research, educational, and medical institutions; and federal, state, and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes in the following forms and quantities:
a. No more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g. gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material shall be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this subdivision may not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year; and
b. No more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this subdivision may not receive more than a total of 70 kg (154 lb) of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material possessed under this subdivision unless it is accounted for under the limits of subdivision 1 a of this subsection; or
c. No more than 7 kg (15.4 lb) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kg (154 lb) of uranium from drinking water during a calendar year under this paragraph; or
d. No more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg (154 lb) of source material in any one calendar year.
2. Any person who receives, possesses, uses, or transfers source material in accordance with the general license in subdivision 1 of this subsection:
a. Is prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the agency in a specific license.
b. Shall not abandon such source material. Source material may be disposed of as follows:
(1) A cumulative total of 0.5 kg (1.1 lb) of source material in a solid, nondispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this subdivision is exempt from the requirements to obtain a license under this part to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under this chapter; or
(2) In accordance with 12VAC5-481-910.
c. Is subject to the provisions in 12VAC5-481-100, 12VAC5-481-110, 12VAC5-481-380, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580, and 12VAC5-481-1110.
d. Shall not export such source material except in accordance with 10 CFR Part 110.
3. Any person who receives, possesses, uses, or transfers source material in accordance with subdivision 1 of this subsection shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the agency about such contamination and may consult with the agency as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used under this general license is not likely to result in exposures that exceed the limits in 12VAC5-481-1161.
4. Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in subdivision 1 of this subsection is exempt from the provisions of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the provisions of 12VAC5-481-910 and 12VAC5-481-1161 to the extent necessary to meet the provisions of subdivisions 2 (b) and 3 of this subsection. However, this exemption does not apply to any person who also holds a specific license issued under this chapter.
5. No person may initially transfer or distribute source material to persons generally licensed under subdivision 1 a or b of this subsection, or equivalent regulations of the NRC or another agreement state, unless authorized by a specific license issued in accordance with subdivision E of this subsection or equivalent provisions of the NRC or another agreement state. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample.
B. General license to receive title to source or radioactive material. A general license is hereby issued authorizing the receipt of title to source or radioactive material without regard to quantity. This general license does not authorize any person to receive, possess, deliver, use or transfer source or radioactive material.
C. Depleted uranium in industrial products and devices.
1. A general license is hereby issued to receive, acquire, possess, use or transfer, in accordance with the provisions of subdivisions 2, 3, 4, and 5 of this subsection, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.
2. The general license in subdivision 1 of this subsection applies only to industrial products or devices that have been manufactured or initially transferred in accordance with a specific license issued by the agency, the NRC, or another agreement state, which authorizes manufacture of the products or devices for distribution to persons generally licensed.
3. Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license in subdivision 1 of this subsection shall file a registration form with the agency by an appropriate method. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium and the agency shall be notified, in writing, within 30 days, of any change afterwards. The registrant shall furnish the following information and such other information as may be required:
a. Name and address of the registrant;
b. A statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in subdivision 1 of this subsection and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and
c. Name, title, or both; address; and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in this subdivision.
4. A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established in subdivision 1 of this subsection:
a. Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium.
b. Shall not abandon such depleted uranium.
c. Shall transfer or dispose of such depleted uranium only by transfer in accordance with 12VAC5-481-570. In the case where the transferee receives the depleted uranium pursuant to the general license established by subdivision 1 of this subsection, the transferor shall furnish the transferee a copy of this subsection and a copy of the appropriate agency form. In the case where the transferee receives the depleted uranium pursuant to a general license contained in a NRC or another agreement state's regulation equivalent to this subsection, the transferor shall furnish the transferee with a copy of this subsection and a copy of the appropriate agency form accompanied by a note explaining that use of the product or device is regulated by the NRC or agreement state under requirements substantially the same as those in this subsection.
d. Within 30 days of any transfer, shall report, in writing, to the agency the name and address of the person receiving the source material pursuant to such transfer.
5. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by subdivision 1 of this subsection is exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of 12VAC5-481 with respect to the depleted uranium covered by that general license.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-421. Requirements for license to initially transfer source material for use under the small quantities of source material general license.
A. An application for a specific license to initially transfer source material for use under 12VAC5-481-420 A or equivalent regulations of the NRC or another agreement state will be approved if:
1. The applicant satisfies the general requirements specified in 12VAC5-481-450; and
2. The applicant submits adequate information on, and the agency approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.
B. Conditions of licenses to initially transfer source material for use under the small quantities of source material general license: quality control, labeling, safety instructions, and records and reports.
1. Each person licensed under subsection A of this section shall label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material."
2. Each person licensed under subsection A of this section shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.
3. Each person licensed under subsection A of this section shall provide the information specified in this subdivision to each person to whom source material is transferred for use under 12VAC5-481-420 A or equivalent provisions of the NRC or another agreement state. This information shall be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:
a. A copy of 12VAC5-481-420 A and 12VAC5-481-570, or relevant equivalent regulations of the NRC or another agreement state.
b. Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.
4. Each person licensed under subsection A of this section shall report transfers as follows:
a. File a report with the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The report shall include the following information:
(1) The name, address, and license number of the person who transferred the source material;
(2) For each general licensee under 10 CFR 40.22 or equivalent agreement state provisions to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name, position, or both and phone number, of the general licensee to whom the material was sent and the type, physical form, and quantity of source material transferred; and
(3) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.
b. File a report with the agency and other agreement state agencies that identifies all persons operating under provisions equivalent to 12VAC5-481-420 A to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the agreement state to which the report is being made:
(1) The name, address, and license number of the person who transferred the source material;
(2) The name and address of the general licensee to whom source material was distributed; a responsible agent, by name, position, or both and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and
(3) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the agreement state.
c. Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under 12VAC5-481-420 A or equivalent NRC and other agreement state provisions during the current period, a report shall be submitted to the agency indicating so. If no transfers have been made to general licensees of the NRC or in a particular agreement state during the reporting period, this information shall be reported to the NRC or responsible agreement state agency upon request of the agency.
5. Each person licensed under subsection A of this section shall maintain all information that supports the reports required by this section concerning each transfer to a general licensee for a period of one year after the event is included in a report to the agency, the NRC, or another agreement state.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 33, Issue 11, eff. February 22, 2017; Volume 34, Issue 2, eff. October 18, 2017.
12VAC5-481-430. General licenses -- radioactive material other than source material.
A. Certain devices and equipment.
1. A general license is hereby issued to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment that have been manufactured, tested, and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the agency or equivalent requirements by the NRC or another agreement state for use pursuant to 12VAC5-481-480 B or C.
a. Devices designed for use as static eliminators that contain, as a sealed source or sources, radioactive material consisting of a total not more than 500 μCi (18.5 MBq) of polonium-210 per device.
b. Devices designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total not more than 500 μCi (18.5 MBq) of polonium-210 per device or a total of not more than 50 mCi (1.85 GBq) of hydrogen-3 per device.
2. The general licenses provided in this subsection are subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
B. Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere.
1. A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and federal, state, or local government agencies to acquire, receive, possess, use, or transfer, in accordance with the provisions of subdivisions 2, 3, 4, 5, and 6 of this subsection, 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.
2. The general license in subdivision 1 of this subsection applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:
a. A specific license issued by the agency; or
b. An equivalent specific license issued by the NRC or another agreement state.
3. The devices shall have been received from one of the specific licensees described in this subsection or through a transfer made under subdivision 4 of this subsection.
4. Any person who owns, acquires, receives, possesses, uses, or transfers radioactive material in a device pursuant to the general license in subdivision 1 of this subsection:
a. 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.
b. 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 six-month intervals or at such other intervals as are specified in the label; however:
(1) Devices containing only krypton need not be tested for leakage of radioactive material; and
(2) Devices containing only tritium or not more than 100 μCi (3.7 MBq) of other beta or gamma emitting material or 10 μCi (0.37 MBq) 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.
c. Shall assure that the tests required by subdivision 4 of this subsection and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:
(1) In accordance with the instructions provided by the labels; or
(2) By a person holding a specific license issued by the agency, the NRC, or another agreement state to perform such activities.
d. Shall maintain records showing compliance with the requirements of subdivision 4 of this subsection. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:
(1) Each record of a test for leakage or radioactive material required by subdivision 4 of this subsection shall be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of.
(2) Each record of a test of the on-off mechanism and indicator required by subdivision 4 of this subsection shall be retained for three 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.
(3) Each record that is required by subdivision 4 of this subsection shall be retained for three years from the date of the recorded event or until the device is transferred or disposed of.
e. Shall immediately suspend operation of the device if there is a failure of, 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 0.005 μCi (185 Bq) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued by the agency, NRC, or another agreement state. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the agency. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 μCi (185 Bq) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, shall be furnished to the agency within 30 days. Under these circumstances, the criteria set out in 12VAC5-481-1161 may be applicable, as determined by the agency on a case-by-case basis.
f. Shall not abandon the device containing radioactive material.
g. Shall not export the device containing radioactive material except in accordance with applicable provisions of this chapter.
h. Shall transfer or dispose of the device containing radioactive material only by export as provided by subdivision 4 g of this subsection, by transfer to another general licensee as authorized in subdivision 4 i of this subsection, or to a person authorized to receive the device by a specific license issued by the agency, the NRC, or another agreement state that authorizes waste collection or as otherwise approved under the following provisions of this subdivision B 4 h:
(1) Within 30 days after the transfer of a device to a specific licensee or export, furnish a report to the agency with the following information:
(a) The identification of the device by manufacturer's or initial transferor's name, model number, and serial number;
(b) The name, address, and license number of the person receiving the device (license number not applicable if exported); and
(c) The date of the transfer; and
(2) Obtain written agency approval before transferring the device to any other specific licensee not specifically identified in this subdivision; 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:
(a) 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;
(b) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by subdivision 4 of this subsection) so that the device is labeled in compliance with 12VAC5-481-880; however, the manufacturer, model number, and serial number shall be retained;
(c) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (e.g., as leak testing procedures); and
(d) Reports the transfer under subdivision 4 of this subsection.
i. Shall transfer the device to another general licensee only if:
(1) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this subsection, a copy of this part and 12VAC5-481-1090 and 12VAC5-481-1100, and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report to the agency:
(a) The manufacturer's or initial transferor's name;
(b) The model number and the serial number of the device transferred;
(c) The transferee's name and mailing address for the location of use; and
(d) The name, title, and phone number of the responsible individual identified by the transferee in accordance with subdivision 4 l of this subsection to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or
(2) 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.
j. Shall comply with the provisions of 12VAC5-481-1090 and 12VAC5-481-1100 for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter.
k. Shall respond to written requests from the agency 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 agency a written justification for the request.
l. 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. 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.
m. Shall annually register devices containing at least 10 mCi (370 MBq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, 1 mCi (37 MBq) of cobalt-60, 0.1 mCi (3.7 MBq) of radium-226, or 1 mCi (37 MBq) 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 represents a separate general licensee and requires a separate registration and fee. The registration fee will be $50 per device.
(1) The registration information shall be submitted to the agency within 30 days of the requested date for registration or as otherwise indicated in the request, and at a minimum include the following information and any other information specifically requested by the agency:
(a) Name and mailing address of the general licensee.
(b) Information about each device, including the manufacturer or initial transferor, model number, serial number, the radioisotope and activity (as indicated on the label).
(c) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under subdivision 4 l of this subsection.
(d) Address or location at which the device or devices are used or stored. For portable devices, the address of the primary place of storage.
(e) Certification by the responsible representative of the general licensee that the information concerning the device or devices has been verified through a physical inventory and checking of label information.
(f) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.
(2) A general licensee holding devices meeting the criteria of subdivision 4 m of this subsection is subject to the bankruptcy notification requirement in 12VAC5-481-500 E.
n. Shall report changes to the mailing address for the location of use, including change in name of general licensee, to the agency within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device's primary place of storage of the device.
o. May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required by subdivision 4 of this subsection need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person and have not been tested within the required test interval they shall be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.
5. The general license in this subsection does not authorize the manufacture or import of devices containing radioactive material.
6. The general license provided in this subsection is subject to the provisions of this part and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
C. The general license provided in 12VAC5-481-420 B is subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580 and Part XIII (12VAC5-481-2950 et seq.) of this chapter.
D. Luminous safety devices for use in aircraft. In addition, this general license is subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580, and Part XIII (12VAC5-481-2950 et seq.) of this chapter.
1. A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than 10 Ci (370 GBq) of tritium or 300 mCi (11.1 GBq) of promethium-147 and that each device has been manufactured, assembled, or initially transferred in accordance with a license issued under the provisions of 12VAC5-481-480 D or manufactured or assembled in accordance with a specific license issued by the NRC or another agreement state that authorizes manufacture or assembly of the device for distribution to persons generally licensed the agency or NRC.
2. Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in this subdivision are exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter, except that they shall comply with the provisions of 12VAC5-481-1090 and 12VAC5-481-1100.
3. This general license does not authorize the manufacture, assembly, repair, or import of luminous safety devices containing tritium or promethium-147.
4. This general license does not authorize the export of luminous safety devices containing tritium or promethium-147.
5. This general license does not authorize the ownership, receipt, acquisition, possession, or use of promethium-147 contained in instrument dials.
6. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
E. General license to own radioactive material.
1. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provision of this subsection, a general license under this subsection is not authorized to manufacture, produce, transfer, receive, possess, use, import, or export radioactive material, except as authorized in a specific license.
2. A general license is hereby issued to receive title to and own special nuclear material without regard to quantity. Notwithstanding any other provision of this subsection, a general license under this subsection is not authorized to acquire, deliver, receive, possess, use, transfer, import, or export special nuclear material, except as authorized in a specific license.
3. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
F. Calibration and reference sources.
1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer americium-241 in the form of calibration or reference sources in accordance with the provisions of subdivisions 4 and 5 of this subsection to any person who holds a specific license issued by the agency that authorizes receipt, possession, use, and transfer of radioactive material.
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 subdivisions 4 and 5 of this subsection to any person who holds a specific license issued by the agency that authorizes him to receive, possess, use, and transfer radioactive material.
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 subdivisions 4 and 5 of this subsection to any person who holds a specific license issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material.
4. The general licenses in subdivisions 1 through 3 of this subsection apply only to calibration or reference sources that have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the NRC pursuant to 10 CFR 32.57 or 10 CFR 70.39, or that have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the agency or another agreement state pursuant to licensing requirements equivalent to those contained in 10 CFR 32.57 or 10 CFR Part 70.39.
5. The general licenses provided in subdivisions 1 through 3 of this subsection are subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580 and Parts IV (12VAC5-481-600 et seq.); X (12VAC5-481-2250 et seq.); and XIII (12VAC5-481-2950 et seq.) of this chapter. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses:
a. Shall not possess at any one time, at any one location of storage or use, more than 5 μCi (185 kBq) of americium-241, plutonium, or radium-226 in such sources;
b. Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label that includes one of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, as appropriate:
(1) The receipt, possession, use, and transfer of this source, Model __________, Serial No. __________, are subject to a general license and the regulations of the Nuclear Regulatory Commission or of a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
CAUTION—RADIOACTIVE MATERIAL
THIS SOURCE CONTAINS (AMERICIUM-241).
(PLUTONIUM) (Showing only the name of the appropriate material.)
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
____________________Name of manufacturer or importer
(2) The receipt, possession, use, and transfer of this source, Model __________, Serial No. __________, are subject to a general license and the regulations of a licensing state. Do not remove this label.
CAUTION—RADIOACTIVE MATERIAL
THIS SOURCE CONTAINS RADIUM-226.
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
____________________Name of manufacturer or importer
c. Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the agency, the NRC, or another agreement state to receive the source;
d. Shall 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 that might otherwise escape during storage; and
e. Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.
6. These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium, or radium-226.
7. This general license does not authorize the export of calibration or reference sources containing americium-241, plutonium, or radium-226.
8. The general license provided in this subsection is subject to the general provisions of this subsection and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
G. General license for use of radioactive material for certain in vitro clinical or laboratory testing.
1. A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use for any of the following stated tests in accordance with the provisions of this subsection the following radioactive materials in prepackaged units for use in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:
a. Iodine-125, in units not exceeding 10 μCi (370 kBq) each.
b. Iodine-131, in units not exceeding 10 μCi (370 kBq) each.
c. Carbon-14, in units not exceeding 10 μCi (370 kBq) each.
d. Hydrogen-3 (tritium), in units not exceeding 50 μCi (1.85 MBq) each.
e. Iron-59, in units not exceeding 20 μCi (740 kBq) each.
f. Selenium-75, in units not exceeding 10 μCi (370 kBq) each.
g. Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 μCi (1.85 kBq) of iodine-129 and 0.005 μCi (185 Bq) of americium-241 each.
h. Cobalt-57, in units not exceeding 10 μCi (0.37 MBq) each.
2. A person shall not receive, acquire, possess, use, or transfer radioactive material under the general license established by subdivision 1 of this subsection unless that person:
a. Has filed the In Vitro Testing GL form with the agency and has received from the agency a validated copy with a registration number assigned. The physician, veterinarian, clinical laboratory, or hospital shall furnish the name and address of the physician, veterinarian, clinical laboratory, or hospital; the location of use; and 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 by this subsection 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; or
b. Has a license that authorizes the medical use of radioactive material that was issued under Part VII (12VAC5-481-1660 et seq.) of 12VAC5-481.
3. A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by subdivision 1 of this subsection shall comply with the following:
a. The general licensee shall not possess at any one time under the general license in subdivision 1 of this subsection at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, cobalt-57, or iron-59 in excess of 200 μCi (7.4 MBq).
b. The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.
c. The general licensee shall use the radioactive material only for the uses authorized by subdivision 1 of this subsection.
d. The general licensee shall not transfer the radioactive material except by transfer to a person authorized to receive it by a license pursuant to this chapter, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.
e. The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in this subsection as required by 12VAC5-481-910.
4. The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to subdivision 1 of this subsection:
a. Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of 12VAC5-481-480 G or in accordance with the provisions of a specific license issued by the NRC or another agreement state that authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for distribution to persons generally licensed, and
b. Unless the following statement, or a substantially similar statement that contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:
"This radioactive material may be received, acquired, possessed, and used only by physicians or veterinarians in the practice of veterinary medicine, 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 of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.
(Name of Manufacturer)"
5. The registrant possessing or using radioactive materials under the general license of subdivision 1 of this subsection shall report in writing to the agency, any changes in the information furnished to the agency in the Registration Certificate – In Vitro Testing With Radioactive Material Under General License within 30 days after the effective date of such change.
6. Any person using radioactive material pursuant to the general license of subdivision 1 of this subsection is exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter with respect to radioactive materials covered by that general license, except that such persons using the Mock Iodine-125 described in subdivision 1 of this subsection shall comply with the provisions of 12VAC5-481-910, 12VAC5-481-1090, and 12VAC5-481-1100.
7. The general license provided in this subsection is subject to the provisions of this part and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
H. Strontium-90 in ice detection devices.
1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 50 μCi (1.85 MBq) of strontium-90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to 12VAC5-481-480 H or in accordance with the specifications contained in a specific license issued to the manufacturer by the NRC or another agreement state authorizing manufacture of the ice detection devices for distribution to persons generally licensed.
2. Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in subdivision 1 of this subsection:
a. Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, (i) discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license pursuant to this part or Part IV (12VAC5-481-600 et seq.) of this chapter, or from the NRC or another agreement state to manufacture or service such devices; or (ii) dispose of the device pursuant to the provisions of 12VAC5-481-910.
b. Shall assure that all labels affixed to the device at the time of receipt, and that bear a statement that prohibits removal of the labels, are maintained thereon.
c. Are exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter except that such persons shall comply with the provisions of 12VAC5-481-910, 12VAC5-481-1090, and 12VAC5-481-1100.
3. The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium-90 in ice detection devices.
4. The general license provided in this subsection is subject to the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
I. Certain items and self-luminous products containing radium-226.
1. A general license is hereby issued to any person to acquire, receive, possess, use, or transfer in accordance with the provisions of the following subdivisions radium-226 contained in the following products manufactured prior to November 30, 2007.
a. Antiquities originally intended for use by the general public. For the purposes of this subsection, "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.
b. Intact timepieces containing greater than 1 μCi (0.037 MBq), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.
c. Luminous items installed in air, marine, or land vehicles.
d. All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.
e. Small radium sources containing no more than 1 μCi (0.037 MBq) of radium-226. For the purposes of this subsection, "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.
2. Persons who acquire, receive, possess, use, or transfer radioactive material under the general license issued in subdivision 1 of this subsection are exempt from the provisions of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter, as well as 12VAC5-481-1090 and 12VAC5-481-1100, 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.
3. Any person who acquires, receives, possesses, uses, or transfers radioactive material in accordance with the general license in subdivision 1 of this subsection:
a. Shall notify the agency 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 shall be furnished to the agency within 30 days.
b. Shall not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to 12VAC5-481-971 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 agency.
c. Shall not export products containing radium-226 except in accordance with this chapter.
d. Shall 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 (42 USC § 6901 et seq.), as authorized under the Energy Policy Act of 2005 (42 USC § 15801 et seq.), 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 another agreement state, or as otherwise approved by the agency.
e. Shall respond to written requests from the agency 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 agency a written justification for the request.
4. The general license in subdivision 1 of this subsection does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.
5. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
J. General license to install and service generally licensed devices. Any person who holds a specific license issued by the NRC or another agreement state authorizing the holder to manufacture, install, or service a device described in this subsection, is hereby granted a general license to install and perform nonradiological service (i.e., leak testing, surveys, routine maintenance) of the devices, provided that:
1. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the NRC or another agreement state; and
2. Such person assures that any labels required to be affixed to the device under regulations of the NRC or another agreement state licensing the manufacture of the device bear a statement that removal of the label is prohibited.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.