Article 2. Exemptions from the Regulatory Requirements
12VAC5-481-390. Source material.
Article 2
Exemptions from the Regulatory Requirements
A. Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from this part and the requirements for a license set forth in this chapter to the extent that they transport or store radioactive material in the regular course of the carriage for another or storage incident thereto.
B. Any person is exempt from Part III (12VAC5-481-380 et seq.) of this chapter to the extent that such person receives, possesses, uses, owns, transfers, or delivers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 0.05% of the mixture, compound, solution or alloy. The exemption contained in this chapter does not apply to Australian-obligated radioactive material, nor does it include byproduct materials as defined in 12VAC5-481-10.
C. Any person is exempt from Part III (12VAC5-481-380 et seq.) of this chapter to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore.
D. Any person is exempt from Parts III (12VAC5-481-380 et seq.), IV (12VAC5-481-600 et seq.), and X (12VAC5-481-2250 et seq.) of this chapter to the extent such person receives, possesses, uses, or transfers:
1. Any quantities of thorium contained in (i) incandescent gas mantles, (ii) vacuum tubes; (iii) welding rods; (iv) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium; (v) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium; (vi) rare earth metals and compounds, mixtures, and products containing not more than 0.25% by weight thorium, uranium, or any combination of these; or (vii) personnel neutron dosimeters provided that each dosimeter does not contain more than 50 milligrams of thorium.
2. Source material contained in the following products:
a. Glaze ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20% by weight source material;
b. Piezoelectric ceramic containing not more than 2.0% by weight source material;
c. Glassware containing not more than 2.0% by weight source material or for glassware manufactured before August 27, 2013, 10% by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction; or
d. Glass enamel or glass enamel frit containing not more than 10% by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983. (On July 25, 1983, the exemption of glass enamel or glass enamel frit was suspended. The exemption was eliminated on September 11, 1984.)
3. Photographic film, negatives, and prints containing uranium or thorium.
4. Any finished product or part fabricated of or containing tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed 4.0% by weight and that the exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part.
5. Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights provided that:
a. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";
b. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: "Unauthorized Alterations Prohibited" (The requirements of this subdivision need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend required by 10 CFR 40.13(c)(5)(ii) in effect on June 30, 1969); and
c. The exemption contained in this subsection shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering.
6. Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:
a. The shipping container is conspicuously and legibly impressed with the legend: "CAUTION—RADIOACTIVE SHIELDING—URANIUM", and
b. The uranium metal is encased in mild steel or equally fire-resistant metal of minimum wall thickness of 1/8 inch (3.2 mm).
7. Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10% by weight thorium or uranium or, for lenses manufactured before August 27, 2013, 30% by weight of thorium; and that the exemption contained in this paragraph does not authorize either:
a. The shaping, grinding, or polishing of such lens or mirror or manufacturing processes other than the assembly of such lens or mirror into optical systems and devices without any alteration of the lens or mirror; or
b. The receipt, possession, use, or transfer of uranium or thorium contained in contact lens, spectacles, or eyepieces in binoculars or other optical instruments.
8. Thorium contained in any finished aircraft engine part contained nickel-thoria alloy, provided that:
a. The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and
b. The thorium content in the nickel-thoria alloy does not exceed 4.0% by weight.
9. The exemptions in this subsection do not authorize the manufacture of any products described.
10. No person may initially transfer for sale or distribution a product containing source material to persons exempt under this subsection or equivalent regulations of the NRC or another agreement state, unless authorized by the NRC with a license issued under 10 CFR 40.52 to initially transfer such products for sale or distribution.
a. Persons initially distributing source material in products covered by the exemptions in this section before August 27, 2013, without specific authorization may continue such distribution for one year beyond this date. Initial distribution may also be continued until the NRC takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than one year beyond this date.
b. Persons authorized to manufacture, process, or produce these materials or products containing source material, and persons who import finished products or parts, for sale or distribution shall be authorized by an NRC license issued under 10 CFR 40.52 for distribution only and are exempt from the requirements of 12VAC5-481-450 and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter.
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 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017.
12VAC5-481-400. Radioactive material other than source material.
A. Exempt concentrations.
1. Except as provided in subdivisions 3 and 4 of this subsection, any person is exempt from the requirements for a license set forth in this part to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in 12VAC5-481-3720.
2. This subsection shall not be deemed to authorize the import of radioactive material or products containing radioactive material.
3. A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in this part to the extent that this person transfers radioactive material (i) contained in a product or material in concentrations not in excess of those specified in 12VAC5-481-3720 and (ii) introduced into the product or material by a licensee holding a specific license issued by the NRC expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by or application to a human being.
4. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this subsection or equivalent regulations by the NRC or another agreement state except in accordance with a license issued under 12VAC5-481-480.
B. Exempt quantities.
1. Except as provided in subdivisions 3, 4, and 5 of this subsection, any person is exempt from the requirements of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities, each of which does not exceed the applicable quantity set forth in 12VAC5-481-3730.
2. Any person who possesses radioactive material received or acquired before September 25, 1971, under the general license provided in 12VAC5-481-430 is exempt from the requirements for a license set forth in this part and from the regulations contained therein to the extent that this person possesses, uses, transfers, or owns radioactive material.
3. This subsection does not authorize for purposes of commercial distribution the production, packaging, repackaging, or transfer of radioactive material or the incorporation of radioactive material into products intended for commercial distribution.
4. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in 12VAC5-481-3730, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this part or equivalent regulations of the NRC or another agreement state, except in accordance with a license issued under 12VAC5-481-480, which license states that the radioactive material may be transferred by the licensee to persons exempt under this part or the equivalent regulations of the NRC or another agreement state.
5. No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in 12VAC5-481-3730, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by this part.
C. Exempt items.
1. Except for persons who apply radioactive material to or persons who incorporate radioactive material into the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:
a. Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified quantities:
(1) 25 mCi (925 MBq) of tritium per timepiece;
(2) 5 mCi (185 MBq) of tritium per hand;
(3) 15 mCi (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial);
(4) 100 μCi (3.7 MBq) of promethium 147 per watch or 200 μCi (7.4 MBq) of promethium 147 per any other timepiece;
(5) 20 μCi (0.74 MBq) of promethium 147 per watch hand or 40 μCi (1.48 MBq) of promethium 147 per other timepiece hand;
(6) 60 μCi (2.22 MBq) of promethium 147 per watch dial or 120 μCi (4.44 MBq) of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial);
(7) The levels of radiation from hands and dials containing promethium 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:
(a) For wrist watches, 0.1 millirad per hour (1 microgray per hour) at 10 centimeters from any surface,
(b) For pocket watches, 0.1 millirad per hour (1 microgray per hour) at 1 centimeter from any surface, or
(c) For any other timepiece, 0.2 millirad per hour (1 microgray per hour) at 10 centimeters from any surface; or
(8) 1 μCi (37 kBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.
b. Other products including:
(1) Static elimination devices that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 μCi (18.5 MBq) of polonium-210 per device;
(2) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 μCi (18.5 MBq) of polonium-210 per device or of a total of not more than 50 mCi (1.85 GBq) of hydrogen-3 (tritium) per device; and
(3) Such devices authorized before October 23, 2012, for use under the general license then provided in 12VAC5-481-430 and equivalent regulations of the NRC or another agreement state and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the agency, the NRC, or another agreement state.
c. Balances of precision containing not more than 1 mCi (37 MBq) of tritium per balance or not more than 0.5 mCi (18.5 MBq) of tritium per balance part manufactured before December 17, 2007.
d. (Reserved.)
e. Marine compasses containing not more than 750 mCi (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 mCi (9.25 GBq) of tritium gas manufactured before December 17, 2007.
f. (Reserved.)
g. Ionization chamber smoke detectors containing not more than 1 μCi (37 kBq) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.
h. Electron tubes (includes: spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents), provided that each tube does not contain more than one of the following specified quantities:
(1) 150 mCi (5.55 GBq) of tritium per microwave receiver protector tube or 10 mCi (370 MBq) of tritium per any other electron tube;
(2) 1 μCi (37 kBq) of cobalt-60;
(3) 5 μCi (185 kBq) of nickel-63;
(4) 30 μCi (1.11 MBq) of krypton-85;
(5) 5 μCi (185 kBq) of cesium-137; or
(6) 30 μCi (1.11 MBq) of promethium-147; and
(7) Provided further that the levels of radiation dose from each electron tube containing radioactive material do not exceed 1 millirad per hour (10 microgray per hour) at 1 centimeter (0.39 inches) from any surface when measured through 7 milligrams per square centimeter of absorber.
i. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:
(1) Each source contains no more than one exempt quantity set forth in 12VAC5-481-3730, and
(2) Each instrument contains no more than 10 exempt quantities. For purposes of this subdivision, an instrument's source or sources may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in 12VAC5-481-3730, provided that the sum of such fractions shall not exceed unity.
(3) For purposes of this subdivision, 0.05 μCi (1.85 kBq) of americium-241 is considered an exempt quantity under 12VAC5-481-3730.
j. (Reserved.)
2. Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in subdivision 1 of this subsection, or who desires to initially transfer for sale or distribution such products containing radioactive material, should apply for a specific license pursuant to 12VAC5-481-480 C, which license states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to subdivision 1 of this subsection.
D. Self-luminous products containing radioactive material.
1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, or except as provided in subdivision 3 of this subsection, any person is exempt from the requirements for a license set forth in this part to the extent that such person receives, possesses, uses, transfers, own, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to 12VAC5-481-480 D, which license authorizes the initial transfer of the product to persons who are exempt from regulatory requirements.
2. Any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 microcurie (3.7 kBq) of radium-226 acquired prior to September 1, 1980.
3. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under subdivision 1 of this subsection should apply for a license and for a certificate of registration in accordance with 12VAC5-481-480 D.
4. The exemption in subdivision 1 of this subsection does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.
E. Gas and aerosol detectors containing radioactive material.
1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property from fires and airborne hazards provided that the detectors containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 12VAC5-481-480 E, which license authorizes use under this subsection. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by the NRC or another agreement state under provisions comparable to 12VAC5-481-480 C authorizing distribution to persons exempt from regulatory requirements.
2. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under subdivision 1 of this subsection, should apply to the agency for a license in accordance with 12VAC5-481-480 C and for a certificate of registration with the NRC in accordance with 10 CFR 32.210.
3. Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an agreement state shall be considered exempt under subdivision 1 of this subsection, provided that the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of 12VAC5-481-480 C.
4. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by the NRC or another agreement state shall be considered exempt under subdivision 1 of this subsection, provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of 12VAC5-481-480 C.
F. Radioactive drug: Capsules containing carbon-14 urea for "in-vivo" diagnostic use for humans.
1. Except as provided in subdivision 2 of this subsection, any person is exempt from the requirements for a license set forth in this part, provided that such person receives, possess, uses, transfers, owns, or acquires capsules containing 1 μCi (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for "in vivo" diagnostic use for humans.
2. Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Part VII (12VAC5-481-1660 et seq.) of this chapter.
3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for a license under and a certification of registration in accordance with 12VAC5-481-480 I.
4. Nothing in this subsection relieves persons from complying with applicable U.S. Food and Drug Administration (FDA), other federal, and state requirements governing receipt, administration, and use of drugs.
G. Carriers. Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from this part to the extent that they transport special nuclear material in the regular course of carriage for another or storage incident thereto. This exemption does not apply to the storage in transit or transport of material by persons covered by a general license issued under 12VAC5-481-430 E.
H. Certain industrial devices.
1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material 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 an ionized atmosphere, any person is exempt from the requirements for a license set forth in § 32.1-229 of the Code of Virginia and in Parts III (12VAC5-481-380 et seq.), IV (12VAC5-481-600 et seq.), V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), X (12VAC5-481-2250 et seq.), XII (12VAC5-481-2660 et seq.), and XIV (12VAC5-481-3140 et seq.) of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the NRC under 10 CFR 32.30, which license authorizes the initial transfer of the device for use under this subsection. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.
2. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material for use under subdivision 1 of this subsection, should apply to the NRC for a license under 10 CFR 32.30 and for a certificate of registration in accordance with 10 CFR 32.210.
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 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017.