S.C. Code Regs. § § 61-63.II.RHA 2.20

Current through Register Vol. 48, 12, December 27, 2024

Section 61-63.II.RHA 2.20 - Exemptions

2.20.1 Source Material.

2.20.1.1 Any person is exempt from these regulations to the extent that such person receives, possesses, uses, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1 percent (0.05 percent) of the mixture, compound, solution, or alloy.

2.20.1.2 Any person is exempt from these regulations 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.

2.20.1.3 Any person is exempt from the requirements for a license set forth in the Act and from the regulations in Parts III and VI of Title A to the extent that such person receives, possesses, uses, or transfers:

2.20.1.3.1 Any quantities of thorium contained in (1) incandescent gas mantles, (2) vacuum tubes, (3) welding rods, (4) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium, (5) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium, or (6) rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these, or (7) personnel neutron dosimeters provided that each dosimeter does not contain more than 50 milligrams of thorium.

2.20.1.3.2 Source material contained in the following products;

(1) glazed ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20 percent by weight source material;

(2) piezoelectric ceramic containing not more than 2 percent by weight source material;

(3) glassware containing not more than 2 percent by weight source material or, for glassware manufactured before August 27, 2013, 10 percent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile or other glass or ceramic used in constructions; and

(4) glass enamel or glass enamel frit containing not more than 10 percent 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.

2.20.1.3.3 Photographic film, negatives, and prints containing uranium or thorium;

2.20.1.3.4 Any finished product or part fabricated of, or containing, tungsten or magnesium-thorium alloys; provided that the thorium content of the alloy does not exceed 4 percent by weight and that the exemption contained in this subparagraph (2.20.1.3.4) shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing or any such product or part;

2.20.1.3.5 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:

2.20.1.3.5.1 Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM";

2.20.1.3.5.2 Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED"; [FN6] and

2.20.1.3.5.3 The exemption contained in this subparagraph (2.20.1.3.5) 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.

2.20.1.3.6 Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:

2.20.1.3.6.1 The shipping container is conspicuously and legibly impressed with the legend: "CAUTION - RADIOACTIVE SHIELDING - URANIUM." and

2.20.1.3.6.2 The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one-eighth inch (3.2 mm);

2.20.1.3.6.3 The shipping container meets the specifications for containers for radioactive materials prescribed by Section178.250. Specification 55, Part 178, of the regulations published by the Department of Transportation ( 49 CFR 178.250).

2.20.1.3.7 Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10 percent by weight of thorium or uranium or, for lenses manufactured before August 27, 2013, 30 percent by weight of thorium. The exemption contained in this subparagraph (2.20.1.3.7) shall not be deemed to authorize either:

2.20.1.3.7.1 The shaping, grinding, or polishing of such lenses 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

2.20.1.3.7.2 The receipt, possession, use or transfer of uranium or thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments.

2.20.1.3.8 Uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie of uranium.

2.20.1.3.9 Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

2.20.1.3.9.1 The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and

2.20.1.3.9.2 The thorium content in the nickel-thoria alloy does not exceed 4 percent by weight.

2.20.1.3.10 No person may initially transfer for sale or distribution a product containing source material to persons exempt under RHA 2.20.1.3, or equivalent regulations unless authorized by a specific license to initially transfer such products for sale or distribution.

2.20.1.3.10.1 Persons initially distributing source material in products covered by the exemptions in RHA 2.20.1.3 before August 27, 2013, without specific authorization may continue such distribution for 1 year beyond this date. Initial distribution may also be continued until the Department takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than 1 year beyond this date.

2.20.1.3.10.2 Persons authorized to manufacture, process, or produce these materials or products containing source material by the NRC or an Agreement State, and persons who import finished products or parts, for sale or distribution must be authorized by a specific license for distribution only and are exempt from the requirements of Parts III and VI of Title A, and RHA 2.6.1 and 2.6.2.

2.20.1.4 The exemptions in this subsection (2.20.1) do not authorize the manufacture, processing, or production of any of the products described herein.

2.20.2 Radioactive Materials Other Than Source Material.

2.20.2.1 Exempt concentrations.

2.20.2.1.1 Except as provided in RHA 2.20.2.1.3 and 2.20.2.1.4, any person is exempt from 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 Schedule C of this part.

2.20.2.1.2 This section shall not be deemed to authorize the import of radioactive material or products containing radioactive material.

2.20.2.1.3 A manufacturer, processor, or producer of a product or material is exempt from this part to the extent that this person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in Schedule C of this part and 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.

2.20.2.1.4 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 section or equivalent NRC or Agreement State regulations, except in accordance with a license issued under RHA 2.7.2.

2.20.2.2 Certain items containing radioactive material. 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 these regulations to the extent that he receives, possesses, uses, transfers, owns, or acquires the following products: [FN7]

2.20.2.2.1 Timepieces or hands or dials containing radium or not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

2.20.2.2.1.1 25 millicuries of tritium per timepiece;

2.20.2.2.1.2 5 millicuries of tritium per hand;

2.20.2.2.1.3 15 millicuries of tritium per dial (bezels when used shall be considered as part of the dial);

2.20.2.2.1.4 100 microcuries of promethium 147 per watch or 200 microcuries of promethium 147 per any other timepiece.

2.20.2.2.1.5 20 microcuries of Promethium-147 per watch hand or 40 microcuries of Promethium-147 per other timepiece hand and;

2.20.2.2.1.6 60 microcuries of promethium 147 per watch dial or 120 microcuries of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial);

2.20.2.2.1.7 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 at 10 centimeters from any surface.

(b) For pocket watches, 0.1 millirad per hour at 1 centimeter from any surfaces;

(c) For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface.

2.20.2.2.1.8 1 microcurie (37 kBq) of Radium-226 timepiece in intact timepieces manufactured prior to November 30, 2007.

2.20.2.2.2 Reserved.

2.20.2.2.3 Balances of precision containing not more than 1 millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part manufactured before December 17, 2007.

2.20.2.2.4 Reserved.

2.20.2.2.5 Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas manufactured before December 17, 2007.

2.20.2.2.6 Reserved.

2.20.2.2.7 Electron tubes: Provided, that each tube does not contain more than one of the following specified quantities of radioactive material:

2.20.2.2.7.1 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;

2.20.2.2.7.2 1 microcurie of cobalt 60;

2.20.2.2.7.3 5 microcuries of nickel 63;

2.20.2.2.7.4 30 microcuries of krypton 85;

2.20.2.2.7.5 5 microcuries of cesium 137;

2.20.2.2.7.6 30 microcuries of promethium 147; And provided further, that the level of radiation due to radioactive material contained in each electron tube does not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber. [FN8]

2.20.2.2.8 Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material; provided that:

2.20.2.2.8.1 Each source contains no more than one exempt quantity set forth in RHA 2.24, Schedule B.

2.20.2.2.8.2 Each instrument contains no more than 10 exempt quantities. For purposes of paragraph 2.20.2.2.8, instrument source(s) 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 RHA 2.24, Schedule D, provided that the sum of such fractions shall not exceed unity; and

2.20.2.2.8.3 For purposes of paragraph 2.20.2.2.8, 0.05 microcuries of Americium-241 is considered an exempt quantity under RHA 2.24, Schedule B.

2.20.2.2.9 Ionization chamber smoke detectors containing not more than 1 microcurie (uCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

2.20.2.2.10 Static elimination devices which contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device.

2.20.2.2.11 Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.

2.20.2.2.12 Such devices authorized before October 23, 2012 for use under the general license then provided in 10 CFR 31.3 and equivalent regulations of Agreement States and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the Department.

2.20.2.2.13 Any person who desires to apply byproduct material to, or to incorporate byproduct material into, the products exempted in RHA 2.20.2.2, or who desires to initially transfer for sale or distribution such products containing byproduct material, should apply for a specific license pursuant to RHA 2.5, which license states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to RHA 2.20.2.2.

2.20.2.3 Gas and aerosol detectors containing byproduct material. Except for persons who manufacture, possess, produce, or initially transfer for sale or distribution gas and aerosol detectors containing byproduct material, any person is exempt from the requirements for a license of Parts II, III, IV, V, VI, VIII, and XI in these regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in gas and aerosol detectors designed to protect health, safety, or property, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 CFR Part 32 which license authorizes the initial transfer of the product for use under this section. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by a Licensing State with comparable provisions to 10 CFR 32.26 authorizing distribution to persons exempt from regulatory requirements.

Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use under RHA 2.20.2.3, should apply for a license under 10 CFR 32.26 and for a certificate of registration in accordance with RHA 2.29.

2.20.2.4 Self-luminous products containing Tritium, Krypton-85, Promethium-147 or Radium except for persons who manufacture, process, or produce, or initially transfer for sale of distribution self-luminous products containing Tritium, Krypton-85, or Promethium-147, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns, 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 by the U.S. Nuclear Regulatory Commission pursuant to Section32.22 of 10 CFR Part 32, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in this paragraph 2.20.2.4 does not apply to Tritium, Krypton-85, or Promethium-147 used in products for frivolous purposes or in toys or adornments.

2.20.2.4.1 Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under RHA 2.20.2.4, should apply for a license pursuant to Section 32.22 of 10 CFR Part 32, and for a certificate of registration in accordance with RHA 2.29.

2.20.2.5 Exempt quantities.

2.20.2.5.1 Except as provided in subparagraphs 2.20.2.5.3 through 2.20.2.5.5, any person is exempt from these regulations 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 RHA 2.24, Schedule B.

2.20.2.5.2 Any person, who possesses byproduct material received or acquired before September 25, 1971, under the general license formerly provided in Paragraph 2.4.1 is exempt from the requirements for a license set forth in this Part to the extent that this person possesses, uses, transfers, or owns byproduct material.

2.20.2.5.3 This paragraph 2.20.2.5 does not authorize the production, packaging, or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.

2.20.2.5.4 No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in RHA 2.24 Schedule B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this paragraph or equivalent regulations of the U.S. Nuclear Regulatory Commission, any Agreement State, or a Licensing State except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.18 of 10 CFR Part 32 which license states that the radioactive material may be transferred by the licensee to persons exempt under this paragraph 2.20.2.5 or the equivalent regulations of the U.S. Nuclear Regulatory Commission or any Agreement State.

2.20.2.5.5 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 RHA 2.24, Schedule B, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the regulations in this part.

2.20.2.5.6.1 Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct 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 of Parts II, III, IV, V, VI, VIII, and XI set forth in Regulation Regulation 61-63, Radioactive Materials (Title A) to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct 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 pursuant to Section 32.30 of 10 CFR Part 32, which license authorizes the initial transfer of the device for use under this section. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

2.20.2.5.6.2 Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under 2.20.2.5.6.1, should apply for a license pursuant to Section 32.30 of 10 CFR Part 32, and for a certificate of registration in accordance with RHA 2.29.

2.20.2.7 Radioactive drug: Capsules containing Carbon-14 urea for "in vivo" diagnostic use for humans.

2.20.2.7.1 Except as provided in 2.20.2.7.2 and 2.20.2.7.3, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires capsules containing luCi(37kBq) Carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.

2.20.2.7.2 Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Part IV of these regulations.

2.20.2.7.3 Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to RHA 2.7.5.

2.20.2.7.4 Nothing in this section relieves persons from complying with applicable FDA, Federal, and other State requirements governing receipt, administration, and use of drugs.

[FN6] T The requirements specified in subdivisions RHA 2.20.1.3.5.1 and 2.20.1.3.5.2 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 RHA 2.20.1.3.5.2 in effect on June 30, 1969.

[FN7] Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20545.

[FN8] For purpose of this paragraph, 2.20.2.2.7 "electron tubes" include 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.

2.20.2.8 Any person who desires to apply byproduct material to, or to incorporate byproduct material into, the products exempted in RHA 2.20.2.2, or who desires to initially transfer for sale or distribution such products containing byproduct material, should apply for a specific license pursuant to 10 CFR 32.14, which license states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to RHA 2.20.2.2.

S.C. Code Regs. § 61-63.II.RHA 2.20

Amended by State Register Volume 38, Issue No. 10, eff. 10/24/2014; State Register Volume 42, Issue No. 02, eff. 2/23/2018.