Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 220 - Rules Relating to Radiation Protection
Part C - LICENSING OF RADIOACTIVE MATERIAL
EXEMPTIONS FROM THE REGULATORY REQUIREMENTS
Section 144-220-C-3 - Radioactive material other than source material

Universal Citation: 10 ME Code Rules § 144-220-C-3

Current through 2024-38, September 18, 2024

A. Exempt Concentrations

(1) Except as provided in C.3.A(2) and C.3.A(4), any person is exempt from this Part to the extent that such person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations not in excess of those listed in Schedule B of this Part.

(2) 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 C.3.A(1) or equivalent regulations of the U.S. Nuclear Regulatory Commission or any Agreement State except in accordance with a specific license issued pursuant to C.11.A. or as provided in 10 CFR 32.11.

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

(4) A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in the Act and from this rule to the extent that he or she transfers radioactive material contained in a product or material in concentrations not in excess of those specified in Schedule A of Part C 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.

B. Exempt Quantities

(1) Except as provided in C.3.B(3) and (4), any person is exempt from the Act and this rule 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 Schedule B of this Part.

(2) Any person who possesses radioactive material received or acquired before September 25, 1971 under the general license then provided under 10 CFR 31.4 or similar general license of an Agreement State is exempt from the requirements for a license set forth in this Part to the extent that such person possesses, uses, transfers or owns such radioactive material.

(3) This paragraph (C.3.B) 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.

(4) No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Schedule B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under C.3.B or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR Part 32.18 which license states that the radioactive material may be transferred by the licensee to persons exempt under C.3.B or the equivalent regulations of the U.S. Nuclear Regulatory Commission or an 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 Schedule B of this Part, 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.

C. Exempt Items

(1) 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 desire to initially transfer for sale or distribute the following products containing radioactive material, any person is exempt from this rule to the extent that he or she receives, possesses, uses, transfers, owns, or acquires the following products:2

(a) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified radiation dose rate:

(i) 25 millicuries (925 MBq) of tritium per timepiece.

(ii) 5 millicuries (185 MBq) of tritium per hand.

(iii) 15 millicuries (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial).

(iv) 100 microcuries (3.7 MBq) of promethium-147 per watch or 200 microcuries (7.4 MBq) of promethium-147 per any other timepiece.

(v) 20 microcuries (0.74 MBq) of promethium-147 per watch hand or 40 microcuries (1.48 MBq) of promethium-147 per other timepiece hand.

(vi) 60 microcuries (2.22 MBq) of promethium-147 per watch dial or 120 microcuries (4.44 MBq) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial).

(vii) 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 (1 µGy) per hour at 10 centimeters from any surface.

(b) For pocket watches, 0.1 millirad (1 µGy) per hour at 1 centimeter from any surface.

(viii) One microcurie (37 kBq) of radium-226 per timepiece in timepieces manufactured prior to the November 30, 2007.

(b) Precision balances containing not more than 37 MBq (1 millicurie) of tritium per balance or not more than 18.5 MBq (0.5 millicurie) of tritium per balance part manufactured before December 17, 2007.

(c) Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas manufactured before December 17, 2007.

(d) Electron tubes; provided, that each tube does not contain more than one of the following specified quantities of radioactive material:

(i) 150 millicuries (5.55 GBq) of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube.

(ii) 1 microcurie (37 kBq) of cobalt-60.

(iii) 5 microcuries (185 kBq) of nickel-63.

(iv) 30 microcuries (1.11 MBq) of krypton-85.

(v) 5 microcuries 185 kBq) of cesium-137.

(vi) 30 microcuries (1.11 MBq) of promethium-147.

And provided further, that the radiation dose rate from each electron tube containing radioactive material does not exceed 1 millirad (10 µGy) per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber.3

(e) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, a source of radioactive material, provided that:

(i) Each source contains no more than one exempt quantity set forth in Schedule B of this Part, and

(ii) Each instrument contains no more than 10 exempt quantities. For purposes of this requirement, an instrument's source(s) may contain either one 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 Schedule B of this Part, provided that the sum of such fractions shall not exceed unity.

(iii) For purposes of this paragraph, 0.05 microcurie (1.85 kBq) of americium-241 is considered an exempt quantity under Schedule B of this Part.

(f) Ionization chamber smoke detectors containing not more than 1 microcurie (37 kBq) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

(g) 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.

(h) 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) Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in C.3.C.(1) (a), or who desires to initially transfer for sale or distribution such products containing radioactive 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 C.3.C.(1) (a)

(3) Self-Luminous products containing radioactive material

(a) Tritium, krypton-85, or promethium-147. Except for persons who manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from this rule 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, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR Part 32 , which license authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in C.3.C(2) does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

(b) Radium-226. Any person is exempt from this rule 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 which were or manufactured prior to July 1, 1999.

(c) 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 C.3.A, should apply for a license under 10 CFR Part 32 .22 and for a certificate of registration in accordance with 10 CFR Part 32.210 .

(4) Gas and aerosol detectors containing radioactive material

(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution, gas and aerosol detectors containing byproduct material, any person is exempt from the requirements set forth in this rule 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 Commission4 pursuant to Section 32.26 of 10 CFR Part 32, which license authorizes the initial transfer of the product. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific license issued by the Agency, the NRC, or an Agreement State under comparable provisions to 10 CFR Part 32.26 authorizing distribution to persons exempt from regulatory requirements.

(b) 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 C.3.C(3)(a), 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 C.11.C.

(c) Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use pursuant to C.3.C.(4)(a) should apply for a license pursuant to 10 CFR 32.26, which license states that the product may be initially transferred by the licensee to persons exempt from the regulations pursuant to C.3.C.(4)(a) or equivalent regulations of the NRC or an Agreement State, and for a certificate of registration in accordance with 10 CFR Part 32.210 .

(5) Exemptions for capsules containing carbon-14 urea for in-vivo diagnostic use for humans

(a) Except as provided in paragraphs (b) and (c) of this section, any person is exempt from the requirements for a license set forth in the regulations in this Part and Part G of 10-144A CMR 220, provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for in-vivo diagnostic use for humans.

(b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Part G of 10-144A CMR 220.

(c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsule shall apply for and receive a specific license pursuant to C.7 of this Part.

(d) Nothing in this section relieves persons from complying with applicable FDA, other federal, and State requirements governing receipt, administration, and use of drugs.

(6) Certain Industrial Devices

(a) 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 licensing set forth in these rules 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 under C.7 of this rule, which license authorizes the initial transfer of the device. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

(b) Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under C.3.C(6) of this section, should apply for a license under C.7 and for a certificate of registration in accordance with 10 CFR Part 32.210.

(7) Additional exemptions are available in Parts A, D, E, G, N, L and W of this rule, as applicable.

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

3 For purposes of C.3.C.1.(g), electron tubes include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents.

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

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