Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 120.000 - The Control of Radiation
RECORDS
Section 120.104 - Radioactive Material Other than Source Material

Universal Citation: 105 CMR 120.000 MA Code of Regs 120.104

Current through Register 1531, September 27, 2024

(A) Exempt Concentrations.

(1) Except as provided in 105 CMR 120.104(A)(3), and (4), any person is exempt from 105 CMR 120.100 to the extent that such person receives, possesses, uses, transfers, owns or acquires products containing byproduct material introduced in concentrations not in excess of those listed in 105 CMR 120.195: Appendix A.

(2)105 CMR 120.104(A) shall not be deemed to authorize the import of byproduct material or products containing byproduct material.

(3) A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in 105 CMR 120.100 to the extent that this person transfers byproduct material contained in a product or material in concentrations not in excess of those specified in 105 CMR 120.195: Appendix A and introduced into the product or material by a licensee holding a specific license issued by NRC expressly authorizing such introduction. This exemption does not apply to the transfer of byproduct 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 byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under 105 CMR 120.104(A) or equivalent regulations of the NRC, or an Agreement State except in accordance with a specific license issued pursuant to 10 CFR 32.11.

(B) Exempt Quantities.

(1) Except as provided in 105 CMR 120.104(B)(2), (3), and (5), any person is exempt from 105 CMR 120.100 to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in individual quantities each of which does not exceed the applicable quantity set forth in 105 CMR 120.196: Appendix B Table I provided they have been distributed pursuant to a license as described in 105 CMR 120.104(B)(3).

(2)105 CMR 120.104(B) does not authorize the production, packaging or repackaging of byproduct material for purposes of commercial distribution, or the incorporation of byproduct material into products intended for commercial distribution.

(3) No person may, for purposes of commercial distribution, transfer byproduct material in the individual quantities set forth in 105 CMR 120.196: Appendix B, Table 1, knowing or having reason to believe that such quantities of byproduct material will be transferred to persons exempt under 105 CMR 120.104(B) or equivalent regulations of the NRC, an Agreement State except in accordance with a specific license issued by the NRC pursuant to 10 CFR Part 32, § 32.18 which license states that the byproduct material may be transferred by the licensee to persons exempt under 105 CMR 120.104(B) or the equivalent regulations of the NRC, an Agreement State.2

(4) Any person who possesses byproduct material received or acquired prior to September 25, 1971 under the general license then provided in 10 CFR 31.4 or similar general license of a State, is exempt from the requirements for a license set forth in 105 CMR 120.100 if such person possesses, uses, transfers, or owns such byproduct material.

(5) No person may, for purposes of producing an increased radiation level, combine quantities of byproduct material covered by the exemption in 105 CMR 120.104(B) so that the aggregate quantity exceeds the limits set forth in 105 CMR 120.196: Appendix B Table 1, except for byproduct material combined within a device placed in use before May 3, 1999, or as otherwise permitted by 105 CMR 120.100.

(C) Exempt Items.

(1) Certain Items Containing Byproduct 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 byproduct materials, any person is exempt from 105 CMR 120.100 to the extent that he receives, possesses, uses, transfers, owns, or acquires the following products:

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

(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:
1. 25 millicuries (925 MBq) of tritium per timepiece.

2. five millicuries (185 MBq) of tritium per hand.

3. 15 millicuries (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial).

4. 100 microcuries (3.7 MBq) of promethium-147 per watch or 200 microcuries (7.4 MBq) of promethium-147 per any other timepiece.

5. 20 microcuries (0.74 MBq) of promethium-147 per watch hand or 40 microcuries (1.48 MBq) of promethium-147 per other timepiece hand.

6. 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).

7. The radiation dose rate 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 ten centimeters from any surface.

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

c. For any other timepiece, 0.2 millirad (2 µGy) per hour at ten centimeters from any surface.

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

(b) Precision balances containing not more than one millicurie (37 MBq) of tritium per balance or not more than 0.5 millicurie (18.5 MBq) 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) Ionization chamber smoke detectors containing not more than 1 microcurie (µCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

(e) Electron tubes; provided, that each tube does not contain more than one of the following specified quantities of byproduct material:
1. 150 millicuries (5.55 GBq) of tritium per microwave receiver protector tube or 10 millicuries (370 MBq) of tritium per any other electron tube.

2. 1 microcurie (37 kBq) of cobalt-60.

3. 5 microcuries (185 kBq) of nickel-63.

4. 30 microcuries (1.11 MBq) of krypton-85.

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

6. 30 microcuries (1.11 MBq) of promethium-147.

And provided further, that the radiation dose rate from each electron tube containing byproduct material will not exceed one millirad (ten µGy) per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber. For purposes of 105 CMR 120.104(C)(1)(e), "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.

(f) 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 105 CMR 120.196: Appendix B, Table 1; and

2. Each instrument contains no more than ten 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 105 CMR 120.196: Appendix B, Table 1, provided that the sum of such fractions shall not exceed unity.

3. For americium-241, 0.05 microcurie (1.85 kBq) is considered an exempt quantity under 105 CMR 120.104(C)(1)(f).

(g)
1. 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. 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.

3. Such devices authorized before October 23, 2012 for use under the general license then provided in 105 CMR 120.122(A) and equivalent regulations of the U.S. Nuclear Regulatory Commission and Agreement States and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the U.S. Nuclear Regulatory Commission.

(h) Any person who desires to apply byproduct material to, or to incorporate byproduct material into, the products exempted in 105 CMR 120.104(C)(1), or who desires to initially transfer for sale or distribution such products containing byproduct material, should apply to the Nuclear Regulatory Commission 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 105 CMR 120.104(C)(1) or equivalent regulations of the Nuclear Regulatory Commission, 10 CFR 30.15(a).

(2) Self-luminous Products Containing Radioactive Material.
(a) Tritium, Krypton-85, or Promethium-147. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from 105 CMR 120.100 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 NRC pursuant to 10 CFR Part 32, § 32.22 which license authorizes the transfer of the product to persons who are exempt from regulatory requirements.

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 105 CMR 120.104(C)(2), should apply to the NRC for a license under 10 CFR 32.22 and for a certificate of registration in accordance with 105 CMR 120.128(N). The exemption in 105 CMR 120.104(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 105 CMR 120.100 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 acquired prior to March 11, 1994.

(3) 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 requirement of a license set forth in 105 CMR 120.100 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 provided that detectors containing byproduct material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR Part 32, § 32.26, which license authorizes the initial transfer of the product for use under 105 CMR 120.104(C)(3). 105 CMR 120.104(C)(3) also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific license issued by a State under comparable provisions to 10 CFR 32.26 authorizing distribution to persons exempt from regulatory requirements.

(b) 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 105 CMR 120.104(C)(3)(a), should apply to the NRC for a license pursuant to 10 CFR 32.26 and for a certificate of registration in accordance with 105 CMR 120.128(N).

(4) Radioactive Drug: Capsules Containing Carbon-14 Urea for In Vivo Diagnostic Use for Humans.
(a) Except as provided in 105 CMR 120.104(C)(4)(b) and (c), any person is exempt from the requirements for a license set forth in M.G.L. c. 111, § 5P and from 105 CMR 120.100 and 120.500 provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1µ Ci) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for in vivo diagnostic use for humans.

(b) Any persons who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to 105 CMR 120.500.

(c) Any person who desires to manufacture, prepare, process, produce, package, or transfer for commercial distribution such capsules shall apply, to NRC, for and receive a specific license pursuant to 10 CFR 32.21.

(d) Nothing in 105 CMR 120.104(C)(4) relieves persons from complying with applicable FDA, other Federal, and State requirements governing receipt, administration, and use of drugs.

(5) 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 the requirement of a license set forth in 105 CMR 120.100 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 by the NRC under 10 CFR 32.30, which license authorizes the initial transfer of the device for use under 105 CMR 120.104(C)(5). 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, or produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use pursuant 105 CMR 120.104(C)(5), should apply to the NRC for a license under 10 CFR 32.30 and for a certificate of registration in accordance with 105 CMR 120.128(N).

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