Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 120.000 - The Control of Radiation
RECORDS
Section 120.122 - General Licenses - Radioactive Material Other than Source Material

Universal Citation: 105 CMR 120.000 MA Code of Regs 120.122

Current through Register 1531, September 27, 2024

(A) Requirements for Other General Licenses (Reserved).

(B) Luminous Safety Devices for Aircraft.

(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:
(a) each device contains not more than 10 curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium-147; and

(b) each device has been manufactured, assembled or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the Agency or any Agreement State to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in 10 CFR Part 32, § 32.53.

(2) Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general license in 105 CMR 120.122(B)(1) are exempt from the requirements of 105 CMR 120.200 through 120.299 and 120.750 through 120.760 except that they shall comply with the provisions of 105 CMR 120.281 and 120.282.

(3) This general license does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium-147.

(4) This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.

(5) This general license is subject to the provisions of 105 CMR 120.005 through 120.016, 120.131, 120.140, 120.150, and 120.770 through 120.798.

(C) Requirements for Other General Licenses (Reserved).

(D) 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 State or local government agencies to acquire, receive, possess, use or transfer in accordance with the provisions of 105 CMR 120.122(D)(2) through (4), 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)
(a) The general license in 105 CMR 120.122(D)(1) applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:
1. a specific license issued by the Agency pursuant to 105 CMR 120.128(D); or

2. an equivalent specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement State, or an equivalent specific license issued by a State with provisions comparable to 105 CMR 120.128(D).

(b) The devices must have been received from one of the specific licensees described in 105 CMR 120.122(D)(2)(a) or through a transfer made under 105 CMR 120.122(D)(3)(i).

(3) Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in 105 CMR 120.122(D)(1):
(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 microcuries (3.7 MBq) of other beta and/or gamma-emitting material or ten microcuries (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 under 105 CMR 120.122(D)(3)(b) and other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are performed:
1. in accordance with the instructions provided by the labels; or

2. by a person holding an applicable specific license from the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State to perform such activities;

(d) shall maintain records showing compliance with the requirements of 105 CMR 120.122(D)(3)(b) and (c). 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, installation, servicing, and removal from installation concerning the radioactive material, its shielding or containment. The licensee shall retain these records as follows:
1. each record of a test for leakage of radioactive material required by 105 CMR 120.122(D)(3)(b) 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 105 CMR 120.122(D)(3)(b) 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; and

3. each record that is required by 105 CMR 120.122(D)(3)(c) shall be maintained for a period of 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 or 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 185 Bq (0.005 microcurie) or more removable radioactive material. The device shall not be operated until it has been repaired by the manufacturer or other person holding an applicable specific license from the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State to repair such devices. The device and any radioactive material from the device shall only be disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained 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 microcurie 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, must be furnished to the Agency within 30 days. Under these circumstances, the criteria set out in 105 CMR 120.243: Vacating Premises , 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 10 CFR110;

(h)
1 shall transfer or dispose of the device containing radioactive material only by export as provided in105 CMR 120.122(D)(3)(g), by transfer to another general licensee as authorized in 105 CMR 120.122(D)(3)(i), or to a person authorized to receive the device by a specific license issued by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State that authorizes waste collection or as otherwise approved under 105 CMR 120.122(D)(3)(h)3.

2. shall furnish a report to the Agency within 30 days after the transfer of a device to a specific licensee or export. The report shall contain:
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.

3. shall obtain written Agency approval before transferring the device to any other specific licensee not specifically identified in 105 CMR 120.122(D)(3)(h)1.; 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 105 CMR 120.122(D)(3)(a)) so that the device is labeled in compliance with 105 CMR 120.240; however the manufacturer, model number, and serial number must be retained;

c. Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

d. Reports the transfer under 105 CMR 120.122(D)(3)(h)2.

(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 105 CMR 120.122(D), a copy of 120.122, 120.009, 120.281, and 120.282, 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 105 CMR 120.122(D)(3)(l) 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 105 CMR 120.281 and 120.282 for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of 105 CMR 120.200 and 120.750;

(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 submitting a letter to the Director, Radiation Control Program, Massachusetts Department of Public Health, and provide written justification as to why it cannot comply;

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)
1. shall register, in accordance with 105 CMR 120.122(D)(3)(m)2. and 3., devices containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 3.7 MBq (0.1 mCi) radium-226, or 37 MBq (1 mCi) 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, as described under 105 CMR 120.122(D)(3)(m)3.d. represents a separate general licensee and requires a separate registration and fee;

2. if in possession of a device meeting the criteria of 105 CMR 120.122(D)(3)(m)1., shall register these devices annually with the Agency and shall pay any prescribed fee. Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the Agency. The registration information must be submitted to the Agency within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of 105 CMR 120.122(D)(3)(m)1. is subject to the bankruptcy notification requirement in 105 CMR 120.131(E); a general licensee holding devices meeting the criteria of 105 CMR 120.122(D)(3)(m)1. is subject to the bankruptcy notification requirement in 105 CMR 120.131(E);

3. in registering devices, the general licensee shall furnish 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: 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 105 CMR 120.122(D)(3)(l);

d. address or location at which the device(s) are used and/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(s) 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.

4. persons generally licensed by an Agreement State, or NRC with respect to devices meeting the criteria in 105 CMR 120.122(D)(3)(m)1. are not subject to registration requirements if the devices are used in areas subject to Agency jurisdiction for a period less than 180 days in any calendar year. The Agency will not request registration information from such licensees.

(n) shall report changes to the mailing address for the location of use (including change in name of general licensee) to the Director, Radiation Control Program, Massachusetts Department of Public Health, 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;

(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 must be locked in the closed position. The testing required by 105 CMR 120.122(D)(3)(b) 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 must 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.

(4) The general license in 105 CMR 120.122(D)(1) does not authorize the manufacture or import of devices containing radioactive material.

[ Note : Persons possessing radioactive material in devices under a general license in 10 CFR 31.5 before January 15, 1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of 10 CFR 31.5 in effect on January 14, 1975.]

(E) General License for 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 105 CMR 120.122(E)(2), (3), and (4), 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 105 CMR 120.122(E)(1)(a), antiquities mean products originally intended for use by the th th general public and distributed in the late 19 and early 20 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 0.037 megabecquerel (one microcurie), 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 0.037 megabecquerel (one microcurie) of radium-226. For the purposes of 105 CMR 120.122(E)(1)(e), "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 byproduct material under the general license issued in 105 CMR 120 122(E)(1) are exempt from the provisions of 105 CMR 120.750, 120.200, and120.142 and 120.009, to the extent that the receipt, possession, use, or transfer of byproduct 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 under 105 CMR 120.100.

(3) Any person who acquires, receives, possesses, uses, or transfers byproduct material in accordance with the general license in 105 CMR 120.122(E)(1):
(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, must be furnished to the Director of 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 105 CMR120.256 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 10 CFR 110.

(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, as authorized under the Energy Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued by the Agency, Nuclear Regulatory Commission, or an 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 Director of the Agency, a written justification for the request.

(4) The general license in 105 CMR 120.122(E)(1) does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

(F) Ownership of Radioactive Material . A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of 105 CMR 120.122, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.

(G) Calibration and Reference Sources.

(1) A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of 105 CMR 120.122(G)(4) and (5), americium-241 in the form of calibration or reference sources:
(a) any person who holds a specific license issued by the Agency which authorizes him to receive, possess, use, and transfer radioactive material; and

(b) any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission which authorizes him to receive, possess, use, and transfer special nuclear 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 105 CMR 120.122(G)(4) and (5) to any person who holds a specific license issued by the Agency which 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 105 CMR 120.122(G)(4) and (5) 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 105 CMR 120.122(G)(1) through (3) apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR Part 32, § 32.57 or 10 CFR Part 70, § 70.39 or which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the Agency, any Agreement State or Licensing State pursuant to licensing requirements equivalent to those contained in 10 CFR Part 32, § 32.57 or 10 CFR Part 70, § 70.39.

(5) The general licenses provided in 105 CMR 120.122(G)(1) through (3) are subject to the provisions of 105 CMR 120.005 through 120.016, 120.131, 120.140, 120.150, and 120.770. 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 five microcuries (185 kBq) of americium-241, five microcuries (185 kBq) of plutonium, or five microcuries (185 kBq) of 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 which includes one of the following statements, as appro­ priate, or a substantially similar statement which 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 U.S. Nuclear Regulatory Commission or of a State with which the U.S. 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) . 3

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 n ot 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 U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing 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 which 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.

(H) Requirements for Other General Licenses (Reserved).

(I) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing. 4

(1) A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of 105 CMR 120.122(I)(2) through (6), the following radioactive materials in prepackaged units for use in 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) Carbon-14, in units not exceeding ten microcuries (370 kBq) each.

(b) Cobalt-57, in units not exceeding ten microcuries (370 kBq) each.

(c) Hydrogen-3 (tritium), in units not exceeding 50 microcuries (1.85 MBq) each.

(d) Iodine-125, in units not exceeding ten microcuries (370 kBq) each.

(e) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each.

(f) Iodine-131, in units not exceeding ten microcuries (370 kBq) each.

(g) Iron-59, in units not exceeding 20 microcuries (740 kBq) each.

(h) Selenium-75, in units not exceeding ten microcuries (370 kBq) each.

(2) No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by 105 CMR 120.122(I)(1) until he has filed form MRCP 120.100-2, "Certificate - In Vitro Testing with Radioactive Material Under General License", with the Agency and received from the Agency a validated copy of form MRCP 120.100-2 with certification number assigned, or, has a license that authorizes the medical use of radioactive material that was issued under 105 CMR 120.500. The physician, veterinarian, clinical laboratory or hospital shall furnish on form MRCP 120.100-2 the following information and such other information as may be required by that form:

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3 Showing only the name of the appropriate material.

4 The New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.

(a) Name and address of the physician, veterinarian, clinical laboratory or hospital;

(b) The location of use; and,

(c) 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 under the general license in 105 CMR 120.122(I)(1) 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.

(3) A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by 105 CMR 120.122(I)(1) shall comply with the following:
(a) The general licensee shall not possess at any one time, pursuant to the general license in 105 CMR 120.122(I)(1), at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 200 microcuries (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 105 CMR 120.122(I)(1)

(d) The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Agency, the U.S. Nuclear Regulatory Commission, any Agreement State or Licensing State, 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 105 CMR 120.122(I)(1)(e) as required by 105 CMR 120.251.

(4) The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to 105 CMR 120.122(I)(1):
(a) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to 105 CMR 120.128(H) or in accordance with the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission, any Agreement State or Licensing State which authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or Mock Iodine-125 to persons generally licensed under 105 CMR 120.122(I) or its equivalent; and

(b) unless one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
1. This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians, 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

2. This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians, 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 a Licensing State.

_______________________

Name of Manufacturer

(5) The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general license of 105 CMR 120.122(I)(1) shall report in writing to the Agency, any changes in the information furnished by him in the "Certificate - In Vitro Testing with Radioactive Material Under General License", form MRCP 120.100­ 2. The report shall be furnished within 30 days after the effective date of such change.

(6) Any person using radioactive material pursuant to the general license of 105 CMR 120.122(I)(1) is exempt from the requirements of 105 CMR 120.200 and 120.750 with respect to radioactive material covered by that general license, except that such persons using the Mock Iodine-125 described in 105 CMR 120.122(I)(1)(e) shall comply with the provisions of 105 CMR 120.251, 120.281 and 120.282.

(J) 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 microcuries (1.85 MBq) of strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license issued by the Agency or an Agreement State to the manufacturer of such device pursuant to licensing requirements equivalent to those in 10 CFR Part 32, § 32.61.

(2) Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in 105 CMR 120.122(J)(1),
(a) shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license from the U.S. Nuclear Regulatory Commission or an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of 105 CMR 120.251;

(b) shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and,

(c) are exempt from the requirements of 105 CMR 120.200 and 120.750 except that such persons shall comply with the provisions of 105 CMR 120.251, 120.281 and 120.282.

(3) This general license does not authorize the manufacture, assembly, disassembly or repair of strontium-90 in ice detection devices.

(4) This general license is subject to the provisions of 105 CMR 120.001 through 120.019, 120.131, 120.140, 120.150, and 120.770.

Disclaimer: These regulations may not be the most recent version. Massachusetts may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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