105 CMR 120.122
General Licenses - Radioactive Material Other than Source Material
(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);
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
general public and distributed in the late 19 and early 20 centuries, such as radium
th
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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) .
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
))))))))))))))))))))))))))))))))))))Q
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 not
remove this label.
CAUTION - RADIOACTIVE MATERIAL
THIS SOURCE CONTAINS RADIUM-226.
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
S))))))))))))))))))))))))))))))))))))Q
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:
S))))))))))))))))))))))))))))))Q
Showing only the name of the appropriate material.
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.