Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 120.000 - The Control of Radiation
RECORDS
Section 120.127 - Special Requirements for Specific Licenses of Broad Scope
Universal Citation: 105 CMR 120.000 MA Code of Regs 120.127
Current through Register 1531, September 27, 2024
105 CMR 120.127 prescribes requirements for the issuance of specific licenses of broad scope for radioactive material and certain regulations governing holders of such licenses.
(A) The different types of broad scope licenses are set forth in 105 CMR 120.127(A):
(1) A "Type A specific license of broad
scope" is a specific license authorizing receipt, acquisition, ownership,
possession, use and transfer of any chemical or physical form of the
radioactive material specified in the license, but not exceeding quantities
specified in the license, for any authorized purpose. The quantities specified
are usually in the multicurie range.
(2) A "Type B specific license of broad
scope" is a specific license authorizing receipt, acquisition, ownership,
possession, use and transfer of any chemical or physical form of radioactive
material specified in
105 CMR
120.197: Appendix C, for any
authorized purpose. The possession limit for a Type B license of broad scope,
if only one radionuclide is possessed thereunder, is the quantity specified for
that radionuclide in
105 CMR
120.197: Appendix C, Column
I. If two or more radionuclides are possessed thereunder, the possession limit
for each is determined as follows: For each radionuclide, determine the ratio
of the quantity possessed to the applicable quantity specified in
105 CMR
120.197: Appendix C, Column
I, for that radionuclide. The sum of the ratios for all radionuclides possessed
under the license shall not exceed unity.
(3) A "Type C specific license of broad
scope" is a specific license authorizing receipt, acquisition, ownership,
possession, use, and transfer of any chemical or physical form of radioactive
material specified in
105 CMR
120.197: Appendix C, for any
authorized purpose. The possession limit for a Type C license of broad scope,
if only one radionuclide is possessed thereunder, is the quantity specified for
that radionuclide in
105 CMR
120.197: Appendix C, Column
II. If two or more radionuclides are possessed thereunder, the possession limit
is determined for each as follows: For each radionuclide, determine the ratio
of the quantity possessed to the applicable quantity specified in
105 CMR
120.197: Appendix C, Column
II, for that radionuclide. The sum of the ratios for all radionuclides
possessed under the license shall not exceed unity.
(B) An application for a Type A specific license of broad scope will be approved if:
(1) the applicant satisfies the general
requirements specified in
105 CMR
120.125;
(2) the applicant has engaged in a reasonable
number of activities involving the use of radioactive material; and
(3) the applicant has established
administrative controls and provisions relating to organization and management,
procedures, record keeping, material control and accounting, and management
review that are necessary to assure safe operations, including:
(a) the establishment of a radiation safety
committee composed of such persons as a radiation safety officer, a
representative of management, and persons trained and experienced in the safe
use of radioactive material;
(b)
the appointment of a radiation safety officer who is qualified by training and
experience in radiation protection, and who is available for advice and
assistance on radiation safety matters; and
(c) the establishment of appropriate
administrative procedures to assure:
1.
control of procurement and use of radioactive material;
2. completion of safety evaluations of
proposed uses of radioactive material which take into consideration such
matters as the adequacy of facilities and equipment, training and experience of
the user, and the operating or handling procedures; and
3. review, approval, and recording by the
radiation safety committee of safety evaluations of proposed uses prepared in
accordance with 105 CMR 120.127(B)(3)(c)2. prior to use of the radioactive
material.
(C) An application for a Type B specific license of broad scope will be approved if:
(1) the applicant satisfies the general
requirements specified in
105 CMR
120.125; and,
(2) the applicant has established
administrative controls and provisions relating to organization and management,
procedures, record keeping, material control and accounting, and management
review that are necessary to assure safe operations, including:
(a) the appointment of a radiation safety
officer who is qualified by training and experience in radiation protection,
and who is available for advice and assistance on radiation safety matters;
and
(b) the establishment of
appropriate administrative procedures to assure;
1. control of procurement and use of
radioactive material;
2. completion
of safety evaluations of proposed uses of radioactive material which take into
consideration such matters as the adequacy of facilities and equipment,
training and experience of the user, and the operating or handling procedures;
and,
3. review, approval, and
recording by the radiation safety officer of safety evaluations of proposed
uses prepared in accordance with 105 CMR 120.127(C)(2)(b)2. prior to use of the
radioactive material.
(D) An application for a Type C specific license of broad scope will be approved if:
(1) the applicant satisfies the general
requirements specified in
105 CMR
120.125;
(2) the applicant submits a statement that
radioactive material will be used only by, or under the direct supervision of,
individuals who have received:
(a) a college
degree at the bachelor level, or equivalent training and experience, in the
physical or biological sciences or in engineering; and
(b) at least 40 hours of training and
experience in the safe handling of radioactive material, and in the
characteristics of ionizing radiation, units of radiation dose and quantities,
radiation detection instrumentation, and biological hazards of exposure to
radiation appropriate to the type and forms of radioactive material to be used;
and
(3) the applicant has
established administrative controls and provisions relating to procurement of
radioactive material, procedures, record keeping, material control and
accounting, and management review necessary to assure safe
operations.
(E) Specific licenses of broad scope are subject to the following conditions:
(1) Unless specifically authorized, persons
licensed pursuant to 105 CMR 120.127 shall not:
(a) conduct tracer studies in the environment
involving direct release of radioactive material;
(b) receive, acquire, own, possess, use, or
transfer devices containing 100,000 curies (3.7 PBq) or more of radioactive
material in sealed sources used for irradiation of materials;
(c) conduct activities for which a specific
license issued by the Agency under
105
CMR 120.126,
120.128
or
120.500,
and
120.800
is required; or
(d) add or cause
the addition of radioactive material to any food, beverage, cosmetic, drug, or
other product designed for ingestion or inhalation by, or application to, a
human being.
(2) Each
Type A specific license of broad scope issued under 105 CMR 120.127 shall be
subject to the condition that radioactive material possessed under the license
may only be used by, or under the direct supervision of, individuals approved
by the licensee's radiation safety committee.
(3) Each Type B specific license of broad
scope issued under 105 CMR 120.127 shall be subject to the condition that
radioactive material possessed under the license may only be used by, or under
the direct supervision of, individuals approved by the licensee's radiation
safety officer.
(4) Each Type C
specific license of broad scope issued under 105 CMR 120.127 shall be subject
to the condition that radioactive material possessed under the license may only
be used by, or under the direct supervision of, individuals who satisfy the
requirements of 105 CMR 120.127(D).
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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