Current through Bulletin 2024-06, March 15, 2024
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 who are exempted from regulatory
requirements may be obtained only from the U.S. Nuclear Regulatory Commission,
Washington, D.C. 20555.
(1) The
different types of broad licenses are set forth below:
(a) 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.
(b) 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 Section
R313-22-100
for any authorized purpose. The possession limit for a Type B broad license, if
only one radionuclide is possessed thereunder, is the quantity specified for
that radionuclide in Section
R313-22-100,
Column I. If two or more radionuclides are possessed thereunder, the possession
limits are determined as follows: For each radionuclide, determine the ratio of
the quantity possessed to the applicable quantity specified in Section
R313-22-100,
Column I, for that radionuclide. The sum of the ratios for the radionuclides
possessed under the license shall not exceed unity.
(c) 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 Section
R313-22-100,
for any authorized purpose. The possession limit for a Type C broad license, if
only one radionuclide is possessed thereunder, is the quantity specified for
that radionuclide in Section
R313-22-100,
Column II. If two or more radionuclides are possessed thereunder, the
possession limits are determined as follows: For each radionuclide, determine
the ratio of the quantity possessed to the applicable quantity specified in
Section
R313-22-100,
Column II, for that radionuclide. The sum of the ratios for the radionuclides
possessed under the license shall not exceed unity.
(2) An application for a Type A specific
license of broad scope shall be approved if all of the following are complied
with:
(a) the applicant satisfies the general
requirements specified in Section
R313-22-33;
(b) the applicant has engaged in a reasonable
number of activities involving the use of radioactive material; and
(c) the applicant has established
administrative controls and provisions relating to organization and management,
procedures, recordkeeping, material control and accounting, and management
review that are necessary to assure safe operations, including:
(i) 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;
(ii)
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
(iii) the establishment of appropriate
administrative procedures to assure:
(A)
control of procurement and use of radioactive material,
(B) 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
(C) review, approval, and recording by the
radiation safety committee of safety evaluations of proposed uses prepared in
accordance with Subsection R313-22-50(2)(c)(iii)(B) prior to use of the
radioactive material.
(3) An application for a Type B specific
license of broad scope shall be approved if all of the following are complied
with:
(a) the applicant satisfies the general
requirements specified in Section
R313-22-33;
(b) the applicant has established
administrative controls and provisions relating to organization and management,
procedures, recordkeeping, material control and accounting, and management
review that are necessary to assure safe operations, including:
(i) 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
(ii) the establishment of
appropriate administrative procedures to assure:
(A) control of procurement and use of
radioactive material,
(B)
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
(C) review,
approval, and recording by the radiation safety officer of safety evaluations
of proposed uses prepared in accordance with Subsection
R313-22-50(3)(b)(iii)(B) prior to use of the radioactive material.
(4) An
application for a Type C specific license of broad scope shall be approved, if:
(a) the applicant satisfies the general
requirements specified in Section
R313-22-33;
(b) the applicant submits a statement that
radioactive material will be used only by, or under the direct supervision of
individuals, who have received:
(i) a college
degree at the bachelor level, or equivalent training and experience, in the
physical or biological sciences or in engineering; and
(ii) at least forty 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
(c) the applicant
has established administrative controls and provisions relating to procurement
of radioactive material, procedures, recordkeeping, material control and
accounting, and management review necessary to assure safe
operations.
(5) Specific
licenses of broad scope are subject to the following conditions:
(a) unless specifically authorized by the
Director, persons licensed pursuant to this section shall not:
(i) conduct tracer studies in the environment
involving direct release of radioactive material;
(ii) 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;
(iii) conduct activities for which a specific
license issued by the Director under Section
R313-22-75,
and Rules R313-25, R313-32 or R313-36 is required; or
(iv) add or cause the addition of radioactive
material to a food, beverage, cosmetic, drug or other product designed for
ingestion or inhalation by, or application to, a human being.
(b) Type A specific licenses of
broad scope issued under Rule R313-22 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.
(c) Type B
specific license of broad scope issued under Rule R313-22 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.
(d) Type C specific license of broad scope
issued under Rule R313-22 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 Subsection
R313-22-50(4).