| (11) having knowledge of and ensuring compliance with
federal and state security measures for radioactive material.
(h) Specific licenses of broad scope.
(1) Types of specific licenses of broad scope.
(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. 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 subsection (jj)(10) of this section. The possession
limit for a Type B specific license of broad scope, if only one radionuclide
is possessed thereunder, is the quantity specified for that radionuclide
in subsection (jj)(10) of this section. 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 subsection (jj)(10)
of this section, for that radionuclide. The sum of the ratios for
all 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 subsection (jj)(10) of this section. The possession
limit for a Type C specific license of broad scope, if only one radionuclide
is possessed thereunder, is the quantity specified for that radionuclide
in subsection (jj)(10) of this section. 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 subsection (jj)(10)
of this section, for that radionuclide. The sum of the ratios for
all radionuclides possessed under the license shall not exceed unity.
(2) An application for a Type A specific license of
broad scope will be approved if:
(A) the applicant satisfies the general requirements
specified in subsection (e) of this section;
(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,
record keeping, material control, and accounting and management review
that are necessary to assure safe operations, including:
(i) the establishment of an RSC composed of such persons
as an RSO, a representative of management, and persons trained and
experienced in the safe use of radioactive materials management to
fulfill the duties and responsibilities specified in subsection (g)
of this section;
(ii) the appointment of a full-time RSO meeting the
requirements of subsection (f)(7) or (8) of this section 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 ensure:
(I) control of procurement and use of radioactive material;
(II) 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
(III) review, approval, and recording by the RSC of
safety evaluations of proposed uses prepared in accordance with subclause
(II) of this clause before use of the radioactive material.
(3) An application for a Type B specific license of
broad scope will be approved if:
(A) the applicant satisfies the general requirements
specified in subsection (e) of this section; and
(B) 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:
(i) the appointment of an RSO who is qualified by training
and experience in radiation protection, and who is available for advice
and assistance on safety matters; and
(ii) the establishment of appropriate administrative
procedures to ensure:
(I) control of procurement and use of radioactive material;
(II) 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
(III) review, approval, and recording by the RSO of
safety evaluations of proposed uses prepared in accordance with subclause
(II) of this clause before use of the radioactive material.
(4) An application for a Type C specific license of
broad scope will be approved if:
(A) the applicant satisfies the general requirements
specified in subsection (e) of this section;
(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 40 hours of training and experience in
the safe handling of radioactive materials, 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,
record keeping, material control and accounting, and management review
necessary to assure safe operations.
(5) An application filed pursuant to subsection (e)
of this section for a specific license other than one of broad scope
will be considered by the department as an application for a specific
license of broad scope under this subsection if the applicable requirements
of this subsection are satisfied.
(6) The following conditions apply to specific licenses
of broad scope.
(A) Unless specifically authorized in accordance with
a separate license, persons licensed under this subsection shall not:
(i) conduct tracer studies in the environment involving
direct release of radioactive material;
(ii) receive, acquire, own, possess, use, transfer,
or import devices containing 100,000 curies or more of radioactive
material in sealed sources used for irradiation of materials;
(iii) conduct activities for which a specific license
issued by the department in accordance with subsections (i) - (u)
of this section and §289.255, §289.256, and §289.259
of this title as required;
(iv) 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; or
(v) commercially distribute radioactive materials.
(B) Each Type A specific license of broad scope issued
under this subsection 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
RSC.
(C) Each Type B specific license of broad scope issued
under this subsection 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
RSO.
(D) Each Type C specific license of broad scope issued
under this subsection 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 paragraph (4) of this subsection.
(i) Specific licenses for introduction of radioactive
material into products in exempt concentrations. No person may introduce
radioactive material into a product or material knowing or having
reason to believe that it will be transferred to persons exempt in
accordance with §289.251 of this title except as specified with
a license issued by the NRC.
(j) Specific licenses for commercial distribution of
radioactive material in exempt quantities.
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