(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.
(1) Authority to transfer possession or control by
the manufacturer, processor, or producer of any equipment, device,
commodity, or other product containing source material, byproduct
material, or naturally occurring and accelerator-produced radioactive
material (NARM) whose subsequent possession, use, transfer, and disposal
by all other persons are exempted from regulatory requirements may
be obtained only from the United States Nuclear Regulatory Commission
(NRC), Washington, DC 20555 in accordance with Title 10, Code of Federal
Regulations (CFR), §32.18.
(2) Licenses issued in accordance with this subsection
do not authorize the following:
(A) combining of exempt quantities of radioactive material
in a single device;
(B) any program advising persons to combine exempt
quantity sources and providing devices for them to do so; and
(C) the possession and use of combined exempt sources,
in a single unregistered device, by persons exempt from licensing
in accordance with §289.251(e)(2) of this title.
(k) Specific licenses for incorporation of byproduct
material or NARM into gas and aerosol detectors. A specific license
authorizing the incorporation of byproduct material or NARM into gas
and aerosol detectors to be distributed to persons exempt from this
chapter shall be issued only by the NRC in accordance with Title 10,
CFR, §32.26.
(l) Specific licenses for the manufacture and commercial
distribution of devices to persons generally licensed in accordance
with §289.251(f)(4)(H) of this title.
(1) In addition to the requirements in subsection (e)
of this section, a specific license to manufacture or commercially
distribute devices containing radioactive material to persons generally
licensed in accordance with §289.251(f)(4)(H) of this title or
equivalent requirements of the NRC or any agreement state will be
issued if the department approves the following information submitted
by the applicant:
(A) the design, manufacture, prototype testing, quality
control, labels, proposed uses, installation, servicing, leak testing,
operating and safety instructions, and potential hazards of the device
to provide reasonable assurance that:
(i) the device can be safely operated by persons not
having training in radiological protection;
(ii) under ordinary conditions of handling, storage,
and use of the device, the radioactive material contained in the device
will not be released or inadvertently removed from the device, and
it is unlikely that any person will receive in any period of one year
a dose in excess of ten percent of the limits specified in §289.202(f)
of this title; and
(iii) under accident conditions (such as fire and explosion)
associated with handling, storage, and use of the device, it is unlikely
that any person would receive an external radiation dose or dose commitment
in excess of the following organ doses:
(I) 15 rems to the whole body; head and trunk; active
blood-forming organs; gonads; or lens of eye;
(II) 200 rems to the hands and forearms; feet and ankles;
localized areas of skin averaged over areas no larger than 1 square
centimeter (cm2 ); or
(III) 50 rems to other organs;
(B) procedures for disposition of unused or unwanted
radioactive material;
(C) each device bears a durable, legible, clearly visible
label or labels approved by the department that contain the following
in a clearly identified and separate statement:
(i) instructions and precautions necessary to assure
safe installation, operation, and servicing of the device (documents
such as operating and service manuals may be identified in the label
and used to provide this information);
(ii) the requirement, or lack of requirement, for leak
testing, or for testing any "on-off" mechanism and indicator, including
the maximum time interval for such testing, and the identification
of radioactive material by isotope, quantity of radioactivity, and
date of determination of the quantity; and
(iii) the information called for in one of the following
statements, as appropriate, in the same or substantially similar form:
(I) For radioactive materials other than NARM, the
following statement is appropriate:
Attached Graphic
(II) For NARM, the following statement is appropriate:
Attached Graphic
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