| (11) having knowledge of and ensuring compliance with
federal and state security measures for radioactive material.
(h) Specific licenses for broad scope authorization
for multiple quantities or types of radioactive material for use in
research and development.
(1) In addition to the requirements in subsection (e)
of this section, a specific license for multiple quantities or types
of radioactive material for use in research and development, not to
include the internal or external administration of radiation or radioactive
material to humans, will be issued if the agency approves the following
documentation submitted by the applicant:
(A) that staff has substantial experience in the use
of a variety of radioisotopes for a variety of research and development
uses;
(B) of a full-time RSO meeting the requirements of
subsection (f)(7) of this section;
(C) establishment of an RSC, including names and qualifications,
with duties and responsibilities in accordance with subsection (g)
of this section. The RSC shall be composed of an RSO, a representative
of executive management, and 1 or more persons trained or experienced
in the safe use of radioactive materials.
(2) Unless specifically authorized, persons licensed
according to paragraph (1) of this subsection shall not conduct tracer
studies involving direct release of radioactive material to the environment.
(3) Unless specifically authorized, in accordance with
a separate license, persons licensed according to paragraph (1) of
this subsection shall not:
(A) receive, acquire, own, possess, use, or transfer
devices containing 100,000 curies (Ci) (3700 terabecquerels) or more
of radioactive material in sealed sources used for irradiation of
materials;
(B) conduct activities for which a specific license
issued by the agency in accordance with subsections (i) - (u) of this
section and §289.255, §289.256, and §289.259 of this
title as required;
(C) 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
(D) commercially distribute radioactive material.
(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 agency 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 10% 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 agency 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
(III) The model and serial number and name of manufacturer
or distributor may be omitted from this label provided they are elsewhere
stated in labeling affixed to the device.
(D) Each device having a separable source housing that
provides the primary shielding for the source also bears, on the source
housing, a durable label containing the device model number and serial
numbers, the isotope and quantity, the words, "Caution-Radioactive
Material," the radiation symbol described in §289.202(z) of this
title, and the name of the manufacturer or initial distributor.
(E) Each device meeting the criteria of §289.251(g)(1)
of this title, bears a permanent (for example, embossed, etched, stamped,
or engraved) label affixed to the source housing if separable, or
the device if the source housing is not separable, that includes the
words, "Caution-Radioactive Material," and, if practicable, the radiation
symbol described in §289.202(z) of this title.
(F) The device has been registered in the Sealed Source
and Device Registry.
(2) In the event the applicant desires that the device
be required to be tested at intervals longer than 6 months, either
for proper operation of the "on-off" mechanism and indicator, if any,
or for leakage of radioactive material, or for both, the applicant
shall include in the application sufficient information to demonstrate
that the longer interval is justified by performance characteristics
of the device or similar devices and by design features that have
a significant bearing on the probability or consequences of radioactive
material leakage from the device or failure of the "on-off" mechanism
and indicator. In determining the acceptable interval for the test
for radioactive material leakage, the agency will consider information
that includes, but is not limited to the following:
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