(A) An application for a specific license to
manufacture and distribute sources and devices containing radioactive material
to persons licensed pursuant to Chapter 3701:1-58 of the Administrative Code or
equivalent regulations of the United States nuclear regulatory commission or
agreement state for use as a calibration, transmission, or reference source or
for the uses listed in rules
3701:1-58-43,
3701:1-58-53,
3701:1-58-55,
and
3701:1-58-72
of the Administrative Code or equivalent regulations of the United States
nuclear regulatory commission or agreement state will be approved if:
(1) The applicant satisfies the general
requirements in rule
3701:1-40-15
of the Administrative Code;
(2)
The applicant submits sufficient information regarding each type of source or
device pertinent to an evaluation of its radiation safety, including:
(a) The radioactive material contained, its
chemical and physical form, and amount;
(b) Details of design and construction of the
source or device;
(c) Procedures
for, and results of, prototype tests to demonstrate that the source or device
will maintain its integrity under stresses likely to be encountered in normal
use and accidents;
(d) For devices
containing radioactive material, the radiation profile of a prototype
device;
(e) Details of quality
control procedures to assure that production sources and devices meet the
standards of the design and prototype tests;
(f) Procedures and standards for calibrating
sources and devices;
(g) Legend and
methods for labeling sources and devices as to their radioactive
content;
(h) Instructions for
handling and storing the source or device from the radiation safety standpoint;
these instructions are to be included on a durable label attached to the source
or device or attached to a permanent storage container for the source or
device: provided, that instructions which are too lengthy for such label may be
summarized on the label and printed in detail on a brochure which is referenced
on the label;
(3) The
label affixed to the source or device, or to the permanent storage container
for the source or device, contains information on the radionuclide, quantity
and date of assay, and a statement that the director has approved distribution
of the (name of source or device) to persons licensed to use radioactive
material identified in rules
3701:1-58-26,
3701:1-58-43,
3701:1-58-53,
and
3701:1-58-55
of the Administrative Code, as appropriate, and to persons who hold an
equivalent license issued by the United States nuclear regulatory commission or
an agreement state;and
(4)
The source or device has been registered in the sealed
source and device registry.
(B) The following is applicable:
(1) In the event the applicant desires that
the source or device be required to be tested for leakage of radioactive
material at intervals longer than six months, he/she shall include in his/her
application sufficient information to demonstrate that such longer interval is
justified by performance characteristics of the source or device or similar
sources or devices and by design features that have a significant bearing on
the probability or consequences of leakage of radioactive material from the
source.
(2) In determining the
acceptable interval for test of leakage of radioactive material, the director
will consider information that includes, but is not limited to:
(a) Primary containment (source
capsule);
(b) Protection of primary
containment;
(c) Method of sealing
containment;
(d) Containment
construction materials;
(e) Form of
contained radioactive material;
(f)
Maximum temperature withstood during prototype tests;
(g) Maximum pressure withstood during
prototype tests;
(h) Maximum
quantity of contained radioactive material;
(i) Radiotoxicity of contained radioactive
material;
(j) Operating experience
with identical sources or devices or similarly designed and constructed sources
or devices.
