Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Approval criteria.
An application for a specific license to manufacture and
distribute sources and devices containing radioactive material to persons
licensed according to parts 4731.4400 to 4731.4527 for use as a calibration,
transmission, or reference source or for the uses listed under parts 4731.4404,
4731.4450, 4731.4460, and 4731.4463 shall be approved if:
A. the applicant satisfies the general
requirements of part 4731.3070;
B.
the applicant submits sufficient information regarding each type of source or
device pertinent to an evaluation of its radiation safety, including:
(1) the radioactive material contained, its
chemical and physical form, and amount;
(2) details of design and construction of the
source or device;
(3) 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;
(4) for devices
containing radioactive material, the radiation profile of a prototype
device;
(5) details of quality
control procedures to ensure that production sources and devices meet the
standards of the design and prototype tests;
(6) procedures and standards for calibrating
sources and devices;
(7) legend and
methods for labeling sources and devices as to their radioactive content;
and
(8) instructions for handling
and storing the source or device from the radiation safety standpoint. These
instructions must be:
(a) included on a
durable label attached to the source or device;
(b) attached to a permanent storage container
for the source of device; or
(c)
summarized on the label, for instructions that are too lengthy for the label,
and printed in detail on a brochure that is referenced on the label;
C. the label affixed to
the source or device, or to the permanent storage container for the source or
device, contains:
(1) information on the
radionuclide;
(2) the
quantity;
(3) the date of assay;
and
(4) a statement that the
commissioner has approved distribution of the (name of source or device) to
persons licensed to use radioactive material identified under parts 4731.4423,
4731.4450, 4731.4460, and 4731.4463, as appropriate, and to persons who hold
equivalent licenses issued by the NRC or an agreement state; and
D. the source or device has been
registered in the Sealed Source and Device Registry.
Subp. 2.
Alternative testing
intervals.
A. 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, the
applicant must include in the application sufficient information to demonstrate
that the longer interval is justified by:
(1)
performance characteristics of the source or device or similar sources or
devices; and
(2) design features
that have a significant bearing on the probability or consequences of leakage
of radioactive material from the source.
B. In determining the acceptable interval for
testing leakage of radioactive material, the commissioner shall consider
information that includes, but is not limited to:
(1) primary containment (source
capsule);
(2) protection of primary
containment;
(3) method of sealing
containment;
(4) containment
construction materials;
(5) form of
contained radioactive materials;
(6) maximum temperature withstood during
prototype tests;
(7) maximum
pressure withstood during prototype tests;
(8) maximum quantity of contained radioactive
material;
(9) radiotoxicity of
contained radioactive material; and
(10) operating experience with identical
sources or devices or similarly designed and constructed sources or
devices.
Subp.
3.
Application pending.
If an application was filed according to subpart 1 on or
before October 15, 1974, for a license to manufacture and distribute a source
or device that was distributed commercially on or before August 16, 1974, the
applicant may continue the distribution until the commissioner issues the
license or notifies the applicant otherwise.