(A) An application for a specific license to
manufacture, or initially transfer devices containing radioactive material to
persons generally licensed under rule
3701:1-46-05
of the Administrative Code or equivalent regulations of the United States
nuclear regulatory commission or an agreement state will be approved if:
(1) The applicant satisfies the general
requirements of rule
3701:1-40-15
of the Administrative Code;
(2)
The applicant submits sufficient information relating to 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:
(a) The device can be safely operated by
persons not having training in radiological protection;
(b) 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 one year a dose in excess of ten per
cent of the annual limits specified in paragraph (A) of rule
3701:1-38-12
of the Administrative Code; and
(c) 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 dose to the appropriate organ as specified in the
appendix A to this rule.
(3) Each device bears a durable, legible,
clearly visible label or labels approved by the director which contain in a
clearly identified and separate statement:
(a) 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);
(b)
The requirements, 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 radionuclide,
quantity of radioactivity, and date of determination of the quantity; and
(c) The information called for in
the following statement in the same or substantially similar form. Devices
licensed by the United States nuclear regulatory commission prior to January
19, 1975, may bear labels authorized by the regulations in effect on January 1,
1975. The receipt, possession, use, and transfer of this device model, serial
no., are subject to a general license or the equivalent and the regulations of
the United States nuclear regulatory commission or a state with which the
United States nuclear regulatory commission has entered into an agreement for
the exercise of regulatory authority. This label shall be maintained on the
device in a legible condition. Removal of this label is prohibited. The model,
serial number, and the name of the manufacturer, or initial transferor may be
omitted from this label provided the information is elsewhere specified in
labeling affixed to the device.
"CAUTION-RADIOACTIVE MATERIAL"
(Name of manufacturer, or initial transferor)
Devices licensed by the United States nuclear regulatory
commission prior to January 19, 1975, may bear labels authorized by the
regulations in effect on January 1, 1975.
The model, serial number, and the name of the manufacturer, or
initial transferor may be omitted from this label provided the information is
elsewhere specified in labeling affixed to the device.
(4) 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 number, the radionuclide and quantity, the words, "Caution: Radioactive
Material," the radiation symbol described in paragraph (A) of rule
3701:1-38-18
of the Administrative Code, and the name of the manufacturer or initial
distributor.
(5) Each device
meeting the criteria of paragraph (C)(13)(a) of rule
3701:1-46-05
of the Administrative Code, bears a permanent (e.g., 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
paragraph (A) of rule
3701:1-38-18
of the Administrative Code.
(B) In the event the applicant desires that
the device be required to be tested at intervals longer than six 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
this application sufficient information to demonstrate that such longer
interval is justified by performance characteristics of the device or similar
devices, and by design features which have a significant bearing on the
probability or consequences of leakage of radioactive material from the device
or failure of the on-off mechanism and indicator. In determining the acceptable
interval for the test for leakage of radioactive material, the director will
consider information which 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 material;
(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
devices or similarly designed and constructed devices.
(C) In the event the applicant desires that
the general licensee under rule 3701:1-46-05 of the Administrative Code, or
under equivalent regulations of the United States nuclear regulatory commission
or an agreement state be authorized to install the device, collect the sample
to be analyzed by a specific licensee for leakage of radioactive material,
service the device, test the on-off mechanism and indicator, or remove the
device from installation, the applicant shall include in the application
written instructions to be followed by the general licensee, estimated calendar
quarter doses associated with such activity or activities, and the bases for
these estimates. The submitted information must demonstrate that performance of
this activity or activities by an individual untrained in radiological
protection, in addition to other handling, storage, and use of devices under
the general license, is unlikely to cause that individual to receive a dose in
excess of ten per cent of the annual limits specified in paragraph (A) of rule
3701:1-38-12
of the Administrative Code.
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Notes
Ohio Admin. Code
3701:1-46-30
Five Year Review (FYR) Dates:
5/23/2022 and
05/23/2027
Promulgated
Under:
119.03
Statutory Authority:
3748.04
Rule Amplifies:
3748.04
Prior Effective Dates: 10/20/2002, 01/20/2008, 04/05/2009,
12/01/2012
Five Year Review (FYR) Dates:
03/29/2017 and
11/01/2020
Promulgated
Under: 119.03
Statutory
Authority: 3748.04
Rule
Amplifies: 3748.04
Prior
Effective Dates: 10/20/2002, 1/20/08, 10/4/10,
12/1/12