Ohio Admin. Code 3701:1-46-49 - Registration of product information
(A)
Any manufacturer
or initial distributor of a sealed source or device containing a sealed source
may submit a request to the director for evaluation of radiation safety
information about its product and for its registration.
(B)
The request for
review must be made in duplicate and sent to the director at the following
address:
(C)
The
request for review of a sealed source or a device must include sufficient
information about the design, manufacture, prototype testing, quality control
program, labeling, proposed uses and leak testing and, for a device, the
request must also include sufficient information about installation, service
and maintenance, operating and safety instructions, and its potential hazards,
to provide reasonable assurance that the radiation safety properties of the
source or device are adequate to protect health and minimize danger to life and
property.
(D)
The director normally evaluates a sealed source or a
device using radiation safety criteria in accepted industry standards. If these
standards and criteria do not readily apply to a particular case, the director
formulates reasonable standards and criteria with the help of the manufacturer
or distributor. The director shall use criteria and standards sufficient to
ensure that the radiation safety properties of the device or sealed source are
adequate to protect health and minimize danger to life and
property.
(E)
After completion of the evaluation, the director
issues a certificate of registration to the person making the request. The
certificate of registration acknowledges the availability of the submitted
information for inclusion in an application for a specific license proposing
use of the product, or concerning use under an exemption from licensing or
general license as applicable for the category of certificate.
(F)
The person
submitting the request for evaluation and registration of safety information
about the product shall manufacture and distribute the product in accordance
with:
(1)
The
statements and representations, including quality control program, contained in
the request; and
(2)
The provisions of the registration
certificate.
(G)
Authority to manufacture or initially distribute a
sealed source or device to specific licensees may be provided in the license
without the issuance of a certificate of registration in the following
cases:
(1)
Calibration and reference sources containing no more than:
(a)
Thirty seven
megabecquerels (one millicurie), for beta and/or gamma emitting radionuclides;
or
(b)
0.37 megabecquerels (10 microcuries), for alpha emitting
radionuclides; or
(2)
The intended
recipients are qualified by training and experience and have sufficient
facilities and equipment to safely use and handle the requested quantity of
radioactive material in any form in the case of unregistered sources or, for
registered sealed sources contained in unregistered devices, are qualified by
training and experience and have sufficient facilities and equipment to safely
use and handle the requested quantity of radioactive material in unshielded
form, as specified in their licenses; and
(a)
The intended
recipients are licensed under chapter 3701:1-40 of the Administrative Code or
comparable provisions of another agreement state or the United States nuclear
regulatory commission; or
(b)
The recipients are authorized for research and
development; or
(c)
The sources and devices are to be built to the unique
specifications of the particular recipient and contain no more than seven
hundred forty gigabecquerels (twenty curies) of tritium or 7.4 gigabecquerels
(two hundred millicuries) of any other
radionuclide.
(H)
After the
certificate is issued, the director may conduct an additional review as he/she
determines is necessary to ensure compliance with current regulatory standards.
In conducting the review, the director will complete his/her evaluation in
accordance with criteria specified in this rule. The director may request such
additional information as he/she considers necessary to conduct his/her review
and the certificate holder shall provide the information as
requested.
(I)
A certificate holder who no longer manufactures or
initially transfers any of the sealed source(s) or device(s) covered by a
particular certificate issued by the director shall request inactivation of the
registration certificate. Such a request must be made to the director by an
appropriate method listed in rule
3701:1-40-04 of
the Administrative Code and must normally be made no later than two years after
the initial distribution of all of the source(s) or device(s) covered by the
certificate has ceased. However, if the certificate holder determines that an
initial transfer was in fact the last initial transfer more than two years
after that transfer, the certificate holder shall request inactivation of the
certificate within ninety days of this determination and briefly describe the
circumstances of the delay.
(J)
If a
distribution license is to be terminated in accordance with rule
3701:1-40-18
of the Administrative Code, the licensee shall request inactivation of its
registration certificates associated with that distribution license before the
director will terminate the license. Such a request for inactivation of
certificate(s) must indicate that the license is being terminated and include
the associated specific license number.
(K)
A specific
license to manufacture or initially transfer a source or device covered only by
an inactivated certificate no longer authorizes the licensee to initially
transfer such sources or devices for use. Servicing of devices must be in
accordance with any conditions in the certificate, including in the case of an
inactive certificate.
Replaces: 3701:1-46-49
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 01/20/2008, 12/01/2012, 11/08/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 12/1/12
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