Ohio Admin. Code 3701:1-40-14 - Application for specific licenses
(A) An applicant for a license to receive and
possess radioactive material shall apply in accordance with rule
3701:1-38-02
of the Administrative Code and this chapter on a form prescribed by the
director. The original application shall be filed with the director.
Information contained in previous applications, statements or reports filed
with the director may be incorporated by reference, provided that the reference
is clear, specific, and has been on file with the department for not more than
two licensing periods, and provided that the item being referenced in the
document is being referenced without change.
(B) The director may at any time after the
filing of the original application require additional information from the
applicant in order to determine whether a license should be issued or whether a
current license should be modified or revoked.
(C) Each application shall be signed by the
applicant or a person duly authorized to act for the applicant.
(D) An application for a license to receive
and possess radioactive material for the conduct of any activity which the
director has determined pursuant to rule
3701:1-40-36
of the Administrative Code could potentially affect the quality of the
environment shall be filed at least nine months prior to commencement of
construction of the plant or facility in which the activity will be conducted
and shall be accompanied by any environmental report required pursuant to rule
3701:1-40-36
of the Administrative Code. The applicant is prohibited from the commencement
of construction activities in areas covered by the environmental reporting
requirements identified in rules
3701:1-40-30
to
3701:1-40-38
of the Administrative Code before the conclusion of these reviews. The terms
"construction" and "commencement of construction" shall have the same meaning
as identified in rule
3701:1-38-01 of the
Administrative Code.
(E)
(1) Except as provided in paragraphs (E)(2),
(E)(3), and (E)(4) of this rule, an application for a specific license to use
radioactive material in the form of a sealed source or in a device that
contains the sealed sources must either:
(a)
Identify the source or device by manufacturer and model number as registered in
the sealed source and device registry of the United States nuclear regulatory
commission in accordance with sealed source and device registry requirements
contained in rule
3701:1-46-49
of the Administrative Code, or with equivalent requirements from an agreement
state or the United States nuclear regulatory commission; or
(b) Contain the information specified in
sealed source and device registry requirements contained in paragraph (C) of
rule
3701:1-46-49
of the Administrative Code so that the director is able to perform the
review.
(2) For sources
or devices manufactured before October 23, 2012 that are not registered with
the director in accordance with rule
3701:1-46-49
of the Administrative Code or equivalent requirements from an agreement state
or the United States nuclear regulatory commission, and for which the applicant
is unable to provide all categories of information specified in rule
3701:1-46-49
of the Administrative Code, the applicant must provide:
(a) All available information identified in
rule
3701:1-46-49
of the Administrative Code concerning the source, and, if applicable, the
device; and
(b) Sufficient
additional information to demonstrate that there is reasonable assurance that
the radiation safety properties of the source or device are adequate to protect
health and minimize danger to life and property. Such information must include
a description of the source or device, a description of radiation safety
features, the intended use and associated operating experience, and the results
of a recent leak test.
(3) For sealed sources and devices allowed to
be distributed without registration of safety information in accordance with
rule
3701:1-46-49
of the Administrative Code, the applicant may supply only the manufacturer,
model number, and radionuclide and quantity.
(4) If it is not feasible to identify each
sealed source and device individually, the applicant may propose constraints on
the number and type of sealed sources and devices to be used and the conditions
under which they will be used, in lieu of identifying each sealed sources and
device.
(F) In the case
of an application for a license specified in rule
3701:1-40-16
of the Administrative Code, or an application for a specific license specified
in Chapter 3701:1-46, 3701:1-48, or 3701:1-58 of the Administrative Code, the
applicant shall provide a proposed decommissioning funding plan or a
certification of financial assurance for decommissioning.
(G) Requirement for an emergency response
plan:
(1) Each application to possess
radioactive materials in excess of the quantities
specified in the appendix to this rule, whether in unsealed form, on
foils or plated sources, or sealed in glass,
in excess of the quantities specified in the
appendix to this rule shall contain either:
(a) An evaluation showing that the maximum
dose to a person offsite due to a release of radioactive materials would not
exceed 0.01 sievert (one rem) TEDE or 0.05 sievert (five rem) to the thyroid;
or
(b) An emergency plan for
responding to a release of radioactive material.
(2) One or more of the following factors may
be used to support an evaluation of the need to submit an emergency plan under
this paragraph:
(a) The radioactive material
is physically separated so that only a portion of the material could be
involved in an accident;
(b) All or
part of the radioactive material is not subject to release during an accident
because of the way it is stored or packaged;
(c) The release fraction in the respirable
size range would be lower than the release fraction specified in the appendix
to this rule due to the chemical or physical form of the material;
(d) The solubility of the radioactive
material would reduce the dose received;
(e) Facility design or engineered safety
features in the facility would cause the release fraction to be lower than the
limit specified in the appendix to this rule;
(f) Operating restrictions or procedures
would prevent a release fraction as large as that shown in the appendix to this
rule; or
(g) Other factors
appropriate for the specific facility as determined by the director.
(3) An emergency plan for
responding to a release of radioactive material submitted under paragraph
(G)(1)(b) of this rule shall include the following information:
(a) A brief description of the licensee's
facility and the area near the site.
(b) An identification of each type of
possible radioactive material accident which may require protective
action.
(c) A classification system
for classifying an accident as either an alert or a site area
emergency.
(d) Identification of
the means of detecting each type of accident in a timely manner.
(e) A brief description of the means and
equipment for mitigating the consequences of each type of accident, including
those provided to protect workers onsite, and a description of the program for
maintaining the equipment.
(f) A
brief description of the methods and equipment to assess releases of byproduct
and accelerator produced materials.
(g) A brief description of the
responsibilities of the licensee's personnel should an accident occur,
including identification of personnel responsible for promptly notifying
offsite response organizations and the department, and identification of
personnel responsible for developing, maintaining, and updating the
plan.
(h) A commitment to, and a
brief description of, the means to promptly notify offsite response
organizations and request offsite assistance, including medical assistance for
the treatment of contaminated injured onsite workers when appropriate. A
control point shall be established. The notification and coordination shall be
planned so that in the event that some personnel, parts of the facility, or
some equipment is not available, that unavailability will not prevent such
notification and coordination. The licensee shall also commit to notifying the
department immediately after notification of the appropriate offsite response
organizations and not later than one hour after the licensee declares an
emergency. These reporting requirements do not supersede or release licensees
from complying with the requirements of the "Emergency Planning and Community
Right-to-Know Act of 1986,"
" Title III,
of Pub. L. 99-499
, 100
Stat. 1728,
42
U.S.C. 11001 et seg. or other state or
federal reporting requirements.
(i)
A brief description of the types of information on facility status, radioactive
releases, and recommended protective actions, if necessary, to be given to
offsite response organizations and to the department.
(j) A brief description of the frequency,
performance objectives and plans for the training that the licensee will
provide workers on how to respond to an emergency including any special
instructions and orientation tours the licensee would offer to fire, police,
medical and other emergency personnel. The training shall familiarize personnel
with site-specific emergency procedures. The training also shall thoroughly
prepare site personnel for their responsibilities in the event of an accident,
including training on the emergency scenarios postulated as most probable for
the specific site, and the use of team training for such scenarios.
(k) A brief description of the means of
restoring the facility to a safe condition after an accident.
(l) Provisions for conducting quarterly
communication checks with offsite response organizations and biennial onsite
exercises to test response to simulated emergencies. Quarterly communication
checks with offsite response organizations must include the check and update of
all necessary telephone numbers. The licensee shall invite offsite response
organizations to participate in the biennial exercises. Participation of
offsite response organizations in biennial exercises, although recommended, is
not required. Exercises must use accident scenarios postulated as most probable
for the specific site and the scenarios shall not be known to most exercise
participants. The licensee shall critique each exercise using individuals not
having direct implementation responsibility for the plan. Critiques of
exercises must evaluate the appropriateness of the plan, emergency procedures,
facilities, equipment, training of personnel, and overall effectiveness of the
response. Deficiencies found by the critiques must be corrected.
(m) A certification that the applicant has
met all responsibilities under the "Emergency Planning and Community
Right-to-Know Act of 1986,"
" Title III,
of Pub. L. 99-499
, 100
Stat. 1728,
42
U.S.C. 11001 et seg , if applicable to
the applicant's activities at the proposed place of use of the byproduct or
accelerator produced material.
(n)
The licensee must have and maintain liability coverage for incidents which
would activate the plan to cover bodily injury and property damage to third
parties caused by incidents which would activate the plan in the amount of at
least one million dollars per occurrence with an annual aggregate of at least
two million dollars, exclusive of legal defense costs.
(4) The licensee shall allow the offsite
response organizations expected to respond in case of an accident sixty days to
comment on the licensee's emergency plan before submitting it to the
department. The licensee shall provide any comments received within the sixty
days to the department with the emergency plan.
(H) Information provided by a licensee or
applicant for a license or license renewal that constitutes a "trade secret" as
defined in section
1333.61
of the Revised Code is not subject to public disclosure in accordance with
sections
1333.61
to
1333.69 of the
Revised Code.
(I) An application
from a medical facility, or educational institution to produce positron
emission tomography (PET) radioactive drugs for noncommercial transfer to
licensees in its consortium authorized for medical use in accordance with rules
in Chapter 3701:1-58 of the Administrative Code shall include:
(1) A request for authorization for the
production of PET radionuclides or evidence of an existing license issued in
accordance with rule
3701:1-38-02
of the Administrative Code for a PET radionuclide production facility within
its consortium from which it receives PET radionuclides.
(2) Evidence that the applicant is qualified
to produce radioactive drugs for medical use by meeting one of the criteria in
paragraph (A)(2) of rule
3701:1-46-43
of the Administrative Code.
(3)
Identification of individual(s) authorized to prepare the PET radioactive drugs
if the applicant is a pharmacy, and documentation that each individual meets
the requirements of an authorized nuclear pharmacist as specified in paragraph
(B) (2) of rule
3701:1-46-43
of the Administrative Code.
(4)
Information identified in paragraph (A)(3) of rule
3701:1-46-43
of the Administrative Code, on the PET drugs to be non-commercially transferred
to members of its consortium.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 07/22/2001, 08/15/2005, 10/04/2010, 07/25/2013, 06/25/2015
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