Current through all regulations passed and filed through March 18, 2024
(A) As used in this rule, "facility" has the
meaning defined in division (H) of section
3748.01 of the Revised Code and
the following:
(1) All buildings, equipment,
structures, and other stationary items that are located on a single site or on
contiguous or adjacent sites and that are operated by the same person and have
common corporate or business interests; and
(2) Portions of a building or structure which
are operated by the same person and have common corporate or business
interests.
(B)
Notwithstanding the definition of "facility," the director may consider sites
that are not contiguous or adjacent as one facility provided that:
(1) The sites are operated by the same
person;
(2) The sites are in the
same license category or categories;
(3) The applicant for a license provides for
one radiation safety officer, and if applicable, one radiation safety
committee, as responsible for all sites; and
(4) The director is reasonably satisfied from
the information provided in the application that the applicant will adequately
control radioactive material at all sites listed in the application.
(a) Unless the director has information of
violations of Chapter 3748. of the Revised Code or the rules adopted thereunder
at one or more sites, the director shall presume the applicant will adequately
control radioactive material at all sites if the sites are located not more
than twenty miles driving distance apart as documented by the licensee, and if
all sites are within a twenty mile radius from the main site as designated on
the license.
(b) The director shall
continue to renew a license issued under this paragraph that contains all the
sites listed thereon provided the licensee demonstrates continued compliance
with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted
thereunder.
(C) Every facility that handles radioactive
material in any license category as specified in appendix A to this rule for
which licensure is required shall apply for a license, license amendment, or
license renewal in accordance with this rule. Application for a license,
license amendment, or license renewal shall be made on any format prescribed
and provided by the director. Licenses shall be issued in accordance with the
requirements of Chapter 3748. of the Revised Code, and the rules adopted
thereunder. Except as otherwise provided in this rule, a license shall expire
five years from the date of issuance.
(1) As
used in this paragraph, site means an address of use listed on the license.
Temporary job sites are exempted.
(a) Any
individual applying for a new license with one or more additional sites or a
current licensee amending a license to add one or more additional sites that
are located more than twenty miles from the main site shall pay an additional
site fee for each such site as follows:
(i)
The additional site fee(s) shall be seventy-five percent of the applicable
annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this
rule.
(ii) Additional site fees
will be invoiced annually with the annual fee.
(b) Broad scope licensees are exempt from
paragraph (C)(1)(a) of this rule.
(2) As used in this paragraph, "service"
means activities performed by a person, other than a worker as defined in rule
3701:1-38-01 of the
Administrative Code, pursuant to an agreement with the facility to perform
activities that deal with sources of radiation for the facility.
(a) These activities include, but are not
limited to the following:
(i) Conduct leak
tests;
(ii) Calibrate survey
instruments;
(iii) Provide quality
control tests;
(iv) Conduct
surveys, characterization, and/or remediation activities;
(v) Manage the disposal of radioactive waste
for other persons; or
(vi) Install
sources or devices or change sources within a device.
(b) License categories affected are:
(i) 3219 - decontamination
services;
(ii) 3220 - leak test
service;
(iii) 3221 - instrument
calibration service only - source less than 3.7 terabecquerels (one hundred
curies);
(iv) 3222 - instrument
calibration service only - source equal to or greater than 3.7 terabecquerels
(one hundred curies);
(v) 3223 -
leak test and instrument calibration - source less than 3.7 terabecquerels (one
hundred curies);
(vi) 3224 - leak
test and instrument calibration - source equal to or greater than 3.7
terabecquerels (one hundred curies);
(vii) 3225 - other services - including
teletherapy, irradiator, and gauge service;
(viii) 3232 - waste disposal service
prepackaged only;
(ix) 3233 - waste
disposal service - incineration; and
(x) 3234 - waste disposal service processing
and/or repackaging.
(D) A radioactive materials license issued by
the department may, at the discretion of the director, have more than one
license category on any one specific license. A licensee may have more than one
radioactive materials license. Except as otherwise provided in paragraph (J) of
this rule, the annual fee for a radioactive material license shall be in an
amount in accordance with appendix A to this rule.
(1) Upon receipt of an application for a new
radioactive material license, the department will issue an invoice for the
appropriate fee specified in appendix A to this rule or paragraph (J) of this
rule. Annual fees will be invoiced based on the month of the license expiration
date and the invoice will state that the fee is due thirty days after the date
of the invoice. License fees are not refundable.
(2) An applicant for a new or a renewal or
amendment of a radioactive material license must submit a complete application
before the director will finalize the review of the application. A complete
application is one in which the applicant has provided all the information
requested by the director, including any additional information requested after
receipt of the application package.
(3) Upon receipt of an application for a
license amendment, the department will issue an invoice for the appropriate fee
for the proposed amendment as specified in appendix A to this rule. If the
amendment is to change the license from operational phase to storage of sealed
sources only incident to disposal of the sources, after the amendment the
annual fee for the license shall be reduced to fifty per cent of the fee for
the operational phase of the license, provided that the sources continue to be
in safe storage and leak tested as provided by license condition for the
specific sources in storage. The inspection frequency will remain the same as
that for the operational phase of the license until after source
disposal.
(4) The applicant for a
new, or renewal or amendment of a radioactive materials license shall provide
to the director all additional information requested within sixty days from the
date of the information request. If the director does not receive the requested
information within the stated time period, the director may consider the
application abandoned. Any further consideration of a new license, or a renewal
or amendment of a license shall be pursuant to another application.
(5) The director shall grant a new license,
license amendment, or license renewal to any applicant who has submitted a
complete application and is in compliance with Chapter 3748. of the Revised
Code and the rules adopted thereunder.
(6) When an amendment to a license results in
a change to a license category with a higher fee, the licensee will be charged
the higher of the two amendment fees for that category. The annual fee for the
licensee will escalate to the new category fee on the date of the next annual
invoice.
(7) The director shall
charge a fee for minor license amendments that do not require review by members
of the technical staff at a rate of one hundred dollars per amendment provided
that no licensee shall be required to pay more than one thousand dollars for
minor amendments in any calendar year. Minor amendments include, but are not
limited to, adding a new gauge of the same type already licensed unless that
additional gauge increases the license or inspection fee, a corporate name
change if the corporate ownership does not change, adding a user name that does
not require review of education and experience, and corporate address change if
the location of the use of the radioactive material does not change. Amendments
to change the radiation safety officer or the chair or members of the radiation
safety committee that require review of education or experience are not minor
amendments.
(8) License
terminations shall be handled as follows:
(a)
Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of
five hundred dollars or fifty per cent of the annual fee, whichever is less,
will be invoiced upon written request from the licensee for termination of the
license. This fee is not refundable.
(b) Except as provided in paragraph (D)(8)(c)
of this rule, if the termination cost, as determined by paragraph (M) of this
rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the
remainder of the termination expense will be assessed at full cost.
(c) If the license termination would be
covered under paragraph (D)(9) of this rule, that paragraph will be used for
the termination process.
(d) The
license termination process will not be completed until the licensee is in
compliance with all rules, including payment of fees.
(9) Licenses, and other approvals related to
the licensed activity requiring decommissioning, decontamination, reclamation,
site restoration, or long-term care due to the continued presence of
radioactive materials shall be charged an annual fee based on the approved
decommissioning funding plan as specified in appendix B to this rule.
(a) A decommissioning plan must be approved
by the department. Prior to approval of the decommissioning plan the licensee
must submit an amendment requesting decommissioning. Until the amendment is
approved the licensee's annualized license fee will be reduced by fifty per
cent. After approval of the amendment containing the decommissioning plan, the
licensee will be invoiced at the annual fee specified in appendix B to this
rule.
(b) The annual fee specified
in appendix B to this rule is based on the cost of decommissioning. The fee is
payable within thirty days of mailing of an invoice by the
department.
(c) Routine
decommissioning oversight by the department will be charged against the annual
amount received and additional invoices will not be issued unless the cost of
activities exceeds the annual amount in any given year.
(d) The facility shall receive a monthly
statement of items and amounts charged against the annual fee.
(e) If the cost of additional activities
arise that require use of additional staff, including any consulting service
that exceeds the amount of the annual fee paid by the licensee, these
additional costs will be included in any invoice as separate items invoiced for
the full cost of the oversight by additional staff or consultants. Oversight
activities will be performed at a frequency which adequately monitors health,
safety, and the environment.
(f)
When the approved decommissioning plan is less than one hundred thousand
dollars, the licensee will remain in the current license category and continue
to pay the required annual fee specified in appendix A to this rule during
decommissioning. Inspections of these licensees will be done as non-routine
inspections. Non-routine inspection fees will not be applied until the number
of decommissioning inspections performed exceed the inspections that would have
been performed if the licensee had not chosen the decommissioning
option.
(g) When the licensee has
completed the decommissioning, and the director has determined that the
licensee cannot terminate the license as provided by the Administrative Code,
Chapter 3748. of the Revised Code or the rules adopted thereunder, but the
licensee has successfully completed the decommissioning of the operation as
required by the approved decommissioning plan, the director will amend the
license to a decommissioning/possession only license. The annual fee for a
decommissioning/possession only license is provided in appendix B to this
rule.
(E)
Licenses shall be renewed in accordance with the standard renewal procedure
established in Chapter 4745. of the Revised Code, except that a licensee, other
than a broad scope licensee, shall apply for renewal of the license ninety days
prior to the expiration date of the current license and broad scope licensees
shall apply for renewal of their license one hundred eighty days prior to
expiration.
(F) The annual fee is
listed in appendix A to this rule "column 5" for a new license or "column 6"
for a renewal license. To recover the costs of oversight activities where
radioactive material is found in the public domain and there is no evident
individual that is determined to be responsible, a surcharge of
5.25 per cent has been included
in the annual fee listed in "column 5" and "column 6" of appendix A to this
rule.
(G) The department shall
charge an inspection fee for all non-routine inspections. A non-routine
inspection is defined as any inspection that the department conducts in
addition to the scheduled routine inspections and one follow-up inspection if
necessary. Non-routine inspections include, without limitation:
(1) An inspection performed as a result of an
incident;
(2) Any pre-license
inspections for a new license applicant when the director determines that an
inspection is necessary to assess the adequacy of the information provided in
the application;
(3) Inspections
prior to license amendment, category change, or termination;
(4) An inspection performed at a facility
that results in the issuance of an adjudication order by the director;
or
(5) Other enforcement or
regulatory inspections, not specified above, that the director determines is
necessary to assess compliance with Chapter 3748. of the Revised
Code.
(H) The fee for a
non-routine inspection shall be based on the actual cost for conducting the
inspection which shall include:
(1) An hourly
charge of seventy dollars per staff person assigned to the inspection, except
staff participating as training will not be included in the charges;
(2) An administrative fee of three hundred
thirty dollars;
(3) All necessary
laboratory analysis costs for samples collected by department personnel;
and
(4) Any staff travel costs
which shall be calculated in accordance with rule 126-01-02 of the
Administrative Code.
(I)
All fees invoiced as provided within this rule, including full cost, routine,
and non-routine inspection fees, shall be paid within thirty days of the
invoice date specified on the invoice. In accordance with sections
3748.07 and
3748.13 of the Revised Code, any
fee that remains unpaid on the ninety-first day after the original invoice date
shall be assessed an additional amount equal to ten per cent of the original
fee.
(1) The department shall mail
invoices by ordinary U.S. mail to the most recent address provided by the
licensee.
(2) The department shall
maintain a list of the invoices issued and date mailed.
(J) Notwithstanding paragraph (D)
of this rule, the department shall charge the following types of licensees
reduced license fees in the following specified amounts:
(1) A private entity that provides services,
does not engage in manufacturing, and that has three hundred fifty thousand to
two million dollars in gross annual receipts, shall pay a total license fee of
seventy-five per cent of the amount specified for that use of radioactive
materials in appendix A to this rule.
(2) A private entity that provides services,
does not engage in manufacturing, and that has less than three hundred fifty
thousand dollars in gross annual receipts shall pay a total license fee of
fifty per cent of the amount specified for that use of radioactive material in
appendix A to this rule.
(3) A
private entity that engages in manufacturing and that has thirty-five to two
hundred employees, irrespective of gross annual receipts, shall pay a total
license fee of seventy-five per cent of the amount specified for that use of
radioactive material in appendix A to this rule.
(4) A private entity that engages in
manufacturing and that has less than thirty-five employees, irrespective of
gross annual receipts, shall pay a total license fee of fifty per cent of the
amount specified for that use of radioactive material in appendix A to this
rule.
(5) A nonprofit entity that
has gross annual receipts of three hundred fifty thousand dollars to two
million dollars shall pay a total license fee of seventy-five per cent of the
amount specified for that use of radioactive material in appendix A to this
rule.
(6) A nonprofit entity that
has gross annual receipts of less than three hundred fifty thousand dollars
shall pay a total license fee of fifty per cent of the amount specified for
that use of radioactive material in appendix A to this rule.
(7) A government jurisdiction or district
with a population of twenty thousand to fifty thousand shall pay a total
license fee of seventy-five per cent of the amount specified for that use of
radioactive material as specified in appendix A to this rule.
(8) A government jurisdiction or district
with a population of less than twenty thousand shall pay a total license fee of
fifty per cent of the amount specified for that use of radioactive materials as
specified in appendix A to this rule.
(9) A health district as defined in section
3709.01 of the Revised Code
shall pay a total license fee of twenty-five per cent of the amount specified
in appendix A to this rule.
(10) An
accredited private or public college or university possessing or using
radioactive material in a sealed or unsealed source solely as a part of a
college or university course supported by tuition and leading to an accredited
degree, but excluding clinical training, shall pay a total license fee as set
forth for category "1129" as that amount is specified in appendix A to this
rule.
The reduced annual fees specified in this paragraph do not
apply to any other fees that a licensee may be required to pay under Chapter
3748. of the Revised Code or rules adopted thereunder. Licensees shall provide
certification of their compliance with the provisions of paragraphs (J)(1) to
(J)(6) of this rule upon initial application and renewal.
(K) The director may modify the
inspection frequency of licensed facilities based upon the performance of the
facility.
(L) In accordance with
section 3748.22 of the Revised Code, the
department shall charge fees sufficient to cover all costs of regulatory,
administrative, and enforcement activities conducted pursuant to Chapter 3748.
of the Revised Code. The director shall recommend to the radiation advisory
council and the public health council changes in the radioactive materials fees
if the director finds that fees do not meet the requirements of section
3748.22 of the Revised
Code.
(M) Fees for those categories
listed as "full cost" such as decommissioning activities, for either partial,
building or selected area of a licensed site, or full decommissioning leading
to license amendment, category change, or termination and for review of sources
and/or devices shall be specified as "full cost" and shall be calculated as the
sum of the seventy dollar hourly charge per staff member for the number of
hours spent on document review and preparation, licensing, inspection,
meetings, teleconferences, in travel, administrative time, the cost of any
special contractors as determined necessary by the director, any environmental
monitoring for radioactive materials and laboratory analysis, any other
associated activities. The administrative fee from paragraph (H)(2) of this
rule shall be used for administrative time. Travel expenses shall also be
invoiced and shall be calculated at the rate determined by rule
126-1-02
of the Administrative Code. These fees will be invoiced monthly.
(N)
(1)
Reciprocity to engage in activities in the state of Ohio which involve
radioactive materials may be authorized provided:
(a) The person requesting reciprocity
possesses a valid radioactive materials license issued by another agreement
state or the United States nuclear regulatory commission which authorizes the
same activities proposed to be conducted in Ohio;
(b) The request for reciprocity is made by
submission of a completed reciprocity application provided by the director, a
copy of the person's radioactive materials license, and payment of the
reciprocity fee specified in appendix A to this rule;
(c) The duration of activities to be
performed in Ohio under reciprocity does not exceed one hundred eighty days in
any one calendar year.
(2) A person who has been granted reciprocity
in Ohio shall notify the director at least three business days in advance of
each time the person proposes to begin a new use of radioactive materials in
the state of Ohio, with the notification made on a form provided by the
director.
(3) Activities conducted
in Ohio under reciprocity are subject to inspection by the department at any
time and the department shall invoice a reciprocity inspection fee of one
thousand dollars for each inspection of a person's authorized reciprocity
activities.
(4) Reciprocity is
authorized for one calendar year, beginning on January first or later date when
reciprocity is initially applied for, and ending on December
thirty-first.
(5) A person who is
authorized reciprocity shall apply for an Ohio radioactive materials license at
least thirty days prior to exceeding one hundred eighty days of activities in
Ohio.
(O) Requests for
safety evaluation of devices, products, or sealed sources used for radioactive
materials either for commercial distribution or manufactured in accordance with
the unique specifications of, and for use by, a single applicant shall be
submitted to the director on a form provided by the director for that review
prior to manufacture or commercial distribution.
(1) The application shall specify a license
amendment for one of the areas listed below:
(a) Safety evaluation of sealed sources or
devices or products containing NARM, byproduct material, source material, or
special nuclear material (less than critical mass) for commercial
distribution.
(b) Safety evaluation
of sealed sources or devices or products containing NARM, byproduct material,
source material, or special nuclear material (less than critical mass)
manufactured in accordance with the unique specifications of, and for use by, a
single applicant.
(2)
The amendment fee for a source or device review shall be "full cost" as
outlined in paragraph ((M) of this rule.
(3) The amendment fee in appendix A to this
rule for categories under manufacturing and distribution shall be for
amendments other than source or device reviews.
(4) Licensees for categories 3211, 3212,
3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty
dollars to cover administrative costs of overall maintenance activities
associated with source or device data submitted to the United States nuclear
regulatory commission. This surcharge is included in the annual fee for the
above listed categories in "column 5" and "column 6" of appendix A to this
rule.
(P) When
considered necessary by the director, the director may conduct a review of
shielding plans or the adequacy of shielding. The director may also conduct
such a review upon the request of the licensee or the applicant for a license.
The applicant or licensee shall pay a fee for review of shielding plans or
adequacy of shielding as specified in paragraph (M) of this rule.
(Q) Individuals with implanted pacemakers
that have a radioactive source will not be charged an annual fee as an
individual because of the necessity of possessing the device. Unless the
director determines other provisions are required, the medical institution that
implanted the device shall hold the license for the individual.
(R) If, because of the complexity of a
review, such as that for a sealed source or device, decommissioning, license,
or incident, it is necessary to obtain the services of a consultant to assist
in a final determination, the licensee or applicant will be invoiced for the
consulting services.
(S) Licensees
with general licenses requiring an annual report to the director shall submit
the report with a fee of four hundred twenty dollars within thirty days of
mailing an invoice by the department and are subject to late penalties in
paragraph (I) of this rule. If a facility has a specific license which is in a
category that would include the generally licensed material, the facility may
add the generally licensed material to the specific license and will not be
charged the additional fee for that generally licensed material. Annual reports
are required for devices under a general license containing radionuclides at or
above activities listed in paragraph (C)(13) of rule
3701:1-46-05
of the Administrative Code.
Click to
view Appendix
Click to
view Appendix
Five Year Review (FYR) Dates:
1/24/2022 and
01/20/2027
Promulgated
Under:
119.03
Statutory Authority:
3748.04
Rule Amplifies:
3748.04
Prior Effective Dates: 09/01/1997, 09/04/2000, 07/22/2001,
10/22/2006, 07/05/2009, 04/15/2013