(A) Upon obtaining
a license from the department pursuant to rule
4501-45-03 of the Administrative
Code, a manufacturer of an ignition interlock device is immediately eligible to
apply for certification from the director for each ignition interlock device
model or type that differ in any aspect intended for lease, sale, or other use
in this state.
(B) A manufacturer
of an ignition interlock device may not be eligible for certification of its
device(s) if any of the manufacturer's owner(s), officers, partners, agents,
employees, contractors, or installers
:
is an employee, or immediate family member of an
employee, of the department or the department of health;
(1) Is an employee, or immediate
family member of an employee, of the department or the department of
health;
(2) Has been convicted of, pled
guilty to, had a judicial finding of guilt for, or had a judicial finding of
eligibility for treatment in lieu of conviction for, any of the
following:
(a) Any felony within ten years of
the date of application;
(b) A misdemeanor, other than a
minor misdemeanor, within five years of the date of application that is
reasonably related to a person's ability to serve safely and honestly in
connection with ignition interlock devices;
(c) A violation of any federal,
state, county, or municipal drug law;
(d) Any act committed in another
state or jurisdiction that, if committed in Ohio would constitute a violation
set forth in this paragraph.
(C)
A manufacturer of
an ignition interlock device, is not eligible for certification of its
device(s) if the manufacturer, including, but not limited to the agents,
employees, contractors, or installer(s), who work in Ohio, has plead guilty to,
or been convicted of, any disqualifying offense in paragraphs (C)(10)(a) to
(C)(10)(d) of this rule.
A manufacturer of an ignition interlock
device may not be eligible for certification of its device(s) if the
manufacturer, including, but not limited to, the agents, employees,
contractors, or installer(s), work in Ohio, has plead guilty to, or been
convicted of, any disqualifying offense in paragraphs (C)(10)(e) to (C)(10)(t)
of rule 4501-45-05 of the Administrative
Code.
(C)(D) A manufacturer
shall submit an "Ignition Interlock Manufacturer Application for Certification"
(OTS 0029) for first-time and renewal of certification of an ignition interlock
device. Beginning January 1, 2024, renewal applications shall be submitted to
the department between October first and December thirtieth each year.
(1) A manufacturer of an ignition interlock
device shall file
a separate application for
certification and renewal for each device model or type that differ in any
aspect. The original certification application includes:with the director a separate and complete, original or
renewal application for certification, for each ignition interlock device model
or type that differ in any aspect, intended for lease, sale or other use in
this state.
(a)
A certificate from an independent testing laboratory
indicating that the ignition interlock device that is the subject of the
manufacturer's application meets or exceeds the model specifications of the
"National Highway Traffic Safety Administration (NHTSA), Department of
Transportation, as published in Volume 78 No. 89 of the Federal Register on May
8, 2013 (78 F.R. 26849, 2013)" attached as an appendix to this rule, and
incorporated as if fully rewritten herein, or any modifications thereto, in
effect at the time of the director's decision regarding certification of the
device. These specifications must include:
(i)
Requiring the
operator to submit to a random retest within ten minutes of starting the
vehicle. A random retest must continue at intervals not to exceed fifteen
minutes after the previous retest, and not to exceed four times in one hour,
for the duration of the travel. An operator shall have a maximum of six minutes
to perform the retest. If a passing sample is not provided, the device shall
continue prompting for additional retests until a passing sample is provided or
the six minutes elapses, whichever comes first. A failed retest shall be logged
if the six minutes elapses and no passing sample is provided. If the vehicle is
accidentally or intentionally powered off and a passing sample has not been
provided the device will prompt for retests until the six minutes has elapsed.
The vehicle may not be restarted after being turned off during a retest
sequence until a passing sample has been provided. The device will revert back
to initial startup requirements after the six minutes has expired without a
passing sample. The manufacturer shall record on the data logger all retests
and associated results along with any evidence of circumvention. All results
must be reported to the court or monitoring agency.
(ii)
That the device
allow a minimum of 1.5 L of breath for an acceptable breath sample and permit
1.2 L upon medical recommendation;
(iii)
The device
shall be calibrated to a set point of twenty thousandths percent per gram of
breath alcohol concentration to start the vehicle and for retest purposes, with
consideration to drivers under twenty-one years of age;
(iv)
That the device
contains a digital image capture device or camera that does not distract or
impede the driver in any manner from safe and legal operation.
(v)
That the device
maintain minimum a calibration stability period of thirty-seven days (thirty
days plus seven-day lockout countdown) or, not to exceed sixty-seven days
(sixty days plus seven-day lockout countdown). Sixty-seven days is respective
to if the device is utilizing of real-time violation reporting.
(b)
A
complete quality assurance plan in accordance with appendix A to the NHTSA
standards referenced in paragraph (D)(1)(a) of this rule.
(c)
A complete copy
of the testing protocol, and the results thereof, conducted by an independent
testing laboratory, for the ignition interlock device which is the subject of
the manufacturer's original application for certification. The testing
protocol, and results, shall be reviewed and approved by the director of
health.
(2) At the time a manufacturer of an
ignition interlock device files its original or renewal application for
certification with the director, together with all required documents, the
manufacturer shall pay a certification fee of one hundred dollars, in the form
of a check or money order, made payable to the treasurer of the state of Ohio.
A manufacturer shall pay a separate certification fee with each application for
certification filed with the director. The certification fee is
non-refundable.
(3)(2) The manufacturer is
responsible for obtaining a criminal background check for any person identified
in the manufacturer's application for certification, any person identified in
any documents filed with the manufacturer's application, and any person who
installs, services, monitors, or removes the manufacturer's ignition interlock
devices. The criminal background check shall be obtained within two weeks of
beginning to provide the specified services and at least every three years
thereafter.
(4)(3) Upon request of the
department, the criminal background check of any person referenced in paragraph
(D)(2) of this rule shall include a request to the bureau of criminal
identification and investigation to conduct a criminal records check that
includes information from the federal bureau of investigation. The manufacturer
shall pay
pays
all costs for the criminal background check. The criminal background check
shall be submitted to the department and not be dated more than forty-five days
from the request.
(D) In addition to the completed
original or renewal application, and all required documents, a manufacturer of
an ignition interlock device shall file with the director:
(1) A certificate from an
independent testing laboratory indicating that the ignition interlock device
that is the subject of the manufacturer's application meets or exceeds the
standards of the "National Highway Traffic Safety Administration (NHTSA),
Department of Transportation, as published in Volume 78 No. 89 of the Federal
Register on May 8, 2013 (78 F.R. 26849, 2013)" attached as an appendix to this
rule, and incorporated as if fully rewritten herein, or any modifications
thereto, in effect at the time of the director's decision regarding
certification of the device;
(a) Require the operator of the
vehicle to submit to a random retest within ten minutes of starting the
vehicle. A random retest must continue at intervals not to exceed fifteen
minutes after the previous retest for the duration of the travel. An operator
shall have six minutes to perform the retest and accept unlimited samples
within the time frame;
(b) Allow a minimum of 1.5 L of
breath for an acceptable breath sample and permit 1.2 L upon medical
recommendation;
(c) The device shall be calibrated
to a set-point of twenty-five thousandths per cent breath alcohol
concentration, with consideration to drivers under twenty-one years of
age;
(d) The device may contain a digital
image identification device and/or GPS provided these features will not
distract or impede the driver in any manner from safe and legal
operation.
(e) Maintain minimum calibration
stability period of thirty-seven days (thirty days plus seven-day lockout
countdown) and not to exceed sixty-seven days (sixty days plus seven-day
lockout countdown).
(2) A complete quality assurance
plan in accordance with appendix A of the NHTSA standards referenced in
paragraph (D)(1) of this rule.
(3) A complete copy of the testing
protocol, and the results thereof, conducted by an independent testing
laboratory, for the ignition interlock device which is the subject of the
manufacturer's original application for certification. The testing protocol,
and results, shall be reviewed and approved by the director of
health;
(4) A copy
of the manufacturer's certificate of product liability insurance for the
ignition interlock device model or type which is the subject of the
manufacturer's application for certification
or
renewal, which
shall:
(a)
Identify
Identifies
the manufacturer;
(b)
Identify
Identifies the department as an additional insured and
certificate holder;
(c)
Identify
Identifies the policy number;
(d)
State
States a policy
limit of at least one million dollars per occurrence;
(e)
State
States the
effective date and the expiration date of the policy;
(f)
State
State that if
the policy is canceled before its expiration date, the issuing insurer will
provide written notice to the department at least thirty days before
cancellation of the policy.
(E)
At the time a
manufacturer of an ignition interlock device files its original or renewal
application for certification with the director, together with all required
documents, the manufacturer shall pay a certification fee of one hundred
dollars, in the form of a check or money order, made payable to the treasurer
of the state of Ohio. A manufacturer shall pay a separate certification fee
with each application for certification filed with the director. The
certification fee is non-refundable.
(F)
Upon application
for renewal of a device certification, the manufacturer shall submit a
completed application and all relevant documents in compliance with paragraphs
(D)(4)(a) to (D)(4)(f), (E), and (G) of this rule.
(E)(G) In
addition to the completed application, and required documents, a manufacturer
shall certify by affidavit to the director that the specific ignition interlock
device which is the subject of the application for certification complies with
divisions (A)(2)(a) to (A)(2)(k) of section
4510.43 of the Revised
Code.
each of the following:
(1) It contains a minimum and
maximum calibration range, in accordance with the NHTSA standards referenced in
paragraph (D)(1) of this rule;
(2) It does not impede the safe
operation of the vehicle;
(3) It has features that are
operating and functioning, and that make circumvention difficult, and that do
not interfere with the normal use of the vehicle;
(4) It correlates well with
established measures of alcohol impairment;
(5) It works accurately and reliably
in an unsupervised environment;
(6) It is resistant to tampering and
shows evidence of tampering if tampering is attempted;
(7) It is difficult to circumvent
and requires premeditation to do so;
(8) It minimizes inconvenience to a
sober user;
(9) It requires a proper, deep-lung
breath sample or other accurate measure of the concentration by weight of
alcohol in the breath;
(10) It operates reliably over the
range of automobile environments;
(11) It is made by a manufacturer
who is covered by product liability insurance.
(F)(H)
The director shall notify a manufacturer
, in
writing, by certified mail, return receipt,
by
electronic mail, acknowledged receipt, whether certification of the
ignition interlock device model or type, that is the subject of the
manufacturer's application, is granted or denied.
(1) If certification is granted, a
manufacturer
shall receive
receives a certificate from the director
. The certificate shall be on a format prescribed
by the director.
Certification
Beginning January 1, 2024, certification of the
specific ignition interlock device
shall
expire
expires
one year from the date of issuance stated on
December thirty-first each year
the certificate, unless certification is suspended
or revoked pursuant to rule 4501-45-05 of the Administrative Code prior to the
expiration date stated on the certificate.
When the director issues a certificate to a
manufacturer of an ignition interlock device, the department shall add the
certified device model or type, together with the manufacturer's name, business
address, and contact information, to the department's list of licensed
manufacturers of ignition interlock devices and certified devices published on
the department's website as listed in paragraph (F) of rule
4501-45-11 of the Administrative
Code.
When the director issues a
certificate to a manufacturer of an ignition interlock device, the department
shall add the certified device model or type, together with the manufacturer's
name, business address, and contact information, to the department's list of
licensed manufacturers of ignition interlock devices and certified devices
published on the department's website as listed in paragraph (F) of rule
4501-45-11 of the Administrative Code.
If a manufacturer of a certified
ignition interlock device changes any of the information published on the
department's website, the manufacturer shall immediately notify the department
in writing, and the department will update its website.
(2) The director shall
deny certification of an ignition interlock device for any reason(s) set forth
in rule
4501-45-05 of the Administrative
Code or the rules of this chapter. If certification is denied, a manufacturer
shall receive written notice
, by certified mail,
return receipt,
by electronic mail,
acknowledged receipt, from the director stating the reason(s)
certification was denied.
(I)
If a manufacturer
of an ignition interlock device, changes any information published on the
departments website the manufacturer shall submit "Ohio Ignition Interlock
Service Center Application/Removals/Updates" (OTS 0023), if the manufacturer
makes any modification(s) to a certified device model or type, the manufacturer
shall immediately submit "Ignition Interlock Manufacturer Application for
Certification" which includes:
(1)
Each modification and the reason(s) for the
modification(s); and
(2)
The director may request a complete copy of the testing
protocol for the modified device, and the results thereof, conducted by an
independent testing laboratory. The testing protocol, and the results, shall be
reviewed and approved by the director of health.
The director shall determine whether
the certification in effect at the time of the notice of modification(s)
applies to the certified ignition interlock device or if the manufacturer must
apply for a separate certification of the modified device. The director shall
notify the manufacturer of the decision.
(G) If a manufacturer of an ignition
interlock device makes any modification(s) to a certified device model or type,
the manufacturer shall immediately notify the director, in writing by certified
mail, return receipt, of each modification and the reason(s) for the
modification(s).
In addition to the notice, the
manufacturer may be required to provide the director with a complete copy of
the testing protocol for the modified device, and the results thereof,
conducted by an independent testing laboratory. The testing protocol, and the
results, shall be reviewed and approved by the director of
health.
The director shall determine whether
the certification in effect at the time of the notice of modification(s)
applies to the certified ignition interlock device or if the manufacturer must
apply for a separate certification of the modified device. The director shall
notify the manufacturer of the decision by certified mail, return
receipt.
(H)(J) If a manufacturer's
product liability insurance coverage for any certified ignition interlock
device is modified
, canceled, or terminated
by its insurer, or the manufacturer, prior
to the expiration date
as stated on the certificate
of product liability insurance provided to the director pursuant to paragraph
(D)(3) of this rule, the manufacturer shall provide the director with
a copy or new certificate of liability insurance
coverage which complies with all requirements set forth in this rule
the following, by certified mail, return
receipt, within
five
thirty days
of receiving
its notice of modification:
(1) A written statement from the
manufacturer detailing the circumstances and reason(s) for the modification of
its product liability insurance;
(2) A copy of the manufacturer's
modified certificate of product liability insurance which complies with all
requirements set forth in paragraph (D)(3) of this rule.
(I) If a manufacturer's product
liability insurance coverage for a certified ignition interlock device is
canceled by its insurer, or terminated by the manufacturer, prior to the
expiration date stated on the certificate of product liability insurance
previously provided to the director, the manufacturer shall provide the
director with the following, by certified mail, return receipt, within five
days of receiving its notice of cancellation or termination:
(1) A written statement from the
manufacturer detailing the circumstances and reason(s) for cancellation, or
termination, of its product liability insurance coverage;
(2) A copy of the manufacturer's new
certificate of liability insurance which complies with all requirements set
forth in paragraph (D)(3) of this rule.
(J)(K) If
a manufacturer of an ignition interlock device allows any time lapse in its
product liability insurance coverage, or fails to provide all documents
required by paragraphs (D)(3), (H), and (I) of this rule, the director shall
suspend or revoke the manufacturer's license and certification(s). The director
shall notify the manufacturer of the suspension(s) or revocation(s) by
certified mail, return receipt.
(K)(L) The manufacturer is
responsible for ensuring that each installer of the manufacturer's
manufacturer's ignition interlock device is adequately
trained and qualified to install, calibrate, and perform monitoring checks of
each ignition interlock device.
(L)(M) No manufacturer or
installer shall engage in any conduct involving dishonesty, fraud, deceit,
misrepresentation, incompetence or other conduct that may reasonably be
interpreted as unethical.
(M)(N) The manufacturer
shall maintain a list of all persons who are trained
to install, service, monitor, or remove ignition interlock
devices.
(N)(O) Manufacturers shall
complete an on site review
of each installation site prior to becoming operational and at least annually
thereafter to ensure that installers are
following all applicable laws and rules, and that the installer's operations
are consistent with the manufacturer's
manufacturer's specifications.
(O)(P)
Each installation site shall maintain a professional,
cleanly
clean
appearance.
(P)(Q) Under no
circumstances will the offender be allowed to watch the installation of the
ignition interlock device. Adequate security measures shall be taken to ensure
that areas where installations of ignition interlock devices occur shall not be
visible to the offender.
(Q)(R) The installer shall
train the offender on the operation of the device at the time of initial
installation.
(R)(S) Unless otherwise
specified by the court supervising the offender, the manufacturer or installer
shall inspect and monitor each ignition interlock device every thirty days, unless the device is utilizing real-time reporting to the
court, in which case the device may be inspected and monitored every sixty
days. The offender will be given a seven
day
seven-day grace period to have the
device inspected.
(S)(T) Manufacturers and
installers shall ensure that ignition interlock events are reported to the
court within two business days of detection, and provide testimony before the
court as needed regarding any ignition interlock events. Ignition interlock
events include the following:
(1) A breath
sample indicating the presence of alcohol in the offender's breath in a
concentration sufficient to prevent the ignition interlock device from allowing
the motor vehicle to be started;
(2) A breath sample during a rolling retest
indicating the presence of alcohol in the offender's breath in a concentration
that would have been sufficient to prevent the ignition interlock device from
allowing the motor vehicle to be started;
(3) The offender's failure to appear for a
monitoring check within the time lines specified in paragraph (S) of this
rule;
(4) The offender's failure to
submit to a rolling retest;
(5) The
device was tampered with or circumvented.
(T)(U) Manufacturers and
installers shall respond to offender requests for technical assistance with the
device as soon as practicable.
(U)(V) Manufacturers shall
comply with all terms and conditions set forth in department orders or consent
agreements.
(V)(W) Any failure to
comply with any law or rule involving the licensing and certification of
ignition interlock devices or other immobilizing or disabling device that is
committed by an installer shall be attributable to the manufacturer.
