(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;
(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.
(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:
(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) 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.
(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 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.
(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 :
(a) Identifies the manufacturer;
(b) Identifies the department as an additional insured and
certificate holder;
(c) Identifies the policy number;
(d) States a policy limit of at least one million dollars per
occurrence;
(e) States the effective date and the expiration date of the
policy;
(f) 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.
(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.
(H) The director shall notify a manufacturer 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 receives a certificate from the director on a format
prescribed by the director. Beginning January 1, 2024, certification of the
specific ignition interlock device expires on December thirty-first each
year.
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.
(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
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.
(J) If a manufacturer's product liability insurance
coverage for any certified ignition interlock device is modified, canceled, or
terminated prior to the expiration date 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 within thirty
days:
(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.
(L) The manufacturer is responsible for ensuring that each
installer of the manufacturer's ignition interlock device is adequately
trained and qualified to install, calibrate, and perform monitoring checks of
each ignition interlock device.
(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.
(N) The manufacturer shall maintain a list of all persons
who are trained to install, service, monitor, or remove ignition interlock
devices.
(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 specifications.
(P) Each installation site shall maintain a professional,
clean appearance.
(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.
(R) The installer shall train the offender on the operation
of the device at the time of initial installation.
(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 grace period to have
the device inspected.
(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.
(U) Manufacturers and installers shall respond to offender
requests for technical assistance with the device as soon as
practicable.
(V) Manufacturers shall comply with all terms and
conditions set forth in department orders or consent agreements.
(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.
