(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:
(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 shall request, in writing, an original or renewal application
for certification from the department. The original and renewal applications
for certification of an ignition interlock device shall be on a format
prescribed by the director as listed in paragraph (D) of rule 4501-45-11 of the
Administrative Code. Renewal application shall be submitted to the department
thirty days prior to certification expiration.
(1) A manufacturer of an
ignition interlock device shall file 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.
(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) The manufacturer is
responsible for obtaining a criminal background check for any person identified
in the manufacturers 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) Upon request of the
department, the criminal background check of any person referenced in paragraph
(C)(3) 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 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, which shall:
(a) Identify the manufacturer;
(b) Identify the department as an additional insured and
certificate holder;
(c) Identify the policy number;
(d) State a policy limit of at least one million dollars per
occurrence;
(e) State 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) 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 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) The director shall notify a
manufacturer, in writing, by certified mail, return 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 a certificate from the director. The
certificate shall be on a format prescribed by the director. Certification of
the specific ignition interlock device shall expire one year from the date of
issuance stated on 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.
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, from the director stating the reason(s)
certification was denied.
(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) If a manufacturer's product
liability insurance coverage for any certified ignition interlock device is
modified 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 the following, by certified mail, return receipt,
within five 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) 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) The manufacturer is responsible for
ensuring that each installer of the manufacturers ignition interlock
device is adequately trained and qualified to install, calibrate, and perform
monitoring checks of each ignition interlock device.
(L) 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) The manufacturer shall maintain a
list of all persons who install, service, monitor, or remove ignition interlock
devices.
(N) Manufacturers shall review each
installation site at least annually to ensure that installers are following all
applicable laws and rules, and that the installer's operations are
consistent with the manufacturers specifications.
(O) Each installation site shall maintain
a professional, cleanly appearance.
(P) 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) The installer shall train the
offender on the operation of the device at the time of initial
installation.
(R) Unless otherwise specified by the
court supervising the offender, the manufacturer or installer shall inspect and
monitor each ignition interlock device every thirty days. The offender will be
given a seven day grace period to have the device inspected.
(S) 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 timelines specified in
paragraph (R) of this rule;
(4) The offender's
failure to submit to a rolling retest;
(5) The device was
tampered with or circumvented.
(T) Manufacturers and installers shall
respond to offender requests for technical assistance with the device as soon
as practicable.
(U) Manufacturers shall comply with all
terms and conditions set forth in department orders or consent
agreements.
(V) 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.