(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.