Section 4501-45-04 - Certification requirements for ignition interlock devices(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.Ohio Admin. Code 4501-45-04
Effective: 5/1/2024
Five Year Review (FYR) Dates: 1/10/2024 and 03/01/2029
Promulgated Under: 119.03
Statutory Authority: 4510.45
Rule Amplifies: 4510.43
Prior Effective Dates: 09/06/1988 (Emer.), 07/22/1990, 08/24/2003, 12/31/2010, 04/01/2016, 01/01/2018