The purpose of this chapter is to establish regulations for the certification, installation, repair, and removal of ignition interlock systems in Maryland and to establish eligibility requirements for participants and minimum standards for service providers under the Maryland Ignition Interlock Program. The Administration shall: Establish standards for the calibration, maintenance, and service of ignition interlock devices by the manufacturer or service provider of that device; Establish protocol for the Maryland Ignition Interlock Program to include eligibility criteria for participants and minimum standards for service providers; Notify the manufacturer in writing if the Administration certifies a device or service provider; Provide for a review of the certification of ignition interlock devices; and Issue a notice, if necessary, to show cause why a device or service provider should be decertified in the State because of a failure to meet the certification requirements set forth in this chapter. A written notice of the Administration's certification of an ignition interlock device or service provider is a public record under Courts and Judicial Proceedings Article, §10-204, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Administration” means the Motor Vehicle Administration. “Administrator” means the Administrator of the Motor Vehicle Administration. “Alcohol” means the generic class of organic compounds known as alcohols and, specifically, the chemical compound ethyl alcohol. For the purpose of ignition interlock devices, there is no requirement expressed or implied that the device be specific for ethyl alcohol. “Alcohol concentration” (BAC) means the amount of alcohol in a person's blood or breath determined by chemical analysis, which shall be measured by grams of alcohol per: 100 milliliters of blood; or 210 liters of breath. “Alveolar air” (also called “deep lung air”) means an air sample which is the last portion of a prolonged, uninterrupted exhalation and which gives a quantitative measurement of alcohol concentration from which blood alcohol concentration can be determined. The alveoli are the smallest air passages in the lungs, surrounded by capillary blood vessels and through which an interchange of gases occurs during respiration. Alcohol in the blood is eliminated from the lungs via the alveoli. “Approved service provider” has the meaning stated in Transportation Article, §16-404.1, Annotated Code of Maryland. “BAC” in this chapter means either breath alcohol concentration or blood alcohol concentration. “Device” or “ignition interlock device” means an ignition interlock system as defined in Transportation Article, §21.902.2, Annotated Code of Maryland. “Interlock” means the mechanism by which a motor vehicle is prevented from starting when the test result of a person's breath alcohol analysis exceeds a preset BAC level. “Manufacturer” means any person engaged in the manufacturing or assembling of ignition interlock devices. “Monitoring” means the approved service provider's action of downloading the information obtained in the device's data logging mechanism and submitting this information to the Administration for review. “Program” means the Ignition Interlock System Program established by the Administration under Transportation Article, §16.404.1, Annotated Code of Maryland. “Purge” means the process by which a device cleanses or removes a previous breath test sample from the device and specifically removes residual alcohol. “Security” means the protection and safeguards incorporated into ignition interlock devices to ensure proper performance and to ensure against failure caused either by inherent defects or human tampering which causes the device not to operate as designed. The National Highway Traffic Safety Administration (NHTSA) Model Specifications for Breath Alcohol Ignition Interlock Devices (BAIID) 57 FR 11772 (1992), as amended, are incorporated by reference as the specifications ignition interlock devices must meet under this chapter. The Administration shall provide notice and a reasonable implementation period to develop a transition and implementation plan for the approval and use of BAIIDs when new NHTSA Model Specifications are released. A manufacturer seeking certification of ignition interlock devices shall apply for certification on a form or in a format prescribed by the Administration and shall certify that its ignition interlock devices: Do not impede the safe operation of the vehicle; Minimize opportunities to be bypassed; Correlate accurately with established measures of blood alcohol levels; Work accurately and reliably in an unsupervised environment; Require a proper and accurate measure of blood alcohol levels; Resist tampering and provide evidence of attempted tampering; Are difficult to circumvent and require premeditation to circumvent; Minimize inconvenience to a sober user; Are manufactured by a party responsible for installation, user training, service, and maintenance; Operate reliably over the range of motor vehicle environments or motor vehicle manufacturing standards; Are manufactured by a person adequately insured for product liability; Provide the option for an electronic log of the driver's experience with the device; and Sold or leased, of the same make and model for which application for certification is sought, meet the requirements for certification set forth in the specifications of the devices. An application for certification shall include, in addition to other information which the Administration may require: The name and address of the manufacturer; The name and model number of the device; A detailed description of the device including instructions for its installation and operation; Technical specifications descriptive of the device’s accuracy, security, data collection and recording, digital photographic image collection, tamper detection, and environmental features; A description of the manufacturer's present or planned provisions for distribution of the device in Maryland including all locations in the State where the device may be purchased, installed, serviced, repaired, calibrated, inspected, and monitored; A certificate from an insurance company licensed in Maryland evidencing that the manufacturer holds product liability insurance as required in Regulation .05 of this chapter; A certified copy of the drawings, schematics, and wiring protocols for the device and its components as confidential commercial information not subject to disclosure under General Provisions Article, Title 4, Annotated Code of Maryland; and A sample warning label, to be affixed to each device, which shall be in compliance with Transportation Article, §27-108, Annotated Code of Maryland. Correlation. The ignition interlock device shall correlate with an alcohol concentration recommended under the current BAIID Model Specifications incorporated by reference under Regulation .02-1 of this chapter with the accuracy provided for in these specifications, but may not be higher than 0.025 percent. A correlation coefficient of 0.90 is considered reliable. Ninety times out of 100, the ignition interlock device shall respond to, detect, and interlock when an individual has an alcohol concentration of 0.025 percent or higher. Reliability. Device user complaints shall be reported as required in Regulation .14 of this chapter. Complaints shall be serviced as follows: Customer error in operation or misuse shall be corrected with additional instructions; Device problems due to component failures shall be corrected through exchange of appropriate package. Accuracy. Breath test devices shall use breath specimens which are alveolar air samples (“deep lung air”) in accordance with established forensic alcohol standards meeting the specifications contained in the current BAIID Model Specifications incorporated by reference under Regulation .02-1 of this chapter. The calibrated setting shall be at 0.025 percent BAC. The device shall have an accuracy of 90 percent and shall detect and interlock when the air sample provided to it contains alcohol at or above the calibrated setting. The ignition interlock device shall be calibrated for proper use and accuracy semiannually, or more frequently as the circumstances may require. Security. The device, the installation of the device, and the monitoring of the device, including the transmission of data to the Administration, shall provide for the security features set forth in the current BAIID Model Specifications incorporated by reference under Regulation .02-1 of this chapter. The manufacturer and the service provider shall take all reasonable steps necessary to prevent tampering or circumvention of the device, as set forth in the current BAIID Model Specifications incorporated by reference under Regulation .02-1 of this chapter. Environmental Features. The device shall operate reliably over the range of motor vehicle environments or motor vehicle manufacturing standards. The device shall: Be resistant to shock and vibration as normally found in a motor vehicle environment; Operate accurately over a temperature range of -20°C to +70°C; and Operate accurately with an altitude range of 0 to 2,500 feet (sea level to 2,500 feet above sea level). Mandatory Operational Features. The device shall: Be designed to permit a restart (grace period) of a vehicle's ignition within 120 seconds after the ignition has been shut off, without requiring a further test; Automatically purge residual alcohol before allowing subsequent tests; Be provided with a supply of disposable mouthpieces with saliva traps, and the manufacturer shall ensure the availability of additional mouthpieces; Be required to be stowed out of the way before starting the motor vehicle; Be designed so that a second breath test is performed once a vehicle has been underway for at least 5 minutes but not more than 30 minutes; and Have an onboard datalogger, which shall be: Capable of being downloaded in an installation facility or in the field through mobile means; and Encrypted with the software programs allowing access to the data stored in the device kept secure and protected from public access. Upon participant request, a service provider shall provide an ignition interlock device that includes: Visual alerts to notify the driver of required actions, including a random test; Vibration alerts that may be effective in alerting a driver who is deaf or hard of hearing; or Both §F(2)(a) and (b) of this regulation. Mandatory Operational Features — Camera. The device shall have a camera with the capability of recording and storing still images without the capability to record sound or video and that records photographic images only while the device is testing the blood alcohol level of the individual taking the test or if tampering with the device is detected. The camera required under §G(1) of this regulation: May not pose a threat to the individual taking the test or passengers of the vehicle in the event it becomes displaced; Shall take an image of the individual taking the test with sufficient clarity and resolution to allow the individual taking the test to be identified; Shall operate in all lighting conditions, and capture a clear image of the individual taking the test for identification; and Shall focus on and take images of the individual taking the test while the individual is completing the breath alcohol test with the ignition interlock device as specified by the Administration. The manufacturer of the device shall carry product liability insurance with minimum liability limits of 1 million dollars per occurrence, with 3 million dollars aggregate total. The liability covered shall include defects in product design and materials as well as in the work of manufacturing, calibration, installation, and removal of devices. The proof of insurance shall include a statement from the insurance company that 30 days' notice will be given to the Administration before cancellation of the insurance. The manufacturer shall provide to the Administration a statement that the manufacturer is totally responsible for product liability and shall defend and indemnify the following from any liability resulting from the device or its installation or use: The State of Maryland, including all of its units and all State personnel as defined in State Government Article, §12-101, Annotated Code of Maryland; The court that ordered installation of the device; and The testing laboratory that has verified that the device meets the Administration's standards and requirements. The manufacturer shall guarantee performance and provide support for service within 48 hours after notification of complaint. This support shall be effective for the duration of the probationary period under which the device is required to be installed in the vehicle. The manufacturer shall affix to each device a warning label containing the following language: “A person tampering with, circumventing, or otherwise misusing this Ignition Interlock System is guilty of a misdemeanor, and, on conviction, is subject to a fine or imprisonment or both.” The manufacturer of the device is responsible for ensuring proper installation procedures to include, but not to be limited to, the following: Devices shall be installed within a building or from a mobile unit fully equipped for adequate installation; Customers or other unauthorized persons may not be allowed to watch the installation of the device; Adequate security measures shall be taken to prevent unauthorized persons from accessing secured materials (tamper seals, installation instructions, computer disks, and any other material required to install, calibrate, monitor, or service the device); Each manufacturer shall develop detailed and written instructions for installation of its device in accordance with the guidelines adopted by the Administration; The installer shall screen the vehicles for acceptable mechanical and electrical conditions, in accordance with the manufacturer's instructions; Conditions that would interfere with the function of the device (for example, low battery or alternator voltage, stalling frequent enough to require additional breath tests, etc.) shall be corrected to an acceptable level; Installations shall be made in a workmanlike manner in accordance with accepted trade standards, and according to the instructions provided by the manufacturer; After a device is installed, the vehicle and device shall be checked to see that the installation was performed properly and that it does not interfere with the normal operation of the vehicle after it has been started; Each installation shall include all of the tamper resistant features required by the manufacturer and the Administration. The manufacturer shall be responsible for ensuring physical anti-tamper securities which include, but which are not limited to, the following: A unique and easily identifiable wire, covering, or sheathing over all wires used to install the device, which are not inside a secured enclosure; A unique and easily identifiable covering, seal, epoxy, or resin at all exposed electrical connections for the device; Connections to the vehicle which shall be under the dash or in an inconspicuous area of the vehicle; A unique and easily identifiable tamper seal, epoxy, or resin at all openings (except the breath and exhaust ports) of the hand-held unit, control, and support units; Depending on the level of electronic anti-tampering security of a device, additional anti-tamper measures that could be taken such as the use of a special mark, seal, paint, epoxy, resin, or other material to mark points likely to be accessed when attempting to bypass or tamper with the device (for example, battery post terminals, wire to starter solenoid, wire to ignition, dash screws). The manufacturer is responsible for ensuring electronic anti-tampering securities which include, but which are not limited to, the following: The device shall detect when the vehicle has been started without a breath test being passed, and shall either display the tamper or record it, or both, in a way that the information can be retrieved at a later date. The device shall retain its tamper detection capabilities when disconnected from the vehicle's power supply, or record that it was disconnected. Devices that lose their memory of tamper events when disconnected from a power source shall have an indicator or interrupt device. The device shall continuously record the time and date for each of the following vehicle and device operations: Breath test fail; Breath test pass; Alcohol level of breath test; and Any attempt to tamper with the device. When a device detects a condition that would be considered tampering, the device shall activate an indicator or interrupt device and capture and store a photographic image. At the time of device installation, the device shall be checked to make sure that it is functioning properly and accurately. Self-diagnostic features shall also be checked. Tamper inspections shall be conducted at any time that the device is given routine inspection, maintenance, or repair. Tamper inspections shall include the following: Inspect all external wiring insulation, connections, and sheathing for the device and where the device connects to the vehicle. Document and photograph any perforations, cuts, or other evidences of possible tampering. Record or document any electronic indications of tampering. Inspect all tamper seals for breaks, tears, or other evidence of tampering. Document and photograph any evidence of tampering. Check device for proper operation to ensure tamper detection capabilities. After all evidence of tampering has been recorded, photographed, and reported to the appropriate law enforcement agencies, restore the system and its tamper seals, etc., to their original condition to prevent further abuse. The Administration or its designees shall have the right to inspect installation and service of the devices. The vehicle operator shall be provided: Written instructions on how to clean and care for the device; Written instructions on what type of vehicle malfunctions or repairs may affect the device, and what to do when such repairs are necessary; Written notice about how the device may be affected by high altitudes; Written notice about the requirement that the vehicle operator must remain in clear view of the camera at all times while a breath sample is being provided; Written and hands-on training on how to use the device after it is installed in the operator's vehicle. This shall include all persons who are authorized to use the vehicle that has had a device installed; and A training video that includes closed captioning. The manufacturer shall provide an emergency 24-hour phone number that a user may contact to receive assistance. Assistance may include technical information, tow service, or road service. Emergency assistance related to the failure of a device shall be provided within 3 hours for vehicles located in or near an area with an installation or repair facility. The device shall be made functional within 48 hours from when the call for assistance is made. The manufacturer shall be responsible for device installation, user training, service, and maintenance. The following apply: Installers shall have the training and skills necessary to install, troubleshoot, and check for proper operation of the device, and to screen the vehicle for acceptable conditions. Personnel who install, calibrate, perform tamper inspections, or perform reporting duties, or all of these, may not have been convicted of a crime substantially related to the qualifications, functions, and duties related to the installation and inspection of the devices. This may include, but is not limited to, persons: Convicted of any alcohol or drug-related offense within the last 3 years; Convicted of more than one alcohol or drug-related offense overall; Convicted of probation violation; Convicted of perjury; or Who have had a license or registration revoked, suspended, or denied for a violation or violations of motor vehicle safety equipment laws. Persons who can show acceptable evidence of rehabilitation may be considered for the positions in §B. Facilities, which may include mobile or satellite units, where interlock devices are installed, serviced, monitored, or removed shall: Be in an area where customers are not allowed to watch the installation, calibration, or removal of a device; Be open during normal business hours with after hours service capability; Be established to service the geographical location and volume of individuals who qualify for and are admitted into the program; Have records maintained for 5 years; and Have and use the required tools, test equipment, and manuals needed to screen vehicles for acceptable mechanical and electrical conditions to install devices. The tools, test equipment, and manuals required under §A(5) of this regulation include, but are not limited to, the following: Tools necessary to ensure electrical connections are made in a workmanlike manner in accordance with accepted trade standards (for example, properly soldered or mechanically crimped with high quality connectors); Heat gun if heat shrink tubing or heat set labels are used; Volt/ohmmeter; Test light; Battery testing equipment and servicing tools (for example, load tester, terminal cleaning tools, battery filler, etc.); and Electrical wiring diagrams or reference guide, or both, for electrical systems on import and domestic vehicles, 20 years old or less, necessary for the installation and operation of the device. Testing shall be performed under the specifications set forth in the current BAIID Model Specifications incorporated by reference under Regulation .02-1 of this chapter by an entity approved by the Administration for the purpose of establishing the accuracy and reliability of candidate breath test ignition interlock devices. Results of Tests. As a prerequisite to certification, the manufacturer shall submit a notarized letter or affidavit, or both, from the Director of an approved testing laboratory certifying that the device by model or class, or both, meets or exceeds all requirements set forth in the current BAIID Model Specifications incorporated by reference under Regulation .02-1 of this chapter. This affidavit shall also include: The name and location of the testing laboratory; The address and phone number of the testing laboratory; A description of the tests performed; Copies of the data and results of the testing procedures; and The names and qualifications of the individuals performing the tests. The manufacturer shall provide to the Administration: Annually, a certified statement that the manufacturing of the model or type of device originally certified has not been modified or altered in any way to require laboratory retesting; Annually, an information report detailing: The number of devices with visual or vibration alerts, or both, that have been issued; The number of deaf and hard of hearing customers; The number of reduced fee interlock units requested by customers; The number of reduced fee interlock units provided; and Annually, a summary of all complaints received and corrective action taken by the manufacturer for each model or type of certified device; Semiannually, a report that the ignition interlock devices were checked for proper use and accuracy, detailing any necessary adjustments; A report on a device denied certification in another state, whether the denial of certification occurs before or after certification by the Administration; and Any other available information upon request. The reports required by §A(2) of this regulation shall be categorized by: Customer error of operation; Faulty automotive equipment other than the device; Apparent misuse or attempts to circumvent the device causing damage; and Device failure due to material defect, design defect, or workmanship errors in construction, installation, or calibration. A denial of certification for an ignition interlock model in another state may, at the discretion of the Administrator, be cause for decertification, revocation, or denial of certification for the same model by the Administration in Maryland. The manufacturer shall provide the Administration and participating agencies the following: Proof of the installation of the system; Reports of the results of the monitoring which: Shall be performed at least every 60 days, or more frequently as the circumstances may require, and May be in the form of an electronic log of the driver's experience with the system; Within 7 days of discovery, reports of any apparent misuse of the device, tampering, circumventing, or attempts to disconnect, or any other pertinent information; and Any other available information upon request. Approved testing laboratories may have fees associated with their work in the testing of the device and shall be paid directly by the manufacturer. All other costs of obtaining certification of an ignition interlock device shall be paid by the manufacturer of the device to the Administration. When notified in writing by the originating court or the Administration, the approved service provider shall remove the device and return the vehicle to normal operating condition. All severed wires shall be permanently reconnected and insulated with heat shrink tubing or its equivalent. Whenever a device is removed for repair and cannot immediately be reinstalled, a substitute device shall be used. A participant's vehicle may not be driven without a required device. Before removal of a device, the manufacturer shall notify the originating court except under the following conditions: Completion of sentence, or other terms of a court order; or Immediate device repair needs. The Administration may revoke approval of a device, and remove it from the list of acceptable devices, upon any of the following grounds: Evidence of repeated device failures due to gross defects in design, materials, or workmanship during manufacture; Termination of manufacturer's liability insurance; Notification that the manufacturer is no longer in business; Voluntary request of the manufacturer to remove a device from the acceptable list; Any findings that the manufacturer is not in compliance with the provisions of this chapter or Transportation Article, §§16-404.1 and 27-108, Annotated Code of Maryland; or Any other reasonable cause to believe the device was inaccurately represented to meet the performance standards. The effective date of revocation shall be 15 days after notification is sent to the manufacturer via certified mail, except in cases where the Administration determines immediate revocation is necessary for the safety and welfare of the public. Manufacturers may request a review of revocation. This request shall be submitted to the Administration, in writing, within 15 days of the revocation. Upon revocation or voluntary surrender of an approval, a manufacturer shall be responsible for removal of all like devices from customers' vehicles. A manufacturer shall be responsible for any costs connected with removal of its revoked devices from customers' vehicles and the installation of new devices from the Administration's list of approved devices. An ignition interlock device certified and installed before October 1, 2019, may continue to be used until the earliest of: The expiration of the original term of the court order; The expiration of the Administration's required term for the device installation; or The customer’s reentry into the Ignition Interlock System Program if the Motor Vehicle Administration allows an individual to reenter the Program after a period of 30 days from the date of removal with a device that was installed prior to October 1, 2019. Service providers who service, install, monitor, calibrate, and provide information on ignition interlock systems shall: Apply to the Administration for certification as an approved service provider; Demonstrate that the service provider is able to competently service, install, monitor, calibrate, and provide information on ignition interlock systems; Be certified by a signed affidavit from the manufacturer that the service provider has been trained by an authorized manufacturer and that the service provider is competent to service, install, monitor, calibrate, and provide information on ignition interlock systems; and Be deemed to be authorized representatives of a manufacturer. After the Administration notifies a service provider of certification approval, the service provider shall: File with the Administration a surety bond in the amount of $10,000; and Notify the Administration within 5 days if the surety bond is canceled, revoked, or suspended. Any service of notice upon an approved service provider who has violated any laws or regulations or whose ignition interlock system is not in compliance with any laws or regulations is deemed as service upon the manufacturer who certified the approved service provider. An approved service provider shall: Provide adequate facilities as required in Regulation .12 of this chapter; Provide service and installation records for inspection on the request of the Administration; Keep all personal and medical information provided to the service provider regarding Program participants confidential except to the Administration and its authorized representatives; Install devices for eligible participants in the Program within 10 days of the date of requested installation by a Program participant; Provide a toll-free 24-hour emergency response number that a participant may call to obtain assistance from the provider with technical information, towing, and road service; On notification by a participant of a device failure: Provide emergency assistance within 3 hours of notification by the participant; and Repair or replace the device within 48 hours after notification by the participant; Monitor devices periodically, not to exceed 30 days; Establish indigence provisions as set forth in COMAR 11.11.11; Within 1 business day of a device's installation, removal, or monitoring appointment, electronically submit to the Administration the information it requires regarding the: Identification of the participant or prospective participant who had the device installed; Identification of the vehicle in which the device is or was installed; and Monitoring data relating to the participant's use of the device for each monitoring period; and Within 1 business day after notification by the Administration that the information received was incomplete, corrupt, or erroneous, electronically resubmit the corrected information to the Administration. Transportation Article, §§12-104(b), 16-404.1, and 21-902.2, Annotated Code of Maryland Effective date: Regulations .01—.18 adopted as an emergency provision effective January 31, 1989 (16:4 Md. R. 487); adopted permanently effective May 29, 1989 (16:10 Md. R. 1109) Chapter revised effective October 4, 1999 (26:20 Md. R. 1547) Regulation .02 amended effective October 1, 2019 (46:19 Md. R. 815) Regulation .02B amended effective November 3, 2008 (35:22 Md. R. 1958) Regulation .02-1 amended effective March 28, 2016 (43:6 Md. R. 409) Regulation .03B amended effective October 1, 2019 (46:19 Md. R. 815); February 24, 2020 (47:4 Md. R. 261) Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 409) Regulation .04F amended effective April 15, 2024 (51:7 Md. Reg. 332) Regulation .04G adopted effective October 1, 2019 (46:19 Md. R. 815) Regulation .08C amended effective October 1, 2019 (46:19 Md. R. 815) Regulation .10A amended effective October 1, 2019 (46:19 Md. R. 815); April 15, 2024 (51:7 Md. Reg. 332) Regulation .10B amended effective July 26, 2010 (37:15 Md. R. 999) Regulation .13 amended effective March 28, 2016 (43:6 Md. R. 409) Regulation .14A amended effective April 15, 2024 (51:7 Md. Reg. 332) Regulation .18 amended effective October 1, 2019 (46:19 Md. R. 815) Regulation .19 repealed effective November 3, 2008 (35:22 Md. R. 1958) Regulation .20B, D amended effective November 3, 2008 (35:22 Md. R. 1958) Regulation .20D amended effective April 15, 2024 (51:7 Md. Reg. 332)