29-250 C.M.R. ch. 8, § 3 - Certification of manufacturers of ignition interlock devices

1. Certification required. No ignition interlock device may be leased, sold, installed or used as part of the program outlined in 29-A MRSA§2508 unless the model or type of device has been approved by the Secretary of State in accordance with the provisions of this rule.

2. Application for certification

A. General. A manufacturer may apply for certification of a device by submitting an application to the Secretary of State as set out below. A separate application is required for each model or type of device for which approval is sought. A manufacturer must certify that the device:

(1) Does not impede the safe operation of a vehicle;

(2) Minimizes opportunities to bypass;

(3) Performs accurately and reliably under all normally anticipated circumstances;

(4) Satisfies the requirements for certification set forth in this rule, and;

(5) Prevents a person from starting a vehicle when the person has a prohibited alcohol concentration.

B. Required information. An application for certification must include all of the following information:

(1) The name, address, telephone number and email address of the manufacturer of the device.

(2) The name and model number of the device.

(3) A detailed description of the device including the complete written instructions provided to installers for installation, operation, service, repair and removal of devices.

(4) Complete technical specifications describing the device's accuracy, reliability, security, data collection and recording, tamper prevention and detection, and environmental features.

(5) A complete and true copy of data from an independent certified laboratory demonstrating that the device meets or exceeds the minimum federal standards contained in the "Model Specifications for Breath Alcohol Ignition Interlock Devices" adopted by the National Highway Traffic Safety Administration in a Notice in the Federal Register, Vol.78, No. 89, Wednesday May 8, 2013 (effective May 8, 2014), a copy of which is attached to this rule and adopted as part of this rule.

(6) A certification from an officer of the laboratory or a certified laboratory technician whom tested the device stating the device was tested in accordance with the federal standards and the device was found to satisfy the requirements of Sections 2 C and 2 D of the "Model Specifications...".

(7) A complete listing of the number, location and type (fixed-site or mobile) of all authorized installers located in the State of Maine, where the device may be purchased, installed, serviced, repaired, calibrated, inspected and monitored, including the contact name, location, telephone number, and hours of operation; the relationship between the manufacturer and installer; and the plan for providing service within 100 miles or two hours, whichever is less, of any restricted driver's residence or place of business or employment. Manufacturers must notify the Secretary of State in writing, within 10 days, of changes in status of any of the authorized installers or future additions or deletions to the list of installers.

(8) A certificate from an insurance company licensed or authorized to do business in Maine evidencing that the manufacturer holds product liability insurance with minimum liability limits of $1,000,000 per occurrence. The policy must provide coverage on a per occurrence basis, and must include coverage for defects in product design and materials, manufacturing, calibration, installation and removal of devices. The certificate must include a statement from the insurance company that 30 days written notice will be given to the Bureau of Motor Vehicles prior to the cancellation of insurance.

(9) The manufacturer's plan to provide financial assistance to those restricted drivers demonstrating financial hardship. The plan must provide for are duction of the cost, inclusive of the total of all fees and charges assessed to the driver, of at least 50%. Financial hardship is demonstrated by presentation of a person's most recent federal income tax return showing an adjusted gross household income below the poverty guidelines for the tax year by the United States Department of Health and Human Services for the person's family size.

(10) Bond. A bond from a surety company authorized to transact business in the State of Maine for the benefit of, and made payable to, the Department of the Secretary of State, Bureau of Motor Vehicles in the amount of $25,000 to ensure faithful compliance with this rule. The bond must be filed with the Bureau of Motor Vehicles within ten days after the manufacturer receives certification approval.

(11) Indemnification statement. A signed statement that the manufacturer must indemnify and hold the State of Maine and the Department of the Secretary of State and his officers, employees and agents from all claims, demands and actions as a result of damage or injury to persons or property which may arise, directly or indirectly, out of any act or omission by the manufacturer relating to the installation, service, repair, use and removal of a device.

3. Effect of representations made on application for certification. The representations made by a manufacturer on the application for certification become conditions to the certification when the certification is approved by the Secretary of State. The failure of a manufacturer to comply with those conditions may result in the suspension or revocation of the certification as provided by Section 3(6).

4. Additional testing. The Secretary of State may have the laboratory test results reviewed by the State of Maine Health and Human Services, Environmental Testing Laboratory and may require the manufacturer to furnish three units of adevice of the same model or type for which certification is being sought from normal production to the State for further testing to determine whether the device meets the requirements for certification. The Secretary of State may require manufacturers to install up to five devices on vehicles approved by the Secretary of State to field test the devices.

5. Action on application.The Secretary of State shall certify, or refuse to certify, adevice after receipt of a complete application and after the device is successfully field tested, if such testing is required. The manufacturer will be notified within 15 days of receipt of the application if the application is incomplete, and the manufacturer will be informed of what information or documents are needed to complete the application.

6. Denial, suspension or revocation of certification. The Secretary of State may deny, suspend, or revoke certification of a manufacturer or device for any of the following reasons:

A. Defects in design, materials, or workmanship causing repeated failures of a device to function as intended.

B. Termination or cancellation of a manufacturer's liability insurance or bond.

C. The manufacturer ceases to manufacture ignition interlock devices.

D. Voluntary request by a manufacturer to cancel approval of a device.

E. Violation by a manufacturer, vendor, installer, service provider or agent, employee or independent contractor of any provisions of this rule or conditions to the certification.

F. Providing materially false or inaccurate information relating to a device's performance standards by the manufacturer or certifying laboratory.

G. Modification or alteration of the components, design, or installation and operation instructions in such a way that the requirements of the minimum federal standards are no longer satisfied, unless the modifications have already been certified.

7. Effective date of suspension or revocation. A suspension or revocation is effective 10 days after notification is sent to the manufacturer by regular mail or such later date as may be specified in the notice. The notice must specify the basis for the action.

8. Right to hearing. A manufacturer whose application for certification is denied or whose certification is suspended or revoked may request an administrative hearing before the Secretary of State. The hearing will be held pursuant to 29-A MRSA §§111 and 112 and Chapter 2 of the rules of the Secretary of State. The issue at the hearing is whether, by a preponderance of the evidence, the manufacturer can show cause why the decision of the Secretary of State should not be upheld.

9. Removal and replacement of devices on suspension or revocation. Within 90 days of the event of suspension or revocation of certification, the manufacturer is responsible for and must bear the cost for the removal of any and all decertified devices and the replacement with a certified device whether their own or another certified manufacturer's device.

10. Notice of modifications and alterations. A manufacturer must notify the Secretary of State immediately, in writing, of any material modification or alteration in the components, design or installation and operating instructions of any device approved for use in this state, and must provide the Secretary of State satisfactory proof (to include retesting by an independent laboratory, if required) prior to sale or distribution of the altered or modified device that these modifications or alterations do not adversely affect the ability of the device to satisfy the requirements of the minimum federal standards contained in the "Model Specifications for Breath Alcohol Ignition Interlock Devices" adopted by the National Highway Traffic Safety Administration. Any device with a material modification or alteration must be re-approved by the Secretary of State.

Notes

29-250 C.M.R. ch. 8, § 3