1. (1) Only a qualified manufacturer may conduct business in New York State with respect to any operator. An interested manufacturer of a certified ignition interlock device seeking to conduct business within New York State shall apply to the division to become a qualified manufacturer in one or more designated regions of New York State.

2. (2) The four regions of the State by counties for purposes of this Part are as follows:

   1. (i) Region 1: Allegany, Cattaraugus, Cayuga, Chautauqua, Chemung, Erie, Genesee, Livingston, Monroe, Niagara, Ontario, Orleans, Schuyler, Seneca, Steuben, Wayne, Wyoming, and Yates;
   2. (ii) Region 2: Broome, Chenango, Clinton, Cortland, Essex, Franklin, Fulton, Hamilton, Herkimer, Jefferson, Lewis, Madison, Oneida, Onondaga, Oswego, St. Lawrence, Tioga, and Tompkins;
   3. (iii) Region 3: Albany, Columbia, Delaware, Dutchess, Greene, Montgomery, Orange, Otsego, Putnam, Rensselaer, Rockland, Saratoga, Schenectady, Schoharie, Sullivan, Ulster, Warren, and Washington; and

   4. (iv) Region 4: Bronx, Kings, Nassau, New York, Queens, Richmond, Suffolk, and Westchester.

      (b)

3. (1) The format and content of any application shall be established by the division. The application deadline for any contractual period of any manufacturer seeking approval of the division as a qualified manufacturer to conduct business in New York State shall be set by the division. Nothing shall preclude the division from establishing an open application process for any interested manufacturers seeking to conduct business on or after such deadline and filing an application to the division for approval. However, where approved, the contractual end date shall be consistent with other qualified manufacturer agreements. The application shall require at a minimum that the manufacturer submit relevant information, reports, and other documents requested by the division with respect to competitive pricing, service performance, select one or more regions in which it shall agree to conduct business, and certify that it will comply with all applicable provisions specified in this Part with respect to service delivery. In addition, the manufacturer or its representative shall provide a signed statement that the manufacturer or its representative will indemnify and hold harmless the State of New York, the division, the Department of Health, every county where it does business, and their officers, employees and agents from all claims, demands and actions as a result of property damage and/or injury or death to persons which arise, directly or indirectly, out of any act or omission by the manufacturer, its representative, or installation/service providers relating to the installation, service, inspection, maintenance, repair, use and/or removal of the ignition interlock device.
4. (2) Every manufacturer who applies shall provide a thorough description of each device intended for use in New York State, provide proof of such certification by the Department of Health for each device intended for use in New York State, and the fee structure associated with that specific device. Descriptive information about the device shall include but not be limited to: make and model of device, special features of the device such as camera, reporting capabilities, removable head, global positioning system, and real-time reporting. Fee structure information shall include any and all fees charged to the operator, including but not limited to installation fee, monthly fee, any special service fees, and de-installation fee. The proposed fee structure shall take into consideration and be based upon an anticipated 10 percent waiver of the fees by criminal courts due to operator unaffordability. Annually, on or about February 15th of each year, the division shall review requests by qualified manufacturers for rate adjustments which shall include information submitted by qualified manufacturers involving unaffordability waivers granted by courts. At its discretion, the division shall approve rate adjustments where appropriate.
5. (3) Every qualified manufacturer with a certified device who wants any operational modification to the device must submit in advance necessary documentation to the Department of Health and obtain departmental approval before releasing the modified device. The manufacturer shall notify the division in writing of their intent of any operational modification and also any subsequent approval and provide a written summary of any requested or approved modification. Operational modification means any change to the product design or function that would or could affect the devices anti-circumvention, anti-tampering or analytical features as determined by the Department of Health.
6. (4) The division shall classify all certified ignition interlock devices into categories based upon features and provide such list to every county. This classification system and subsequent device classification is subject to change by the division as new information becomes available. Upon review of a manufacturer's application, the division shall make a determination whether the manufacturer satisfies all requirements to be designated a qualified manufacturer and provide notification to the applicant and every county within the region that the qualified manufacturer may conduct business. Every qualified manufacturer shall enter into a contractual agreement for a minimum period of three years with the division setting forth the requirements of the qualified manufacturer and all of its installation/service providers consistent with this Part and the application submission approved by the division. However, where a qualified manufacturer enters into a contractual agreement with the division after the regular term of division contracts with other qualified manufacturers, the expiration date shall be consistent with other contracts in this area.

7. (c) Every qualified manufacturer shall:

   1. (1) adhere to all regulatory provisions of the Department of Health with respect to certification, testing, labeling, reporting and any additional requirements, and shall also specifically adhere to its responsibilities contained in this Part;
   2. (2) agree that an ignition interlock device shall conform to the National Highway Traffic Safety Administration (NHTSA) and Department of Health specifications, be calibrated at a set point of .025 BAC percent, and also require the operator after passing the start-up test allowing the engine to start, to submit to an initial rolling test within a randomly variable interval ranging from 5 to 15 minutes. Subsequent rolling tests shall continue to be required at random intervals not to exceed 30 minutes for the duration of the travel. A start-up re-test shall be required within 5 to 15 minutes of a failed start-up test. A rolling re-test shall be required within one to three minutes after a failed or missed rolling test. An ignition interlock device shall enter into a lockout mode upon the following events: one failed start-up retest, one missed start-up re-test, one failed rolling re-test or one missed rolling re-test within a service period, or one missed service visit;
   3. (3) agree to any reduced breath sample volume as permitted by NHTSA from 1.5 liters to 1.2 liters, or any subsequent NHTSA reduced volume sample, where an individual has submitted sufficient documentation from a physician of a condition which prevents regular operation at normal breath volume levels and such proof authorizing reduction in the breath sample volume has been approved by the applicable criminal court and notification has been provided to the qualified manufacturer by the applicable monitor;
   4. (4) agree to adhere to a maximum fee/charge schedule with respect to all operator's costs associated with such devices, offer a payment plan for any operator determined to be financially unable to pay the cost of the ignition interlock device where a payment plan is so ordered, and provide a device free of fee/charge to the operator where the cost is waived by the sentencing court, or pursuant to such other agreement as may be entered into for provision of the device. Any contractual agreement between the operator and the qualified manufacturer or its installation/service providers shall permit an early termination without penalty to the operator when a certificate of completion has been issued, where the sentence has been revoked, and whenever the operator has been transferred to a jurisdiction where the manufacturer does not do business. Nothing shall prevent a qualified manufacturer from lowering the fee/charge schedule during the course of an operator's contract and/or the contractual agreement with the division;
   5. (5) agree to service every county within a region and ensure that there shall be an installation/service provider located in New York State within 50 miles from the operator's residence or location where the vehicle is parked or garaged, whichever is closest and ensure repair or replacement of a defective ignition interlock device shall be made available within the same 50 mile radius by a fixed or mobile installation/service provider, or through a qualified manufacturer sending a replacement, within 48 hours of receipt of a complaint, or within 72 hours where an intervening weekend or holiday. Mobile servicing may be permissible provided that the above facility requirements are met and a specific mobile servicing unit with regular hours is indicated;

   6. (6) guarantee that an installation/service provider or the manufacturer shall download the usage history of every operator's ignition interlock device within 30 calendar days of initial installation(s) and during subsequent service visits every 30 calendar days where the device does not automatically transmit data directly to the monitor; and within 30 calendar days of initial installation(s) and during subsequent service visits every 60 calendar days where the device automatically transmits data directly to the monitor; or if the operator fails to appear for a service visit(s) as soon thereafter as the device can be downloaded, and provide the monitor with such information and in such format as determined by the division. Further guarantee that the installation/service provider, unless the manufacturer provides such notification, shall take appropriate, reasonable and necessary steps to confirm any report of failed tasks, failed tests, circumvention, or tampering and thereafter notify the appropriate monitor within three business days of knowledge or receipt of data, indicating:

      1. (i) installation of a device on an operator's vehicle(s);
      2. (ii) report of a failed start-up re-test;
      3. (iii) report of a missed start-up re-test;
      4. (iv) report of a failed rolling re-test;
      5. (v) report of a missed rolling re-test;
      6. (vi) report of the device entering lockout mode;
      7. (vii) failure of an operator to appear at a scheduled service visit; or
      8. (viii) report of an alleged circumvention or tampering with the ignition interlock devices as prohibited by paragraph (a), (c) or (d) of subdivision (9) of section 1198 of the Vehicle and Traffic Law, or an attempt thereof;
   7. (7) adhere to real time reporting and emergency notification program requirements, where such is required in any county plan. Where real time reporting is utilized, such reports provided to the monitor as required above must occur contemporaneously as the event occurs or as soon as cellular reception permits. Where an emergency notification program is utilized, immediate report notification as required above must be transmitted to the appropriate monitor and any other law enforcement specified by the county;
   8. (8) provide, no more than monthly to the operator upon his or her request, the operator's usage history, including any report of failed tasks, failed tests, circumvention, or tampering. An operator may only make one request during any month for such information. Such request shall be in writing and provide either an email address or self-addressed stamped envelope;
   9. (9) agree to safeguard personal information with respect to any operator and any reports and provide access to such records only as authorized herein, by law, or by court order. All records maintained by the manufacturer and any of its installation/service providers with respect to ignition interlock devices in New York State shall be retained in accordance with section 358.9 of this Part;
   10. (10) ensure that the manufacturer and/or installation/service provider, where applicable, complies with reporting requirements established by the division in providing information and reports to the division, and on a case-by-case basis to localities as may be necessary with respect to an operator's use of the ignition interlock device;
   11. (11) establish and distribute to the division, its installation/service providers, and any county where it does business, a current list of all installation/service providers in the county, including business name, address and telephone number and maintain a toll-free 24 hour telephone number to be called from anywhere in the continental United States for an up-to-date listing of installation/service providers in the continental United States and for emergency assistance. Distribute an up-to-date listing of New York State installation/service providers to the division;

   12. (12) provide written certification to the division in a format prescribed by the division that all installation/service providers:

       1. (i) have been trained in advance as to installation, maintenance, troubleshooting, set point requirement of .025 BAC percent, and recalibration of such manufacturer's devices;
       2. (ii) have instructions as to installation and usage of such manufacturer's devices;
       3. (iii) have agreed to comply with their manufacturer's service agreements;
       4. (iv) have agreed to comply with the provisions of this subdivision and subdivision (d) of this section;
       5. (v) have agreed to provide hands-on training to the operator, any member of the same family or household, or any owner of a motor vehicle in which an ignition interlock device is being installed, with a valid driver's license who appears with the operator at installation to receive training as to the operation of an installed device on the vehicle, and to provide written or video instructional material to the operator;
       6. (vi) have been informed of New York State law governing circumvention of ignition interlock devices and penalties associated therewith;
       7. (vii) have agreed to safeguard personal information with respect to any operator and any reports and provide access to such records only as authorized herein, by law, or court order; and
       8. (viii) have been made aware that non-compliance will result in immediate removal and updating the listing of installation/service providers identified in paragraph (11) of this subdivision. An installation/service provider may be reinstated by the division, at its discretion, upon satisfactory proof from the qualified manufacturer of corrective action;
   13. (13) conduct annual quality assurance audits or reviews of installation/service providers to ensure compliance with applicable laws, regulations and any contractual agreements and provide the division with yearly sworn statements that such audits have been conducted, as well as a copy of the findings of such annual quality assurance audits. Failure to conduct quality assurance audits may result in removal of the qualified manufacturer from doing business in the State of New York. Nothing shall preclude the division and/or its representative from conducting random audits and quality assurance audits or reviews;
   14. (14) take all reasonable steps necessary to prevent tampering or circumvention of the ignition interlock device and promptly notify the division, the applicable county's monitor and district attorney of any reasonable belief that an employee of an installation/service provider has attempted to alter or has altered ignition interlock data or has been otherwise involved in tampering or circumventing an ignition interlock device of any operator or any attempt thereof. Failure to notify the monitor and the district attorney may result in removal of the qualified manufacturer from doing business in the State of New York;
   15. (15) provide immediate written notice to the division and the applicable county monitor(s) of any removal of any installation/service provider and the reasons for such;
   16. (16) provide immediate written notice to the division and the Department of Health whenever the manufacturer's device, services, and/or operations has been compromised or does not function as intended in New York State or any other state or jurisdiction in which the manufacturer does business, or disapproved, suspended in whole or in part, revoked, or otherwise cancelled by another state or jurisdiction, or has received notice or communication from another state or jurisdiction that any such actions are imminent;

   17. (17) submit such reports, as requested and in such format and timeframes as determined by the division, for each model or type of certified device, including, but not limited to:

       1. (i) operator and other vehicular user operation error;
       2. (ii) faulty automotive equipment that directly impact successful implementation and use of the device;
       3. (iii) apparent misuse or attempts to circumvent or tamper/bypass a device;
       4. (iv) device malfunctions, including proposed and follow-up action taken by the manufacturer to correct such malfunctions;
       5. (v) deficiencies in device calibration stability;
       6. (vi) deficiencies in device reporting or information transmission as a result of any reason, including but not limited to service outages or downtimes of any nature;
       7. (vii) any proposed operational modification or other proposed operational and/or administrative change, including but not limited to server, firmware, and other technical change or business structural change which may have the potential of affecting service delivery or reporting; and
       8. (viii) operator, vehicular user, and installation/service provider complaints;
   18. (18) provide documentation and verification of insurance (to be submitted upon each policy issuance or renewal) covering product liability, including coverage in New York State, with a minimum policy limit of $1 million per occurrence, and $3 million aggregate total. The manufacturer shall provide a signed statement holding harmless the State of New York, the division, every county, and their employees and agents from all claims, demands, and actions, as a result of damage or injury to persons or property that may arise, directly or indirectly, out of any act or omission by the manufacturer or their installation/service provider relating to the installation, service, repair, use and/or removal of an ignition interlock device;
   19. (19) provide documentation and verification of and maintain a standby letter of credit (SLOC) as specified in the manufacturer’s contract with New York State;
   20. (20) submit any other information determined by the division to be relevant to the effectiveness, reliability and value of ignition interlock devices as a sentencing sanction and/or monitoring tool;
   21. (21) agree that the consequences of a failure to adhere to any manufacturer requirements specified in this Part and/or in contractual provisions with the State of New York may result in suspension or removal of the qualified manufacturer from doing business in the State of New York, or, in the event of suspension, such terms and conditions required by the division in any manufacturer’s reconciliation plan; and
   22. (22) agree to only provide an unlock code to an operator within two hours of a scheduled service visit. The unlock code shall be a unique one time code and only functional for two hours immediately preceding the service visit scheduled as a result of a vehicle being rendered inoperable due to a lockout mode.

8. (d) Every qualified manufacturer shall ensure that its installation/service providers comply with the following additional requirements:

   1. (1) the ignition interlock device shall be installed in vehicle(s) owned or operated by the operator within seven business days of the operator's request for installation of the device;
   2. (2) provide to all operators, at the time of device installation a hardcopy statement of fees/charges clearly specifying warranty details, schedule of lease payments where applicable, any additional costs anticipated for routine recalibration, service visits, and listing any items available without charge if any, along with a list of installation/service providers in their respective county, a toll-free 24 hour telephone number to be called from anywhere in the continental United States to secure up-to-date information as to all installation/service providers located anywhere in the continental United States and for emergency assistance, and a technical support number available during specified business hours to reach a trained staff person to answer questions and to respond to mechanical concerns associated with the ignition interlock device;
   3. (3) record the odometer reading of the motor vehicle in which the ignition interlock device is installed and during all service visits;
   4. (4) remove an ignition interlock device and return the vehicle to normal operating condition only after having received a certificate of completion or a letter of de-installation from the monitor as authorized pursuant to section 358.7 of this Part. Where at the time of removal the installation/service provider or qualified manufacturer notices any failed tests that have not been backed up by a successful re-test, the monitor shall be notified for approval before the removal is made. If a device is removed for repair and cannot be reinstalled immediately, a substitute device shall be provided;
   5. (5) installation shall be performed in a professional manner by persons trained and authorized by the manufacturer pursuant to paragraph (c)(12) of this section;
   6. (6) installation shall be performed according to the manufacturer's detailed written instructions, with calibration to the required set point of .025 BAC percent and in a manner so as to ensure proper vehicular operation;
   7. (7) at the time of installation permanently affix the warning label notice prescribed by the Department of Health in a highly visible location on the installed ignition interlock device;
   8. (8) be equipped with the necessary tools and equipment to ensure proper ignition interlock device installation and removal;
   9. (9) perform installations and maintenance, including recalibrations, within a secure area of the installation/service provider's or qualified manufacturer's business establishment or at a location serviced by a mobile unit to prevent unauthorized persons from observing or accessing secured items such as tamper seals and installation, data download, transmission, or recalibration instructions;
   10. (10) maintain records of installation and maintenance work performed on the devices;
   11. (11) screen vehicles for mechanical and electrical conditions that would interfere with the functioning of the device, such as low battery or alternator voltage, defective horn, untuned engine, and frequent stalling;
   12. (12) prior to installation, require that the operator complete mechanical repairs or adjustments where necessary for the proper functioning of the device. In such event, the seven business day installation period in paragraph (1) of this subdivision shall commence when repairs or adjustments are completed;

   13. (13) prior to installation of the ignition interlock device, obtain and record the following information from every operator:

       1. (i) photo identification;
       2. (ii) the name and policy number of his/her automobile insurance;
       3. (iii) the vehicle identification number (VIN) of all motor vehicles owned or routinely driven by the operator, and a statement disclosing the names of all other individuals who operate the motor vehicle(s) owned or driven by the operator; and
       4. (iv) a notarized affidavit from the registered owner of the vehicle granting permission to install the device if the vehicle is not registered to the operator;
   14. (14) if, during the installation, the operator fails to pass the initial breath test, the installation will be halted and the monitor promptly notified;
   15. (15) after installation during any service visit, recalibrate as necessary or required in this Part and check the device and vehicle to ensure proper operation;
   16. (16) notify the applicable monitor when an ignition interlock device has been installed on an operator's vehicle(s) within three business days of installation;

   17. (17) complete the following with respect to service visits:

       1. (i) document photo identification from the operator during all required in-person services;
       2. (ii) provide service/monitoring of the ignition interlock device as required herein;
       3. (iii) recalibrate as necessary the ignition interlock device at each service visit;
       4. (iv) check for signs of circumvention or tampering; and
   18. (18) adhere to any other applicable State or Federal requirement.

(a)