Section Trans 313.04 - Device approval procedure(1) APPROVAL REQUIREMENT.(a) No device may be leased, sold, serviced, repaired, installed or used unless the model and any system firmware or software used on the device have been approved by the department in accordance with the requirements of this chapter. Approval may be granted by testing the functionality of the device with the proposed changes.(b) Device approval is personal to an applicant and cannot be assigned or transferred. Upon sale of production rights to a device, change in ownership of a manufacturer or vendor, or other change resulting in a new person seeking to distribute devices in this state, the new person must apply for device approval. The department may waive some or all of the testing of the device portion of the approval process if the new applicant is able to demonstrate that no substantive changes to the device have been made since the prior approval.(2) APPLICATION. (a) An applicant may apply for approval of a device by submitting a written application to the department in the manner prescribed in this chapter on the department's form, and shall certify that the device:1. Does not impede the safe operation of a vehicle;2. Minimizes opportunities to bypass the device;3. Performs accurately and reliably under all circumstances;4. Minimizes inconvenience to customers and other vehicle operators;5. Satisfies the requirements for certification set forth in this section, and;6. Prevents a customer from starting a vehicle when the customer has a prohibited alcohol concentration. Note: The application form SP4010 may be obtained by sending an email request to BAIID@dot.wi.gov or via U.S. Mail at Chemical Testing Section, 3502 Kinsman Blvd., Madison, WI, 53704.
(b) The applicant shall include all of the following information in an application for device approval: 1. The name and address of the manufacturer of the device.2. The name and model number of the device. A separate application is required for each model or type of device.3. A detailed description of the device including complete instructions for installation, operation, service, repair and removal, including all documents used as training materials or manuals for installation, maintenance or removal of the device at service centers.4. Complete description of device functionality including technical specifications describing the device's accuracy, reliability, security, data collection and recording, tamper detection, alert mode and environmental features.5. A complete and accurate copy of an independent laboratory report issued to the applicant substantiating that the device meets or exceeds the minimum federal standards adopted in sub. (5). The report shall be submitted with a notarized certification from the independent laboratory and shall include copies of the laboratory's certificates of accreditation. Note: Wisconsin requires devices to maintain calibration stability over a period of at least 67 days so that the devices may be relied upon as accurate from service date to service date.
6. A description of the applicant's present or planned provisions for distribution and service of the device in Wisconsin. The applicant shall, within 6 months of receipt by the department of an application for approval of a device, provide the chemical testing section with a list of all locations in Wisconsin where the device may be purchased, installed, removed, serviced, repaired, calibrated, inspected and monitored.7. A certificate from an insurance company licensed in Wisconsin evidencing that the manufacturer holds product liability insurance as required in s. Trans 313.05.8. Indication of whether the manufacturer or manufacturer-approved authorized device repair facility, or both, will repair handsets and vehicle modules. If any device repair facilities are not directly operated by the manufacturer, the qualification and background requirements for repair technicians at those facilities must also be submitted to the department.9. Copies of all contracts, lease agreements, and other form documents used by the service providers to enter into a contractual relationship with a customer.10. A list of other jurisdictions in which the applicant applied for approval of the device in that jurisdiction and a statement as to whether the application was approved, denied, withdrawn, remains pending, or was subject to some other disposition. If the application was denied, withdrawn, or subject to some other disposition, the applicant shall provide an explanation for that action on the application and copies of all documents from that jurisdiction documenting the decision in that jurisdiction and the reasons for that decision.11. A release authorizing any other jurisdiction to share with the department any and all tests or evaluations of the device, data derived therefrom, and all materials provided to the other jurisdiction in support of that other application.12. A certificate of authority or registration, obtained from the Wisconsin Department of Financial Institutions, in accordance with s. 180.1501 or 183.1004, Stats., or a copy of the articles of incorporation for any cooperative filed in accordance with s. 185.82, Stats., for all manufacturers, vendors and service providers anticipating to lease, sell, service, repair, install or uninstall the device in Wisconsin.13. All relevant manufacturer, vendor and service provider documents relating to the quality assurance of the calibration procedure and device verification checks.14. An affirmation, on the department's form, of all the following:a. That the applicant will provide, at the written request of the state, or any prosecutor in this state, testimony that is sought in any civil or criminal proceeding or administrative hearing regarding the device, its manufacture, use, or function, its installation, repair or removal, interpretation of any recorded report or information from or about the device, or the performance of any duties required under this chapter, without cost to the state, county, municipality, town, police agency, or prosecutor. Note: If allowed under judicial rules, local rule or order, this testimony may be provided through teleconferencing or an online remote process.
b. That the manufacturer will provide statewide service for the device in accordance with s. Trans 313.09 (1).15. Contact information for its registered agent for service of process in this state. The applicant shall notify the department if its registered agent changes.16. The minimum qualifications for a manufacturer-approved authorized service center and training materials provided to or used by manufacturer-approved authorized service centers.17. If the device has previously been evaluated by the department, an explanation of all modifications made to the hardware and software of the device since that evaluation, a data supported explanation as to why the applicant believes that the modifications made to the device should result in the successful evaluation of the device, and any test results for the device the applicant has performed. Note: This provision is intended to reduce waste by eliminating a requirement to re-evaluate a device that failed testing previously, unless the applicant can explain and demonstrate with evidence the basis for believing the device will pass if retested.
18. A document that clearly describes the manufacturer's or vendor's quality control process for resolving noncompliance with the requirements of this chapter by its service providers.19. An explanation of responsibility for responding to consumer questions and complaints, as required by s. Trans 313.10 (2) (c).20. Any other information required on the department's form.(c) An applicant shall respond to all the department's inquiries into any deficiency of the applicant's application in a timely manner. If an applicant fails to respond to and remedy any application deficiency brought to its attention by the department within 90 days, the application is considered incomplete and the applicant shall restart the application process.(3) TIME FOR DECISION. The department shall approve or disapprove a device not later than 30 days after receipt of all required application materials and completion of all equipment testing.(3m) EVALUATION QUEUE. (a) Once the department receives an application with all the information required in sub. (2), the department shall place that application in an evaluation queue maintained by the department.(b) The department shall evaluate devices in the order its corresponding application is placed in the evaluation queue, except as provided in par. (d).(c) The department shall notify an applicant at the time its device reaches the point in the evaluation queue that the department is prepared to begin testing the device.(d) The department may require installation of devices under sub. (4) (b) by a prescribed deadline. Failure to install devices by that deadline may result in the device evaluation being delayed. If an applicant fails to install devices by any required deadline, the department may provide notice to the next applicant in the evaluation queue and evaluate that other device.(4) EVALUATION.(a) The applicant shall submit at least two devices, as specified in the application, to the department for evaluation. The department may require different functions or features to be activated for the two devices.(b) The applicant, or its agent on its behalf, shall install the device in a vehicle provided by the department. When applicable, the applicant shall provide the department with an adequate supply of disposable mouthpieces.(c) The department shall independently evaluate each device to ensure compliance with the requirements in sub. (5). The evaluation criteria include, but are not limited to, repeated testing of alcohol-laden samples, filtered samples, circumvention attempts and tampering.(d) During the evaluation period, the applicant shall provide the department with a computer that has all software for the department to access test data from the device in near real-time or no later than 24 hours after a test is performed, or some other mechanism that provides that functionality.(e) If the department disapproves a device based on a failed evaluation, an application for the device may not be evaluated, nor placed in the evaluation queue under sub. (3m) (a), nor may the device be evaluated for 6 months. The department may waive this required 6-month period if the application is accompanied by all application materials specified in sub. (2) (b) 17.(5) STANDARDS AND SPECIFICATIONS. An applicant shall ensure that any device that it distributes for use in the state of Wisconsin meets all the following requirements: (a)Minimum federal standards for devices. All devices shall meet or exceed the standards established by the U.S. department of transportation, national highway traffic safety administration, identified as "Model Specifications for Breath Alcohol Ignition Interlock Devices (BAIID)" 78 Fed. Reg. 89, pp. 26849-26867 (May 8, 2013). Note: This federal standard is available on file at the Legislative Reference Bureau and from the Department of Transportation, Division of State Patrol, Chemical Testing Section, 3502 Kinsman Blvd, Madison, WI, 53704-2549, or online at https://www.govinfo.gov/content/pkg/FR-2013-05-08/pdf/2013-10940.pdf.
(b)Retest feature. The device shall be programmed to have a retest feature. The retest feature shall require the driver to submit to a sample sequence no more than 5 minutes after the vehicle is made operable following a successful start sequence. The retest feature shall require additional subsequent tests at random intervals of 5 to 30 minutes until the vehicle ceases operation.(bm)Failed retests. The device's retest feature shall be programmed to include all of the following features:1. 'Activation of Alert.' A driver's failure to provide a breath sample that is less than the device's alcohol setpoint shall trigger a confirmation retest sequence, as described in subd. 2. If the driver does not provide a passing breath sample in response to the confirmation retest, the device shall activate the device's alert mode until the earlier of the time the vehicle is shut off, or the time the driver provides a passing breath sample to the device.2. 'Confirmation retest.' Upon activation of a confirmation retest sequence under subd. 1., a device shall wait 2 minutes and then commence a sample sequence. If no passing sample is provided as part of the sample sequence, the device shall activate its alert mode. Upon expiration of the sample sequence, the device shall resume normal retest intervals. Note: If the vehicle is shut off before a passing breath sample is provided, a passing breath sample shall be required to restart the vehicle. See par. (j) 2. and 3.
(c)Testing protocol feature. Whenever the device demands a breath sample, the device shall be programmed to allow multiple attempts, but no fewer than 3 attempts, to provide a breath sample within a 5-minute period.(ce)Start sequence. The device shall be programmed to allow the customer to operate the vehicle if the device records a passing breath sample during the start sequence. If the device fails to record a passing breath sample in the start sequence, then the device shall prevent the customer from operating the vehicle. Note: This paragraph does not require a time period to elapse between start sequences. "Temporary lockouts" that were required under prior law are eliminated.
(cm)Permanent lockout feature. The device shall be programmed to enter a permanent lockout condition when service is not completed within 7 days of a service reminder. Note: Entering permanent lockout mode prevents initiation of a start sequence for the vehicle. See s. Trans 313.03(17).
(cs)Violation reset. The device shall be programmed to have a violation reset feature that is triggered by any of the following: 2. Detection of one or more tampering or circumvention attempts.(d)Recorded data. A device shall record data in a format that allows the data to be wirelessly transmitted or printed and that includes all of the following: 1. The date and time of any use or attempted use of a vehicle.2. The date and time of any attempt to tamper, circumvent or bypass the device.2m. The date and time of any sample reported by the device.3. The result of any request for a sample made by the device including, if a breath sample was provided, the date, time and alcohol concentration, in grams per 210 liters, of each breath sample provided to the device.3m. The date and time of any activation or deactivation of the device's alert mode.4. The date and time of any malfunctions of the device.5. The date and time of any failures to provide retest samples.6. The date that a "service required" message is issued to the customer.7. The date that any service is performed.8. All images captured by the device, including the date and time those images were captured.(dm)Electronic transfer of data. The device shall provide a means of electronically transferring the data collected under par. (d) to the database described in sub. (6). Data related to violations shall be transmitted using near real-time reporting of violations via electronic transmission as provided in par. (m). Usage and other data shall be reported by means of a downloaded report of all required data fields downloaded from the device at time of service for the service interval preceding the service. All data shall be provided in the format specified by the department. Note: Under s. Trans 313.07 (1) (e), device approval for use in the state of Wisconsin may be revoked, suspended or denied if an entity fails to transmit data in the manner described in this paragraph.
(e)Information provided to customer. A device must provide all of the following information to a customer:2. Reminder of the date for service, beginning 7 days prior to a scheduled service date as part of each start sequence.3. Reminder as part of each start sequence to obtain service by the seventh day following the date a violation reset is initiated. Note: For the definition of "violation reset" see s. Trans 313.03 (27).
4. A qualitative result for each breath sample. Note: An adequate qualitative result might indicate whether sample was a passing breath sample (see definition in s. Trans 313.03 (16r)), a failed sample, a failure to provide a sample or an error. The result should indicate to the user why the device prevents operation of the vehicle, requires a confirmation test, enters alert mode or behaves in a manner inconsistent with behavior following a passing breath sample. Display of specific alcohol concentrations, quantitative results, is not permitted.
(f)Camera feature. A camera feature is required for all devices. It shall capture an image at the time the device user is providing a sample, or if no sample is provided, at test expiration. The image shall provide a clear and accurate image of persons seated in a front seat of the vehicle and the entire front seat including any pass-through area to rear positions of the vehicle, so that it is possible to determine whether circumvention is being attempted or utilized.(g)Alcohol specific quantification sensor. The device shall use an alcohol-specific quantification sensor that provides an accurate and reliable measure of alcohol in the breath sample.(h)Bypass switch. Except as provided in pars. (i) and (j), the device may not contain a bypass switch or mechanism that allows a person to bypass, circumvent or manually override the device in any manner, which would allow a person to operate the vehicle without providing a passing breath sample. Note: Allowing a person to operate a vehicle using a lockout code in accordance with par. (i) or to restart a vehicle in accordance with par. (j) does not violate this requirement.
(i)Lockout code feature. The device may be programmed to allow a person to operate the vehicle by using a lockout code provided by the manufacturer, at its discretion, with the following requirements:1. A lockout code may only be used to operate the vehicle once in any 60-day service interval.2. The lockout code is functional only when the device is in permanent lockout.3. The lockout code is functional for one use only and expires no later than 24 hours after the manufacturer provides the lockout code to a person.4. The lockout code shall enable the device to accept a breath sample, and if the vehicle is started, the device must operate in accordance with this section.5. The device shall revert to permanent lockout mode if the lockout code expires.6. The device shall revert to permanent lockout mode if the lockout code is used, the vehicle is turned off and the restart period described in s. Trans 313.03 (20) expires.(j)Restart feature. The device shall be programmed to have a restart feature with the following functions:1. If the vehicle stalls or is turned off following a successful test and before a retest is required under par. (b), the device shall permit the vehicle to restart without requiring a breath sample during the 2-minute period following the vehicle stalling or being turned off. The restart feature under this subdivision may not alter the time interval required for the next retest.2. If the most recently provided breath sample was above the alcohol setpoint, then the restart feature may not function until the customer provides a passing breath sample.3. If the device has prompted the customer for a retest, then the restart feature may not function until the customer provides a passing breath sample.(k)Removable handset. A device that has a removable handset may be programmed to permit a customer to disconnect the handset of the device, when the vehicle is turned off, without triggering the device's tamper detection feature or causing the device to record a violation.(l)Daylight savings feature. The device shall be programmed to automatically adjust for daylight savings time.(m)Near real-time reporting feature. The device shall be programmed to have a near real-time reporting feature. Each time the device records a violation, the device must electronically report the violation. The report shall include the sample sequences that created the violation, the 10 preceding sample sequences, and a maximum of 10 subsequent sample sequences to the database established under sub. (6). The report shall be transmitted once the device is within range of Wi-Fi, cellular or satellite service or other wireless electronic transmission system the device is configured to utilize. Once a violation or preceding sample sequence has been reported, that violation or preceding sample sequence need not be re-reported with subsequent violation reports.(n)Security features. The device shall include all of the following security features: 1. A unique and easily identifiable tamperproof seal or connector on all wired connections used to install the device.2. Connections to the vehicle that can be found under the dash or in an inconspicuous area of the vehicle.3. A unique and easily identifiable tamperproof seal on the vehicle module and handset.(6) IGNITION INTERLOCK DATA SYSTEM. (a) The manufacturer or vendor shall establish a computerized database to store all information collected under sub. (5) (d).(b) Except as provided in par. (h), the manufacturer or vendor shall provide remote access to that database for all of the following:2. Any law enforcement agency.5. Department of corrections officials.6. Probation and parole officials.8. Any university or research group engaged in a study approved by the department.(c) Except as provided in par. (h), the manufacturer or vendor shall design the system to permit the authorized users to login to a secure website and review or download the data stored under par. (a).(d) Except as provided in par. (h), the manufacturer or vendor shall: 1. Make data available by device ID or serial number, by customer name, or by Wisconsin driver license number.2. Allow for sorting or filtering of data.3. Make data available in its entirety for department-approved academic or department study purposes.(e) Except as provided in par. (h), the manufacturer or vendor shall make the system allow an authorized user to request alerts if a particular customer commits a violation. Alerts may be provided by electronic mail, text message, or other delivery service. Log-in to the system may be required to review digital images, digital videos, or confidential information related to a violation.(g) For research-related purposes, location data may be shared with an academic or research institution approved by the department under par. (b) 8., provided that the research entity creates a mechanism to prevent disclosure of the location information to third parties, including law enforcement, and stores the data in a manner and for a purpose approved by the department.(h) If the department establishes a centralized database for ignition interlock data, the department may require manufacturers and vendors to upload data collected under sub. (5) (d) and reported under sub. (5) (dm). Reporting shall be accomplished using a department defined data dictionary and, in a format, and in the frequency established by the department. Issuance of an order by the department under this paragraph and a manufacturer or vendor's uploading to the centralized database shall relieve the manufacturer or vendor from having to comply with pars. (b) to (e). Note: The reporting provisions of this subsection are intended to provide a mechanism by which ignition interlock providers can communicate effectively with law enforcement and the department as provided in s. 110.10(4) and (5), Stats.
(7) AUTHORIZED REPAIR FACILITIES. (a) A manufacturer may repair handsets, vehicle modules, other device components and auxiliary components that it manufactured.(b) The manufacturer shall identify all repair facilities that it authorizes to conduct repairs.(c) The manufacturer shall provide evidence of the technical competence of repair facilities identified under par. (b).(d) Technical competence of repair facilities is required for device approval.(8) EXERCISE OF RELEASE OF INFORMATION. If the department requests information regarding a device from another jurisdiction using a release provided under sub. (2) (b) 11., the department shall notify the applicant of the fact that it is making the request and provide the manufacturer with an opportunity to identify any materials the manufacturer believes are confidential and to comment on the testing or evaluation conducted by the other jurisdiction.Wis. Admin. Code Department of Transportation Trans 313.04
Cr. Register, August, 1993, No. 452, eff. 9-1-93.Amended by, CR 20-020: renum. (1) to (1) (a) and am., cr. (1) (b), am. (2) (a) (intro.), (b) (intro.), 3. to 6., cr. (2) (b) 8. to 20., (c), am. (3), cr. (3m), am. (4) (a), (b), cr. (4) (d), (e), (5) (intro.), am. (5) (a), r. and recr. (5) (b), cr. (5) (bm), am. (5) (c), cr. (5) (ce) to (cs), am. (5) (d) (intro.), cr. (5) (d) 2m., am. 3., cr. (5) (d) 3m., 8., (dm), (e) (title), r. (5) (e) 1., am. (5) (e) 2., renum. (5) (e) 3. (intro.) to (5) (e) 3. and am., r. (5) (e) 3. a. to d., cr. (5) (e) 4., (f) to (n), (6) to (8) Register September 2021 No. 789, eff. 10-1-21; correction in (2) (b) 12., (5) (j) 1., (6) (h) made under s. 35.17, Stats., Register September 2021 No. 789, eff. 10/1/2021Amended by, correction in (4) (e), (5) (bm) 2. made under s. 35.17, Stats., Register October 2022 No. 802, eff. 11/1/2022