FR notice 10 2010 Proposed Interlock Model Specs.pdf

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FOR FURTHER INFORMATION CONTACT

section by October 19, 2010. Persons may request time to make an oral presentation. Persons may also submit written comments. Written comments and requests to make oral presentations at the meeting should reach Drew Dawson at the address listed below or via the Document Management System and must be received by October 19, 2010.

All submissions received must include the docket number, NHTSA– 2010–0136, and may be submitted by any one of the following methods: (1) You may submit or retrieve comments online through the Document Management System (DMS) at http:// www.regulations.gov/ under the docket number listed at the beginning of this notice. The DMS is available 24 hours each day, 365 days each year. Electronic submission and retrieval help guidelines are available under the help section of the Web site; (2) you may submit comments by E-mail to drew.dawson@dot.gov or noah.smith@dot.gov; or (3) you may submit comments by Fax to (202) 366– 7149.

An electronic copy of this document may be downloaded from the Federal Register’s home page at http:// www.archives.gov and the Government Printing Office’s database at http:// www.access.gpo.gov/nara.

Please note, that even after the comment closing date, we will continue to file relevant information in the docket as it becomes available.

FOR FURTHER INFORMATION CONTACT:

Drew Dawson, Director, Office of Emergency Medical Services, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., NTI–140, Washington, DC 20590,Telephone number (202) 366–9966; E-mail Drew.Dawson@dot.gov.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the Federal Advisory Committee Act (FACA), Public Law 92–463, as amended (5 U.S.C. App.

1 et seq.) The NEMSAC will hold a meeting on Tuesday, October 26, 2010, via teleconference.

Agenda of Council Teleconference Meeting, October 26, 2010

The tentative agenda includes the following:

Tuesday, October 26, 2010

(1) Opening Remarks—Chair and Designated Federal Officer;

(2) Introduction of Members and all in attendance;

(3) Federal Advisory Council Act Overview;

(4) NHTSA Office of EMS Overview;

(5) Other Federal agency EMS activities;

(6) FICEMS Overview;

(7) Public Comment Period;

(8) Next Steps and Future Meetings.

While the entire meeting is open to the public, the public comment period will take place on October 26, 2010, between 4 p.m. and 4:15 p.m.

Public Attendance: The meeting is open to the public. Persons with disabilities who require special assistance should advise Drew Dawson of their anticipated special needs as early as possible. Members of the public who wish to make comments on Tuesday, October 26, between 4 p.m.

and 4:15 p.m. are requested to register in advance. In order to allow as many people as possible to speak, speakers are requested to limit their remarks to 3 minutes. For those wishing to submit written comments, please follow the procedure noted above.

Individuals wishing to register for attendance in the teleconference must provide their name, affiliation, phone number, and e-mail address to Drew Dawson by e-mail at drew.dawson@dot.gov or by telephone at (202) 366–9966 no later than October 19, 2010. There will be limited call-in lines, so please register early. Pre-registration is necessary to enable proper arrangements.

Minutes of the NEMSAC Meeting will be available to the public online through the DOT Document Management System (DMS) at: http://www.regulations.gov under the docket number listed at the beginning of this notice and on http:// www.ems.gov

Issued on: October 1, 2010.

Jeffrey P. Michael, Associate Administrator for Research and Program Development.

[FR Doc. 2010–25164 Filed 10–5–10; 8:45 am]

BILLING CODE 4910–59–P

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA–2010–0033]

Model Specifications for Breath Alcohol Ignition Interlock Devices (BAIIDs)

AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

ACTION: Notice.

SUMMARY: This notice proposes revisions to the Model Specifications for Breath Alcohol Ignition Interlock

Devices (BAIIDs). The Model Specifications are guidelines for the performance and testing of BAIIDs.

These devices are designed to prevent a driver from starting a motor vehicle when the driver’s breath alcohol concentration (BrAC) is at or above a set alcohol level. Most States currently use BAIIDs as a sanction for drivers convicted of driving while intoxicated offenses. In 1992, this technology was new. Now that it has matured, NHTSA proposes to revise the 1992 Model Specifications, to test BAIIDs for conformance and to maintain a conforming products list (CPL) of BAIIDs that have been found to meet the Model Specifications. These proposed revisions are based, in part, on input from interested parties during an open comment period.

DATES: Written comments may be submitted to this agency and must be received no later than December 6, 2010.

ADDRESSES: You may submit comments identified by DOT Docket ID Number NHTSA–2010–0033 by any of the following methods:

• Electronic submissions: Go to http://www.regulations.gov. Follow the online instructions for submitting comments.

• Fax: 202–493–2251.

• Mail: Docket Management Facility, M–30, U.S. Department of Transportation, West Building, Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590.

• Hand Delivery or Courier: West Building, Ground Floor, Room W12– 140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Eastern Time, Monday through Friday, except Federal holidays.

Regardless of how you submit your comments, you should identify the Docket number of this document.

Instructions: For detailed instructions on submitting comments and additional information, see http:// www.regulations.gov. Note that all comments received will be posted without change to http:// www.regulations.gov, including any personal information provided. Please see the ‘‘Privacy Act’’ heading below.

Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the complete User Notice and Privacy Notice for Regulations.gov at http://www.regulations.gov/search/ footer/privacyanduse.jsp.

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Docket: For access to the docket to read background documents or comments received, go to http:// www.regulations.gov at any time or to West Building, Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Eastern Time, Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. De Carlo Ciccel, Behavioral Research Division, NTI–131, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590;

Telephone number: (202) 366–1694; E-mail: decarlo.ciccel@dot.gov. For legal issues: Ms. Jin Kim, Attorney-Advisor, Office of the Chief Counsel, NCC–113, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590;

Telephone number: (202) 366–1834; E-mail: jin.kim@dot.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In 1992, the National Highway Traffic Safety Administration (NHTSA) adopted and published Model Specifications for Breath Alcohol Ignition Interlock Devices (BAIIDs). (57 FR 11772.) Ignition interlocks are alcohol breath-testing devices installed in motor vehicles that require the driver to provide a breath sample in order to start the engine and to provide a breath sample periodically while the engine is running. If the breath sample provided by the driver contains more than a predetermined alcohol concentration, the ignition interlock device prevents the vehicle from starting.

Before NHTSA adopted the Model Specifications, a number of States passed laws authorizing the use of ‘‘certified’’ BAIIDs. However, there was no single standard or test procedure among the States for certifying BAIIDs.

Manufacturers of ignition interlock devices requested that the Federal Government develop and issue standards for certifying such devices rather than leaving the industry subject to numerous State standards and test requirements. After notice and comment, NHTSA adopted the Model Specifications for BAIIDs to provide a degree of consistency.

Since the Model Specifications were adopted in 1992, many States have incorporated them or some variation into their certification requirements.

Persons required to use BAIIDs are generally under the direct supervision of a court or another State agency (e.g., Motor Vehicle Administration). As of March 2010, 47 States and the District of Columbia allow the use of BAIIDs for some driving while intoxicated (DWI) offenders. Of these States, 22 mandate the use of BAIIDs for repeat DWI offenders, and 13 mandate or highly incentivize the use of BAIIDs by all DWI offenders, including first-time offenders.

While many States have incorporated the Model Specifications to certify BAIIDs used by DWI offenders, there remains considerable variability among State certification requirements. Due to this variability and to rapid technological advances in the industry, States and manufacturers of BAIIDs have requested that NHTSA test the devices against the Model Specifications and maintain a conforming products list (CPL) of devices found to meet the Model Specifications, similar to CPLs that NHTSA maintains for other breath alcohol measuring devices, such as Alcohol Screening Devices, Evidential Breath Testers, and Calibrating Units for Breath Alcohol Testers.

In response to these requests, NHTSA proposes to revise and update the 1992 Model Specifications, add provisions for the agency to conduct conformance testing of BAIIDs, and maintain a CPL of BAIIDs that have been found to meet those Model Specifications. This proposal is not intended to take the place of any State certification requirements; rather, it would establish a voluntary testing and conformance program.

In advance of these proposed revisions of the 1992 Model Specifications, NHTSA published a request for comments on February 15, 2006. (71 FR 8047.) NHTSA explained that it was interested in obtaining comments from interested parties in 13 specific areas:

(1) Accuracy and precision requirements. Is the current set point of

0.025 grams of alcohol per 210 Liters of air (g/dL) appropriate or should it be changed? Are the current specifications for 90 percent accuracy at 0.01 g/dL above the set point in the unstressed testing conditions, and 90 percent accuracy at 0.02 g/dL above the set point in the stressed testing condition appropriate?

(2) Sensor technology. The 1992 Model Specifications do not address what type of sensor technology should be used to satisfy those performance requirements. Should the Model Specifications limit sensor technology to alcohol-specific sensors (such as fuel cell technology based on electro-chemical oxidation of alcohol) or other emerging sensor technologies? Or, should NHTSA not specify the sensor technology and rely on performance requirements?

(3) Sample size requirements. The 1992 Model Specifications set the minimum breath sampling size at 1.5 Liters. Informal comments received over the years have suggested that this requirement may be too high. Should NHTSA consider lowering the minimum breath sampling size requirement? Should NHTSA include a minimum sample size and minimum back pressure at the input-mouthpiece of the device?

(4) Temperature extreme testing. The 1992 Model Specifications call for testing at ¥40 °C, ¥20 °C, +70 °C and +85 °C, but allow for the removability of the alcohol sensing unit so that it may be kept at an artificial temperature when the vehicle may be subject to extremely cold or hot temperatures. Is this approach to extreme temperature testing sufficient, or should it be more stringent?

(5) Radio Frequency Interference (RFI) or Electromagnetic Interference (EMI) Testing. The RFI testing protocol in the 1992 Model Specifications uses power sources that are no longer commonly in use. New power sources that may interfere with the operation of BAIIDs (e.g., cell phones) have output power commensurate with equipment in use today. What are the appropriate levels to measure RFI/EMI?

(6) Circumvention testing. The 1992 Model Specifications offer a number of procedures for evaluating whether existing devices can be easily circumvented. Are these procedures sufficient or should new or modified procedures be incorporated into the Model Specifications?

(7) The Vehicle-Interlock Interface.

Anecdotal reports from ignition interlock manufacturers have suggested that it is sometimes difficult to install existing interlock systems in some of the newer electronic ignition systems.

Should NHTSA establish any guidelines regarding the vehicle-interlock interface?

(8) Calibration stability. Is the duration of calibration stability testing sufficient? Should ignition interlocks be required to hold their calibration for a longer period of time, thereby requiring less frequent calibration checks?

(9) Ready-to-use Times. Should NHTSA establish a ‘‘ready-to-use’’ time period for extreme cold temperatures, such that devices must operate within a given period of time under extreme cold conditions?

(10) NHTSA testing. Should NHTSA undertake the responsibility to evaluate ignition interlocks against its Model Specifications and publish a Conforming Products List (CPL) of devices meeting those specifications?

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(11) International Harmonization. Is it important to harmonize the ignition interlock Model Specifications with standards in other parts of the world, such as the European Union, Canada, and Australia?

(12) Specifications for Ignition Interlock Programs. Does the ignition interlock community (users, manufacturers, States, etc.) favor NHTSA development of an interlock program, in addition to Model Specifications for devices?

(13) Acceptance Testing. NHTSA’s current Model Specifications involve ‘‘type-testing’’ (i.e., testing particular models of BAIIDs for conformance) of various models of BAIIDs. Should NHTSA establish standardized acceptance-testing procedures (i.e., testing each individual device for conformance), instead of the current type-testing guidelines? What testing should be included in such Model Specifications? Who should conduct the testing?

In addition to the above 13 specific areas, NHTSA’s 2006 notice solicited comments on other areas that might enhance the revisions of the Model Specifications. Comments were received from five manufacturers of interlock devices, five State government representatives, two automobile manufacturers, one association of interlock installers and the European Committee for Electrotechnical Standardization (CENELEC). Today’s notice responds to these comments in setting forth the agency’s proposal.

In addition, this notice sets forth the proposed procedures for submitting BAIIDs for NHTSA testing (Appendix A) and re-examination of BAIIDs that have been tested (Appendix B).

II. Response to Comments The comments were supportive of the agency’s proposal to revise the Model Specifications, noting that they had served well in organizing the interlock field but that some adjustments were warranted to assure more consistency in the quality of equipment in use today.

A. Set Point, Accuracy and Precision Requirements

There was a lot of variability among comments on the alcohol set point (i.e., Breath Alcohol Concentration (BrAC) at which a BAIID is set to lock the ignition). Two commenters stated that the 1992 Model Specification requirements for set point was appropriate and should not be changed.

One State representative recommended a 0.025 g/dL set point for adults and a

0.02 g/dL set point for minors. Other State representatives commented that the alcohol set point could be more stringent. One commenter stated that several States already use a 0.02 g/dL set point.

NHTSA proposes to lower the set point for testing BAIIDs from 0.025 g/dL to 0.02 g/dL. This is the critical point that is used in the Breath Alcohol Screening Devices to indicate the presence of alcohol. Accordingly, for listing on the Conforming Products List (CPL), NHTSA proposes to test BAIIDs that are capable of locking out at a set point of 0.02 g/dL. NHTSA believes that

0.02 g/dL is an appropriate set point because it is an appropriate level to test the presence of alcohol among offenders using ignition interlocks and it is our understanding that the technology is available for BAIIDs to have a set point at 0.02 g/dL.

A few commenters stated that the 1992 Model Specifications for accuracy and precision were appropriate. Most commenters indicated that with improved technology, a greater degree of accuracy was possible, but did not specify to what degree. One interlock manufacturer advocated 95 percent accuracy with a precision of 19 out of 20 test trials at 0.01 g/dL above the set point for unstressed conditions (i.e., normal) and 100 percent accuracy and with a precision of 20 out of 20 test trials at 0.02 g/dL above the set point for stressed conditions (i.e., atypical, such as extreme temperatures).

Accuracy is the degree to which a BAIID measures the BrAC correctly. For example, for a BAIID to be accurate, a breath sample with no alcohol present (0.000 g/dL) must not lock the ignition.

Precision is the degree to which that same measure can be repeated. In the previous example, for that BAIID to be precise, that same alcohol free breath sample should not lock the ignition 20 out of 20 test trials.

NHTSA agrees with the commenters that because of improved technology, BAIIDs should be subject to a higher degree of accuracy and precision.

NHTSA proposes to define the accuracy and precision requirements for BAIIDs by testing at ±0.012 g/dL above and below the nominal set point of 0.02 g/ dL, i.e., 0.032 g/dL and 0.008 g/dL, respectively. At 0.032 g/dL, not more than 1 ignition unlock in 20 trials would be allowed. At 0.008 g/dL, not more than 1 ignition lock in 20 trials would be allowed. No ignition locks in 20 trials would be allowed at 0.000 g/dL. This increases the accuracy from 90 percent to 95 percent at ±0.012 g/dL above and below the nominal set point of 0.02 g/ dL, and 100 percent at 0.000 g/dL.

NHTSA determined these proposed test levels by using standard statistical techniques for small samples.

B. Sensor Technology Most commenters stated that it is important to require alcohol-specific technology in the Model Specifications, but that the particular sensor design should not be specified. A small group, including States, favored the use of a particular sensor design (e.g., fuel cell).

One interlock manufacturer stated that a non-alcohol-specific technology, such as a semi-conductor that senses alcohol differently and costs about 50 percent less than a fuel cell, was an economic alternative to the fuel cell.

While alcohol-specific sensor technologies have made great advances, this proposal does not limit the sensor technology used in the BAIIDs as long as the BAIID meets the performance requirements of the Model Specifications. We believe that this approach will allow a wider variety of options, including the use of emerging technologies as they become available.

C. Sample Size Requirement Most commenters advocated lowering the current 1.5 Liters (L) minimum sample size (to either 1.2 L or 1.0 L). A subset of these commenters felt that anything lower than 1.2 L should be set only on recommendation of a physician.

One commenter thought that a 1.5 L air sample was not enough to ensure an accurate measure of the alcohol content.

NHTSA agrees with the recommendation to lower the minimum sample size to 1.2 L and proposes a minimum 1.2 L sample size. NHTSA believes that, at this level, accuracy can be attained and that users will be able to deliver this smaller sample size.

Some commenters felt that a minimum back pressure, which controls the force of the air entering the BAIID, was not necessary if the sample size was not lower than 1.0 L. One commenter suggested requiring 1.2 L sample size with a minimum back pressure and a flow rate of 0.2 L/second. A manufacturer suggested requiring 1.2 L sample size with a back pressure of 20 hectoPascal (hPa) (e.g., 2 kiloPascals (kPa)) and a flow rate of 0.1 L/sec. One State suggested an exhale-inhale-exhale pattern as an alternative to setting a standard. Two States suggested a 1.2 L sample size with back pressure, temperature and time requirements.

Two commenters felt that NHTSA should only set the minimum sample size, and should not prescribe the means by which the sample delivery would be accomplished.

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NHTSA proposes to require a minimum flow rate of 0.1 L/sec. Flow rate is the length of time that a sample breath is delivered into the BAIID. NHTSA believes that a 0.1 L/sec minimum flow rate is a level that will enable more people to deliver an adequate sample.

By lowering the minimum sample size and adding a minimum flow rate, NHTSA does not believe that specifying a minimum back pressure is necessary.

NHTSA believes that this proposal will make the BAIID available to a larger population of users.

D. Extreme Temperature Testing, Removable Sensing Heads or Units

One interlock manufacturer suggested that NHTSA test for extreme temperature at ¥45 °C, as temperatures reach that level in high latitudes and high altitudes. Another interlock manufacturer suggested that NHTSA leave the testing temperature unchanged and continue to allow the sensing unit to be removed from the vehicle. Most commenters felt that the current testing temperature extremes of ¥40 °C and +85 °C were appropriate, but did not object to tests at more extreme temperatures. The CENELEC suggested that the component of the device that is mounted in the engine compartment be tested for +125 °C in addition to ¥45 °C. CENELEC further suggested that the ¥45 °C temperature test be conducted at 75 percent of nominal battery voltage because extreme temperatures can reduce available voltage from a vehicle battery.

NHTSA proposes to retain the current extreme temperature tests at ¥40 °C and +85 °C. The agency believes that the current temperature range is reasonably representative of the environments encountered in the United States.

However, NHTSA proposes to conduct additional high temperature tests for components of the BAIID installed in the passenger compartment (at +49 °C) and in the engine compartment (at +85 °C), and to specify the humidity level for these high temperature tests.

Further, NHTSA proposes to discontinue testing at ¥20 °C and +70 °C because our experience indicates that testing at the extreme temperatures is sufficient.

NHTSA also agrees that the ¥40 °C temperature test should be performed at 9 volts, which is representative of 75 percent of the nominal battery voltage (i.e., 12-volt automobile battery).

NHTSA believes that the test should be conducted at this voltage because vehicles often do not operate at the optimal battery voltage. Accordingly, NHTSA proposes to test BAIIDs using a 9-volt direct current (DC) power source, simulating a 12-volt DC battery operating at low temperatures.

Many commenters stated that NHTSA should not allow the removal of the sensing unit because BAIIDs are expected to operate at a variety of ambient temperature conditions. One State favored a removable mouthpiece (to protect users’ lips from extreme temperatures), rather than a removable sensing unit, and another State favored a prescribed warm-up period. NHTSA agrees with the commenters that the sensing unit should not be removable because it can more easily be damaged or mishandled, leading to frequent repairs and increased cost. Accordingly, NHTSA proposes to test only BAIIDs without removable sensing heads or units. (The agency does not object to BAIIDs with a removable mouthpiece.)

E. RFI or EMI Testing Commenters noted that appropriate power for RFI testing should be considered because an increasing number of electronic devices are being operated in close proximity to BAIIDs, such as gaming, remote keyless entry, portable medical and Bluetooth-capable devices. Two BAIID manufacturers suggested that the European Standard for EMI be adopted because it describes electromagnetic compatibility of vehicles for broadband and narrowband interference and shielding. Two commenters noted that CB radios were more relevant sources of interference and that the CENELEC standard is unnecessarily restrictive on EMI. A State government commenter suggested that the Society of Automotive Engineers (SAE) J551 Vehicle Electromagnetic Immunity-Bulk Current Injection Standard be applied to BAIIDs.

NHTSA agrees that the current specifications do not adequately define or describe RFI/EMI tests. NHTSA proposes to test BAIIDs for emissions and transmissions of RFI/EMI and immunity to RFI/EMI using the SAE Surface Vehicle Standard J1113 series for Class C devices (devices essential to the operation or control of the vehicle) and the International Special Committee on Radio Interference (CISPR), Subcommittee of International Electrotechnical Committee (IEC), specifically CISPR 25, for RFI/EMI testing. NHTSA proposes these tests because we believe that they represent a broad consensus in the industry.

F. Tampering and Circumvention Testing

There was some criticism that the 1992 Model Specifications for tampering and circumvention testing are confusing and lack specificity. One

BAIID manufacturer felt that the U.S.

should adopt the CENELEC standards for charcoal filters, water bubbler, condensation through a long cool tube and pressurized air, and interlock bypass. Another BAIID manufacturer commented that there are aspects of the circumvention detection specifications that are difficult to quantify because different companies develop their own proprietary anti-circumvention strategies (e.g., a learned hum code or toot sequence). This manufacturer commented that program standards should address this by imposing consequences for tampering with devices. Three State government commenters suggested that NHTSA should set higher anti-circumvention standards and have a counter system or data log that records attempts to start the vehicle by bypassing the ignition.

One State thought that the use of time, pressure, differing blow patterns and breath temperature should help prevent circumvention. States believed that device design should not present challenges to the user, and that the individual’s breath signature should be used as the basis for anti-circumvention efforts.

Although NHTSA believes that an individual’s breath signature (i.e., a person’s unique breath pattern) is a good goal for the future, NHTSA’s proposal does not include individual breath signature as an anti-circumvention measure. NHTSA does not believe that technology is sufficiently advanced to warrant including individual breath signature in this proposal. However, NHTSA agrees with commenters that the circumvention requirements are confusing. Accordingly, the agency proposes to clarify and specify the requirement for circumvention and tampering tests and to specify that the BAIID must have tamper proof seals to indicate when a BAIID has been disconnected from the ignition.

G. Vehicle-interlock interface Interlock manufacturers and providers supported a standard interlock-vehicle interface, and recommended that NHTSA require all vehicles to have either a communications bus interface or another hard-wired interface connector for specific use for any ignition interlock device. Other commenters suggested that a common interface would be a great convenience since it would make installation easier.

However, two automobile manufacturers commented that although there may be benefits, requiring all vehicles to have a common interface for BAIIDs presented significant challenges

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While we understand the installation convenience that would be afforded by a common vehicle interlock interface, such a requirement goes beyond the scope of this proposal, which is limited to the BAIID itself and not to changes to the vehicle.

H. Calibration Stability and Service Interval

NHTSA received comments regarding both calibration stability and service interval requirements. Some manufacturers commented that NHTSA should establish separate requirements for the minimum period of calibration stability and the service interval.

NHTSA notes that these two requirements are interrelated. If a BAIID’s calibration remains stable for a given period of time, it follows that service will be required after that period to verify the calibration of the BAIID.

For clarity, NHTSA proposes to define calibration stability as the ability of the BAIID to hold its accuracy and precision over a defined time period and calibration interval as the maximum time period that a BAIID may be used without a calibration check, after which the ignition must lock. NHTSA proposes to define the service interval as the maximum time period that a BAIID may be used without maintenance.

For both the calibration interval and the service interval, most commenters stated that the BAIID should enter a lockout countdown to notify the BAIID user that the BAIID needs a calibration check or maintenance, service or data download, and the BAIID should prevent the vehicle from starting at the end of the lockout countdown period. In response to these comments, NHTSA proposes to incorporate a 7-day lockout countdown for both calibration interval and service interval. NHTSA believes that requiring a lockout countdown for both the calibration interval and the service interval is important to ensure that the BAIID is accurately reading breath samples and is properly working.

NHTSA further proposes that during the lockout countdown period, the BAIID should notify the user of the time remaining before the ignition locks.

However, NHTSA declines to impose any countdown or lockout requirement for downloading data, as this decision should properly be left to the States or the courts for decision.

NHTSA proposes to revise the calibration stability requirements. The 1992 Model Specifications called for calibration stability for 7 days beyond the manufacturer’s designated calibration stability period of 30, 45, or 60 days. For example, if the manufacturer required that the calibration of BAIIDs be checked after 60 days, the BAIID would need to hold the calibration for 67 days. NHTSA now proposes that BAIIDs must hold calibration for a minimum 30 days plus the 7-day lockout countdown described previously (i.e., 37 days) in order to conform to the Model Specifications.

Although some manufacturers have BAIIDs that are claimed to hold calibration for a longer time period, NHTSA proposes to test the calibration stability at 37 days (i.e., 30 days plus the 7-day lockout countdown) and to require lockout after 37 days.

Accordingly, NHTSA proposes that only BAIIDs that meet both the 37-day calibration stability test and the 30+ 7-day lockout countdown function will be listed on the CPL.

NHTSA also proposes to add service interval requirements. The 1992 Model Specifications did not specifically require a service interval period.

Although the term ‘‘service interval’’ is used in the 1992 Model Specifications, that term was used only in relation to calibration stability. It is our understanding that some States use this term to denote the time period for maintenance and data download as well as calibration stability checks.

Commenters from State governments recommended that NHTSA require that BAIIDs have a service interval not greater than 30 days, plus a 7-day lockout countdown. NHTSA agrees with these comments and proposes to incorporate this requirement in the Model Specifications because requiring regular maintenance checks is important to ensure that the BAIID is properly working. As noted above, we do not specify a lockout requirement for data download.

I. Ready-to-Use Times and Retest Commenters stated that a quicker ready-to-use time is possible with newer technology. A commenter stated that one of the biggest complaints with users of BAIIDs is the waiting time for the breath test, and that reducing the waiting time may increase the acceptance of BAIIDs. Several manufacturers indicated that a faster ready time of 3 minutes at low temperatures was achievable.

NHTSA agrees that with current technology, BAIIDs can be ready for use faster than the times provided under the 1992 Model Specifications. NHTSA proposes that at temperatures above ¥40 °C (¥40 °F), BAIIDs should be ready for use in 1 minute or less and be ready to retest in 1 minute or less. For temperatures at ¥40 °C (¥40 °F), NHTSA proposes that the BAIID should be ready for use in 3 minutes or less and ready to retest in 3 minutes or less.

NHTSA proposes to test this performance.

NHTSA does not intend that retests be conducted while the vehicle is moving, but rather while the engine is running with the vehicle stopped in a safe location on the side of the road. The proposed Model Specifications make this point clear.

J. NHTSA Testing Commenters favored a certified testing laboratory program. Most advocated a NHTSA test program and the development of a Conforming Products List (CPL) based on the Model Specifications. One commenter favored having a single private testing laboratory certified by NHTSA for this purpose.

Several manufacturers noted significant problems with State certification requirements leading to questionable test results for some products. In general, both manufacturers and States favored a NHTSA test program because it would organize and standardize the industry and exclude less effective BAIIDs. One commenter suggested that NHTSA require BAIID re-certification in the event of an instrument design change and/or at some reasonable interval.

NHTSA proposes to test BAIIDs for conformance with the Model Specifications. See Appendix A for proposed BAIID submission procedures.

NHTSA also proposes to maintain and publish periodically a CPL with BAIIDs that have been tested and found to conform to the Model Specifications.

NHTSA proposes to manage this new program as it does its other breath alcohol instrument testing programs, including the re-examination of BAIIDs at its sole discretion (Appendix B) and requiring manufacturers to inform NHTSA of any changes or modifications to a tested BAIID. As with NHTSA’s other testing programs, NHTSA also proposes to require manufacturers to submit a quality assurance plan (QAP) for BAIIDs being tested. A QAP is a manufacturer’s plan for maintaining the integrity and the calibration of a BAIID.

NHTSA proposes that the QAP include the following information: instructions for checking the calibration of the BAIID (i.e., recommended calibrating unit, BrAC of 0.02 g/dL, agreement not greater than ±0.005 BrAC, verification of accuracy of readout, actions to take for failed calibration check), instructions for downloading the data from the data logger, instructions to maintain the BAIID, instructions on checking for

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61825 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices tampering, and any other information regarding quality assurance unique to the instrument. See Appendix C, the proposed sample QAP template.

Testing of BAIIDs will be subject to the availability of Federal funds. If Federal funds are not available, NHTSA will discontinue testing BAIIDs until funds become available.

K. International Harmonization

There was considerable variability from commenters on this issue. Those favoring harmonization with the CENELEC standards argued that in an increasingly global marketplace, common standards would benefit both economic and safety concerns. Some against harmonization stated that aspects of the CENELEC standard are potentially restrictive and costly. Others opposed harmonization because the U.S. organized the BAIID industry by emphasizing safety and design flexibility in a way that encouraged the domestic industry and avoided costly requirements.

NHTSA believes that there are some benefits to harmonizing some standards, and has proposed to incorporate aspects of CENELEC standards as identified elsewhere in this proposal.

L. Interlock Program Specifications

Some commenters stated that interlock program specifications or interlock program guidelines (i.e., programs to implement the use of BAIIDs) have been and should remain a function of State government. Others largely expressed support for NHTSA development of interlock program guidelines, especially in the areas of installation requirements, monitoring and recalibration of devices, and recognizing device tampering. While NHTSA believes that such a program is important, today’s notice addresses only BAIID performance criteria and testing of BAIIDs. NHTSA may explore interlock program guidelines in a future action.

M. Acceptance Testing

Some commenters stated that acceptance testing is being performed by some States, but that the criteria vary among those States. These commenters stated that NHTSA should establish standardized acceptance-testing procedures in addition to the 1992 Model Specifications. Several commenters requested that the term ‘‘acceptance testing’’ be more clearly defined. One commenter recommended that NHTSA establish enforceable guidelines, mandatory audits and periodic re-examinations.

NHTSA defines ‘‘acceptance testing’’ as the pass-fail evaluation of each individual device performed before placing that device into service. Because of limited resources, NHTSA proposes to conduct ‘‘type-testing’’ (i.e., testing of a sample of a particular model of BAIID, rather than every device manufactured).

N. Additional Comments

1. Two commenters suggested that

BAIID manufacturers make available the operating software codes of the BAIIDs, including disclosure of how the BAIIDs monitor their own malfunctions and the criteria the devices use to trigger recalls.

NHTSA does not believe that making a manufacturer’s proprietary software publicly available is desirable or necessary, as the agency’s proposal sets forth performance specifications, not design specifications. Moreover, making such information public may lead to increased circumvention and tampering.

2. Commenters suggested that data loggers distinguish calibration tests from user samples. NHTSA agrees that distinguishing such information would be useful for monitoring the BAIID user.

Accordingly, NHTSA proposes that the BAIID must include a data logger that will distinguish calibration tests from user samples as well as record all start attempts and outcomes, such as emergency override, circumvention, tampering, and BrAC for each start attempt. The data must be presented in chronological order (i.e., by date and time of event). See Appendix D for a sample format for downloaded data from the data logger. The audit trail should also indicate the version of the metrological software (i.e., the BAIID’s operating system) in use. All printed and downloaded reports should indicate the software version. NHTSA proposes to test these features.

The agency understands that some customers (such as States) request certain changes to the BAIID, so that read-out data is presented in a particular format. Such customization is generally accomplished through software modifications. Testing customer-driven software modifications is beyond the scope of this program. Moreover, if such modifications were permitted to be performed to the internal software of the BAIID at a customer’s behest, the integrity of the CPL would be compromised as the BAIID tested could then differ from customized devices in production. However, NHTSA is aware that States (and local jurisdictions) use different set points in their interlock programs. Therefore, we do not believe that changes to the set point, alone, should be deemed impermissible modifications. Accordingly, the agency’s proposal does not allow any modifications of internal BAIID software at the behest of customers, except for adjustments to the set point. (We note that for testing purposes, NHTSA proposes to test BAIIDs with an alcohol set point of 0.02 g/dL.) Manufacturers wishing to accommodate a customer’s interest in data formatting options should do so by providing a port that allows connection of a peripheral device with its own formatting software.

Manufacturers are advised that, when submitting a BAIID to NHTSA for testing, they must submit the basic model without any customized or add-on software.

3. Commenters suggested that the BAIID memory should be located in a fixed control box. NHTSA agrees with these commenters and proposes to add this to the General Requirements and BAIID Features because a fixed control box provides less opportunity for potential damage to the BAIID memory.

4. Commenters suggested that restarts should be allowed only if a vehicle stalls, but not if the ignition is intentionally turned-off or if a BAIID malfunctions or is awaiting a retest.

NHTSA proposes that a restart (i.e., without a breath sample) should be allowed when the vehicle stalls, provided the restart is accomplished in no more than 20 seconds. NHTSA also proposes that in all other situations where the vehicle malfunctions, the vehicle should be prevented from starting without a breath test.

Commenters further suggested that if a BAIID malfunctions or fails, the device should default to preventing the vehicle from starting. NHTSA agrees with the commenters and proposes that if a BAIID malfunctions or fails (e.g., improper voltage, temperature exceeding operating range, dead sensor, etc.), the BAIID should prevent the vehicle from starting.

5. Some commenters stated that an emergency override was a useful feature. NHTSA declines to propose that BAIIDs be required to have an emergency override feature (i.e., the ability to start the vehicle without a breath test) in order to conform with the Model Specifications. However, should a BAIID be equipped with an emergency override feature, NHTSA proposes to allow its activation to start the vehicle only once. After that, the BAIID must indicate the need for service and record the use of the emergency override. No additional emergency overrides would be allowed during the lifetime of the BAIID installation. The agency proposes to test this feature. NHTSA also proposes that this emergency override feature have a default to prevent an

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6. A commenter suggested that the BrAC test results be displayed to the driver. NHTSA declines to propose that BAIIDs display the BrAC test results to the driver and does not propose to add this requirement in the Model Specifications. NHTSA believes that the role of the BAIID is to detect the presence of alcohol and to prevent the driver from operating the vehicle if alcohol is present. We believe that displaying the BrAC goes beyond the purpose of the BAIID. Accordingly, NHTSA does not propose to test BAIIDs for the accuracy of the BrAC display.

NHTSA proposes to test only the accuracy of the notifications to a BAIID user that are related to the features tested by NHTSA, such as warm-up time, retest, calibration check and service interval.

In addition, NHTSA proposes to remove a number of tests for optional features identified in the 1992 Model Specifications.

7. A commenter suggested that an interlock-specific tone (other than a honking horn) be used to alert outsiders to BAIID violations. At this time, NHTSA does not believe that audible sounds or lights to alert the public to interlock violations are necessary, and does not include the suggestion in this proposal.

8. A commenter suggested that several CENELEC standards be adopted into the Model Specifications, including a dust test, a drop test for removable sensor heads, vibration tests, and protection against reverse polarity on all circuits.

That commenter also suggested that instruction guides or manuals be provided to the interlock installers and user.

In two decades of experience, NHTSA has received no reports suggesting that dust is an issue or source of concern in BAIIDs installed in vehicles. Therefore, we are not proposing a dust standard.

As the agency’s proposal does not allow the removal of the sensor head, we are not proposing a drop test. NHTSA proposes to update the vibration and cigarette smoke tests from the 1992 Model Specifications to incorporate aspects of the CENELEC standard (see Test 7 and Test 12, respectively).

NHTSA agrees with the commenter that electrical properties of the vehicle (contact safety, etc.) must not adversely affect or be affected by a properly installed BAIID. NHTSA also agrees that instruction guides or manuals should be made available to interlock installers and users.

O. Other Proposed Revisions

The agency proposes to re-organize the Model Specifications to improve clarity. NHTSA also proposes to delete the commentary sections of the 1992 Model Specifications because these sections are no longer necessary. Also, we have not retained the previous organization of sections on safety and utility, and we have specified in more detail the tests for humidity, cigarette smoke, retest, and circumvention and tampering. In addition, the proposed Model Specifications no longer include a separate test for user displays, but rather incorporate the test for user display under other tests (e.g., warm up time, retest, calibration interval, service interval). The proposed Model Specifications delineate conformance tests and performance requirements.

NHTSA proposes to delete the following terms as no longer applicable:

Safety and Utility (Safety Feature, Utility Feature, and Optional Feature), Stress Tests, Certification Tests, Clearance Rates, Device, Fail-safe, False-negative, False-positive, High end and Low end. NHTSA also proposes to add three terms—calibration stability, calibration interval, and service interval.

See Section II, H.

NHTSA proposes to delete the Certification Test Summary and the Equipment List that appeared in Appendices A and B because these provisions are obsolete, and relevant information is incorporated in the Tests.

NHTSA proposes to add two tests to the Model Specifications—High Altitude (Test 11) and Acetone (Test 13). NHTSA believes that because high altitudes may affect semi-conductor type alcohol sensors, this condition should be tested. NHTSA believes that acetone should be tested because it is the most common interfering substance for BAIIDs. Finally, of the tests listed, Test 17 (Data Integrity and Format) must be performed last as this test checks the integrity of the downloaded data. See also Appendix D for a sample format for downloaded data from the data logger.

In addition, NHTSA proposes that in order to be listed on the CPL, manufacturers must submit a self-certification, certifying that the manufacturer meets the requirements of the U.S. Department of Health and Human Services Public Health Services, Food and Drug Administration’s (FDA) Good Manufacturing Practices regulations for devices used for medical purposes (21 CFR Part 820), and that the device’s label meets the requirements contained in FDA’s Labeling regulations for devices used for medical purposes (21 CFR 809.10), even if the devices are not to be used for medical purposes. If NHTSA becomes aware that a manufacturer of a BAIID on the CPL is not in compliance with the requirements in FDA’s Good Manufacturing Practices regulations for devices used for medical purposes or that the device’s label does not comply with the requirements in FDA’s labeling regulations for devices used for medical purposes, NHTSA may remove the manufacturer’s BAIID from the CPL.

The agency encourages interested parties to review carefully this notice and the Model Specifications set forth below, and to submit comments in the manner identified in Addresses above.

These proposed Model Specifications, if adopted in final, would not have the force of regulations and are not binding.

States and others may adopt these Model Specifications and rely on NHTSA’s type-test results or they may conduct their own tests according to their own procedures and specifications.

After consideration of the comments, the agency proposes the Model Specifications for Breath Alcohol Ignition Interlock…