Document ID: NHTSA-2013-0058-0001
Agency: nhtsa
Document Type: Notice
Title: Model Specifications for Breath Alcohol Ignition Interlock Devices
Posted Date: 2013-05-08T04:00Z

[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26849-26867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10940]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0058]

Model Specifications for Breath Alcohol Ignition Interlock 
Devices (BAIIDs)

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

ACTION: Notice.

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SUMMARY: This notice revises the Model Specifications for Breath 
Alcohol Ignition Interlock Devices (BAIIDs). The Model Specifications 
are guidelines for the performance and uniform 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. Every State in the United States has enacted a law 
providing for the use of BAIIDs as a sanction for drivers convicted of 
driving while intoxicated offenses. This notice revises the 1992 Model 
Specifications, to test BAIIDs for conformance. These Model 
Specifications are based, in part, on input from interested parties 
during an open comment period. This notice also indicates that NHTSA 
will delay rendering a decision about the feasibility and timing of a 
Conforming Products List (CPL) until more information is available. 
Accordingly, NHTSA plans to conduct an assessment to determine whether 
establishing and maintaining a CPL is feasible, prior to rendering a 
decision.

DATES: Effective Date: This notice is effective May 8, 2014.

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; Email: 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; Email: jin.kim@dot.gov.

SUPPLEMENTARY INFORMATION:

[[Page 26850]]

Table of Contents

I. Background
    A. 2006 Request for Comments
    B. 2010 Proposed Model Specifications
II. Comments Received in Response to 2010 Notice
    A. General Comments
    B. Overarching Issues
    1. Sensor Technology
    2. Removable Heads and Fixed Control Boxes
    3. Retests
    4. Alerts
    5. Emergency Override
    6. Calibration Stability and Service Interval
    C. Technical Issues Relating to Particular Sections of the Model 
Specifications
    1. Terms Used in Model Specifications (Section B)
    2. General Provisions and Features of BAIIDs (Section C)
    a. Ignition, Ignition Switch and Locking
    b. Set point of .02 g/dL and minimum flow rate of 0.1 L/sec
    c. Federal Drug Administration (FDA) Requirements
    3. BAIID Test Procedures (Section D)
    a. General Test Conditions and Performance Requirements
    i. Breath Sample Volume and Flow Rate
    ii. Precision
    iii. Terminology
    iv. Readiness
    b. Conformance Tests
    Test 1--Precision and Accuracy
    Test 2--Breath Sample Volume and Flow Rate
    Test 3--Calibration Stability
    Test 4--Input Power
    Tests 5 and 6--Extreme Temperature and Humidity and Warm Up Time 
at -40[deg] C
    Test 7--Vibration
    Test 8--Retest
    Test 9--Tampering and Circumvention
    Test 10--Restart of Stalled Motor Vehicle
    Test 11--High Altitude
    Test 12--Cigarette Smoke
    Test 13--Acetone
    Test 14--Emergency Override
    Test 15--Radiofrequency Interference/Electromagnetic 
Interference
    Test 16--Service Interval Display
    Test 17--Data Integrity and Format
    D. Other Comments Received Regarding the Model Specifications
    1. Dust Test
    2. Vehicle-Interlock Interface
    3. International Harmonization
    4. Ignition Interlock Program Guidelines
    E. NHTSA Testing of BAIIDs and Conforming Products List (CPL)
    F. Appendices to the 2010 Notice
III. New Model Specifications
    Model Specifications for Breath Alcohol Ignition Interlock 
Devices (BAIIDs)
    Appendix A--Quality Assurance Template
    Appendix B--Sample Format for Downloaded Data From the Interlock 
Data Logger

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 an acceptable breath sample in order to start the 
engine. If the breath sample provided by the driver contains more than 
a predetermined alcohol concentration, the ignition interlock device 
prevents the vehicle from starting. Ignition interlocks also require 
drivers to provide breath samples periodically while the engine is 
running, to ensure that their alcohol concentration remain under the 
predetermined level.
    Before NHTSA adopted the Model Specifications in 1992, a number of 
States enacted 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). All 50 States have enacted laws providing for 
the use of BAIIDs for impaired driving offenders. Currently, of these 
States, 18 mandate or highly incentivize the use of BAIIDs by all 
impaired driving offenders (including first-time offenders); an 
additional 20 States mandate the use of BAIIDs by repeat and/or high 
BAC offenders (at .15 or greater).
    While many States have incorporated the Model Specifications to 
certify BAIIDs used by impaired driving offenders, there remains 
considerable variability among State certification requirements. Due to 
this variability and rapid technological advances in the industry, 
States and manufacturers of BAIIDs had requested that NHTSA update the 
Model Specifications. They also urged NHTSA to test the devices against 
the Model Specifications and maintain a Conforming Products List (CPL) 
of devices found to meet the Model Specifications.

A. 2006 Request for Comments

    In preparation for the revision of the Model Specifications, NHTSA 
published two notices in the Federal Register. On February 15, 2006 (71 
FR 8047), NHTSA published a request for comments, explaining that the 
agency intended to revise the 1992 Model Specifications and was 
interested in obtaining comments from interested parties in 13 specific 
areas. The areas included: Accuracy and precision requirements; sensor 
technology; sample size requirements; temperature extreme testing; 
radio frequency interference (RFI) or electromagnetic interference 
(EMI); circumvention testing; the vehicle-interlock interface; 
calibration stability; ready-to-use times; NHTSA testing; international 
harmonization; specifications for ignition interlock programs; and 
acceptance testing.

B. 2010 Proposed Model Specifications

    In general, the comments to the 2006 notice were supportive of the 
agency's intent to revise the 1992 Model Specifications, but they noted 
that some adjustments were warranted to assure more consistency in the 
quality of equipment in use at that time. On October 6, 2010 (75 FR 
61820), NHTSA published a separate notice containing proposed revisions 
to the 1992 Model Specifications. That notice addressed the 13 topics 
that had been listed in the Federal Register notice published in 2006. 
It also addressed additional issues that were raised in the comments 
responding to the 2006 notice, including: Set points; removable sensing 
heads or units; tampering testing; service interval; retests; among 
others.

II. Comments Received in Response to 2010 Notice

    NHTSA received comments from 20 individuals and organizations in 
response to the 2010 notice, including five States (Iowa, Illinois, 
Oklahoma, Wisconsin and Colorado); nine BAIID manufacturers (Alcohol 
Countermeasure Systems (ACS), Alcohol Detection Systems (ADS), Consumer 
Safety Technology (CST), Draeger Safety Diagnostics, Guardian Interlock 
Systems, LifeSafer Interlock, National Interlock Systems, Omega Point 
Systems and Smart Start); one manufacturer of Evidential Breath Testing 
Devices (Intoximeters); one citizen; two coalitions/associations 
(American Association of Motor Vehicle Administrators (AAMVA) and the 
Coalition of Ignition Interlock Manufacturers (CIIM)); and two BAIID 
installers/providers (Ignition Interlock

[[Page 26851]]

Systems of Iowa (IISI) and Road Safety Technologies).

A. General Comments

    Many of the comments were supportive of the proposed changes to the 
Model Specifications. However, a number of comments raised serious 
concerns. Many comments suggested that, despite NHTSA statements to the 
contrary, some aspects of the proposed Model Specifications seemed 
tantamount to program guidelines or design (and not performance) 
specifications. In addition, a number of comments suggested that NHTSA 
seemed ``out of touch'' with certain current State practices and 
technology, and the proposed Model Specifications seemed ``inflexible'' 
in some respects. These comments stressed that certain aspects of the 
proposed Model Specifications would negatively impact technical 
innovation and State programs. Other, more technical, issues were also 
raised.
    NHTSA appreciated receiving the many candid and thoughtful comments 
submitted in response to the 2010 notice. The agency has considered 
them carefully and made a number of revisions to the Model 
Specifications as a result. In particular, the agency agrees that the 
Model Specifications should define performance criteria and not specify 
design features. The agency also agrees that some decisions are 
programmatic in nature and should not be included in these Model 
Specifications, which are intended to apply to the performance of BAIID 
units, not the manner in which States and local jurisdictions conduct 
their programs. The agency defers to the discretion of States and local 
jurisdictions regarding programmatic decisions and, as appropriate, 
seeks to incorporate flexibility in these Model Specifications, in an 
effort to support the programmatic decisions of States and local 
jurisdictions.
    In this notice, the agency first discusses these overarching 
issues, which generated the greatest number of comments. Discussions 
about the more technical issues, which relate more directly to 
particular sections of the Model Specifications, follow.
    Another topic that generated many comments related to the question 
of whether NHTSA should undertake the responsibility of evaluating 
ignition interlocks against the Model Specifications and publish a CPL 
of devices meeting those specifications. For reasons described in more 
detail later in this notice (Section II.E.), NHTSA will delay rendering 
a decision about the feasibility and timing of a CPL until more 
information is available. NHTSA plans to conduct an assessment to 
determine whether establishing and maintaining a CPL is feasible, prior 
to rendering a decision.

B. Overarching Issues

1. Sensor Technology
    The Federal Register notice published in 2006 indicated that the 
1992 Model Specifications did not address the type of sensor technology 
that should be used to satisfy the performance requirements, and asked 
whether the Model Specifications should limit sensor technology to 
alcohol-specific sensors (such as fuel cell technology based on 
electrochemical oxidation of alcohol) or other emerging sensor 
technologies, or whether NHTSA should not specify the sensor technology 
and rely instead on performance requirements. (71 FR 8047.)
    In the 2010 Federal Register notice, NHTSA stated that, while 
alcohol-specific sensor technologies have made great advances, the 
proposal would not limit the sensor technology used in the BAIIDs as 
long as the BAIID meets the performance requirements of the Model 
Specifications. In that notice, the agency expressed the belief that 
this approach would allow a wider variety of options, including the use 
of emerging technologies as they become available. (75 FR 61822.)
    The agency received nine comments regarding this topic. The 
comments were overwhelmingly opposed to the agency's proposal not to 
specify or restrict sensor technology.
    For example, Road Safety Technologies stated, ``It is critical that 
the interlock device be as accurate as the technology can allow.'' (p. 
1.) Similarly, LifeSafer asserted, ``As jurisdictions have embraced and 
expanded their use of BAIID technology, they have demanded alcohol-
specific sensor technology. [Interlocks that] are not alcohol-specific 
. . . tarnish the reputation of the industry . . ., [which] undermines 
interlock efficacy and creates lasting misperceptions.'' (p. 4-5.) 
AAMVA expressed its belief that ``non-specific alcohol devices are 
prone to false positives and unwarranted lockouts, leading to a lower 
acceptance rate amongst drivers.'' (p. 1.) Colorado stated, ``it is 
unfortunate that the proposed specifications do not seize the 
opportunity to move all our programs towards greater success, customer 
convenience, acceptance and satisfaction by requiring alcohol-specific 
technology.'' (p. 2.)
    NHTSA agrees with the comments that the Model Specifications should 
ensure that BAIIDs are as accurate as possible and that it is not 
desirable to accept devices that generate high levels of false 
positives. The agency is also persuaded by the comments that current 
technology has progressed sufficiently to expect that BAIIDs should be 
able to distinguish between alcohol and other chemicals or substances. 
Accordingly, the Model Specifications provide in Test 12 and 13 that 
BAIIDs should distinguish between alcohol and other specific 
substances, such as acetone and cigarette smoke, which are commonly 
found on breath. BAIIDs that are unable to distinguish these substances 
from alcohol will not meet the Model Specifications.
    Some comments went further and urged the agency to require fuel 
cell technology and/or ban the use of semi-conductors. NHTSA declines 
to take this further step, since requiring one particular technology or 
prohibiting another would be equivalent to setting a design (and not a 
performance) standard.
2. Removable Heads and Fixed Control Boxes
    In the 2010 notice, NHTSA proposed 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 
proposed to test only BAIIDs without removable sensing heads or units, 
though the agency clarified that it does not object to BAIIDs with a 
removable mouthpiece. (75 FR 61823.)
    This aspect of the proposal generated a large number of comments in 
strong opposition. For example, Consumer Safety Technology (CST) stated 
that it found ``the provision for the prohibition of removal of the 
sensing head to be inexplicable and unjustified.'' (p. 1.) According to 
CST, ``All ignition interlocks have removable handsets. This provision 
would make every interlock noncompliant.'' (p. 1.) Road Safety 
Technologies pointed out that, ``In practice, many interlock providers 
now recommend to their customers that the sensing head be taken inside 
to keep it warm or cool in inclement weather [or] to prevent the 
vehicle from being stolen.'' (p. 1.)
    Guardian asserted that placing a restriction on removable heads 
would be ``design restrictive.'' (p. 2.) Guardian continued, ``There 
should not be any restriction of design imposed by NHTSA. If a BAIID 
can meet . . . and successfully comply with the test requirements, the 
design of the device itself should be left to the manufacturer and the 
marketplace.'' (p. 2.)

[[Page 26852]]

    A number of State comments also opposed the restriction. According 
to Illinois, ``Currently, [it] has seven vendors whose BAIIDs are 
certified by the Secretary of State, all of which use BAIIDs that have 
a removable sensing head . . . The Illinois Secretary of State has 
administered a BAIID program since 1995 and not once during the past 15 
years has the Secretary received any complaints from BAIID users, 
installers or vendors that the BAIID has been damaged or mishandled as 
a result of removal of the sensing head.'' (p. 1) Objections were 
received also from other BAIID manufacturers, the Coalition of Ignition 
Interlock Manufacturers (CIIM), interlock providers, Iowa and Oklahoma. 
Wisconsin did not oppose the restriction, but urged NHTSA to specify 
that the sensing head be removable only by the service provider; not 
the customer.
    NHTSA has reconsidered this aspect of its proposal based on the 
comments. The agency acknowledges that prohibiting removable sensing 
heads may constitute a design (and not a performance) standard and may 
unintentionally stifle new technologies. In addition, it could 
interfere with current State practices. Accordingly, the revised Model 
Specifications do not state a preference with regard to whether BAIIDs 
should have removable sensing heads. However, a provision has been 
added to the General Provisions and Features section of the Model 
Specifications (Section C), providing that if the BAIID has a removable 
sensing head, the vehicle should not start without use of the sensing 
head.
    To ensure performance, BAIIDs should be tested as a unit under 
appropriate tests, as provided in the Model Specifications, including 
Tests 5 and 6, under extreme temperature conditions. If a BAIID 
includes removable components, such components should be tested in 
accordance with the manufacturer's user instructions.
    NHTSA has not adopted the recommendation from Wisconsin to specify 
that only service providers may remove the sensing heads. We believe 
that such a restriction is a programmatic decision and does not relate 
to the performance of BAIID units.
    NHTSA also proposed that BAIID memory should be located in a fixed 
control box. This aspect of the proposal was intended to prevent damage 
to the BAIID memory.
    Draeger agreed with this aspect of the proposal, stating that it 
will ensure data integrity. However, most comments opposed this part of 
the proposal. For example, National Interlock stated, ``Current 
interlock technology stores data in the sampling head, the control box 
or both. Regardless of the memory storage location, the data is 
preserved in memory for download . . . We believe that it is not 
necessary for NHTSA to mandate that the memory storage be in a fixed 
control box.'' (p. 2.) Similar comments were received from Smart Start. 
Guardian added that this proposed restriction would limit ``innovation 
in product development and technological advancement'' (p. 5.) 
andinterfere with current State practices. Comments in opposition were 
received also from Iowa, Colorado, Ignition Interlock Systems of Iowa 
(IISI) and Alcohol Detection Systems (ADS). Oklahoma requested 
clarification of the terms ``memory'', ``fixed'' and ``control box.'' 
(p. 2.)
    NHTSA has carefully considered these comments. The agency wishes to 
ensure the integrity of the data. However, the agency does not wish to 
specify design features or unnecessarily stifle new technologies. It 
also does not wish to interfere with current State practices. 
Accordingly, the revised Model Specifications have been revised to 
remove the specification that the memory be contained in a fixed 
control box. The interlock data logger of each BAIID should be tested, 
wherever it is maintained under the manufacturer's design.
3. Retests
    As stated earlier, ignition interlocks test drivers for alcohol 
before they can start their vehicle's engine. Interlocks also retest 
drivers for alcohol periodically while the engine is running. In the 
2010 notice, the agency stated that ``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.'' (75 Fed. Reg. 61824.)
    Many of the comments objected to this statement. For example, 
LifeSafer asserted, ``All interlock vendors advise the client/user to 
pull off the road in a `safe' place to take the retest. The practical 
reality is 99% of the 500,000-1,000,000 plus retests per day are not 
taken in this fashion, but rather safely delivered while the vehicle is 
in motion with little or minimal driver distraction.'' (p. 3-4.) Some 
of the comments asked NHTSA for evidence demonstrating that drivers are 
at increased risk when taking a retest.
    Colorado asserted that, while requiring that a retest be conducted 
while ``stopped in a safe location . . . may appear to serve public 
safety, current interlock devices are designed to be so unobtrusive 
that they are easier to manipulate [than] a vehicle's sound system, GPS 
or climate control system.'' Moreover, Colorado argued that ``there are 
too many traffic situations that make pulling over less safe, even with 
an extended period within which to deliver the sample'' such as ``long 
mountain tunnels'' or ``other congested environments with tight lanes 
and limited shoulders.'' (p. 2.)
    NHTSA is very concerned about distracted driving and the risks that 
distraction can pose for drivers and other road users. However, the 
agency acknowledges that it currently has little data regarding crashes 
involving drivers taking interlock retests. We will continue to monitor 
the data and respond to any new trends that are identified.
    Draeger pointed out, in its comments, that the manner in which 
retests should be conducted ``is a requirement for the driver and is 
not directly related to the BAIID itself or its design and 
functionality.'' (p. 3.) NHTSA agrees with this assessment. 
Accordingly, while the agency strongly urges drivers to conduct retests 
when and where it is safe to do so, the Model Specifications no longer 
specify how retests should be conducted. This is more appropriately a 
function for States and local jurisdictions. The Model Specifications 
have been revised to remove this reference.
4. Alerts
    In response to the 2006 notice, one commenter suggested that an 
interlock-specific tone (other than a honking horn) be used to alert 
outsiders to BAIID violations. In the 2010 notice, NHTSA responded that 
it does not believe that audible sounds or lights to alert the public 
to interlock violations are necessary. (75 FR 61826.) The agency did 
not include the suggestion in its proposal.
    The comments in response to this aspect of the 2010 notice were 
mixed. Consumer Safety Technology (CST) agreed that ``the honking of 
the vehicle horn is disruptive enough to attract attention to a driver 
in violation of a . . . retest.'' (p. 9.) Smart Start did not take a 
position about the horn, but expressed its belief that ``it . . . 
promotes unsafe driving when lights are flashing on and off to alert 
the public.'' (p. 5.)
    IISI requested the evidence that NHTSA relied on to reach the 
conclusion that audible sounds or lights are not necessary to alert the 
public to interlock violations. According to IISI, ``Our technicians, 
who collectively meet

[[Page 26853]]

with hundreds of IID users every day, would say that the threat of the 
honking horn on a failed or ignored random retest is the single 
greatest deterrent to the IID user's attempting to have another person 
pass a test so the impaired driver can sneak home undetected.'' (p. 1.)
    Similarly, ACS asserted that NHTSA's position ``is contrary to 25 
years of experience with alcohol interlock programs in which audible 
sounds and (to a lesser extent) visual indications are required by 
jurisdictional authorities as both a warning to others and a deterrent 
to the driver to ignore a retest requirement.'' (p. 22.)
    As stated above with regard to retests, NHTSA is concerned about 
distracted driving and believes that certain types of alerts may serve 
as a distraction to drivers. On the other hand, the agency acknowledges 
that alerts may play an important role in creating deterrence for 
drivers in violation of a retest, and in drawing the attention of other 
drivers on the offending motor vehicle.
    More importantly, upon reconsideration, NHTSA has reached the 
conclusion that decisions about the types of alerts that may be 
required and/or permitted are programmatic in nature, and should be at 
the discretion of States and local jurisdictions. Accordingly, the 
Model Specifications do not address the use of alerts. Such decisions 
may vary from State to State, and the options that vendors choose to 
offer ultimately will be dictated through the marketplace.
5. Emergency Override
    Some comments received in response to the 2006 notice stated that 
an emergency override is a useful feature. In the 2010 notice, NHTSA 
declined to propose that BAIIDs must include this feature (i.e., the 
ability to start the vehicle without a breath test) in order to meet 
the Model Specifications. However, should a BAIID be equipped with an 
emergency override feature, NHTSA proposed to test the feature, but 
indicated that it could start the vehicle only once. The 2010 proposal 
provided that whenever the override feature was activated, the BAIID 
must indicate the need for service and record the use of the emergency 
override. No additional emergency overrides should be allowed during 
the lifetime of the BAIID installation. The agency proposed to test 
this feature. NHTSA also proposed that this emergency override feature 
have a default to prevent an override from being used when the BAIID 
malfunctions or fails. (75 FR 61825-26.)
    The comments received in response to this portion of the proposal 
were varied. CST argued that ``emergency overrides should not be 
allowed as they essentially allow a drunk driver one free pass to drive 
drunk.'' (p. 5.) ACS and LifeSafer both agreed that emergency overrides 
should be allowed, but disagreed that an override should be permitted 
only once during the lifetime of the installation. ACS pointed out that 
not all jurisdictions permit the use of an emergency override, but of 
those that do, ``the restriction on use is typically once per 
monitoring period (service interval), rather than once per installation 
(program duration).'' (p. 21.) LifeSafer also disagreed that the 
override feature should not function when the BAIID malfunctions or 
fails. In fact, LifeSafer asserted, ``From a service standpoint, this 
is exactly when an override should be allowed.'' (p. 14.)
    NHTSA believes the decision whether to permit the use of an 
emergency override feature is programmatic in nature and should be left 
to the discretion of States and local jurisdictions. Accordingly, as 
proposed, the Model Specifications do not address whether BAIIDs should 
be equipped with an emergency override feature. The Model 
Specifications have been modified to remove specifications related to 
emergency overrides and they remove the proposed override test.
6. Calibration Stability and Service Interval
    In the 2006 notice, NHTSA asked, ``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?'' (71 FR 8048.)
    In the agency's 2010 notice, in response to comments received, 
NHTSA explained that, ``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.'' 
(75 FR 61824.)
    NHTSA proposed 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.'' NHTSA 
explained that, ``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) . . .'' (75 FR 61824.)
    NHTSA also proposed in the 2010 notice to add service interval 
requirements of ``not greater than 30 days, plus a 7-day lockout 
countdown.'' (75 FR 61824.)
    More than half of the comments addressed this issue. All of the 
comments objected to this aspect of the agency's proposal. Iowa 
described it as ``a step backwards'' (p. 1); Wisconsin said it is 
``overly restrictive'' (p. 2); CST called it ``an inexplicable 
regression in standards that will result in increased costs to the 
participant and consequently result in a marked reduction in 
participation in state interlock programs.'' (p. 3.)
    CIIM explained that ``This is an area where technology has 
significantly improved since the last time NHTSA asked for comments. 
Most devices can go 2 or 3 months without needing to have its 
calibration checked.'' (p. 2.) Accordingly, CIIM suggested a longer 
calibration period. ACS sought to clarify that calibration stability 
and service intervals are not the same. ``Calibration stability is a 
performance criterion of the BAIID to be included in Model 
Specifications; whereas, service interval is programmable as a function 
of the performance of a participant and is a program matter.'' (p. 13.) 
In addition, National Interlock pointed out that, ``The proposed [Model 
Specifications] would appear to prohibit specialized programming of the 
BAIID device or software to meet the specific requirements of 
jurisdictions.'' (p. 2.)
    NHTSA agrees with the comments that current technology now permits 
ignition interlocks to maintain stable calibration for longer periods 
of time. The Model Specifications continue to provide for a minimum 
calibration stability period of 37 days (30 days plus the 7-day lockout 
countdown) and for BAIIDs to be tested (under Test 3) to determine 
conformance with this period. This minimum calibration period should 
provide some consistency and the 30-day period would allow results of 
this test to be available quickly. In addition, in recognition of 
recent technological advances and current practice in the field, the 
Model Specifications provide manufacturers with the opportunity to 
demonstrate that their BAIIDs can maintain their calibration stability 
for longer periods of time, by providing for testing of BAIIDs also at 
60 days, 90 days and 180 days, plus 7 days.
    As suggested in the comments, NHTSA agrees that it is appropriate 
to decouple the period of calibration stability and the service 
interval. States and local jurisdictions make decisions about service 
intervals based on a

[[Page 26854]]

number of different factors, including the need to supervise some 
offenders more closely or the desirability of providing an incentive 
(and permitting a longer service interval) for offenders who have 
demonstrated compliance with their sentence. In addition, NHTSA 
recognizes that BAIIDs can be programmed to vary the service interval, 
based on the circumstances in each case. Accordingly, the Model 
Specifications do not provide for a specific service interval period. 
Rather, the agency defers to States and local jurisdictions to 
determine the service intervals they believe are appropriate.
    However, in one important respect, these two periods are very much 
related. States and local jurisdictions are reminded that, if they 
choose to use service intervals that are longer than 37 days, the 
BAIIDs they select should be capable of maintaining a stable 
calibration for the requisite period of time.
    Smart Start suggested that a maximum number of violation points 
should be defined and allowed, and recommended 5. (p. 4.) NHTSA 
believes that, like the service interval, this is a programmatic issue 
and should be set by States and local jurisdictions. Accordingly, the 
Model Specifications have not been modified to specify a maximum number 
of violation points.

C. Technical Issues Relating to Particular Sections of the Model 
Specifications

1. Terms Used in Model Specifications (Section B)
    The 2010 notice contained proposed definitions for 14 terms. ACS 
took issue with the proposed definition for the term, ``Service 
interval'', which the notice proposed to define as ``The maximum time 
period that a BAIID may be used without maintenance or data download, 
after which the ignition must lock.'' ACS pointed out that, ``Service 
interval is not a device performance criteria; it is a program 
guideline, which is the time period during which the participant may 
drive between monitoring appointments, based upon the jurisdiction 
restrictions and the compliance of the participant with program 
conditions.'' (p. 26.) NHTSA agrees with this point and has changed the 
definition of this term accordingly.
    Oklahoma suggested that the word ``pertinent'' should be removed 
from the proposed definition of ``Interlock Data Logger--A device 
within a BAIID that records all pertinent events, dates and times 
during the period of installation and use of a BAIID.'' NHTSA has made 
this modification, as well, to avoid limiting the information that is 
recorded on the interlock data logger.
    Other comments supported the proposed definitions.
2. General Provisions and Features of BAIIDs (Section C)
    The 2010 notice proposed that BAIIDs must meet certain requirements 
in order to conform to the Model Specifications, including:
     Pass conformance tests 1 through 16
     Not compromise normal functions of the vehicle
     Not have a removable sensing head
     Contain memory in a fixed control box
     Have tamper proof seals
     Capable of locking out a specified BrAC at a set point of 
.02 g/dL with a minimum flow rate of 0.1 L/sec
     Bypass or disable a remote start device, if installed on a 
vehicle
     Clear instructions to the driver
     An interlock data logger that will record all start 
attempts and outcomes
     Track all changes to the metrological software
    In addition, the notice proposed that manufacturers of BAIIDs must 
submit:
     The operator's manual and other documentation
     The quality assurance plan (QAP)
     A self-certification that the manufacturer meets the 
requirements of the U.S. Department of Health and Human Services, 
Public Health Service, Food and Drug Administration (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).
    As discussed in detail previously, the agency received many 
comments concerning the removable sensing head and the fixed control 
box, and modifications have been made to the Model Specifications in 
response to these comments.
    The comments concurred with most of the other requirements and 
features. However, comments were raised regarding some of these 
provisions.
    a. Ignition, Ignition Switch and Locking--Oklahoma (p. 1) and ACS 
(e.g., p. 28-30) pointed out that the 2010 notice included some 
incorrect references to ``ignition'', ``ignition switch'' and 
``locking'' of the ignition. These references have been corrected.
    b. Set point of 0.02 g/dL and minimum flow rate of 0.1 L/sec--In 
the 2006 notice, NHTSA asked whether the current set point of 0.025 
grams of alcohol per 210 Liters of air (g/dL) is appropriate or whether 
it should be changed. (71 FR 8047.) The comments received in response 
to the 2006 notice were varied, including that the 0.025 g/dL level 
should not be changed, that the set point should be more stringent and 
that the agency should establish a set point of 0.025 g/dL for adults 
and 0.02 g/dL for minors.
    In response to these comments, in the 2010 notice, NHTSA proposed 
lowering the set point from 0.025 g/dL to 0.02 g/dL. (75 Fed. Reg. 
61822.) Comments received in response to this aspect of the 2010 
proposal were mixed again. For example, AAMVA questioned the need to 
lower the set point and suggested that a lower level could lead to 
unwarranted lockouts. (p. 2.) IISI asked whether this change was being 
proposed for the purpose of enforcing ``abstinence from alcohol 
consumption'' as opposed to ensuring ``highway safety.'' (p. 3.) Some 
comments, including those from Smart Start and Wisconsin, expressed 
support for the proposed change. LifeSafer supported the change and 
suggested that BAIIDs should be required to provide and record a 
``warn'' when they register at 0.01 g/dL and above. (p. 5.)
    The 2010 notice proposed a minimum flow rate of 0.1 Liters per 
second (L/sec). (75 FR 61823.) ACS suggested it should be set no lower 
than 0.2 L/sec. (p. 9.)
    The agency is not attempting to influence program purposes, but 
rather is seeking simply to define the Model Specifications to test the 
precision and accuracy of BAIID devices. We recognize that State BrAC 
levels are not uniform. Most are set at 0.02 g/dL, but others are set 
at other (generally higher) levels. NHTSA continues to believe that 
0.02 g/dL is an appropriate set point to use for the testing of BAIIDs 
under these Model Specifications. This set point will ensure accuracy 
for the States, whether they are using 0.02 g/dL or a higher level. 
That choice is still each State's to make.
    In addition, the change from 0.25 g/dL to 0.20 g/dL will align the 
BAIID Model Specifications with NHTSA's other Model Specifications, 
which pertain to evidential breath testing instruments (EBTs), 
calibrating units and alcohol screening devices. Moreover, NHTSA 
continues to believe that the technology is available for BAIIDs to 
achieve and maintain a set point at this level. Accordingly, this 
portion of the proposed revision is adopted without change. The 
recommendation to require a ``warning'' at the 0.01 g/dL level has not 
been adopted, since practices vary from State to State.
    NHTSA agrees with ACS's comment regarding the flow rate. In fact, 
the 0.1

[[Page 26855]]

minimum flow rate included in the General Conditions and Features 
section of the notice was an unintentional error on the agency's part. 
The General Test Conditions section of the 2010 notice stated that 
unless specified otherwise in a particular conformance test, each test 
would use an ambient flow rate of 0.3 L/sec. Consistent with this 
provision, the General Conditions and Features section should have 
indicated that BAIIDs be tested with a flow rate of 0.3 L/sec. The 
Model Specifications have been modified accordingly.
    In accordance with the revised Model Specifications, BAIIDs should 
record and maintain a record of all breath samples provided.
    c. Federal Drug Administration (FDA) Requirements--In the 2010 
notice, in response to comments received regarding the 2006 notice, 
NHTSA proposed that manufacturers must submit a self-certification that 
the manufacturer meets the requirements of the FDA Good Manufacturing 
Practices (GMP) 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).
    Some comments supported this aspect of the proposal. CST said that 
holding interlock providers to this ``more rigorous'' standard was 
``positive.'' (p. 3.) ACS agreed, in principle, with requiring that 
interlock manufacturers comply with FDA's GMP requirements, but asked 
how the requirement will be enforced? ACS did not believe a self-
certification process would be adequate. (p. 24.)
    However, most comments strongly objected to these requirements. The 
comments from National Interlock were representative. They stated, 
``The BAIID is not a medical device and is not intended to be used for 
medical purposes. The application of these regulations will place 
tremendous cost and burden on the manufacturers of BAIIDs, with the 
possibility of raising costs of programs beyond what is reasonable for 
a driver to pay. This could result in a higher incidence of individuals 
driving without a license, and without a BAIID, which would be contrary 
to federal and state policy to increase the use of BAIIDs as an alcohol 
countermeasure.'' (p. 2.) Draeger added, ``Breath alcohol test systems 
intended solely for forensic (law enforcement) purposes are currently 
exempt from . . . premarket notification and other FDA requirements. . 
. . BAIID devices intended for use by law enforcement are therefore 
exempted by the FDA from GMP compliance. . . . We recommend that NHTSA 
defer to the FDA's judgment and guidance on this matter. . . .'' (p. 
4.)
    It is NHTSA's understanding that the FDA Good Manufacturing 
Practices (GMP) regulations (21 CFR Part 820) apply to devices used for 
medical purposes. While the FDA has applied these regulations to some 
alcohol devices, such as screeners that are used for medical purposes, 
the FDA has not exercised jurisdiction over instruments used for other 
purposes, such as Evidential Breath Testing Instruments (EBTs), which 
are used for law enforcement purposes. Similarly, it is our 
understanding that, to date, the FDA has not exercised jurisdiction 
over BAIIDs. In addition, NHTSA has not, at this time, reached a 
decision about whether it will develop a CPL. Accordingly, 
manufacturers of BAIIDs must comply with any applicable FDA 
requirements, but NHTSA has removed the reference in the Model 
Specifications to submission of a self-certification of compliance with 
the FDA regulations.
    Smart Start (p. 6) and Guardian (p. 5) suggested that, if quality 
assurance requirements are to be imposed, NHTSA should consider using 
ISO standards instead of the FDA requirements. While manufacturers may 
adopt the ISO standards if they wish to do so, the agency does not 
believe there is sufficient justification to add this as a condition in 
the Model Specification for all manufacturers of BAIIDs.
3. BAIID Test Procedures (Section D)
    The 2010 notice proposed to include 17 separate tests in the Model 
Specifications. It also proposed a number of general test conditions, 
pertaining to the number of trials, ambient temperature, ambient 
atmospheric pressure, sample parameters and simulated breath samples. 
In addition, the notice proposed a number of performance requirements 
relating to tests at 0.000 g/dL, 0.008 g/dL and 0.032 g/dL. The notice 
also proposed that a BAIID must be ready for use one minute after it is 
turned on and it must be ready for a second test within one minute of a 
preceding test.
a. General Test Conditions and Performance Requirements
    The 2010 notice proposed that unless specified otherwise under a 
particular conformance test, BAIIDs must meet a number of performance 
conditions under all tests conducted.
i. Breath Sample Volume and Flow Rate
    In the 2006 notice, NHTSA indicated that the 1992 Model 
Specifications set the minimum breath sampling size at 1.5 liters and 
asked whether NHTSA should consider lowering the minimum breath 
sampling size requirement. (71 FR 8047-48.) Most comments received in 
response to that notice advocated lowering the minimum sampling size to 
either 1.2 L or 1.0 L. In the 2010 notice, in response to these 
comments, NHTSA proposed lowering the minimum sampling size from 1.5 L 
to 1.2 L. Unless specified otherwise in the particular conformance 
test, BAIIDs should be tested at a volume of 1.2 liters and an ambient 
flow rate of 0.3L/sec. (75 FR 61822, 61828.) Breath sample volume 
relates to how much a person blows into a BAIID. Flow rate is the 
intensity of the blow.
    The comments received in response to the 2010 notice were mixed. 
CST questioned the wisdom of lowering the minimum breath sampling size 
to 1.2 L, claiming that it could reduce the quality of the breath 
sample. (p. 3.) Wisconsin expressed a preference for retaining the size 
at 1.5 L (p. 2), as did Draeger, with allowances for reductions to 1.2 
L upon medical recommendation (p. 4). On the other hand, Smart Start, 
ACS and LifeSafer all supported the reduction. Smart Start expressed 
the belief that this change would permit more individuals to 
participate in interlock programs. (p. 2.) ACS recommended that minimum 
back pressure also be included. (p. 8.)
    NHTSA agrees that lowering the minimum breath sampling size will 
make the BAIID available to a larger population of users, including 
individuals with smaller or diminished lung capacity. No evidence was 
submitted to indicate that the reduced volume will diminish the 
integrity of breath samples. Accordingly, this element of the Model 
Specifications is adopted without change. If a State wishes to set its 
minimum breath sampling size at 1.5 L and permit a 1.2 L level upon a 
medical recommendation, the Model Specifications will be able to 
support them in that decision. The ambient flow rate will remain at 0.3 
L/sec. The agency believes that the other criteria included in the 
Model Specifications, provide sufficient safeguards against 
circumvention, without the need to address back pressure as well. 
Accordingly, a back pressure test has not been added.
ii. Precision
    The 2010 notice stated that BAIIDs must experience no ignition 
locks in 20

[[Page 26856]]

trials at 0.000 g/dL (grams of alcohol/210 liters of air); not more 
than one ignition lock in 20 trials at 0.008 g/dL; and not more than 
one ignition unlock in 20 trials at 0.032 g/dL. (75 Fed. Reg. 61828.) 
These performance requirements represented an increase from 90 percent 
to 95 percent compliance at the 0.008 and 0.032 levels and 100 percent 
at 0.000.
    Oklahoma suggested that no ignition ``locks'' should be permitted 
in 20 trials at both the 0.000 and 0.008 levels and no ignition 
``unlocks'' should be permitted in 20 trials at the 0.032 level. (p. 
3.) Wisconsin also recommended 100% conformance at all levels. (p. 2.) 
Smart Start asserted that the difference between 100% and 95% ``does 
not matter.'' Some changes in accuracy and precision ``potentially 
[add] costs to the BAIID and [have] no real world added benefit.'' (p. 
1.) No other comments addressed this issue. In these revised Model 
Specifications, NHTSA has sought to strike a balance between the 
capabilities of the latest technology, the variability among various 
products currently on the market, as well as costs and other factors. 
Accordingly, as proposed in the 2010 notice, the performance 
requirements have been increased in these revised Model Specifications 
at the 0.000 level, by providing that the vehicle must not be prevented 
from starting even once during 20 trials. However, the Model 
Specifications do not require 100 percent compliance at all levels. 
They provide that the vehicle must not be prevented from starting more 
than once during 20 trials at the 0.008 level and must not start more 
than once during 20 trials at the 0.032 level. (See Section D of the 
Model Specifications, Performance Requirements.)
iii. Terminology
    ACS and Oklahoma noted that the terms ``locked'' and ``unlocked'', 
while easily understood, are technically inaccurate. They suggest that 
they be replaced. The agency has made adjustments in these revised 
Model Specifications to avoid use of these terms, such as by describing 
whether or not the vehicle will start, instead of using the terms 
``locked'' and ``unlocked''.
iv. Readiness
    The 1992 model specifications provided for a wait time of up to 5 
minutes for a driver to take a breath test. A common complaint by users 
of BAIIDs was the long wait times for breath tests by BAIID users. 
Comments to the 2006 notice indicated that, with improved technology, 
faster ready-to-use times were achievable, even in extreme low 
temperatures because BAIIDs now have quick start capabilities.
    The 2010 notice proposed that, unless specified otherwise in a 
particular test, BAIIDs must be ready for use within one minute after 
they are turned on and ready for a second test within one minute of a 
preceding test. (75 Fed. Reg. 61824.) A number of comments expressed 
concern that the proposed change was too extreme. ACS pointed out that, 
if the BrAC is at or above the set point, the BAIID will enter into a 
lock out period of 3-5 minutes. ACS stated, ``The examiner must request 
special parameter settings if a one minute retest period is required.'' 
(p. 29.) LifeSafer made a similar comment, suggesting that 90 seconds 
should be allowed ``to completely purge the prior alcohol-laden 
sample.'' (p. 15.) NHTSA has decided to adopt a compromise readiness 
time period of 3 minutes as the performance level in the Model 
Specifications, which the agency believes is appropriate and 
achievable, based on current practices and the current state of 
technology. NHTSA has revised the Performance Requirements in Section D 
of the Model Specifications to provide for this change.
    No other comments were received objecting to the General Test 
Conditions or Performance Requirements.
b. Conformance Tests
    The 2010 notice proposed 17 separate conformance tests regarding 
the performance of BAIIDs. Some of the tests were supported by the 
comments. Questions, objections and suggestions were raised regarding 
others. Each test, the comments that it generated and the agency's 
responses are discussed in detail below.
Test 1--Precision and Accuracy
    As explained in the 2010 notice, ``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 prevent the vehicle from starting. ``Precision'' is the degree to 
which that same measure can be repeated. In the previous example, for 
the BAIID to be precise, that same alcohol free breath sample should 
not prevent the vehicle from starting consistently over time. (75 FR 
61822.)
    In the 2010 notice, NHTSA proposed testing BAIIDs at 0.012 g/dL above and below the set point of 0.02 g/dL, i.e., at 
0.032 g/dL and 0.008 g/dL. (75 Fed. Reg. 61822.) Wisconsin suggested 
that testing should be carried out at 25 percent so that 
tests would be conducted at 0.015 g/dL rather than 0.008 g/dL and 0.025 
g/dL rather than .032 g/dL. (p. 2.) All other comments either supported 
or did not object to the proposed levels. As explained in the 2010 
notice, NHTSA arrived at these proposed levels by using standard 
statistical techniques for small samples. (75 Fed. Reg. 61822.) The 
0.012 interval corresponds to a 2 sigma requirement for 
compliance. The levels proposed in the 2010 notice are adopted without 
change.
    ACS suggested that the BAIID should record the measured BrAC value 
from the data log to conduct statistical analysis. (p. 29.) Draeger 
proposed adding a result requirement to each test point. (p. 4.) The 
Model Specifications do not require a numerical readout. They require 
only that the BAIID functions properly at each appropriate BrAC, by 
preventing or permitting a vehicle to start, as appropriate. BAIID 
manufacturers may offer a feature that provides a numerical readout, if 
they choose to do so. However, the Model Specifications do not specify 
that such a feature be offered and do not specify a test for that 
particular function.
Test 2--Breath Sample Volume and Flow Rate
    As described above, the General Test Conditions provide that, 
unless specified otherwise in a particular conformance test, all tests 
will be conducted using a volume of 1.2 liters and a flow rate of 0.3 
L/sec. The purpose of Test 2 is to evaluate the performance of BAIIDs 
under different breath sample volumes and flow rates. Tests 2a and 2b 
are designed to test the amount (volume) of air blown into the BAIID, 
using a smaller and a larger sample volume (1.0 and 1.5 liters, 
respectively). Tests 2c and 2d are designed to test the intensity (flow 
rate) of the blow, using a slower and a faster flow rate (0.1 and 0.7 
L/sec, respectively).
    The 2010 notice proposed that BAIIDs should prevent a vehicle from 
starting when the sample volume is 1.0 liters and permit the vehicle to 
start with a sample volume of 1.5 liters. (75 FR 61828.) These elements 
of Tests 2a and 2b are adopted without change.
    The 2010 notice proposed that BAIIDs should permit the vehicle to 
start using both flow rates. (75 FR 61828.) As mentioned earlier in 
this notice in Section II.C.2.b., ACS commented that the flow rate 
should be set no lower than 0.2 L/sec (p. 9), and the agency agrees. 
Consistent with this change, the Model Specifications are revised to 
provide that BAIIDs should prevent a vehicle from starting when the 
flow rate is 0.1 L/sec and it should permit the

[[Page 26857]]

vehicle to start with a flow rate of 0.7 L/sec.
Test 3--Calibration Stability
    These issues are discussed fully in Section II.B.6. above. In 
response to comments received, the Model Specifications continue to 
provide for a minimum calibration stability period of 37 days (30 days 
plus the 7-day lockout countdown) and BAIIDs should be tested (under 
Test 3) to determine conformance with this period. In addition, the 
Model Specifications provide manufacturers with the opportunity to 
demonstrate that their BAIIDs can maintain their calibration stability 
for longer periods of time, by providing for testing of BAIIDs also at 
60 days, 90 days and 180 days, plus 7 days.
Test 4--Input Power
    No comments were received regarding this proposed test. It is 
adopted without change.
Tests 5 and 6--Extreme Temperature and Humidity and Warm Up Time at -40 
[deg]C
    The 1992 Model Specifications called for testing at -40 [deg]C, -20 
[deg]C, +70 [deg]C and +85 [deg]C, but allowed 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. In its 2006 notice, NHTSA asked whether this approach to 
extreme temperature testing seemed sufficient or whether it should be 
more stringent. (71 Fed. Reg. 8048.)
    The agency received a variety of comments in response to the 2006 
notice and, in 2010, proposed to retain the current extreme temperature 
tests at -40 [deg]C and +85 [deg]C, believing it to be reasonably 
representative of the environments encountered in the United States. In 
addition, NHTSA proposed to conduct additional high temperature tests 
for components of the BAIID installed in the passenger compartment (at 
+49 [deg]C) and in the engine compartment (at +85 [deg]C), and to 
specify the humidity level for these high temperature tests. The agency 
proposed to discontinue the tests at -20 [deg]C and +70 [deg]C, because 
the agency's experience indicated that testing at the extreme 
temperatures is sufficient. (75 FR 61823.)
    NHTSA also proposed a warm up test in the 2010 notice to ensure 
that BAIIDs are ready to test and ready for retest within 3 minutes 
under extreme temperature conditions, at -40 [deg]C. (75 FR 61824.)
    Draeger suggested that a warm-up time of up to 3 minutes at 9V and 
-40 [deg]C is overly severe, and proposed that the test be changed to 
require a warm-up time of up to 3 minutes at 9V and -20 [deg]C, but 
most comments supported the range that NHTSA proposed in the notice. 
(p. 5.)
    Wisconsin applauded NHTSA's proposed adoption of tests at extreme 
temperatures, stating that ``this will more effectively simulate BAIID 
operation in cold-weather climates. (p. 2.) ACS agreed that the 
proposed extreme temperature testing at -40 [deg]C and +85 [deg]C 
should adequately address the needs of the environmental tests for the 
U.S. ACS disagreed that the -20 [deg]C and +70 [deg]C tests should be 
discontinued, asserting that these temperatures provide different 
stress levels on devices and that Tests 5 and 6 should be conducted 
under all of these conditions, and at +22 [deg]C, as well. (p. 9, 31.) 
Smart Start also suggested that the intermediate temperature tests 
should be retained. (p. 2.) LifeSafer urged the agency to harmonize the 
extreme temperature tests with the CENELEC (the European standard), at 
least on the high-side. (p. 7-8.)
    NHTSA notes that the purpose of Tests 5 and 6 is to determine the 
BAIIDs' ability to perform at extreme temperatures and humidity. The 
temperatures that NHTSA included in the proposed Model Specifications 
are adopted without change, since they accurately represent extreme 
temperatures experienced in the United States. Other tests contained in 
the Model Specifications, including Tests 1-4 and others, should be 
performed at ambient temperatures. Accordingly, the agency believes 
intermediate temperatures need not be included under Tests 5 and 6.
    Wisconsin recommended that the procedures used when testing at 
extreme temperatures must ensure that measurements are taken when the 
device is at the prescribed temperature and humidity and has not been 
allowed to vary. (p. 3.) NHTSA agrees with this comment. Steps should 
be taken during testing to prevent temperature and humidity drift, such 
as by testing BAIID devices in a temperature chamber.
    A number of comments objected specifically to the proposed 
requirements regarding readiness for retest at various temperatures. 
ACS asserted that the requirements are overly simplistic, requiring 
that BAIIDs are ready for retest within three minutes at -40 [deg]C, 
and one minute at -39 [deg]C. (p. 15.) Smart Start recommended that 
NHTSA consider adopting the CENELEC standard regarding this 
requirement, which provides that devices are to be tested at an ambient 
temperature of -40 [deg]C and +85 [deg]C with no time limit; at -20 
[deg]C within 3 minutes and at -5 [deg]C within 90 seconds. (p. 4.)
    Similarly, LifeSafer sought clarification regarding the readiness 
requirements for this test and others, noting that the various tests 
seem to require that devices need to be ready for retest within one 
minute, three minutes, five minutes or other periods of time. According 
to LifeSafer, retest sequences are typically 5-6 minutes before a 
Refused Violation is recorded. Imposing a 90 second wait between tests 
will allow a user three attempts to pass the retest. LifeSafer 
suggested that after a fail, a 90 second (versus a 60 second) interval 
between test attempts will produce a more precise result and is a 
reasonable period to require the user to wait after failing a test. (p. 
11-12.)
    NHTSA acknowledges that the variety of different wait times 
contained in the Model Specifications could cause confusion and has 
decided they are not warranted. Upon further review, the agency finds 
that it is preferable to establish more consistency in the readiness 
requirements and believes the objectives of each test can be achieved 
with a wait time of 3 minutes. Accordingly, NHTSA has revised the Model 
Specifications to provide that BAIIDs must be ready for all tests and 
retests within a period of 3 minutes. This change represents an 
improvement over the 1992 Model Specifications, is not as restrictive 
as the 2010 proposal and is consistent with (though not identical to) 
the European standard. See also the discussion above in Section 
II.C.3.a. of this notice.
    Some comments addressed the voltage levels. Lifesafer, for example, 
expressed concern that the 9v level would be too low at -40 [deg]C. (p. 
15.) On the other hand, ACS agreed with the agency's proposal, stating 
that ``this emulates a real world circumstance in a vehicle during 
winter months and with less than optimal batteries.'' (p. 10.) This was 
the agency's intention. NHTSA wanted to simulate less than optimal 
conditions, which commonly occur in winter. This aspect of the proposal 
is adopted without change.
    Comments were received also concerning NHTSA's statements in the 
proposal prohibiting use of a removable sensing head. These comments 
are discussed in detail in Section II.B.2. above. As explained above, 
the revised Model Specifications do not prohibit the use of removable 
heads and provide allowances for these components under

[[Page 26858]]

extreme temperatures, consistent with manufacturer instructions to 
users.
Test 7--Vibration
    The agency received no objections to the proposed vibration test, 
although ACS noted that, ``Instead of interpreting the requirements of 
the vibration test,'' NHTSA could consider simply referring to ``SAE 
standards for automobile electronic components.'' (p. 32.) This 
proposed test is adopted without change.
Test 8--Retest
    Under Test 8, NHTSA proposed a series of tests to simulate the 
BAIID functions that must operate in connection with retests once the 
vehicle has been started, including an indication to the driver that a 
retest must be taken, and an indication that a service call is required 
when tested with a BrAC of 0.032.
    In the 2010 notice, the agency stated that it ``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.'' (75 FR 61824.) This issue is discussed fully in 
Section II.B.3. above. In response to comments received, the preamble 
to this notice no longer specifies how retests should be conducted. The 
Model Specifications also are revised to remove this reference. They 
otherwise are not changed.
Test 9--Tampering and Circumvention
    In the 2006 notice, NHTSA stated that the 1992 Model Specifications 
offer a number of procedures for evaluating whether existing devices 
can be easily circumvented and it asked whether these procedures are 
sufficient or whether new or modified procedures should be added. (71 
FR 8048.)
    The comments to this notice criticized the Model Specifications for 
being confusing and lacking specificity. The comments offered a variety 
of specific suggestions. In the 2010 notice, NHTSA acknowledged that 
the circumvention requirements in the Model Specifications were 
confusing and proposed to clarify them and specify that BAIIDs must 
have tamper proof seals to indicate when a BAIID has been disconnected 
from the ignition. (75 FR 61823.) The 2010 proposal also included tests 
for ``hot wiring'', push start, un-warmed air sample, warmed air 
sample, cooled 0.032 BrAC sample and filtered 0.032 BrAC sample. The 
proposal indicated that each attempt must be noted on the interlock 
data logger. (75 FR 61829.) A sample format for downloaded data from an 
interlock data logger was included in Appendix D to the 2010 notice. 
(75 FR 61832-33.)
    Smart Start supported the proposed tests, and emphasized the 
importance of anti-circumvention and anti-tampering techniques, 
stating, ``There is a general mistrust in public perception that anyone 
can test on an interlock, thereby allowing the non sober driver to 
start their interlock equipped vehicle. NHTSA should take the lead in 
setting standards that negate this negative perception and instill 
public confidence in this technology that can separate drinking from 
driving.'' (p. 3.)
    However, Smart Start also suggested that the Model Specifications 
could go further. Other comments strongly agreed. Wisconsin stated, 
``Inclusion of tamper proof seals and routine monitoring for tampering 
during BAIID service does not go far enough to ensure that ignition 
interlock devices have sufficient features to prevent circumvention and 
the subsequent driving by impaired individuals. The proposed model 
specifications should require anti-circumvention measures in addition 
to electronically logging these events. These measures could include 
use of breath signature, humidity, differing blow patterns, 
photography, pressure, temperature or time to prevent BAIID 
circumvention.'' (p. 4.)
    The comments seem to support tests (a) and (b) (hot wiring and push 
start), but they criticized the other four tests. CST explained that 
these four tests ``are based upon circumventions that plagued interlock 
programs in the early years of [such programs]. To even conduct these 
tests you would need an interlock with a very rare setting, the setting 
that allows the breath sample to be given in a long continuous blow.'' 
(p. 4.)
    Intoximeters asserted that tests (c)-(f) are intended to test the 
instruments' ability to prevent tampering and circumvention, ``but in 
fact do not do so.'' According to Intoximeters, ``Many BAIID devices 
are using a hum and blow or blow and hum method to determine if a 
person is providing the sample.'' (p. 1.) LifeSafer mentioned also 
other techniques, including the flow and suck back. (p. 9.) 
Intoximeters asserted, ``It is disingenuous to show that an instrument 
is meeting these tests, when in fact the common anti-circumvention 
techniques are not being tested at all.'' (p. 1.) CST indicated that 
thirty eight states are already using these anti-circumvention breath 
sample patterns. (p. 4-5.) Intoximeter suggested that these anti-
circumvention methods should be reviewed and tests should be 
established to determine if they can be beaten. (p. 1.)
    Regarding Test 9b (push start), Draeger asserted that depending on 
the chosen technology, it may take up to 2 minutes until the movement 
or motor run is detected. Accordingly, Draeger suggested that the Model 
Specifications should be revised to provide that the vehicle be driven 
for at least two minutes. (p. 5.)
    NHTSA has decided to continue to include the hot wiring and push 
start tests (9a and 9b) in the Model Specifications. To ensure that the 
results are properly recorded under the push start test, the Model 
Specifications specify that the vehicle should be run under this test 
for at least two minutes.
    NHTSA recognizes that increasingly, interlock companies are 
introducing new, more sophisticated anti-circumvention features into 
their products, designed to ensure that the driver is blowing into the 
BAIID and to prevent circumvention. Manufacturers are employing a 
variety of anti-circumvention methods, including blow and hum, hum and 
blow, and suck and blow patterns, as well as the use of cameras. NHTSA 
appreciates that these methods might make some of the tests proposed in 
the 2010 notice (9c-f) appear to be unnecessary or obsolete.
    However, the revised Model Specifications do not specify the use of 
any particular type of anti-circumvention feature, since that would be 
tantamount to a design, rather than a performance, standard. In 
addition, since the technology associated with these features is still 
evolving and continuing to change rapidly, NHTSA will not attempt to 
establish further minimum performance criteria for this function at 
this time. Accordingly, at the present time, NHTSA will continue to 
include Tests 9c-f in the revised Model Specifications.
Test 10--Restart of Stalled Motor Vehicle
    Comments received in response to the 2006 notice 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. In the 2010 notice, NHTSA proposed 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 proposed that in all other situations where the 
vehicle malfunctions, the vehicle should be prevented from starting 
without a breath test. (75 FR 61825.)
    The agency received a number of comments in response to this aspect 
of the proposal, all of which were in

[[Page 26859]]

opposition. The comments uniformly argued that a period of 20 seconds 
is too short and could create unnecessary safety risks, particularly if 
a vehicle stalls in a hazardous area. Draeger pointed out that panic 
often occurs in a critical stall situation. (p. 5.) IISI asked whether 
NHTSA had received any reports that warranted a reduction in the ``3 
minute time period * * * by nearly 90% to 20 seconds.'' (p. 3.)
    NHTSA acknowledges that stalls can take place in locations, such as 
on railroad tracks or in heavy traffic, which could present serious 
hazards should a driver be unable to restart the vehicle. While the 
comments suggested a variety of counter-proposals, ranging from 1-3 
minutes, NHTSA notes that no comments, in response to either the 
agency's 2006 notice or its 2010 notice objected to the 3 minute time 
period contained in the 1992 Model Specifications. Accordingly, the 
agency has decided to retain the time period of 3 minutes.
Test 11--High Altitude
    The 2010 notice proposed the addition of a high altitude test and 
proposed that it would apply only to BAIIDs using semiconductor alcohol 
sensors, based on a belief that high altitudes affect these types of 
sensors. (75 FR 61826, 61829.) Some comments objected to this unequal 
treatment. ACS did not object to inclusion of this test, but 
recommended that it be applied to all alcohol interlocks submitted for 
conformance testing. (p. 34.) CST asserted that this high altitude test 
is warranted also for fuel cell devices, but urged that ``semiconductor 
technology should be outlawed'' altogether. (p. 5.)
    As explained earlier in this notice in Section II.B.1., the agency 
will not specify particular types of technology that should or should 
not be used. Instead, the Model Specification specify performance 
criteria to be met. To ensure consistent treatment of all instruments 
and to anticipate the possibility of other instruments that might be 
introduced into the marketplace, all BAIIDs should be tested under 
these high altitude conditions.
Test 12--Cigarette Smoke
    This proposed test would require a person who is alcohol-free to 
smoke approximately \1/2\ of a cigarette, and wait one minute or a 
period specified by the BAIID manufacturer before testing. The proposal 
indicated that a simulator may be used in lieu of a smoker. (75 FR 
61829.) ACS objected to this proposed test, stating ``This is not a 
performance test equally applied to all BAIIDs if the manufacturer can 
specify how long to wait after the person smokes the cigarette.'' ACS 
suggested instead that the test should specify, for example, that 30 
seconds be applied equally to all BAIIDs. (p. 34.) NHTSA disagrees. 
Like some other elements of these Model Specifications, some 
conformance tests should be conducted in accordance with the 
manufacturer's user instructions. If a manufacturer instructs users 
that they must wait 10 minutes after smoking a cigarette before they 
may use the BAIID, Test 12 should be conducted in accordance with those 
instructions. We note, however, that a BAIID that imposes this sort of 
limitation on the user may experience disadvantages in the marketplace. 
This aspect of Test 12 has been clarified, by specifying that the test 
should be conducted in accordance with the manufacturer's user 
instructions.
    ACS also asked about the possible use of a simulator to conduct 
this test. Specifically, ACS asked how the test would simulate a person 
who smokes \1/2\ a cigarette and then wait a fixed period of time. (p. 
34.) NHTSA no longer believes that a simulator needs to be used for the 
cigarette smoke test. Accordingly, reference to a simulator in this 
portion of the Model Specifications has been deleted. No other comments 
objected to this proposed test. It is otherwise adopted without change.
Test 13--Acetone
    The 2010 notice proposed adding an acetone test, based on NHTSA's 
belief that it is the most common interfering substance for BAIIDs. (75 
FR 61826.) No comments objected to the inclusion of this test, although 
CST noted that ``the concentration being used for the test is higher 
than would be experienced by a diabetic about to go into a diabetic 
coma, and thus . . . does not really reflect real world conditions.'' 
(p. 5.) Wisconsin noted that alcohol-specific sensors, such as fuel 
cells, will have no difficulty passing this test, since substances 
other than alcohol will have no effect. However, Wisconsin urged that 
units that are not specific to alcohol, such as semi-conductors, 
``should be rigorously tested for the impact of interferences such as 
acetone and other volatile organic compounds.'' (p. 5.)
    This test has been adopted with a lower concentration of acetone 
(115 microliters, rather than 230), which is a more realistic level. 
The test should be applied to all BAIIDs. No other changes have been 
made.
Test 14--Emergency Override
    This issue was discussed fully in Section II.B.5. NHTSA believes 
the decision whether to permit the use of an emergency override feature 
is programmatic in nature and should be left to the discretion of 
States and local jurisdictions. Accordingly, as proposed, the Model 
Specifications do not specify that BAIIDs be equipped with an emergency 
override feature in order to meet the Model Specifications. Since this 
feature is not specified, the Model Specifications will not include a 
test of this feature. The Model Specifications are modified to 
eliminate the reference to a feature that prevents an override from 
being used when the BAIID malfunctions or fails and it removes proposed 
Test 14.
Test 15--Radiofrequency Interference/Electromagnetic Interference
    In the 2006 notice, NHTSA explained that the RFI testing protocol 
in the 1992 Model Specifications uses power sources that are no longer 
commonly in use, but noted that new power sources that may interfere 
with the operation of BAIIDs (e.g., cell phones) have output power 
commensurate with equipment in use today. The agency asked what are the 
appropriate levels to measure RFI/EMI. (71 FR 8048.)
    The comments pointed out that 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. The comments offered a variety of recommendations to address 
these potentially interfering power sources.
    In the 2010 notice, NHTSA expressed its belief that the current 
specifications do not adequately define or describe RFI/EMI tests and 
proposed 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 Electro-technical 
Committee (IEC); specifically, CISPR 25, for RFI/EMI testing. NHTSA 
stated that it believed these procedures represent a broad consensus in 
the industry. (75 FR 61823.)
    The agency received comments regarding this test from Smart Start, 
ACS, LifeSafer, ADS, CST and the State of Wisconsin. Most of the 
comments supported the proposed tests, although CST expressed the 
belief that the tests may be unnecessary. (p. 5.) ADS recommended that 
the appropriate level for testing should be 1W or less, since that 
level would be sufficient to identify potential cell phone 
interference. (p. 2.)

[[Page 26860]]

Wisconsin recommended that immunity testing for electrical equipment 
should be conducted in conformity with EN 61326-1:2001. (p. 5.)
    The agency has not changed these elements of the Test. NHTSA 
believes the tests should not be limited to cell phone interference. 
The EN 61326-1:2001 test cited in Wisconsin's comment is used for 
remote locations, such as bridges, roads, etc., and not for motor 
vehicles.
Test 16--Service Interval Display
    As discussed more fully in Section II.B.6. and in the discussion 
regarding Test 3, NHTSA agrees that it is appropriate to decouple the 
period of calibration stability and the service interval. States and 
local jurisdictions make decisions about service intervals based on a 
number of different factors, including the need to supervise some 
offenders more closely or the desirability of providing an incentive 
(and permitting a longer service interval) for offenders who have 
demonstrated compliance with their sentence. In addition, NHTSA 
recognizes that BAIIDs can be programmed to vary the service interval, 
based on the circumstances in each case. Accordingly, the Model 
Specifications do not provide for a specific service interval period. 
Rather, the agency defers to States and local jurisdictions to 
determine the service intervals they believe are appropriate.
    However, Test 16 has a different function. Its purpose is to ensure 
that the BAIID's display of the service interval is working properly. 
While NHTSA recognizes that service intervals may be set at a variety 
of time periods, the Model Specifications provide that a period of 30 
days (with a 7-day lockout countdown) should be used for the purpose of 
this test. Under Test 16, after a period of 30 days, the BAIID should 
prominently display that the vehicle be taken to a designated 
maintenance facility for maintenance and data downloads within seven 
days. This message should continue to be displayed for seven days. 
Following the seven-day period, if the BAIID is not serviced at a 
designated maintenance facility, it should not allow the vehicle to be 
started.
Test 17--Data Integrity and Format
    NHTSA proposed that the data be downloaded from the interlock data 
logger after all other tests have been completed. (75 FR 61831.) No 
comments objected to this requirement.

D. Other Comments Received Regarding the Model Specifications

1. Dust Test
    In the 2010 notice, NHTSA indicated that one comment to the 2006 
notice had suggested that several CENELEC standards be adopted into the 
Model Specifications, including the dust standard. The agency responded 
that 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. Accordingly, NHTSA did not propose to include a 
dust standard in the Model Specifications. (75 FR 61826.) A number of 
comments specifically agreed with the agency's decision, including 
Smart Start and IISI. A dust standard has not been added.
2. Vehicle-Interlock Interface
    The 2006 notice indicated that 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. The agency asked whether NHTSA should establish any 
guidelines regarding the vehicle-interlock interface. (71 FR 8048.)
    The comments received in response were mixed. In general, interlock 
manufacturers and providers supported a standard interlock-vehicle 
interface; vehicle manufacturers asserted that requiring a common 
interface presented significant challenges that could compromise 
vehicle ignition security systems and anti-theft immobilizing 
technologies. In the 2010 notice, NHTSA acknowledged that a common 
interface could afford installation convenience. However, the agency 
indicated that it would not specify such a requirement in the Model 
Specification and explained that ``such a requirement goes beyond the 
scope of this proposal, which is limited to the BAIID itself and not to 
changes to the vehicle.'' (75 FR 61823-24.)
    The comments received in response to this issue were mixed. For 
example, National Interlock asked NHTSA to reconsider its decision and 
establish specifications regarding a common interface. (p. 1.) ADS said 
it would support this type of provision. (p. 2.) CST agreed with the 
vehicle manufacturers that a common interface could compromise anti-
theft systems and should not be required. (p. 7.) Draeger expressed its 
view that requiring a specific interface on all vehicles might be 
impractical. (p. 3-4.) ACS agreed with the agency that the interface is 
beyond the scope of these Model Specifications. (p. 12.) CIIM argued 
that, ``As advances in the automobile industry evolve, installation of 
interlock devices becomes more difficult. There are examples of 
installations taking hours, even days to complete as remote starters 
and push button ignitions become more prevalent.'' CIIM urged NHTSA to 
``facilitate a dialogue between the two industries about this issue.'' 
(p. 3.)
    NHTSA will take CIIM's recommendation under advisement. However, 
the agency continues to believe that a common interface in vehicles for 
ignition interlocks is outside the scope of these Model Specifications. 
Accordingly, the agency has not included such a requirement in this 
notice.
3. International Harmonization
    In the 2006 notice, NHTSA asked about the importance of harmonizing 
NHTSA's Model Specifications for BAIIDs with standards in other parts 
of the world. (71 FR 8048.) The comments received in response to this 
aspect of the notice were varied. Some comments supported harmonization 
with CENELEC (the European standard) due to increasingly global 
economy; others opposed harmonization based on a belief that aspects of 
the CENELEC standard are potentially restrictive and costly. In 
response, NHTSA proposed to maintain an independent set of Model 
Specifications, but to incorporate selected elements of the CENELEC, 
including vibration and cigarette smoke. (75 FR 61825.)
    As noted above, the comments favored inclusion of these tests and 
some comments suggested that other CENELEC tests be included as well, 
including high temperature, dust and the drop test.
    NHTSA has carefully considered other standards, including CENELEC, 
and as appropriate, has incorporated consistent provisions into these 
Model Specifications. In some cases, variations are warranted, based on 
cost, conditions and the manner in which BAIIDs are used in the United 
States. Further discussions regarding individual tests are contained in 
other sections of this notice.
4. Ignition Interlock Program Guidelines
    In the 2006 notice, NHTSA asked whether the ignition interlock 
community (users, manufacturers, States, etc.) favor NHTSA development 
of an ``interlock program'' in addition to Model Specifications for 
devices. (71 FR 8048.) Some comments supported the development of 
ignition interlock program guidelines; others expressed the belief that 
program guidelines have

[[Page 26861]]

been and should remain a function of State government.
    NHTSA did not include program guidelines in the 2010 notice, but 
indicated that the agency may explore the development of such 
guidelines in the future. (75 FR 61825.) The comments generally 
supported this position. AAMVA urged NHTSA to ensure that any such 
guidelines are ``based on scientifically valid research'' and ``allow 
the necessary flexibility.'' (p. 1.)
    As stated earlier in this notice, NHTSA is committed to providing 
support, and not dictating practices, to the States. Over the last few 
years in particular, the agency has sought to provide information, 
support and technical assistance to the States in a variety of ways. 
NHTSA hosted a National Ignition Interlock Summit and invited 
representatives from every State to attend. NHTSA has also produced a 
number of publications containing information about ignition interlock 
programs, including ``Ignition Interlocks--What You Need to Know: A 
Toolkit for Policymakers, Highway Safety Professionals and Advocates'' 
(DOT HS 811 246), ``Key Features for Ignition Interlock Programs'' (DOT 
HS 811 262), National Ignition Interlock Summit Proceedings'' 
(available on www.ghsa.org) and a series of New Mexico ignition 
interlock studies (see Traffic Tech 401; November 2010). In addition, 
NHTSA supported the development of the Alcohol Interlock Curriculum for 
Practitioners by the Traffic Injury Research Foundation (TIRF) 
(available on www.tirf.ca) and has supported technical assistance 
workshops, meetings and training (in cooperation with TIRF) and a 
series of regional Ignition Interlock Summits (in cooperation with 
Mothers Against Drunk Driving). Also, NHTSA has provided financial 
assistance to support the establishment of a new National organization, 
representing State Ignition Interlock Program Administrators.
    NHTSA will continue to provide support and assistance to States as 
they seek to expand and strengthen their ignition interlock programs, 
and the agency will consider whether the development of program 
guidelines would add value to the field. However, such guidelines are 
outside the scope of this notice and have not been included in the 
Model Specifications.

E. NHTSA Testing of BAIIDs and Conforming Products List (CPL)

    In the 2006 notice, the agency asked, whether NHTSA should 
undertake the responsibility to evaluate ignition interlocks against 
its Model Specifications and publish a CPL of devices meeting those 
specifications. (71 FR 8048.)
    In the 2010 notice, in response to comments received, NHTSA 
explained that the comments favored a certified testing laboratory 
program. Most advocated a NHTSA test program and the development of a 
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. (75 FR 61824.)
    In the 2010 notice, NHTSA proposed to test BAIIDs for conformance 
with the Model Specifications. NHTSA also proposed to maintain and 
publish periodically a CPL with BAIIDs that have been tested and found 
to conform to the Model Specifications. NHTSA proposed to manage this 
new program as it does its other breath alcohol instrument testing 
programs. (75 FR 61824.)
    NHTSA explained that 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. (75 
FR 61825.) In the proposed Submission Procedures contained in Appendix 
A of the 2010 notice, NHTSA proposed that it would ``test BAIIDs on a 
first-come, first-served basis.'' (75 FR 61831.)
    More than half of the comments addressed this issue and many of 
them raised concerns, though the concerns expressed were varied. Some 
of the comments related to the potential of insufficient funds and 
whether Volpe has the capacity to conduct the testing. For example, 
Oklahoma stated, ``We cannot support the limitation that `All tests are 
subject to the availability of Federal funds.' '' (p. 2.) ACS asserted 
that ``Volpe Laboratories lacks the equipment, expertise and perhaps 
financial resources to conduct the range of qualification tests on 
alcohol interlocks for conformance with the Model Specifications.'' (p. 
16.) The comments offered various possible solutions to address these 
concerns, including that the manufacturers fund the testing of BAIIDs 
(Smart Start), that there be a funding limitation (Draeger) or that 
NHTSA consider certifying independent laboratories to perform some or 
all of the testing (ACS, Alcohol Detection Systems, Draeger, Guardian, 
National Interlock, Coalition of Ignition Interlock Manufacturers).
    In general, the comments were supportive of a NHTSA CPL. Guardian's 
comments were typical. They stated, ``whether the test results are 
provided by NHTSA or by [an outside laboratory], a conforming product 
should be placed on the NHTSA conforming products list.'' Guardian 
asserted further, ``If NHTSA cannot agree to this critical element, 
then there should NOT be a CPL for these products.'' (p. 2.)
    While some comments seemed to express alarm about the statement in 
the 2010 notice that the testing program would be subject to the 
availability of funds, this limitation applies to all Federal programs, 
including NHTSA's current testing programs for evidential breath 
testers, calibrating units and other breath alcohol instruments and 
devices.
    The Volpe National Systems Center is currently in the process of 
developing the capacity to conduct Radiofrequency Interference (RFI) 
and Electromagnetic Interference (EMI) testing. Volpe is capable of 
conducting all other tests delineated in the Model Specifications. 
NHTSA expects that Volpe will have the ability to conduct the RFI/EMI 
tests in the near future. Until then, Volpe has the ability to procure 
these tests from other qualified laboratories.
    However, the comments raise a valid concern about the ability of 
any one laboratory, including Volpe, to test all available BAIID models 
in a sufficiently timely manner, especially during the initial period 
when these revised Model Specifications will initially go into effect. 
The agency also appreciates the concern that some comments expressed 
regarding the testing of BAIIDs on a first-come, first-served basis. 
The agency does not wish to take any steps that would create an unfair 
competitive advantage for some manufacturers over others.
    Since these revised Model Specifications represent a substantial 
departure from the existing 1992 specifications, NHTSA will delay 
rendering a decision about the feasibility and timing of a CPL until 
more information is available about the implications for testing costs, 
resource requirements and the time necessary to conduct product 
testing.
    Accordingly, NHTSA plans to conduct an assessment to determine 
whether establishing and maintaining a CPL is feasible, prior to 
rendering a decision.

[[Page 26862]]

    If the agency determines that a CPL is feasible, NHTSA will 
announce its intention to develop a CPL in a Federal Register notice 
and will, at that time, outline the procedures that will apply, 
including steps for submitting BAIIDs for compliance testing. The 
agency would seek to establish procedures that ensure a level playing 
field, in terms of competition among ignition interlock manufacturers.
    Accordingly, NHTSA expects that manufacturers will continue to 
certify, and States and local jurisdictions will continue to determine, 
that BAIIDs conform to the Model Specifications essentially in the same 
manner that is currently being used. However, the revised Model 
Specifications, rather than the 1992 version, should be used, once they 
become effective. The Model Specifications will not take effect 
immediately, but rather will be delayed for one year, to provide 
manufacturers of BAIIDs sufficient time to make conforming 
modifications to their instruments and to conduct testing, as 
warranted.

F. Appendices to the 2010 Notice

    The 2010 notice contained four appendices. Appendix A included 
submission procedures for conformance testing of BAIIDs. (75 FR 61831.) 
Appendix B included procedures for the re-examination of BAIIDs, which 
occur at the sole discretion of NHTSA. (75 FR 61831-32.) Appendix C 
provided a template for a Quality Assurance Plan. (75 FR 61832.) 
Appendix D provided a sample format for downloaded data from the 
interlock data logger. (75 FR 61832-33.)
    As explained above, NHTSA has not yet decided whether it will 
develop a CPL. It will first conduct an assessment to determine its 
feasibility. If the agency decides that a CPL is feasible, NHTSA will 
publish a Federal Register notice announcing its plans to proceed and 
will, at that time, outline the procedures that will apply.
    Accordingly, the first two appendices that were contained in the 
2010 notice (then identified as Appendix A and Appendix B) are not 
included in this notice. The other two appendices that were contained 
in the 2010 notice (then identified as Appendix C and Appendix D) have 
been renamed as Appendix A and Appendix B, respectively.

III. New Model Specifications

    On October 6, 2010, NHTSA proposed revisions to the 1992 Model 
Specifications for BAIIDs. (75 FR 61820.) Those proposed revisions were 
based, in part, on input from the comments received in 2006. Today, in 
response to the October 6, 2010 notice, the 1992 Model Specifications 
have been revised.
    This Notice is not intended to take the place of any State 
certification requirements; rather, it provides for a voluntary testing 
and conformance program.
    These Model Specifications do not have the force of regulations and 
are not binding. States and others may adopt these Model Specifications 
and rely on any tests that NHTSA may conduct, or they may conduct their 
own tests according to their own procedures and specifications.
    After consideration of the comments, the Model Specifications for 
Breath Alcohol Ignition Interlock Devices have been revised to reflect 
the decisions discussed above and are set forth below.

    Authority:  23 U.S.C. 403; 49 CFR 1.95; 49 CFR Part 501.

MODEL SPECIFICATIONS FOR BREATH ALCOHOL IGNITION INTERLOCK DEVICES 
(BAIIDs)

A. Purpose and Scope
    The purpose of these specifications is to establish recommended 
performance criteria and test methods for breath alcohol ignition 
interlock devices (BAIIDs), commonly referred to as alcohol interlocks 
or ignition interlocks. BAIIDs are breath alcohol sensing instruments 
designed to prevent the motor vehicle from starting unless the driver 
first provides a breath sample whose alcohol concentration is below the 
set point into the BAIID. If the measured breath alcohol concentration 
(BrAC) is at or above a set level, the vehicle will not start. BAIIDs 
are currently being used as court sanctions as well as administrative 
conditions of licensure. Drivers convicted of impaired driving may be 
required to use BAIIDs in their vehicle under court supervision or as 
part of a required path to full reinstatement of driving privileges. 
These specifications are intended for use in conformance testing of 
BAIIDs installed in vehicles. These specifications are voluntary and do 
not impose any compliance obligations on BAIID manufacturers or others.
B. Terms
    Alcohol--Ethanol or ethyl alcohol (C2H5OH).
    Alcohol set point--Breath Alcohol Concentration (BrAC) at which a 
BAIID is set to prevent a vehicle from starting.
    Breath Alcohol Concentration (BrAC)--The amount of alcohol in a 
given amount of breath, expressed in weight per volume (w/v) based upon 
grams of alcohol per 210 liters (L) of breath, in accordance with the 
Uniform Vehicle Code, Chapter 11, Section 11-903.4 and 5.\1\
---------------------------------------------------------------------------

    \1\ Available from the National Committee on Uniform Traffic 
Laws and Ordinances, 107 South West Street, 110, 
Alexandria, VA 22314 (http://www.ncutlo.org).
---------------------------------------------------------------------------

    Breath alcohol ignition interlock device (BAIID)--A device that is 
designed to allow a driver to start a vehicle if the driver's BrAC is 
below the set point and to prevent the driver from starting the vehicle 
if the driver's BrAC is at or above the set point.
    Breath Sample--Normal expired human breath primarily containing air 
from the deep lung.
    Calibration Stability--The ability of a BAIID to hold its accuracy 
and precision over a defined time period.
    Circumvention--An attempt to bypass the correct operation of a 
BAIID, whether by use of an altered breath sample, by starting the 
vehicle by any means without first providing a breath sample.
    Filtered air sample--Any human breath sample that has intentionally 
been altered so as to remove alcohol from it.
    Interlock Data Logger--A device within a BAIID that records all 
events, dates, and times during the period of installation and use of a 
BAIID.
    Retest--A breath test that is required after the initial engine 
start-up breath test and while the engine is running. This is also 
referred to as a running retest.
    Service Interval--The time period established by the State or 
jurisdiction that a BAIID may be used without maintenance or data 
download. If the device is not serviced within the period, warnings are 
provided and the device will prevent further operation.
    Simulator--A device that produces an alcohol-in-air test sample of 
known concentration (e.g., a Breath Alcohol Sampling Simulator (BASS)) 
\2\ or a device that meets the NHTSA Model Specifications for 
Calibrating Units (72 FR 34742)).
---------------------------------------------------------------------------

    \2\ See NBS Special Publication 480-41, July 1981. Available 
from Superintendent of Documents, U.S. Government Printing Office, 
Washington, DC 20402.
---------------------------------------------------------------------------

    Tampering--An attempt to physically disable, disconnect, adjust, or 
otherwise alter the proper operation of a BAIID.
C. General Provisions and Features of BAIIDs
    Conforming BAIIDs must meet the following provisions:
    The BAIID must pass each of the conformance tests 1 through 16 in 
Section D, unless explicitly excluded from a test by the specific terms 
of these specifications.

[[Page 26863]]

    Installation and service of the BAIID in a vehicle must not 
compromise any normal function of the vehicle, including anti-theft 
functions, on-board computer functions, or vehicle safety features 
required by the Federal Motor Vehicle Safety Standards, and must not 
cause harm to the vehicle occupants. Care should be taken to protect 
against reverse polarity and damage to other circuits and to ensure 
that the BAIID does not drain the vehicle's battery while in sleep mode 
(i.e., power save mode).
    The BAIID must have tamper proof seals to indicate when a BAIID has 
been disconnected from the ignition.
    The BAIID must be capable of permitting a vehicle to start or 
preventing it from starting at specified breath alcohol concentrations.
    The BAIID must be tested at an alcohol set point of 0.02 g/dL with 
a flow rate of 0.3 L/sec. Upon detecting an alcohol concentration at or 
above that set point, the BAIID must prevent the vehicle from starting 
for a period of time before another test can be performed.
    If the vehicle is equipped with a remote start device, the BAIID 
must be installed so that the remote start function is bypassed or 
disabled and a valid breath test must be performed before the vehicle 
may be started.
    If the BAIID has a removable sensing head, the BAIID may not allow 
the vehicle to start without use of the sensing head.
    The BAIID must include clear instructions to the driver (e.g., when 
to blow, when to wait, when to start the vehicle, when to retest, when 
a lockout countdown occurs, including the time remaining before the 
BAIID may be used again to start the vehicle, and when to seek 
service).
    Manufacturers must submit the operator's manual (user's guide or 
instructions to the user), the maintenance manual, and specifications 
and drawings fully describing the BAIID.
    In addition, manufacturers must submit the quality assurance plan 
(QAP). The QAP must 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 
interlock data logger, instructions to maintain the BAIID, instructions 
on checking for tampering, and any other information regarding quality 
assurance unique to the BAIID. See Appendix A for a sample QAP 
template.
    The design of the BAIID must include an interlock data logger that 
will record, at a minimum, all start attempts and outcomes, including 
an emergency override if applicable, delineation of calibration checks, 
circumvention, tampering, operator attempts to start the vehicle, and 
BrAC for each start attempt. The data must be presented in 
chronological order (i.e., by date and time of event). See Appendix B 
for a sample format for downloaded data from the interlock data logger. 
The manufacturer must provide a means of downloading the data from the 
interlock data logger.
    Any change to a BAIID that could affect its performance, including 
potentially software changes, should require additional testing. The 
BAIID must track all changes to the metrological software and indicate 
the software version and date on all printed and downloaded reports. 
NHTSA is aware that States (and local jurisdictions) use different set 
points in their interlock programs, and changes to the set point, 
alone, would not require additional testing. The Model Specifications 
provide that BAIIDs are to be tested at an alcohol set point of 0.02 g/
dL.
D. BAIID Test Procedures
General Test Conditions
    Unless otherwise specified in a conformance test, the following 
conditions apply to each test:
     Number of trials at each alcohol level = 20
     Ambient temperature: 22 [deg]C  3 [deg]C (71.6 
[deg]F  5.4 [deg]F).
     Ambient atmospheric pressure: 97.5 kPa  10.5 
kPa (25.7 and 31.9 inches Hg).
     Sample parameters: volume 1.2 liters; ambient flow rate 
0.3 Liters per second; maximum delivery pressure 2.5 kPa; temperature 
34 [deg]C (93.2[emsp14][deg]F)
     Simulated breath samples will be generated by the BASS \3\ 
or by a wet bath type calibrating unit that is listed on the NHTSA 
Conforming Products List for such devices. Solutions used in the 
calibrating device will be prepared as described in the NHTSA Model 
Specifications for Calibrating Units published June 25, 2007 (72 FR 
34742).
---------------------------------------------------------------------------

    \3\ See NBS Special Publication 480-41, July 1981. Available 
from Superintendent of Documents, U.S. Government Printing Office, 
Washington, DC 20402.
---------------------------------------------------------------------------

Performance Requirements
    Unless otherwise specified in a conformance test, the BAIID must 
meet the following performance requirements in each test:
     Tests at 0.000 g/dL BrAC: the vehicle must not be 
prevented from starting during 20 trials.
     Test at 0.008 g/dL BrAC: the vehicle must not be prevented 
from starting more than once during 20 trials.
     Tests at 0.032 g/dL BrAC (grams alcohol/210 liters of 
air): the vehicle must not start more than once during 20 trials.
     A BAIID must be ready for use 3 minutes or less after it 
is turned on. A BAIID must be ready for a second test within 3 minutes 
or less of a preceding test.
Conformance Tests
    Unless otherwise specified in a test, these conformance tests need 
not be conducted in any particular order. Except when a test or portion 
of a test specifically requires the use of a motor vehicle, either a 
motor vehicle or a bench test set-up that simulates the relevant 
functions of a motor vehicle may be used.
Test 1. Precision and Accuracy
    Test the BAIID at the following alcohol concentrations:
    a. 0.000 g/dL BrAC,
    b. 0.008 g/dL BrAC, and
    c. 0.032 g/dL BrAC.
Test 2. Breath Sample Volume and Flow Rate
    Use a mass flow meter to monitor sample volume. Conduct each test 
(a-d) five times.
    a. Test at 0.000 g/dL BrAC with sample volume 1.0 liter. The BAIID 
must prevent the vehicle from starting and indicate insufficient volume 
5 out of 5 times.
    b. Test at 0.000 g/dL BrAC with sample volume 1.5 liters. The BAIID 
must permit the vehicle to start 5 out of 5 times.
    c. Test at 0.000 g/dL BrAC with sample volume 1.2 liters at 0.1 L/
s. The BAIID must prevent the vehicle from starting 5 out of 5 times.
    d. Test at 0.000 g/dL BrAC with sample volume 1.2 liters at 0.7 L/
s. The BAIID must permit the vehicle to start 5 out of 5 times.
Test 3. Calibration Stability
    Initialize the BAIID to begin the calibration stability test. A 
BAIID must not be re-calibrated after the start of Test 3. Conduct Test 
1. Repeat Test 1 at 37 days. Test 2 and Tests 4-15 may be performed 
between these two Precision and Accuracy tests.
    If requested by the manufacturer, repeat Test 1 at 67 days, 97 days 
and 187 days. These additional tests are optional. They exceed the 
minimum requirements of this test.

[[Page 26864]]

Test 4. Input Power
    Conduct Test 1b and Test 1c at the following input power 
conditions:
    a. Test at 11 VDC input power.
    b. Test at 16 VDC input power.
Test 5. Extreme Temperature and Humidity
    Using a temperature/humidity chamber:
    a. Soak the BAIID at -40 [deg]C (-40 [deg]F) for 1 hour, then 
conduct Test 1b and Test 1c at that temperature using 9 VDC input 
power.
    b. Soak the BAIID at 49 [deg]C (120 [deg]F), 95 percent relative 
humidity for 1 hour, then conduct Test 1b and Test 1c at that 
temperature and humidity using 16 VDC input power.
    c. This part of the test applies only to BAIIDs with components 
installed in the engine compartment. Soak the components of the BAIID 
that are installed in the engine compartment at 85 [deg]C (185 [deg]F), 
95 percent relative humidity for 1 hour, then conduct Test 1b and Test 
1c at that temperature and humidity using 16 VDC input power. The 
components that are installed in the passenger compartment should 
remain at ambient temperature and humidity conditions. Removable 
components will be tested in accordance with the manufacturer's 
instructions to the user. (See General Test Conditions).
Test 6. Warm Up Time at -40 [deg]C
    Using a temperature chamber, soak the BAIID for 1 hour at -40 
[deg]C. With input power set at 9 VDC, the BAIID must be ready to test 
in 3 minutes, and ready to retest in 3 minutes after being turned on. 
Conduct Test 6 five times. The BAIID must indicate that it is ready to 
test or ready to retest in 3 minutes all five times. This test may be 
conducted in conjunction with Test 5 Extreme Temperature and Humidity.
Test 7. Vibration
    Vibrate the BAIID in simple harmonic motion on each of three main 
axes uniformly through the frequency schedule specified below. For 
components not intended to be mounted on the engine, vibrate according 
to Test 7a; for components intended to be mounted on the engine, 
vibrate according to Test 7b. If a BAIID consists of several components 
connected by electrical wires or connected wirelessly, vibrate these 
components separately. After completion of the vibration, remove the 
BAIID from the shake table and conduct Test 1b and Test 1c.

                                          Vibration Frequency Schedule
----------------------------------------------------------------------------------------------------------------
                                                                                    Amplitude,     Acceleration,
             Test 7                  Frequency       Number of      Sweep rate,     inches 0 to   gravity (g), 0
                                     range, Hz        cycles        octave/min         peak           to peak
----------------------------------------------------------------------------------------------------------------
a...............................       10 to 500              10               1            0.2                3
b...............................       10 to 500              10               1            0.08              15
----------------------------------------------------------------------------------------------------------------

Test 8. Retest
    If a BAIID includes a feature designed to detect whether the 
vehicle is moving, conduct Test 8 using a motor vehicle. If a BAIID 
does not include a feature designed to detect whether the vehicle is 
moving, conduct Test 8 using a motor vehicle or a bench test set-up 
that simulates the relevant functions of a motor vehicle.
    a. Within an interval of 5 to 7 minutes after a vehicle 
successfully starts, using a 0.000 g/dL BrAC test sample, and while the 
engine is still running, the BAIID must indicate that a second breath 
sample is required. Conduct Test 1b five times. The BAIID must treat 
this test as a passed retest all 5 times.
    b. Within an interval of 5 to 7 minutes after a vehicle 
successfully starts, using a 0.000 g/dL BrAC test sample, and while the 
engine is still running, the BAIID must indicate that a second breath 
sample is required. Conduct Test 1c five times. The BAIID must treat 
this test as a failed retest and prominently indicate the need for a 
service call.
    A failed retest must be identified as an alert condition and 
flagged on the interlock data logger. A missed retest must be flagged 
on the interlock data logger. After the driver is alerted to retest, if 
the engine is accidentally or intentionally powered off, the BAIID must 
not allow the vehicle to start without a service call.
Test 9. Tampering and Circumvention
    Attempt to start the ignition as indicated below. Conduct each test 
(a through f) five times. Each attempt to start the engine must be 
logged by the interlock data logger.
    a. ``Hot wiring''. Start the engine by electrically bypassing the 
BAIID. The interlock data logger must record the ignition on with no 
breath test.
    b. Push start. A motor vehicle must be used for this part of Test 
9. Use a vehicle equipped with a manual transmission. Start the engine 
by pushing the vehicle with another vehicle or by coasting the vehicle 
downhill before engaging the clutch. The vehicle must run for at least 
two minutes. The interlock data logger must record the ignition on with 
no breath test.
    c. Un-warmed air sample. Deliver an alcohol-free air sample of at 
least 2 liters into the BAIID using an air filled plastic bag which is 
fitted to the sampling tube and squeezed in a manner that mimics a 
person blowing into the BAIID. The vehicle must not start.
    d. Warmed air sample. Prepare a 12-ounce foam coffee cup fitted 
with a bubble tube inlet and a vent tube (rubber or tygon tubing) 
attached through the plastic lid. Fill the cup with 8 ounces of water 
warmed to 36 [deg]C and attach the lid. Attach the vent tube to the 
BAIID and pass an air sample of at least 2 liters through the bubble 
tube into the heated water and thence into the BAIID. The flow rate 
must not be high enough to cause a mechanical transfer of water to the 
BAIID. The vehicle must not start.
    e. Cooled 0.032 BrAC sample. Attach a 4 foot long tygon tube of \3/
8\ inch inside diameter which has been cooled to ice temperature to the 
inlet of the BAIID, then test at 0.032 BrAC. The vehicle must not 
start.
    f. Filtered 0.032 BrAC sample. Prepare a 1 to 2 inch diameter 3 to 
5 inches long paper tube loosely packed with an active absorbent 
material. Use loose cotton plugs to retain the absorbent in the paper 
tube. Pack the tube so that a person can easily blow 2 liters of air 
through the assembly within 5 seconds. Test the absorbent by passing a 
2 liter 0.032 BrAC sample though the assembly within 5 seconds. If the 
air passing out of the BAIID is found to have a concentration of 0.006 
BrAC or less, prepare 5 tubes packed in the same manner, fit separately 
to the BAIID and test at 0.032 BrAC. The vehicle must not start.
    g. Alternative to Tests 9c--9f. If a BAIID includes an anti-
circumvention feature designed to ensure that the driver is blowing 
into the BAIID, test its operation at 0.000 BrAC in lieu of tests 9c--
9f.

[[Page 26865]]

Test 10. Restart of Stalled Motor Vehicle
    Conduct Test 10 using a motor vehicle.
    Using a 0.000 g/dL BrAC sample, turn on the ignition. Turn off the 
ignition. Attempt to restart the ignition without a breath sample in 
less than 3 minutes--the vehicle must start. Turn off the ignition. 
Attempt to restart the ignition without a breath sample within 3 
minutes after turning off the ignition--the vehicle must not start. 
Conduct Test 10 five times.
Test 11. High Altitude
    Conduct Test 1b and Test 1c each at pressures of 80 kPa and 110 kPa 
(600 mmHg and 820 mmHg). Conduct Test 11 five times at each indicated 
pressure. At indicated pressure levels, for Test 1b, the ignition must 
treat the test as a passed test; for Test 1c, the ignition must treat 
the test as a failed test.
Test 12. Cigarette Smoke
    Direct a cigarette smoker, who is alcohol-free, to smoke 
approximately \1/2\ of a cigarette. The smoker must wait 1 minute or 
the period specified by the BAIID manufacturer in its user instructions 
before testing. Conduct Test 12 three times. The vehicle must start.
Test 13. Acetone
    Test the BAIID for acetone interference. Conduct Test 1b by adding 
115 microliters of acetone \4\ to the 500 milliliters of .008 g/dL BrAC 
alcohol simulator solution. Conduct Test 1b three times. The vehicle 
must start.
---------------------------------------------------------------------------

    \4\ The amount of acetone specified is experimentally determined 
based on water to air partition factor of 365 to 1 at 34 [deg]C to 
yield an acetone concentration in the air sample of 0.5 mg/liter.
---------------------------------------------------------------------------

Test 14. Radiofrequency Interference (RFI)/Electromagnetic Interference 
(EMI)
    The Society of Automotive Engineers (SAE) Surface Vehicle Standard 
J1113 series, Required Function Performance Status, as defined in 
Surface Vehicle Standard J1113-1 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, 
will be used to evaluate BAIID electromagnetic immunity and 
compatibility. The test severity levels are specified below. The tests 
must be performed while the BAIID is in the drive and standby modes.
    a. J1113-1 2006-10 General and definitions. Electromagnetic 
Compatibility Measurement Procedures and Limits for Vehicles, Boats, 
and Machines (Except Aircraft) (16.6 Hz to 18 GHz).
    b. J1113-2 2004-07 Conducted immunity 30 Hz to 250 kHz--Power 
leads.

------------------------------------------------------------------------
                                             Severity
                  Level                    (volts, peak       Status
                                             to peak)
------------------------------------------------------------------------
1.......................................            0.15               I
2.......................................            0.50               I
3.......................................             1.0               I
4.......................................             3.0              II
------------------------------------------------------------------------

    c. J1113-4 2004-08 Conducted immunity--Bulk Current Injection (BCI) 
Method.

------------------------------------------------------------------------
                                             Severity
                  Level                     (milliamps)       Status
------------------------------------------------------------------------
1.......................................        25 to 60               I
2.......................................        60 to 80              II
3.......................................       80 to 100             III
4.......................................             100              IV
------------------------------------------------------------------------

    d. J1113-11 2007-06 Immunity to Conducted Transients on Power 
Leads.

------------------------------------------------------------------------
                                                     Severity
            Pulse (12 v sys)               Level     (volts)     Status
------------------------------------------------------------------------
1......................................          1        -25          I
                                                 2        -50         II
                                                 3        -75         II
                                                 4       -100         IV
2a.....................................          1         25          I
                                                 2         40         II
                                                 3         50         II
                                                 4         75         IV
2b.....................................          1         10          I
3a.....................................          1        -35          I
                                                 2        -75         II
                                                 3       -112         II
                                                 4       -150         IV
3b.....................................          1         25          I
                                                 2         50         II
                                                 3         75         II
                                                 4        100         IV
4......................................          1         -4          I
                                                 2         -5         II
                                                 3         -6         II
                                                 4         -7         IV
5......................................          1         87         IV
------------------------------------------------------------------------

    e. J1113-13 2004-11 Part 13: Immunity to Electrostatic Discharge.

------------------------------------------------------------------------
                       Severity                              Status
------------------------------------------------------------------------
                            Contact discharge
------------------------------------------------------------------------
0-4 kV...............................................                  I
4-8 kV...............................................                 II
8 kV.................................................                 IV
------------------------------------------------------------------------
                              Air discharge
------------------------------------------------------------------------
0-4 kV...............................................                  I
4-15 kV..............................................                 II
15 kV................................................                 IV
------------------------------------------------------------------------

    f. J1113-21 2005-10 Immunity to Electromagnetic Fields, 30 MHz to 
18 GHz.

------------------------------------------------------------------------
                    Severity (V/M)                           Status
------------------------------------------------------------------------
Up to 60.............................................                  I
60-80................................................                 II
80-100...............................................                III
100-150..............................................                 IV
------------------------------------------------------------------------

    g. J1113-22 2003-11 Immunity to magnetic fields

------------------------------------------------------------------------
                    Severity (uT)                            Status
------------------------------------------------------------------------
40...................................................                  I
40-50................................................                 II
50-80................................................                III
80...................................................                 IV
------------------------------------------------------------------------

    h. IEC CISPR 25 Limits of Radio Disturbance.

                       Radiated Disturbance Limits
                 [1 M test distance, 120 kHz bandwidth]
------------------------------------------------------------------------
            30-75 MHz                  75-400 MHz         400-1000 MHz
------------------------------------------------------------------------
a 62-25.13 x log(F/30)..........  52 + 15.13 x log(F/                 63
                                   75).
b 52-25.13 x log(F/30)..........  42 + 15.13 x log(F/                 53
                                   75).
------------------------------------------------------------------------
a: broadband, quasi-peak detector.
b: narrowband, average detector.
limit in dB (uV/M) at frequency F.

[[Page 26866]]

                      Conducted Transient Emissions
------------------------------------------------------------------------
                                                         Maximum pulse
                    Pulse polarity                       amplitude (12
                                                        volt system) (V)
------------------------------------------------------------------------
Positive.............................................                 75
Negative.............................................               -100
------------------------------------------------------------------------

                                   Limits for Broadband Conducted Disturbances
----------------------------------------------------------------------------------------------------------------
                 0.15-0.3              0.53-2.0             5.9-6.2              30-54              68-108
   MHz    ------------------------------------------------------------------------------------------------------
               P          QP         P         QP         P        QP         P        QP         P        QP
----------------------------------------------------------------------------------------------------------------
      a         93         80         79         66        65        52        65        52        49        36
      b         80         67         76         63        62        49        62        49        56        43
----------------------------------------------------------------------------------------------------------------
a: power lines, limit in dB (uV).
b: control lines, limit in dB (uA).
P: peak detector.
 QP: quasi-peak detector.

                                  Limits for Narrowband Conducted Disturbances
----------------------------------------------------------------------------------------------------------------
      MHz            0.15-0.3        0.53-2.0         5.9-6.2          30-54           68-87          76-108
----------------------------------------------------------------------------------------------------------------
           a               70              50              45              40              30              36
           b               60              50              45              40              40              46
----------------------------------------------------------------------------------------------------------------
a: power lines, limit in dB (uV).
b: control lines, limit in dB (uA).
limits by peak detection.

Test 15. Service Interval Display
    Initialize the BAIID to begin the service interval period. After 
thirty (30) days, the BAIID must prominently indicate that it must be 
taken to a designated maintenance facility for maintenance and data 
downloads within 7 days or the vehicle will not start and the event 
will be logged. Over the course of the 7-day lockout countdown, the 
BAIID must prominently indicate that the BAIID is in need of service 
and the time remaining until ignition lockout. During this period, the 
vehicle may be started if other conditions for starting the vehicle are 
met. At the end of the 7-day lockout period, the BAIID must prominently 
indicate that the BAIID is in need of service and the vehicle must not 
start. Other tests (except Tests 14 and 16) may be performed during 
this 37-day period.
Test 16. Data Integrity and Format
    Complete all other tests before performing Test 16. Download the 
data from the interlock data logger and compare it to the data recorded 
for each test. Disconnect, then reconnect the power to the interlock 
data logger. Download the data again and compare it to the first data 
download. No lost or corrupted data is allowed. Check the data format 
(i.e., date and time of event) to verify conformance with the sample 
format in Appendix D.

APPENDIX A--QUALITY ASSURANCE PLAN TEMPLATE

[Manufacturer name]

Quality Assurance Plan for

[Interlock name AND Model number]

[date]

    This Quality Assurance Plan (QAP) and the operating instructions 
for the [Interlock name] provide step-by-step instructions for 
checking the accuracy of the calibration of a BAIID and the 
maintenance of the BAIID. (As noted in the Model Specifications, 
BAIIDs must hold calibration for at least 37 days (30 days + 7 day 
lockout countdown) and must prominently display the service interval 
and provide for a 7 day lockout countdown.)
-----------------------------------------------------------------------

    1. Provide step-by-step instructions for checking the 
calibration of the BAIID. These instructions must include:
     Indication of the period of time that the BAIID can 
maintain calibration;
     Recommended calibrating unit(s) (listed on NHTSA's 
Conforming Products List of Calibrating Units for Breath Alcohol 
Testers) and instructions for using the calibrating unit(s);
     Breath alcohol concentration to be used in the 
calibration check(s): 0.02 g/dL BrAC;
     Agreement of the calibration check with the breath 
alcohol concentration of the calibrating unit: not greater than 
 0.005 BrAC
     Description of how to verify the accuracy of the BAIID 
reading of BrAC (e.g., from an instrument read out, printout, 
interlock data logger, etc.);
     Description of actions that must be taken if the BAIID 
fails the calibration check.
    2. Provide instructions on downloading the data from the 
interlock data logger.
    3. Provide instructions on how to maintain the BAIID (i.e., what 
must be examined during maintenance; any functions that require less 
frequent checks). Such instructions must detail any corrective 
action to be taken if the BAIID fails to perform as well as any 
events that would require a BAIID to be taken out of service and 
returned to the manufacturer.
    4. Provide instructions on how to check for tampering.
    5. Other information regarding quality assurance unique to this 
instrument, if any:
    Contact information for the BAIID manufacturer regarding 
calibration and maintenance issues:

APPENDIX B--SAMPLE FORMAT FOR DOWNLOADED DATA FROM THE INTERLOCK DATA 
LOGGER

               Example 1--Acceptable Start and Drive Cycle
------------------------------------------------------------------------
                                             Start attempts  (engine
             Date                Time               activity)
------------------------------------------------------------------------
4/21/07......................     0951  start attempt.
                                        sample accepted.
                                        BrAC (alcohol absent, e.g.,
                                         0.000, 0.008).
                                        starter active.
                                  0952  engine on.
                                  0956  retest.
                                        sample accepted.
                                        BrAC (alcohol absent, e.g.,
                                         0.000, 0.008).

[[Page 26867]]

 
                                  1032  engine off.
------------------------------------------------------------------------

          Example 2--Acceptable Start But Fail Rolling Re-Start
------------------------------------------------------------------------
                                             Start attempts  (engine
             Date                Time               activity)
------------------------------------------------------------------------
4/22/07......................     2316  start attempt.
                                        sample accepted.
                                        BrAC (alcohol absent, e.g.,
                                         0.008).
                                        starter active.
                                  2317  engine on.
                                  2319  retest.
                                        BrAC (alcohol present, e.g.,
                                         0.025).
                                        warning given.
4/23/07......................     0047  engine off.
------------------------------------------------------------------------

                          Example 3--Push Start
------------------------------------------------------------------------
                                             Start attempts  (engine
             Date                Time               activity)
------------------------------------------------------------------------
4/23/07......................     2054  ignition keyed.
                                        warning given.
                                        starter not active.
                                  2055  engine on.
                                        warning given.
                                  2120  engine off.
------------------------------------------------------------------------

         Example 4--Start Attempted But Alcohol Detected. Retry
------------------------------------------------------------------------
                                             Start attempts  (engine
             Date                Time               activity)
------------------------------------------------------------------------
4/21/07......................     1652  start attempt.
                                        sample accepted.
                                        BrAC (alcohol present, e.g.,
                                         0.030).
                                  1653  warning given.
                                  1656  start attempt.
                                        sample accepted.
                                        BrAC (alcohol absent, e.g.,
                                         0.015).
                                        starter active.
                                  1657  engine on.
                                  1702  retest.
                                        sample accepted.
                                        BrAC (alcohol absent, e.g.,
                                         0.010).
                                  1850  engine off.
------------------------------------------------------------------------

         Example 5--Start Attempted Using Filtered Sample. Retry
------------------------------------------------------------------------
                                             Start attempts  (engine
             Date                Time               activity)
------------------------------------------------------------------------
4/15/07......................     2016  start attempt.
                                        low temp.
                                        warning given.
                                  2205  start attempt.
                                        sample accepted.
                                        BrAC (alcohol absent, 0.000).
                                        starter active.
                                  2206  engine on.
                                  2352  engine off.
------------------------------------------------------------------------

                      Example 6--Calibration Check
------------------------------------------------------------------------
                                             Start attempts  (engine
             Date                Time               activity)
------------------------------------------------------------------------
4/28/07......................     0900  start attempt.
                                        sample accepted.
                                        BrAC (alcohol absent, 0.000 or
                                         0.008).
                                        starter active.
                                  0903  engine on.
                                  0926  retest.
                                        sample accepted.
                                        BrAC (alcohol absent, 0.000 or
                                         0.008).
                                  1032  engine on.
                                  1045  Calibration check.
------------------------------------------------------------------------

    Issued on: May 3, 2013.
Jeffrey Michael,
Associate Administrator for the Office of Research and Program 
Development National Highway Traffic Safety Administration.
[FR Doc. 2013-10940 Filed 5-7-13; 8:45 am]
BILLING CODE 4910-59-P