[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26849-26867]
From the Federal Register Online via the Government Publishing 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: [email protected].
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: [email protected].
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