[Federal Register Volume 75, Number 193 (Wednesday, October 6, 2010)]
[Notices]
[Pages 61820-61833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25131]
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[Docket No. NHTSA-2010-0033]
Model Specifications for Breath Alcohol Ignition Interlock
Devices (BAIIDs)
AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Notice.
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SUMMARY: This notice proposes revisions to the Model Specifications for
Breath Alcohol Ignition Interlock Devices (BAIIDs). The Model
Specifications are guidelines for the performance and testing of
BAIIDs. These devices are designed to prevent a driver from starting a
motor vehicle when the driver's breath alcohol concentration (BrAC) is
at or above a set alcohol level. Most States currently use BAIIDs as a
sanction for drivers convicted of driving while intoxicated offenses.
In 1992, this technology was new. Now that it has matured, NHTSA
proposes to revise the 1992 Model Specifications, to test BAIIDs for
conformance and to maintain a conforming products list (CPL) of BAIIDs
that have been found to meet the Model Specifications. These proposed
revisions are based, in part, on input from interested parties during
an open comment period.
DATES: Written comments may be submitted to this agency and must be
received no later than December 6, 2010.
ADDRESSES: You may submit comments identified by DOT Docket ID Number
NHTSA-2010-0033 by any of the following methods:
Electronic submissions: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
Fax: 202-493-2251.
Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9
a.m. and 5 p.m., Eastern Time, Monday through Friday, except Federal
holidays.
Regardless of how you submit your comments, you should identify the
Docket number of this document.
Instructions: For detailed instructions on submitting comments and
additional information, see http://www.regulations.gov. Note that all
comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Please see the ``Privacy Act'' heading below.
Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review the
complete User Notice and Privacy Notice for Regulations.gov at http://www.regulations.gov/search/footer/privacyanduse.jsp.
[[Page 61821]]
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Eastern Time, Monday through
Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. De Carlo
Ciccel, Behavioral Research Division, NTI-131, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC
20590; Telephone number: (202) 366-1694; E-mail:
[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; E-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In 1992, the National Highway Traffic Safety Administration (NHTSA)
adopted and published Model Specifications for Breath Alcohol Ignition
Interlock Devices (BAIIDs). (57 FR 11772.) Ignition interlocks are
alcohol breath-testing devices installed in motor vehicles that require
the driver to provide a breath sample in order to start the engine and
to provide a breath sample periodically while the engine is running. If
the breath sample provided by the driver contains more than a
predetermined alcohol concentration, the ignition interlock device
prevents the vehicle from starting.
Before NHTSA adopted the Model Specifications, a number of States
passed laws authorizing the use of ``certified'' BAIIDs. However, there
was no single standard or test procedure among the States for
certifying BAIIDs. Manufacturers of ignition interlock devices
requested that the Federal Government develop and issue standards for
certifying such devices rather than leaving the industry subject to
numerous State standards and test requirements. After notice and
comment, NHTSA adopted the Model Specifications for BAIIDs to provide a
degree of consistency.
Since the Model Specifications were adopted in 1992, many States
have incorporated them or some variation into their certification
requirements. Persons required to use BAIIDs are generally under the
direct supervision of a court or another State agency (e.g., Motor
Vehicle Administration). As of March 2010, 47 States and the District
of Columbia allow the use of BAIIDs for some driving while intoxicated
(DWI) offenders. Of these States, 22 mandate the use of BAIIDs for
repeat DWI offenders, and 13 mandate or highly incentivize the use of
BAIIDs by all DWI offenders, including first-time offenders.
While many States have incorporated the Model Specifications to
certify BAIIDs used by DWI offenders, there remains considerable
variability among State certification requirements. Due to this
variability and to rapid technological advances in the industry, States
and manufacturers of BAIIDs have requested that NHTSA test the devices
against the Model Specifications and maintain a conforming products
list (CPL) of devices found to meet the Model Specifications, similar
to CPLs that NHTSA maintains for other breath alcohol measuring
devices, such as Alcohol Screening Devices, Evidential Breath Testers,
and Calibrating Units for Breath Alcohol Testers.
In response to these requests, NHTSA proposes to revise and update
the 1992 Model Specifications, add provisions for the agency to conduct
conformance testing of BAIIDs, and maintain a CPL of BAIIDs that have
been found to meet those Model Specifications. This proposal is not
intended to take the place of any State certification requirements;
rather, it would establish a voluntary testing and conformance program.
In advance of these proposed revisions of the 1992 Model
Specifications, NHTSA published a request for comments on February 15,
2006. (71 FR 8047.) NHTSA explained that it was interested in obtaining
comments from interested parties in 13 specific areas:
(1) Accuracy and precision requirements. Is the current set point
of 0.025 grams of alcohol per 210 Liters of air (g/dL) appropriate or
should it be changed? Are the current specifications for 90 percent
accuracy at 0.01 g/dL above the set point in the unstressed testing
conditions, and 90 percent accuracy at 0.02 g/dL above the set point in
the stressed testing condition appropriate?
(2) Sensor technology. The 1992 Model Specifications do not address
what type of sensor technology should be used to satisfy those
performance requirements. Should the Model Specifications limit sensor
technology to alcohol-specific sensors (such as fuel cell technology
based on electro-chemical oxidation of alcohol) or other emerging
sensor technologies? Or, should NHTSA not specify the sensor technology
and rely on performance requirements?
(3) Sample size requirements. The 1992 Model Specifications set the
minimum breath sampling size at 1.5 Liters. Informal comments received
over the years have suggested that this requirement may be too high.
Should NHTSA consider lowering the minimum breath sampling size
requirement? Should NHTSA include a minimum sample size and minimum
back pressure at the input-mouthpiece of the device?
(4) Temperature extreme testing. The 1992 Model Specifications call
for testing at -40 [deg]C, -20 [deg]C, +70 [deg]C and +85 [deg]C, but
allow for the removability of the alcohol sensing unit so that it may
be kept at an artificial temperature when the vehicle may be subject to
extremely cold or hot temperatures. Is this approach to extreme
temperature testing sufficient, or should it be more stringent?
(5) Radio Frequency Interference (RFI) or Electromagnetic
Interference (EMI) Testing. The RFI testing protocol in the 1992 Model
Specifications uses power sources that are no longer commonly in use.
New power sources that may interfere with the operation of BAIIDs
(e.g., cell phones) have output power commensurate with equipment in
use today. What are the appropriate levels to measure RFI/EMI?
(6) Circumvention testing. The 1992 Model Specifications offer a
number of procedures for evaluating whether existing devices can be
easily circumvented. Are these procedures sufficient or should new or
modified procedures be incorporated into the Model Specifications?
(7) The Vehicle-Interlock Interface. Anecdotal reports from
ignition interlock manufacturers have suggested that it is sometimes
difficult to install existing interlock systems in some of the newer
electronic ignition systems. Should NHTSA establish any guidelines
regarding the vehicle-interlock interface?
(8) Calibration stability. Is the duration of calibration stability
testing sufficient? Should ignition interlocks be required to hold
their calibration for a longer period of time, thereby requiring less
frequent calibration checks?
(9) Ready-to-use Times. Should NHTSA establish a ``ready-to-use''
time period for extreme cold temperatures, such that devices must
operate within a given period of time under extreme cold conditions?
(10) NHTSA testing. Should NHTSA undertake the responsibility to
evaluate ignition interlocks against its Model Specifications and
publish a Conforming Products List (CPL) of devices meeting those
specifications?
[[Page 61822]]
(11) International Harmonization. Is it important to harmonize the
ignition interlock Model Specifications with standards in other parts
of the world, such as the European Union, Canada, and Australia?
(12) Specifications for Ignition Interlock Programs. Does the
ignition interlock community (users, manufacturers, States, etc.) favor
NHTSA development of an interlock program, in addition to Model
Specifications for devices?
(13) Acceptance Testing. NHTSA's current Model Specifications
involve ``type-testing'' (i.e., testing particular models of BAIIDs for
conformance) of various models of BAIIDs. Should NHTSA establish
standardized acceptance-testing procedures (i.e., testing each
individual device for conformance), instead of the current type-testing
guidelines? What testing should be included in such Model
Specifications? Who should conduct the testing?
In addition to the above 13 specific areas, NHTSA's 2006 notice
solicited comments on other areas that might enhance the revisions of
the Model Specifications. Comments were received from five
manufacturers of interlock devices, five State government
representatives, two automobile manufacturers, one association of
interlock installers and the European Committee for Electrotechnical
Standardization (CENELEC). Today's notice responds to these comments in
setting forth the agency's proposal.
In addition, this notice sets forth the proposed procedures for
submitting BAIIDs for NHTSA testing (Appendix A) and re-examination of
BAIIDs that have been tested (Appendix B).
II. Response to Comments
The comments were supportive of the agency's proposal to revise the
Model Specifications, noting that they had served well in organizing
the interlock field but that some adjustments were warranted to assure
more consistency in the quality of equipment in use today.
A. Set Point, Accuracy and Precision Requirements
There was a lot of variability among comments on the alcohol set
point (i.e., Breath Alcohol Concentration (BrAC) at which a BAIID is
set to lock the ignition). Two commenters stated that the 1992 Model
Specification requirements for set point was appropriate and should not
be changed. One State representative recommended a 0.025 g/dL set point
for adults and a 0.02 g/dL set point for minors. Other State
representatives commented that the alcohol set point could be more
stringent. One commenter stated that several States already use a 0.02
g/dL set point.
NHTSA proposes to lower the set point for testing BAIIDs from 0.025
g/dL to 0.02 g/dL. This is the critical point that is used in the
Breath Alcohol Screening Devices to indicate the presence of alcohol.
Accordingly, for listing on the Conforming Products List (CPL), NHTSA
proposes to test BAIIDs that are capable of locking out at a set point
of 0.02 g/dL. NHTSA believes that 0.02 g/dL is an appropriate set point
because it is an appropriate level to test the presence of alcohol
among offenders using ignition interlocks and it is our understanding
that the technology is available for BAIIDs to have a set point at 0.02
g/dL.
A few commenters stated that the 1992 Model Specifications for
accuracy and precision were appropriate. Most commenters indicated that
with improved technology, a greater degree of accuracy was possible,
but did not specify to what degree. One interlock manufacturer
advocated 95 percent accuracy with a precision of 19 out of 20 test
trials at 0.01 g/dL above the set point for unstressed conditions
(i.e., normal) and 100 percent accuracy and with a precision of 20 out
of 20 test trials at 0.02 g/dL above the set point for stressed
conditions (i.e., atypical, such as extreme temperatures).
Accuracy is the degree to which a BAIID measures the BrAC
correctly. For example, for a BAIID to be accurate, a breath sample
with no alcohol present (0.000 g/dL) must not lock the ignition.
Precision is the degree to which that same measure can be repeated. In
the previous example, for that BAIID to be precise, that same alcohol
free breath sample should not lock the ignition 20 out of 20 test
trials.
NHTSA agrees with the commenters that because of improved
technology, BAIIDs should be subject to a higher degree of accuracy and
precision. NHTSA proposes to define the accuracy and precision
requirements for BAIIDs by testing at 0.012 g/dL above and
below the nominal set point of 0.02 g/dL, i.e., 0.032 g/dL and 0.008 g/
dL, respectively. At 0.032 g/dL, not more than 1 ignition unlock in 20
trials would be allowed. At 0.008 g/dL, not more than 1 ignition lock
in 20 trials would be allowed. No ignition locks in 20 trials would be
allowed at 0.000 g/dL. This increases the accuracy from 90 percent to
95 percent at 0.012 g/dL above and below the nominal set
point of 0.02 g/dL, and 100 percent at 0.000 g/dL. NHTSA determined
these proposed test levels by using standard statistical techniques for
small samples.
B. Sensor Technology
Most commenters stated that it is important to require alcohol-
specific technology in the Model Specifications, but that the
particular sensor design should not be specified. A small group,
including States, favored the use of a particular sensor design (e.g.,
fuel cell). One interlock manufacturer stated that a non-alcohol-
specific technology, such as a semi-conductor that senses alcohol
differently and costs about 50 percent less than a fuel cell, was an
economic alternative to the fuel cell.
While alcohol-specific sensor technologies have made great
advances, this proposal does not limit the sensor technology used in
the BAIIDs as long as the BAIID meets the performance requirements of
the Model Specifications. We believe that this approach will allow a
wider variety of options, including the use of emerging technologies as
they become available.
C. Sample Size Requirement
Most commenters advocated lowering the current 1.5 Liters (L)
minimum sample size (to either 1.2 L or 1.0 L). A subset of these
commenters felt that anything lower than 1.2 L should be set only on
recommendation of a physician. One commenter thought that a 1.5 L air
sample was not enough to ensure an accurate measure of the alcohol
content. NHTSA agrees with the recommendation to lower the minimum
sample size to 1.2 L and proposes a minimum 1.2 L sample size. NHTSA
believes that, at this level, accuracy can be attained and that users
will be able to deliver this smaller sample size.
Some commenters felt that a minimum back pressure, which controls
the force of the air entering the BAIID, was not necessary if the
sample size was not lower than 1.0 L. One commenter suggested requiring
1.2 L sample size with a minimum back pressure and a flow rate of 0.2
L/second. A manufacturer suggested requiring 1.2 L sample size with a
back pressure of 20 hectoPascal (hPa) (e.g., 2 kiloPascals (kPa)) and a
flow rate of 0.1 L/sec. One State suggested an exhale-inhale-exhale
pattern as an alternative to setting a standard. Two States suggested a
1.2 L sample size with back pressure, temperature and time
requirements. Two commenters felt that NHTSA should only set the
minimum sample size, and should not prescribe the means by which the
sample delivery would be accomplished.
In addition to lowering the minimum sample size to 1.2 L as
discussed above,
[[Page 61823]]
NHTSA proposes to require a minimum flow rate of 0.1 L/sec. Flow rate
is the length of time that a sample breath is delivered into the BAIID.
NHTSA believes that a 0.1 L/sec minimum flow rate is a level that will
enable more people to deliver an adequate sample. By lowering the
minimum sample size and adding a minimum flow rate, NHTSA does not
believe that specifying a minimum back pressure is necessary. NHTSA
believes that this proposal will make the BAIID available to a larger
population of users.
D. Extreme Temperature Testing, Removable Sensing Heads or Units
One interlock manufacturer suggested that NHTSA test for extreme
temperature at -45 [deg]C, as temperatures reach that level in high
latitudes and high altitudes. Another interlock manufacturer suggested
that NHTSA leave the testing temperature unchanged and continue to
allow the sensing unit to be removed from the vehicle. Most commenters
felt that the current testing temperature extremes of -40 [deg]C and
+85 [deg]C were appropriate, but did not object to tests at more
extreme temperatures. The CENELEC suggested that the component of the
device that is mounted in the engine compartment be tested for +125
[deg]C in addition to -45 [deg]C. CENELEC further suggested that the -
45 [deg]C temperature test be conducted at 75 percent of nominal
battery voltage because extreme temperatures can reduce available
voltage from a vehicle battery.
NHTSA proposes to retain the current extreme temperature tests at -
40 [deg]C and +85 [deg]C. The agency believes that the current
temperature range is reasonably representative of the environments
encountered in the United States. However, NHTSA proposes to conduct
additional high temperature tests for components of the BAIID installed
in the passenger compartment (at +49 [deg]C) and in the engine
compartment (at +85 [deg]C), and to specify the humidity level for
these high temperature tests. Further, NHTSA proposes to discontinue
testing at -20 [deg]C and +70 [deg]C because our experience indicates
that testing at the extreme temperatures is sufficient.
NHTSA also agrees that the -40 [deg]C temperature test should be
performed at 9 volts, which is representative of 75 percent of the
nominal battery voltage (i.e., 12-volt automobile battery). NHTSA
believes that the test should be conducted at this voltage because
vehicles often do not operate at the optimal battery voltage.
Accordingly, NHTSA proposes to test BAIIDs using a 9-volt direct
current (DC) power source, simulating a 12-volt DC battery operating at
low temperatures.
Many commenters stated that NHTSA should not allow the removal of
the sensing unit because BAIIDs are expected to operate at a variety of
ambient temperature conditions. One State favored a removable
mouthpiece (to protect users' lips from extreme temperatures), rather
than a removable sensing unit, and another State favored a prescribed
warm-up period. NHTSA agrees with the commenters that the sensing unit
should not be removable because it can more easily be damaged or
mishandled, leading to frequent repairs and increased cost.
Accordingly, NHTSA proposes to test only BAIIDs without removable
sensing heads or units. (The agency does not object to BAIIDs with a
removable mouthpiece.)
E. RFI or EMI Testing
Commenters noted that appropriate power for RFI testing should be
considered because an increasing number of electronic devices are being
operated in close proximity to BAIIDs, such as gaming, remote keyless
entry, portable medical and Bluetooth-capable devices. Two BAIID
manufacturers suggested that the European Standard for EMI be adopted
because it describes electromagnetic compatibility of vehicles for
broadband and narrowband interference and shielding. Two commenters
noted that CB radios were more relevant sources of interference and
that the CENELEC standard is unnecessarily restrictive on EMI. A State
government commenter suggested that the Society of Automotive Engineers
(SAE) J551 Vehicle Electromagnetic Immunity-Bulk Current Injection
Standard be applied to BAIIDs.
NHTSA agrees that the current specifications do not adequately
define or describe RFI/EMI tests. NHTSA proposes to test BAIIDs for
emissions and transmissions of RFI/EMI and immunity to RFI/EMI using
the SAE Surface Vehicle Standard J1113 series for Class C devices
(devices essential to the operation or control of the vehicle) and the
International Special Committee on Radio Interference (CISPR),
Subcommittee of International Electrotechnical Committee (IEC),
specifically CISPR 25, for RFI/EMI testing. NHTSA proposes these tests
because we believe that they represent a broad consensus in the
industry.
F. Tampering and Circumvention Testing
There was some criticism that the 1992 Model Specifications for
tampering and circumvention testing are confusing and lack specificity.
One BAIID manufacturer felt that the U.S. should adopt the CENELEC
standards for charcoal filters, water bubbler, condensation through a
long cool tube and pressurized air, and interlock bypass. Another BAIID
manufacturer commented that there are aspects of the circumvention
detection specifications that are difficult to quantify because
different companies develop their own proprietary anti-circumvention
strategies (e.g., a learned hum code or toot sequence). This
manufacturer commented that program standards should address this by
imposing consequences for tampering with devices. Three State
government commenters suggested that NHTSA should set higher anti-
circumvention standards and have a counter system or data log that
records attempts to start the vehicle by bypassing the ignition. One
State thought that the use of time, pressure, differing blow patterns
and breath temperature should help prevent circumvention. States
believed that device design should not present challenges to the user,
and that the individual's breath signature should be used as the basis
for anti-circumvention efforts.
Although NHTSA believes that an individual's breath signature
(i.e., a person's unique breath pattern) is a good goal for the future,
NHTSA's proposal does not include individual breath signature as an
anti-circumvention measure. NHTSA does not believe that technology is
sufficiently advanced to warrant including individual breath signature
in this proposal. However, NHTSA agrees with commenters that the
circumvention requirements are confusing. Accordingly, the agency
proposes to clarify and specify the requirement for circumvention and
tampering tests and to specify that the BAIID must have tamper proof
seals to indicate when a BAIID has been disconnected from the ignition.
G. Vehicle-interlock interface
Interlock manufacturers and providers supported a standard
interlock-vehicle interface, and recommended that NHTSA require all
vehicles to have either a communications bus interface or another hard-
wired interface connector for specific use for any ignition interlock
device. Other commenters suggested that a common interface would be a
great convenience since it would make installation easier. However, two
automobile manufacturers commented that although there may be benefits,
requiring all vehicles to have a common interface for BAIIDs presented
significant challenges
[[Page 61824]]
that could compromise vehicle ignition security systems and anti-theft
immobilizing technologies.
While we understand the installation convenience that would be
afforded by a common vehicle interlock interface, such a requirement
goes beyond the scope of this proposal, which is limited to the BAIID
itself and not to changes to the vehicle.
H. Calibration Stability and Service Interval
NHTSA received comments regarding both calibration stability and
service interval requirements. Some manufacturers commented that NHTSA
should establish separate requirements for the minimum period of
calibration stability and the service interval. NHTSA notes that these
two requirements are interrelated. If a BAIID's calibration remains
stable for a given period of time, it follows that service will be
required after that period to verify the calibration of the BAIID. For
clarity, NHTSA proposes to define calibration stability as the ability
of the BAIID to hold its accuracy and precision over a defined time
period and calibration interval as the maximum time period that a BAIID
may be used without a calibration check, after which the ignition must
lock. NHTSA proposes to define the service interval as the maximum time
period that a BAIID may be used without maintenance.
For both the calibration interval and the service interval, most
commenters stated that the BAIID should enter a lockout countdown to
notify the BAIID user that the BAIID needs a calibration check or
maintenance, service or data download, and the BAIID should prevent the
vehicle from starting at the end of the lockout countdown period. In
response to these comments, NHTSA proposes to incorporate a 7-day
lockout countdown for both calibration interval and service interval.
NHTSA believes that requiring a lockout countdown for both the
calibration interval and the service interval is important to ensure
that the BAIID is accurately reading breath samples and is properly
working. NHTSA further proposes that during the lockout countdown
period, the BAIID should notify the user of the time remaining before
the ignition locks. However, NHTSA declines to impose any countdown or
lockout requirement for downloading data, as this decision should
properly be left to the States or the courts for decision.
NHTSA proposes to revise the calibration stability requirements.
The 1992 Model Specifications called for calibration stability for 7
days beyond the manufacturer's designated calibration stability period
of 30, 45, or 60 days. For example, if the manufacturer required that
the calibration of BAIIDs be checked after 60 days, the BAIID would
need to hold the calibration for 67 days. NHTSA now proposes that
BAIIDs must hold calibration for a minimum 30 days plus the 7-day
lockout countdown described previously (i.e., 37 days) in order to
conform to the Model Specifications. Although some manufacturers have
BAIIDs that are claimed to hold calibration for a longer time period,
NHTSA proposes to test the calibration stability at 37 days (i.e., 30
days plus the 7-day lockout countdown) and to require lockout after 37
days. Accordingly, NHTSA proposes that only BAIIDs that meet both the
37-day calibration stability test and the 30+ 7-day lockout countdown
function will be listed on the CPL.
NHTSA also proposes to add service interval requirements. The 1992
Model Specifications did not specifically require a service interval
period. Although the term ``service interval'' is used in the 1992
Model Specifications, that term was used only in relation to
calibration stability. It is our understanding that some States use
this term to denote the time period for maintenance and data download
as well as calibration stability checks. Commenters from State
governments recommended that NHTSA require that BAIIDs have a service
interval not greater than 30 days, plus a 7-day lockout countdown.
NHTSA agrees with these comments and proposes to incorporate this
requirement in the Model Specifications because requiring regular
maintenance checks is important to ensure that the BAIID is properly
working. As noted above, we do not specify a lockout requirement for
data download.
I. Ready-to-Use Times and Retest
Commenters stated that a quicker ready-to-use time is possible with
newer technology. A commenter stated that one of the biggest complaints
with users of BAIIDs is the waiting time for the breath test, and that
reducing the waiting time may increase the acceptance of BAIIDs.
Several manufacturers indicated that a faster ready time of 3 minutes
at low temperatures was achievable.
NHTSA agrees that with current technology, BAIIDs can be ready for
use faster than the times provided under the 1992 Model Specifications.
NHTSA proposes that at temperatures above -40 [deg]C (-40 [deg]F),
BAIIDs should be ready for use in 1 minute or less and be ready to
retest in 1 minute or less. For temperatures at -40 [deg]C (-40
[deg]F), NHTSA proposes that the BAIID should be ready for use in 3
minutes or less and ready to retest in 3 minutes or less. NHTSA
proposes to test this performance.
NHTSA does not intend that retests be conducted while the vehicle
is moving, but rather while the engine is running with the vehicle
stopped in a safe location on the side of the road. The proposed Model
Specifications make this point clear.
J. NHTSA Testing
Commenters favored a certified testing laboratory program. Most
advocated a NHTSA test program and the development of a Conforming
Products List (CPL) based on the Model Specifications. One commenter
favored having a single private testing laboratory certified by NHTSA
for this purpose. Several manufacturers noted significant problems with
State certification requirements leading to questionable test results
for some products. In general, both manufacturers and States favored a
NHTSA test program because it would organize and standardize the
industry and exclude less effective BAIIDs. One commenter suggested
that NHTSA require BAIID re-certification in the event of an instrument
design change and/or at some reasonable interval.
NHTSA proposes to test BAIIDs for conformance with the Model
Specifications. See Appendix A for proposed BAIID submission
procedures. NHTSA also proposes to maintain and publish periodically a
CPL with BAIIDs that have been tested and found to conform to the Model
Specifications. NHTSA proposes to manage this new program as it does
its other breath alcohol instrument testing programs, including the re-
examination of BAIIDs at its sole discretion (Appendix B) and requiring
manufacturers to inform NHTSA of any changes or modifications to a
tested BAIID. As with NHTSA's other testing programs, NHTSA also
proposes to require manufacturers to submit a quality assurance plan
(QAP) for BAIIDs being tested. A QAP is a manufacturer's plan for
maintaining the integrity and the calibration of a BAIID. NHTSA
proposes that the QAP include the following information: instructions
for checking the calibration of the BAIID (i.e., recommended
calibrating unit, BrAC of 0.02 g/dL, agreement not greater than 0.005 BrAC, verification of accuracy of readout, actions to take
for failed calibration check), instructions for downloading the data
from the data logger, instructions to maintain the BAIID, instructions
on checking for
[[Page 61825]]
tampering, and any other information regarding quality assurance unique
to the instrument. See Appendix C, the proposed sample QAP template.
Testing of BAIIDs will be subject to the availability of Federal
funds. If Federal funds are not available, NHTSA will discontinue
testing BAIIDs until funds become available.
K. International Harmonization
There was considerable variability from commenters on this issue.
Those favoring harmonization with the CENELEC standards argued that in
an increasingly global marketplace, common standards would benefit both
economic and safety concerns. Some against harmonization stated that
aspects of the CENELEC standard are potentially restrictive and costly.
Others opposed harmonization because the U.S. organized the BAIID
industry by emphasizing safety and design flexibility in a way that
encouraged the domestic industry and avoided costly requirements.
NHTSA believes that there are some benefits to harmonizing some
standards, and has proposed to incorporate aspects of CENELEC standards
as identified elsewhere in this proposal.
L. Interlock Program Specifications
Some commenters stated that interlock program specifications or
interlock program guidelines (i.e., programs to implement the use of
BAIIDs) have been and should remain a function of State government.
Others largely expressed support for NHTSA development of interlock
program guidelines, especially in the areas of installation
requirements, monitoring and recalibration of devices, and recognizing
device tampering. While NHTSA believes that such a program is
important, today's notice addresses only BAIID performance criteria and
testing of BAIIDs. NHTSA may explore interlock program guidelines in a
future action.
M. Acceptance Testing
Some commenters stated that acceptance testing is being performed
by some States, but that the criteria vary among those States. These
commenters stated that NHTSA should establish standardized acceptance-
testing procedures in addition to the 1992 Model Specifications.
Several commenters requested that the term ``acceptance testing'' be
more clearly defined. One commenter recommended that NHTSA establish
enforceable guidelines, mandatory audits and periodic re-examinations.
NHTSA defines ``acceptance testing'' as the pass-fail evaluation of
each individual device performed before placing that device into
service. Because of limited resources, NHTSA proposes to conduct
``type-testing'' (i.e., testing of a sample of a particular model of
BAIID, rather than every device manufactured).
N. Additional Comments
1. Two commenters suggested that BAIID manufacturers make available
the operating software codes of the BAIIDs, including disclosure of how
the BAIIDs monitor their own malfunctions and the criteria the devices
use to trigger recalls. NHTSA does not believe that making a
manufacturer's proprietary software publicly available is desirable or
necessary, as the agency's proposal sets forth performance
specifications, not design specifications. Moreover, making such
information public may lead to increased circumvention and tampering.
2. Commenters suggested that data loggers distinguish calibration
tests from user samples. NHTSA agrees that distinguishing such
information would be useful for monitoring the BAIID user. Accordingly,
NHTSA proposes that the BAIID must include a data logger that will
distinguish calibration tests from user samples as well as record all
start attempts and outcomes, such as emergency override, circumvention,
tampering, and BrAC for each start attempt. The data must be presented
in chronological order (i.e., by date and time of event). See Appendix
D for a sample format for downloaded data from the data logger. The
audit trail should also indicate the version of the metrological
software (i.e., the BAIID's operating system) in use. All printed and
downloaded reports should indicate the software version. NHTSA proposes
to test these features.
The agency understands that some customers (such as States) request
certain changes to the BAIID, so that read-out data is presented in a
particular format. Such customization is generally accomplished through
software modifications. Testing customer-driven software modifications
is beyond the scope of this program. Moreover, if such modifications
were permitted to be performed to the internal software of the BAIID at
a customer's behest, the integrity of the CPL would be compromised as
the BAIID tested could then differ from customized devices in
production. However, NHTSA is aware that States (and local
jurisdictions) use different set points in their interlock programs.
Therefore, we do not believe that changes to the set point, alone,
should be deemed impermissible modifications. Accordingly, the agency's
proposal does not allow any modifications of internal BAIID software at
the behest of customers, except for adjustments to the set point. (We
note that for testing purposes, NHTSA proposes to test BAIIDs with an
alcohol set point of 0.02 g/dL.) Manufacturers wishing to accommodate a
customer's interest in data formatting options should do so by
providing a port that allows connection of a peripheral device with its
own formatting software. Manufacturers are advised that, when
submitting a BAIID to NHTSA for testing, they must submit the basic
model without any customized or add-on software.
3. Commenters suggested that the BAIID memory should be located in
a fixed control box. NHTSA agrees with these commenters and proposes to
add this to the General Requirements and BAIID Features because a fixed
control box provides less opportunity for potential damage to the BAIID
memory.
4. Commenters suggested that restarts should be allowed only if a
vehicle stalls, but not if the ignition is intentionally turned-off or
if a BAIID malfunctions or is awaiting a retest. NHTSA proposes that a
restart (i.e., without a breath sample) should be allowed when the
vehicle stalls, provided the restart is accomplished in no more than 20
seconds. NHTSA also proposes that in all other situations where the
vehicle malfunctions, the vehicle should be prevented from starting
without a breath test.
Commenters further suggested that if a BAIID malfunctions or fails,
the device should default to preventing the vehicle from starting.
NHTSA agrees with the commenters and proposes that if a BAIID
malfunctions or fails (e.g., improper voltage, temperature exceeding
operating range, dead sensor, etc.), the BAIID should prevent the
vehicle from starting.
5. Some commenters stated that an emergency override was a useful
feature. NHTSA declines to propose that BAIIDs be required to have an
emergency override feature (i.e., the ability to start the vehicle
without a breath test) in order to conform with the Model
Specifications. However, should a BAIID be equipped with an emergency
override feature, NHTSA proposes to allow its activation to start the
vehicle only once. After that, the BAIID must indicate the need for
service and record the use of the emergency override. No additional
emergency overrides would be allowed during the lifetime of the BAIID
installation. The agency proposes to test this feature. NHTSA also
proposes that this emergency override feature have a default to prevent
an
[[Page 61826]]
override from being used when the BAIID malfunctions or fails. See
Section II, N, 4 above.
6. A commenter suggested that the BrAC test results be displayed to
the driver. NHTSA declines to propose that BAIIDs display the BrAC test
results to the driver and does not propose to add this requirement in
the Model Specifications. NHTSA believes that the role of the BAIID is
to detect the presence of alcohol and to prevent the driver from
operating the vehicle if alcohol is present. We believe that displaying
the BrAC goes beyond the purpose of the BAIID. Accordingly, NHTSA does
not propose to test BAIIDs for the accuracy of the BrAC display. NHTSA
proposes to test only the accuracy of the notifications to a BAIID user
that are related to the features tested by NHTSA, such as warm-up time,
retest, calibration check and service interval.
In addition, NHTSA proposes to remove a number of tests for
optional features identified in the 1992 Model Specifications.
7. A commenter suggested that an interlock-specific tone (other
than a honking horn) be used to alert outsiders to BAIID violations. At
this time, NHTSA does not believe that audible sounds or lights to
alert the public to interlock violations are necessary, and does not
include the suggestion in this proposal.
8. A commenter suggested that several CENELEC standards be adopted
into the Model Specifications, including a dust test, a drop test for
removable sensor heads, vibration tests, and protection against reverse
polarity on all circuits. That commenter also suggested that
instruction guides or manuals be provided to the interlock installers
and user.
In two decades of experience, NHTSA has received no reports
suggesting that dust is an issue or source of concern in BAIIDs
installed in vehicles. Therefore, we are not proposing a dust standard.
As the agency's proposal does not allow the removal of the sensor head,
we are not proposing a drop test. NHTSA proposes to update the
vibration and cigarette smoke tests from the 1992 Model Specifications
to incorporate aspects of the CENELEC standard (see Test 7 and Test 12,
respectively). NHTSA agrees with the commenter that electrical
properties of the vehicle (contact safety, etc.) must not adversely
affect or be affected by a properly installed BAIID. NHTSA also agrees
that instruction guides or manuals should be made available to
interlock installers and users.
O. Other Proposed Revisions
The agency proposes to re-organize the Model Specifications to
improve clarity. NHTSA also proposes to delete the commentary sections
of the 1992 Model Specifications because these sections are no longer
necessary. Also, we have not retained the previous organization of
sections on safety and utility, and we have specified in more detail
the tests for humidity, cigarette smoke, retest, and circumvention and
tampering. In addition, the proposed Model Specifications no longer
include a separate test for user displays, but rather incorporate the
test for user display under other tests (e.g., warm up time, retest,
calibration interval, service interval). The proposed Model
Specifications delineate conformance tests and performance
requirements.
NHTSA proposes to delete the following terms as no longer
applicable: Safety and Utility (Safety Feature, Utility Feature, and
Optional Feature), Stress Tests, Certification Tests, Clearance Rates,
Device, Fail-safe, False-negative, False-positive, High end and Low
end. NHTSA also proposes to add three terms--calibration stability,
calibration interval, and service interval. See Section II, H.
NHTSA proposes to delete the Certification Test Summary and the
Equipment List that appeared in Appendices A and B because these
provisions are obsolete, and relevant information is incorporated in
the Tests.
NHTSA proposes to add two tests to the Model Specifications--High
Altitude (Test 11) and Acetone (Test 13). NHTSA believes that because
high altitudes may affect semi-conductor type alcohol sensors, this
condition should be tested. NHTSA believes that acetone should be
tested because it is the most common interfering substance for BAIIDs.
Finally, of the tests listed, Test 17 (Data Integrity and Format) must
be performed last as this test checks the integrity of the downloaded
data. See also Appendix D for a sample format for downloaded data from
the data logger.
In addition, NHTSA proposes that in order to be listed on the CPL,
manufacturers must submit a self-certification, certifying that the
manufacturer meets the requirements of the U.S. Department of Health
and Human Services Public Health Services, Food and Drug
Administration's (FDA) Good Manufacturing Practices regulations for
devices used for medical purposes (21 CFR Part 820), and that the
device's label meets the requirements contained in FDA's Labeling
regulations for devices used for medical purposes (21 CFR 809.10), even
if the devices are not to be used for medical purposes. If NHTSA
becomes aware that a manufacturer of a BAIID on the CPL is not in
compliance with the requirements in FDA's Good Manufacturing Practices
regulations for devices used for medical purposes or that the device's
label does not comply with the requirements in FDA's labeling
regulations for devices used for medical purposes, NHTSA may remove the
manufacturer's BAIID from the CPL.
The agency encourages interested parties to review carefully this
notice and the Model Specifications set forth below, and to submit
comments in the manner identified in Addresses above.
These proposed Model Specifications, if adopted in final, would not
have the force of regulations and are not binding. States and others
may adopt these Model Specifications and rely on NHTSA's type-test
results or they may conduct their own tests according to their own
procedures and specifications.
After consideration of the comments, the agency proposes the Model
Specifications for Breath Alcohol Ignition Interlock Devices as set
forth below.
Authority: 23 U.S.C. 403; 49 CFR 1.50; 49 CFR part 501.
Model Specifications for Breath Alcohol Ignition Interlock Devices
(BAIID)
A. Purpose and Scope
1. In General
The purpose of these specifications is to establish 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
be connected to the ignition system in a way that prevents 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 ignition is locked and the vehicle will not start. BAIIDs
are currently being used as court sanctions as well as administrative
conditions of licensure. Drivers convicted of Driving While Intoxicated
(DWI) 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. BAIIDs found to
conform to these specifications will be placed on a conforming products
list
[[Page 61827]]
(CPL) published in the Federal Register. NHTSA will periodically update
this CPL. These specifications are voluntary and do not impose any
compliance obligations on BAIID manufacturers or others.
2. Limitations
NHTSA will test BAIIDs for conformance with these Model
Specifications on a first-come, first-served basis, subject to the
manufacturer submission requirements of Appendix A. Any re-examination
of BAIIDs will be conducted at the agency's sole discretion, in
accordance with the provisions of Appendix B. All tests are subject to
the availability of Federal funds.
B. Terms
Alcohol--Ethanol or ethyl alcohol (C2H5OH).
Alcohol set point--Breath Alcohol Concentration (BrAC) at which a
BAIID is set to lock the ignition.
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 Interval--The maximum time period that a BAIID may be
used without a calibration check, after which the ignition must lock.
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 without using the ignition switch, or by any other 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
pertinent 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 with the vehicle
stopped in a safe location on the side of the road. This is also
referred to as a running retest or a rolling retest.
Service Interval--The maximum time period that a BAIID may be used
without maintenance or data download, after which the ignition must
lock.
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 Requirements and Features of BAIIDs
In order to be listed on NHTSA's Conforming Products List (CPL), a
BAIID must meet the following requirements:
The BAIID must pass each of the conformance tests 1 through 17 in
Section D, unless explicitly excluded from a test by the specific terms
of these specifications.
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 not have a removable sensing head or unit, but may
include the use of a detachable mouthpiece for breath sample delivery.
The BAIID memory must be in a fixed control box.
The BAIID must have tamper proof seals to indicate when a BAIID has
been disconnected from the ignition.
The BAIID must be capable of locking out at a specified breath
alcohol concentration. The submitted BAIID will be tested at an alcohol
set point of 0.02 g/dL with a minimum flow rate of 0.1 L/sec. Upon
detecting an alcohol concentration at or above that set point, the
BAIID must lock the ignition 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 so that a valid breath test must be performed before the
vehicle may be started.
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 locks the vehicle's ignition, 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 to the Volpe Center.
In addition, manufacturers must submit the quality assurance plan
(QAP) to NHTSA for approval. 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 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 C for sample QAP template.
Manufacturer must also submit a self-certification to NHTSA,
certifying that the manufacturer meets the requirements of the U.S.
Department of Health and Human Services Public Health Services, Food
and Drug Administration's (FDA) Good Manufacturing Practices
regulations for devices used for medical purposes (21 CFR Part 820),
and that the device's label meets the requirements contained in FDA's
Labeling regulations for devices used for medical purposes (21 CFR
809.10), even if the devices are not to be used for medical purposes.
(If NHTSA becomes aware that a manufacturer of a BAIID on the CPL is
not in compliance with the requirements in FDA's Good Manufacturing
Practices regulations for devices used for medical purposes or that the
device's label does not comply with the requirements in FDA's labeling
regulations for devices used for medical purposes, NHTSA may remove the
manufacturer's BAIID from the CPL.)
The design of the BAIID must include a data logger that will record
all start
[[Page 61828]]
attempts and outcomes, including an emergency override, 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 D for a sample format for downloaded data from the data
logger. The manufacturer must provide NHTSA with a means of downloading
the data from the data logger.
The BAIID must track all changes to the metrological software and
indicate the software version and date on all printed and downloaded
reports. The BAIID must not include any add-on or specialized software
to meet the needs of a specific customer. Manufacturers wishing to
accommodate a customer's interest in data formatting options should do
so by providing a port that allows connection of a peripheral device
with its own formatting software. We are aware that States (and local
jurisdictions) use different set points in their interlock programs,
and such changes to the set point, alone, would not be deemed
impermissible. However, NHTSA will test BAIIDs at an alcohol set point
of 0.02 g/dL.
D. BAIID Test Procedures
General Test Conditions
Unless otherwise specified in the 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 [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 the conformance test, the BAIID must
meet the following performance requirements in each test:
Tests at 0.032 g/dL BrAC (grams alcohol/210 liters of
air): not more than 1 ignition unlock in 20 trials is allowed.
Test at 0.008 g/dL BrAC: not more than 1 ignition lock in
20 trials is allowed.
Tests at 0.000 g/dL BrAC: no ignition lock in 20 trials is
allowed.
A BAIID must be ready for use 1 minute after it is turned
on. A BAIID must be ready for a second test within 1 minute 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, NHTSA may
elect to use either a motor vehicle or a bench test set-up that
simulates the relevant functions of a motor vehicle.
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 lock the ignition 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 not lock the ignition 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 not lock the ignition 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 not lock the ignition 5 out of 5 times.
Test 3. Calibration Interval and 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.
After 30 days, the BAIID must prominently indicate a 7-day lockout
countdown, i.e., an indication that the BAIID must be taken to a
designated facility for a calibration check within 7 days or the
ignition will lock and the event will be logged. Over the course of the
7-day lockout countdown, the BAIID must prominently indicate that the
BAIID needs a calibration check, the time remaining until ignition
lockout, but the ignition must not lock. At the end of this 7-day
lockout countdown, the BAIID must prominently indicate that the BAIID
needs a calibration check and the ignition must lock.
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 (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,
[[Page 61829]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acceleration,
Test 7 Frequency range, Number of cycles Sweep rate, Amplitude, inches gravity (g), 0 to
Hz octave/min 0 to peak 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. Retests must
not be conducted while the vehicle is moving, but must be conducted
while the engine is running with the vehicle stopped in a safe location
on the side of the road.
a. Within an interval of 5 to 7 minutes after a successful ignition
unlock, using a 0.000 g/dL BrAC test sample, and while the ignition
remains unlocked and the engine is running, the BAIID must indicate
that a second breath sample is required. Conduct Test 1b five times.
The ignition must remain unlocked all 5 times.
b. Within an interval of 5 to 7 minutes after a successful ignition
unlock, using a 0.000 g/dL BrAC test sample, and while the ignition
remains unlocked and the engine is running, the BAIID must indicate
that a second breath sample is required. Conduct Test 1c five times.
The ignition must remain unlocked, but the BAIID must prominently
indicate the need for a service call (i.e., this is an indication of a
failed retest).
A failed retest must be identified as an alert condition and
flagged on the data logger. A missed retest must be flagged on the data
logger. After the driver is alerted to retest, if the engine is
accidentally or intentionally powered off, the BAIID must not unlock
without a service call. If a BAIID includes a feature designed to
detect whether the vehicle is moving, perform the above tests with and
without vehicle movement.
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 data logger.
a. ``Hot wiring''. Start the engine by electrically bypassing the
BAIID. The 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 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 ignition must remain locked.
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 ignition must remain locked.
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 ignition must remain
locked.
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 ignition must remain locked.
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 20 seconds--the ignition must not lock. Turn off the
ignition. Attempt to restart the ignition without a breath sample
between 20 to 25 seconds after turning off the ignition--the ignition
must lock. Conduct Test 10 five times.
Test 11. High Altitude
This test applies only to BAIIDs with a semiconductor-type alcohol
sensor. 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 remain unlocked; for Test 1c, the ignition must remain
locked.
Test 12. Cigarette Smoke
Direct a cigarette smoker, who is alcohol-free, to smoke
approximately [frac12] of a cigarette. The smoker must wait 1 minute or
a period specified by the BAIID manufacturer before testing. Conduct
Test 12 three times. The ignition must not lock. (A simulator may be
used in lieu of a smoker.)
Test 13. Acetone
Test the BAIID for acetone interference. Conduct Test 1b by adding
230 microliters of acetone \4\ to the 500 milliliters of .008 g/dL BrAC
alcohol simulator solution. Conduct Test 1b three times. The ignition
must not lock.
---------------------------------------------------------------------------
\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. Emergency Override
This test applies only to BAIIDs equipped with an emergency
override feature. Follow the BAIID manufacturer's instructions to
activate the emergency override feature without providing a breath
sample. Upon a first
[[Page 61830]]
activation, verify that the BAIID allows the vehicle to start. Attempt
to activate the emergency override feature two additional times without
providing a breath sample. Verify that the BAIID does not allow the
vehicle to start on either of those subsequent attempts. The ignition
must not lock on the first attempt, and must lock on both subsequent
attempts. All other functions of the BAIID should operate normally,
including the running retest and data logging.
Test 15. Radiofrequency Interference/Electromagnetic Interference
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 (volts,
Level peak to peak) Status
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
Level Severity (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 -25 I.
1................................... 2 -50 II.
3 -75 II.
4 -100 IV.
1 25 I.
2a.................................. 2 40 II.
3 50 II.
4 75 IV.
2b.................................. 1 10 I.
1 -35 I.
3a.................................. 2 -75 II.
3 -112 II.
4 -150 IV.
1 25 I.
3b.................................. 2 50 II.
3 75 II.
4 100 IV.
1 -4 I.
4................................... 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.
Conducted Transient Emissions
------------------------------------------------------------------------
Maximum pulse amplitude
Pulse polarity (12 volt system) (V)
------------------------------------------------------------------------
Positive....................................... 75
Negative....................................... -100
------------------------------------------------------------------------
Limits for Broadband Conducted Disturbances (MHz)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.15-0.3 0.53-2.0 5.9-6.2 30-54 68-108
------------------------------------------------------------------------------------------------------
P QP P QP P QP P QP P QP
--------------------------------------------------------------------------------------------------------------------------------------------------------
a................................................ 93 80 79 66 65 52 65 52 49 36
[[Page 61831]]
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 16. Service Interval
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 ignition will lock 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, the time
remaining until ignition lockout, but the ignition must not lock. At
the end of this 7-day lockout countdown, the BAIID must prominently
indicate that the BAIID is in need of service and the ignition must
lock. Other tests (except Tests 15 and 17) may be performed during this
37-day period.
Test 17. Data Integrity and Format
Complete all other tests before performing Test 17. Download the
data from the data logger and compare it to the data recorded for each
test. Disconnect, then reconnect the power to the 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--Submission Procedures for Conformance Testing of Breath
Alcohol Ignition Interlock Devices (BAIID)
NHTSA will test Breath Alcohol Ignition Interlock Devices
(BAIIDs) at the DOT Volpe National Transportation Systems Center
(Volpe Center). 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.
Manufacturers that wish to submit a BAIID for testing must apply
in writing to the Office of Behavioral Safety Research, NTI-130,
NHTSA, 1200 New Jersey Avenue, SE., Washington, DC 20590.
Manufacturers must apply separately for each BAIID. NHTSA will test
BAIIDs on a first-come, first-served basis. NHTSA will contact
manufacturers with a test date and instructions for BAIID delivery
to the Volpe Center. Manufacturers should not send devices until
NHTSA has scheduled a test date.
When NHTSA has scheduled a test date, the manufacturer must
submit one BAIID. If the BAIID is designed with special features,
the BAIID must be submitted with instructions explaining how to turn
each feature on and off. The manufacturer must also submit the
operator's manual (user's guide or instructions to the user), the
maintenance manual, quality assurance plan (QAP) (Appendix C),
including recalibration and service requirements that are provided
to the installation providers with the purchase or lease of the
BAIID, self-certification as to the FDA's good manufacturing
practices and device labeling requirements, as well as
specifications and drawings fully describing the BAIID and its use.
Manufacturers seeking confidential treatment for submitted
information must follow the procedures set out in 49 CFR part 512.
The manufacturer is responsible for ensuring that the BAIID is
operating properly and calibrated prior to the initiation of the
test. Once testing begins, the manufacturer will not be allowed
access to the BAIID or to the test site.
BAIIDs that are tested by the Volpe Center and determined to
conform to the Model Specifications will be listed on a Conforming
Products List (CPL). NHTSA will not accept test results from other
sources. Except as specifically noted under a test procedure, BAIIDs
must conform to the specifications in all 17 tests in order to be
listed on the CPL.
Any malfunction of a BAIID resulting in failure to complete any
of the required tests satisfactorily will result in a determination
that the BAIID does not conform to the Model Specifications. If a
BAIID fails any one of the tests, the agency at its own discretion
may stop any further tests. If a BAIID fails to conform to the Model
Specifications, NHTSA will notify the manufacturer in writing, and
provide the reasons for the failure.
NHTSA will publish and update the CPL periodically in the
Federal Register.
Appendix B--Re-Examination* of Breath Alcohol Ignition Interlock
Devices (BAIID)
*Re-examination of a BAIID is at the sole discretion of NHTSA
and subject to the availability of Federal funds.
1. Re-Examination of Nonconforming BAIID
If test results reveal that a BAIID does not meet the Model
Specifications, a manufacturer may resubmit the BAIID for re-
examination after appropriate corrections have been made to the
BAIID. The manufacturer must follow the submission procedures in
Appendix A. In addition, the manufacturer must provide written
documentation of the changes or corrections that have been made to
the BAIID to bring the device into conformance with the Model
Specifications.
2. Changes to BAIID Listed on the Conforming Products List (CPL)
Manufacturers contemplating changes to a BAIID listed on the CPL
(other than modification of the set point) are advised that any
change may affect the status of the BAIID on the CPL. The
manufacturer should inform NHTSA of the contemplated change(s) to
determine whether re-examination of the BAIID is necessary. The
manufacturer should submit the following information to NHTSA:
Model name of the changed device.
Nature and reason for change.
Scope of change (e.g., Will existing BAIIDs or BAIIDs
in the marketplace be retrofitted? Will the change apply to some
users but not others?)
Will the change affect performance of the BAIID under
the Model Specifications? (Precision and accuracy, temperature
operations, vibrations, other laboratory readings, etc.)
How will the change(s) be documented for the benefit of
the user? (e.g., Will the
[[Page 61832]]
change(s) be documented in service bulletins and/or service manuals?
If not, why not?)
Drawings of the changed BAIID.
If NHTSA determines that the changes to the BAIID may affect the
conformance of the BAIID with the Model Specifications, NHTSA will
request that the changed BAIID be sent for testing. Refusal to
provide the changed BAIID for testing may result in the removal of
the BAIID from the CPL.
3. Re-Examination of BAIID Listed on the CPL
If available information indicates that a BAIID on the CPL may
not perform in accordance with the Model Specifications, NHTSA may
direct the Volpe Center to re-examine the BAIID. To assist in this
effort, NHTSA may request manufacturers to send another BAIID sample
for testing. (Refusal to provide another BAIID sample may result in
the removal of the BAIID from the CPL.) Based on the new tests,
NHTSA will determine whether the BAIID continues to conform to the
Model Specifications. If the BAIID does not meet the Model
Specifications, the BAIID will be removed from the CPL.
Appendix C--Quality Assurance Plan Template
[Manufacturer name], Quality Assurance Plan for [Interlock name AND
Model number] [date]
Under the National Highway Traffic Safety Administration (NHTSA)
Breath alcohol ignition interlock testing program, interlocks are
evaluated according to the NHTSA Model Specifications for Breath
Alcohol Ignition Interlocks (BAIIDs). Those models that conform to
the Model Specifications are added to the Conforming Products List
for Breath Alcohol Ignition Interlocks. 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 37
days (30 days + 7 day lockout countdown) and must have a service
interval of 37 days (30 days + 7 day lockout countdown).
1. Provide step-by-step instructions for checking the
calibration of the BAIID. These instructions must include:
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, 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 data
logger.
3. Provide instructions on how to maintain the BAIID (i.e., what
must be examined at the 30 day service interval; 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 D--Sample Format for Downloaded Data From Data Logger
----------------------------------------------------------------------------------------------------------------
Date Time Start attempts (engine activity)
----------------------------------------------------------------------------------------------------------------
Example 1. Acceptable start and drive cycle
----------------------------------------------------------------------------------------------------------------
4/21/07............................ 0951 start attempt.
.............. sample accepted.
.............. BrAC (alcohol absent, e.g., 0.000, 0.008).
.............. unlock.
.............. ignition keyed.
.............. starter active.
.............. 0952 engine on.
.............. 0956 rolling retest.
.............. sample accepted.
.............. BrAC (alcohol absent, e.g., 0.000, 0.008).
.............. 1032 engine off.
----------------------------------------------------------------------------------------------------------------
Example 2. Acceptable start but fail rolling re-start
----------------------------------------------------------------------------------------------------------------
4/22/07............................ 2316 start attempt.
.............. sample accepted.
.............. BrAC (alcohol absent, e.g., 0.008).
.............. unlock.
.............. ignition keyed.
.............. starter active.
2317 engine on.
2319 rolling retest.
.............. BrAC (alcohol present, e.g., 0.025).
.............. warning given.
4/23/07............................ 0047 engine off.
----------------------------------------------------------------------------------------------------------------
Example 3. Push start
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
4/21/07............................ 1652 start attempt.
[[Page 61833]]
.............. sample accepted.
.............. BrAC (alcohol present, e.g., 0.030).
.............. lock.
1653 warning given.
1656 start attempt.
.............. sample accepted.
.............. BrAC (alcohol absent, e.g., 0.015).
.............. unlock.
.............. ignition keyed.
.............. starter active.
1657 engine on.
1702 rolling retest.
.............. sample accepted.
.............. BrAC (alcohol absent, e.g., 0.010).
1850 engine off.
----------------------------------------------------------------------------------------------------------------
Example 5. Start attempted using filtered sample. Retry
----------------------------------------------------------------------------------------------------------------
4/15/07............................ 2016 start attempt.
.............. low temp.
.............. warning given.
2205 start attempt.
.............. sample accepted.
.............. BrAC (alcohol absent, 0.000).
.............. unlock.
.............. ignition keyed.
.............. starter active.
2206 engine on.
2352 engine off.
----------------------------------------------------------------------------------------------------------------
Example 6. Calibration Check
----------------------------------------------------------------------------------------------------------------
4/28/07............................ 0900 start attempt.
.............. sample accepted.
.............. BrAC (alcohol absent, 0.000 or 0.008).
.............. unlock.
.............. ignition keyed.
.............. starter active.
0903 engine on.
0926 rolling retest.
.............. sample accepted.
.............. BrAC (alcohol absent, 0.000 or 0.008).
1032 engine on.
1045 Calibration check.
----------------------------------------------------------------------------------------------------------------
Issued on: October 1, 2010.
Jeff Michael,
Associate Administrator for the Office of Research and Program
Development, National Highway Traffic Safety Administration.
[FR Doc. 2010-25131 Filed 10-5-10; 8:45 am]
BILLING CODE 4910-59-P