61820 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT

section by October 19, 2010. Persons 

may request time to make an oral 

presentation. Persons may also submit 

written comments. Written comments 

and requests to make oral presentations 

at the meeting should reach Drew 

Dawson at the address listed below or 

via the Document Management System 

and must be received by October 19, 

2010. 

All submissions received must 

include the docket number, NHTSA– 

2010–0136, and may be submitted by 

any one of the following methods: (1) 

You may submit or retrieve comments 

online through the Document 

Management System (DMS) at http:// 

www.regulations.gov/ under the docket 

number listed at the beginning of this 

notice. The DMS is available 24 hours 

each day, 365 days each year. Electronic 

submission and retrieval help 

guidelines are available under the help 

section of the Web site; (2) you may 

submit comments by E-mail to 

drew.dawson@dot.gov or 

noah.smith@dot.gov; or (3) you may 

submit comments by Fax to (202) 366– 

7149. 

An electronic copy of this document 

may be downloaded from the Federal 

Register’s home page at http:// 

www.archives.gov and the Government 

Printing Office’s database at http:// 

www.access.gpo.gov/nara. 

Please note, that even after the 

comment closing date, we will continue 

to file relevant information in the docket 

as it becomes available. 

FOR FURTHER INFORMATION CONTACT: 

Drew Dawson, Director, Office of 

Emergency Medical Services, National 

Highway Traffic Safety Administration, 

1200 New Jersey Avenue, SE., NTI–140, 

Washington, DC 20590,Telephone 

number (202) 366–9966; E-mail 

Drew.Dawson@dot.gov. 

SUPPLEMENTARY INFORMATION: Notice of 

this meeting is given under the Federal 

Advisory Committee Act (FACA), Public 

Law 92–463, as amended (5 U.S.C. App. 

1 et seq.) The NEMSAC will hold a 

meeting on Tuesday, October 26, 2010, 

via teleconference. 

Agenda of Council Teleconference 

Meeting, October 26, 2010 

The tentative agenda includes the 

following: 

Tuesday, October 26, 2010 

(1) Opening Remarks—Chair and 

Designated Federal Officer; 

(2) Introduction of Members and all in 

attendance; 

(3) Federal Advisory Council Act 

Overview; 

(4) NHTSA Office of EMS Overview; 

(5) Other Federal agency EMS 

activities; 

(6) FICEMS Overview; 

(7) Public Comment Period; 

(8) Next Steps and Future Meetings. 

While the entire meeting is open to 

the public, the public comment period 

will take place on October 26, 2010, 

between 4 p.m. and 4:15 p.m. 

Public Attendance: The meeting is 

open to the public. Persons with 

disabilities who require special 

assistance should advise Drew Dawson 

of their anticipated special needs as 

early as possible. Members of the public 

who wish to make comments on 

Tuesday, October 26, between 4 p.m. 

and 4:15 p.m. are requested to register in 

advance. In order to allow as many 

people as possible to speak, speakers are 

requested to limit their remarks to 3 

minutes. For those wishing to submit 

written comments, please follow the 

procedure noted above. 

Individuals wishing to register for 

attendance in the teleconference must 

provide their name, affiliation, phone 

number, and e-mail address to Drew 

Dawson by e-mail at 

drew.dawson@dot.gov or by telephone 

at (202) 366–9966 no later than October 

19, 2010. There will be limited call-in 

lines, so please register early. Preregistration is necessary to enable 

proper arrangements. 

Minutes of the NEMSAC Meeting will 

be available to the public online through 

the DOT Document Management System 

(DMS) at: http://www.regulations.gov 

under the docket number listed at the 

beginning of this notice and on http:// 

www.ems.gov 

Issued on: October 1, 2010. 

Jeffrey P. Michael, 

Associate Administrator for Research and 

Program Development. 

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

BILLING CODE 4910–59–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

[Docket No. NHTSA–2010–0033] 

Model Specifications for Breath 

Alcohol Ignition Interlock Devices 

(BAIIDs) 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Notice. 

SUMMARY: This notice proposes 

revisions to the Model Specifications for 

Breath Alcohol Ignition Interlock 

Devices (BAIIDs). The Model 

Specifications are guidelines for the 

performance and testing of BAIIDs. 

These devices are designed to prevent a 

driver from starting a motor vehicle 

when the driver’s breath alcohol 

concentration (BrAC) is at or above a set 

alcohol level. Most States currently use 

BAIIDs as a sanction for drivers 

convicted of driving while intoxicated 

offenses. In 1992, this technology was 

new. Now that it has matured, NHTSA 

proposes to revise the 1992 Model 

Specifications, to test BAIIDs for 

conformance and to maintain a 

conforming products list (CPL) of 

BAIIDs that have been found to meet the 

Model Specifications. These proposed 

revisions are based, in part, on input 

from interested parties during an open 

comment period. 

DATES: Written comments may be 

submitted to this agency and must be 

received no later than December 6, 

2010. 

ADDRESSES: You may submit comments 

identified by DOT Docket ID Number 

NHTSA–2010–0033 by any of the 

following methods: 

• Electronic submissions: Go to 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

• Fax: 202–493–2251. 

• Mail: Docket Management Facility, 

M–30, U.S. Department of 

Transportation, West Building, Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

• Hand Delivery or Courier: West 

Building, Ground Floor, Room W12– 

140, 1200 New Jersey Avenue, SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Eastern Time, Monday through 

Friday, except Federal holidays. 

Regardless of how you submit your 

comments, you should identify the 

Docket number of this document. 

Instructions: For detailed instructions 

on submitting comments and additional 

information, see http:// 

www.regulations.gov. Note that all 

comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. Please 

see the ‘‘Privacy Act’’ heading below. 

Privacy Act: Anyone is able to search 

the electronic form of all comments 

received into any of our dockets by the 

name of the individual submitting the 

comment (or signing the comment, if 

submitted on behalf of an association, 

business, labor union, etc.). You may 

review the complete User Notice and 

Privacy Notice for Regulations.gov at 

http://www.regulations.gov/search/ 

footer/privacyanduse.jsp. 

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Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 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; Email: decarlo.ciccel@dot.gov. For legal 

issues: Ms. Jin Kim, Attorney-Advisor, 

Office of the Chief Counsel, NCC–113, 

National Highway Traffic Safety 

Administration, 1200 New Jersey 

Avenue, SE., Washington, DC 20590; 

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

SUPPLEMENTARY INFORMATION: 

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 electrochemical oxidation of alcohol) or other 

emerging sensor technologies? Or, 

should NHTSA not specify the sensor 

technology and rely on performance 

requirements? 

(3) Sample size requirements. The 

1992 Model Specifications set the 

minimum breath sampling size at 1.5 

Liters. Informal comments received over 

the years have suggested that this 

requirement may be too high. Should 

NHTSA consider lowering the 

minimum breath sampling size 

requirement? Should NHTSA include a 

minimum sample size and minimum 

back pressure at the input-mouthpiece 

of the device? 

(4) Temperature extreme testing. The 

1992 Model Specifications call for 

testing at ¥40 °C, ¥20 °C, +70 °C and 

+85 °C, but allow for the removability of 

the alcohol sensing unit so that it may 

be kept at an artificial temperature when 

the vehicle may be subject to extremely 

cold or hot temperatures. Is this 

approach to extreme temperature testing 

sufficient, or should it be more 

stringent? 

(5) Radio Frequency Interference (RFI) 

or Electromagnetic Interference (EMI) 

Testing. The RFI testing protocol in the 

1992 Model Specifications uses power 

sources that are no longer commonly in 

use. New power sources that may 

interfere with the operation of BAIIDs 

(e.g., cell phones) have output power 

commensurate with equipment in use 

today. What are the appropriate levels to 

measure RFI/EMI? 

(6) Circumvention testing. The 1992 

Model Specifications offer a number of 

procedures for evaluating whether 

existing devices can be easily 

circumvented. Are these procedures 

sufficient or should new or modified 

procedures be incorporated into the 

Model Specifications? 

(7) The Vehicle-Interlock Interface. 

Anecdotal reports from ignition 

interlock manufacturers have suggested 

that it is sometimes difficult to install 

existing interlock systems in some of the 

newer electronic ignition systems. 

Should NHTSA establish any guidelines 

regarding the vehicle-interlock 

interface? 

(8) Calibration stability. Is the 

duration of calibration stability testing 

sufficient? Should ignition interlocks be 

required to hold their calibration for a 

longer period of time, thereby requiring 

less frequent calibration checks? 

(9) Ready-to-use Times. Should 

NHTSA establish a ‘‘ready-to-use’’ time 

period for extreme cold temperatures, 

such that devices must operate within a 

given period of time under extreme cold 

conditions? 

(10) NHTSA testing. Should NHTSA 

undertake the responsibility to evaluate 

ignition interlocks against its Model 

Specifications and publish a 

Conforming Products List (CPL) of 

devices meeting those specifications? 

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(11) International Harmonization. Is it 

important to harmonize the ignition 

interlock Model Specifications with 

standards in other parts of the world, 

such as the European Union, Canada, 

and Australia? 

(12) Specifications for Ignition 

Interlock Programs. Does the ignition 

interlock community (users, 

manufacturers, States, etc.) favor 

NHTSA development of an interlock 

program, in addition to Model 

Specifications for devices? 

(13) Acceptance Testing. NHTSA’s 

current Model Specifications involve 

‘‘type-testing’’ (i.e., testing particular 

models of BAIIDs for conformance) of 

various models of BAIIDs. Should 

NHTSA establish standardized 

acceptance-testing procedures (i.e., 

testing each individual device for 

conformance), instead of the current 

type-testing guidelines? What testing 

should be included in such Model 

Specifications? Who should conduct the 

testing? 

In addition to the above 13 specific 

areas, NHTSA’s 2006 notice solicited 

comments on other areas that might 

enhance the revisions of the Model 

Specifications. Comments were received 

from five manufacturers of interlock 

devices, five State government 

representatives, two automobile 

manufacturers, one association of 

interlock installers and the European 

Committee for Electrotechnical 

Standardization (CENELEC). Today’s 

notice responds to these comments in 

setting forth the agency’s proposal. 

In addition, this notice sets forth the 

proposed procedures for submitting 

BAIIDs for NHTSA testing (Appendix A) 

and re-examination of BAIIDs that have 

been tested (Appendix B). 

II. Response to Comments 

The comments were supportive of the 

agency’s proposal to revise the Model 

Specifications, noting that they had 

served well in organizing the interlock 

field but that some adjustments were 

warranted to assure more consistency in 

the quality of equipment in use today. 

A. Set Point, Accuracy and Precision 

Requirements 

There was a lot of variability among 

comments on the alcohol set point (i.e., 

Breath Alcohol Concentration (BrAC) at 

which a BAIID is set to lock the 

ignition). Two commenters stated that 

the 1992 Model Specification 

requirements for set point was 

appropriate and should not be changed. 

One State representative recommended 

a 0.025 g/dL set point for adults and a 

0.02 g/dL set point for minors. Other 

State representatives commented that 

the alcohol set point could be more 

stringent. One commenter stated that 

several States already use a 0.02 g/dL set 

point. 

NHTSA proposes to lower the set 

point for testing BAIIDs from 0.025 g/dL 

to 0.02 g/dL. This is the critical point 

that is used in the Breath Alcohol 

Screening Devices to indicate the 

presence of alcohol. Accordingly, for 

listing on the Conforming Products List 

(CPL), NHTSA proposes to test BAIIDs 

that are capable of locking out at a set 

point of 0.02 g/dL. NHTSA believes that 

0.02 g/dL is an appropriate set point 

because it is an appropriate level to test 

the presence of alcohol among offenders 

using ignition interlocks and it is our 

understanding that the technology is 

available for BAIIDs to have a set point 

at 0.02 g/dL. 

A few commenters stated that the 

1992 Model Specifications for accuracy 

and precision were appropriate. Most 

commenters indicated that with 

improved technology, a greater degree of 

accuracy was possible, but did not 

specify to what degree. One interlock 

manufacturer advocated 95 percent 

accuracy with a precision of 19 out of 

20 test trials at 0.01 g/dL above the set 

point for unstressed conditions (i.e., 

normal) and 100 percent accuracy and 

with a precision of 20 out of 20 test 

trials at 0.02 g/dL above the set point for 

stressed conditions (i.e., atypical, such 

as extreme temperatures). 

Accuracy is the degree to which a 

BAIID measures the BrAC correctly. For 

example, for a BAIID to be accurate, a 

breath sample with no alcohol present 

(0.000 g/dL) must not lock the ignition. 

Precision is the degree to which that 

same measure can be repeated. In the 

previous example, for that BAIID to be 

precise, that same alcohol free breath 

sample should not lock the ignition 20 

out of 20 test trials. 

NHTSA agrees with the commenters 

that because of improved technology, 

BAIIDs should be subject to a higher 

degree of accuracy and precision. 

NHTSA proposes to define the accuracy 

and precision requirements for BAIIDs 

by testing at ±0.012 g/dL above and 

below the nominal set point of 0.02 g/ 

dL, i.e., 0.032 g/dL and 0.008 g/dL, 

respectively. At 0.032 g/dL, not more 

than 1 ignition unlock in 20 trials would 

be allowed. At 0.008 g/dL, not more 

than 1 ignition lock in 20 trials would 

be allowed. No ignition locks in 20 trials 

would be allowed at 0.000 g/dL. This 

increases the accuracy from 90 percent 

to 95 percent at ±0.012 g/dL above and 

below the nominal set point of 0.02 g/ 

dL, and 100 percent at 0.000 g/dL. 

NHTSA determined these proposed test 

levels by using standard statistical 

techniques for small samples. 

B. Sensor Technology 

Most commenters stated that it is 

important to require alcohol-specific 

technology in the Model Specifications, 

but that the particular sensor design 

should not be specified. A small group, 

including States, favored the use of a 

particular sensor design (e.g., fuel cell). 

One interlock manufacturer stated that a 

non-alcohol-specific technology, such as 

a semi-conductor that senses alcohol 

differently and costs about 50 percent 

less than a fuel cell, was an economic 

alternative to the fuel cell. 

While alcohol-specific sensor 

technologies have made great advances, 

this proposal does not limit the sensor 

technology used in the BAIIDs as long 

as the BAIID meets the performance 

requirements of the Model 

Specifications. We believe that this 

approach will allow a wider variety of 

options, including the use of emerging 

technologies as they become available. 

C. Sample Size Requirement 

Most commenters advocated lowering 

the current 1.5 Liters (L) minimum 

sample size (to either 1.2 L or 1.0 L). A 

subset of these commenters felt that 

anything lower than 1.2 L should be set 

only on recommendation of a physician. 

One commenter thought that a 1.5 L air 

sample was not enough to ensure an 

accurate measure of the alcohol content. 

NHTSA agrees with the 

recommendation to lower the minimum 

sample size to 1.2 L and proposes a 

minimum 1.2 L sample size. NHTSA 

believes that, at this level, accuracy can 

be attained and that users will be able 

to deliver this smaller sample size. 

Some commenters felt that a 

minimum back pressure, which controls 

the force of the air entering the BAIID, 

was not necessary if the sample size was 

not lower than 1.0 L. One commenter 

suggested requiring 1.2 L sample size 

with a minimum back pressure and a 

flow rate of 0.2 L/second. A 

manufacturer suggested requiring 1.2 L 

sample size with a back pressure of 20 

hectoPascal (hPa) (e.g., 2 kiloPascals 

(kPa)) and a flow rate of 0.1 L/sec. One 

State suggested an exhale-inhale-exhale 

pattern as an alternative to setting a 

standard. Two States suggested a 1.2 L 

sample size with back pressure, 

temperature and time requirements. 

Two commenters felt that NHTSA 

should only set the minimum sample 

size, and should not prescribe the 

means by which the sample delivery 

would be accomplished. 

In addition to lowering the minimum 

sample size to 1.2 L as discussed above, 

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NHTSA proposes to require a minimum 

flow rate of 0.1 L/sec. Flow rate is the 

length of time that a sample breath is 

delivered into the BAIID. NHTSA 

believes that a 0.1 L/sec minimum flow 

rate is a level that will enable more 

people to deliver an adequate sample. 

By lowering the minimum sample size 

and adding a minimum flow rate, 

NHTSA does not believe that specifying 

a minimum back pressure is necessary. 

NHTSA believes that this proposal will 

make the BAIID available to a larger 

population of users. 

D. Extreme Temperature Testing, 

Removable Sensing Heads or Units 

One interlock manufacturer suggested 

that NHTSA test for extreme 

temperature at ¥45 °C, as temperatures 

reach that level in high latitudes and 

high altitudes. Another interlock 

manufacturer suggested that NHTSA 

leave the testing temperature unchanged 

and continue to allow the sensing unit 

to be removed from the vehicle. Most 

commenters felt that the current testing 

temperature extremes of ¥40 °C and 

+85 °C were appropriate, but did not 

object to tests at more extreme 

temperatures. The CENELEC suggested 

that the component of the device that is 

mounted in the engine compartment be 

tested for +125 °C in addition to ¥45 

°C. CENELEC further suggested that the 

¥45 °C temperature test be conducted 

at 75 percent of nominal battery voltage 

because extreme temperatures can 

reduce available voltage from a vehicle 

battery. 

NHTSA proposes to retain the current 

extreme temperature tests at ¥40 °C and 

+85 °C. The agency believes that the 

current temperature range is reasonably 

representative of the environments 

encountered in the United States. 

However, NHTSA proposes to conduct 

additional high temperature tests for 

components of the BAIID installed in 

the passenger compartment (at +49 °C) 

and in the engine compartment (at +85 

°C), and to specify the humidity level 

for these high temperature tests. 

Further, NHTSA proposes to 

discontinue testing at ¥20 °C and +70 

°C because our experience indicates that 

testing at the extreme temperatures is 

sufficient. 

NHTSA also agrees that the ¥40 °C 

temperature test should be performed at 

9 volts, which is representative of 75 

percent of the nominal battery voltage 

(i.e., 12-volt automobile battery). 

NHTSA believes that the test should be 

conducted at this voltage because 

vehicles often do not operate at the 

optimal battery voltage. Accordingly, 

NHTSA proposes to test BAIIDs using a 

9-volt direct current (DC) power source, 

simulating a 12-volt DC battery 

operating at low temperatures. 

Many commenters stated that NHTSA 

should not allow the removal of the 

sensing unit because BAIIDs are 

expected to operate at a variety of 

ambient temperature conditions. One 

State favored a removable mouthpiece 

(to protect users’ lips from extreme 

temperatures), rather than a removable 

sensing unit, and another State favored 

a prescribed warm-up period. NHTSA 

agrees with the commenters that the 

sensing unit should not be removable 

because it can more easily be damaged 

or mishandled, leading to frequent 

repairs and increased cost. Accordingly, 

NHTSA proposes to test only BAIIDs 

without removable sensing heads or 

units. (The agency does not object to 

BAIIDs with a removable mouthpiece.) 

E. RFI or EMI Testing 

Commenters noted that appropriate 

power for RFI testing should be 

considered because an increasing 

number of electronic devices are being 

operated in close proximity to BAIIDs, 

such as gaming, remote keyless entry, 

portable medical and Bluetooth-capable 

devices. Two BAIID manufacturers 

suggested that the European Standard 

for EMI be adopted because it describes 

electromagnetic compatibility of 

vehicles for broadband and narrowband 

interference and shielding. Two 

commenters noted that CB radios were 

more relevant sources of interference 

and that the CENELEC standard is 

unnecessarily restrictive on EMI. A 

State government commenter suggested 

that the Society of Automotive 

Engineers (SAE) J551 Vehicle 

Electromagnetic Immunity-Bulk Current 

Injection Standard be applied to BAIIDs. 

NHTSA agrees that the current 

specifications do not adequately define 

or describe RFI/EMI tests. NHTSA 

proposes to test BAIIDs for emissions 

and transmissions of RFI/EMI and 

immunity to RFI/EMI using the SAE 

Surface Vehicle Standard J1113 series 

for Class C devices (devices essential to 

the operation or control of the vehicle) 

and the International Special Committee 

on Radio Interference (CISPR), 

Subcommittee of International 

Electrotechnical Committee (IEC), 

specifically CISPR 25, for RFI/EMI 

testing. NHTSA proposes these tests 

because we believe that they represent 

a broad consensus in the industry. 

F. Tampering and Circumvention 

Testing 

There was some criticism that the 

1992 Model Specifications for 

tampering and circumvention testing are 

confusing and lack specificity. One 

BAIID manufacturer felt that the U.S. 

should adopt the CENELEC standards 

for charcoal filters, water bubbler, 

condensation through a long cool tube 

and pressurized air, and interlock 

bypass. Another BAIID manufacturer 

commented that there are aspects of the 

circumvention detection specifications 

that are difficult to quantify because 

different companies develop their own 

proprietary anti-circumvention 

strategies (e.g., a learned hum code or 

toot sequence). This manufacturer 

commented that program standards 

should address this by imposing 

consequences for tampering with 

devices. Three State government 

commenters suggested that NHTSA 

should set higher anti-circumvention 

standards and have a counter system or 

data log that records attempts to start 

the vehicle by bypassing the ignition. 

One State thought that the use of time, 

pressure, differing blow patterns and 

breath temperature should help prevent 

circumvention. States believed that 

device design should not present 

challenges to the user, and that the 

individual’s breath signature should be 

used as the basis for anti-circumvention 

efforts. 

Although NHTSA believes that an 

individual’s breath signature (i.e., a 

person’s unique breath pattern) is a 

good goal for the future, NHTSA’s 

proposal does not include individual 

breath signature as an anticircumvention measure. NHTSA does 

not believe that technology is 

sufficiently advanced to warrant 

including individual breath signature in 

this proposal. However, NHTSA agrees 

with commenters that the 

circumvention requirements are 

confusing. Accordingly, the agency 

proposes to clarify and specify the 

requirement for circumvention and 

tampering tests and to specify that the 

BAIID must have tamper proof seals to 

indicate when a BAIID has been 

disconnected from the ignition. 

G. Vehicle-interlock interface 

Interlock manufacturers and providers 

supported a standard interlock-vehicle 

interface, and recommended that 

NHTSA require all vehicles to have 

either a communications bus interface 

or another hard-wired interface 

connector for specific use for any 

ignition interlock device. Other 

commenters suggested that a common 

interface would be a great convenience 

since it would make installation easier. 

However, two automobile 

manufacturers commented that although 

there may be benefits, requiring all 

vehicles to have a common interface for 

BAIIDs presented significant challenges 

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61824 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 

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 °C (¥40 °F), BAIIDs should be 

ready for use in 1 minute or less and be 

ready to retest in 1 minute or less. For 

temperatures at ¥40 °C (¥40 °F), 

NHTSA proposes that the BAIID should 

be ready for use in 3 minutes or less and 

ready to retest in 3 minutes or less. 

NHTSA proposes to test this 

performance. 

NHTSA does not intend that retests be 

conducted while the vehicle is moving, 

but rather while the engine is running 

with the vehicle stopped in a safe 

location on the side of the road. The 

proposed Model Specifications make 

this point clear. 

J. NHTSA Testing 

Commenters favored a certified 

testing laboratory program. Most 

advocated a NHTSA test program and 

the development of a Conforming 

Products List (CPL) based on the Model 

Specifications. One commenter favored 

having a single private testing laboratory 

certified by NHTSA for this purpose. 

Several manufacturers noted significant 

problems with State certification 

requirements leading to questionable 

test results for some products. In 

general, both manufacturers and States 

favored a NHTSA test program because 

it would organize and standardize the 

industry and exclude less effective 

BAIIDs. One commenter suggested that 

NHTSA require BAIID re-certification in 

the event of an instrument design 

change and/or at some reasonable 

interval. 

NHTSA proposes to test BAIIDs for 

conformance with the Model 

Specifications. See Appendix A for 

proposed BAIID submission procedures. 

NHTSA also proposes to maintain and 

publish periodically a CPL with BAIIDs 

that have been tested and found to 

conform to the Model Specifications. 

NHTSA proposes to manage this new 

program as it does its other breath 

alcohol instrument testing programs, 

including the re-examination of BAIIDs 

at its sole discretion (Appendix B) and 

requiring manufacturers to inform 

NHTSA of any changes or modifications 

to a tested BAIID. As with NHTSA’s 

other testing programs, NHTSA also 

proposes to require manufacturers to 

submit a quality assurance plan (QAP) 

for BAIIDs being tested. A QAP is a 

manufacturer’s plan for maintaining the 

integrity and the calibration of a BAIID. 

NHTSA proposes that the QAP include 

the following information: instructions 

for checking the calibration of the BAIID 

(i.e., recommended calibrating unit, 

BrAC of 0.02 g/dL, agreement not 

greater than ±0.005 BrAC, verification of 

accuracy of readout, actions to take for 

failed calibration check), instructions 

for downloading the data from the data 

logger, instructions to maintain the 

BAIID, instructions on checking for 

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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 addon software. 

3. Commenters suggested that the 

BAIID memory should be located in a 

fixed control box. NHTSA agrees with 

these commenters and proposes to add 

this to the General Requirements and 

BAIID Features because a fixed control 

box provides less opportunity for 

potential damage to the BAIID memory. 

4. Commenters suggested that restarts 

should be allowed only if a vehicle 

stalls, but not if the ignition is 

intentionally turned-off or if a BAIID 

malfunctions or is awaiting a retest. 

NHTSA proposes that a restart (i.e., 

without a breath sample) should be 

allowed when the vehicle stalls, 

provided the restart is accomplished in 

no more than 20 seconds. NHTSA also 

proposes that in all other situations 

where the vehicle malfunctions, the 

vehicle should be prevented from 

starting without a breath test. 

Commenters further suggested that if 

a BAIID malfunctions or fails, the device 

should default to preventing the vehicle 

from starting. NHTSA agrees with the 

commenters and proposes that if a 

BAIID malfunctions or fails (e.g., 

improper voltage, temperature 

exceeding operating range, dead sensor, 

etc.), the BAIID should prevent the 

vehicle from starting. 

5. Some commenters stated that an 

emergency override was a useful 

feature. NHTSA declines to propose that 

BAIIDs be required to have an 

emergency override feature (i.e., the 

ability to start the vehicle without a 

breath test) in order to conform with the 

Model Specifications. However, should 

a BAIID be equipped with an emergency 

override feature, NHTSA proposes to 

allow its activation to start the vehicle 

only once. After that, the BAIID must 

indicate the need for service and record 

the use of the emergency override. No 

additional emergency overrides would 

be allowed during the lifetime of the 

BAIID installation. The agency proposes 

to test this feature. NHTSA also 

proposes that this emergency override 

feature have a default to prevent an 

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61826 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 

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, Falsenegative, 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 selfcertification, 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 

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Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 61827 

1Available from the National Committee on 

Uniform Traffic Laws and Ordinances, 107 South 

West Street, #110, Alexandria, VA 22314 (http:// 

www.ncutlo.org). 

2See NBS Special Publication 480–41, July 1981. 

Available from Superintendent of Documents, U.S. 

Government Printing Office, Washington, DC 

20402. 

(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, firstserved 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

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)). 

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 selfcertification 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 

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61828 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 

3See NBS Special Publication 480–41, July 1981. 

Available from Superintendent of Documents, U.S. 

Government Printing Office, Washington, DC 

20402. 

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 °C ± 3 °C 

(71.6 °F ± 5.4 °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 °C (93.2 °F) 

• Simulated breath samples will be 

generated by the BASS3 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). 

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 °C (¥40 °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 °C (120 °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 °C (185 °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 °C 

Using a temperature chamber, soak 

the BAIID for 1 hour at ¥40 °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, 

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4The amount of acetone specified is 

experimentally determined based on water to air 

partition factor of 365 to 1 at 34 °C to yield an 

acetone concentration in the air sample of 0.5 mg/ 

liter. 

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

Test 7 Frequency range, 

Hz Number of cycles Sweep rate, octave/min 

Amplitude, inches 

0 to peak 

Acceleration, 

gravity (g), 

0 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. 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 °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 c 

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. 

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 

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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. 

Level Severity 

(volts, 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. 

Pulse 

(12 v sys) Level Severity (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. 

Pulse 

(12 v sys) Level Severity (volts) Status 

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 × log(F/30) ........................................................ 52 + 15.13 × log(F/75) ............................................................ 63 

b: 52 ¥25.13 × log(F/30) ........................................................ 42 + 15.13 × log(F/75) ............................................................ 53 

a: Broadband, quasi-peak detector. 

b: Narrowband, average detector. 

Limit in dB (uV/M) at frequency F. 

CONDUCTED TRANSIENT EMISSIONS

Pulse polarity Maximum pulse amplitude (12 volt system) (V) 

Positive ................. 75 

CONDUCTED TRANSIENT EMISSIONS— 

Continued 

Pulse polarity Maximum pulse amplitude (12 volt system) (V) 

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 

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LIMITS FOR BROADBAND CONDUCTED DISTURBANCES (MHZ)—Continued 

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 

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 reexamination 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 

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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 reexamine 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 61833 

Date Time Start attempts 

(engine activity) 

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 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

[Docket No. FMCSA–2010–0161] 

Qualification of Drivers; Exemption 

Applications; Vision 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT. 

ACTION: Notice of final disposition. 

SUMMARY: FMCSA announces its 

decision to exempt 17 individuals from 

the vision requirement in the Federal 

Motor Carrier Safety Regulations 

(FMCSRs). The exemptions will enable 

these individuals to operate commercial 

motor vehicles (CMVs) in interstate 

commerce without meeting the 

prescribed vision standard. The Agency 

has concluded that granting these 

exemptions will provide a level of safety 

that is equivalent to, or greater than, the 

level of safety maintained without the 

exemptions for these CMV drivers. 

DATES: The exemptions are effective 

October 6, 2010. The exemptions expire 

on October 8, 2012. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Mary D. Gunnels, Director, Medical 

Programs, (202)–366–4001, 

fmcsamedical@dot.gov, FMCSA, 

Department of Transportation, 1200 

New Jersey Avenue, SE., Room W64– 

224, Washington, DC 20590–0001. 

Office hours are from 8:30 a.m. to 5 p.m. 

Monday through Friday, except Federal 

holidays. 

SUPPLEMENTARY INFORMATION: 

Electronic Access 

You may see all the comments online 

through the Federal Document 

Management System (FDMS) at http:// 

www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments, go to http:// 

www.regulations.gov at any time or 

Room W12–140 on the ground level of 

the West Building, 1200 New Jersey 

Avenue, SE., Washington, DC, between 

9 a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The 

FDMS is available 24 hours each day, 

365 days each year. If you want 

acknowledgment that we received your 

comments, please include a selfmstockstill on DSKH9S0YB1PROD with NOTICES