[Federal Register Volume 72, Number 121 (Monday, June 25, 2007)]
[Notices]
[Pages 34742-34748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3060]


-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2007-28067]


Highway Safety Programs; Model Specifications for Calibrating 
Units for Breath Alcohol Testers; Conforming Products List of 
Calibrating Units for Breath Alcohol Testers

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the Model Specifications for Calibrating 
Units for Breath Alcohol Testers (Model Specifications) by adopting an 
alternate test procedure for evaluating the accuracy of both wet bath 
and dry gas breath alcohol calibrating units infra-red spectroscopy, as 
proposed in the Federal Register on August 13, 1997 (62 FR 43416). 
Published with this notice is an updated Conforming Products List of 
Calibrating Units for Breath Alcohol Testers (CPL) of calibrating units 
that meet the Model Specifications. This updated CPL includes 22 new 
listings--8 wet bath units and 14 dry gas units.

DATES: Effective Date: The amendments to the Model Specifications and 
the issuance of the CPL become effective on June 25, 2007.

FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. J. De Carlo 
Ciccel, Office of Behavioral Safety Research, NTI-130, National Highway 
Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, 
DC 20590; Telephone (202) 366-1694. For legal issues: Ms. Allison 
Rusnak, Office of Chief Counsel, NCC-113, National Highway Traffic 
Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 
20590; Telephone (202) 366-1834.

SUPPLEMENTARY INFORMATION: On August 18, 1975 (40 FR 36167), NHTSA 
published a standard for Calibrating Units for Breath Alcohol Testers. 
A Qualified Products List of calibrating units for breath alcohol 
testers that met the standard was first issued on November 30, 1976 (41 
FR 53389).
    On December 14, 1984, NHTSA issued a notice to convert the 
mandatory standards for calibrating units for breath alcohol testers to 
Model Specification for such devices (49 FR 48865) and to establish a 
Conforming Products List (CPL) of calibrating units meeting the Model 
Specifications. Calibrating units provide known concentrations of 
ethanol vapor for the calibration or calibration checks of instruments 
that measure breath alcohol (BrAC).
    On December 29, 1994, NHTSA published a notice amending the Model 
Specifications and updating the CPL for calibrating units (59 FR 
67377). The notice also proposed and sought comments about providing an 
alternate test procedure using National Institute for Standards and 
Technology (NIST) Reference Gas Mixtures for evaluating the accuracy 
and precision of dry-gas ethanol calibrating units. The agency amended 
the Model Specifications on August 13, 1997 by incorporating the NIST 
test procedure (62 FR 43416). In that same notice, NHTSA updated the 
CPL and proposed an alternate test procedure for evaluating the 
accuracy and precision for evaluating wet bath and dry gas calibrating 
units using infra-red spectroscopy.
    Having received no comments regarding the infra-red spectroscopy 
test procedure, this notice adopts the alternate procedure for 
evaluating wet bath and dry gas calibrating units using infra-red 
spectroscopy as proposed. This notice also amends the CPL of 
Calibrating Units for Breath Alcohol Testers, adding 8 wet bath units 
and 14 dry gas units.

A. Procedures for a Product Submission

    Testing of calibrating units submitted by manufacturers to these 
Model Specifications will continue to be conducted by the DOT Volpe 
National Transportation Systems Center (VNTSC). Tests will continue to 
be conducted semi-annually or as necessary. Manufacturers wishing to 
submit calibrating units for testing must apply to NHTSA for a test 
date (Office of Behavioral Safety Research, NTI-130, 1200 New Jersey 
Avenue, SE., Washington, DC 20590, Telephone (202) 366-1694). Normally, 
at least 30 days will be required from the date of notification until 
the test can be scheduled. One week prior to the

[[Page 34743]]

scheduled initiation of the test program, the manufacturer shall 
deliver at least one unit of the device to be tested to: VNTSC, RTV-4F, 
55 Broadway, Cambridge, MA 02142. The manufacturer shall be responsible 
for ensuring that the unit is operating properly. If the manufacturer 
wishes to submit a duplicate, backup unit, it may do so.
    When a manufacturer delivers a device to be tested, it shall also 
deliver to VNTSC specifications and drawings that fully describe the 
unit and the Operator's Manual and Maintenance Manual normally supplied 
with purchase of the equipment. NHTSA will consider claims of 
confidentiality under 49 CFR Part 512.
    The manufacturer shall also deliver the instructions that will 
accompany the device when it is sold. The instructions shall include 
information about the procedures to be followed to protect against 
possible condensation that might occur as a result of freezing during 
shipment and to correct for atmospheric pressure. The instructions 
shall also include information about any offsets that may apply to the 
use of a particular type of breath tester. NHTSA will examine these 
instructions to ensure that they provide sufficient information about 
these matters. Products submitted without this information will not be 
tested.
    The manufacturer will have the right to check the calibrating unit 
between arrival at VNTSC and the start of the test and to ensure that 
the calibrating unit is in proper working condition. The manufacturer 
will have no access to the calibrating unit during the tests. Any 
malfunction of the calibrating unit that results in failure to complete 
any of the tests satisfactorily will result in a finding that it does 
not conform to the Model Specifications. If a unit fails to conform, it 
may be resubmitted for testing after appropriate corrective action has 
been taken.
    On the basis of these results, NHTSA periodically will publish a 
CPL identifying the calibrating units that conform to the Model 
Specifications.
    Re-testing of units will be conducted when necessary. NHTSA intends 
to modify and improve these Model Specifications as new data and 
improved test procedures become available. (The test procedures may be 
altered in specific instances, if necessary, to meet the unique design 
features of a calibrating unit). If these Model Specifications are 
modified, notification will be provided in the Federal Register. If 
NHTSA determines that re-testing to the modified specifications is 
necessary, a manufacturer whose equipment is listed on the CPL will be 
notified to resubmit the equipment for testing to the modified 
specifications only.
    NHTSA reserves the right to test any unit on the CPL throughout its 
useful life to ensure that the unit is performing in accordance with 
the Model Specifications. If at any time a manufacturer plans to change 
the design of a calibrating unit currently on the CPL, the manufacturer 
shall submit the proposed changes to the NHTSA Office of Behavioral 
Safety Research for review. Based on this review, NHTSA will decide 
whether the change will require re-testing of the unit. Normally, such 
re-testing will be accomplished the next time testing is performed. 
Guidance to manufacturers on considerations governing this decision is 
available from NHTSA upon request.
    NHTSA's Office of Behavioral Safety Research will be the point of 
contact for information about acceptance testing and field performance 
of equipment already on the list. NHTSA requests that users of 
calibrating units provide both acceptance and field performance data to 
NHTSA when such data is available. Information from users will be used 
to: (1) Help NHTSA determine whether units continue to perform 
according to the Model Specifications, and (2) ensure that field use 
does not indicate excessive breakdown or maintenance problems.
    If information gathered indicates that a device on the CPL is not 
performing in accordance with the Model Specifications or demonstrates 
problems involving the device, NHTSA will direct VNTSC to conduct a 
special investigation. This investigation may include visits to users 
and additional tests of the unit obtained from the open market. If the 
investigation indicates that the units actually sold on the market are 
not meeting the Model Specifications, then the manufacturer will be 
notified that the unit may be removed from the CPL. The manufacturer 
shall have 30 days from the date of notification to reply.
    Based on the VNTSC investigation and any data provided by the 
manufacturer, NHTSA will decide whether the unit should remain on the 
CPL. Upon resubmission, the manufacturer must submit a statement 
describing what has been done to overcome the problems that led to the 
removal of the unit in question from the CPL.

B. Infra-Red Spectroscopy

    This notice incorporates into the Model Specifications an alternate 
procedure for evaluating wet bath and dry gas calibrating units using 
infra-red spectroscopy. When infra-red spectroscopy is used, the wet 
bath or dry gas sample to be analyzed is passed into a chamber through 
which infra-red radiation is transmitted. The wavelength of the 
transmitted radiation is chosen so that some of it is absorbed by 
alcohol. According to the Beer-Lambert Law of absorption of 
radiation,\1\ the amount of energy absorbed by the sample in the 
chamber is proportional to the concentration of the alcohol in the 
sample. By measuring the amount of radiation transmitted when the 
sample chamber is empty and the amount transmitted when the sample is 
present, the concentration of the alcohol in the sample can be 
determined.
---------------------------------------------------------------------------

    \1\ Farrington Daniels & Robert Alberty, ``Physical Chemistry'' 
3d. Ed. John Wiley & Sons, New York, 1996.
---------------------------------------------------------------------------

    The agency believes that use of infra-red spectroscopy offers 
important advantages. First, the technique can be used to evaluate both 
wet bath calibrating units and dry gas calibrating units because 
surface interactions do not affect the analysis. Second, standards used 
in the evaluations can be prepared at VNTSC, eliminating the necessity 
of obtaining standards from an outside source.

C. Conforming Products List

    The CPL, which appears as an Appendix to this notice, lists the 
calibrating units that have been re-tested to date at the lower BACs 
(i.e., at 0.020, 0.040, 0.080, and 0.160) and found to conform to the 
Model Specifications reprinted herein. The CPL also lists devices that 
have not been tested at the lower BAC levels (.020, .040, .080 and 
.0160), but were listed on the CPL for calibrating units on the basis 
that they were tested and found to conform to the earlier Model 
Specifications (49 FR 48864) when tested at BAC levels 0.050, 0.100 and 
0.150. These devices are identified on the CPL with an asterisk.
    The CPL published today includes 22 new listings--8 wet bath units 
and 14 dry gas units. The wet bath units include: CALWAVE dt-100, 
submitted by Davtech Analytical Service, Canada; Model 10-4D, Model 10-
4D Revision A, Model 2100 (aka: Model 210021), Model 2100 Revision A, 
and 590 submitted by Guth Laboratories, Inc., Harrisburg, Pennsylvania; 
Alcotest CU 34 submitted by National Draeger, Inc., Durango, Colorado; 
and Model 3402C-2K submitted by RepCo Marketing, Inc., Raleigh, North 
Carolina. The dry gas units \2\ include: 103 ppm/108L and 270

[[Page 34744]]

ppm/30L submitted by Airgas, Inc., (previously know as Gateway Airgas, 
Inc., A.G. Specialty Gas Co., or Acetylene Gas Co) St. Louis, Missouri; 
115 ppm/34L, 115 ppm/103L, 230 ppm/34L, 230 ppm/103L, 260.5 ppm/58L, 
260.5 ppm/537L, and 260.5 ppm/15L submitted by Air Liquide, CALGAZ, 
Cambridge, Maryland; and Scotty 28 0.040 BAC/28L, 0.045 BAC/28L, 0.080 
BAC/28L, 0.100 BAC/28L, 0.105 BAC/28L submitted by Scott Specialty 
Gases, Inc., Plumsteadville, Pennsylvania. One device, Toxitest Model 
ABS120 by Federal Signal Corporation, is being removed from the CPL as 
it is no longer manufactured.
---------------------------------------------------------------------------

    \2\ The naming convention of the dry gas units added to the CPL 
today is illustrative of the ethanol concentration in the volume of 
nitrogen dry gas. Concentration is expressed in parts per million 
(ppm) or marketed as breath alcohol concentrations (BAC) and volume 
is expressed in Liters(L).
---------------------------------------------------------------------------

    In consideration of the foregoing, NHTSA amends the Model 
Specifications for Calibrating United as set forth below.

Model Specifications for Calibrating United for Breath Alcohol Testers

1.0 Purpose and Scope

    These specifications establish performance criteria and methods for 
testing of calibrating units which provide known concentrations of 
ethanol vapor for the calibration or calibration checks of breath 
alcohol testers. The results of this testing are intended for use in 
the conformance testing for the maintenance of a Conforming Products 
List for calibrating units.

2.0 Definitions

    2.1 Conformance testing. Testing to check the conformance of a 
product with these model specifications in advance of and independent 
of any specific procurement action.
    2.2 Concentration units. Blood alcohol concentration: grams alcohol 
per 100 milliliters blood or grams alcohol per 210 liters of breath in 
accordance with the Uniform Vehicle Code, Section 11-903(a)(5).\3\ BrAC 
is often used to indicate that the measurement is a breath measurement, 
i.e. grams alcohol per 210 liters of breath.
---------------------------------------------------------------------------

    \3\ Available from National Committee on Uniform Traffic Laws 
and Ordinances, 405 Church Street, Evanston, IL 60201.
---------------------------------------------------------------------------

    2.3 Relative Standard Deviation (RSD). The ratio of the standard 
deviation (SD) of a series of measurements to the mean of the series 
expressed as a percentage:

RSD = (SD/Mean) x 100 percent

    2.4 Standard Deviation (SD). A common indication of precision in 
the measurement of the concentration of a succession of N vapor 
samples.

SD = {Sum (Xi-Xm)2/(N-1){time} \1/2\
Where:

Xi = a single measurement result;
Xm = the average of the measurements;
N = the number of measurements made in the test.

    2.5 Systematic Error (SE). An indication of the accuracy of the 
measurement of the concentration of a succession of vapor samples.

SE = Xm - test BrAC

    2.6 Least Squares Fit Calibration Curve. A Line fitted to a number 
of measurement pairs, one the independent value (X) and the other the 
dependent value (Y), over a measurement range.
    The fitted line is of the form: Y = a + bX, where intercept, a = 
Ym-bm, and slope, b = 
(SumXiYi-NXm) / 
(SumXi2-nXm2)

3.0 Tests and Requirements

    If the BrAC of the CU is fixed, perform the tests at the fixed 
BrAC; otherwise, prepare the CU for testing at 0.08 BrAC except as 
otherwise required in Test 1 below. Each of the tests requires 10 
measurements to three decimal places using the test procedure specified 
in 3.1, 3.2, or 3.3, respectively. The CU will be operated according to 
the manufacturer's instructions. Unless otherwise specified, the tests 
will be performed in the absence of drafts and at prevailing normal 
laboratory temperature, humidity, and barometric pressure. Performance 
requirements are:

-0.002 BrAC <= SE <= +0.002 BrAC; RSD <= 2%

    Test 1. Precision and Accuracy. Test at each specified BrAc.

Test 1.1: 0.020 BrAC
Test 1.2: 0.040 BrAC
Test 1.3: 0.080 BrAC
Test 1.4: 0.160 BrAC

    Test 2. Ambient Temperature. Use a temperature chamber controllable 
to  [deg]C. Soak the CU at the specified temperature for 1 
hour, being careful to prevent drafts on the device, then test at that 
temperature.

Test 2.1: 10 [deg]C
Test 2.2: 30 [deg]C

    Test 3. Input Power. If the CU is powered by nominal voltages of 
120 volts AC of 12 volts DC, condition the device for one half hour at 
the appropriate input voltage specified below, then test at that 
voltage. Monitor the input power with a voltmeter accurate to  2% full scale in the range used and re-adjust the voltage, if 
necessary. If the voltage is Ac, conduct test 3.1 and 3.2.
    If the voltage is DC, conduct tests 3.3 and 3.4.

Test 3.1: 108 Volts/AC
Test 3.2: 123 Volts/AC
Test 3.3: 11 Volts/DC
Test 3.4: 15 Volts/DC
    Test 4. Electrical Safety Inspection. Examine the CU for protection 
of the operator from electrical shock. Examine for proper use of input 
power fuses, and verify that there are no exposed male connectors at 
high potential. Determine that overheating does not occur during 
operation and that undue fire hazards do not exist.
3.1 Test Procedure (Original, wet-bath calibrating units)
    Equipment and Supplies: Gas Chromatograph capable of complete 
resolution of ethanol in test samples, with heated gas sampling valve. 
Water bath thermostated at 34 [deg]C  0.1 [deg]C. Glass 
Reference Sample Bottles (300 ml capacity or greater) with Stopper and 
Inlet and Outlet Air Hoses (see Figure 1). Hoses should be about 1/8'' 
OD Teflon tubing. Reference Ethanol Solutions prepared using Class A 
glassware and American Chemical Society reagent grade ethanol or USP 
grade ethanol. The purity of the ethanol used shall be compared with 
the National Institute of standards and Technology (NIST) Standard 
Reference Material for ethanol. Use the value of Harger, et al., for 
the partition ratio for concentration of ethanol in headspace to 
concentration in solution at 34 [deg]C, Ka/w = 0.000393 \4\ to prepare 
two solutions which, when thermostated at 34 [deg]C, produce headspace 
ethanol vapor concentrations that bracket the test BrAC by no more than 
 20%. Small Air Pump for bubbling air through reference 
solutions (see Figure 1).
---------------------------------------------------------------------------

    \4\ RN Harger, BB Raney, EG Bridwell, MF Kitchel J. Biol. Chem. 
183, 197-213 (1950). Additional data from Harger in a private 
communication (see 49 FR 48869).
---------------------------------------------------------------------------

    Step 1. Prepare the Gas Chromatograph for measurement of vapor 
samples. Adjust instrument temperatures, gas flows, detector, and 
recording device for optimum response for ethanol. Prepare the CU for 
use according to manufacturer's instructions.
    Step 2. Fill two reference solution bottles to \3/4\ full with 
above reference solutions. Insert stopper assemblies with bubble line 
and alcohol vapor line in place and put bottles in the water bath with 
water level up to the stopper. Connect air pump to bubble line. Connect 
alcohol vapor line to gas chromatograph sampling valve inlet fitting. 
Allow 1 hour for temperature equilibrium to be achieved.

[[Page 34745]]

    Step 3. Turn on air pump which has been pre-set to pump air through 
the reference solution bottle-gas chromatograph sampling assembly at a 
rate just sufficient to thoroughly flush the system in 10 seconds. 
After flushing is complete, allow the sample to relax to atmospheric 
pressure, then inject the reference sample onto the gas chromatograph 
column. In this way, obtain 5 chromatograms of one of the reference 
solution headspace ethanol vapors.
    Step 4. Thoroughly flush the sample loop with vapors from the CU 
device, while avoiding over-pressurizing of the sampling system. To 
prevent condensation of alcohol, warm the transfer line if necessary. 
Allow the sample to relax to atmospheric pressure, then inject the 
sample onto the column. In this way, obtain 10 ethanol chromatograms 
using the CU device.
    Step 5. Repeat step 3 using the second reference solution.
    Step 6. Calculations. Peak height to BrAC conversion factor. For 
each ethanol peak obtained in Step 3 and Step 5, calculate a conversion 
factor for ethanol concentration by dividing the equivalent BrAC of the 
vapor sample by the peak height obtained for that sample. From the 10 
samples, obtain the mean and the RSD of the conversion factors. If the 
RSD obtained fails to meet the criteria for RSD in 3.0, perform 
necessary troubleshooting and repeat the procedure from Step 1. Use the 
mean of the conversion factors to calculate the BrAC for each of the 10 
ethanol peaks obtained in Step 4. Calculate the mean, the RSD, and the 
systematic error of the experimental BrACs.
[GRAPHIC] [TIFF OMITTED] TN25JN07.000

3.2 Test Procedures (for dry gas calibrating units). Alternate Test 
Method using National Institute of Standards and Technology Reference 
Gas Mixtures (NISTRGMs) in place of wet bath reference samples
    The following alternate method for the evaluation of dry gaseous 
ethanol calibration devices is presented.
    Additional required material: For the alternate method for 
evaluation of dry gaseous ethanol calibration devices, the following 
will be required: Four cylinders of National Institute of Standards and 
Technology ethanol-in-inert gas Technical Reference Gas Mixtures 
(NISTRGMs) which span the BrAC range 0.01 to 0.16.
    Alternate procedure for evaluation of dry gaseous ethanol 
calibration devices. This procedure substitutes the use of NISTRGMs in 
place of the wet bath reference samples when evaluating dry gas CUs.
    Step A1. Connect one of the NISTRGM cylinders to the inlet of the 
gas chromatograph sampling valve and pass reference gas through the 
sampling system at a rate just sufficient to thoroughly flush the 
system in about 10 seconds. Allow the sample to relax to atmospheric 
pressure, then inject the sample onto the column. In this way, obtain 5 
chromatograms of the reference gas.
    Step A2. Repeat Step A1 for each of the four NISTRGM reference gas 
mixtures.
     Step A3. Calculate the RSD of the concentration divided by peak 
height data obtained in Step A1 and Step A2. If the calculated RSD 
meets the criteria of 3.0, calculate the slope and intercept of the 
least squares fit calibration line for conversion of peak height to 
BrAC. Using the average peak height of each NISTRGM and the slope and 
intercept data, calculate the concentration of each NISTRGM. If the 
resulting concentrations are within the stated accuracy of the NISTRGM, 
proceed to Step A4.
    Step A4. Connect the calibrating device to the inlet of the gas

[[Page 34746]]

chromatograph sampling system and allow the calibrating device gas to 
flow at a rate just sufficient to thoroughly flush the sampling system 
in about 10 seconds. Allow the sample to relax to atmospheric pressure, 
then inject the sample onto the column. In this way, obtain 10 
chromatograms of the calibrating device gas.
    Step A5. Calculations. Using the peak height data obtained in Step 
A4 and intercept and slope data obtained in Step A3, calculate the BrAC 
for each of the 10 peak heights. Calculate the mean, RSD, and 
systematic error of the calculated BrACs.
3.3 Test Procedures (for dry gas or wet bath calibrating units)
    This alternate procedure uses infra-red spectroscopy that is 
suitable for evaluating ethanol vapor samples from either wet-bath CUs 
or from dry-gas CUs.
    3.3.1 General. This method uses the Beer-Lambert Law of absorption 
of radiant energy by fluids.

I = Io x e-abc

Where:
Io is the energy entering the sample chamber of a 
spectrophotometer containing the sample to be analyzed.
I is the energy transmitted from the sample chamber.
a is the absorptivity of the sample.
b is the radiation path length of the sample chamber.
c is the concentration of the sample in the sample chamber.

    A convenient form of the Beer-Lambert law is

Ln(Io/I) = abc

where the term Ln(Io/I), the logarithm of the ratio of 
incident to transmitted energy, is called the absorbance of the sample. 
In the procedure described below, the terms a and b are treated as a 
single quantity, ab, and the term c is BrAC.
    3.3.2 Test Procedure.
    Equipment and Supplies. Infra-red Spectrophotometer with sample 
chamber that can be heated to above 40 [deg]C. A non-dispersive 
instrument with appropriate band pass filters and configured to measure 
breath alcohol samples, such as an infra-red evidential breath tester 
listed on the NHTSA Conforming Products List for evidential breath 
testers may be used. The detector voltage of the instrument must be 
accessible for measurement. The sampling hoses of the device may be 
altered for more convenient processing of test samples. Water bath 
thermostated at 34 [deg]C  0.1 [deg]C. Glass Reference 
Sample Bottles (300 ml capacity or greater) and Stoppers with Bubble 
and Alcohol Vapor lines (see Figure 2). Reference Ethanol Solutions 
prepared using Class A glassware and American Chemical Society reagent 
grade ethanol or USP grade ethanol. The purity of the ethanol used 
shall be compared with the National Institute of Standards and 
Technology (NIST) Standard Reference Material for ethanol. Use the 
value of Harger, et al., for the partition ratio for concentration of 
ethanol in headspace to concentration in solution at 34 [deg]C, 
Ka/w = 0.000393\2\ to prepare two aqueous alcohol solutions 
which bracket the test BrAC by no more than  20%. A 
cylinder of inert Flushing Gas, which is optically clear in the 
absorption region used for measurement. This gas will be used to flush 
the sample chamber of the spectrophotometer and to deliver reference 
headspace vapors and wet bath sample vapors into the sample chamber. 
Pressure regulating valve with Teflon delivery hose for controlling 
flow and delivery of flushing gas.
    Step B1. Prepare the spectrometer for measurement of vapor samples. 
Prepare the CU for use according to manufacturer's instructions.
    Step B2. Fill a reference sample bottles to \3/4\ full with water 
and two reference sample bottles to \3/4\ full with the above reference 
solutions. Insert stopper assemblies ensuring that the end of the 
bubble line reaches to at least 4 inches below the surface of the 
solution, then place the bottles in the water bath with water level up 
to the stopper. Allow 1 hour for temperature equilibrium to be 
achieved.
    Step B3. Connect the bubble line of the sample bottle containing 
water only to the flushing gas valve and the vapor line to the 
spectrophotometer inlet and flush the sample chamber with water vapor 
and obtain the detector voltage reading. Then flush the detector 
chamber with flushing gas only and obtain the detector reading. Repeat 
2 times to obtain 3 sets of readings. If the CU being evaluated is a 
wet bath device, skip this step and proceed to Step B4.
    Step B4. In the manner of Step B3, obtain 5 sets of detector 
readings using one of the reference alcohol solution bottles.
    Step B5. In the manner of Step B3, obtain 10 sets of detector 
readings from the CU being evaluated. If the CU is a wet bath device, 
use the flushing gas to fill the sample chamber, operating the device 
according to manufacturer's instructions. If the CU device is dry gas 
device, fill the sample chamber according to manufacturer's 
instructions.
    Step B6. Repeat Step B5 using the other reference alcohol solution 
bottle.
    Step B7. Repeat Step B3.
    Step B8. Calculations. For each measurement pair, Io is 
the detector voltage obtained for the flushing gas alone in the sample 
chamber and I is the voltage obtained for the flushing gas with 
reference sample or test sample in the sample chamber corrected for 
water vapor absorption, i.e.; the detector voltage obtained for 
headspace reference samples at 0.000 BrAC. Use the average of the 6 
voltage readings obtained for the water samples for the correction for 
water vapor absorption (I = Isample - Iwater). In 
the case of wet bath device samples, there is no correction for water 
vapor absorption. If the detector is biased, it will be the difference 
between the bias voltage and the above voltage.
    Calculate the absorbance for each of the 10 reference samples. 
Divide each absorbance by the corresponding BrAC of the sample. Obtain 
the mean (which is the factor ab), SD, and RSD for the 10 ratios. If 
the RSD is more than 2%, troubleshoot the procedure and repeat.
    Calculate the absorbance for each of the 10 CU test samples. Divide 
each by the ab factor to obtain the BrAC for each of the 10 CU samples. 
Obtain the mean, SD, RSD, and SE.

[[Page 34747]]

[GRAPHIC] [TIFF OMITTED] TN25JN07.001

    Appendix--Conforming Products List of Calibrating Units for Breath 
Alcohol Testers [Manufacturer and Calibrating Unit] \1\
---------------------------------------------------------------------------

    \1\ Infra-red (IR) and fuel cell breath testers may be 
calibrated with either wet bath or dry gas CUs. However, it is 
inadvisable to use dry gas CUs when calibrating gas chromatograph 
EBTs.

Conforming Products List of Calibrating Units for Breath Alcohol Testers
------------------------------------------------------------------------
                                                      Type of device
                  Manufacturers                  -----------------------
                                                    Dry gas    Wet bath
------------------------------------------------------------------------
1. Airgas, Inc. (Formerly known as: Gateway
 Airgas, AG Specialty Gas, or Acetylene Gas
 Co.), St. Louis, MO
     Ethanol Breath Alcohol Standard....          X   ..........
     103 parts per million (ppm)/108              X   ..........
     Liters (L).................................
     270 ppm/30L........................          X   ..........
2. Air Liquide CALGAZ, Cambridge, MD
     115 ppm/34L........................          X   ..........
     115 ppm/105L.......................          X   ..........
     230 ppm/34L........................          X   ..........
     230 ppm/105L.......................          X   ..........
     260.5 ppm/58L......................          X   ..........
     260.5 ppm/537L.....................          X   ..........
     260.5 ppm/15L......................          X   ..........
3. CMI, Inc., Owensboro, KY
     Toxitest II........................  ..........          X
4. Davtech Analytical Services, Canada
     CALWAVE dT-100.....................  ..........          X
5. Guth Laboratories, Inc., Harrisburg, PA
     Model 34C Simulator (variations:     ..........          X
     Model 34C Cal DOJ, 34-C-FM, and 34C-NPAS)..
     Model 3412.........................  ..........          X
     Model 10-4 and 10-4D...............  ..........          X
     Model 10-4D Revision A.............  ..........          X
     Model 1214.........................  ..........          X
     Model 2100 (formerly Model 210021).  ..........          X
     Model 2100 Revision A..............  ..........          X
     590................................  ..........          X
6. Intoximeters, Inc., St. Louis, MO
     Alco Breath Alcohol Standards*.....          X   ..........
7. Lion Laboratories, Cardiff, Wales, UK (a
 subsidiary of CMI, Inc.)
     AlcoCal Breath Alcohol Standard....          X   ..........
8. Liquid Technology Corp., Orlando, FL
     Ethanol-in-Nitrogen................          X   ..........
9. Luckey Laboratories, Inc., San Bernardino, CA
     Simulator*.........................  ..........          X

[[Page 34748]]

 
10. National Draeger, Inc., Durango, CO
     Mark II-A..........................  ..........          X
     Alcotest CU 34.....................  ..........          X
11. PLD of Florida, Inc., Rockledge, FL
     BA 500.............................  ..........          X
12. Protection Devices, Inc., U.S. Alcohol
 Testing, Inc., Rancho Cucamonga, CA
     LS34 Model 6100*...................  ..........          X
13. RepCo Marketing, Inc., Raleigh, NC
     AS-1...............................  ..........          X
     Model 3402C........................  ..........          X
     Model 3402C-2K.....................  ..........          X
14. Scott Specialty Gases, Inc., Plumsteadville,
 PA
     Model EBSTM Gaseous Ethanol Breath           X   ..........
     Standard...................................
     Scotty 28 0.040 BAC/28L............          X   ..........
     Scotty 28 0.045 BAC/28L............          X   ..........
     Scotty 28 0.080 BAC/28L............          X   ..........
     Scotty 28 0.100 BAC/28L............          X   ..........
     Scotty 28 0.105 BAC/28L............          X   ..........
15. Smith & Wesson Electronic Co., Springfield,
 MA
     Mark II-A Simulator*...............  ..........          X
16. Systems Innovation, Inc., Hallstead, PA
     True-Test MD 901*..................  ..........          X
17. U.S. Alcohol Testing, Rancho Cucamonga, CA
     Alco-Simulator 2000*...............  ..........          X
     Alco-Simulator 61000...............  ..........          X
------------------------------------------------------------------------
*Six instruments marked with an asterisk (*) meet the Model
  Specifications in 49 FR 48864 (December 14, 1984), i.e. instruments
  tested at 0.050, 0.100, and 0.150). Instruments not marked with an
  asterisk meet the model specifications detailed in this notice, and
  were tested at 0.020, 0.040, 0.080, and 0.160 BrAC.


    Authority: 23 U.S.C. 402; delegations of authority at 49 CFR 
1.50 and 501.

    Issued on: June 25, 2007.
Marilena Amoni,
Associate Administrator for the Office of Research and Program 
Development.
[FR Doc. 07-3060 Filed 6-22-07; 8:45 am]
BILLING CODE 4910-59-M