[Federal Register Volume 59, Number 249 (Thursday, December 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32091]


[[Page Unknown]]

[Federal Register: December 29, 1994]


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Federal Aviation Administration
National Highway Traffic Safety Administration
[Docket No. 94-068; Notice 1]

 

Highway Safety Programs; Model Specifications for Calibrating 
Units for Breath Alcohol Testers

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

ACTION: Notice; Request for comments.

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SUMMARY: This notice amends the Model Specifications for Calibrating 
Units for Breath Alcohol Testers in order to align test levels with 
those in Model Specifications for Devices to Measure Breath Alcohol. 
Under the earlier calibrating unit specifications, devices were 
evaluated at 0.050, 0.100, and 0.150 BAC. To achieve alignment with the 
amended breath tester specifications, this notice amends the 
calibrating unit specifications to perform evaluations at 0.020, 0.040, 
0.080, and 0.160 BAC. It also sets the acceptable Systematic Error at 
not greater than 0.002 BAC at all BAC levels tested, rather 
than the previous 2%. Finally, it makes a number of changes 
to automate and make more efficient the procedures used for the 
prescribed gas chromatography (GC) testing, as compared with the manual 
GC procedures previously used and described in the 1984 Model 
Specifications. Published with this notice is an amended Conforming 
Products List (CPL) of calibrating units that meet the amended Model 
Specifications for Calibrating Units. This notice also proposes and 
seeks comments concerning a new, alternate testing procedure for the 
evaluation of dry gaseous ethanol calibration devices, and other 
changes designed to simplify the Model Specifications and make them 
easier to read.

DATES: The amendments to the model specifications that change the BAC 
levels at which evaluations are performed, adjust the Systematic Error 
level, automate GC procedures, and the issuance of the CPL become 
effective on December 29, 1994. Comments on the alternate testing 
method, and the simplified text of the Model Specifications presented 
in this Notice must be received no later than January 30, 1995.

ADDRESSES: Comments regarding the alternate testing procedure and the 
simplified text of the Model Specifications should refer to the docket 
number and the number of this notice and be submitted (preferably in 
ten copies) to the NHTSA Docket Section, Rm. 5109, 400 Seventh St., SW, 
Washington, DC 20590 (Docket hours are from 9:30 a.m. to 4 p.m.).

FOR FURTHER INFORMATION CONTACT: Dr. James F. Frank, Office of Alcohol 
and State Programs (OASP), NTS-21, National Highway Safety 
Administration, 400 Seventh Street, S.W., Washington, D.C. 20590. 
Telephone (202) 366-5593.

SUPPLEMENTARY INFORMATION: On December 14, 1984, the National Highway 
Traffic Safety Administration (NHTSA) issued a notice to convert 
mandatory standards for evidential breath testers (EBTs) and 
calibrating units for breath alcohol testers (CUs) to Model 
Specifications for such devices (49 FR 48855 and 49 FR 48865 
respectively). The Notices indicated that the Agency would continue to 
test EBTs and CUs and would release its findings to provide States 
which choose not to conduct their own testing with adequate information 
upon which to base their purchasing decisions.
    Since publication of the Model Specifications in 1984, States have 
been moving toward a lowering of alcohol levels which indicate illegal 
alcohol impaired driving and enacting new laws targeting youthful 
offenders (i.e., ``zero tolerance'' laws). In addition, the Department 
of Transportation (DOT) has been engaged in rulemaking to require 
alcohol testing of transportation workers in safety sensitive positions 
at low alcohol levels. For these reasons, on September 17, 1993 (58 FR 
48705), NHTSA amended the Model Specifications for Devices to measure 
breath alcohol by lowering the BAC level at which devices are 
evaluated. Under the earlier specifications, evidential breath testers 
(EBTs) were evaluated at 0.000, 0.050, 0.101, and 0.151 BAC. The 
September 1994 notice amended the Specifications for EBTs to require 
testing at 0.000, 0.020, 0.040, 0.080, 0.160 BAC. The Model 
Specifications for calibrating units similarly called for evaluations 
at 0.050, 0.100, and 0.150 BAC. Today's notice amends the Model 
Specifications to perform evaluations of these devices also at 0.020, 
0.040, 0.080, and 0.160 BAC. It also changes the acceptable Systematic 
Error to not be greater than 0.002 BAC at each alcohol 
concentration (rather than 2%), and makes a number of 
changes to implement automated procedures for the use of gas 
chromatography to assess the precision and accuracy of calibrating 
units, rather than the manual procedures previously used and described 
in the 1984 Model Specifications.
    In addition, today's notice proposes to simplify the Model 
Specifications, such as by omitting descriptive details regarding 
laboratory procedures, thereby making the Model Specifications shorter 
and easier to read. However, the proposed changes do not represent 
substantive alterations in the procedures followed or in the criteria 
used to determine whether devices meet these Model Specifications. 
Today's notice also proposes to include in the Model Specifications an 
alternate procedure for evaluating dry gaseous ethanol calibrating 
devices. This procedure substitutes National Institute of Standards and 
Technology Reference Gas Mixtures (NISTRGMs) in place of wet reference 
samples previously used. The proposed revised Model Specifications, 
incorporating both the alternate procedures and the simplifications, 
are contained in Appendix A to this notice. Comments are sought 
regarding the agency's proposal.
    The model specifications are not intended to replace the current 
qualification programs required in certain States for this equipment or 
to directly regulate the manufacturers of CUs. Organizations and 
agencies may adopt these model specifications and rely on NHTSA's test 
results, or may conduct their own tests according to their own 
procedures and specifications. They may wish to make use of this 
program in addition to setting their own requirements. While the agency 
is not imposing its findings on State and local governments, NHTSA 
encourages each State to consider adopting the NHTSA model 
specifications as their own. It should be noted that transportation 
employers covered by 49 CFR Part 40, Procedures for Transportation 
Workplace Drug and Alcohol Testing Programs, are required to use only 
CUs that meet the criteria established by that regulation.

Procedures

    Testing of CUs submitted by manufacturers to these Model 
Specifications will continue to be conducted by the DOT Volpe National 
Transportation Systems Center (VNTSC). Procedures for submitting 
devices for evaluation have not changed. Tests will continue to be 
conducted semi-annually or as necessary. Manufacturers wishing to 
submit CUs for testing must apply to NHTSA for a test date (Office of 
Alcohol and State Programs, NTS-21, NHTSA, 400 Seventh Street, S.W., 
Washington, D.C. 20590). Normally, at least 30 days will be required 
from the date of notification until the test can be scheduled. One week 
prior to the scheduled initiation of the test program, the manufacturer 
will deliver at least one unit of the device to be tested to: VNTSC, 
DTS-75, Kendall Square, Cambridge, MA 02142. The manufacturer shall be 
responsible for ensuring that the unit is operating properly and is in 
proper calibration. If the manufacturer wishes to submit a duplicate, 
backup unit, it may do so. In addition to the Operator's Manual and the 
Maintenance Manual normally supplied with the purchase of this 
equipment, the manufacturer shall deliver to VNTSC specifications and 
drawings which fully describe its units. Proprietary information will 
be respected. (See 49 CFR Part 512, regarding the procedures by which 
NHTSA will consider claims of confidentiality.)
    The manufacturer will have the right to check the CU between 
arrival in Cambridge and the start of the test, and to ensure that the 
CU is in proper working condition but will have no access to it during 
the tests. Any malfunction of the CU which 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.
    On the basis of these results, NHTSA will publish a Conforming 
Products List (CPL) identifying the CUs that conform to the Model 
Specifications.
    Retesting 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 unique design 
features of a CU). 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 specification only.
    NHTSA shall certify that the CPL does, in fact, reflect CUs which 
meet the performance criteria set forth in the model specifications.
    If at any time a manufacturer changes the design of a CU currently 
on the CPL, the manufacturer shall submit the proposed changes to the 
Office of Alcohol and State Programs (OASP) for review. Based on this 
review, NHTSA will decide whether the change will require retesting of 
the unit. Normally, such retesting will be accomplished at the next 
testing period. Guidance to manufacturers on considerations governing 
this decision are available from NHTSA's OASP upon request.
    OASP will be the point of contact for information about acceptance 
testing and field performance of equipment already on the list. When it 
is available, NHTSA requests that users of CUs provide both acceptance 
and field performance data to OASP. Information from users will be used 
to: (1) help NHTSA determine whether units continue to perform 
according to the NHTSA Model Specifications and (2) ensure that field 
use does not indicate excessive breakdown or maintenance problems.
    If information gathered indicates that an instrument on the CPL is 
not performing in accordance with the Model Specifications, NHTSA will 
direct VNTSC to conduct a special investigation. This study 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 dropped from the 
list. In this event 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 
list. Upon resubmission, the manufacturer must submit a statement 
describing what has been done to overcome the problems which led to the 
dropping of the unit in question from the list.

Conforming Products List

    The Conforming Products List (CPL) which appears as Appendix B to 
this notice lists the calibrating units that have been retested to date 
at the lower BACs and found to conform to the amended model 
specifications herein. The CPL also lists devices that have not yet 
been tested at the new (and lower) BAC levels (at 0.020, 0.040, 0.080, 
and 0.160), but which were listed on our last CPL for calibrating units 
(58 FR 26030) on the basis that they were tested and found to conform 
to the previous Model Specifications (at 0.050, 0.100, and 0. 150). 
These devices have been identified with an asterisk.
    The fact that a unit does not appear on the list, or is not yet 
listed as having met the new Model Specifications, does not necessarily 
indicate that it failed to meet the Specifications. The unit may not 
have been included because it has not yet been tested. As additional 
testing is completed, any additional devices that meet the Model 
Specifications, as amended, will be included in our next publication of 
the CPL for calibrating units.
    This publication of the CPL includes a number of changes that 
should be noted. (1) The Breath Alcohol Simulator BAS311 manufactured 
by Century Systems, Inc., Arkansas City, KS has been removed from the 
list. The company has been out of business since the late 1970s and the 
devices have not been sold since then. No devices are known to be in 
use today. (2) National Draeger, Inc., Pittsburgh, PA now manufactures 
the Mark II-A simulator previously made by Smith & Wesson Electronic 
Co., Springfield, MA. NHTSA will now list National Draeger as the 
manufacturer of the Mark IIA. NHTSA will also continue to list the 
Smith & Wesson Mark IIA, as units are still in use in the field.
    It should also be noted that Scott Specialty Gases/Scott Medical 
Products, Inc., Plumsteadville, PA has submitted for testing Model 
EBSTM Gaseous Ethanol Breath Standard, a dry gas standard. This 
device has been tested against the proposed Model Specifications, using 
the alternate testing procedure proposed in this publication. It has 
been found to meet the proposed Specifications. If the alternate 
procedure is incorporated into the Model Specifications, as proposed, 
this device will be added to the CPL. In addition, A.G. Specialty Gas 
(also known as Acetylene Gas Company), St. Louis, MO has submitted for 
testing their Ethanol Breath Alcohol Standard. This dry gas device has 
also been tested against the proposed Model Specifications, using the 
alternate testing procedures described in this publication. It has also 
been found to meet the proposed specifications. If the alternate 
procedure is incorporated into the Model Specifications, as proposed, 
this dry gas device will also be added to the CPL.

Comments

    Interested persons are invited to comment on the proposed alternate 
testing procedure described in this notice, as well as the simplified 
and streamlined text of the proposed Model Specifications. It is 
requested, but not required that 10 copies be submitted. Comments must 
not exceed 15 pages in length (49 CFR 553.221). Necessary attachments 
may be appended to those submissions without regard to the 15 page 
limit. This limitation is intended to encourage commentors to detail 
their primary arguments in a concise fashion.
    All comments received before the close of business on the comment 
closing date indicated above will be considered, and will be available 
for examination in the docket at the above address, both before and 
after that date. To the extent possible, comments filed after the 
closing date will also be considered. However, the amendments to the 
Model Specifications may be published at any time after that date, and 
any comments received after the closing date and too late for 
consideration with regard to the action will be treated as suggestions 
for future revisions to the specifications. NHTSA will continue to file 
relevant material in the docket after the closing date as it becomes 
available. It is recommended that interested persons continue to 
examine the docket for new material.
    Those persons who desire to be notified upon receipt of their 
comments in the docket should enclose a self-addressed stamped postcard 
in the envelope with their comments. Upon receiving the comments, the 
docket supervisor will return the postcard by mail.
    This action has been analyzed in accordance with the principles and 
criteria contained in Executive Order 12612 and it has been determined 
that it has no federalism implication that warrants the preparation of 
a federalism assessment.
    In consideration of the foregoing, NHTSA amends the Model 
Specifications for Calibrating Units, as last published in the Federal 
Register on December 14, 1984 (49 FR 48865), as set forth below. NHTSA 
proposes to further amend these Model Specifications, as set forth in 
Appendix A.

Model Specifications for Calibrating Units for Breath Alcohol 
Testers

    1. Sections 4.2, 4.4 and 4.5.1 are amended by replacing the phrase 
``2 percent'' each time it appears after the words ``plus or minus'' 
with the phrase ``0.002 BAC''.
    2. Section 5.1.3.1 is amended by replacing the last sentence with: 
``Otherwise, test the calibrating units at concentrations of 0.02, 
0.04, 0.08, and 0.16 BAC.''
    3. Section 5.1.3.4 is revised to read as follows:
    5.1.3.4  Fit the above sealed reference solution bottle with the 
transfer line which connects the headspace vapors of the reference 
solutions to the GC sampling valve. Fit another hose which allows an 
airpump to bubble air at a controlled rate to the bottom of the 
reference solution (see Figure 1). Immerse the bottles to the level of 
the rubber septa in a circulating water bath maintained at an 
appropriate temperature between 25 deg. and 35 deg. C., constant to 
within 0.1 deg. C.
    4. Section 5.1.3.6 and 5.1.3.7 are deleted and the section numbers 
reserved.
    5. Sections 5.1.3.8 and 5.1.3.9 are revised to read as follows:
    5.1.3.8  By control of the air pump, flush the headspace vapors of 
the reference solution through the GC sampling system at a rate just 
sufficient to completely flush the sampling system in 10 seconds. 
Inject the sample onto the GC column. After injection of the vapor, 
obtain the ethanol chromatogram and measure the area of the ethanol 
peak.
    5.1.3.9  Repeat 5.1.3.8 four more times so as to obtain a total of 
5 ethanol chromatograms and peak areas from the first reference sample.
    6. Section 5.1.3.10 is amended by deleting the words ``as shown in 
Figure 1'' and by replacing the last two sentences with the following 
two sentences, ``If the recommended flow rate from the calibration unit 
exceeds 200 ml/min., a sample splitting device may be used to reduce 
the flow rate into the gas-sampling system. Obtain 10 ethanol 
chromatograms and measure each ethanol peak area.''
    7. Sections 5.1.3.11 and 5.1.3.18 are revised to read as follows:
    5.1.3.11  Using the second reference sample, repeat 5.1.3.8 five 
times to obtain 5 ethanol chromatograms and peak areas from the second 
reference sample.
    5.1.3.18  Repeat 5.1.3.8 to 5.1.3.17 at other concentrations if 
necessary to satisfy 5.1.3.1.
    8. Section 5.3 is revised by replacing the heading ``AC-Line 
voltage test.'' with the heading ``Input Power Tests.''; by renumbering 
Sections 5.3.1, 5.3.2, 5.3.3 and 5.3.4 as 5.3.1.1, 5.3.1.2, 5.3.1.3 and 
5.3.1.4; by inserting the heading ``AC Input Power.'' in 5.3.1 and by 
adding a new 5.3.2 to read as follows:
    5.3.2  DC Input Power
    5.3.2.1  Apply DC power to the unit under test through a DC power 
supply having an output adjustable from 0 to 20 volts and a current 
rating as required by the instrument under test.
    5.3.2.2  Monitor the DC power supply output voltage on a DC 
voltmeter having an accuracy of 2% in the range 11-15 
volts.
    5.3.2.3  Adjust the voltage at the breath tester calibrating unit 
to 11 volts. After at least one-half hour, check the voltage and 
readjust to 11 volts if necessary. Then immediately repeat the 
precision and accuracy test (5.1 as amended), at a concentration 
between 0.02 and 0.16 BAC to obtain the relative standard deviation and 
the systematic error.

    5.3.2.4  Increase the voltage to 15 volts. After at least one-half 
hour, readjust the voltage if necessary and again repeat the precision 
and accuracy test (5.1, as amended) at a concentration between 0.02 and 
0.16 BAC to obtain the relative standard deviation and the systematic 
error.

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

    Issued on: December 23, 1994.
Michael B. Brownlee,
Associate Administrator for Traffic Safety Programs.

Appendix A--Model Specifications for Calibrating Units for Breath 
Alcohol Testers

1. 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. Definitions.
    2.2  Conformance testing. Testing to check the conformance of a 
product with these model specifications in advance of and independent 
of any specific procurement action.
    2.3  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).1 BrAC is often used to indicate that the measurement is 
a breath measurement. In these Model Specifications, concentration 
units of test samples are referred to as BAC units and are grams 
alcohol per 210 liters of air. See section 3.1.
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    \1\Available from National Committee on Uniform Traffic Laws and 
Ordinances, 405 Church Street, Evanston, IL 60201.
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    2.4  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.

  Standard deviation=
{Sum (Xi-Xm)\2\(N-1)}\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. An indication of the accuracy of the 
measurement of the concentration of a succession of vapor samples.

    Systematic error={(Xm-test BAC)/test BAC}100 percent
    2.6  Least Squares Fit Calibration Curve. A line fitted to a number 
of measurement pairs, one the dependent value (in section 3.1 stated 
BAC, Y) and the other the independent value (peak height, X), over a 
measurement range.
    The fitted line is of the form

Y=a+bX,

where
    intercept, a=Y-bXm

and

    slope, b=(SumXiYi-nXmYm) / 
(SumXi\2\-nXm\2\)

3.0 Tests and Requirements
    If the BAC of the CU is fixed, perform the tests at the fixed BAC; 
otherwise, prepare the CU for testing at 0.08 BAC except as otherwise 
required in Test 1. Each of the tests require 10 measurements to three 
decimal places using the test procedure specified in 3.1. 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 BACSE+0.002 BAC;
RSD2%

    Test 1. Precision and Accuracy. Test at each specified BAC.
    Test 1.1: 0.020 BAC
    Test 1.2. 0.040 BAC
    Test 1.3: 0.080 BAC
    Test 1.4: 0.160 BAC
    Test 2. Ambient Temperature. Use a temperature chamber controllable 
to 2oC. 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 or 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 readjust the voltage, 
if necessary.
    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
    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 (100 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 head space to 
concentration in solution at 34 deg.C, Ka/w=0.000393 2 to prepare 
two solutions which, when thermostated at 34 deg.C, produce head space 
ethanol vapor concentrations that bracket the test BAC by no more than 
20%. Small Air Pump for bubbling air through reference 
solutions (see Figure 1).
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    \2\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).
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    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 and place bottles 
in the water bath with water level up to the stopper. Connect air pump 
to inlet air hose of reference solution bottle. Connect outlet hose to 
gas chromatograph sampling valve inlet fitting. Allow 1 hour for 
temperature equilibrium to be achieved.
    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 chromatogram of one of the reference 
solution head space 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 chromatogram 
using the CU device.
    Step 5. Repeat step 3 using the second reference solution.
    Step 6. Calculations. Peak height to BAC conversion factor. For 
each ethanol peak obtained in step 2 and step 5, calculate a conversion 
factor for ethanol concentration by dividing the equivalent BAC of the 
vapor sample by the peak height obtained for that sample. From the ten 
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 BAC for each of the 10 
ethanol peaks obtained in step 4. Calculate the mean, the RSD, and the 
systematic error of the experimental BACs.

TN29DE94.034

The following alternate method for the evaluation of dry gaseous 
ethanol calibration devices is presented.
    Additional required material: For the proposed 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 BAC range 0.01 to 0.16.
    Alternate Procedure for evaluation of dry gaseous ethanol 
calibration devices. If it is evident that the gas chromatograph column 
being used according to the model specifications described above is 
causing an excessive systematic error in comparing samples from dry 
gaseous ethanol calibrating devices with the moist head space vapor 
samples from the thermostated reference solutions, the following 
alternate procedure may be used. This procedure substitutes National 
Institute for Standards and Technology Reference Gas Mixtures (NISTRGM) 
in place of the moist reference samples.
    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 
chromatogram 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 
BAC. 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 
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 
chromatogram 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 BAC 
for each of the 10 peak heights. Calculate the mean, RSD, and 
systematic error of the calculated BACs.

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

1. CMI, Inc., Owensboro, KY:
     Toxitest II
2. Federal Signal Corporation, CMI, Inc., Minturn, CO:
     Toxitest Model ABS120*
3. Guth Laboratories, Inc., Harrisburg, PA:
     Model 34C Simulator3
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    \3\Several variations of the Model 34C Simulator have also been 
submitted to NHTSA for evaluation and meet these Model 
Specifications. They are: Model 34C Cal DOJ; Model 34C-FM; and 34C-
NPAS.
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     Model 3412
     Model 10-4
     Model 1214
4. Intoximeters, Inc., St. Louis, MO:
     Alco Breath Alcohol Standard*
5. Luckey Laboratories, Inc., San Bernardino, CA:
     Simulator*
6. National Draeger, Inc., Pittsburgh, PA: 
     Mark II-A
7. PLD of Florida, Inc., Rockledge, FL: 
     BA 500
8. Protection Devices, Inc./U.S. Alcohol Testing, Inc., Rancho 
Cucamonga, CA:
     LS34 Model 6100*
9. Repco Marketing, Inc., Raleigh, NC:
     AS-1
10. Smith & Wesson Electronic Co., Springfield, MA:
     Mark II-A Simulator*
11. Systems Innovation, Inc., Hallsteaed, PA: 
     True-Test MD 901*
12. U.S. Alcohol Testing, Rancho Cucamonga, CA:
     Alco-Simulator 2000*
     Alco-Simulator 61000
    *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 amended model specifications detailed in this 
notice.

[FR Doc. 94-32091 Filed 12-23-94; 12:34 pm]
BILLING CODE 4910-59-P