43416 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices

DEPARTMENT OF TRANSPORTATION

Federal Transit Administration

[FTA Docket No. 97–2789]

Notice of Request for the

Reinstatement of an Expired

Information Collection

AGENCY: Federal Transit Administration,

DOT.

ACTION: Notice of request for comments.

SUMMARY: In accordance with the

Paperwork Reduction Act of 1995, this

notice announces the intention of the

Federal Transit Administration (FTA) to

request the Office of Management and

Budget (OMB) to reinstate the following

expired information collection:

49 U.S.C. Section 5310—Capital

Assistance Program for Elderly Persons

and Persons with Disabilities and 49

U.S.C. Section 5311-Nonurbanized Area

Formula Program.

DATES: Comments must be submitted

before October 14, 1997.

ADDRESSES: All written comments must

refer to the docket number that appears

at the top of this document and be

submitted to the United States

Department of Transportation, Central

Dockets Office, PL–401, 400 Seventh

Street, S.W., Washington, D.C. 20590.

All comments received will be available

for examination at the above address

from 10:00 a.m. to 5:00 p.m., e.t.,

Monday through Friday, except Federal

holidays. Those desiring notification of

receipt of comments must include a selfaddressed, stamped postcard/envelope.

FOR FURTHER INFORMATION CONTACT: Ms.

Sue Masselink, Office of Program

Management, (202) 366–2053.

SUPPLEMENTARY INFORMATION: Interested

parties are invited to send comments

regarding any aspect of this information

collection, including: (1) The necessity

and utility of the information collection

for the proper performance of the

functions of the FTA; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the collected information; and (4)

ways to minimize the collection burden

without reducing the quality of the

collected information. Comments

submitted in response to this notice will

be summarized and/or included in the

request for OMB approval of this

information collection.

Title: 49 U.S.C. Section 5310—Capital

Assistance Program for Elderly Persons

and Persons with Disabilities and 49

U.S.C. Section 5311 Nonurbanized Area

Formula Program. (OMB Number: 2132–

0500.)

Background

The Capital Assistance Program for

Elderly Persons and Persons with

Disabilities provides financial assistance

for the specialized transportation

service needs of elderly persons and

persons with disabilities. The program

is administered by the States and may

be used in all areas, urbanized, small

urban, and rural. The Nonurbanized

Area Formula Program provides

financial assistance for the provision of

public transportation services in

nonurbanized areas and this program is

also administered by the States. 49

U.S.C. Sections 5310 and 5311 authorize

FTA to review applications for federal

financial assistance to determine

eligibility and compliance with

statutory and administrative

requirements. Information collected

during the application stage includes

the project budget, which identifies

funds requested for project

implementation; a program of projects,

which identifies subrecipients to be

funded, the amount of funding that each

will receive, and a description of the

projects to be funded; the project

implementation plan; the State

management plan; a list of annual

certifications and assurances; and

public hearings notice, certification and

transcript. The applications must

contain sufficient information to enable

FTA to make the findings required by

law to enforce the program

requirements. Information collected

during the project management stage

includes an annual financial status

report, an annual program status report,

and pre-award and post-delivery audits.

The annual financial report and

program status report provide a basis for

monitoring approved projects to ensure

timely and appropriate expenditure of

federal funds by grant recipients.

Respondents: State and local

government, business or other for-profit

institutions, non-profit institutions, and

small business organizations.

Estimated Annual Burden on

Respondents: 102.44 hours for each of

the respondents.

Estimated Total Annual Burden:

11,370 hours.

Frequency: Annual.

Issued: August 7, 1997.

Gordon J. Linton,

Administrator.

[FR Doc. 97–21333 Filed 8–12–97; 8:45 am]

BILLING CODE 4910–57–P

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety

Administration

[Docket No. 94–068; Notice 2]

Highway Safety Programs; Model

Specifications for Calibrating Units for

Breath Alcohol Testers; Conforming

Products List of Calibrating Units

AGENCY: National Highway Traffic

Safety Administration (NHTSA), DOT.

ACTION: Notice; request for comments.

SUMMARY: This notice amends the Model

Specifications for Calibrating Units for

Breath Alcohol Testers by incorporating

an alternative testing procedure using

National Institute for Standards and

Technology (NIST) Reference Gas

Mixtures (RGMs) for the evaluation of

dry gaseous ethanol calibrating devices

and making other changes that were

previously proposed to simplify the

Model Specifications and to make them

easier to read. This notice also proposes

and seeks comment on a new alternate

procedure for evaluating the accuracy of

both wet bath and dry gas breath alcohol

calibrating units using infra-red

spectroscopy. Published with this notice

is an amended Conforming Products

List (CPL) of calibrating units that meet

the Model Specifications. This amended

list includes five new listings, one wet

bath unit and four dry gas units.

DATES: The amendments to the Model

Specifications and the issuance of the

Conforming Products List of calibrating

units meeting the Model Specifications

become effective on August 13, 1997.

Comments on the alternate testing

procedure using infra-red spectroscopy

proposed as an amendment to the

Model Specifications published herein

must be received by October 14, 1997.

ADDRESSES: Comments regarding the

alternate testing procedure 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.,

S.W. Washington, D.C. 20590 (Docket

hours are from 9:30 a.m. to 4 p.m.).

FOR FURTHER INFORMATION CONTACT: Dr.

James F. Frank, Impaired Driving

Division, Office of Traffic Injury Control

Programs (OTICP), NTS–11, 400

Seventh St., SW, Washington, DC

20590. Telephone (202) 366–5593.

SUPPLEMENTAL 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, of

devices which met the standard, was
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices 43417

1 Dubowski, K. and N.A. Essary ‘‘Vapor-Alcohol

Control Tests with Compressed Ethanol-Gas

Mixtures: Scientific Basis and Actual Performance.’’

Journal of Analytical Toxicology (1996)20, 484.

2Silverman, L.D., Wong, K. and Miller, S.

‘‘Confirmation of Ethanol Compressed-Gas Standard

Concentrations by a NIST-traceable, absolute

chemical method and comparison to wet breath

alcohol simulators.’’ Accepted for Publication in the

Journal of Analytical Toxicology, 1997.

first issued on November 30, 1976 (41

FR 53389).

On December 14, 1984, NHTSA

issued a notice to convert the mandatory

standards for evidential breath testers

and calibrating units for breath alcohol

testers to Model Specifications for such

devices (49 FR 48855 and 49 FR 48865,

respectively) and to establish a

Conforming Products List (CPL) of

evidential breath testers and calibrating

units meeting the Model Specifications.

Amendments to the CPL have been

published in the Federal Register since

that time. Evidential breath testers are

instruments that measure the alcohol

content of deep lung breath samples

with sufficient accuracy for evidential

purposes. Calibrating units provide

known concentrations of ethanol vapor

for the calibration or calibration checks

of instruments which measure breath

alcohol.

NHTSA published a notice in the

Federal Register (59 FR 67377) on

December 29, 1994, amending the

Model Specifications for calibrating

units for breath alcohol testers and

updating the CPL for calibrating units.

The notice also proposed and sought

comments about providing an alternate

testing procedure for evaluating the

accuracy and precision of dry-gas

ethanol calibrating units.

Officials who use breath alcohol

testers must verify their accuracy at

appropriate intervals during use. The

traditional means for ensuring accuracy

has been by checking the breath tester

calibration by use of a ‘‘wet bath’’

calibrator, a device which provides

moist alcohol in air samples at

accurately known concentrations. Dry

gas calibrating units have become

available as an alternate means for

calibration checking.

A dry gas calibrator produces alcoholin-inert gas samples (e.g., nitrogen or

argon) at accurately known

concentrations from a compressed gas

cylinder. Dry gas calibrators, like wet

bath calibrators, can be used to calibrate

certain types of breath testers, but an

evaluation of their precision and

accuracy requires alternate procedures.

Today’s notice amends the Model

Specifications for Calibrating Units for

Breath Alcohol Testers by incorporating

an alternative testing procedure using

National Institute for Standards and

Technology Reference Gas Mixtures for

the evaluation of dry gaseous ethanol

calibrating devices and making other

changes that were previously proposed

to simplify the Model Specifications

and to make them easier to read.

Additional minor changes were made to

ensure accuracy and improve clarity of

the document. Also, the term BrAC has

replaced the term BAC throughout the

model specifications to ensure

consistency with usage recommended in

the Uniform Vehicle Code.

Today’s notice also proposes an

additional new alternate procedure for

evaluating wet bath and dry gas

calibrating units using infra-red

spectroscopy. The agency believes that

use of infra-red spectroscopy will offer

several important advantages in the

evaluation of both wet bath and dry gas

calibrating units. Comments are sought

regarding the agency’s proposal.

A. Comments Received

1. Overview

The agency received two comments in

response to the notice of December 29,

1994: one from Scott Specialty Gas Co.

(Scott Gas), a manufacturer of a dry gas

calibrating unit, and one from U.S.

Alcohol Testing (USAT), a manufacturer

of an evidential breath test device and

a wet bath calibrating unit that is

currently listed on the NHTSA CPL.

Scott Gas was generally supportive of

the proposed revisions to the Model

Specifications. USAT stated that it

would favor the use of dry gaseous

ethanol calibrating devices when ‘‘it has

been adequately demonstrated that dryEtOH [calibration units] give results

comparable to those obtained with

conventional wet bath simulator

calibration units.’’

Neither of the respondents

specifically commented on the proposed

revisions to simplify the Model

Specifications. As stated in the notice,

these proposed revisions did ‘‘not

represent substantive alterations in the

procedures followed or in the criteria

used to determine whether devices meet

these model specifications.’’ The

proposed revisions have been adopted

without change.

Both Scott Gas and USAT raised

questions in their comments about those

aspects of the Model Specifications

relating to the proposed new alternate

testing procedure for evaluating the

accuracy and precision of dry gas

calibrating units. The comments

addressed a number of key issues,

including the comparability of wet bath

and dry gas calibrating units and certain

specific conditions affecting dry gas

calibrating units. The issues that were

contained in the comments are

summarized and discussed below.

2. Comparability Between Wet Bath and

Dry Gas Calibrating Units

USAT commented that ‘‘[T]he use of

a dry gas EtOH standard makes no

physical sense until it can be

demonstrated that the presence of water

vapor in the breath samples analyzed

has no effect on the analytical outcome

on the ethanol concentration of the

breath samples analyzed by the

[evidential breath tester].’’

While it is true that dry gas and

human breath differ in moisture

content, NHTSA has found no reason to

exclude the use of dry gas calibrating

units solely on this basis. If a calibrating

unit (either wet bath or dry gas) meets

the precision and accuracy criteria of

the Model Specifications, the calibrating

unit should be considered acceptable for

general use.

Independent research has confirmed

the comparability of dry gas and wet

bath calibrating units and the accuracy

of dry gas calibrating units. Kurt M.

Dubowski and Natalie A. Essary studied

the performance of dry gas calibrating

units and concluded that ‘‘dry gas

vapor-alcohol control [VAC] samples

conformed to established formal

specifications and * * * compared

favorably with simulator effluents for

control tests of breath alcohol analyzers

which are capable of adjusting VAC

results for ambient atmospheric

pressure.’’ 1 Lance D. Silverman, et al.

reported on the comparability of wet

bath and dry gas calibrating units. These

researchers determined that there was

substantial equivalence between both

types of calibrating units. Their data

‘‘based on collection of ethanol in an

impinger and titration using a modified

California Department of Health method

* * * confirm[ed] the alcohol content

of EBS compressed gases standards by

an absolute, wet chemical method.’’ 2

3. Should the Model Specifications Be

Expanded To Address Unique

Conditions Affecting Dry Gas

Calibrating Units?

USAT challenged the use of dry gas

calibrating units based on the following

factors: (a) condensation in the cylinder

as a consequence of low temperatures

during shipment; (b) the need to make

corrections due to changes in

atmospheric pressure; and (c) the

performance of dry gas calibrators over

a range of temperatures and

concentrations.

NHTSA has considered these

comments carefully and has concluded

that dry gas calibrating units are suitable

for evaluation according to the Model
43418 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices

3Flores, Arthur, ‘‘Dry Gas Calibration Units

Report’’ U.S. Department of Transportation Volpe

National Transportation Systems Center, Cambridge

MA, September 1996.

4 Farrington Daniels & Robert Alberty, ‘‘Physical

Chemistry’’ 3rd Ed., John Wiley & Sons, New York,

1966.

Specifications and believes that the

Model Specifications are sufficient to

ensure the accuracy and precision of dry

gas calibrating units. However, in light

of the concerns raised by USAT, the

agency has amended the procedures for

submitting a product for certification.

When a manufacturer submits a product

to the agency for testing, it now must

submit also a set of the instructions that

are provided to end users. The

instructions must sufficiently describe

the procedures to be followed to protect

against condensation in dry gas

cylinders that might occur as a result of

freezing during shipment and to correct

for atmospheric pressure.

(a) Condensation in Dry Gas Cylinders

as the Result of Freezing

USAT commented that dry gas

calibrating units were previously shown

to have a ‘‘memory effect when

transported or stored at temperatures

somewhat below room temperature.’’

NHTSA acknowledges that dry gas

calibrators could freeze during shipment

and this could affect test results. As a

result of freezing, alcohol could

condense in the inside surface of the

cylinder. If this were to happen, reequilibration of the alcohol with the

nitrogen after warming to room

temperature could take a long time. It is

possible that the gas in such cylinders

might be used before re-equilibration

occurred with the result that samples

would be obtained at incorrect

concentrations.

Manufacturers of dry gas calibrating

units recommend that, after receiving

the dry gas cylinders, users should

warm the cylinders to room

temperature, then lay them down on a

flat surface and physically roll them

back and forth for a period of ten

minutes to ensure equilibration of the

contents. To test whether this procedure

would ensure that the dry gas

calibrators remained accurate, several

cylinders of Lion Laboratories AlcoCal

dry gas calibrators were placed in the

freezer compartment of a refrigerator

overnight at a temperature of ¥15°C,

then taken out of the freezer, warmed to

room temperature and rolled on a table

top for ten minutes. Data was collected

confirming that tanks that were rolled

after freezing gave accurate results.3

As described in the section on

procedures for product submission

included at the end of this notice, when

manufacturers submit their instruments

for testing, they are required to submit

copies of the instructions they provide

to end users. NHTSA will examine these

instructions to ensure that they provide

sufficient information about this

procedure. Products submitted without

this information will not be tested.

(b) The Effect of Variable Atmospheric

Pressure on Dry Gas Calibrators

USAT commented that dry gas

calibrating units may exhibit a pressuredependent concentration effect that wet

bath calibrating units do not. The

packaging of a dry gas calibrator

compresses a large volume of an

alcohol-in-inert gas mixture into a metal

cylinder of only about one (1) liter. The

concentration of the alcohol in the gas

is given by the Ideal Gas Law 4: PV =

nRT, where P is the pressure of the gas,

V is the volume, n is the number of

moles of gas, R is the gas constant, and

T is the temperature of the gas. The

concentration of the gas is obtained as

a function of pressure and temperature:

Concentration = n/V = P/RT.

When a calibration check is

performed, some of the gas in the

cylinder is released by operating the

release valve. The volume of the

released gas will expand and its

pressure will drop until prevailing

atmospheric pressure is reached. The

gas is prepared so that the desired

concentration is obtained at normal

atmospheric pressure, 760 millimeters

of mercury. However, atmospheric

pressure varies slightly from day to day

and can change suddenly at times. The

most significant effect comes from high

elevations, where prevailing

atmospheric pressure is significantly

lower than 760. Atmospheric pressure

corrections are made using an equation

derived from the Ideal Gas Law: C = C760

X P/760, where C is concentration and

P is the prevailing atmospheric

pressure.

In order for any calibrating unit to

operate properly under such

atmospheric pressures, accurate

pressure correction must be made. The

agency has tested the dry gas calibrating

units placed on the CPL in this

publication using this pressure

correction procedure and has

determined that these devices meet the

Model Specifications. The agency

concludes that the pressure dependent

concentration effect is consistent and

well established and that pressure

correction procedures suggested by

manufacturers are effective and produce

accurate results.

As described in the section on

procedures for product submission

included at the end of this notice, when

manufacturers submit their instruments

for testing, they are required to submit

copies of the instructions they provide

to end users. While manufacturers

already provide information on pressure

corrections in their instructions to end

users, these Model Specifications have

been amended to require that the

instructions include information about

how atmospheric pressure corrections

should be made. NHTSA will examine

manufacturers’ instructions to ensure

that they provide sufficient information

about these pressure correction

procedures. Products submitted without

this information will not be tested.

NHTSA believes that these procedures

will be effective when used by properly

qualified breath alcohol technicians.

(c) The Performance of Dry Gas

Calibrators Over Range of Temperatures

and Concentrations

Throughout its written comments,

USAT argues that dry gas standards

should not be accepted because they

have not been shown to be comparable

to wet bath standards. USAT argues:

Further substantial equivalence of the dryEtOH and wet simulators must be shown

over the range of environmental temperatures

and pressures likely to be encountered

during normal field usage of any of the

devices appearing on the CPL * * * [and]

over the range of NHTSA tested

concentrations * * * throughout the

operating lifetime of the dry gas [calibrating

units] * * *

Results of comparative performance of dryETOH [calibrating units] versus wet

simulator [calibrating units] need to be

publicly presented in scientific forums and

published in the technical literature to

establish a level of confidence that dry gas

[calibrating units] yield substantially

equivalent results to those obtained for

decades from conventional wet simulator

[calibrating units].

USAT commented that ‘‘Dry gas EtOH

[calibrating units] must be required to

show equivalent performance over the

entire range of environmental

conditions used to test wet bath

simulator [calibrating units].’’ The

agency tests both wet bath and dry gas

calibrating units according to the Model

Specifications. The agency believes that

the Model Specifications require testing

over an appropriate range of

temperatures and concentrations. Dry

gas calibrating units are required to

show equivalent performance over the

entire range of environmental

conditions used to test wet bath

calibrating units.
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices 43419

4. Are Dry Gas Calibrating Units

Sufficiently Accurate?

USAT states that it would favor use of

dry gas calibrating units when ‘‘it has

been adequately demonstrated that dry

EtOH [calibrating units] give results

comparable to those obtained with

conventional ‘wet bath simulator

calibration units’.’’

The same Model Specifications used

to test the accuracy and precision of wet

bath calibrating units are used to ensure

the quality and performance of dry gas

calibrating units. All units are tested

over the same range of temperatures and

concentrations. All dry gas calibrating

units placed on the CPL in this

publication conform to the Model

Specifications. Any unit that fails to

meet the requirements of the Model

Specifications would not be included on

the agency’s list of conforming products.

5. Miscellaneous Issues

(a) Quality Assurance Plan

Scott Gas recommended that the

agency require Quality Assurance Plans

(QAPs) for calibrating units. QAPs are

used to provide information on the

correct use, proper maintenance

procedures and other specific

requirements of a calibration device.

Scott Gas recommended that the QAP

address issues such as NIST traceability,

mechanisms for product coding and

traceability, list of proper delivery

equipment, specifications on the

containers being submitted for approval,

shipping and storage information,

written laboratory certification and

manufacturing procedures, DOT

specification documentation on

containers, a specified uncertainty at the

95% confidence level and shelf life

results.

NHTSA strongly endorses the need

for quality control in manufacturing, but

believes that this is addressed

appropriately by the manufacturers of

these instruments. When calibrating

units are used by law enforcement

officials, quality control measures are

also taken under the programs of each

state. In transportation workplace

testing, quality control is ultimately

handled by the existing requirement for

QAPs for evidential breath testers and

alcohol screening devices (Screeners)

which address calibration accuracy. The

evidential breath tester QAPs call for

calibration checks using an approved

calibrating unit. If an evidential breath

tester or a Screener gives an incorrect

reading when a calibration check or a

calibration is conducted, it suggests that

there is an error in the system consisting

of the evidential breath tester (or

Screener), the breath alcohol technician,

or the calibrating unit. NHTSA believes

that the safeguards already in place in

the QAPs for evidential breath testers

and Screeners make it unnecessary to

require an additional QAP specific to

the calibrating unit.

(b) Stability of Dry Gas Calibrators Over

Their Operating Life

USAT commented that ‘‘Further

substantial equivalence of the dry-EtOH

and wet simulators must be shown over

the range of NHTSA tested

concentrations * * * throughout the

operating lifetime of the dry gas

[calibrating units] * * *’’ Scott Gas also

commented that ‘‘presentation of gas

manufacturer stability documentation to

NHTSA, before inclusion on the CPL,

plus NHTSA evaluation of aged product

should be done in order to assess the

‘‘real life’’ performance of the product.’’

The agency’s experience indicates

that dry gas calibrating units are

normally stable even after years of

storage. In addition, NHTSA has

verified that National Institute of

Standards and Technology Reference

Gas Mixtures used to evaluate dry gas

cylinders remained stable to within

±0.001 BrAC for a one year period. The

agency has concluded that

manufacturers will not be required to

provide stability documentation.

NHTSA shall certify that the CPL

does, in fact, reflect calibrating units

which meet the performance criteria set

forth in the Model Specifications.

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. In addition, in the

section on procedures for a product

submission, included at the end of this

notice, NHTSA requests that users of

calibrating units provide both

acceptance and field performance data

to NHTSA’s Office of Traffic Injury

Control Programs. NHTSA will conduct

a special investigation if information

gathered from the field indicates that a

device on the CPL is not performing in

accordance with the Model

Specifications.

After the recent expansion of the use

of dry gas calibrators, one manufacturer

found that the concentration of some

dry gas calibrators had changed from the

stated concentrations after weeks or

months of storage. A recall of all

cylinders in use was ordered. The

problem was investigated and, after

extensive testing it was traced to defects

in certain cylinders and was corrected.

(c) National Institute of Standards and

Technology Reference Gas Mixtures

In the Notice published on December

24, 1994, NHTSA proposed to revise the

Model Specifications to permit use of

National Institute of Standards and

Technology Reference Gas Mixtures

(NISTRGMs) as reference samples to

evaluate the accuracy of dry gas

calibrating units by gas chromatography.

Use of these dry gas standards allows

reliable evaluation of dry gas calibrators

by the gas chromatograph technique.

USAT commented that:

It is rumored that NISTRGMs are

manufactured by Scott Specialty Gases/Scott

Medical Products Inc. If true, the NHTSAproposed substitution of NISTRGMs to

replace wet bath simulator standards for the

testing of any Scott Gas gaseous standards

amounts to one manufacturer certifying itself

and claiming the blessing of both NIST and

NHTSA.

The NISTRGMs obtained by the Volpe

center were manufactured by Scott

Specialty Gases, but were obtained from

and analyzed independently by the

Department of Commerce National

Institute for Standards and Technology

(NIST). NIST attested in writing to the

accuracy of each individual cylinder of

gas which was obtained by the Volpe

Center.

(d) The Comparability of Dry Gas

Calibrating Units When Used With a

Variety of Evidential Breath Testing

Devices

USAT commented that ‘‘dry gas

standards are likely to give different

results when used on [evidential breath

testers] based on different

technologies.’’ According to USAT,

there have been reports that dry gas

calibrating units do not yield the same

results for certain breath testers as wet

bath calibrating units. USAT asserts that

a small ‘‘offset’’ in test result reportedly

occurs when dry gas calibrators are used

for these breath testers compared with

wet calibrators at the same

concentration. The offset for fuel cell

breath testers is reported to be ¥0.002

BrAC when dry calibrators are used to

check calibration of fuel cell evidential

breath testers.

Performance requirements contained

in NHTSA’s Model Specifications for

evidential breath testers require that

these instruments be accurate to ±0.005

or 5% of test BrAC, whichever is

greater, with a standard deviation not

greater than 0.004. The performance

requirements for calibrating units

require the devices to be accurate to

within 0.002 BrAC of the test BrAC with

relative standard deviation of 2%. Any

offset associated with a particular

calibrator is not considered.
43420 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices

5Flores, Arthur, ‘‘Dry Gas Calibrating Units

Report’’, U.S. Department of Transportation, Volpe

National Transportation Systems Center,

Cambridge, MA, September, 1996.

Agency testing indicates that dry gas

calibrating units can be used with infrared and fuel cell breath testers.5 The

agency tested four fuel cell testers, one

fuel cell/infra-red combination tester

with readout from the fuel cell sensor,

and one infra-red tester to obtain wet

dry comparison data. The instruments

tested were:

Life Loc, Inc. PBA 3000 and PBA 3000X (FC)

CMI, Inc. Intoxilyzer 400 (FC)

Intoximeters, Inc. AlcoSensor IV (FC)

National Draeger, Inc. Breathalyzer 7410–II

(FC)

Intoximeters, Inc. EC–IR (FC/IR)

CMI, Inc. Intoxilyzer 5000 (IR)

Measurements were made alternately

using first a sample from a wet bath

calibrator, then a sample from a dry gas

calibrator. Five measurements of each

type of sample were made on each of

the testers. The wet calibrator solutions

were prepared to produce the same

concentrations as the corresponding dry

gas. Wet samples were produced using

RepCo Marketing simulators (wet bath

calibrating units). Dry samples were

obtained from dry gas calibrating units

from Scott Specialty Gases, Inc. (0.04

BrAC) and Gateway Airgas, Inc. (0.04

and 0.088 BrAC). The concentration of

the Scott gas was verified by

Intoximeters, Inc. and the concentration

of the gas from Gateway Airgas was

verified by infra-red spectroscopy at the

Volpe center. The factory calibrations of

the breath testers were not adjusted. The

reliability of the ‘‘true value’’ of the wet

or dry standards can be taken as known

values to within about ±0.001 BrAC.

Thus, the true value of a wet sample or

a dry sample at 0.040 BrAC can be

expected to be correct to within about

±0.001 BrAC.

The differences between wet bath and

dry gas calibrating units were negligible

when the comparisons were made using

infra-red breath testers. These

differences were around 0.002 BrAC and

are not noticeable unless comparisons

are made carefully, because this value is

near the accuracy limit of the calibrating

units.

The differences observed when

comparisons were made using fuel cell

type breath testers, the next most widely

used type of breath tester, were more

noticeable, especially at high alcohol

levels. The offset for fuel cell breath

testers averaged somewhat less than 4%

of the nominal BrAC when dry gas

calibrators were used to check

calibration of fuel cell evidential breath

testers. The offsets found for the breath

testers ranged from ¥0.0014 BrAC to

0.0026 BrAC when compared at the 0.04

BrAC level, and from ¥0.0020 to 0.0052

when compared at the 0.088 level. The

standard deviations for the wet and dry

data were in the fourth decimal place

except in one instance when a value of

0.002 was obtained, which was still

acceptable. These results indicate that

the offsets are small and reproducible

enough that reliable corrections can be

applied to ensure accurate test results.

The offsets observed cannot be assumed

to arise only from the inherent

differences in measurement of moist

samples compared to the measurement

of dry samples since there are also

uncertainties of ±0.001 in the true

concentration of wet bath or dry gas

calibration unit vapors.

Offsets must be indicated by

manufacturers in their instructions to

end users. Manufacturers are required to

include their instructions in a

submission of a calibrating unit for

testing. The agency will examine the

instructions to ensure that they provide

sufficient information on offsets

necessary for certain breath testers.

Products submitted without this

information will not be tested.

Gas Chromatograph breath testers

depend on extensive surface interaction

with the sample being analyzed, and the

greatest differences between dry and

wet standards are seen with this type of

breath tester. In its laboratory, NHTSA

has found that the effects are not stable.

They vary with type and condition of

resolving column used. Accordingly,

NHTSA believes that dry gas calibrating

units should not be used with gas

chromatograph breath testers because

the results are too variable. The agency

will include a footnote on the CPL

concerning the use of dry gas standards

with gas chromatograph evidential

breath testers, indicating that the agency

does not recommend the use of dry gas

calibrating units with gas

chromatograph evidential breath testers.

B. 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 Traffic Injury Control Programs,

NTS–11, 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, 55

Broadway, Kendall Square, 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. Proprietary

information will be respected. (See 49

CFR Part 512, regarding the procedures

by which NHTSA will consider claims

of confidentiality.)

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 in Cambridge and the start of the

test, and to ensure that the calibrating

unit is in proper working condition but

will have no access to it during the tests.

Any malfunction of the calibrating unit

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 after appropriate corrective

action has been taken.

On the basis of these results, NHTSA

will publish a Conforming Products List

(CPL) identifying the calibrating units

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 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 retesting to the modified
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices 43421

6Farrington Daniels & Robert Alberty, ‘‘Physical

Chemistry’’ 3d Ed. John Wiley & Sons, New York,

1966.

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 will certify that the CPL does,

in fact, reflect calibrating units which

meet the performance criteria set forth

in the Model Specifications. 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 Office of Traffic Injury Control

Programs for review. Based on this

review, NHTSA will decide whether the

change will require retesting of the unit.

Normally, such retesting will be

accomplished the next time testing is

performed. Guidance to manufacturers

on considerations governing this

decision are available from NHTSA’s

OTICP, upon request.

OTICP 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

calibrating units provide both

acceptance and field performance data

to OTICP. 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

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 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 that led to the

dropping of the unit in question from

the list.

C. Infra-red Spectroscopy

In this notice, NHTSA is proposing an

alternate procedure which uses infra-red

spectroscopy for the evaluation of dry

gas units (see Appendix A). It is

proposed as an amendment to the

Model Specifications for Calibrating

Units published in this notice. In infrared spectroscopy, 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,6 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.

The agency believes that use of infrared spectroscopy will offer several

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 effect the analysis.

Second, standards used in the

evaluations can be prepared at the

Volpe Center, eliminating the necessity

of obtaining standards from an outside

source.

D. Comments

Interested persons are invited to

comment on the proposed alternate

procedure described in this notice. 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 selfaddressed stamped postcard in the

envelope with their comments. Upon

receiving the comments, the docket

supervisor will return the postcard by

mail.

E. 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 (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 these lower BAC levels,

but which were listed on a previous CPL

for calibrating units (58 FR 26030) on

the basis that they were tested and

found to conform to the earlier model

specifications when tested at BAC levels

0.050, 0.100 and 0.150. These devices

have been identified with an asterisk.

This CPL also includes five new

listings: four dry-gas calibrating units

and one wet-bath calibrating unit. The

dry gas units include: Model EBSTM’’

Gaseous Ethanol Breath Standard

submitted by Scott Specialty Gases, Inc.

of Plumsteadville, PA; the Ethanol

Breath Alcohol Standard submitted by

Gateway Airgas (previously known as

A.G. Specialty Gas Company, or

Acetylene Gas Company) of St. Louis,

MO; the AlcoCal Breath Alcohol

Standard submitted by Lion

Laboratories, plc of Cardiff, Wales, UK;

and Compressed ethanol-in-nitrogen

submitted by Liquid Technology

Corporation of Orlando, FL. All of the

dry-gas calibrating units were tested

using the alternate procedure that uses

the NISTRGM. The new wet-bath unit is

Model 3402C submitted by RepCo

Marketing, Inc., of Raleigh, NC.

In consideration of the foregoing,

NHTSA amends the Model

Specifications for Calibrating Units, as

last published in the Federal Register

on December 29, 1994 (59 FR 67377), as

set forth below. NHTSA proposes to

further amend these Model

Specifications, as set forth in Appendix

A.
43422 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices

7Available from National Committee on Uniform

Traffic Laws and Ordinances, 405 Church Street,

Evanston, IL 60201.

8RN 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).

Model Specifications for Calibrating

Units 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).7 BrAC is

often used to indicate that the

measurement is a breath measurement,

i.e. gram alcohol per 210 liters of breath.

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)×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)}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¥bXm, and slope,

b=(SumXiYi¥NXmYm)/(SumXi

2¥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 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 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

±2°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 °C

Test 2.2: 30 °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 re-adjust the voltage, if

necessary. If the voltage is AC, conduct

tests 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, Wetbath)

Equipment and Supplies: Gas

Chromatograph capable of complete

resolution of ethanol in test samples,

with heated gas sampling valve. Water

bath thermostated at 34°C ±0.1°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 head space

to concentration in solution at 34°C, Ka/

w = 0.000393 8 to prepare two solutions

which, when thermostated at 34°C,

produce head space 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).

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.

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 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

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 2 and step
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices 43423

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 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 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.

BILLING CODE 4910–59–P

Figure 1. Wet Bath Reference Sample Set-up. Sample lines 1⁄8′′ Teflon. The bubble line should extend at least 4

inches below surface of the solution. The length of the alcohol vapor line from the headspace to the gas chromatograph

should be minimized.

BILLING CODE 4910–59–C

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-ininert 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

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.

Authority: 23 U.S.C. 402; delations of

authority at 49 CFR 1.50 and 501.

Issued: August 7, 1997.

James Hedlund,

Associate Administrator for Traffic Safety

Programs.

Appendix A—Proposed Alternate

Procedure Using Infra-Red

Spectroscopy

This appendix presents an alternate

procedure using infra-red spectroscopy

that is suitable for evaluating vapor

samples from either wet-bath CUs, or

from dry-gas CUs.
43424 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices

3.3 Proposed Test Procedures (for

dry gas or wet bath calibrating units).

3.3.1 General. General. The 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 BeerLambert 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°

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

Comforting 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 thernostated

at 34°C ±0.1°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 head space

to concentration in solution at 34° C,

Ka/w = 0.0003932 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 bottle

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 4.

Step B4. In the manner of Step 3,

obtain 5 sets of detector readings using

one of the reference alcohol solution

bottles.

Step B5. In the manner of Step 3,

obtain 10 sets of detector readings from

the CU being evaluated. If the CU is a

wet bath device, use the flushing gas fill

the sample chamber, operating the

device according to manufacturer’s

instructions. If the CU device is a dry

gas device, fill the sample chamber

according to manufacturer’s

instructions.

Step B6. Repeat Step 5 using the other

reference alcohol solution bottle.

Step B7. Repeat Step 3.

Step B8. Calculations. For each

measurement pair, I0 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 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, I

will be the difference between the bias

voltage and the above voltage.

Calulate the absorbance of 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%,

trouble shoot 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.

BILLING CODE: 4910–59–P
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Notices 43425

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.

2Several 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 34–C–FM; and 34C–

NPAS.

Figure 2. Equipment set-up. Bubble and sample lines 1⁄8′′ teflon, minimized length. Depth of bubble line into reference

solution at least 4′′. The alcohol vapor line from the headspace to the IR specrophotometer should be minimized.

BILLING CODE: 4910–59–C

Appendix B—Conforming Products List

of Calibrating Units for Breath Alcohol

Testers [Manufacturer and Calibrating

Unit].1

1. CMI, Inc., Owensboro, KY:

• Toxitest II

2. Federal Signal Corporation, CMI, Inc.,

Minturn, CO:

• Toxitest Model ABS120*

3. Gateway Airgas, Inc. (Formerly

known as AG Specialty Gas, and

Acetylene Gas Company), St. Louis,

MO.

• Ethanol Breath Alcohol Standard (a

dry gas standard).

4. Guth Laboratories, Inc., Harrisburg,

PA:

• Model 34C Simulator 2

• Model 3412

• Model 10–4

• Model 1214

5. Intoximeters, Inc., St. Louis, MO:

• Alco Breath Alcohol Standard* (a

dry gas standard)

6. Lion Laboratories, plc, Cardiff, Wales,

UK (a subsidiary of CMI, Inc.)

◆ AlcoCal Gas Standard (a dry gas

standard).

7. Liquid Technology Corporation,

Orlando, FL

◆ Alcohol-in-Nitrogen Calibrating

Unit (a dry-gas standard).

8. Luckey Laboratories, Inc., San

Bernadino, CA:

• Simulator*

9. National Draeger, Inc., Durango, CO.

• Mark II–A

10. PLD of Florida, Inc., Rockledge, FL:

• BA 500

11. Protection Devices, Inc., U.S.

Alcohol Testing, Inc., Rancho

Cucamonga, CA:

• LS34 Model 6100*

12. Repco Marketing, Inc., Raliegh, NC:

• AS–1

• Model 3402C

13. Scott Specialty Gases, Inc.,

Plumsteadville, PA

• Model EBS TM Gaseous Ethanol

Breath Standard (a dry-gas

standard).

14. Smith & Wesson Electronic Co.,

Springfield, MA:

• Mark II–A Simulator*

15. Systems Innovation, Inc., Hallsteaed,

PA

• True-Test MD 901*

16. 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 model specifications detailed

in this notice, and were tested at 0.020,

0.040, 0.080, and 0.160 BrAC.

[FR Doc. 97–21331 Filed 8–12–97; 8:45 am]

BILLING CODE 4910–59–P

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety

Administration

[Docket No. 97–051; Notice 1]

Notice of Receipt of Petition for

Decision That Nonconforming 1987–

1997 Kawasaki ZX400 Motorcycles Are

Eligible for Importation

AGENCY: National Highway Traffic

Safety Administration, DOT.

ACTION: Notice of receipt of petition for

decision that nonconforming 1987–1997

Kawasaki ZX400 motorcycles are

eligible for importation.

SUMMARY: This document announces

receipt by the National Highway Traffic

Safety Administration (NHTSA) of a

petition for a decision that 1987–1997

Kawasaki ZX400 motorcycles that were

not originally manufactured to comply

with all applicable Federal motor

vehicle safety standards are eligible for

importation into the United States

because (1) they are substantially

similar to vehicles that were originally

manufactured for importation into and

sale in the United States and that were

certified by their manufacturer as

complying with the safety standards,

and (2) they are capable of being readily

altered to conform to the standards.

DATES: The closing date for comments

on the petition is September 12, 1997.

ADDRESSES: Comments should refer to

the docket number and notice number,

and be submitted to: Docket Section,

Room 5109, National Highway Traffic

Safety Administration, 400 Seventh St.,