Document ID: NHTSA-2007-27133-0001
Agency: nhtsa
Document Type: Rule
Title: Highway Safety Programs; Proposed Amendments to Model Specifications for Screening; Devices To Measure Alcohol in Bodily Fluids
Posted Date: 2007-12-14T05:00Z

[Federal Register: December 14, 2007 (Volume 72, Number 240)]
[Notices]               
[Page 71188-71191]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de07-88]                         

[[Page 71188]]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[NHTSA Docket No. 2007-27133]

 
Highway Safety Programs; Proposed Amendments to Model 
Specifications for Screening; Devices To Measure Alcohol in Bodily 
Fluids

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

ACTION: Notice of Proposed Amendments to Model Specifications for 
Screening Devices To Measure Alcohol in Bodily Fluids.

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SUMMARY: This notice proposes revisions to Model Specifications for 
Screening Devices to Measure Alcohol in Bodily Fluids (Model 
Specifications) published in the Federal Register on August 2, 1994 (59 
FR 39382). These devices test for the presence of alcohol using breath 
or bodily fluids such as saliva. The Model Specifications support State 
laws that target youthful offenders (i.e., ``zero tolerance'' laws) and 
the Department of Transportation's regulations on Alcohol Misuse 
Prevention, and encourage industry efforts to develop new technologies 
(e.g., non-breath devices) that measure alcohol content from bodily 
fluids.
    This notice proposes to remove testing of Interpretive Screening 
Devices (ISDs) and use of the Breath Alcohol Sample Simulator (BASS) 
device from the Model Specifications. The ISDs do not provide an 
unambiguous test result, as test results for ISDs are subjective and 
require interpretation by a test administrator or technician. Because 
the agency has determined the BASS device is not necessary for 
inclusion in the Model Specifications, this notice proposes to remove 
all references to the BASS device.
    Additionally, in order to ensure product integrity, this notice 
proposes guidelines for retesting devices when manufacturers 
contemplate changes, revisions, or upgrades to alcohol screening 
devices on the Conforming Products List (CPL).
    The proposed revisions to these Model Specifications would not 
affect devices currently listed on the CPL.

DATES: Written comments may be submitted to this agency and must be 
received by January 14, 2008.

ADDRESSES: Comments should refer to the docket number and be submitted 
(preferably in two copies) to: Docket Management Facility, West 
Building, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 
20590. Alternatively, you may submit your comments electronically by 
logging onto the Docket Management System (DMS) Web site at http://dms.dot.gov.
 Click on ``Help'' to view instructions for filing your 

comments electronically. Regardless of how you submit your comments, 
you should identify the Docket number of this document. You may call 
the docket at (202) 647-5527. Docket hours are 9 a.m. to 5 p.m., Monday 
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. De Carlo 
Ciccel, Behavioral Research Division, NTI-131, National Highway Traffic 
Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 
20590; Telephone: (202) 366-1694. For legal issues: Ms. Allison Rusnak, 
Office of Chief Counsel, NCC-113, National Highway Traffic Safety 
Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590; 
Telephone: (202) 366-1834.

SUPPLEMENTARY INFORMATION: 

I. Background

    As indicated in the Model Specifications published in 1994, the 
agency will modify and improve the Model Specifications as new data and 
test procedures become available and will alter the test procedures, as 
necessary, to meet unique design features of specific devices. Since 
publication of the Model Specifications, the agency has encountered 
difficulties ensuring the accuracy of testing ISDs and also has 
determined the use of the BASS is not necessary for inclusion in the 
Model Specifications. These events make it necessary to revise the 
Model Specifications.

A. Interpretive Screening Devices

    The Model Specifications currently allow for evaluation of 
screening devices that require subjective interpretation of test 
results by a test administrator or technician. These ISDs differ from 
devices that provide objective test results, including the use of 
digital technology or the appearance of lights or marks based on the 
presence or absence of alcohol. For instance, use of pass/fail lights 
or enzymes that react with alcohol to produce an unambiguous mark 
provide objective test results.
    The Model Specifications require that interpretive devices be 
evaluated subjectively under five lighting conditions (fluorescent, 
incandescent, mercury, sodium and daylight) by a panel of ten novice 
evaluators who are not color blind. Since publication of the Model 
Specifications, NHTSA evaluated eight separate ISDs. Of these eight ISD 
evaluations, none resulted in a successful outcome in the panel test 
described above. In one evaluation, the device passed the test under 
all lighting conditions except sodium. This device is no longer 
manufactured. Although many novice evaluators were able to judge the 
correct test outcome in the eight ISD evaluations, some could not, even 
though the manufacturers' instructions were conveyed to the evaluators 
and all evaluators passed tests to determine their color perception 
ability. This subjective interpretation of test results does not ensure 
accuracy and precision required to protect public safety. Due to 
repeated problems in evaluating ISDs, NHTSA is proposing to remove 
altogether testing of ISDs from the Model Specifications. Specifically, 
the agency proposes to update sections 3.2, 4.1 and 4.2, delete 
sections 4.3 and 4.4, and renumber sections accordingly. In addition, 
the agency proposes to delete from Appendix A all references to 
interpretive or color indicator tests.

B. Breath Alcohol Sample Simulator

    The Model Specifications currently provide for the use of the 
Breath Alcohol Sample Simulator (BASS) device for providing alcohol-in-
air test samples. The use of the BASS device is not necessary for 
inclusion in the Model Specifications because the BASS device is 
intended for use in testing the sampling efficiency of evidential 
breath testers. There is no sampling efficiency test in the Model 
Specifications for alcohol screening devices. The alcohol-in-air test 
sample for breath alcohol screening devices is supplied by a 
calibrating unit. Therefore, the agency proposes to remove section 3.5 
and all references to the BASS device from these Model Specifications, 
and renumber sections accordingly. The agency would also revise section 
3.4 to include the updated citation for NHTSA's Model Specifications 
for Calibrating Units.

C. Guidelines for Re-Testing Modified Screening Devices

    The Model Specifications provide procedures to conduct special 
investigations and re-test a device if information gathered indicates 
that a device listed on the CPL is not performing in accordance with 
the Model Specifications. The agency proposes the addition of Appendix 
B to provide guidance regarding notification and re-testing when 
manufacturers contemplate revisions to devices listed on the CPL. The 
proposed Appendix follows the language used in the Model

[[Page 71189]]

Specifications for evidential breath testing devices (58 FR 48705).
    Upon notification by a manufacturer of a contemplated change to a 
device listed on the CPL, NHTSA proposes that it would determine 
whether re-testing is required. Such determination would look at 
several factors, including the nature and reason for the change, the 
scope of the change, the effects of the change on the performance of 
the device, and how the change will be documented for the benefit of 
the user.
    NHTSA would list device revisions and whether re-testing was 
required in the next update to the CPL. Appendix B also would state 
that NHTSA may re-test any device listed on the CPL at any time to 
determine continued compliance and performance with the Model 
Specifications. A device found not to perform in accordance with the 
Model Specifications would be subject to the special investigation 
procedures discussed below.

II. Procedures

    This notice proposes no changes to the procedures for the Model 
Specifications other than those discussed above. This section describes 
the current procedures. The DOT Volpe National Transportation Systems 
Center (VNTSC), RTV-4F, Kendall Square, Cambridge, MA 02142 tests 
products manufacturers submit to determine whether the products meet 
the model specifications. Tests are conducted semiannually, or as 
necessary. Manufacturers are required to apply to NHTSA for a test date 
by writing to the Office of Behavioral Safety Research, NTI-130, NHTSA, 
1200 New Jersey Avenue, SE., Washington, DC 20590. At least 30 days are 
typically required from the date of notification until the test can be 
scheduled.
    One week prior to the scheduled initiation of the test program, 
manufacturers must deliver their devices to VNTSC. If the devices are 
disposable, the manufacturer must deliver at least 300 such devices; if 
the devices are reusable, the manufacturer must submit only a single 
device. If a manufacturer of a reusable device wishes to submit a 
duplicate, backup instrument, it may so do. The manufacturer is 
responsible for ensuring that the devices operate properly and are 
packaged correctly. The manufacturer must also deliver the operator's 
manual (or instructions) and the maintenance manual (if any) that would 
be supplied or is supplied with the purchase of the device, as well as 
specifications and drawings fully describing the device and its use. 
Proprietary information will be respected. (See 49 CFR Part 512, 
regarding the procedure by which NHTSA will consider claims of 
confidentiality.)
    In addition, the manufacturer must submit a self-certification, 
certifying that the manufacturer meets the requirements according to 
the U.S. Food and Drug Administration (FDA) Good Manufacturing 
Practices regulations for devices used for medical purposes (21 CFR 
Part 820), and that the device's label meets the requirements in FDA's 
Labeling regulations for devices used for medical purposes (21 CFR 
809.10), even if the devices are not to be used for medical purposes. 
See Appendix A to this notice.
    The manufacturer has the right to check its device(s) between the 
time of its arrival at VNTSC and the start of the tests, but will have 
no access to the device(s) during the tests. Any malfunction of a 
device resulting in failure to complete any of the tests satisfactorily 
will result in a determination that the device does not conform to the 
Model Specifications. If a device is found not to conform to the Model 
Specifications, it may be resubmitted for the next testing cycle after 
appropriate corrections have been made. The agency reserves the 
discretion to determine the appropriateness of any retest.
    The agency intends to update and republish the CPL in the Federal 
Register annually. Republications of the CPL add conforming alcohol 
screening devices tested since the last CPL republication.
    NHTSA will continue to provide notification in the Federal Register 
when the agency amends the Model Specifications as new data and test 
procedures become available and will retest devices when necessary.
    The NHTSA Office of Behavioral Safety Research is the point of 
contact for information about acceptance testing and field performance 
of devices. NHTSA requests that users of alcohol screening devices 
provide both acceptance and field performance data to the Office of 
Behavioral Safety Research when such data are available. Information 
from users will help NHTSA monitor whether alcohol screening devices 
are performing according to the NHTSA Model Specifications.
    If information gathered indicates that a device on the CPL is not 
performing in accordance with the Model Specifications, NHTSA will 
direct VNTSC to conduct a special investigation. An investigation may 
include visits to users and additional tests of the device as obtained 
from the open market. If the investigation indicates that a device 
actually sold on the market does not meet the Model Specifications, the 
manufacturer will be notified that the device may be removed from the 
CPL. In this event, the manufacturer will 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 device 
should remain on the CPL. If the device is removed from the CPL, the 
manufacturer will be permitted to resubmit an improved device to VNTSC 
for testing when it believes the problems causing its failure have been 
resolved. Upon resubmission, the manufacturer must submit a statement 
describing what has been done to overcome the problems that led to 
failure of the device.
    If information gathered indicates that the manufacturer of a device 
on the CPL does not comply with the requirements in FDA's Good 
Manufacturing Practices regulations for devices used for medical 
purposes or that the device's label does not comply with the 
requirements in FDA's labeling regulations for devices used for medical 
purposes, NHTSA will investigate the matter in consultation with FDA 
and will notify the manufacturer that the device may be removed from 
the CPL. The manufacturer will have 30 days from the date of 
notification to reply. Based on any data provided by the manufacturer 
and investigative findings, NHTSA will decide whether the device should 
remain on the CPL. If the device is removed from the CPL, the 
manufacturer will be permitted to resubmit a self-certification, 
certifying that the manufacturer or its device complies with these FDA 
requirements when it believes the problems causing its non-compliance 
have been resolved. Upon resubmission, the manufacturer must submit a 
statement describing what has been done to overcome the problems that 
led to non-compliance.
    These proposed amendments have been analyzed in accordance with the 
principles and criteria contained in Executive Order 12612, and it has 
been determined that there are no federalism implications that warrant 
the preparation of a federalism assessment.
    In accordance with the foregoing, the proposed amendments of the 
Model Specifications for Screening Devices to Measure Alcohol in Bodily 
Fluids, are set forth below.

[[Page 71190]]

Model Specifications for Alcohol Screening Devices
1. Purpose and Scope
    These specifications establish performance criteria and methods for 
testing of alcohol screening devices. Alcohol screening devices use 
bodily fluids to detect the presence of 0.020 or more BAC (see below) 
with sufficient accuracy for screening purposes. These specifications 
are intended primarily for use in the conformance testing of alcohol 
screening devices.
2. Classification
2.1 Disposable Alcohol Screening Devices

    Alcohol screening devices designed for a single use.

2.2 Reusable Alcohol Screening Devices

    Alcohol screening devices designed to be reused.
3. Definitions
3.1 Alcohol

    The intoxicating agent in beverage alcohol, ethyl alcohol or other 
low molecular weight alcohols including methyl or isopropyl alcohol.

3.2 Alcohol Screening Device

    A device that is used to detect the presence of 0.020 or more BAC. 
The device may measure any bodily fluid for this purpose, but shall 
provide output in BAC units. Test results must be indicated 
unambiguously by numerical read-out or by other means, such as by the 
use of lights or by the appearance of a distinctive mark but not by 
color change.

3.3 Blood Alcohol Concentration (BAC)

    Grams of alcohol per 100 milliliters of blood or grams of 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); or grams of alcohol per 100 
milliliters of saliva.

    \1\ Available from the National Committee on Uniform Traffic 
Laws and Ordinances, 107 S. West Street, 10, Alexandria, VA 
22314. Web site address: http://www.ncutlo.org.

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3.4 Calibrating Unit

    A device that produces an alcohol-in-air test sample of known 
concentration and that meets the NHTSA Model Specifications for 
Calibrating Units (72 FR 34742).

3.5 Bodily Fluid

    Any bodily fluid capable of being used to estimate alcohol 
concentration, provided the relationship between such bodily fluid and 
BAC has been established according to scientifically acceptable 
standards. Such fluids include but are not limited to blood, exhaled 
deep lung breath and saliva.

3.6 Scientifically Acceptable Substitutes

    Fluids that have been scientifically accepted as equivalent to 
bodily fluids for testing purposes, such as aqueous alcohol test 
solutions on a one-to-one basis for blood or saliva.
4. Test Methods and Requirements
    Testing will be performed according to the instructions that 
normally accompany the submitted device and under the conditions 
specified in the tests below.

4.1 Test 1. Precision and Accuracy

    Perform 40 trials under normal laboratory conditions including 20 
trials at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit 
for this test for breath devices and preparations of bodily fluids or 
scientifically acceptable substitutes for non-breath devices. Perform 
tests using a VNTSC investigator.
    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.

4.2 Test 2. Blank Reading

    Perform 20 trials under normal laboratory conditions at 0.000 BAC. 
Use non-alcoholic human breath for breath devices and non-alcoholic 
bodily fluids or scientifically acceptable substitutes for non-breath 
devices. Perform tests using a VNTSC investigator.
    To conform: No positive results. If the device is capable of 
providing a reading of greater than 0.000 BAC and less than 0.020 BAC, 
not more than one such result.

4.3 Test 3. Cigarette Smoke Interference (Only Breath and Saliva Test 
Devices)

    Perform five trials at 0.000 BAC. Select an alcohol-free person who 
smokes cigarettes for this test. Ask the person selected to smoke 
approximately one half of a cigarette. Within one minute after smoking, 
or after a waiting period specified in the manufacturer's instructions, 
administer the alcohol screening device test according to the 
manufacturer's instructions. Then ask the person to smoke another 
inhalation and repeat the test to produce a total of five trials.
    To conform: No positive results.

4.4 Temperature

    Test at low and high ambient temperature.

4.4.1 Test 4.1. Low Ambient Temperature

    Perform 40 trials at 10 degrees Centigrade (C), including 20 trials 
at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for 
this test for breath devices and preparations of bodily fluids or 
scientifically acceptable substitutes for non-breath devices.
    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.

4.4.2 Test 4.2. High Ambient Temperature

    Perform trials of 40 devices at 40 degrees C, including 20 trials 
at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for 
this test for breath devices and preparations of bodily fluids or 
scientifically acceptable substitutes for non-breath devices.
    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.

4.5 Test 5. Vibration

    Perform 40 trials, including 20 trials at 0.008 BAC and 20 trials 
at 0.032 BAC. Use a calibrating unit for this test for breath devices 
and preparations of bodily fluids or scientifically acceptable 
substitutes for non-breath devices.
    Mount the screening device on a shake table and vibrate the table 
in simple harmonic motion through each of its three major axes, as 
specified below. Sweep through each frequency range in 2.5 minutes, 
then reverse the sweep to the starting frequency in 2.5 minutes. 
Disposable testers may be placed in a suitable box mounted on the shake 
table. Test after vibration.

------------------------------------------------------------------------
                                                           Amplitude
                  Frequency  (hertz)                    (inches, peak to
                                                             peak)
------------------------------------------------------------------------
10 to 30.............................................               0.30
30 to 60.............................................               0.15
------------------------------------------------------------------------

    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC not more than one non-positive result.

Appendix A--Labeling Instructions for Alcohol Screening Devices 
Intended Use

    Provide the intended use including the specimen matrix (e.g. 
saliva, breath), the assay type (quantitative, semi-quantitative), 
the purpose of performing the assay, and the individual designated 
to perform the assay.
    E.g.: This product is intended for the (quantitative, semi-
quantitative) determination of alcohol in--define matrix (for e.g., 
saliva, breath, sweat) to perform screening alcohol assays.

[[Page 71191]]

    This product is recommended for use by individuals who have been 
trained in the administration of screening devices.

Description of Testing System

    Provide the principles of the procedure for performing the 
alcohol screening assay.
    E.g.: This product uses (alcohol dehydrogenase, infrared 
technology, etc.) to perform the test.

Chemical Reaction Sequence

    Describe the chemical reaction sequence, if applicable.
    Reagents: List the concentration, strength, and composition of 
the reactive ingredients.
    List the non-reactive ingredients.

Reagent Preparation and Storage

    Provide instructions for preparing the reagents, if applicable.
    Provide instructions for storing the reagents, if applicable.
    Provide any signs of deterioration of the reagents, if 
applicable.
    Provide the reagents' shelf life and opened expiration dating, 
if applicable.
    E.g.: Unopened tests are stable until the date printed on the 
product container when stored at 22-28[deg] C. Opened test must be 
used at once.
    Provide a caution not to use the reagents beyond the expiration 
dating.

Precautions

    1. List any reagents that may be hazardous such as caustic 
compounds, sodium azide or other hazardous reagents and instructions 
for disposal, if applicable.
    2. Provide warning to user to treat all samples as potentially 
infective. Include instructions for handling and disposal of the 
sample.

Specimen Collection

    Provide instructions for collecting and handling the sample.
    Provide criteria for specimen rejection, if applicable.

Calibration

    Disposable tests are pre-calibrated. No additional calibration 
is required.
    Reusable (Instrumented) tests require calibration.
    Provide information regarding how calibrations are to be 
conducted, if applicable, including the number and concentration of 
calibrators, and the frequency of calibration.
    Provide instructions for calibration and recalibration.
    Provide the criteria for acceptability of calibration.

Test Procedure (Disposable)

    Provide adequate step-by-step instructions for performing the 
test and determining the results.

Test Procedure (Re-Usable/Instrumented)

    Provide adequate step-by-step instruction for performing the 
test.
    Provide the installation procedures and, if applicable, any 
special requirements.
    Provide the space and ventilation requirements.
    Provide the description of the required frequency of equipment 
maintenance and function checks.
    Provide the instructions for any remedial action to be taken 
when the equipment performs outside of operating range.
    Provide any operational precautions and limitations.
    Provide instructions for the protection of equipment and 
instrumentation from fluctuations or interruptions in electrical 
current that could adversely affect test results and reports, if 
applicable.

Quality Control (QC)

Disposable Tests

    If applicable, the function and stability of the test can be 
determined by the examination of the procedural ``built in'' 
controls contained in the product. If these controls are not 
working, the test is invalid and must be repeated.

Disposable/Instrumented Devices

    If external quality control materials are used, provide number, 
type, matrix and concentration of the QC materials.
    Provide directions for performing quality control procedures.
    Provide an adequate description of the remedial action to be 
taken when the QC results fail to meet the criteria for 
acceptability.
    Provide directions for interpretation of the results of quality 
control samples.

Results

    Describe how the user obtains the test results, from an 
instrument read-out, printout, etc.
    Describe the results in terms of blood alcohol concentration.
    Describe what concentration indicates a positive result and what 
concentration indicates a negative result.

Limitations

    List the substances or factors that may interfere with the test 
and cause false results including technical or procedural errors.

Dynamic Range

    Provide the operating range of the product.

Precision and Accuracy

    Only devices that meet the precision and accuracy of these Model 
Specifications will be included on NHTSA's Conforming Products List 
for alcohol screening devices.

Specificity

    List the substances that have been evaluated with your product 
that do or do not interfere at the concentration indicated.

References

    Provide pertinent bibliography.

Technical Assistance

    List an 800 number the user may contact for further information 
or technical assistance.

Appendix B--Guidelines for Re-testing of Modified Screening Devices

    Manufacturers contemplating revisions to an alcohol screening 
device listed on the Conforming Products List (CPL) are advised that 
the revision may affect the status of the device on the CPL. The 
manufacturer should inform NHTSA of the contemplated change so that 
a judgment can be made whether or not re-testing the revised alcohol 
screening device is necessary. The following lists the type of 
information NHTSA uses in determining the necessity to re-test an 
alcohol screening device, and is provided as guidance to 
manufacturers:
     Manufacturer and Model Name.
     Nature and reason for change.
     Scope of change (e.g., Will existing devices be 
retrofitted? Will the change apply to some users but not others?)
     Will the change affect performance of the device with 
regards to the Model Specifications? (Precision and accuracy, blank 
reading, temperature operations, or vibrations.)
     How will the change(s) be documented for the benefit of 
the user? (e.g., Will the change(s) be documented in service 
bulletins and/or service manuals? If not, why not?)
    If necessary for clarity, drawings of the listed and changed 
device may also be helpful in the NHTSA's deliberations.
    If, upon review of information provided by a manufacturer, it is 
determined that re-testing is not warranted, a statement to that 
effect will be included in the next scheduled CPL update.
    Additionally, NHTSA reserves the right to re-test any device on 
the open market to determine continued compliance and performance in 
accordance with these Model Specifications. Devices found not to 
comply with or perform in accordance with the Model Specifications 
are subject to the investigation provisions stated above in Section 
II, Procedures.

(Authority: 23 U.S.C. 403; 49 CFR 1.50; 49 CFR Part 501).

    Issued on: December 14, 2007.
Marilena Amoni,
Associate Administrator for the Office of Research and Program 
Development.

[FR Doc. E7-24282 Filed 12-13-07; 8:45 am]

BILLING CODE 4910-59-P