Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids, 16956-16960 [E8-6520]

Agencies

• National Highway Traffic Safety Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Notices]
[Pages 16956-16960]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6520]


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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[NHTSA Docket No. 2008-0030]


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

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

ACTION: Notice.

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SUMMARY: This notice revises 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 removed testing of Interpretive Screening Devices 
(ISDs) and use of the Breath Alcohol Sample Simulator (BASS) device 
from the Model Specifications. The ISDs did 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 removes all references to the 
BASS device.
    Additionally, in order to ensure product integrity, this notice 
provides guidelines for retesting devices when manufacturers 
contemplate changes, revisions, or upgrades to alcohol screening 
devices on the Conforming Products List (CPL).
    These revisions to the Model Specifications will not affect devices 
currently listed on the CPL.

DATES: Effective Date: Revisions to these Model Specifications become 
effective on March 31, 2008.

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: Mr. David Bonelli, 
Office of Chief Counsel, NCC-113, National Highway Traffic Safety 
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; 
Telephone: (202) 366-5834.

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 encountered 
difficulties ensuring the accuracy of testing ISDs and also determined 
the use of the BASS is not necessary for inclusion in the Model 
Specifications. These events made it necessary to revise the Model 
Specifications.
    On December 14, 2007, (72 FR 71188), NHTSA proposed and sought 
comments on amendments and revisions to the Model Specifications 
published in 1994. In the notice, NHTSA explained that the 1994 Model 
Specifications allowed 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. Also, the 
1994 Model Specifications required 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 1994 Model 
Specifications, NHTSA evaluated eight separate ISDs. Of those 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 proposed to remove 
altogether testing of ISDs and all references to interpretive or color 
indicator tests from the Model Specifications.
    The 1994 Model Specifications provided for the use of the Breath 
Alcohol Sample Simulator (BASS) device for delivering 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 proposed to remove all references to the BASS device from the 
Model Specifications.
    The 1994 Model Specifications also 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 proposed 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 Specifications for evidential breath testing devices (58 FR 
48705). Upon notification by a manufacturer of a contemplated change to 
a device listed

[[Page 16957]]

on the CPL, NHTSA proposed 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.
    Having received no comments on any aspect of the agency's proposal, 
this notice adopts the proposed revisions, including the ``Procedures'' 
and ``Model Specifications for Alcohol Screening Devices,'' without 
change.

II. Procedures

    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 need 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 is to 
be supplied with the purchase of the device, as well as specifications 
and drawings fully describing the device and its use. Information 
determined to be proprietary 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 Part 
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 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. However, the agency reserves 
the discretion to determine whether to conduct 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 that are in the marketplace. 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 
indicate potential performance problems. 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 may 
direct VNTSC to conduct a special investigation. An investigation may 
include visits to users and additional tests of devices obtained on 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. The agency reserves the discretion to determine whether to 
conduct any retest.
    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 may 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.
    In accordance with the foregoing, the amendments of the Model 
Specifications for Screening Devices to Measure Alcohol in Bodily 
Fluids, are set forth below.

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

[[Page 16958]]

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 alcohol per 100 milliliters of blood or grams alcohol per 210 
liters of breath in accordance with the Uniform Vehicle Code, Section 
11-903(a)(5) \1\ (BrAC is often used to indicate that the measurement 
is a breath measurement); or grams alcohol per 100 milliliters of 
saliva.
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    \1\ Available from the National Committee on Uniform Traffic 
Laws and Ordinances, 107 S. West Street,  10, Alexandria, 
VA 22314. Web site address: https://www.ncutle.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 take another smoke 
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.

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

[[Page 16959]]

    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.: Tests in unopened packaging are stable until the date printed 
on the product container when stored at 22-28 degrees C. If packaging 
is opened, tests must be conducted at once.
    Provide a caution not to use the reagents beyond the expiration 
date.
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 its 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 the 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, e.g., 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(s).
     Scope of change(s) (e.g., Will existing devices be 
retrofitted? Will the change apply to some users but not others?)
     Will the change(s) affect performance of the device with 
regard 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 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.
    NHTSA reserves the right to test any CPL-listed 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.


[[Page 16960]]


    Issued on: March 25, 2008.
Marilena Amoni,
Associate Administrator for the Office of Research and Program 
Development.
[FR Doc. E8-6520 Filed 3-28-08; 8:45 am]
BILLING CODE 4910-59-P