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31 March 2008
[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Notices]
[Page 16956-16960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr08-139]
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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: http://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.
------------------------------------------------------------------------
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