Highway Safety Programs; Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids |
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Topics: National Highway Traffic Safety Administration
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Michael B. Brownlee
Federal Register
February 15, 1994
[Federal Register: February 15, 1994]
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[NHTSA Docket No. 94-004; Notice 1]
Highway Safety Programs; Model Specifications for Screening
Devices to Measure Alcohol in Bodily Fluids
AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.
ACTION: Notice; Request for comments.
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SUMMARY: This notice proposes Model Specifications for the performance
and testing of alcohol screening devices. These devices test for the
presence of alcohol, and may use breath or other bodily fluids, such as
saliva, to do so. NHTSA is proposing these specifications to support
State laws that target youthful offenders (i.e., ``zero tolerance''
laws) and the Department of Transportation's regulations on Alcohol
Misuse Prevention, and in recognition of industry efforts to develop
new technologies (i.e., non-breath devices) that measure alcohol
content from bodily fluids.
A Conforming Products List (CPL) will be published identifying the
devices that meet NHTSA's Model Specifications. The CPL can serve as a
guide for those interested in purchasing devices that screen for the
presence of alcohol.
DATES: Comments must be received no later than April 18, 1994.
ADDRESSES: Comments should refer to the docket number and the number of
this notice and be submitted (preferably in ten copies) to the Docket
Section, room 5109, 400 Seventh Street, SW., Washington, DC 20590
(Docket hours are from 9:30 a.m. to 4 p.m.).
FOR FURTHER INFORMATION CONTACT: Ms. Lori A. Miller, Office of Alcohol
and State Programs, NTS-21, National Highway Traffic Safety
Administration, 400 Seventh Street, SW., Washington, DC 20590.
Telephone (202) 366-9835.
SUPPLEMENTARY INFORMATION: On December 14, 1984 (49 FR 48854), the
National Highway Traffic Safety Administration (NHTSA) issued a notice
converting the mandatory standards for breath alcohol testing devices
(38 FR 30459) to Model Specifications. The notice indicated that the
agency would continue to test evidential breath testing devices (EBTs)
and would release its findings by publishing a Conforming Products List
(CPL) to provide States that choose not to conduct their own testing
with adequate information upon which to base their purchasing
decisions. These Model Specifications provided for EBTs to be tested at
alcohol concentration levels of 0.000, 0.050, 0.101 and 0.151.
Since 1984, a number of States have amended their laws by lowering
the alcohol level at which drivers are deemed to be impaired or enacted
new laws targeting youthful offenders, including ``zero tolerance''
laws, which provide that it is an offense for a person under the age of
21 to drive with any alcohol concentration level above 0.00 (or in some
cases above 0.01 or 0.02).
On December 15, 1992 (57 FR 59382), the U.S. Department of
Transportation (DOT) published a Notice of Proposed Rulemaking (NPRM)
proposing rules to implement the ``Omnibus Transportation Employee
Testing Act of 1991,'' which requires alcohol testing programs in the
aviation, motor carrier, rail, and mass transit industries, in the
interest of public safety. The Research and Special Programs
Administration (RSPA) proposed similar regulations for the pipeline
industry. In general, the NPRM proposed to prohibit covered employees
from performing safety-sensitive functions when test results indicate
alcohol concentration levels of 0.04 or greater. The NPRM proposed to
apply slightly different consequences to employees having alcohol
concentration levels of 0.02 or greater but less than 0.04.
To determine alcohol concentration, the NPRM proposed to use breath
as measured by only those EBTs listed on NHTSA's CPL which are capable
of providing a printed result, sequentially numbering the tests
conducted, and distinguishing alcohol from acetone at the 0.02 BAC
level.
DOT received comments in response to this rulemaking action
recommending that if NHTSA's Model Specifications are to be used for
the transportation workplace alcohol testing programs, the Model
Specifications should be consistent with the requirements of the rules.
They suggested, for example, that the Model Specifications which test
devices at 0.000, 0.050, 0.101 and 0.151 BAC should be amended to test
devices at the 0.020 and 0.040 BAC levels.
In light of the trend in the States toward lowering alcohol levels
and to address the comments received in response to DOT's NPRM, NHTSA
amended its Model Specifications for EBTs on September 17, 1993 (58 FR
48705), by changing the alcohol concentration levels at which
instruments are evaluated. The amended Model Specifications provide for
devices to be tested at 0.000, 0.020, 0.040, 0.080 and 0.160 BAC. Tests
for the presence of acetone were also added in the revised Model
Specifications. In addition, the agency tested EBTs against the new
Model Specifications and updated the CPL.
On October 15, 1993, Enzymatics, Inc., submitted a petition for
reconsideration to NHTSA regarding the Notice published on September
17, 1993. The petitioner, a manufacturer of a saliva alcohol test,
argued that NHTSA should establish a procedure for the inclusion on the
CPL of devices other than breath alcohol devices. More specifically,
the petitioner objected to the ``exclusive reliance on EBTs'' in DOT's
proposed rules.
In a final rule published elsewhere in today's Federal Register,
DOT amends its procedures for conducting urine drug testing and adds
procedures for conducting alcohol testing in transportation workplaces
(49 CFR Part 40). This final rule differs from the NPRM in a number of
key respects. The final rule does require the use of breath testing
devices listed on the CPL for EBTs. However, the final rule permits the
use of portable EBTs that are on NHTSA's CPL as screening tests,
provided confirmation tests are conducted using EBTs that are capable
of providing a printed result, sequentially numbering the tests
conducted and distinguishing alcohol from acetone at the 0.02 BAC
level. In addition, the final rule indicates that NHTSA is publishing a
separate notice in today's Federal Register proposing to adopt Model
Specifications and a CPL that would permit additional alcohol testing
devices to be used for screening purposes.
This Federal Register notice is the one to which the final rule
refers. It proposes to establish Model Specifications for alcohol
screening devices, which differ from the Model Specifications for
Evidential Breath Testing devices in a number of important respects.
These proposed Model Specifications are designed to test whether
devices are suitable for screening, not evidential, purposes. In
addition, they are designed to test the performance of devices that may
use bodily fluids other than breath (such as saliva) to determine the
presence of alcohol.
Under these proposed Model Specifications, an alcohol screening
device is defined as a device that is used to detect the presence of
0.020 or more BAC. The Model Specifications propose that the test
result may be indicated by numerical read-out or by other means, such
as by the use of lights or color changes.
The Model Specifications propose that the device may measure any
bodily fluid, but the output must be in blood alcohol concentration
(BAC) units. Further, the relationship between the bodily fluid being
measured and BAC must be properly established so that a means for
evaluating the device can be devised. The relationship between breath
alcohol concentration (BrAC) and blood alcohol concentration (BAC) is
well established, and several studies have been published establishing
a relationship between BAC and saliva alcohol concentration1.
Accordingly, the proposed Model Specifications specifically provide
that blood, breath or saliva may be used.
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\1\Jones, A.W., ``Distribution of ethanol between saliva and
blood in man,'' Clinical and Experimental Pharmacology and
Physiology, 1979a, 6(1), 53-59.
Jones, A.W., ``Inter- and intra-individual variations in the
saliva/blood alcohol ratio during ethanol metabolism in man,''
Clinical Chemistry, 1979b, 25(8), 1394-1398.
Jones, A.W., ``Quantitative relationships among ethanol
concentrations in blood, breath, saliva and urine during ethanol
metabolism in man,'' In Goldberg, L. (Ed.) Alcohol Drugs and Traffic
Safety, Vol. II. Proceedings, 8th International Conference on
Alcohol, Drugs and Traffic Safety, June 15-19, 1980, Stockholm,
Sweden: Almqvist & Wiksell International, 1981, pp. 550-569.
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In addition, these Model Specifications identify the proposed
conversion factors for devices that use these bodily fluids. The
conversion factors between blood and breath are commonly accepted.
Based on the available literature, NHTSA believes it is appropriate to
use a one-to-one conversion factor between blood and saliva, and has
included this factor in these proposed Model Specifications. We request
comments on the proposed use of this conversion factor.
NHTSA proposes that if a manufacturer intends to use any bodily
fluid other than blood, breath, or saliva to determine the presence of
alcohol, the relationship between that fluid's alcohol concentration
and blood alcohol concentration must be established according to
scientifically acceptable standards.
Under these proposed Model Specifications, alcohol screening
devices would be tested at 0.008 and 0.032 BAC under normal laboratory
conditions to determine their precision and accuracy at detecting the
presence of 0.020 or more BAC (Test 1), and at 0.000 BAC to determine
the performance of these devices when providing blank readings (Test
2). The .008 and .032 BAC levels were selected based on criteria for
precision and accuracy that are equivalent to those used for EBTs. They
require that devices perform at a level of accuracy within
0.005 of 0.020 BAC (thereby establishing target values
within 0.015 and 0.025 BAC), and a level of precision which yields a
standard deviation not greater than 0.0042. To achieve a confidence
rate of 95% in the results of these 20 tests, we propose to establish
measurement points at 1.73 standard deviations (or 0.007 BAC) below and
above the lower and upper values, respectively (i.e., 0.015 - 0.007 =
0.008 BAC and 0.025 + 0.007 = 0.032 BAC).
NHTSA proposes to use a Breath Alcohol Sample Simulator (BASS),
non-alcoholic human breath, and a calibrating unit to test breath
devices. The agency proposes to use preparations of bodily fluids or
scientifically acceptable substitutes for non-breath devices. For
example, the agency proposes to use aqueous alcohol test solutions
equivalent to blood or saliva on a one-to-one basis to test saliva
devices.
The agency proposes to conduct 40 trials under Test 1 (20 at .008
BAC and 20 at .032 BAC) and 20 trials under Test 2 (at .000 BAC). For
reusable devices, these 60 trials would be conducted using a single
unit. For disposable devices, these 60 trials would be conducted using
60 separate units.
Some alcohol screening devices indicate the presence of alcohol in
a manner that is unambiguous and requires no interpretation, such as by
the use of a light or numerical reading. For these devices, NHTSA
proposes that Tests 1 and 2 (at .008, .032 and .000 BAC) would be
performed by an investigator at the DOT Volpe National Transportation
Systems Center (VNTSC). To conform with the Model Specifications, the
device must perform with no positive results at .000 BAC, not more than
one positive result at .008 BAC and not more than one non-positive
result at .032 BAC. If the device is capable of providing a reading of
greater than 0.000 BAC and less than 0.020 BAC, the device must perform
with not more than one such result at .000 BAC.
Other devices indicate the presence of alcohol in a manner that
requires interpretation and may involve some ambiguity, such as by the
use of color changes. For these devices, NHTSA proposes that Tests 1
and 2 (at .008, .032 and .000 BAC) would be performed by ten
individuals who have no knowledge of test BACs and qualify as test
interpreters. VNTSC would select these individuals using manufacturer's
restrictions, if any. These individuals would be asked to read the
manufacturer's instructions for the interpretation of the device's
read-out, and interpret the test results independently. To conform with
the Model Specifications, the device must perform, with each
interpreter, with no positive results at .000 BAC, not more than one
positive result at .008 BAC and not more than one non-positive result
at .032 BAC. If the device is capable of providing a reading of greater
than 0.000 BAC and less than 0.020 BAC, the device must perform, with
each interpreter, with not more than one such result at .000 BAC.
Through the independent interpretation of ten individuals, NHTSA
believes the Model Specifications would ensure that the results of
tested devices are visible and will remain so for a reasonable period
of time (the tests require approximately two hours to run), and are
likely to be interpreted in a consistent manner. NHTSA requests
comments on this aspect of the proposed Model Specifications.
To NHTSA's knowledge, no reusable devices use interpretive
readings. Typically, these readings are produced using a chemical
reaction, which results in a color change, a method which lends itself
more readily to a single use device. For this reason, the agency
believes it is unlikely that manufacturers would begin to use such
interpretive readings in reusable devices. Accordingly, NHTSA has not
proposed a methodology for testing reusable interpretive devices. We
request comments on this aspect of the agency's proposal.
For disposable devices that use interpretive readings, the Model
Specifications propose to combine Tests 1 and 2, and number the units
and expose them to the three BAC levels using a methodology that would
not reveal to the person interpreting the test the dosage received by
any particular unit. NHTSA requests comments on this proposed
methodology.
Devices would also be tested to determine whether acetone or, in
the case of breath or saliva devices, cigarette smoke affects the
functioning of the instruments. NHTSA requests comments on whether
devices should be tested for interference from other substances. In
addition, high (40 deg.C) and low (10 deg.C) ambient temperature and
vibration tests would be conducted for these devices to determine their
ability to function under a range of environmental conditions. NHTSA
proposes that these tests (3.1, 3.2, 4.1, 4.2 and 5) would be performed
by an investigator at VNTSC. Five trials would be conducted at .000 BAC
under Test 3.2. Forty trials (including 20 at .008 and 20 and .032 BAC)
would be conducted under each of these other tests.
To conform with the Model Specifications, the device must perform
with no positive results at each test performed at .000 BAC, not more
than one positive result at each test performed at .008 BAC and not
more than one non-positive result at each test performed at .032 BAC.
If the device is capable of providing a reading of greater than 0.000
BAC and less than 0.020 BAC, the device must perform with not more than
one such result at .000 BAC.
When devices such as these are used for medical purposes, the
manufacturers of the devices are required to obtain marketing clearance
from the Food and Drug Administration (FDA), in accordance with FDA
regulations that address issues such as quality assurance in
manufacturing, shelf-life and labeling. Currently, FDA does not assert
jurisdiction (provide marketing clearance) for alcohol screening
devices used for law enforcement purposes and workplace testing.
However, because of the nature of alcohol screening devices and the
conditions under which they are to be used, NHTSA believes it is
important for manufacturers of these devices to conform with certain
requirements, imposed by FDA on devices used for medical purposes,
prior to the inclusion of the devices on NHTSA's CPL.
Accordingly, NHTSA proposes to require that each device submitted
for testing under the Model Specifications must be accompanied by a
self-certification from the manufacturer, certifying that it meets the
requirements contained in FDA's Good Manufacturing Practices
regulations for devices used for medical purposes (21 CFR Part 820),
and that the device's label meets the requirements contained 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.
By requiring a self-certification, NHTSA is not requiring that
manufacturers obtain FDA marketing clearance, but simply that they
self-certify that they believe that they have met the above-referenced
requirements. (For technical assistance or a copy of the Device Good
Manufacturing Practices Manual for Medical Devices, manufacturers
should contact FDA's Division of Small Manufacturers by calling toll
free at 1-800-638-2041.)
This notice includes, as an Appendix, a proposed set of Labeling
Instructions for Alcohol Screening Devices that has been prepared in
consultation with FDA to assist manufacturers of alcohol screening
devices in developing a label that conforms to 21 CFR Part 809.10. The
template addresses issues such as restrictions that may apply to
operators of the device and conditions under which the device should or
should not be operated.
These Model Specifications are not regulations. Organizations and
agencies may adopt these Model Specifications and rely on NHTSA's test
results or may conduct their own tests according to their own
procedures and specifications. It should be noted, however, that
transportation employers covered by 49 CFR Part 40, Procedures for
Transportation Workplace Drug and Alcohol Testing Programs, are
required to use only alcohol testing devices that meet the criteria
established by that regulation. See DOT's final rule published
elsewhere in today's Federal Register.
Once the Model Specifications for Alcohol Screening Devices are
finalized and a CPL of conforming devices is published, DOT will issue
procedural rules for using approved alcohol screening devices in
transportation workplaces, including provisions for how and where such
devices could be used and the steps that must be taken to collect
bodily fluids.
Procedures
NHTSA proposes that testing of products submitted by manufacturers
to these Model Specifications would be conducted by the DOT Volpe
National Transportation Systems Center (VNTSC), DTS 75, Kendall Square,
Cambridge, MA 02142. Tests would be conducted semiannually, or as
necessary. Manufacturers would be required to apply to NHTSA for a test
date by writing to the Office of Alcohol and State Programs (OASP),
NTS-21, NHTSA, 400 Seventh Street, SW., Washington, DC 20590. Normally,
at least 30 days would be required from the date of notification until
the test could be scheduled.
One week prior to the scheduled initiation of the test program, a
manufacturer would be required to deliver its devices to VNTSC. If the
devices are disposable, the manufacturer would be required to deliver
300 such devices; if the devices are reusable, the manufacturer would
be required to submit only a single device. If a manufacturer wishes to
submit a duplicate, backup instrument, however, it may do so. The
manufacturer would be responsible for ensuring that the devices operate
properly and are packaged correctly. The manufacturer would also be
required to deliver the operator's manual (or instructions) and the
maintenance manual (if any) supplied with the purchase of the device,
as well as specifications and drawings which fully describe these
devices. Proprietary information would be respected. (See 49 CFR Part
512, regarding the procedure by which NHTSA will consider claims of
confidentiality.)
In addition, the manufacturer would be required to submit a self-
certification, certifying that the manufacturer meets the requirements
in FDA's 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 to this notice.
NHTSA proposes that the manufacturer would have the right to check
its devices between the time of their arrival at VNTSC and the start of
the tests, but would have no access to the devices during the tests.
Any malfunction of a device which results in failure to complete any of
the tests satisfactorily would result in a determination that the
device does not conform to the Model Specifications. If a device is
found not to conform, it may be resubmitted for the next testing series
after appropriate corrections have been made.
Following publication of this notice and the public comment period,
NHTSA plans to publish a second notice in the Federal Register
containing the final Model Specifications. After the second notice is
published, NHTSA plans to begin testing of alcohol screening devices to
determine whether they comply with the performance criteria included in
the Model Specifications.
A Conforming Products List (CPL) will be published and updated
periodically. It will include a list of alcohol screening devices that
were submitted with the proper certifications and found to meet or
exceed the proposed Model Specifications.
NHTSA proposes to modify and improve these Model Specifications as
new data and test procedures become available and to alter the test
procedures, if necessary, to meet unique design features of a specific
device. For each such modification, NHTSA would provide notification in
the Federal Register and would retest devices when necessary.
OASP would be the point of contact for information about acceptance
testing and field performance of devices. NHTSA requests that users of
these devices provide both acceptance and field performance data to
OASP when such data are available. Information from users would 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 would
direct VNTSC to conduct a special investigation. An investigation may
include visits to users and additional tests of the device obtained
from the open market. If the investigation indicates that the devices
actually sold on the market are not meeting the Model Specifications,
the manufacturer would be notified that the device may be removed from
the list. In this event, the manufacturer would have 30 days from the
date of notification to reply. Based on the VNTSC investigation and any
data provided by the manufacturer, NHTSA would decide whether the
device should remain on the list. If the device is removed from the
list, the manufacturer would 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 would
be required to submit a statement describing what has been done to
overcome the problems which 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 would investigate the matter in consultation with FDA
and would notify the manufacturer that the device may be removed from
the list. The manufacturer would have 30 days from the date of
notification to reply. Based on any data provided by the manufacturer
and investigative findings, NHTSA would decide whether the device
should remain on the list. If the device is removed from the list, the
manufacturer would be permitted to resubmit a self-certification,
certifying that the manufacturer complies with these FDA requirements
when it believes the problems causing its non-compliance have been
resolved. Upon resubmission, the manufacturer would be required to
submit a statement describing what has been done to overcome the
problems which led to non-compliance.
Comments
Interested persons are invited to comment on this proposal.
Comments are sought on the proposed conversion factors included in
these proposed Model Specifications, particularly for saliva, and what
may constitute acceptable criteria for bodily fluids other than saliva,
blood and breath.
Related issues regarding screeners that are of interest include the
potential of interfering substances (i.e. nicotine and acetone) to
affect results, and whether the Model Specifications should test for
additional potentially interfering substances.
NHTSA also requests comments, particularly from manufacturers or
users (and potential users) of these devices, regarding problems that
have occurred or could arise due to insufficient labeling or
manufacturing practices. Commentors should identify issues they believe
need to be addressed by NHTSA's notice regarding manufacturing
practices and labeling requirements, and indicate whether they believe
FDA regulations are most appropriate to address these issues.
Alternatively, if commentors believe there is not a need to apply
manufacturing practices and labeling requirements to alcohol screening
devices when used for law enforcement and workplace testing purposes,
they should submit comments to this effect and include the reasons for
their belief.
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 Model Specifications
may be published at any time after that date, and any comments received
after the closing date and too late for consideration with regard to
the action will be treated as suggestions for future revisions to the
specifications. NHTSA will continue to file relevant material in the
docket after the closing date as it becomes available. It is
recommended that interested persons continue to examine the docket for
new material.
Those persons who desire to be notified upon receipt of their
comments in the docket should enclose a self-addressed stamped postcard
in the envelope with their comments. Upon receiving the comments, the
docket supervisor will return the postcard by mail.
This action has been analyzed in accordance with the principles and
criteria contained in Executive Order 12612 and it has been determined
that it has no federalism implication that warrants the preparation of
a federalism assessment.
In accordance with the foregoing, the proposed Model Specifications
for performance testing of alcohol screening devices are set forth
below.
Authority: 23 U.S.C. 402; delegations of authority at 49 CFR
1.50 and 501.
Michael B. Brownlee,
Associate Administrator for Traffic Safety Programs.
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 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 may be indicated by numerical
read-out or by other means, such as by the use of lights or color
changes.
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)2 (BrAC is often used to indicate that the measurement
is a breath measurement); or grams alcohol per 100 milliliters of
saliva.
\2\Available from the National Committee on Traffic Laws and
Ordinances, 405 Church Street, Evanston IL 60201.
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3.4 Calibrating Unit
A device that produces an alcohol-in-air test sample of known
concentration that meets the NHTSA Model Specifications for Calibrating
Units (49 FR 48865).
3.5 Breath Alcohol Sample Simulator (BASS)
A device that provides an alcohol-in-air test sample with known and
adjustable alcohol concentration profile, flow rate, and air
composition at 34 deg. centigrade. (See NBS Special Publication 480-41,
July 19813 for a description of a BASS unit suitable for use in
the required testing.)
\3\Available from Superintendent of Documents, U.S. Government
Printing Office, Washington, D.C. 20402.
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3.6 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.
3.7 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 which
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 the BASS device for
breath devices and preparations of bodily fluids or scientifically
acceptable substitutes for non-breath devices.
For disposable alcohol screening devices that indicate the presence
of alcohol in a manner that requires interpretation, combine Tests 1
and 2, in accordance with 4.3 below.
For alcohol screening devices that indicate the presence of alcohol
in a manner that does not require interpretation, perform the test
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 preparations of
non-alcoholic bodily fluids or scientifically acceptable substitutes
for non-breath devices.
For disposable alcohol screening devices that indicate the presence
of alcohol in a manner that requires interpretation, combine Tests 1
and 2, in accordance with 4.3 below.
For alcohol screening devices that indicate the presence of alcohol
in a manner that does not require interpretation, perform the test
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 Methodology for Combining Tests 1 and 2 for Disposable
Interpretive Devices.
Perform the test using ten individuals who qualify as test
interpreters (according to the manufacturer's restrictions, if any) and
who have no knowledge of test BACs. Ask each individual to read the
manufacturer's instructions for interpretation of the device's read-
out.
Label sixty devices from 1 to 60 and randomly separate them into
three groups of twenty. Record the numbers in each group. Use two of
the groups of devices for Test 1 and the remaining group for Test 2.
Dose each group at the BAC levels specified in Tests 1 and 2. Order the
sixty devices into a single set from 1 to 60 and ask each individual to
independently interpret the results of these trials.
Ask each individual to record each result as being one of the
following: ``at .00 BAC''; ``above .00 and below .02 BAC''; ``at or
above .02 BAC''; or ``can't tell''. Dosing of devices and
interpretation of results will be accomplished within a two hour
period.
To conform, with each interpreter, no positive results at .000 BAC,
not more than one positive result at .008 BAC and not more than one
non-positive result at .032 BAC. If the device is capable of providing
a reading of greater than 0.000 BAC and less than 0.020 BAC, with each
interpreter, not more than one such result at .000 BAC.
4.4 Interference
Test for the effect of acetone and, in the case of breath or saliva
devices, cigarette smoke.
4.4.1 Test 3.1. Acetone.
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.
Prepare test BACs to include an acetone concentration equivalent to
a BAC of 0.010 grams per 100 milliliters blood. For breath screening
devices, add 115 microliters of acetone per 500 milliliters of solution
for use in the calibrating unit.\4\
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\4\Based on an experimentally determined water to air partition
factor 365 to 1 at 34 deg. to yield acetone-in-air concentrations of
0.5 milligrams per liter.
---------------------------------------------------------------------------
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 3.2. Cigarette smoke (breath and saliva test devices only).
Perform five trials at 0.000 BAC. Use non-alcoholic human breath
for breath devices and preparations of non-alcoholic bodily fluids or
scientifically acceptable substitutes for non-breath devices.
Select a 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, ask him or her to blow into the screening
device according to 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.
4.5 Temperature.
Test at low and high ambient temperature.
4.5.1 Test 4.1 Low Ambient Temperature.
Perform 40 trials at 10 deg.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.
4.5.2 Test 4.2 High Ambient Temperature.
Perform trials of 40 devices at 40 deg.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.
4.6 Test 5.0. 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. The 40
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--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,
semiquantitative) 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.
Reagents
List the concentration, strength, composition of the reactive
ingredients.
List the non-reactive ingredients.
Reagent Preparation and Storage
Provide instructions for preparing the reagents, if applicable.
Provide the instructions for storing the reagents, if applicable.
Provide any signs of deterioration of the reagents, if applicable.
Provide the reagent's 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. If visually read, warn the user the result should not be
interpreted by readers who are color-blind or visually impaired.
3. 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.
If the test is disposable (non-instrumented) and involves a color
reaction, include the time frame for which the test must be read and
recorded.
e.g. Read within 15 minutes.
Test Procedure (Reusable/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 the 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 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 a colored bar,
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
Precision and Accuracy specifications are included in the National
Highway Traffic Safety Administration's (NHTSA's) Model Specifications
for Alcohol Screening Devices. Only devices that meet 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.
[FR Doc. 94-1858 Filed 2-3-94; 1:00 pm]
BILLING CODE 4910-59-P