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
August 2, 1994
[Federal Register: August 2, 1994]
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[NHTSA Docket No. 94-004; Notice 2]
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 establishes 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 establishing 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 (e.g., 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: The Model Specifications established by this notice become
effective August 2, 1994.
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 15, 1992 (57 FR 59382), the U.S.
Department of Transportation (DOT) published a notice of proposed
rulemaking (NPRM) 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. 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 those evidential breath testing devices (EBTs) listed on
NHTSA's Conforming Products List (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. EBT's listed
on NHTSA's CPL have been tested and determined to meet the agency's
Model Specifications for EBTs, which were last amended on September 17,
1993 (58 FR 48705).
In a final rule published on February 15, 1994 (59 FR 7340), DOT
amended its regulations and added procedures for conducting alcohol
testing in transportation workplaces (49 CFR Part 40). This final rule
differed from the NPRM in a number of respects. The final rule required
the use of breath testing devices listed on the CPL for EBTs. For
screening devices, it permitted the use of EBTs on the CPL that do not
print the result, but only if confirmation tests are conducted using
EBTs listed on the CPL which are capable of providing a printed result.
(These devices must also be capable of distinguishing alcohol from
acetone at the 0.02 BAC level and sequentially numbering the tests
conducted.)
NHTSA published a separate notice in the same issue of the Federal
Register (59 FR 7372) proposing to adopt Model Specifications and a CPL
that would permit additional alcohol testing devices to be used for
screening purposes. In its notice, NHTSA proposed 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. It stated that the proposed Model Specifications
are designed to test whether devices are suitable for screening, not
evidential, purposes and that 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.
NHTSA requested comments on these proposed Model Specifications.
Comments Received
The agency received twenty comments in response to the notice.
Comments were received from manufacturers of screening devices and
related equipment, persons representing sectors of the transportation
industry subject to the DOT regulations (including rail, transit, motor
carriers and pipelines) and substance abuse program administrators, an
interested individual and a health professional.
General Comments
The comments, in general, were supportive of the agency's proposed
Model Specifications. Some of the comments praised the notice for
proposing to increase flexibility, stimulate development and reduce
barriers and cost for those charged with implementing DOT's new alcohol
testing rules.
A number of commenters raised concerns about the schedule NHTSA
would following publishing the final Model Specifications. DOT's final
rule becomes effective for large employers (in general, with 50 or more
safety-sensitive employees) on January 1, 1995. The commenters,
therefore, urged the agency to issue the Model Specifications and
approve conforming devices prior to that date. Two commenters
recommended that if final rules and product evaluations are not
completed within a specified period of time (one commenter suggested
August 1 1994, another mid-1994), the effective date of DOT's final
rule should be delayed.
In response to these comments, NHTSA has sought to publish the
final Model Specifications as quickly as possible. As described further
below, we intend to begin testing immediately, and hope to publish
within 30 days from today's date a Conforming Products List (CPL) of
screening devices that have been tested to date and conform to these
Model Specifications. The CPL will be updated and published
periodically, as further testing is completed.
A number of commenters raised issues that pertain to other notices
that were published in the Federal Register on February 15, 1994, such
as DOT's final rule (59 FR 7340) on Procedures for Transportation
Workplace Drug and Alcohol Testing Programs (49 CFR Part 40) or the
final rules and common preamble (59 FR 7302) on the Limitation on
Alcohol Use by Transportation Workers. Others raised issues that are
also outside the scope of NHTSA's notice and request for comments. For
example, one respondent commented that all alcohol testing should be
performed by law enforcement representatives. Another respondent urged
the Department to permit testing to be conducted only using evidential
breath testing devices. Other commenters suggested that the use of non-
breath alcohol tests (which use blood, saliva or urine samples) as a
condition for employment is an invasion of privacy and a violation of
individual rights.
NHTSA's Model Specifications contain the performance criteria and
methods for the testing of alcohol screening devices. It does not
address whether such devices are permitted to be used to perform
screening tests, who is authorized to administer such tests or who is
subject to them. These issues are addressed instead in DOT's final
rules.
Other commenters raised questions or concerns regarding the Model
Specifications for Evidential Breath Testing Devices, last revised on
September 17, 1993 (58 F.R. 48705), or the Model Specifications for
Breath Alcohol Ignition Interlock Devices (BAIIDs), published on April
7, 1992 (57 F.R. 11772).
Issues such as these are outside the scope of the notice published
in February proposing Model Specifications for alcohol screening
devices, and therefore have not been addressed in this notice adopting
Model Specifications.
Specific Comments on Model Specifications
No comments were received regarding some portions of the proposed
Model Specifications. These portions have been adopted without change.
For further discussion regarding these portions, interested persons
should review the February notice. Portions of the proposed Model
Specifications that generated comment, and the issues raised in the
comments, are discussed below.
1. Purpose, Scope, Classification and Definitions
In its February 15, 1994 notice, NHTSA proposed to define an
alcohol screening device as a device that is used to detect the
presence of 0.020 or more BAC, and that indicates the test result by
numerical read-out or by other means, such as by the use of lights or
color changes. All comments addressing these aspects of the Model
Specifications supported the definition. They have been adopted without
change.
The notice proposed that the Model Specifications would provide
that devices may measure any bodily fluid (including blood, breath or
saliva), but that the output must be in blood alcohol concentration
(BAC) units. It explains that NHTSA believes the relationship between
BAC and the bodily fluid being measured be properly established so that
a means for evaluating the device can be devised, and that NHTSA
considers use of a one-to-one conversion factor between blood and
saliva to be appropriate. NHTSA requested comments in the February 15
notice on the proposed use of a one-to-one conversion factor for
saliva, and on what may constitute acceptable criteria for bodily
fluids other than saliva, blood and breath.
All comments regarding the one-to-one conversion factor and the
applicability of the proposed Model Specifications to blood, breath and
saliva were supportive of NHTSA's proposal. These aspects of the Model
Specifications have been adopted without change.
Comments were received from the manufacturer of an alcohol
screening device that uses ocular vapor analysis. The type of analysis
used by this device measures alcohol using vapors from the surface of
the eye. The commenter requested that the model specifications include
the ocular vapor analysis technique as an acceptable and recognized
method.
The Model Specifications, as proposed in the agency's February 15
notice and as finally adopted in today's Federal Register notice,
define an alcohol screening device as a device that may measure ``any
bodily fluid'' for the purpose of detecting the presence of 0.020 or
more BAC. This definition is clearly broad enough to include use of the
ocular vapor analysis technology.
NHTSA did not include in its proposal, however, testing procedures
for all conceivable types of screening technologies. Rather, it
proposed testing procedures for the types of screening technologies
currently most commonly available. The notice explained that the agency
would modify and improve the Model Specifications as new data and test
procedures become available, and that it would alter the test
procedures, if necessary, to meet unique design features of specific
devices. If the test procedures need to be altered to test the ocular
vapor analysis technology, NHTSA would make such alterations. Any
needed alterations would be published in the Federal Register.
One commenter, a manufacturer of alcohol breath testing devices,
raised concerns about devices that are not capable of detecting ethyl
alcohol and isopropyl alcohol. The commenter stated that if devices
cannot identify all three of these alcohols, they will produce false
negative alcohol readings.
The definition of alcohol included in the proposed Model
Specifications permits alcohol screening devices to detect different
types of alcohol (including ethyl alcohol, methyl alcohol and isopropyl
alcohol), but does not require that devices must be capable of
distinguishing between each type. To determine compliance with the
Model Specifications, the agency proposed that it would conduct tests
using ethanol.
NHTSA does not disagree that the potential for false negative
results may exist should be a technology be employed in a screening
device that is specific to ethanol only and an individual has consumed
methyl or isopropyl alcohol. However, the agency is aware of no
screening devices using such a technology. Rather, the screening
devices available today on the market generally employ technologies
that are not specific to any single type of alcohol, and, therefore,
are capable of detecting (but not distinguishing between) ethanol and
the other alcohols.
As a result, and since ethanol is the alcohol most often consumed,
we believe that the probability of obtaining false negative results by
screeners that conform to these Model Specifications is extremely low.
The proposed definition has been adopted without change.
2. Statistical Accuracy
In its February 15 notice, NHTSA proposed to test alcohol screening
devices 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 notice explained that the .008 and .032 BAC levels were
selected based on criteria for precision and accuracy that are
equivalent to those used for EBTs. The criteria require that devices
perform at a level of accuracy within 0.005 of 0.020 BAC
(thereby establishing target valves 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 approximately 95% in the
results of these 20 tests, we proposed 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).
One commenter expressed the opinion that the proposed method of
testing does not truly reflect the accuracy standard of
0.005 BAC with standard deviation not to exceed .0042 BAC.
This commenter recommended that instruments should be tested instead at
the .020 BAC level, that results should fall within the 0.15 and .025
BAC range, and that a deviation of not more than .0042 should be
maintained. The commenter's response further stated that, to achieve a
confidence rate of 95%, only 5% of the tests conducted should be
outside the .015 to .025 BAC range.
The method proposed by this commenter would require that devices
identify the precise BAC level detected by the instrument. The Model
Specifications do not include such a requirement. Rather, they simply
require that devices are capable of detecting the presence of alcoholic
at the 0.020 or greater BAC level. To accommodate the use of non-
numerical as well as numerical alcohol screening devices, the Model
Specifications use two test points which are 1.73 times the maximum
allowed standard deviation on either side of 0.020 0.005
BAC (0.008 and 0.032). The number of false positives and false negative
allowed were obtained based on the use of Student's distribution (a
small sample approximation to the normal distribution).
One commenter illustrated a range of error that would be permitted
under the proposed Model Specifications, and suggested that the Model
Specifications be amended to permit a smaller range of error. Another
commenter, addressing the same concern, proposed that the Model
Specifications be amended to provide for the adjustment of the test at
.032. This commenter recommends that we conduct 20 tests at .025 with
no more than one false negative result and 20 tests at .015 with no
more than two false positives. NHTSA believes these proposals would
require that screening devices perform at a higher level of precision
than is required for EBTs. The procedures contained in the proposed
Model Specifications have been adopted without change.
3. Test Methods
NHTSA proposed to use a Breath Alcohol Sample Simulator (BASS),
non-alcoholic human breath, and a calibrating unit to test breath
devices. For non-breath devices, the agency proposed to use
preparations of bodily fluids or scientifically acceptable substitutes.
For example, the agency proposed to use aqueous alcohol test solutions
equivalent to blood or saliva on a one-to-one basis to test saliva
devices.
One commenter, a manufacturer of a saliva device, expressed its
view that there are no fluids that are scientifically acceptable
equivalents to bodily fluids. The commenter asserted that aqueous
alcohol test solutions lack the viscosity, solid content and inhibitors
that are present in bodily fluids such as saliva, and recommended that
the agency instead collect saliva specimens from individuals known to
be alcohol-free. According to the commenter, the non-alcohol saliva
pool could then be spiked with various alcohol solutions for device
evaluation.
NHTSA disagrees with this respondent's comment. The agency has data
finding that aqueous alcohol test solutions are acceptable substitutes
for saliva-alcohol testing purposes.\1\ In addition, while we agree
that aqueous solutions and saliva do have different characteristics, we
have no reason to believe that these difference would interfere with
the agency's ability to test the capability of saliva screening devices
to detect alcohol content. The final Model Specifications continue to
provide that aqueous alcohol test solutions will be used.
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\1\Flores, A.L., Spicer, A. and Frank, J.F., ``Laboratory
Testing of a Saliva-Alcohol Test Device by Enzymatics, Inc.,''
Washington, D.C., U.S. Department of Transportation, National
Highway Traffic Safety Administration, Technical Report No. DOT-HS
807 893, December 1992.
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Two commenters recommended that NHTSA use alcohol reference
material 1828, obtained from the National Institute of Standards and
Technology (NIST), to prepare all standard solutions. One of these
commenters also suggested that, following preparation, these solutions
should themselves be analyzed against a referee method (enzymatic or
gas chromatography) which has been calibrated using NIST standards.
NHTSA does not plant to use NIST 1828 material in its standard
solutions. However, the agency presently uses the material for the
purpose for which it was intended, as a reference material for
calibration purposes, and will continue to do so.
The agency proposed 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.
NHTSA's notice explained that 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 proposed 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 notice stated that 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.
NHTSA's notice explained that 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 proposed 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 notice proposed that
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 to providing a reading of greater than 0.000 BAC and less than
0.020 BAC, the notice proposed that the device must perform, with each
interpreter, with not more than one such result at .000 BAC. These
aspects of the Model Specifications have been adopted without change.
An organization that represents substance abuse program
administrators suggested that, if practical, the ten individuals select
to interpret the devices should have no medical training since it is
likely that the persons who will be administering the tests in the
field will have no such training. The agency plans to select
individuals with varying backgrounds and experience. While we do not
believe there is justification for imposing a restriction on the
selection of individuals who have medical training, it is likely that
few if any of the individuals selected will have such training.
A manufacturer of saliva screening devices suggested that the Model
Specifications should provide for a familiarization period, to ensure
that investigators and individuals who will be evaluating these devices
are familiar with the manner in which the devices should operate.
The preamble to the proposed Model Specifications explained that
individual evaluators will be asked to read the manufacturer's
instructions before they perform their evaluations. These individuals
will be provided sufficient time to become familiar with these
instructions, and will also be given instructions for conducting the
evaluations. Investigators will also provide themselves with sufficient
time to read the manufacturer's instructions and become familiar with
the devices they are testing, as well as the evaluation procedures.
NHTSA stated in the February 15 notice that, through the
independent interpretation of ten individuals, it believed the Model
Specifications would ensure that the results of tested devices are
visible and will remain so for a reasonable period of time and area
likely to be interpreted in a consistent manner. The notice indicated
that the tests would require approximately two hours to run. The agency
requested comments on these aspects of the proposed Model and
Specifications.
The comments were supportive of these aspects of the proposed Model
Specifications, except that two commenters objected to the requirement
that screening results remain visible for two hours. One of the
commenters considered this to be an unreasonable requirement,
particularly when (according to the commenter) the primary basis for
the requirement is the convenience of the testing facility that will be
evaluating the device. The other commenter was concerned that this two-
hour period could invalidate the results, since some devices require
that the user read and record the test result within a specific period
of time (such as two minutes).
Upon further consideration based on these comments, NHTSA has
decided to modify the requirement that results must remain visible for
two hours. It is not feasible, however, for the agency to eliminate the
requirement altogether. In part to facilitate the evaluation of these
devices, and also to be consistent with the DOT Alcohol Testing
Procedures (49 CFR Part 40), which provide that the waiting period
between screening and confirmation tests must be at least 15 minutes
but should be no longer than 20 minutes, NHTSA will modify its testing
methods so that the interpretation of results will be accomplished
within 20 minutes of dosing. Accordingly, the results of disposable
interpretive devices will need to remain visible for a period of only
20 minutes.
The notice explained that, to NHTSA's knowledge, no reusable
devices currently use interpretive readings and the agency believes it
is unlikely that manufacturers would begin to use such readings in
reusable devices. Accordingly, NHTSA proposed that the Model
Specifications would not include a methodology for testing reusable
interpretive devices. We requested comments on this aspect of the
proposed Model Specifications. The commenters that addressed this issue
agreed with the agency's proposal.
For disposable devices that use interpretive readings, NHTSA
proposed 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 requested comments on this proposed methodology. No
comments were received. The proposed methodology has been adopted
without change.
The February notice proposed to test devices to determine whether
acetone or, in the case of breath or saliva devices, cigarette smoke
affects the functioning of the instruments. The notice also requested
comments on whether devices should be tested for interference from
other substances.
With regard to the test for acetone interference, one commenter
agreed that there is a need for such a test. Another commenter strongly
recommended that the test be deleted from the Model Specifications. The
commenter argued that acetone is unlikely to interfere with the
measurement of breath alcohol and, if persons have levels of acetone
that are sufficiently high to cause interference, such persons should
not be performing safety sensitive functions. In addition, the
commenter stated that requiring devices to distinguish between alcohol
and acetone would greatly increase instrument cost and restrict
participation for certain instruments.
NHSTA has reconsidered its position on this issue, and decided that
alcohol screening devices should not be required to distinguish between
alcohol and acetone, particularly since the instruments used for
confirmation testing are capable of distinguishing between these
substances. Based on existing data,\2\ we do not expect a high
incidence of acetone interference and, in the unlikely event that a
device indicates a positive result due to the presence of acetone, this
will be detected in the confirmation test. The Model Specifications
have therefore been amended to eliminate the acetone test.
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\2\Flores, A.L. and Frank, J.F., ``The Likelihood of Acetone
Interference in Breath Alcohol Measurement,'' Washington, DC, U.S.
Department of Transportation, National Highway Traffic Safety
Administration, Technical Report No. DOT HS 806 922, 1985.
Frank, J.F. and Flores, A.L., ``The Livelihood of Actone
Interference in Breath Alcohol Measurement,'' Alcohol, Drugs, and
Driving, 3 (2), 1-8, April-June 1987.
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With regard to cigarette smoke and other interfering substances, we
received only one comment, which stated that non-interference from
smoking, eating and drinking should not be a conformance requirement
since these activities can be avoided before a test is performed. If
the evaluation of cigarette smoke is retained in the Model
Specifications, this commenter recommended that it be performed for
information purposes only.
NHTSA expects the likelihood of cigarette smoke interference will
be much greater than acetone interference, and has decided to retain
the cigarette smoke test. As provided in the Model Specifications, the
test will be performed in accordance with the manufacturer's
instructions. Any waiting period specified in the manufacturer's
instructions will be strictly observed. The test will be performed
within one minute after the person smokes the cigarette where no
waiting period is specified in the manufacturer's instructions. NHTSA
did not propose to conduct a test for interference from eating and
drinking, and we have not added any such test in the final Model
Specifications.
The commenter also suggested that, if the Model Specifications
continue to include a cigarette smoke test, that the method used for
conducting this test on saliva screening devices should be similar to
that used for breath screening devices. NHTSA concurs that this
comment, and has revised the Model Specifications to clarify its
application to both saliva and breath devices.
The agency also proposes to conduct high (40 deg.C) and low
(10 deg.C) ambient temperature and vibration tests for alcohol
screening devices to determine their ability to function under a range
of environmental conditions. NHTSA proposes that these tests 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
at .032 BAC) would be conducted under each of these other tests.
One commenter, a manufacturer of a passive alcohol sensor, noted
that the proposed temperature range for testing is more severe than
that for EBT testers. This commenter is correct. The temperature range
is more severe because it is anticipated that screening tests may be
performed outside in widely varying temperature conditions. Tests
performed with EBTs are generally performed indoors where temperatures
are controlled. The proposed temperature range has been adopted without
change.
Another commenter, a manufacturer of a saliva test device,
suggested that the specimens for saliva testing should be held at body
temperature (37 deg.C) while performing the two ambient temperature
evaluations ``to stimulate real-life situations.'' NHTSA disagrees with
this comment. When saliva tests are being conducted in the field, the
temperature of the saliva will change soon after the sample is taken
from the person's mouth. NHTSA therefore believes the procedures
contained in its proposed Model Specifications more accurately simulate
the conditions under which actual testing will be conducted. This
portion of the Model Specifications has been adopted without change.
The manufacturer of an alcohol breath testing device commented that
disposable devices, which cannot be checked for calibration on a
periodic basis, should be evaluated throughout their useful life. This
manufacturer also recommended that devices which require that results
be checked through a visual inspection should be tested under a variety
of light conditions, such as fluorescent, mercury vapor, sodium vapor
and daylight.
NHTSA disagrees that the Model Specifications should provide for
the evaluation of disposal devices throughout their useful life. As
explained in the February 15 notice, manufacturers of alcohol screening
devices must meet the requirements contained in FDA's Good
Manufacturing Practices regulations for devices used for medical
purposes (21 CFR Part 820), and they must include labels on their
devices that meet the requirements contained 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.
The Labeling Instructions for Alcohol Screening Devices included as
an Appendix to the February notice instructed, among other things, that
the label ``Provide the reagent's shelf life and opened expiration
dating, if applicable.'' In addition, manufacturers must determine
shelf life and expiration dating in accordance with FDA's regulations
on Good Manufacturing Practices.
NHTSA has asked users of alcohol screening devices to provide both
acceptance and field performance data to the agency's Office of Alcohol
and State Programs (OASP) when such data are available. As we explained
in the February notice, if information gathered indicates that a device
on the CPL is not performing in accordance with the Model
Specifications, that a manufacturer is not complying with FDA's Good
Manufacturing Practices, or that a device's label does not comply with
FDA's Labeling regulations, an investigation would be conducted and
appropriate measures would be taken. For these reasons, the Model
Specifications have not been amended to provide for the evaluation of
disposable devices throughout their useful life.
NHTSA accepts the recommendation that certain devices should be
tested under a variety of light conditions. The Model Specifications
have been amended to provide that interpretive devices which require
that results be checked through a visual inspection should be tested
under incandescent, mercury vapor, sodium vapor and daylight as well as
fluorescent conditions.
To conform with the Model Specifications, the notice proposed that
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 notice proposed
that the device must perform with not more than one such result at .000
BAC. No comments were received regarding this aspect of the proposal.
It has been adopted without change, except that the final Model
Specifications clarify that there can be no more than one ``can't
tell'' result for disposable interpretive devices.
4. FDA Involvement
When alcohol screening devices 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 stated in its
February 15 notice that 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 proposed to require that each device submitted
for testing under the Model Specifications 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.
NHTSA received a number of comments regarding this aspect of its
proposal. One commenter favored direct FDA regulation of all workplace
alcohol testing products and, if necessary, FDA enforcement. This
commenter encouraged DOT and NHTSA to continue their discussions with
FDA. Another commenter agreed that the guidelines written in FDA's Good
Manufacturing Practices regulation could be useful as a basis for
labeling and manufacturing requirements, but this and other commenters
recommended that FDA not get involved. According to one commenter,
``FDA is already overloaded, and long delays could result from their
involvement in this project.'' Another commenter recommended that, ``if
an instrument is not to be used in the medical field . . . FDA [should]
not assert jurisdiction.''
By requiring a self-certification, NHTSA was not proposing to
require that manufacturers obtain FDA marketing clearance, but simply
that the manufacturers self-certify that they meet the above-referenced
requirements. NHTSA stands by this aspect of its proposal.
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.
NHTSA's February notice included, as an Appendix, a proposed set of
Labeling Instructions for Alcohol Screening Devices that had 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 labeling instructions addressed issues such as restrictions
that may apply to operators of the device and conditions under which
the device should or should not be operated.
One respondent commented on certain aspects of the labeling
instructions. The commenter supported the inclusion of details on
calibration, calibration frequency, and the manufacturer's name,
address, and telephone and fax numbers, but disagreed that an ``800''
number is necessary. In addition, the commenter stated that frequency
is subject to use, and some users will prefer to return a unit to the
manufacturer rather than engage in its calibration.
For the convenience of users, many of whom will be conducting
alcohol screening tests in the field, the Labeling Instructions for
Alcohol Screening Devices, which are included as an Appendix to today's
notice, continue to provide that manufacturers list an 800 number the
user may contact for further information or technical assistance. With
regard to the calibration of devices, the Labeling Instructions
continue to provide that disposable devices are pre-calibrated, and
need no additional calibration. They also continue to provide that
reusable devices require calibration, and instruct that the labels on
such devices provide information regarding how calibrations are to be
conducted, instructions for calibration and recalibration and the
criteria for acceptability of calibration.
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.
NHTSA intends to begin testing of alcohol screening devices
immediately, and hopes to publish a CPL of devices that have been
tested to date and conform to these Model Specifications within 30 days
from today's date. The CPL will be updated and published periodically,
as further testing is completed. Once the first CPL is published, DOT
will develop and issue procedural rules for using approved alcohol
screening devices in transportation workplaces, including provisions
for how and where such devices can be used and the steps that must be
taken to collect bodily fluids. Employers are reminded that these
screening devices are not authorized for use under 49 CFR Part 40 until
that regulation is amended.
Procedures
The procedures proposed in the February 15 notice have been adopted
without change. Testing of products submitted by manufacturers to these
Model Specifications will be conducted by the DOT Volpe National
Transportation Systems Center (VNTSC), DTS-75, Kendall Square,
Cambridge, MA 02142. Tests will be conducted semiannually, or as
necessary. Manufacturers are 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, S.W., Washington, D.C. 20590. Normally, at
least 30 days will be required from the date of notification until the
test can be scheduled.
One week prior to the scheduled initiation of the test program,
manufacturers will be required to deliver their devices to VNTSC. If
the devices are disposable, the manufacturer must deliver 300 such
devices; if the devices are disposable, interpretive and require that
results be checked through a visual inspection (and therefore must be
tested under various light conditions), the manufacturer must deliver
600 such devices; if the devices are reusable, the manufacturer must
submit only a single device. If a manufacturer of a reusable device
wishes to submit a duplicate, backup instrument, it may do so. The
manufacturer shall be 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) normally supplied with the purchase of the device, as well as
specifications and drawings which fully describe these devices.
Proprietary information will be respected. (See 49 CFR Part 512,
regarding the procedure by which NHTSA will consider claims of
confidentiality.)
In addition, the manufacturer must submit a self-certification,
certifying that the manufacturer meets the requirements 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 Part 809.10), even if the devices are not to be used
for medical purposes. See the Appendix to this notice.
The manufacturer has the right to check its devices between the
time of their arrival at VNTSC and the start of the tests, but will
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 will 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.
NHTSA plans to begin testing of alcohol screening devices
immediately to determine whether they comply with the performance
criteria included in the Model Specifications.
A Conforming Products List (CPL) will be updated and published
periodically. It will include a list of alcohol screening devices that
were submitted with the proper certifications and found to meet or
exceed the Model Specifications.
One commenter requested that manufacturers should be permitted to
commercialize their products as soon as they receive notification from
NHTSA that their product has been found to meet or exceed the Model
Specifications, rather than wait until the CPL listing their device is
published. NTSHA intends to notify manufacturers that their devices
meet the Model Specifications, and manufacturers may receive such
notices and an evaluation report prior to the publication of a CPL
listing their instrument. A decision about the point at which it would
be appropriate for manufacturers to commercialize their instruments,
however, is outside the scope of this notice.
NHTSA intends 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 is 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 will help
NHTSA monitor whether alcohol screening devices are performing
according to the NHTSA Model Specifications.
If information gathered indicates that a device on the CPL is not
performing in accordance with the Model Specifications, NHTSA will
direct VNTSC to conduct a special investigation. An investigation may
include visits to users and additional tests of the device 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 will be notified that the device may be removed from
the list. 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 list. If the device is removed from the list, 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 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 will investigate the matter in consultation with FDA
and will notify the manufacturer that the device may be removed from
the list. 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 list. If the device is removed from the list, the
manufacturer will 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 must submit a statement
describing what has been done to overcome the problems which led to
non-compliance.
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 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)\3\ (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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\3\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 1981\4\ for a description of a BASS unit suitable for use in the
required testing.)
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\4\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 using
fluorescent light, 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 using
fluorescent light 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 under normal laboratory conditions using
fluorescent light 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 twenty minute
period.
To conform, with each interpreter, no positive results at .000 BAC,
not more than one positive result at .008 BAC, not more than one non-
positive result at .032 BAC and not more than one ``can't tell''
result. 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 Test 3. Light Conditions (only interpretive devices which require
that results be checked through a visual inspection)
Perform Tests 1 and 2, in accordance with 4.3, under each of the
following light conditions: incandescent light; mercury vapor light;
sodium vapor light; and daylight.
Under each light condition, the device must meet the criteria
established in 4.3: To conform, with each interpreter, no positive
results at .000 BAC, not more than one positive result at .008 BAC, not
more than one non-positive result at .032 BAC and not more than one
``can't tell'' result. 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.
4.5 Test 4. Cigarette smoke interference (only breath and saliva test
devices)
Perform five trials at 0.000 BAC. Select an alcohol-free person who
smokes cigarettes for this test. Ask the person selected to smoke
approximately one half of a cigarette. Within one minute after smoking,
or after a waiting period specified in the manufacturer's instructions,
administer the alcohol screening device test according to the
manufacturer's instructions. Then ask the person to smoke another
inhalation and repeat the test to produce a total of five trials.
To conform, no positive results.
4.6 Temperature
Test at low and high ambient temperature.
4.6.1 Test 5.1 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.
4.6.2 Test 5.2 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.
4.7. Test 6. 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
(inches,
Frequency (hertz) 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 appicable.
Provide 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.
Speciment 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 acceptabiity 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 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 nagative 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 Alochol Screening devices. Only devices that meet
these model specificiations 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. 94-18750 Filed 7-28-94 4:30 pm]
BILLING CODE 4910-59-M