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

American Government Special Collections Reference Desk

American Government Topics:  National Highway Traffic Safety Administration

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

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.
---------------------------------------------------------------------------

    \3\Available from the National Committee on Traffic Laws and 
Ordinances, 405 Church Street, Evanston IL 60201.
---------------------------------------------------------------------------

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.)
---------------------------------------------------------------------------

    \4\Available from Superintendent of Documents, U.S. Government 
Printing Office, Washington, D.C. 20402.
---------------------------------------------------------------------------

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

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