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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
February 15, 1994

[Federal Register: February 15, 1994]


DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration
[NHTSA Docket No. 94-004; Notice 1]

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

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

ACTION: Notice; Request for comments.

-----------------------------------------------------------------------

SUMMARY: This notice proposes Model Specifications for the performance 
and testing of alcohol screening devices. These devices test for the 
presence of alcohol, and may use breath or other bodily fluids, such as 
saliva, to do so. NHTSA is proposing these specifications to support 
State laws that target youthful offenders (i.e., ``zero tolerance'' 
laws) and the Department of Transportation's regulations on Alcohol 
Misuse Prevention, and in recognition of industry efforts to develop 
new technologies (i.e., non-breath devices) that measure alcohol 
content from bodily fluids.
    A Conforming Products List (CPL) will be published identifying the 
devices that meet NHTSA's Model Specifications. The CPL can serve as a 
guide for those interested in purchasing devices that screen for the 
presence of alcohol.

DATES: Comments must be received no later than April 18, 1994.

ADDRESSES: Comments should refer to the docket number and the number of 
this notice and be submitted (preferably in ten copies) to the Docket 
Section, room 5109, 400 Seventh Street, SW., Washington, DC 20590 
(Docket hours are from 9:30 a.m. to 4 p.m.).

FOR FURTHER INFORMATION CONTACT: Ms. Lori A. Miller, Office of Alcohol 
and State Programs, NTS-21, National Highway Traffic Safety 
Administration, 400 Seventh Street, SW., Washington, DC 20590. 
Telephone (202) 366-9835.

SUPPLEMENTARY INFORMATION: On December 14, 1984 (49 FR 48854), the 
National Highway Traffic Safety Administration (NHTSA) issued a notice 
converting the mandatory standards for breath alcohol testing devices 
(38 FR 30459) to Model Specifications. The notice indicated that the 
agency would continue to test evidential breath testing devices (EBTs) 
and would release its findings by publishing a Conforming Products List 
(CPL) to provide States that choose not to conduct their own testing 
with adequate information upon which to base their purchasing 
decisions. These Model Specifications provided for EBTs to be tested at 
alcohol concentration levels of 0.000, 0.050, 0.101 and 0.151.
    Since 1984, a number of States have amended their laws by lowering 
the alcohol level at which drivers are deemed to be impaired or enacted 
new laws targeting youthful offenders, including ``zero tolerance'' 
laws, which provide that it is an offense for a person under the age of 
21 to drive with any alcohol concentration level above 0.00 (or in some 
cases above 0.01 or 0.02).
    On December 15, 1992 (57 FR 59382), the U.S. Department of 
Transportation (DOT) published a Notice of Proposed Rulemaking (NPRM) 
proposing rules to implement the ``Omnibus Transportation Employee 
Testing Act of 1991,'' which requires alcohol testing programs in the 
aviation, motor carrier, rail, and mass transit industries, in the 
interest of public safety. The Research and Special Programs 
Administration (RSPA) proposed similar regulations for the pipeline 
industry. In general, the NPRM proposed to prohibit covered employees 
from performing safety-sensitive functions when test results indicate 
alcohol concentration levels of 0.04 or greater. The NPRM proposed to 
apply slightly different consequences to employees having alcohol 
concentration levels of 0.02 or greater but less than 0.04.
    To determine alcohol concentration, the NPRM proposed to use breath 
as measured by only those EBTs listed on NHTSA's CPL which are capable 
of providing a printed result, sequentially numbering the tests 
conducted, and distinguishing alcohol from acetone at the 0.02 BAC 
level.
    DOT received comments in response to this rulemaking action 
recommending that if NHTSA's Model Specifications are to be used for 
the transportation workplace alcohol testing programs, the Model 
Specifications should be consistent with the requirements of the rules. 
They suggested, for example, that the Model Specifications which test 
devices at 0.000, 0.050, 0.101 and 0.151 BAC should be amended to test 
devices at the 0.020 and 0.040 BAC levels.
    In light of the trend in the States toward lowering alcohol levels 
and to address the comments received in response to DOT's NPRM, NHTSA 
amended its Model Specifications for EBTs on September 17, 1993 (58 FR 
48705), by changing the alcohol concentration levels at which 
instruments are evaluated. The amended Model Specifications provide for 
devices to be tested at 0.000, 0.020, 0.040, 0.080 and 0.160 BAC. Tests 
for the presence of acetone were also added in the revised Model 
Specifications. In addition, the agency tested EBTs against the new 
Model Specifications and updated the CPL.
    On October 15, 1993, Enzymatics, Inc., submitted a petition for 
reconsideration to NHTSA regarding the Notice published on September 
17, 1993. The petitioner, a manufacturer of a saliva alcohol test, 
argued that NHTSA should establish a procedure for the inclusion on the 
CPL of devices other than breath alcohol devices. More specifically, 
the petitioner objected to the ``exclusive reliance on EBTs'' in DOT's 
proposed rules.
    In a final rule published elsewhere in today's Federal Register, 
DOT amends its procedures for conducting urine drug testing and adds 
procedures for conducting alcohol testing in transportation workplaces 
(49 CFR Part 40). This final rule differs from the NPRM in a number of 
key respects. The final rule does require the use of breath testing 
devices listed on the CPL for EBTs. However, the final rule permits the 
use of portable EBTs that are on NHTSA's CPL as screening tests, 
provided confirmation tests are conducted using EBTs that are capable 
of providing a printed result, sequentially numbering the tests 
conducted and distinguishing alcohol from acetone at the 0.02 BAC 
level. In addition, the final rule indicates that NHTSA is publishing a 
separate notice in today's Federal Register proposing to adopt Model 
Specifications and a CPL that would permit additional alcohol testing 
devices to be used for screening purposes.
    This Federal Register notice is the one to which the final rule 
refers. It proposes to establish Model Specifications for alcohol 
screening devices, which differ from the Model Specifications for 
Evidential Breath Testing devices in a number of important respects. 
These proposed Model Specifications are designed to test whether 
devices are suitable for screening, not evidential, purposes. In 
addition, they are designed to test the performance of devices that may 
use bodily fluids other than breath (such as saliva) to determine the 
presence of alcohol.
    Under these proposed Model Specifications, an alcohol screening 
device is defined as a device that is used to detect the presence of 
0.020 or more BAC. The Model Specifications propose that the test 
result may be indicated by numerical read-out or by other means, such 
as by the use of lights or color changes.
    The Model Specifications propose that the device may measure any 
bodily fluid, but the output must be in blood alcohol concentration 
(BAC) units. Further, the relationship between the bodily fluid being 
measured and BAC must be properly established so that a means for 
evaluating the device can be devised. The relationship between breath 
alcohol concentration (BrAC) and blood alcohol concentration (BAC) is 
well established, and several studies have been published establishing 
a relationship between BAC and saliva alcohol concentration1. 
Accordingly, the proposed Model Specifications specifically provide 
that blood, breath or saliva may be used.
---------------------------------------------------------------------------

    \1\Jones, A.W., ``Distribution of ethanol between saliva and 
blood in man,'' Clinical and Experimental Pharmacology and 
Physiology, 1979a, 6(1), 53-59.
    Jones, A.W., ``Inter- and intra-individual variations in the 
saliva/blood alcohol ratio during ethanol metabolism in man,'' 
Clinical Chemistry, 1979b, 25(8), 1394-1398.
    Jones, A.W., ``Quantitative relationships among ethanol 
concentrations in blood, breath, saliva and urine during ethanol 
metabolism in man,'' In Goldberg, L. (Ed.) Alcohol Drugs and Traffic 
Safety, Vol. II. Proceedings, 8th International Conference on 
Alcohol, Drugs and Traffic Safety, June 15-19, 1980, Stockholm, 
Sweden: Almqvist & Wiksell International, 1981, pp. 550-569.
---------------------------------------------------------------------------

    In addition, these Model Specifications identify the proposed 
conversion factors for devices that use these bodily fluids. The 
conversion factors between blood and breath are commonly accepted. 
Based on the available literature, NHTSA believes it is appropriate to 
use a one-to-one conversion factor between blood and saliva, and has 
included this factor in these proposed Model Specifications. We request 
comments on the proposed use of this conversion factor.
    NHTSA proposes that if a manufacturer intends to use any bodily 
fluid other than blood, breath, or saliva to determine the presence of 
alcohol, the relationship between that fluid's alcohol concentration 
and blood alcohol concentration must be established according to 
scientifically acceptable standards.
    Under these proposed Model Specifications, alcohol screening 
devices would be tested at 0.008 and 0.032 BAC under normal laboratory 
conditions to determine their precision and accuracy at detecting the 
presence of 0.020 or more BAC (Test 1), and at 0.000 BAC to determine 
the performance of these devices when providing blank readings (Test 
2). The .008 and .032 BAC levels were selected based on criteria for 
precision and accuracy that are equivalent to those used for EBTs. They 
require that devices perform at a level of accuracy within 
0.005 of 0.020 BAC (thereby establishing target values 
within 0.015 and 0.025 BAC), and a level of precision which yields a 
standard deviation not greater than 0.0042. To achieve a confidence 
rate of 95% in the results of these 20 tests, we propose to establish 
measurement points at 1.73 standard deviations (or 0.007 BAC) below and 
above the lower and upper values, respectively (i.e., 0.015 - 0.007 = 
0.008 BAC and 0.025 + 0.007 = 0.032 BAC).
    NHTSA proposes to use a Breath Alcohol Sample Simulator (BASS), 
non-alcoholic human breath, and a calibrating unit to test breath 
devices. The agency proposes to use preparations of bodily fluids or 
scientifically acceptable substitutes for non-breath devices. For 
example, the agency proposes to use aqueous alcohol test solutions 
equivalent to blood or saliva on a one-to-one basis to test saliva 
devices.
    The agency proposes to conduct 40 trials under Test 1 (20 at .008 
BAC and 20 at .032 BAC) and 20 trials under Test 2 (at .000 BAC). For 
reusable devices, these 60 trials would be conducted using a single 
unit. For disposable devices, these 60 trials would be conducted using 
60 separate units.
    Some alcohol screening devices indicate the presence of alcohol in 
a manner that is unambiguous and requires no interpretation, such as by 
the use of a light or numerical reading. For these devices, NHTSA 
proposes that Tests 1 and 2 (at .008, .032 and .000 BAC) would be 
performed by an investigator at the DOT Volpe National Transportation 
Systems Center (VNTSC). To conform with the Model Specifications, the 
device must perform with no positive results at .000 BAC, not more than 
one positive result at .008 BAC and not more than one non-positive 
result at .032 BAC. If the device is capable of providing a reading of 
greater than 0.000 BAC and less than 0.020 BAC, the device must perform 
with not more than one such result at .000 BAC.
    Other devices indicate the presence of alcohol in a manner that 
requires interpretation and may involve some ambiguity, such as by the 
use of color changes. For these devices, NHTSA proposes that Tests 1 
and 2 (at .008, .032 and .000 BAC) would be performed by ten 
individuals who have no knowledge of test BACs and qualify as test 
interpreters. VNTSC would select these individuals using manufacturer's 
restrictions, if any. These individuals would be asked to read the 
manufacturer's instructions for the interpretation of the device's 
read-out, and interpret the test results independently. To conform with 
the Model Specifications, the device must perform, with each 
interpreter, with no positive results at .000 BAC, not more than one 
positive result at .008 BAC and not more than one non-positive result 
at .032 BAC. If the device is capable of providing a reading of greater 
than 0.000 BAC and less than 0.020 BAC, the device must perform, with 
each interpreter, with not more than one such result at .000 BAC.
    Through the independent interpretation of ten individuals, NHTSA 
believes the Model Specifications would ensure that the results of 
tested devices are visible and will remain so for a reasonable period 
of time (the tests require approximately two hours to run), and are 
likely to be interpreted in a consistent manner. NHTSA requests 
comments on this aspect of the proposed Model Specifications.
    To NHTSA's knowledge, no reusable devices use interpretive 
readings. Typically, these readings are produced using a chemical 
reaction, which results in a color change, a method which lends itself 
more readily to a single use device. For this reason, the agency 
believes it is unlikely that manufacturers would begin to use such 
interpretive readings in reusable devices. Accordingly, NHTSA has not 
proposed a methodology for testing reusable interpretive devices. We 
request comments on this aspect of the agency's proposal.
    For disposable devices that use interpretive readings, the Model 
Specifications propose to combine Tests 1 and 2, and number the units 
and expose them to the three BAC levels using a methodology that would 
not reveal to the person interpreting the test the dosage received by 
any particular unit. NHTSA requests comments on this proposed 
methodology.
    Devices would also be tested to determine whether acetone or, in 
the case of breath or saliva devices, cigarette smoke affects the 
functioning of the instruments. NHTSA requests comments on whether 
devices should be tested for interference from other substances. In 
addition, high (40 deg.C) and low (10 deg.C) ambient temperature and 
vibration tests would be conducted for these devices to determine their 
ability to function under a range of environmental conditions. NHTSA 
proposes that these tests (3.1, 3.2, 4.1, 4.2 and 5) would be performed 
by an investigator at VNTSC. Five trials would be conducted at .000 BAC 
under Test 3.2. Forty trials (including 20 at .008 and 20 and .032 BAC) 
would be conducted under each of these other tests.
    To conform with the Model Specifications, the device must perform 
with no positive results at each test performed at .000 BAC, not more 
than one positive result at each test performed at .008 BAC and not 
more than one non-positive result at each test performed at .032 BAC. 
If the device is capable of providing a reading of greater than 0.000 
BAC and less than 0.020 BAC, the device must perform with not more than 
one such result at .000 BAC.
    When devices such as these are used for medical purposes, the 
manufacturers of the devices are required to obtain marketing clearance 
from the Food and Drug Administration (FDA), in accordance with FDA 
regulations that address issues such as quality assurance in 
manufacturing, shelf-life and labeling. Currently, FDA does not assert 
jurisdiction (provide marketing clearance) for alcohol screening 
devices used for law enforcement purposes and workplace testing.
    However, because of the nature of alcohol screening devices and the 
conditions under which they are to be used, NHTSA believes it is 
important for manufacturers of these devices to conform with certain 
requirements, imposed by FDA on devices used for medical purposes, 
prior to the inclusion of the devices on NHTSA's CPL.
    Accordingly, NHTSA proposes to require that each device submitted 
for testing under the Model Specifications must be accompanied by a 
self-certification from the manufacturer, certifying that it meets the 
requirements contained in FDA's Good Manufacturing Practices 
regulations for devices used for medical purposes (21 CFR Part 820), 
and that the device's label meets the requirements contained in FDA's 
Labeling regulations for devices used for medical purposes (21 CFR Part 
809.10), even if the devices are not to be used for medical purposes. 
By requiring a self-certification, NHTSA is not requiring that 
manufacturers obtain FDA marketing clearance, but simply that they 
self-certify that they believe that they have met the above-referenced 
requirements. (For technical assistance or a copy of the Device Good 
Manufacturing Practices Manual for Medical Devices, manufacturers 
should contact FDA's Division of Small Manufacturers by calling toll 
free at 1-800-638-2041.)
    This notice includes, as an Appendix, a proposed set of Labeling 
Instructions for Alcohol Screening Devices that has been prepared in 
consultation with FDA to assist manufacturers of alcohol screening 
devices in developing a label that conforms to 21 CFR Part 809.10. The 
template addresses issues such as restrictions that may apply to 
operators of the device and conditions under which the device should or 
should not be operated.
    These Model Specifications are not regulations. Organizations and 
agencies may adopt these Model Specifications and rely on NHTSA's test 
results or may conduct their own tests according to their own 
procedures and specifications. It should be noted, however, that 
transportation employers covered by 49 CFR Part 40, Procedures for 
Transportation Workplace Drug and Alcohol Testing Programs, are 
required to use only alcohol testing devices that meet the criteria 
established by that regulation. See DOT's final rule published 
elsewhere in today's Federal Register.
    Once the Model Specifications for Alcohol Screening Devices are 
finalized and a CPL of conforming devices is published, DOT will issue 
procedural rules for using approved alcohol screening devices in 
transportation workplaces, including provisions for how and where such 
devices could be used and the steps that must be taken to collect 
bodily fluids.

Procedures

    NHTSA proposes that testing of products submitted by manufacturers 
to these Model Specifications would be conducted by the DOT Volpe 
National Transportation Systems Center (VNTSC), DTS 75, Kendall Square, 
Cambridge, MA 02142. Tests would be conducted semiannually, or as 
necessary. Manufacturers would be required to apply to NHTSA for a test 
date by writing to the Office of Alcohol and State Programs (OASP), 
NTS-21, NHTSA, 400 Seventh Street, SW., Washington, DC 20590. Normally, 
at least 30 days would be required from the date of notification until 
the test could be scheduled.
    One week prior to the scheduled initiation of the test program, a 
manufacturer would be required to deliver its devices to VNTSC. If the 
devices are disposable, the manufacturer would be required to deliver 
300 such devices; if the devices are reusable, the manufacturer would 
be required to submit only a single device. If a manufacturer wishes to 
submit a duplicate, backup instrument, however, it may do so. The 
manufacturer would be responsible for ensuring that the devices operate 
properly and are packaged correctly. The manufacturer would also be 
required to deliver the operator's manual (or instructions) and the 
maintenance manual (if any) supplied with the purchase of the device, 
as well as specifications and drawings which fully describe these 
devices. Proprietary information would be respected. (See 49 CFR Part 
512, regarding the procedure by which NHTSA will consider claims of 
confidentiality.)
    In addition, the manufacturer would be required to submit a self-
certification, certifying that the manufacturer meets the requirements 
in FDA's Good Manufacturing Practices regulations for devices used for 
medical purposes (21 CFR Part 820), and that the device's label meets 
the requirements in FDA's Labeling regulations for devices used for 
medical purposes (21 CFR 809.10) even if the devices are not to be used 
for medical purposes. See Appendix to this notice.
    NHTSA proposes that the manufacturer would have the right to check 
its devices between the time of their arrival at VNTSC and the start of 
the tests, but would have no access to the devices during the tests. 
Any malfunction of a device which results in failure to complete any of 
the tests satisfactorily would result in a determination that the 
device does not conform to the Model Specifications. If a device is 
found not to conform, it may be resubmitted for the next testing series 
after appropriate corrections have been made.
    Following publication of this notice and the public comment period, 
NHTSA plans to publish a second notice in the Federal Register 
containing the final Model Specifications. After the second notice is 
published, NHTSA plans to begin testing of alcohol screening devices to 
determine whether they comply with the performance criteria included in 
the Model Specifications.
    A Conforming Products List (CPL) will be published and updated 
periodically. It will include a list of alcohol screening devices that 
were submitted with the proper certifications and found to meet or 
exceed the proposed Model Specifications.
    NHTSA proposes to modify and improve these Model Specifications as 
new data and test procedures become available and to alter the test 
procedures, if necessary, to meet unique design features of a specific 
device. For each such modification, NHTSA would provide notification in 
the Federal Register and would retest devices when necessary.
    OASP would be the point of contact for information about acceptance 
testing and field performance of devices. NHTSA requests that users of 
these devices provide both acceptance and field performance data to 
OASP when such data are available. Information from users would help 
NHTSA monitor whether alcohol screening devices are performing 
according to the NHTSA Model Specifications.
    If information gathered indicates that a device on the CPL is not 
performing in accordance with the Model Specifications, NHTSA would 
direct VNTSC to conduct a special investigation. An investigation may 
include visits to users and additional tests of the device obtained 
from the open market. If the investigation indicates that the devices 
actually sold on the market are not meeting the Model Specifications, 
the manufacturer would be notified that the device may be removed from 
the list. In this event, the manufacturer would have 30 days from the 
date of notification to reply. Based on the VNTSC investigation and any 
data provided by the manufacturer, NHTSA would decide whether the 
device should remain on the list. If the device is removed from the 
list, the manufacturer would be permitted to resubmit an improved 
device to VNTSC for testing when it believes the problems causing its 
failure have been resolved. Upon resubmission, the manufacturer would 
be required to submit a statement describing what has been done to 
overcome the problems which led to failure of the device.
    If information gathered indicates that the manufacturer of a device 
on the CPL does not comply with the requirements in FDA's Good 
Manufacturing Practices regulations for devices used for medical 
purposes or that the device's label does not comply with the 
requirements in FDA's Labeling regulations for devices used for medical 
purposes, NHTSA would investigate the matter in consultation with FDA 
and would notify the manufacturer that the device may be removed from 
the list. The manufacturer would have 30 days from the date of 
notification to reply. Based on any data provided by the manufacturer 
and investigative findings, NHTSA would decide whether the device 
should remain on the list. If the device is removed from the list, the 
manufacturer would be permitted to resubmit a self-certification, 
certifying that the manufacturer complies with these FDA requirements 
when it believes the problems causing its non-compliance have been 
resolved. Upon resubmission, the manufacturer would be required to 
submit a statement describing what has been done to overcome the 
problems which led to non-compliance.

Comments

    Interested persons are invited to comment on this proposal. 
Comments are sought on the proposed conversion factors included in 
these proposed Model Specifications, particularly for saliva, and what 
may constitute acceptable criteria for bodily fluids other than saliva, 
blood and breath.
    Related issues regarding screeners that are of interest include the 
potential of interfering substances (i.e. nicotine and acetone) to 
affect results, and whether the Model Specifications should test for 
additional potentially interfering substances.
    NHTSA also requests comments, particularly from manufacturers or 
users (and potential users) of these devices, regarding problems that 
have occurred or could arise due to insufficient labeling or 
manufacturing practices. Commentors should identify issues they believe 
need to be addressed by NHTSA's notice regarding manufacturing 
practices and labeling requirements, and indicate whether they believe 
FDA regulations are most appropriate to address these issues. 
Alternatively, if commentors believe there is not a need to apply 
manufacturing practices and labeling requirements to alcohol screening 
devices when used for law enforcement and workplace testing purposes, 
they should submit comments to this effect and include the reasons for 
their belief.
    It is requested but not required that 10 copies be submitted. 
Comments must not exceed 15 pages in length (49 CFR 553.221). Necessary 
attachments may be appended to those submissions without regard to the 
15 page limit. This limitation is intended to encourage commentors to 
detail their primary arguments in a concise fashion.
    All comments received before the close of business on the comment 
closing date indicated above will be considered, and will be available 
for examination in the docket at the above address, both before and 
after that date. To the extent possible, comments filed after the 
closing date will also be considered. However, the Model Specifications 
may be published at any time after that date, and any comments received 
after the closing date and too late for consideration with regard to 
the action will be treated as suggestions for future revisions to the 
specifications. NHTSA will continue to file relevant material in the 
docket after the closing date as it becomes available. It is 
recommended that interested persons continue to examine the docket for 
new material.
    Those persons who desire to be notified upon receipt of their 
comments in the docket should enclose a self-addressed stamped postcard 
in the envelope with their comments. Upon receiving the comments, the 
docket supervisor will return the postcard by mail.
    This action has been analyzed in accordance with the principles and 
criteria contained in Executive Order 12612 and it has been determined 
that it has no federalism implication that warrants the preparation of 
a federalism assessment.
    In accordance with the foregoing, the proposed Model Specifications 
for performance testing of alcohol screening devices are set forth 
below.

    Authority: 23 U.S.C. 402; delegations of authority at 49 CFR 
1.50 and 501.
Michael B. Brownlee,
Associate Administrator for Traffic Safety Programs.

Model Specifications for Alcohol Screening Devices

1. Purpose and Scope

    These specifications establish performance criteria and methods for 
testing of alcohol screening devices. Alcohol screening devices use 
bodily fluids to detect the presence of 0.020 or more BAC with 
sufficient accuracy for screening purposes. These specifications are 
intended primarily for use in the conformance testing of alcohol 
screening devices.

2. Classification

2.1  Disposable Alcohol Screening Devices
    Alcohol screening devices designed for a single use.
2.2  Reusable Alcohol Screening Devices
    Alcohol screening devices designed to be reused.

3. Definitions.

3.1  Alcohol
    The intoxicating agent in beverage alcohol, ethyl alcohol or other 
low molecular weight alcohols including methyl or isopropyl alcohol.

3.2  Alcohol Screening Device
    A device that is used to detect the presence of 0.020 or more BAC. 
The device may measure any bodily fluid for this purpose, but shall 
provide output in BAC units. Test results may be indicated by numerical 
read-out or by other means, such as by the use of lights or color 
changes.

3.3  Blood alcohol concentration (BAC)
    Grams alcohol per 100 milliliters of blood or grams alcohol per 210 
liters of breath in accordance with the Uniform Vehicle Code, Section 
11-903(a)(5)2 (BrAC is often used to indicate that the measurement 
is a breath measurement); or grams alcohol per 100 milliliters of 
saliva.

    \2\Available from the National Committee on Traffic Laws and 
Ordinances, 405 Church Street, Evanston IL 60201.
---------------------------------------------------------------------------

3.4  Calibrating Unit
    A device that produces an alcohol-in-air test sample of known 
concentration that meets the NHTSA Model Specifications for Calibrating 
Units (49 FR 48865).

3.5  Breath Alcohol Sample Simulator (BASS)
    A device that provides an alcohol-in-air test sample with known and 
adjustable alcohol concentration profile, flow rate, and air 
composition at 34 deg. centigrade. (See NBS Special Publication 480-41, 
July 19813 for a description of a BASS unit suitable for use in 
the required testing.)

    \3\Available from Superintendent of Documents, U.S. Government 
Printing Office, Washington, D.C. 20402.
---------------------------------------------------------------------------

3.6  Bodily Fluid
    Any bodily fluid capable of being used to estimate alcohol 
concentration, provided the relationship between such bodily fluid and 
BAC has been established according to scientifically acceptable 
standards. Such fluids include but are not limited to blood, exhaled 
deep lung breath and saliva.

3.7  Scientifically Acceptable Substitutes
    Fluids that have been scientifically accepted as equivalent to 
bodily fluids for testing purposes, such as aqueous alcohol test 
solutions on a one-to-one basis for blood or saliva.

4. Test Methods and Requirements

    Testing will be performed according to the instructions which 
normally accompany the submitted device and under the conditions 
specified in the tests below.

4.1  Test 1. Precision and Accuracy.
    Perform 40 trials under normal laboratory conditions, including 20 
trials at 0.008 BAC and 20 trials at 0.032 BAC. Use the BASS device for 
breath devices and preparations of bodily fluids or scientifically 
acceptable substitutes for non-breath devices.
    For disposable alcohol screening devices that indicate the presence 
of alcohol in a manner that requires interpretation, combine Tests 1 
and 2, in accordance with 4.3 below.
    For alcohol screening devices that indicate the presence of alcohol 
in a manner that does not require interpretation, perform the test 
using a VNTSC investigator. To conform at 0.008 BAC, not more than one 
positive result. To conform at 0.032 BAC, not more than one non-
positive result.

4.2  Test 2. Blank Reading.
    Perform 20 trials under normal laboratory conditions at 0.000 BAC. 
Use non-alcoholic human breath for breath devices and preparations of 
non-alcoholic bodily fluids or scientifically acceptable substitutes 
for non-breath devices.
    For disposable alcohol screening devices that indicate the presence 
of alcohol in a manner that requires interpretation, combine Tests 1 
and 2, in accordance with 4.3 below.
    For alcohol screening devices that indicate the presence of alcohol 
in a manner that does not require interpretation, perform the test 
using a VNTSC investigator. To conform, no positive results. If the 
device is capable of providing a reading of greater than 0.000 BAC and 
less than 0.020 BAC, not more than one such result.

4.3  Methodology for Combining Tests 1 and 2 for Disposable 
Interpretive Devices.
    Perform the test using ten individuals who qualify as test 
interpreters (according to the manufacturer's restrictions, if any) and 
who have no knowledge of test BACs. Ask each individual to read the 
manufacturer's instructions for interpretation of the device's read-
out.
    Label sixty devices from 1 to 60 and randomly separate them into 
three groups of twenty. Record the numbers in each group. Use two of 
the groups of devices for Test 1 and the remaining group for Test 2. 
Dose each group at the BAC levels specified in Tests 1 and 2. Order the 
sixty devices into a single set from 1 to 60 and ask each individual to 
independently interpret the results of these trials.
    Ask each individual to record each result as being one of the 
following: ``at .00 BAC''; ``above .00 and below .02 BAC''; ``at or 
above .02 BAC''; or ``can't tell''. Dosing of devices and 
interpretation of results will be accomplished within a two hour 
period.
    To conform, with each interpreter, no positive results at .000 BAC, 
not more than one positive result at .008 BAC and not more than one 
non-positive result at .032 BAC. If the device is capable of providing 
a reading of greater than 0.000 BAC and less than 0.020 BAC, with each 
interpreter, not more than one such result at .000 BAC.

4.4  Interference
    Test for the effect of acetone and, in the case of breath or saliva 
devices, cigarette smoke.

4.4.1  Test 3.1. Acetone.
    Perform 40 trials, including 20 trials at 0.008 BAC and 20 trials 
at 0.032 BAC. Use a calibrating unit for this test for breath devices 
and preparations of bodily fluids or scientifically acceptable 
substitutes for non-breath devices.
    Prepare test BACs to include an acetone concentration equivalent to 
a BAC of 0.010 grams per 100 milliliters blood. For breath screening 
devices, add 115 microliters of acetone per 500 milliliters of solution 
for use in the calibrating unit.\4\
---------------------------------------------------------------------------

    \4\Based on an experimentally determined water to air partition 
factor 365 to 1 at 34 deg. to yield acetone-in-air concentrations of 
0.5 milligrams per liter.
---------------------------------------------------------------------------

    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.

4.4.2  Test 3.2. Cigarette smoke (breath and saliva test devices only).
    Perform five trials at 0.000 BAC. Use non-alcoholic human breath 
for breath devices and preparations of non-alcoholic bodily fluids or 
scientifically acceptable substitutes for non-breath devices.
    Select a person who smokes cigarettes for this test. Ask the person 
selected to smoke approximately one half of a cigarette. Within one 
minute after smoking, or after a waiting period specified in the 
manufacturer's instructions, ask him or her to blow into the screening 
device according to manufacturer's instructions. Then ask the person to 
smoke another inhalation and repeat the test to produce a total of five 
trials.
    To conform, no positive results.

4.5  Temperature.
    Test at low and high ambient temperature.
4.5.1  Test 4.1 Low Ambient Temperature.
    Perform 40 trials at 10 deg.C, including 20 trials at 0.008 BAC and 
20 trials at 0.032 BAC. Use a calibrating unit for this test for breath 
devices and preparations of bodily fluids or scientifically acceptable 
substitutes for non-breath devices.
    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.

4.5.2  Test 4.2 High Ambient Temperature.
    Perform trials of 40 devices at 40 deg.C, including 20 trials at 
0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for this 
test for breath devices and preparations of bodily fluids or 
scientifically acceptable substitutes for non-breath devices.
    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.

4.6  Test 5.0. Vibration.
    Perform 40 trials, including 20 trials at 0.008 BAC and 20 trials 
at 0.032 BAC. Use a calibrating unit for this test for breath devices 
and preparations of bodily fluids or scientifically acceptable 
substitutes for non-breath devices.
    Mount the screening device on a shake table and vibrate the table 
in simple harmonic motion through each of its three major axes, as 
specified below. Sweep through each frequency range in 2.5 minutes, 
then reverse the sweep to the starting frequency in 2.5 minutes. The 40 
disposable testers may be placed in a suitable box mounted on the shake 
table. Test after vibration. 

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

    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.

Appendix--Labeling Instructions for Alcohol Screening Devices

Intended Use

    Provide the intended use including the specimen matrix (e.g. 
saliva, breath), the assay type (quantitative, semi-quantitative) the 
purpose of performing the assay and the individual designated to 
perform the assay.

e.g. This product is intended for the (quantitative, 
semiquantitative) determination of alcohol in----define matrix (for 
e.g., saliva, breath, sweat) to perform screening alcohol assays.
This product is recommended for use by individuals who have been 
trained in the administration of screening devices.

Description of Testing System

    Provide the principles of the procedure for performing the alcohol 
screening assay.

e.g. This product uses alcohol dehydrogenase, infrared technology, 
etc. to perform the test.

Chemical Reaction Sequence

    Describe the chemical reaction sequence, if applicable.

Reagents

    List the concentration, strength, composition of the reactive 
ingredients.
    List the non-reactive ingredients.

Reagent Preparation and Storage

    Provide instructions for preparing the reagents, if applicable.
    Provide the instructions for storing the reagents, if applicable.
    Provide any signs of deterioration of the reagents, if applicable.
    Provide the reagent's shelf life and opened expiration dating, if 
applicable.

e.g. Unopened tests are stable until the date printed on the product 
container when stored at 22-28 deg.C. Opened test must be used at 
once.

    Provide a caution not to use the reagents beyond the expiration 
dating.

Precautions

    1. List any reagents that may be hazardous such as caustic 
compounds, sodium azide or other hazardous reagents and instructions 
for disposal, if applicable.
    2. If visually read, warn the user the result should not be 
interpreted by readers who are color-blind or visually impaired.
    3. Provide warning to user to treat all samples as potentially 
infective. Include instructions for handling and disposal of the 
sample.

Specimen Collection

    Provide instructions for collecting and handling the sample.
    Provide criteria for specimen rejection, if applicable.

Calibration

    Disposable tests are pre-calibrated. No additional calibration is 
required.
    Reusable (Instrumented) tests require calibration.
    Provide information regarding how calibrations are to be conducted, 
if applicable, including the number and concentration of calibrators, 
and the frequency of calibration.
    Provide instructions for calibration and recalibration.
    Provide the criteria for acceptability of calibration.

Test Procedure (Disposable)

    Provide adequate step-by-step instructions for performing the test.
    If the test is disposable (non-instrumented) and involves a color 
reaction, include the time frame for which the test must be read and 
recorded.

e.g. Read within 15 minutes.

Test Procedure (Reusable/Instrumented)

    Provide adequate step-by-step instruction for performing the test.
    Provide the installation procedures and, if applicable, any special 
requirements.
    Provide the space and ventilation requirements.
    Provide the description of the required frequency of equipment 
maintenance and function checks.
    Provide the instructions for any remedial action to be taken when 
the equipment performs outside of operating range.
    Provide any operational precautions and limitations.
    Provide the instructions for the protection of equipment and 
instrumentation from fluctuations or interruptions in electrical 
current that could adversely affect test results and reports, if 
applicable.

Quality Control (QC)

Disposable Tests

    If applicable, the function and stability of the test can be 
determined by examination of the procedural ``built in'' controls 
contained in the product. If these controls are not working, the test 
is invalid and must be repeated.

Disposable/Instrumented Devices

    If external quality control materials are used, provide number, 
type, matrix and concentration of the QC materials.
    Provide directions for performing quality control procedures. 
Provide an adequate description of the remedial action to be taken when 
the QC results fail to meet the criteria for acceptability.
    Provide directions for interpretation of the results of quality 
control samples.

Results

    Describe how the user obtains the test results, from a colored bar, 
instrument read-out, printout, etc.
    Describe the results in terms of blood alcohol concentration.
    Describe what concentration indicates a positive result and what 
concentration indicates a negative result.

Limitations

    List the substances or factors that may interfere with the test and 
cause false results including technical or procedural errors.

Dynamic Range

    Provide the operating range of the product.

Precision and Accuracy

    Precision and Accuracy specifications are included in the National 
Highway Traffic Safety Administration's (NHTSA's) Model Specifications 
for Alcohol Screening Devices. Only devices that meet these model 
specifications will be included on NHTSA's Conforming Products List for 
alcohol screening devices.

Specificity

    List the substances that have been evaluated with your product that 
do or do not interfere at the concentration indicated.

References

    Provide pertinent bibliography

Technical Assistance

    List an 800 number the user may contact for further information or 
technical assistance.

[FR Doc. 94-1858 Filed 2-3-94; 1:00 pm]
BILLING CODE 4910-59-P

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