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

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.

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In addition, these Model Specifications identify the proposed

conversion factors for devices that use these bodily fluids. The

conversion factors between blood and breath are commonly accepted.

Based on the available literature, NHTSA believes it is appropriate to

use a one-to-one conversion factor between blood and saliva, and has

included this factor in these proposed Model Specifications. We request

comments on the proposed use of this conversion factor.

NHTSA proposes that if a manufacturer intends to use any bodily

fluid other than blood, breath, or saliva to determine the presence of

alcohol, the relationship between that fluid's alcohol concentration

and blood alcohol concentration must be established according to

scientifically acceptable standards.

Under these proposed Model Specifications, alcohol screening

devices would be tested at 0.008 and 0.032 BAC under normal laboratory

conditions to determine their precision and accuracy at detecting the

presence of 0.020 or more BAC (Test 1), and at 0.000 BAC to determine

the performance of these devices when providing blank readings (Test

2). The .008 and .032 BAC levels were selected based on criteria for

precision and accuracy that are equivalent to those used for EBTs. They

require that devices perform at a level of accuracy within

0.005 of 0.020 BAC (thereby establishing target values

within 0.015 and 0.025 BAC), and a level of precision which yields a

standard deviation not greater than 0.0042. To achieve a confidence

rate of 95% in the results of these 20 tests, we propose to establish

measurement points at 1.73 standard deviations (or 0.007 BAC) below and

above the lower and upper values, respectively (i.e., 0.015 - 0.007 =

0.008 BAC and 0.025 + 0.007 = 0.032 BAC).

NHTSA proposes to use a Breath Alcohol Sample Simulator (BASS),

non-alcoholic human breath, and a calibrating unit to test breath

devices. The agency proposes to use preparations of bodily fluids or

scientifically acceptable substitutes for non-breath devices. For

example, the agency proposes to use aqueous alcohol test solutions

equivalent to blood or saliva on a one-to-one basis to test saliva

devices.

The agency proposes to conduct 40 trials under Test 1 (20 at .008

BAC and 20 at .032 BAC) and 20 trials under Test 2 (at .000 BAC). For

reusable devices, these 60 trials would be conducted using a single

unit. For disposable devices, these 60 trials would be conducted using

60 separate units.

Some alcohol screening devices indicate the presence of alcohol in

a manner that is unambiguous and requires no interpretation, such as by

the use of a light or numerical reading. For these devices, NHTSA

proposes that Tests 1 and 2 (at .008, .032 and .000 BAC) would be

performed by an investigator at the DOT Volpe National Transportation

Systems Center (VNTSC). To conform with the Model Specifications, the

device must perform with no positive results at .000 BAC, not more than

one positive result at .008 BAC and not more than one non-positive

result at .032 BAC. If the device is capable of providing a reading of

greater than 0.000 BAC and less than 0.020 BAC, the device must perform

with not more than one such result at .000 BAC.

Other devices indicate the presence of alcohol in a manner that

requires interpretation and may involve some ambiguity, such as by the

use of color changes. For these devices, NHTSA proposes that Tests 1

and 2 (at .008, .032 and .000 BAC) would be performed by ten

individuals who have no knowledge of test BACs and qualify as test

interpreters. VNTSC would select these individuals using manufacturer's

restrictions, if any. These individuals would be asked to read the

manufacturer's instructions for the interpretation of the device's

read-out, and interpret the test results independently. To conform with

the Model Specifications, the device must perform, with each

interpreter, with no positive results at .000 BAC, not more than one

positive result at .008 BAC and not more than one non-positive result

at .032 BAC. If the device is capable of providing a reading of greater

than 0.000 BAC and less than 0.020 BAC, the device must perform, with

each interpreter, with not more than one such result at .000 BAC.

Through the independent interpretation of ten individuals, NHTSA

believes the Model Specifications would ensure that the results of

tested devices are visible and will remain so for a reasonable period

of time (the tests require approximately two hours to run), and are

likely to be interpreted in a consistent manner. NHTSA requests

comments on this aspect of the proposed Model Specifications.

To NHTSA's knowledge, no reusable devices use interpretive

readings. Typically, these readings are produced using a chemical

reaction, which results in a color change, a method which lends itself

more readily to a single use device. For this reason, the agency

believes it is unlikely that manufacturers would begin to use such

interpretive readings in reusable devices. Accordingly, NHTSA has not

proposed a methodology for testing reusable interpretive devices. We

request comments on this aspect of the agency's proposal.

For disposable devices that use interpretive readings, the Model

Specifications propose to combine Tests 1 and 2, and number the units

and expose them to the three BAC levels using a methodology that would

not reveal to the person interpreting the test the dosage received by

any particular unit. NHTSA requests comments on this proposed

methodology.

Devices would also be tested to determine whether acetone or, in

the case of breath or saliva devices, cigarette smoke affects the

functioning of the instruments. NHTSA requests comments on whether

devices should be tested for interference from other substances. In

addition, high (40 deg.C) and low (10 deg.C) ambient temperature and

vibration tests would be conducted for these devices to determine their

ability to function under a range of environmental conditions. NHTSA

proposes that these tests (3.1, 3.2, 4.1, 4.2 and 5) would be performed

by an investigator at VNTSC. Five trials would be conducted at .000 BAC

under Test 3.2. Forty trials (including 20 at .008 and 20 and .032 BAC)

would be conducted under each of these other tests.

To conform with the Model Specifications, the device must perform

with no positive results at each test performed at .000 BAC, not more

than one positive result at each test performed at .008 BAC and not

more than one non-positive result at each test performed at .032 BAC.

If the device is capable of providing a reading of greater than 0.000

BAC and less than 0.020 BAC, the device must perform with not more than

one such result at .000 BAC.

When devices such as these are used for medical purposes, the

manufacturers of the devices are required to obtain marketing clearance

from the Food and Drug Administration (FDA), in accordance with FDA

regulations that address issues such as quality assurance in

manufacturing, shelf-life and labeling. Currently, FDA does not assert

jurisdiction (provide marketing clearance) for alcohol screening

devices used for law enforcement purposes and workplace testing.

However, because of the nature of alcohol screening devices and the

conditions under which they are to be used, NHTSA believes it is

important for manufacturers of these devices to conform with certain

requirements, imposed by FDA on devices used for medical purposes,

prior to the inclusion of the devices on NHTSA's CPL.

Accordingly, NHTSA proposes to require that each device submitted

for testing under the Model Specifications must be accompanied by a

self-certification from the manufacturer, certifying that it meets the

requirements contained in FDA's Good Manufacturing Practices

regulations for devices used for medical purposes (21 CFR Part 820),

and that the device's label meets the requirements contained in FDA's

Labeling regulations for devices used for medical purposes (21 CFR Part

809.10), even if the devices are not to be used for medical purposes.

By requiring a self-certification, NHTSA is not requiring that

manufacturers obtain FDA marketing clearance, but simply that they

self-certify that they believe that they have met the above-referenced

requirements. (For technical assistance or a copy of the Device Good

Manufacturing Practices Manual for Medical Devices, manufacturers

should contact FDA's Division of Small Manufacturers by calling toll

free at 1-800-638-2041.)

This notice includes, as an Appendix, a proposed set of Labeling

Instructions for Alcohol Screening Devices that has been prepared in

consultation with FDA to assist manufacturers of alcohol screening

devices in developing a label that conforms to 21 CFR Part 809.10. The

template addresses issues such as restrictions that may apply to

operators of the device and conditions under which the device should or

should not be operated.

These Model Specifications are not regulations. Organizations and

agencies may adopt these Model Specifications and rely on NHTSA's test

results or may conduct their own tests according to their own

procedures and specifications. It should be noted, however, that

transportation employers covered by 49 CFR Part 40, Procedures for

Transportation Workplace Drug and Alcohol Testing Programs, are

required to use only alcohol testing devices that meet the criteria

established by that regulation. See DOT's final rule published

elsewhere in today's Federal Register.

Once the Model Specifications for Alcohol Screening Devices are

finalized and a CPL of conforming devices is published, DOT will issue

procedural rules for using approved alcohol screening devices in

transportation workplaces, including provisions for how and where such

devices could be used and the steps that must be taken to collect

bodily fluids.

Procedures

NHTSA proposes that testing of products submitted by manufacturers

to these Model Specifications would be conducted by the DOT Volpe

National Transportation Systems Center (VNTSC), DTS 75, Kendall Square,

Cambridge, MA 02142. Tests would be conducted semiannually, or as

necessary. Manufacturers would be required to apply to NHTSA for a test

date by writing to the Office of Alcohol and State Programs (OASP),

NTS-21, NHTSA, 400 Seventh Street, SW., Washington, DC 20590. Normally,

at least 30 days would be required from the date of notification until

the test could be scheduled.

One week prior to the scheduled initiation of the test program, a

manufacturer would be required to deliver its devices to VNTSC. If the

devices are disposable, the manufacturer would be required to deliver

300 such devices; if the devices are reusable, the manufacturer would

be required to submit only a single device. If a manufacturer wishes to

submit a duplicate, backup instrument, however, it may do so. The

manufacturer would be responsible for ensuring that the devices operate

properly and are packaged correctly. The manufacturer would also be

required to deliver the operator's manual (or instructions) and the

maintenance manual (if any) supplied with the purchase of the device,

as well as specifications and drawings which fully describe these

devices. Proprietary information would be respected. (See 49 CFR Part

512, regarding the procedure by which NHTSA will consider claims of

confidentiality.)

In addition, the manufacturer would be required to submit a self-

certification, certifying that the manufacturer meets the requirements

in FDA's Good Manufacturing Practices regulations for devices used for

medical purposes (21 CFR Part 820), and that the device's label meets

the requirements in FDA's Labeling regulations for devices used for

medical purposes (21 CFR 809.10) even if the devices are not to be used

for medical purposes. See Appendix to this notice.

NHTSA proposes that the manufacturer would have the right to check

its devices between the time of their arrival at VNTSC and the start of

the tests, but would have no access to the devices during the tests.

Any malfunction of a device which results in failure to complete any of

the tests satisfactorily would result in a determination that the

device does not conform to the Model Specifications. If a device is

found not to conform, it may be resubmitted for the next testing series

after appropriate corrections have been made.

Following publication of this notice and the public comment period,

NHTSA plans to publish a second notice in the Federal Register

containing the final Model Specifications. After the second notice is

published, NHTSA plans to begin testing of alcohol screening devices to

determine whether they comply with the performance criteria included in

the Model Specifications.

A Conforming Products List (CPL) will be published and updated

periodically. It will include a list of alcohol screening devices that

were submitted with the proper certifications and found to meet or

exceed the proposed Model Specifications.

NHTSA proposes to modify and improve these Model Specifications as

new data and test procedures become available and to alter the test

procedures, if necessary, to meet unique design features of a specific

device. For each such modification, NHTSA would provide notification in

the Federal Register and would retest devices when necessary.

OASP would be the point of contact for information about acceptance

testing and field performance of devices. NHTSA requests that users of

these devices provide both acceptance and field performance data to

OASP when such data are available. Information from users would help

NHTSA monitor whether alcohol screening devices are performing

according to the NHTSA Model Specifications.

If information gathered indicates that a device on the CPL is not

performing in accordance with the Model Specifications, NHTSA would

direct VNTSC to conduct a special investigation. An investigation may

include visits to users and additional tests of the device obtained

from the open market. If the investigation indicates that the devices

actually sold on the market are not meeting the Model Specifications,

the manufacturer would be notified that the device may be removed from

the list. In this event, the manufacturer would have 30 days from the

date of notification to reply. Based on the VNTSC investigation and any

data provided by the manufacturer, NHTSA would decide whether the

device should remain on the list. If the device is removed from the

list, the manufacturer would be permitted to resubmit an improved

device to VNTSC for testing when it believes the problems causing its

failure have been resolved. Upon resubmission, the manufacturer would

be required to submit a statement describing what has been done to

overcome the problems which led to failure of the device.

If information gathered indicates that the manufacturer of a device

on the CPL does not comply with the requirements in FDA's Good

Manufacturing Practices regulations for devices used for medical

purposes or that the device's label does not comply with the

requirements in FDA's Labeling regulations for devices used for medical

purposes, NHTSA would investigate the matter in consultation with FDA

and would notify the manufacturer that the device may be removed from

the list. The manufacturer would have 30 days from the date of

notification to reply. Based on any data provided by the manufacturer

and investigative findings, NHTSA would decide whether the device

should remain on the list. If the device is removed from the list, the

manufacturer would be permitted to resubmit a self-certification,

certifying that the manufacturer complies with these FDA requirements

when it believes the problems causing its non-compliance have been

resolved. Upon resubmission, the manufacturer would be required to

submit a statement describing what has been done to overcome the

problems which led to non-compliance.

Comments

Interested persons are invited to comment on this proposal.

Comments are sought on the proposed conversion factors included in

these proposed Model Specifications, particularly for saliva, and what

may constitute acceptable criteria for bodily fluids other than saliva,

blood and breath.

Related issues regarding screeners that are of interest include the

potential of interfering substances (i.e. nicotine and acetone) to

affect results, and whether the Model Specifications should test for

additional potentially interfering substances.

NHTSA also requests comments, particularly from manufacturers or

users (and potential users) of these devices, regarding problems that

have occurred or could arise due to insufficient labeling or

manufacturing practices. Commentors should identify issues they believe

need to be addressed by NHTSA's notice regarding manufacturing

practices and labeling requirements, and indicate whether they believe

FDA regulations are most appropriate to address these issues.

Alternatively, if commentors believe there is not a need to apply

manufacturing practices and labeling requirements to alcohol screening

devices when used for law enforcement and workplace testing purposes,

they should submit comments to this effect and include the reasons for

their belief.

It is requested but not required that 10 copies be submitted.

Comments must not exceed 15 pages in length (49 CFR 553.221). Necessary

attachments may be appended to those submissions without regard to the

15 page limit. This limitation is intended to encourage commentors to

detail their primary arguments in a concise fashion.

All comments received before the close of business on the comment

closing date indicated above will be considered, and will be available

for examination in the docket at the above address, both before and

after that date. To the extent possible, comments filed after the

closing date will also be considered. However, the Model Specifications

may be published at any time after that date, and any comments received

after the closing date and too late for consideration with regard to

the action will be treated as suggestions for future revisions to the

specifications. NHTSA will continue to file relevant material in the

docket after the closing date as it becomes available. It is

recommended that interested persons continue to examine the docket for

new material.

Those persons who desire to be notified upon receipt of their

comments in the docket should enclose a self-addressed stamped postcard

in the envelope with their comments. Upon receiving the comments, the

docket supervisor will return the postcard by mail.

This action has been analyzed in accordance with the principles and

criteria contained in Executive Order 12612 and it has been determined

that it has no federalism implication that warrants the preparation of

a federalism assessment.

In accordance with the foregoing, the proposed Model Specifications

for performance testing of alcohol screening devices are set forth

below.

Authority: 23 U.S.C. 402; delegations of authority at 49 CFR

1.50 and 501.

Michael B. Brownlee,

Associate Administrator for Traffic Safety Programs.

Model Specifications for Alcohol Screening Devices

1. Purpose and Scope

These specifications establish performance criteria and methods for

testing of alcohol screening devices. Alcohol screening devices use

bodily fluids to detect the presence of 0.020 or more BAC with

sufficient accuracy for screening purposes. These specifications are

intended primarily for use in the conformance testing of alcohol

screening devices.

2. Classification

2.1 Disposable Alcohol Screening Devices

Alcohol screening devices designed for a single use.

2.2 Reusable Alcohol Screening Devices

Alcohol screening devices designed to be reused.

3. Definitions.

3.1 Alcohol

The intoxicating agent in beverage alcohol, ethyl alcohol or other

low molecular weight alcohols including methyl or isopropyl alcohol.

3.2 Alcohol Screening Device

A device that is used to detect the presence of 0.020 or more BAC.

The device may measure any bodily fluid for this purpose, but shall

provide output in BAC units. Test results may be indicated by numerical

read-out or by other means, such as by the use of lights or color

changes.

3.3 Blood alcohol concentration (BAC)

Grams alcohol per 100 milliliters of blood or grams alcohol per 210

liters of breath in accordance with the Uniform Vehicle Code, Section

11-903(a)(5)2 (BrAC is often used to indicate that the measurement

is a breath measurement); or grams alcohol per 100 milliliters of

saliva.

\2\Available from the National Committee on Traffic Laws and

Ordinances, 405 Church Street, Evanston IL 60201.

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3.4 Calibrating Unit

A device that produces an alcohol-in-air test sample of known

concentration that meets the NHTSA Model Specifications for Calibrating

Units (49 FR 48865).

3.5 Breath Alcohol Sample Simulator (BASS)

A device that provides an alcohol-in-air test sample with known and

adjustable alcohol concentration profile, flow rate, and air

composition at 34 deg. centigrade. (See NBS Special Publication 480-41,

July 19813 for a description of a BASS unit suitable for use in

the required testing.)

\3\Available from Superintendent of Documents, U.S. Government

Printing Office, Washington, D.C. 20402.

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3.6 Bodily Fluid

Any bodily fluid capable of being used to estimate alcohol

concentration, provided the relationship between such bodily fluid and

BAC has been established according to scientifically acceptable

standards. Such fluids include but are not limited to blood, exhaled

deep lung breath and saliva.

3.7 Scientifically Acceptable Substitutes

Fluids that have been scientifically accepted as equivalent to

bodily fluids for testing purposes, such as aqueous alcohol test

solutions on a one-to-one basis for blood or saliva.

4. Test Methods and Requirements

Testing will be performed according to the instructions which

normally accompany the submitted device and under the conditions

specified in the tests below.

4.1 Test 1. Precision and Accuracy.

Perform 40 trials under normal laboratory conditions, including 20

trials at 0.008 BAC and 20 trials at 0.032 BAC. Use the BASS device for

breath devices and preparations of bodily fluids or scientifically

acceptable substitutes for non-breath devices.

For disposable alcohol screening devices that indicate the presence

of alcohol in a manner that requires interpretation, combine Tests 1

and 2, in accordance with 4.3 below.

For alcohol screening devices that indicate the presence of alcohol

in a manner that does not require interpretation, perform the test

using a VNTSC investigator. To conform at 0.008 BAC, not more than one

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

positive result.

4.2 Test 2. Blank Reading.

Perform 20 trials under normal laboratory conditions at 0.000 BAC.

Use non-alcoholic human breath for breath devices and preparations of

non-alcoholic bodily fluids or scientifically acceptable substitutes

for non-breath devices.

For disposable alcohol screening devices that indicate the presence

of alcohol in a manner that requires interpretation, combine Tests 1

and 2, in accordance with 4.3 below.

For alcohol screening devices that indicate the presence of alcohol

in a manner that does not require interpretation, perform the test

using a VNTSC investigator. To conform, no positive results. If the

device is capable of providing a reading of greater than 0.000 BAC and

less than 0.020 BAC, not more than one such result.

4.3 Methodology for Combining Tests 1 and 2 for Disposable

Interpretive Devices.

Perform the test using ten individuals who qualify as test

interpreters (according to the manufacturer's restrictions, if any) and

who have no knowledge of test BACs. Ask each individual to read the

manufacturer's instructions for interpretation of the device's read-

out.

Label sixty devices from 1 to 60 and randomly separate them into

three groups of twenty. Record the numbers in each group. Use two of

the groups of devices for Test 1 and the remaining group for Test 2.

Dose each group at the BAC levels specified in Tests 1 and 2. Order the

sixty devices into a single set from 1 to 60 and ask each individual to

independently interpret the results of these trials.

Ask each individual to record each result as being one of the

following: ``at .00 BAC''; ``above .00 and below .02 BAC''; ``at or

above .02 BAC''; or ``can't tell''. Dosing of devices and

interpretation of results will be accomplished within a two hour

period.

To conform, with each interpreter, no positive results at .000 BAC,

not more than one positive result at .008 BAC and not more than one

non-positive result at .032 BAC. If the device is capable of providing

a reading of greater than 0.000 BAC and less than 0.020 BAC, with each

interpreter, not more than one such result at .000 BAC.

4.4 Interference

Test for the effect of acetone and, in the case of breath or saliva

devices, cigarette smoke.

4.4.1 Test 3.1. Acetone.

Perform 40 trials, including 20 trials at 0.008 BAC and 20 trials

at 0.032 BAC. Use a calibrating unit for this test for breath devices

and preparations of bodily fluids or scientifically acceptable

substitutes for non-breath devices.

Prepare test BACs to include an acetone concentration equivalent to

a BAC of 0.010 grams per 100 milliliters blood. For breath screening

devices, add 115 microliters of acetone per 500 milliliters of solution

for use in the calibrating unit.\4\

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\4\Based on an experimentally determined water to air partition

factor 365 to 1 at 34 deg. to yield acetone-in-air concentrations of

0.5 milligrams per liter.

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

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

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