Federal Register / Vol. 60, No. 76 / Thursday, April 20, 1995 / Rules and Regulations 19675

the procurement of the printing of

Standard Form 149, U.S. Government

National Credit Card.

3. Section 101–26.408–4(c) is

redesignated § 101–26.503 and revised

to read as follows:

§ 101–26.503 Multiple award schedule

purchases made by GSA supply

distribution facilities.

GSA supply distribution facilities are

responsible for quickly and

economically providing customers with

frequently needed common-use items.

Stocking a variety of commercial, highdemand items purchased from FSS

multiple award schedules is an

important way in which GSA supply

distribution facilities meet this

responsibility.

4. The heading for Subpart 101–26.4

is revised and the text is removed and

reserved to read as follows:

Subpart 101–26.4—Federal Supply

Schedules—[Reserved]

5. Section 101–26.507 is revised to

read as follows:

§ 101–26.507 Security equipment.

Federal agencies and other activities

authorized to purchase security

equipment through GSA sources shall

do so in accordance with the provisions

of this § 101–26.507. Under section 201

of the Federal Property and

Administrative Services Act of 1949 (40

U.S.C. 481), the Administrator of GSA

has determined that fixed-price

contractors and lower tier

subcontractors who are required to

protect and maintain custody of security

classified records and information may

purchase security equipment from GSA

sources. Delivery orders for security

equipment submitted by such

contractors and lower tier

subcontractors shall contain a statement

that the security equipment is needed

for housing Government security

classified information and that the

purchase of such equipment is required

to comply with the security provision of

a Government contract. In the event of

any inconsistency between the terms

and conditions of the delivery order and

those of the Federal Supply Schedule

contract, the latter shall govern. Security

equipment shall be used as prescribed

by the cognizant security office.

6. Section 101–26.507–3 is revised to

read as follows:

§ 101–26.507–3 Purchase of security

equipment from Federal Supply Schedules.

To ensure that a readily available

source exists to meet the unforeseen

demands for security equipment,

Federal Supply Schedule contracts have

been established to satisfy requirements

that are not appropriate for consolidated

procurement and do not exceed the

maximum order limitations.

Dated: March 17, 1995.

Julia M. Stasch,

Acting Administrator of General Services.

[FR Doc. 95–9744 Filed 4–19–95; 8:45 am]

BILLING CODE 6820–24–M

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket 50018]

RIN 2105–AC20

Procedures for Transportation

Workplace Drug and Alcohol Testing

Programs; Procedures for NonEvidential Alcohol Screening Devices

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule; request for

comments.

SUMMARY: When the Department of

Transportation published its final

alcohol testing rules in February 1994,

it said that if non-evidential screening

devices were approved, the devices

could be used for screening tests in

DOT-mandated alcohol testing

programs. Several such devices have

now been determined by the National

Highway Traffic Safety Administration

to be capable of detecting the presence

of alcohol at the 0.02 or greater level of

alcohol concentration. This rule

establishes procedures for the use of

these devices.

DATES: This rule is effective May 22,

1995. Comments on amendments to

§§ 40.59(c), 40.63(d)(1), and 40.63(e)(2)

should be received by June 5, 1995.

Late-filed comments will be considered

to the extent practicable.

FOR FURTHER INFORMATION CONTACT:

Albert Alvarez, Director, Department of

Transportation, Office of Drug

Enforcement and Program Compliance,

400 7th Street SW., Washington, DC

20590, Room 9404A, 202–366–3784; or

Robert C. Ashby, Deputy Assistant

General Counsel for Regulation and

Enforcement, 400 7th Street SW., Room

10424, Washington, DC 20590; 202–

366–9306.

SUPPLEMENTARY INFORMATION:

Background

When the Department published its

final alcohol testing rules on February

15, 1994 (59 FR 7302 et seq.), the

Department established breath testing,

using evidential breath testing devices

(EBTs), as the method to be used.

However, in response to comments

requesting additional flexibility in

testing methods, the Department said

that—

NHTSA [the National Highway Traffic

Safety Administration] will develop model

specifications (using precision and accuracy

criteria), evaluate additional screening

devices against them, and periodically

publish a conforming products list of those

additional screening devices (not exclusively

breath testing devices) that meet the model

specifications. * * * Please note that the

Department will also have to undertake

separate rulemaking proceedings to establish

procedures for the use of any devices after

they are approved. (Id. at 7316.)

NHTSA published model

specifications, tested several screening

devices and, on December 2, 1994,

published a conforming products list

(CPL) including four non-evidential

breath testing devices and one saliva

testing device. As noted in the February

15 common preamble cited above,

before these devices can be used in DOT

alcohol testing programs, this

procedural rule has to be issued. When

this rule becomes effective, employers

may begin using the approved nonevidential screening devices. We emphasize that these devices may

be used only for alcohol screening tests.

Confirmation tests must be performed

on EBTs. To the greatest extent feasible,

we have drafted these procedures to

incorporate the same basic requirements

as the existing alcohol testing

procedures. This makes the procedures

simple and achieves the flexibility that

is the goal of using non-evidential

devices.

Comments and Responses

As of the close of the comment

period, the Department received 23

comments on the January 17, 1995,

notice of proposed rulemaking (NPRM)

for this rule (60 FR 3371). Ten of these

comments were from employers or

employer associations, another 10 were

from manufacturers or distributors of

breath testing equipment, and three

were from other testing industry

participants. The comments focused on

several issues.

Interval Between Screening and

Confirmation Tests

In the NPRM leading to the February

15, 1994, final rule on alcohol testing

procedures (57 FR 59416; December 15,

1992), the Department proposed a 15-

minute waiting period before the

confirmation test. The purpose of this

waiting period was to ensure that

residual mouth alcohol did not

artificially raise the confirmation test

result. The Department had considered,
19676 Federal Register / Vol. 60, No. 76 / Thursday, April 20, 1995 / Rules and Regulations

and asked for comment on, the idea of

requiring such a waiting period before

all screening tests, but we decided

against proposing such a requirement

because it would waste employers’ and

employees’ time in the great majority of

screening tests that we expect to be

negative. Because the Department

believed, and notable forensic experts in

the alcohol testing field agreed, that the

confirmation test should follow the

screening test as immediately as

possible, the Department proposed a

maximum of 20 minutes (i.e., no more

than 5 minutes beyond the 15-minute

waiting period) between the two tests.

The NPRM said that—

The purpose of establishing a maximum

limit for the waiting period is to prevent the

manipulation of confirmation results by

affording time for the metabolism of alcohol

so that results will be lower than first

recorded on the initial test. Should there be

greater flexibility in the timing of

confirmation tests? (Id.)

In the final rule (59 FR 7351; February

15, 1994), the Department retained the

15–20-minute interval between the

screening and confirmation tests. The

preamble discussion of this issue was as

follows:

There were 29 comments concerning the

waiting period before the confirmation test,

fifteen of which supported the 15-minute

minimum time proposed in the NPRM. Four

comments wanted a shorter interval (e.g., two

or five minutes) and four supported a longer

interval (e.g., 20 or 30 minutes). Two

comments opposed any requirement

concerning an interval. Six comments either

wanted no maximum waiting time or

preferred to rely on the employer’s or EBT

manufacturer’s discretion.

The waiting period is important. It is

intended to give the employee the

opportunity to ensure that any residual

mouth alcohol does not influence the result

of the confirmation test. According to the

Department’s information, fifteen minutes is

the minimum period after which one can be

confident that any residual mouth alcohol

has disappeared. A shorter interval is not

feasible for this reason. At the same time,

waiting a long period between tests can be

costly in terms of lost employee time and

could influence the outcome of the

confirmation test. In order to guard against

lengthy delays in the performance of

confirmation tests, which can allow alcohol

concentration levels to fall, the final rule

retains the 20-minute maximum. It should be

pointed out that failing to observe the

minimum 15-minute period is a ‘‘fatal flaw’’

(see § 40.79(a)), automatically invalidating a

test. This is because the Department believes

it is important to prevent artificially high

readings due to mouth alcohol residue.

However, taking longer than 20 minutes

between tests is not a ‘‘fatal flaw.’’ The

Department is aware that circumstances may

sometimes result in stretching the time

between tests for a few additional minutes.

(Id.)

In establishing the 15–20-minute

interval, then, the Department

considered and decided the issue based

on a specific request for and review of

comments.

In the NPRM leading to this final rule,

the Department again addressed this

issue.

Confirmation tests must be performed on

EBTs, within 20 minutes of the screening

test, as provided in existing 49 CFR 40.65(b).

The Department is aware that increasing this

interval for situations in which nonevidential devices are used could provide

additional flexibility to employers, by

increasing the distance that a non-evidential

screening test could be conducted away from

a confirmation EBT. However, as noted in the

preamble to the February 15, 1994, final Part

40 rule, conducting the confirmation test

within a brief time from the screening test is

important to prevent metabolization of

alcohol over time from negating what would

otherwise be ‘‘positive’’ test results. This is

no less true in a case where the screening test

is conducted on a non-evidential device than

where the screening test is conducted on an

EBT. For this reason, the Department is not

proposing to increase this interval, though

we seek comment on the degree to which an

increased interval between screening and

confirmation tests could increase the utility

of non-evidential devices, without

concomitant loss of otherwise positive tests.

(60 FR 3371; January 17, 1995.)

The Department received 11

comments on this issue. Four of these

comments, all from breath testing

equipment manufacturers or

distributors, recommended retaining the

15–20-minute timeframe for completing

tests. One commented that even a brief

increase (e.g., five minutes) in the

interval could result in losing otherwise

positive results. Seven comments (5

employers or employer associations and

2 testing service providers)

recommended increasing the interval.

The longer intervals they suggested

included 30 minutes, one hour, and two

hours. Their basic rationale was that if

employers had to get an employee from

a field site where a non-evidential

device was used for a screening test to

a site where an EBT was available

within 20 minutes, it would deter the

use of non-evidential screening devices

and limit the cost savings and increased

flexibility that would result from using

such devices. Two of the comments said

that the loss of otherwise positive tests

could be a small one.

The Department established

consequences for employees testing at

the .02 and .04 alcohol concentration

levels because even these low levels of

alcohol concentration can adversely

affect the performance of safetysensitive functions by transportation

employees. If, because long periods of

time intervene between screening and

confirmation tests, significant numbers

of individuals with such alcohol

concentrations are able to avoid the

consequences of their conduct, the

deterrent effects and safety benefits of

the alcohol testing rules will be

reduced. Consequently, to help

determine its response to the comments

on this issue, the Department obtained

further information about the effects of

lengthier delays on tested alcohol

concentration.

According to this information, most

people (male and female) appear to

eliminate alcohol in a range between

0.01 and 0.02 percent per hour. This is

the range most forensically accepted

and commonly cited. Individual

employees’ results will, of course, have

individual differences based on such

factors as gender, body weight, acquired

tolerance for alcohol, etc. The following

chart displays this data. The chart starts

with a screening test alcohol

concentration, at the moment the

screening test result is obtained. It then

shows what the predicted range of

confirmation tests results would be after

a 30–120 minute interval, assuming (as

is very likely to be the case in most

instances) that the individual’s alcohol

concentration is in the declining phase

at the time of the screening test.

SCREENING TEST ALCOHOL CONCENTRATION

Interval .06 .05 .04 .03

20 minutes ........................................................................................................ .053–.056 .043–.046 .033–.036 .023–.026

30 minutes ........................................................................................................ .050–.055 040–.045 .030–.035 .020–.025

40 minutes ........................................................................................................ .046–.053 .036–.043 .026–.033 <.02–.023

60 minutes ........................................................................................................ .040–.050 .030–.040 .020–.030 <.02–.020

120 minutes ...................................................................................................... .020–.040 <.02–.030 <.02–.020 <.02
Federal Register / Vol. 60, No. 76 / Thursday, April 20, 1995 / Rules and Regulations 19677

The chart shows that at any of the

alcohol concentration levels shown, the

longer intervals (e.g., 1–2 hours)

suggested by some commenters would

often result in loss of what would

otherwise be valid ‘‘positive’’ tests, or

even the loss of the ability to remove

individuals from safety-sensitive

functions for eight hours (24 hours in

the case of the motor carrier industry).

The Department does not have data that

allow us to predict the distribution of

various levels of screen positives among

tested employees (e.g., what percentage

of employees would screen at .02, .04,

.08, 1.0, etc.). Consequently, we do not

know what overall percentage of screen

positives would be lost as the result of

longer intervals. Nevertheless, it is clear

that the effect of longer intervals would

be to effectively immunize persons with

alcohol concentrations in the .03–.06

range from the consequences stated in

the regulations. Procedural flexibility of

this magnitude would nullify the

intended substantive impact of the

rules.

The Department does not believe that

it is appropriate to establish a provision

which it knows, in advance, would

make it more likely that someone who

had violated the Department’s

regulations could avoid accountability

for his or her actions. Nor would it be

appropriate to increase significantly the

opportunities for violators to

manipulate the system to their

advantage. Based on three years of

rulemaking, participants had reason to

know that the Department has

consistently expected confirmation tests

to follow screening tests as soon as

possible. For these reasons, the

Department is not going to increase the

interval to the extent some commenters

requested.

However, the data show that an

individual whose alcohol concentration

at the time of the screening test was .05–

.06 would still, on average, test at .04 or

above after a 30-minute interval. An

individual whose alcohol concentration

at the time of the screening test was .04

would test, on average, below .04 after

a 30-minute interval, but this individual

would also test below .04 after the

present 20-minute interval.

Consequently, increasing the interval

from 20 to 30 minutes is unlikely to

have a marked adverse effect on

achieving the regulation’s objectives.

Such an increase would permit

employers some additional degree of

flexibility. Because the Department’s

regulatory policy is to provide

appropriate flexibility to regulated

parties, where doing so does not

adversely affect the safety objectives of

a rule, the Department has decided to

increase the interval between the tests

from 20 to 30 minutes. This change, to

§ 40.65(b), also affects the interval

between EBT screening and

confirmation tests.

One question that some comments

raised is what the consequences are if a

confirmation test is not conducted

within 30 minutes of the screening test.

First, the Department reemphasizes that

a test conducted more than 30 minutes

later than the screening test is not fatally

flawed. For example, if an individual’s

confirmation test result is .04 or above,

the test is valid and its consequences

apply even though the confirmation test

was conducted more than 30 minutes

after the screening test. Second, an

employer that conducts confirmation

tests more than 30 minutes after

screening tests—particularly if the

employer has a pattern or practice of

doing so—is subject to being found in

violation of an operating

administration’s regulation. This has

similar consequences to any other

finding by an operating administration

that an employer is failing to implement

the regulation properly. To allow

operating administrations to determine

whether employers are meeting this

requirement, the Department is adding a

sentence to § 40.65(b) instructing the

BAT conducting the confirmation test to

note, in the remarks section of the form,

any occasion on which the confirmation

test is late and the reason for the delay.

Observation During Transit

The use of non-evidential screening

devices would often occur at a site

removed from the site of the EBT

confirmation test. In this situation, the

NPRM proposed that the employee

would have to be observed by the saliva

testing technician (STT) or an employer

representative while traveling between

the two sites. Two breath testing

equipment manufacturers agreed with

this proposal, while one employer

association opposed it, saying it was

unnecessary. The Department will

retain this provision. Clearly, it is not

appropriate for someone who has just

tested at .02 or above to drive himself

or herself to the next testing site.

Someone else will necessarily be

responsible for the employee’s

transportation. That someone else

should be an individual with a stake in

the success of the testing process (i.e.,

an STT or an employer representative),

who can ensure that the employee

arrives at the confirmation testing site

safely and in a timely manner and

reduce the probability that the employee

could engage in behavior that might

result in a refused or invalid test. This

person should also be responsible for

monitoring the employee with respect to

observing the 15-minute deprivation

period between the initial and

confirmation tests. (The Department’s

view is that the time the employee

spends in transit between tests, if the

employee is under observation as

provided in this section, counts toward

the mandatory 15-minute deprivation

period.) The final rule applies this same

requirement to the situation in which an

EBT without printing capability is used

for the screening test and the employee

is taken to a confirmation EBT for the

confirmation test.

Procedures for Screening Tests

One commenter noted that the NPRM

failed to require (as existing Part 40

requires for breath tests) that the STT

inform the employee about the

procedures to be followed in the test.

The final rule adds this requirement.

The NPRM provided that the STT

would take the reading from the saliva

device in the time frame specified by

the manufacturer. This led to comments

that the testing process could be

unnecessarily delayed, since the

manufacturer’s instructions on the only

saliva device now approved by NHTSA

appeared to call for a 2–15 minute

period for reading the device. The

Department discussed this matter with

the manufacturer, which said that the

device may always be read after two

minutes. After 15 minutes, the result

begins to degrade. Consistent with this

understanding of the device, the final

rule requires STTs to take a reading two

minutes after inserting the swab into the

device. The fatal flaws section now

provides that a test is invalid if the

reading is taken less than two or more

than 15 minutes after insertion of the

swab into the device.

One of the issues addressed in the

NPRM was what the STT should do

when a saliva test fails (e.g, the device

indicates that a sample is unacceptable,

the swab falls on the floor). The NPRM

proposed that, in this case, the STT

would first administer another saliva

test, using a new saliva device. There

were no comments on this provision,

which the Department will retain. The

Department will add one safeguard to

this provision. The Department

understands that, at least in some cases,

companies may pre-place saliva

packages in workplaces (e.g., in the

glove compartment of a truck). Such a

device might be used for the initial

saliva test. If that test is not successfully

completed, the final rule provides that

the STT must use a new device that has

been in the STT’s (or employer’s)

possession prior to the test, rather than

under the control of the employee. This
19678 Federal Register / Vol. 60, No. 76 / Thursday, April 20, 1995 / Rules and Regulations

safeguard will help to preclude

questions about whether environmental

degradation or tampering could have

affected the result of the screening test.

The NPRM proposed that if there

were two consecutive failures of saliva

tests, the employee would be referred

for a breath test. The NPRM sought

comment on whether this breath test

should be on an EBT. Two breath testing

equipment manufacturers favored using

an EBT under these circumstances; two

employer groups and a consortium

thought doing so was unnecessary (i.e.,

that another non-evidential test was

adequate). The Department has

concluded that it makes the most sense

to resort to an EBT in these

circumstances. As noted in the NPRM

preamble, going, after two saliva tests, to

another non-evidential breath testing

device, and then having to go to an EBT

for confirmation, would unnecessarily

lengthen the procedure and could result

in the loss of what would otherwise be

a positive test. The Department believes

that keeping the procedure compact is

most consistent with the objectives of

the program.

There were several miscellaneous

comments about testing procedures.

One asked for more specificity about the

type of gloves an STT should use if the

STT is swabbing an employee’s mouth.

The Department believes that reference

to a surgical glove—the kind that

doctors and dentists use in examining

patients—is adequate, though we have

made the requirement more specific by

deleting the NPRM’s reference to other

types of hand protection. Comments

from two breath testing equipment

manufacturers suggested that there

should be serial numbers for each saliva

device on the package and on the device

itself, which if mismatched would result

in a fatal flaw. Given that the

procedures call for the STT to open the

package in the presence of the

employee, matching serial numbers

seems superfluous and a likely source of

unnecessary problems in the collection

process. Another commenter suggested

allowing the employee to select his or

her own saliva device from among

several that the STT would offer. The

Department has no objection to this

practice, but it seems unnecessary to

require STTs to proceed in this fashion.

The NPRM called for the STT to use

a logbook in connection with a nonevidential breath testing device. This

proposed requirement paralleled the

existing Part 40 requirement for

situations in which an EBT without

printing and sequential numbering

capability is used for a screening test.

The proposal did not apply to saliva

devices, since a logbook traveling with

the device makes no sense in the

context of a disposable device.

In reexamining this requirement in

the context of this rulemaking, the

Department has determined that the

paperwork burden involved is not

justified by the utility of the

requirement to the program. It

essentially duplicated material required

to be entered on the form. For this

reason, the Department will not make

the proposed requirement final with

respect to non-evidential breath testing

devices. The same logic applies to the

existing requirement for using a logbook

in connection with EBTs that do not

have printout and sequential numbering

capabilities. Consequently, the

Department is withdrawing this

requirement as well. The amendments

to § 40.59, 40.63(d)(1), and 40.63(e)(3)

remove references to this requirement.

One of the amendments to § 40.63(e)

corrects a codification error in this

section resulting from the Department’s

August 19, 1994, amendment to part 40

(see 59 FR 43001). This action

redesignates the presently codified

paragraph (e)(3) as (e)(4), and adds the

proper (e)(3)—modified to delete the

reference to the logbook—back into the

section. There is also an editorial

correction to delete a substantively

duplicative reference to the

‘‘quantitative result.’’ The section

already requires entry of the ‘‘displayed

result.’’ Because the Department did not

propose to do so in the NPRM, we will

seek comments on these amendments,

which reduce paperwork burdens, for

45 days.

Forms

The NPRM suggested that STTs

conducting non-evidential breath tests

would use the existing breath testing

form, while STTs conducting saliva

tests would use a modified form. Four

commenters suggested having one form

for all tests rather than having separate

forms. One of these commenters

provided a suggested modification of

the existing alcohol testing form that

included boxes to check for what sort of

test was involved. Three other

commenters approved the idea of a

separate form for saliva testing. One of

these suggested adding blocks in which

the starting and ending times of

screening and confirmation tests would

be noted, and also suggested adding

other information to the form, such as

initials by the observer who traveled to

the confirmation site with the employee,

the serial number of the saliva device,

and the expiration date of the saliva

device.

The Department is persuaded that for

the sake of simplicity and avoiding

confusion in the program, it is

preferable to have only one form used

in DOT alcohol testing. The Department

believes that some of the suggestions

commenters made—particularly

including boxes to check off indicating

the testing method and the inclusion of

starting and ending times of tests—have

merit. The Department is also aware,

however, that it is important to issue

this rule as soon as possible so that

those employers who choose to do so

can begin using non-evidential devices.

Redesigning a form, securing Office of

Management and Budget approval for it,

and printing it all take a good deal of

time. Consequently, the Department is

making an interim solution part of this

final rule. For now, employers will

continue to use the existing alcohol

form. The rule will direct STTs to note

in the remarks section of the form that

a non-evidential breath or saliva device,

as applicable, was used for the

screening test.

Subsequently, the Department intends

to revise the alcohol testing form,

incorporating some of the ideas

proposed in the NPRM and in the

comments responding to it. After the

revised form is published, we anticipate

permitting employers to exhaust stocks

of existing forms before being required

to use it.

STT Training

One employer and nine breath testing

equipment manufacturers or distributors

commented on the NPRM’s proposal to

require training for STTs, using a

modified version of the Department’s

BAT training course. The employer

wanted to be sure that STTs would be

trained in how to operate the nonevidential devices they would use. The

NPRM and final rule both provide that

this must be the case. Of the remaining

commenters, six favored the NPRM’s

concept of using a modified, shorter

version of the BAT course for training

of STTs, while the other three appeared

to favor a closer integration of BAT and

STT training.

The Department is aware that, while

many people who have trained as BATs

will also operate as STTs, there may

also be many situations in which, in

order to gain flexibility and reduce

costs, employers may wish to use

people who will only administer nonevidential screening tests. For this

reason, we believe it is reasonable to

establish training requirements for

individuals who will be STTs only, and

who will not train as BATs. The

Department has prepared an STT

training course, which will be the basis

for training STTs. This will be made

available to the public at a modest
Federal Register / Vol. 60, No. 76 / Thursday, April 20, 1995 / Rules and Regulations 19679

charge from the Government Printing

Office. Training for STTs (as well as for

BATs who will conduct non-evidential

screening tests) must include hands-on

training in the use of the specific nonevidential devices they will use. If the

screening device used is a disposable,

single-use device that requires the STT

to evaluate a color change, some criteria

for correct judgments should be

included in the training.

Quality Assurance Plans (QAPs)

One commenter, a manufacturer of

standards for calibrating alcohol testing

devices, suggested that there be QAPs

for calibration devices. There is a

NHTSA conforming products list for

such devices, and the Department is not

convinced that additional requirements

are needed now. Another commenter

asked who is responsible for compliance

with the QAP. The manufacturer is

responsible for creating the QAP and

getting NHTSA approval for it, and the

employer or its agent is responsible for

operating the equipment in conformity

with it. A breath testing manufacturer

recommended that saliva device QAPs

call for periodic testing of each lot of

devices. The commenter said that

environmental conditions (e.g., storage

conditions) could affect the accuracy of

the devices, perhaps leading to an

unacceptable number of false negatives.

The Department is concerned that

periodic testing of large numbers of

disposable devices may not be feasible

and could be overly costly and

burdensome. Employers are required to

comply with manufacturers’ QAPs,

which will provide for appropriate

storage conditions. While the

Department will not impose such a

requirement as part of this final rule, the

Department can revisit this issue if

experience suggests that false negatives

with a particular type of device become

a serious problem.

One of the requirements of a QAP for

disposable devices is that they include

the shelf life of the devices. With the

QAP, the Department wishes

manufacturers to submit the data on

which the shelf life determination for

the device is based (e.g., tests over time

of devices drawn from manufacturers’

lots).

Regulatory Analyses and Notices

This is not a significant rule under

Executive Order 12866 or under the

Department’s Regulatory Policies and

Procedures. It does not impose costs on

regulated parties. It facilitates the use of

devices that may increase flexibility,

and decrease costs, for employers who

choose to use them. There are not

sufficient Federalism implications to

warrant the preparation of a Federalism

Assessment. The Department certifies

that this rule will not have a significant

economic impact on a substantial

number of small entities. To the extent

that there is any such impact, it is

expected to be a small favorable impact,

since some small entities may be able to

conduct screening tests at a lower cost.

List of Subjects in 49 CFR Part 40

Drug testing, Alcohol testing,

laboratories, Reporting and

recordkeeping requirements, Safety,

Transportation.

Issued this 5th day of April, 1995, at

Washington, DC.

Federico Pen ̃ a,

Secretary of Transportation.

For the reasons set forth in the

preamble, 49 CFR Part 40 is amended as

follows:

PART 40—[AMENDED]

1. The authority citation for Part 40

continues to read as follows:

Authority: 49 U.S.C. 102,301,322; 49

U.S.C. app. 1301nt., app. 1434nt., app. 2717,

app. 1618a.

§ 40.51 [Amended]

2. Section 40.51(c) is amended by

adding the words ‘‘or non-evidential

alcohol screening device’’ after the word

‘‘EBT’’.

§ 40.59 [Amended]

3. The heading of § 40.59 is revised to

read ‘‘The breath alcohol testing form’’.

4. Section 40.59(c) is removed.

5. Section 40.63(d)(1) is revised to

read as follows:

§ 40.63 Procedures for screening tests.

* * * * *

(d)(1) If the EBT does not meet the

requirements of § 40.53(b) (1) through

(3), the BAT shall ensure, before a

screening test is administered to each

employee, that he or she and the

employee read the sequential test

number displayed on the EBT. The BAT

shall record the displayed result, test

number, testing device, serial number of

the testing device, and time in Step # of

the form.

* * * * *

6. In § 40.63, paragraph (e)(4) is

removed, paragraph (e)(3) is

redesignated as paragraph (e)(4), and a

new paragraph (e)(3) is added, to read

as follows:

§ 40.63 Procedures for screening tests.

* * * * *

(e) * * *

(3) If the employee does not sign the

certification in Step 4 of the form for a

test, it shall not be considered a refusal

to be tested. In this event, the BAT shall

note the employee’s failure to sign in

the ‘‘Remarks’’ section of the form.

* * * * *

7. A new § 40.63(h) is added, to read

as follows:

§ 40.63 Procedures for screening tests.

* * * * *

(h) If the confirmation test will be

conducted at a different site from the

screening test, the employer or its agent

shall ensure that—

(1) The employee is advised against

taking any of the actions mentioned in

the first sentence of § 40.65(b) of this

Part;

(2) The employee is advised that he or

she must not drive, perform safetysensitive duties, or operate heavy

equipment, as noted in Block 4 of the

alcohol testing form; and

(3) The employee is under observation

of a BAT, STT, or other employer

personnel while in transit from the

screening test site to the confirmation

test site.

8. In § 40.65(b), the third sentence is

revised to read: ‘‘The confirmation test

shall be conducted within 30 minutes of

the completion of the screening test.’’

§ 40.65 [Amended]

9. In § 40.65, paragraph (b) is

amended by adding, at the end thereof,

to read: ‘‘If the BAT conducts the

confirmation test more than 30 minutes

after the result of the screening test has

been obtained, the BAT shall note in the

‘‘Remarks’’ section of the form the time

that elapsed between the screening and

confirmation tests and the reason why

the confirmation test could not be

conducted within 30 minutes of the

screening test.’’

10. A new Subpart D of Part 40 is

added, to read as follows:

Subpart D—Non-Evidential Alcohol

Screening Tests

40.91—Authorization for use of nonevidential alcohol screening devices

40.93—The screening test technician

40.95—Quality assurance plans for nonevidential screening devices

40.97—Locations for non-evidential alcohol

screening tests

40.99—Testing forms

40.101—Screening test procedure

40.103—Refusals to test and uncompleted

tests

40.105—Inability to provide an adequate

amount of breath or saliva

40.107—Invalid tests

40.109—Availability and disclosure of

alcohol testing information about

individual employees

40.111—Maintenance and disclosure of

records concerning non-evidential

testing devices and STTs.
19680 Federal Register / Vol. 60, No. 76 / Thursday, April 20, 1995 / Rules and Regulations

Subpart D—Non-Evidential Alcohol

Screening Devices

§ 40.91 Authorization for use of nonevidential alcohol screening devices.

Non-evidential alcohol screening

tests, performed using screening devices

included by the National Highway

Traffic Safety Administration on its

conforming products list for nonevidential screening devices, may be

used in lieu of EBTs to perform

screening tests required by operating

administrations’ alcohol testing

regulations. Non-evidential screening

devices may not be used for

confirmation alcohol tests, which must

be conducted using EBTs as provided in

Subpart C of this Part.

§ 40.93 The screening test technician.

(a) Anyone meeting the requirements

of this Part to be a BAT may act as a

screening test technician (STT),

provided that the individual has

demonstrated proficiency in the

operation of the non-evidential

screening device he or she is using.

(b) Any other individual may act as an

STT if he or she successfully completes

a course of instruction concerning the

procedures required by this Part for

conducting alcohol screening tests. Only

the Department of Transportation model

course, or a course of instruction

determined by the Department of

Transportation’s Office of Drug

Enforcement and Program Compliance

to be equivalent to it, may be used for

this purpose.

(c) With respect to any non-evidential

screening device involving changes,

contrasts, or other readings that are

indicated on the device in terms of

color, STTs shall, in order to be

regarded as proficient, be able to discern

correctly these changes, contrasts or

readings.

(d) The STT shall receive additional

training, as needed, to ensure

proficiency, concerning new or

additional devices or changes in

technology that he or she will use.

(e) The employer or its agent shall

document the training and proficiency

of each STT it uses to test employees

and maintain the documentation as

provided in § 40.83.

(f) The provisions of § 40.51(b) and

(c); § 40.57; § 40.59; § 40.61; § 40.63

(e)(1)–(2), (f), (g), and (h); § 40.69; and

§ 40.81; and other provisions, as

applicable, of this Part apply to STTs as

well as to BATs.

§ 40.95 Quality assurance plans for nonevidential screening devices.

(a) In order to be used for alcohol

screening tests subject to this part, a

non-evidential screening device shall

have an approved quality assurance

plan (QAP) developed by the

manufacturer and approved by the

National Highway Traffic Safety

Administration (NHTSA).

(1) The plan shall designate the

method or methods to be used to

perform quality control checks; the

temperatures at which the nonevidential screening device shall be

stored and used, as well as other

environmental conditions (e.g., altitude,

humidity) that may affect the

performance of the device; and, where

relevant, the shelf life of the device.

(2) The QAP shall prohibit the use of

any device that does not pass the

specified quality control checks or that

has passed its expiration date.

(b) The manufacturers’ instructions on

or included in the package for each

saliva testing device shall include

directions on the proper use of the

device, the time frame within which the

device must be read and the manner in

which the reading is made.

(c) The employer and its agents shall

comply with the QAP and

manufacturer’s instructions for each

non-evidential screening device it uses

for alcohol screening tests subject to this

Part.

§ 40.97 Locations for non-evidential

alcohol screening tests.

(a) Locations for non-evidential

alcohol screening tests shall meet the

same requirements set forth for breath

alcohol testing in § 40.57 of this Part.

(b) The STT shall supervise only one

employee’s use of a non-evidential

screening device at a time. The STT

shall not leave the alcohol testing

location while the screening test

procedure for a given employee is in

progress.

§ 40.99 Testing forms.

STTs conducting tests using a nonevidential screening device shall use the

alcohol testing form as provided in

§ 40.59 and Appendix B of this Part for

the screening test.

§ 40.101 Screening test procedure.

(a) The steps for preparation for

testing shall be the same as provided for

breath alcohol testing in § 40.61 of this

Part.

(b) The STT shall complete Step 1 on

the form required by § 40.99. The

employee shall then complete Step 2 on

the form, signing the certification.

Refusal by the employee to sign this

certification shall be regarded as a

refusal to take the test.

(c) If the employer is using a nonevidential breath testing device, the STT

shall follow the same steps outlined for

screening tests using EBTs in § 40.63.

(d) If the employer is using a saliva

testing device, the STT shall take the

following steps:

(1) The STT shall explain the testing

procedure to the employee.

(2) The STT shall check the expiration

date of the saliva testing device, show

the date to the employee, and shall not

use a device at any time subsequent to

the expiration date.

(3) The STT shall open an

individually sealed package containing

the device in the presence of the

employee.

(4) The STT shall offer the employee

the opportunity to use the swab. If the

employee chooses to use the swab, the

STT shall instruct the employee to

insert the absorbent end of the swab into

the employee’s mouth, moving it

actively throughout the mouth for a

sufficient time to ensure that it is

completely saturated, as provided in the

manufacturer’s instructions for the

device.

(5) If the employee chooses not to use

the swab, or in all cases in which a new

test is necessary because the device did

not activate (see paragraph (d)(8) of this

section), the STT shall insert the

absorbent end of the swab into the

employee’s mouth, moving it actively

throughout the mouth for a sufficient

time to ensure that it is completely

saturated, as provided in the

manufacturer’s instructions for the

device. The STT shall wear a surgical

grade glove while doing so.

(6) The STT shall place the device on

a flat surface or otherwise in a position

in which the swab can be firmly placed

into the opening provided in the device

for this purpose. The STT shall insert

the swab into this opening and maintain

firm pressure on the device until the

device indicates that it is activated.

(7) If the procedures of paragraph

(d)(3)–(d)(5) of this section are not

followed successfully (e.g., the swab

breaks, the STT drops the swab on the

floor or another surface, the swab is

removed or falls from the device before

the device is activated), the STT shall

discard the device and swab and

conduct a new test using a new device.

The new device shall be one that has

been under the control of the employer

or STT prior to the test. The STT shall

note in the remarks section of the form

the reason for the new test. In this case,

the STT shall offer the employee the

choice of using the swab himself or

herself or having the STT use the swab.

If the procedures of paragraph (d)(3)–

(d)(5) of this section are not followed

successfully on the new test, the

collection shall be terminated and an
Federal Register / Vol. 60, No. 76 / Thursday, April 20, 1995 / Rules and Regulations 19681

explanation provided in the remarks

section of the form. A new test shall

then be conducted, using an EBT for

both the screening and confirmation

tests.

(8) If the procedures of paragraph

(d)(3)–(d)(5) of this section are followed

successfully, but the device is not

activated, the STT shall discard the

device and swab and conduct a new

test, in the same manner as provided in

paragraph (d)(7) of this section. In this

case, the STT shall place the swab into

the employee’s mouth to collect saliva

for the new test.

(9) The STT shall read the result

displayed on the device two minutes

after inserting the swab into the device.

The STT shall show the device and its

reading to the employee and enter the

result on the form.

(10) Devices, swabs, gloves and other

materials used in saliva testing shall not

be reused, and shall be disposed of in

a sanitary manner following their use,

consistent with applicable

requirements.

(e) In the case of any screening test

performed under this section, the STT,

after determining the alcohol

concentration result, shall follow the

applicable provisions of § 40.63 (e)(1)–

(2), (f), (g), and (h). The STT shall also

enter, in the ‘‘Remarks’’ section of the

form, a notation that the screening test

was performed using a non-evidential

breath testing device or a saliva device,

as applicable. Following completion of

the screening test, the STT shall date the

form and sign the certification in Step

3 of the form.

§ 40.103 Refusals to test and uncompleted

tests.

(a) Refusal by an employee to

complete and sign the alcohol testing

form required by § 40.99 (Step 2), to

provide a breath or saliva sample, to

provide an adequate amount of breath,

or otherwise to cooperate in a way that

prevents the completion of the testing

process, shall be noted by the STT in

the remarks section of the form. This

constitutes a refusal to test. The testing

process shall be terminated and the STT

shall immediately notify the employer.

(b) If the screening test cannot be

completed, for reasons other than a

refusal by the employee, or if an event

occurs that would invalidate the test,

the STT shall, if practicable,

immediately begin a new screening test,

using a new testing form and, in the

case of a test using a saliva screening

device, a new device.

§ 40.105 Inability to provide an adequate

amount of breath or saliva.

(a) If an employee is unable to provide

sufficient breath to complete a test on a

non-evidential breath testing device, the

procedures of § 40.69 apply.

(b) If an employee is unable to

provide sufficient saliva to complete a

test on a saliva screening device (e.g.,

the employee does not provide

sufficient saliva to activate the device),

the STT, as provided in § 40.101 of this

Part, shall conduct a new test using a

new device. If the employee refuses to

complete the new test, the STT shall

terminate testing and immediately

inform the employer. This constitutes a

refusal to test.

(c) If the new test is completed, but

there is an insufficient amount of saliva

to activate the device, STT shall

immediately inform the employer,

which shall immediately cause an

alcohol test to be administered to the

employee using an EBT.

§ 40.107 Invalid tests.

An alcohol test using a non-evidential

screening device shall be invalid under

the following circumstances:

(a) With respect to a test conducted on

a saliva device—

(1) The result is read before two

minutes or after 15 minutes from the

time the swab is inserted into the

device;

(2) The device does not activate;

(3) The device is used for a test after

the expiration date printed on its

package; or

(4) The STT fails to note in the

remarks section of the form that the

screening test was conducted using a

saliva device;

(b) With respect to a test conducted

on any non-evidential alcohol testing

device, the STT has failed to note on the

remarks section of the form that the

employee has failed or refused to sign

the form following the recording on the

form of the test result.

§ 40.109 Availability and disclosure of

alcohol testing information about individual

employees.

The provisions of § 40.81 apply to

records of non-evidential alcohol

screening tests.

§ 40.111 Maintenance and disclosure of

records concerning non-evidential testing

devices and STTs.

Records concerning STTs and nonevidential testing devices shall be

maintained and disclosed following the

same requirements applicable to BATs

and EBTs under § 40.81 of this Part.

[FR Doc. 95–9552 Filed 4–19–95; 8:45 am]

BILLING CODE 4910–62–P

National Highway Traffic Safety

Administration

49 CFR Part 571

[Docket No. 94–104; Notice 2]

RIN 2127–AF45

Federal Motor Vehicle Safety

Standards; Lamps, Reflective Devices

and Associated Equipment

AGENCY: National Highway Traffic

Safety Administration (NHTSA), DOT.

ACTION: Final rule.

SUMMARY: This notice amends the

Federal motor vehicle safety standard

on lighting to allow the photometric

conformance of rear center

highmounted stop lamps to be

determined by a grouping of test points.

This action is consistent with the

agency’s requirements for other lamps

and will lessen the testing burden for

manufacturers.

DATES: The effective date of the final

rule is May 22, 1995.

FOR FURTHER INFORMATION CONTACT:

Richard Van Iderstine, Office of

Rulemaking, NHTSA (202–366–5280).

SUPPLEMENTARY INFORMATION: Dennis

Moore of Livermore, California,

petitioned for rulemaking to amend

Standard No. 108 to allow ‘‘a ‘Zonal’

approach * * * for Compliance

Photometric Testing of 3rd Brake Lights

which has already been adopted for Tail

Lights, Regular Brake Lights and Turn

Signals.’’ Under S5.1.1.6 of Standard

No. 108, taillamps and parking lamps

need not meet the minimum

photometric values specified for each of

the test points of the relevant SAE

Standards incorporated by reference,

provided that the sum of the minimum

candlepower measured at the test points

is not less than that specified for each

group listed in Figure 1c. In addition,

the more recent SAE Standards for stop

lamps and turn signal lamps that have

been incorporated into Standard No.

108 no longer specify values for

individual test points (though including

them as photometric design guidelines).

Instead, they specify required values for

‘‘zones’’ only.

In contrast, the applicable

photometric values for center

highmounted stop lamps (CHMSLs) are

those of Figure 10 of Standard No. 108

and are for individual test points. Moore

viewed this as an anomaly. He believes

that laboratory test results vary so

greatly that CHMSLs must be

overdesigned to ensure compliance at

each test point. As a result, they draw

more power and have a shorter life

expectancy. He argued that because