[Federal Register Volume 60, Number 76 (Thursday, April 20, 1995)]
[Rules and Regulations]
[Pages 19675-19681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9552]



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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 Non-Evidential Alcohol Screening Devices
AGENCY: Office of the Secretary, DOT.

ACTION: Final rule; request for comments.
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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 
Secs. 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 non-evidential 
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, [[Page 19676]] 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 Sec. 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 non-evidential 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 
safety-sensitive 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
----------------------------------------------------------------------------------------------------------------

    [[Page 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 
Sec. 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 Sec. 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 [[Page 19678]] 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 
non-evidential 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 Sec. 40.59, 40.63(d)(1), and 
40.63(e)(3) remove references to this requirement. One of the 
amendments to Sec. 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 non-evidential 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 non-evidential 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 [[Page 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 non-evidential 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 Pena,
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.


Sec. 40.51  [Amended]

    2. Section 40.51(c) is amended by adding the words ``or non-
evidential alcohol screening device'' after the word ``EBT''.


Sec. 40.59  [Amended]

    3. The heading of Sec. 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:


Sec. 40.63  Procedures for screening tests.

* * * * *
    (d)(1) If the EBT does not meet the requirements of Sec. 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 Sec. 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:


Sec. 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 Sec. 40.63(h) is added, to read as follows:


Sec. 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 Sec. 40.65(b) of this Part;
    (2) The employee is advised that he or she must not drive, perform 
safety-sensitive 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 Sec. 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.''


Sec. 40.65  [Amended]

    9. In Sec. 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 non-evidential alcohol screening 
devices
40.93--The screening test technician
40.95--Quality assurance plans for non-evidential 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. [[Page 19680]] 

Subpart D--Non-Evidential Alcohol Screening Devices


Sec. 40.91  Authorization for use of non-evidential 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 non-evidential 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.


Sec. 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 Sec. 40.83.
    (f) The provisions of Sec. 40.51(b) and (c); Sec. 40.57; 
Sec. 40.59; Sec. 40.61; Sec. 40.63 (e)(1)-(2), (f), (g), and (h); 
Sec. 40.69; and Sec. 40.81; and other provisions, as applicable, of 
this Part apply to STTs as well as to BATs.


Sec. 40.95  Quality assurance plans for non-evidential 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 non-
evidential 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.


Sec. 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 
Sec. 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.


Sec. 40.99  Testing forms.

    STTs conducting tests using a non-evidential screening device shall 
use the alcohol testing form as provided in Sec. 40.59 and Appendix B 
of this Part for the screening test.


Sec. 40.101  Screening test procedure.

    (a) The steps for preparation for testing shall be the same as 
provided for breath alcohol testing in Sec. 40.61 of this Part.
    (b) The STT shall complete Step 1 on the form required by 
Sec. 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 non-evidential breath testing 
device, the STT shall follow the same steps outlined for screening 
tests using EBTs in Sec. 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 [[Page 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 Sec. 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.


Sec. 40.103  Refusals to test and uncompleted tests.

    (a) Refusal by an employee to complete and sign the alcohol testing 
form required by Sec. 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.


Sec. 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 Sec. 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 Sec. 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.


Sec. 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.


Sec. 40.109  Availability and disclosure of alcohol testing information 
about individual employees.

    The provisions of Sec. 40.81 apply to records of non-evidential 
alcohol screening tests.


Sec. 40.111  Maintenance and disclosure of records concerning non-
evidential testing devices and STTs.

    Records concerning STTs and non-evidential testing devices shall be 
maintained and disclosed following the same requirements applicable to 
BATs and EBTs under Sec. 40.81 of this Part.

[FR Doc. 95-9552 Filed 4-19-95; 8:45 am]
BILLING CODE 4910-62-P