[Federal Register Volume 60, Number 10 (Tuesday, January 17, 1995)]
[Proposed Rules]
[Pages 3371-3374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1188]



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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket No. 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: Notice of proposed rulemaking.

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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 met precision and accuracy requirements. This proposed 
rule is intended to establish procedures for the use of these devices.

DATES: Comments should be received by February 16, 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, S.W., Washington D.C., 20590, Room 9404, 202-366-3784; 
or Robert C. Ashby, Deputy Assistant General Counsel for Regulation and 
Enforcement, 400 7th Street, S.W., Room 10424. 202-366-9306.

SUPPLEMENTARY INFORMATION: When the Department published its final 
alcohol testing rules in February 1994 (59 FR 7302 et seq., February 
15, 1994), 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, while NHTSA has now determined that these devices meet the model 
specifications, their use in DOT-mandated alcohol testing programs 
would be authorized only in accordance with these proposed procedures 
(just as EBTs are authorized for use only in accordance with existing 
Part 40 procedures). Until these proposed procedures are final and in 
effect, employers are not authorized to use the non-evidential 
screening devices.
    These devices could be used under final procedural rules, it should 
be emphasized, only for alcohol screening tests. 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 in order to prevent metabolization of alcohol over time from 
negating what otherwise would 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.
    In drafting these proposed procedures, the Department used the 
model of its existing alcohol testing procedures, with modifications 
appropriate to the different devices involved. This makes the proposed 
procedures simple and achieves the flexibility that is the goal of 
using non-evidential devices.
    Proposed Sec. 40.91 simply states that non-evidential devices, 
approved by NHTSA, can be used for screening but not for confirmation 
tests. Proposed Sec. 40.93 addresses the more complex issue of who may 
act as a screening test technician (STT), with what degree of training. 
First, any BAT meeting the requirements of the existing Part 40 may act 
as an STT, provided that the individual has demonstrated proficiency on 
the particular non-evidential device he or she will use (by completing 
a ``Unit VIII'' of the DOT model BAT course, or similar section of a 
DOT-approved equivalent course, specific to the particular device).
    There may be some individuals who will act as STTs who do not act 
as BATs. These individuals would conduct only screening tests using 
non-evidential devices and would never use EBTs or conduct confirmation 
tests. The Department is adapting its model BAT course for use in 
training such persons. We anticipate that this course will be a 
substantially shorter version of the BAT course, focusing on screening 
procedures only. The Department will make this course outline available 
by the time a final rule based on this proposal is published. Someone 
who successfully completes this course could act as an STT, under 
paragraph (b) of this section. The remainder of the section, with 
respect to additional training, documentation of training, and other 
subjects, parallels existing Part 40.
    Proposed Sec. 40.97 concerns locations for screening tests. 
Location requirements are the same as the parallel section in the 
existing Part 40 alcohol procedures. Proposed Sec. 40.99 provides that 
like employers using an EBT without the features needed for 
confirmation tests, employers using non-evidential breath testing 
devices would use the same form as, and a log book like, those cited in 
Sec. 40.59 of the existing alcohol testing procedures. A slightly 
modified form is described at the end of the proposed rule text. The 
Department seeks comment on whether it would be better to take this 
approach or to attempt to modify the existing alcohol testing form to 
encompass non-breath based testing.
    For employers using non-evidential breath testing, proposed 
Sec. 40.101 provides that the STT or BAT would follow essentially the 
same procedures as are followed for a screening test using an EBT. The 
technology and testing process using a non-evidential breath testing 
device and an EBT are similar enough that the existing procedures can 
[[Page 3372]] be used as they are. For purposes of these proposed 
procedures, we view the results displayed on non-evidential breath 
devices as equivalent to those displayed on EBTs, even if the mode of 
display is different. We seek comment on whether any greater 
specificity concerning the display of results on non-evidential breath 
testing devices is needed.
    Saliva testing devices are another matter, since they use a 
different technology and require different procedures. Proposed 
Sec. 40.101(d) spells out these procedures. After opening the package 
containing the device, the STT lets the employee choose whether to use 
the swab him- or herself or whether to have the STT use the swab. For 
the sake of hygiene, the STT would wear a surgical glove or other 
adequate sanitary hand protection whenever the STT performs this task. 
This is advisable both from the point of view of the STT and the 
employee. Such a requirement is likely to make all parties more 
accepting of this testing method, and the Department proposes to 
require it for this reason. The Department is informed by the 
Occupational Health and Safety Administration (OSHA) that its rules 
concerning bloodborne pathogens (29 CFR 1910.1030) do not apply to 
saliva testing of this sort, since those rules do not designate saliva 
as a ``potentially infectious material'' except in the context of 
dental procedures. However, employers should check applicable state or 
local laws to determine if they impose any additional requirements. 
These same comments apply to the disposal of saliva test materials (see 
Sec. 40.101(f)).
    The point of the swabbing exercise is to get the absorbent end of 
the swab completely saturated so that it will activate the device. Once 
the swab is saturated, the STT places it into the receptacle on the 
device, maintaining pressure on the device until the device is 
activated. The manufacturer's instructions will describe how the STT is 
to know whether the device has been activated. For example, the device 
that is now on the NHTSA CPL has an indicator spot that turns a 
particular color when the device is activated.
    There are two main types of problems that can happen in this 
process. First, the process of using the device can miscarry (e.g., the 
swab breaks or falls to the floor). In this case, the STT is instructed 
to start the process over with a new device and swab. In this case, the 
STT would note the occurrence in the ``remarks'' section of the form. 
The Department seeks comments on whether it would be advisable to use a 
new form in this situation. Second, the process can work correctly, but 
the device does not activate. In this case, the STT also begins the 
process anew, but the STT, rather than the employee, must use the swab 
(this is because insufficient saturation of the swab is a common reason 
for the failure of the device to activate).
    Once the device activates, the STT reads the result. This reading 
must take place within the time frame specified in the manufacturer's 
instructions for the device (e.g., 2-15 minutes in the case of the 
saliva device now on the CPL). The instructions will also indicate the 
manner in which the reading is made (e.g., a numerical scale or other 
indication that there is an alcohol concentration of .02 or greater). 
Following the reading of the result, the STT proceeds in the same 
manner as does the BAT in a case when an EBT not having the features 
necessary for confirmation tests is used. The Department is proposing 
to amend the procedures for this situation, both where an EBT and where 
a non-evidential screening device is used. Under this proposal, 
following a screening test showing a result of .02 or greater, the 
employee would have to be advised against eating, drinking, etc.; would 
have to be advised against driving (as noted in Block 4 of the form); 
and would have to be under observation while going from the screening 
test site to the confirmation test site.
    Refusals to test and incomplete tests (proposed Sec. 40.103) are 
handled in a manner parallel to that of existing alcohol Part 40 
procedures. There is also a parallel to existing alcohol Part 40's 
procedures for situations in which an adequate sample is not provided 
(Sec. 40.105). For non-evidential breath devices, the same ``shy lung'' 
procedures that are used with EBTs (see Sec. 40.69) are employed. For 
saliva devices, in situations such as the apparent inability of the 
employee to saturate the swab sufficiently to activate the device, the 
STT would first conduct a new test, as provided in Sec. 40.101. If the 
same thing happens on the new test, the STT makes a note in the 
``remarks'' section of the form. The employer is then responsible for 
immediately conducting a breath test. Since an EBT must be available 
within 20 minutes in order to conduct a confirmation test, this 
approach appears workable. The Department seeks comment on whether the 
rule should specify that an EBT be used for this purpose, since going 
from a saliva device to a non-evidential breath test device to an EBT 
(if needed for confirmation) could unnecessarily lengthen the entire 
procedure, perhaps resulting in the loss of what otherwise would be a 
positive test.
    It is our understanding that individuals cannot voluntarily control 
the production of saliva. Consequently, there is no precise parallel to 
``shy lung'' or ``shy bladder''situations in the case of saliva 
testing, and refusals would occur only if the employee declined to 
permit the technician to use the swab or declined to take a subsequent 
breath test. A medical review, parallel to that provided in the urine 
and breath testing situations, appears unnecessary here.
    Proposed Sec. 40.107 is a brief list of ``fatal flaws'' in non-
evidential screening tests. For saliva tests, these include results 
read in an untimely manner, use of a device past its designated shelf 
life, and the failure of the device to activate. Other fatal flaws are 
similar to those in the existing Part 40 alcohol testing procedures. 
The requirements concerning availability and disclosure of information 
about employees and maintenance and disclosure of records concerning 
STTs and non-evidential devices are also the same as those of existing 
Part 40 procedures.

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 10th Day of January, 1995, at Washington, D.C.
Federico Pena,
Secretary of Transportation.


    For the reasons set forth in the preamble, 49 CFR part 40 is 
proposed to be amended as follows:
    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. [[Page 3373]] 


Sec. 40.51  [Amended]

    2. Sec. 40.51(c) is proposed to be amended by adding the words ``or 
non-evidential alcohol screening device'' after the word ``EBT.''
    3. A new Sec. 40.63(h) is proposed to be 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.
    4. A new Subpart D of Part 40 is proposed to be 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 and manufacturers' instructions for 
non-evidential screening devices.
40.97  Locations for non-evidential alcohol screening tests.
40.99  Testing forms and log books.
40.101  Screening test procedure.
40.103  Refusals to test and uncompleted tests.
40.105  Inability to provide an adequate sample.
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 alcohol screening test devices and screening test 
technicians.

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) of this Part apply to 
STTs as well as to BATs.


Sec. 40.95  Quality assurance plans and manufacturers' instructions 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 a DOT-approved 
quality assurance plan (QAP) developed by the manufacturer.
    (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 reach the device must be read 
and indicate the manner in which the reading is made.
    (c) The employer 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 testing procedure for a given 
employee is in progress.


Sec. 40.99  Testing forms and log books.

    (a) Employers using a non-evidential breath testing device shall 
use the alcohol testing form and log book as provided in Sec. 40.59 and 
Appendix B of this Part for the screening test.
    (b) Employers using a saliva screening device shall use the alcohol 
testing form found in Appendix C of this Part.


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 check the expiration date of the saliva testing 
device, and shall not use a device at any time subsequent to the 
expiration date.
    (2) The STT shall open an individually sealed package containing 
the device in the presence of the employee.
    (3) 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 [[Page 3374]] 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.
    (4) 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)(7) 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 glove or other adequate 
sanitary hand protection while doing so, consistent with applicable 
requirements.
    (5) 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.
    (6) If the procedures of paragraphs (d)(2)-(d)(4) 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 STT 
shall note in the remarks section of the form that 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 paragraphs (d)(2)-(d)(4) of this section are not 
followed successfully on the new test, the collection shall be 
terminated and an explanation provided in the remarks section of the 
form. A new test shall then be conducted, using breath testing.
    (7) If the procedures of paragraphs (d)(2)-(d)(4) 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)(6) of this section. In this case, 
the STT shall place the swab into the employee's mouth to collect 
saliva for the new test.
    (8) The STT shall read the result displayed on the device within 
the time provided in the manufacturer's instructions for the device. 
The STT shall show the device and its reading to the employee and enter 
the result on the form.
    (9) 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). 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, or if an event 
occurs that would invalidate the test, the STT shall, if practicable, 
begin a new screening test, using a new testing form and, in the case 
of 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 a breath alcohol test to be 
administered to the employee.


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 not read within the time frame specified by the 
manufacturer's instructions for the device.
    (2) The device does not activate;
    (3) The device is used for a test after the expiration date printed 
on its package;
    (b) With respect to any test conducted on a non-evidential alcohol 
testing device--
    (1) 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; or
    (2) The procedures of Sec. 40.101(d) are not followed.


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 alcohol screening test devices and screening test 
technicians.

    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.
    5. A new Appendix C to Part 40 is proposed to be added, to read as 
follows:

Appendix C to Part 40--The Saliva Alcohol Testing Form

    [A printed version of the saliva alcohol testing form was not ready 
at the time of the publication of this notice. However, for the 
information of commenters, the form is in most respects identical to 
the existing breath alcohol testing form. Differences are as follows: 
References to the ``Breath Alcohol Testing Form'' and the ``Breath 
Alcohol Technician'' would be replaced by references to the ``Saliva 
Alcohol Testing Form'' and ``Screening Test Technician,'' respectively. 
References to ``breath alcohol testing'' would be replaced by 
references to ``saliva alcohol testing.'' In Block 3, the line 
directing confirmation test results to be attached to the back of the 
form would be deleted, as would the space for attaching such results on 
the back of the form. Also in Block 3, the words ``Testing Device 
Serial Number'' would be deleted and the words ``Device Expiration 
Date'' substituted.]

[FR Doc. 95-1188 Filed 1-12-95; 3:50 pm]
BILLING CODE 4910-62-P