[Federal Register Volume 67, Number 190 (Tuesday, October 1, 2002)]
[Rules and Regulations]
[Pages 61521-61523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24731]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-2002-13431]
RIN 2105-AD13


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.

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

SUMMARY: The Department of Transportation (DOT) originally established 
procedures for use of non-evidential alcohol screening devices (ASDs) 
in April, 1995. At that time, we indicated that as additional ASDs were 
determined by the National Highway Traffic Safety Administration 
(NHTSA) to be capable of detecting the presence of alcohol at the 0.02 
or greater level of alcohol concentration, they would be suitable for 
use within DOT regulated industry testing programs. Because NHTSA has 
approved a device, the operating mechanism of which differs from other 
ASDs, the Department had no Part 40 procedures for its use. This rule 
establishes procedures for the use of this device.

DATES: This rule is effective October 31, 2002.

FOR FURTHER INFORMATION CONTACT: Jim L. Swart, Drug and Alcohol Policy 
Advisor at 202-366-3784 (voice), 202-366-3897 (fax), or at: 
[email protected] (e-mail).

SUPPLEMENTARY INFORMATION:

Background

    When the Department originally published its alcohol testing rules 
on February 15, 1994 (54 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 would develop model specifications, evaluate additional screening 
devices, and periodically publish a conforming products list of those 
additional screening devices that meet model specifications. The 
Department noted, too, that the Department would also have to undertake 
separate rulemaking proceedings to establish procedures for use by DOT-
regulated industries of any devices after they are approved by NHTSA.
    On April 20, 1995 (FR Vol. 60, No. 76), the Department published 
procedures for use of ASDs, both breath devices and saliva devices. At 
that time, the Department did not anticipate that additional devices 
would be developed that, while using breath or saliva as the means of 
obtaining a result, would necessitate new procedures for their use. As 
a result, the revised Part 40 (65 FR 79462) published December 19, 2000 
stated, in part, that ASDs on the NHTSA conforming products list (CPL) 
could be used for Part 40 alcohol screening tests. Because NHTSA added 
an ASD to their CPL and the Department had no procedures for its use, 
we were forced to amend that rule. On August 9, 2001 (65 FR 41944) Part 
40 was amended to read, ``You may use an ASD that is on the NHTSA CPL 
for DOT alcohol tests only if there are instructions for its use in 
this part.''
    This effectively prevented use of this ASD for DOT testing purposes 
even though it was on NHTSA's CPL. The Department has taken steps to 
rectify this situation by developing procedures for this ASD's use and 
by amending the regulation accordingly. We have also taken the step to 
fine-tune the regulation to include in regulation text the fact that 
breath alcohol technicians (BAT), knowledgeable of how to use an ASD 
(or ASDs), can conduct screening tests using them.
    Instructions for use of the breath tube are somewhat parallel to 
those for the saliva device. Both devices prohibit use of the device 
after the expiration date has been reached. Both have procedures for 
conducting additional tests if proper procedures cannot be followed. 
Both have some similar fatal flaw criteria.
    The breath tube requires the STT or BAT to remove a tube from the 
box and break the device's ampule in the presence of the employee. The 
STT or BAT must then attach an inflation bag to the appropriate end of 
the tube. The employee is given the opportunity to hold the tube and 
provided instructions regarding how to blow (i.e., forcefully and 
steadily for approximately 12 seconds) through the tube.
    The rules also provide instructions for reading the results. In 
this case, the STT or BAT must compare the color of the crystals in the 
breath tube with the colored crystals on manufacturer-produced control 
tube. Comparisons must take place within specific time frames.
    Fatal Flaws'' require tests to be cancelled. Problems with the 
breath tube which cause fatal flaws are: The STT or BAT reads the 
device either sooner or after than the time allotted; and the device is 
used after its expiration date.
    The breath tube works this way. When a person's breath is blown 
though the tube it goes around and across the tube's crystals. If the 
person's breath contains no alcohol, the crystals remain their original 
color. However, if the person's breath contains alcohol, the alcohol 
causes a chemical reaction leading to a change in crystal color. A 
color change matching the color of crystals in the control tube is 
indicative of a screening test result that must subsequently be 
confirmed using an EBT. Such a color change indicates that the 
screening test result is 0.02 or above.

Regulatory Analyses and Notices

    This rule is not a significant rule for purposes of Executive Order 
12866 and DOT. It does not increase costs on regulated parties. In fact 
it may facilitate the use of a device 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.
    The Department is issuing this as a final rule without opportunity 
for notice and public comment. The Department determined that doing so 
would be impracticable, unnecessary, and contrary to the public 
interest because this breath device already appears on NHTSA's CPL and 
has, therefore, proven to be an accurate screening device for Part 40 
alcohol screening tests.

List of Subjects in 49 CFR Part 40

    Alcohol testing, Drug testing, laboratories, Reporting and 
recordkeeping requirements, Safety, Transportation.


[[Page 61522]]


    Issued this 20th day of September at Washington, DC.
Norman Y. Mineta,
Secretary of Transportation.

    For reasons set forth in the preamble, the Department of 
Transportation amends Part 40 of Title 49, Code of Federal Regulations, 
as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

    1. The authority citation for 49 CFR part 40 continues to read as 
follows:

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
45101 et seq.


     2. Revised Sec.  40.245 to read as follows:


Sec.  40.245  What is the procedure for an alcohol screening test using 
a saliva ASD or a breath tube ASD?

    (a) As the STT or BAT, you must take the following steps when using 
the saliva ASD:
    (1) Check the expiration date on the device or on the package 
containing the device and show it to the employee. You may not use the 
device after its expiration date.
    (2) Open an individually wrapped or sealed package containing the 
device in the presence of the employee.
    (3) Offer the employee the opportunity to use the device. If the 
employee uses it, you must instruct the employee to insert it into his 
or her mouth and use it in a manner described by the device's 
manufacturer.
    (4) If the employee chooses not to use the device, or in all cases 
in which a new test is necessary because the device did not activate 
(see paragraph (a)(7) of this section), you must insert the device into 
the employee's mouth and gather saliva in the manner described by the 
device's manufacturer. You must wear single-use examination or similar 
gloves while doing so and change them following each test.
    (5) When the device is removed from the employee's mouth, you must 
follow the manufacturer's instructions regarding necessary next steps 
in ensuring that the device has activated.
    (6)(i) If you were unable to successfully follow the procedures of 
paragraphs (a)(3) through (a)(5) of this section (e.g., the device 
breaks, you drop the device on the floor), you must discard the device 
and conduct a new test using a new device.
    (ii) The new device you use must be one that has been under your 
control or that of the employee before the test.
    (iii) You must note on the ``Remarks'' line of the ATF the reason 
for the new test. (Note: You may continue using the same ATF with which 
you began the test.)
    (iv) You must offer the employee the choice of using the device or 
having you use it unless the employee, in the opinion of the STT or 
BAT, was responsible (e.g., the employee dropped the device) for the 
new test needing to be conducted.
    (v) If you are unable to successfully follow the procedures of 
paragraphs (a)(3) through (a)(5) of this section on the new test, you 
must end the collection and put an explanation on the ``Remarks'' line 
of the ATF.
    (vi) You must then direct the employee to take a new test 
immediately, using an EBT for the screening test.
    (7) If you are able to successfully follow the procedures of 
paragraphs (a)(3)--(a)(5) of this section, but the device does not 
activate, you must discard the device and conduct a new test, in the 
same manner as provided in paragraph (a)(6) of this section. In this 
case, you must place the device into the employee's mouth to collect 
saliva for the new test.
    (8) You must read the result displayed on the device no sooner than 
the device's manufacturer instructs. In all cases the result displayed 
must be read within 15 minutes of the test. You must then show the 
device and it's reading to the employee and enter the result on the 
ATF.
    (9) You must never re-use devices, swabs, gloves or other materials 
used in saliva testing.
    (10) You must note the fact that you used a saliva ASD in Step 3 of 
the ATF.
    (b) As the STT or BAT, you must take the following steps when using 
the breath tube ASD:
    (1) Check the expiration date on the device or on the package 
containing the device and show it to the employee. You must not use the 
device after its expiration date.
    (2) Remove a device from the package and break the tube's ampule in 
the presence of the employee.
    (3) Secure an inflation bag onto the appropriate end of the device, 
as directed by the manufacturer on the device's instructions.
    (4) Offer the employee the opportunity to use the device. If the 
employee chooses to use (e.g. hold) the device, instruct the employee 
to blow forcefully and steadily into the blowing end of device until 
the inflation bag fills with air (approximately 12 seconds).
    (5) If the employee chooses not to hold the device, you must hold 
it and provide the use instructions in paragraph (b)(4) of this 
section.
    (6) When the employee completes the breath process, take the device 
from the employee (or if you were holding it, remove it from the 
employee's mouth); remove the inflation bag; and either hold the device 
or place it on a clean flat surface while waiting for the reading to 
appear.
    (7)(i) If you were unable to successfully follow the procedures of 
paragraphs (b)(4) through (b)(6) of this section (e.g., the device 
breaks apart, the employee did not fill the inflation bag), you must 
discard the device and conduct a new test using a new one.
    (ii) The new device you use must be one that has been under your 
control or that of the employer before the test.
    (iii) You must note on the ``Remarks'' line of the ATF the reason 
for the new test. (Note: You may continue using the same ATF with which 
you began the test.)
    (iv) You must offer the employee the choice of holding the device 
or having you hold it unless the employee, in the your opinion, was 
responsible (e.g., the employee failed to fill the inflation bag) for 
the new test needing to be conducted.
    (v) If you are unable to successfully follow the procedures of 
paragraphs (b)(4) through (b)(6) of this section on the new test, you 
must end the collection and put an explanation on the ``Remarks'' line 
of the ATF.
    (vi) You must then direct the employee to take a new test 
immediately, using another type of ASD (e.g., saliva device) or an EBT.
    (8) If you were able to successfully follow the procedures of 
paragraphs (b)(4) through (b)(6) of this section, you must compare the 
color of the crystals in the device with the colored crystals on the 
manufacturer-produced control tube no sooner than the manufacturer 
instructs. In all cases color comparisons must take place within 15 
minutes of the test.
    (9) You must follow the manufacturer's instructions for determining 
the result of the test. You must then show both the device and the 
control tube side-by-side to the employee and record the result on the 
ATF.
    (10) You must never re-use devices or gloves used in breath tube 
testing. The inflation bag must be voided of air following removal from 
a device. One inflation bag can be used for up to 10 breath tube tests.
    (11) You must note the fact that you used a breath tube device in 
Step 3 of the ATF.
    3. Amend Sec.  40.267 by revising the introductory text and 
paragraph (a) to read as follows:

[[Page 61523]]

Sec.  40.267  What problems always cause an alcohol test to be 
cancelled?

    As an employer, a BAT, or an STT, you must cancel an alcohol test 
if any of the following problems occur. These are ``fatal flaws.'' You 
must inform the DER that the test was cancelled and must be treated as 
if the test never occurred. These problems are:
    (a) In the case of a screening test conducted on a saliva ASD or a 
breath tube ASD:
    (1) The STT or BAT reads the result either sooner than or later 
than the time allotted by the manufacturer and this Part (see Sec.  
40.245(a)(8) for the saliva ASD and Sec. 40.245(b)(8) for the breath 
tube ASD).
    (2) The saliva ASD does not activate (see Sec.  40.245(a)(7); or
    (3) The device is used for a test after the expiration date printed 
on the device or on its package (see Sec.  40.245(a)(1) for the saliva 
ASD and Sec.  40.245(b)(1) for the breath tube ASD).
* * * * *
[FR Doc. 02-24731 Filed 9-30-02; 8:45 am]
BILLING CODE 4910-62-P