[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]
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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.
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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]
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