[Federal Register Volume 72, Number 7 (Thursday, January 11, 2007)]
[Rules and Regulations]
[Pages 1298-1299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-242]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-2007-26828]
RIN 2105-AD64


Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs: Procedures for Non-Evidential Alcohol Screening Devices

AGENCY: Office of the Secretary, DOT.

ACTION: Interim final rule.

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SUMMARY: The National Highway Transportation Safety Administration 
(NHTSA) has recently approved a new breath tube alcohol screening 
device (ASD) which will qualify for use in DOT Agency regulated testing 
once it appears on NHTSA's conforming products list (CPL). This interim 
final rule (IFR) will provide procedures for use of the new device and 
remove procedures for a previously approved breath tube ASD which is no 
longer being manufactured.

DATES: This rule is effective January 11, 2007. Comments to the interim 
final rule should be submitted by February 12, 2007. Late-filed 
comments will be considered to the extent practicable.

ADDRESSES: Written Comments: Submit written comments to the Docket 
Management System, U.S. Department of Transportation, Room PL-401, 400 
Seventh Street, SW., Washington, DC 20590-0001. You may submit comments 
identified by the docket number (OST-2007-26828) by any of the 
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Web site: http://dms.dot.gov. Follow the instructions for 
submitting comments on the DOT electronic docket site.
     Fax: 1-202-493-2478.
     Mail: Docket Management System; U.S. Department of 
Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, 
Washington, DC 20590-0001.
     Hand Delivery: To the Docket Management System; Room PL-
401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., 
Washington, DC between 9 a.m. and 5 p.m., Monday through Friday, except 
Federal Holidays.
    Instructions: All submissions must include the agency name and 
docket number or Regulatory Identification Number (RIN) for this 
notice. Note that all comments received will be posted without change 
to http://dms.dot.gov including any personal information provided.

FOR FURTHER INFORMATION CONTACT: George Ellis or Bohdan Baczara, Office 
of Drug and Alcohol Policy and Compliance, Room 10403, 400 Seventh 
Street, SW., Washington, DC 20590; 202-366-3784 (voice), 202-366-3897 
(fax), or [email protected] (e-mail).

SUPPLEMENTARY INFORMATION:

Purpose

    Department regulations require that in order for an employer to 
utilize a specific ASD to conduct required DOT alcohol tests, the 
device must (a) Have been approved by NHTSA as meeting required model 
specifications, (b) be published by NHTSA in the Federal Register on 
their most current ASD CPL, and (c) have Department-approved procedures 
in part 40 for its use. The procedures in this IFR will ensure that the 
NHTSA-approved breath tube ASD will be immediately available for use by 
employers upon publication of NHTSA's ASD CPL in the Federal Register.

Background

    When it 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 required 
method. However, in response to comments requesting additional 
flexibility in testing methods, the Department said that NHTSA would 
develop model specifications for non-evidential alcohol screening 
devices, evaluate additional screening devices against those 
specifications, and periodically publish a conforming products list of 
screening devices that met the model specifications. The Department 
noted, too, that the Department would also have to undertake separate 
rulemaking proceedings to establish part 40 procedures for use by DOT-
regulated industries of any devices approved by NHTSA.
    On April 20, 1995 (60 FR 19675), the Department published 
procedures for use of both breath and saliva ASDs. At that time, the 
Department did not anticipate that additional breath and saliva 
screening devices would be developed that would necessitate new 
procedures for their use. As a result, the revised part 40 published 
December 19, 2000 (65 FR 79462) stated, in part, that ASDs on the NHTSA 
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.''
    On October 1, 2002 (67 FR 61521), the Department published 
procedures for the use of a breath tube ASD that had been approved by 
NHTSA and added to their May 4, 2001 CPL (66 FR 22639). By 2005, that 
device was no longer being manufactured, and was removed from the CPL 
effective September 19, 2005 (70 FR 54972).
    NHTSA has recently approved a new breath tube ASD and anticipates 
adding it to their CPL in late January 2007. However, the breath tube 
procedures currently in our regulation are not consistent with 
instructions for use of the newly approved ASD. In this IFR, we have 
amended part 40 by eliminating procedures specific for the breath tube 
ASD which is no longer being manufactured and adding procedures for use 
of the newly approved device.
    Instructions for use of the new ASD are generally similar to those 
for the previously approved breath tube device. The principal 
difference is in how the alcohol result is read by the technician. 
Instead of comparing the color of the crystals in the ASD with the 
colored crystals in a manufacturer-produced control tube, the new ASD 
uses an electronic analyzer to provide the technician and the employee 
with an automated visual result of negative (a flashing green light) or 
positive (a flashing red light) at 0.02. The Department will retain the 
requirement to read the result within 15 minutes of the test to ensure 
a confirmation test, when necessary, is conducted in a timely manner.
    The addition of an electronic analyzer with this type of breath 
tube ASD will also add an entry to the list of fatal flaws which would 
require the alcohol screening test to be cancelled.

[[Page 1299]]

According to the manufacturer, each electronic analyzer is pre-
calibrated for use with a specific lot of detector devices. Use of an 
electronic analyzer not pre-calibrated for that lot will result in a 
fatal flaw.
    Please note that employers participating in the DOT alcohol testing 
program are not authorized to use the new alcohol screening device 
until it appears on the NHTSA ASD CPL.

Regulatory Analyses and Notices

    The statutory authority for this rule derives from the Omnibus 
Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 
5331, 20140, 31306, and 54101 et seq.) and the Department of 
Transportation Act (49 U.S.C. 322).
    This IFR is not significant for purposes of Executive Order 12866 
or the DOT's regulatory policies and procedures. It represents minor 
modifications to our procedures which do not increase costs on 
regulated parties. In fact, it would facilitate the use of an alcohol 
screening device that may increase flexibility and lower costs for 
employers who choose to use them over more expensive options already 
approved by the Department. Consequently, the Department certifies 
under the Regulatory Flexibility Act that this interim 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 negligible.
    Under the criteria of section 553 of the Administrative Procedure 
Act (APA), an agency may determine that prior notice and public comment 
are impractical, unnecessary, or contrary to the public interest. The 
Department believes that this interim change meets this requirement. 
The rule will impose no burdens on any parties, and NHTSA has already 
determined that the device is technically acceptable for use in the DOT 
alcohol testing program. We have concluded that it is necessary to make 
this procedural amendment without prior notice and comment in order to 
ensure that employers can use the ASD when it is placed on NHTSA's CPL 
as a qualified device (meeting DOT specifications for accuracy and 
precision). These same reasons provide good cause under the APA to make 
this rule effective immediately. The Department will, however, consider 
any comments concerning the procedures for use of the ASD.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedures, Alcohol abuse, Alcohol 
testing, Drug abuse, Drug testing, Laboratories, Reporting and 
recordkeeping requirements, Safety, Transportation.

49 CFR Subtitle A

Authority and Issuance

    Issued at Washington DC this 4th day of January, 2007.
Mary E. Peters,
Secretary of Transportation.

0
For reasons discussed 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 
TESING PROGRAMS

0
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.


0
2. Revise Sec.  40.245(b)(1), (2), (3), (6), (8), (9), and (10) 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?

* * * * *
    (b) * * *
    (1) Check the expiration date on the detector device and the 
electronic analyzer or on the package containing the device and the 
analyzer and show it to the employee. You must not use the device or 
the analyzer after their expiration date. You must not use an analyzer 
which is not specifically pre-calibrated for the device being used in 
the collection.
    (2) Remove the device from the package and secure an inflation bag 
onto the appropriate end of the device, as directed by the manufacturer 
on the device's instructions.
    (3) Break the tube's ampoule in the presence of the employee.
* * * * *
    (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 prepare the device to 
be read by the analyzer in accordance with the manufacturer's 
directions.
* * * * *
    (8) If you were able to successfully follow the procedures of 
paragraphs (b)(4) through (b)(6) of this section and after having 
waited the required amount of time directed by the manufacturer for the 
detector device to incubate, you must place the device in the analyzer 
in accordance with the manufacturer's directions. The result must be 
read from the analyzer no earlier then the required incubation time of 
the device. In all cases, the result must be read within 15 minutes of 
the test.
    (9) You must follow the manufacturer's instructions for determining 
the result of the test. You must show the analyzer result to the 
employee and record the result on Step 3 of the ATF.
    (10) You must never re-use detector devices or any gloves used in 
breath tube testing. The inflation bag must be voided of air following 
removal from a device. Inflation bags and electronic analyzers may be 
re-used but only in accordance with the manufacturer's directions.
* * * * *

0
3. Amend Sec.  40.267 by adding a new paragraph (a)(4) to read as 
follows:


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

    (a) * * *
    (4) The breath tube ASD is tested with an analyzer which has not 
been pre-calibrated for that device's specific lot (see Sec.  
40.245(b)(1)).
* * * * *
 [FR Doc. E7-242 Filed 1-10-07; 8:45 am]
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