[Federal Register Volume 73, Number 166 (Tuesday, August 26, 2008)]
[Rules and Regulations]
[Pages 50222-50226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19816]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-2003-15245]
RIN 2105-AD55


Procedures for Transportation Workplace Drug Testing Programs

AGENCY: Office of the Secretary, DOT.

[[Page 50223]]


ACTION: Change in effective date; request for comments.

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SUMMARY: In response to petitions from certain transportation industry 
and labor groups, the Department of Transportation is changing the 
effective date of 49 CFR 40.67(b) from August 25, 2008, to November 1, 
2008. The Department is also requesting comments concerning the content 
of Sec.  40.67(b) for 30 days. This section of the Department's drug 
testing procedural rule requires employers to ensure that all follow-up 
and return-to-duty drug tests are directly observed.

DATES: The effective date of the revision of 49 CFR 40.67(b) published 
June 25, 2008 (73 FR 35970) is delayed from August 25, 2008, to 
November 1, 2008. Comments should be submitted by September 25, 2008.

ADDRESSES: You may submit comments identified by the docket number 
(OST-2003-15245) by any of the following methods:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting 
comments.
    <bullet> Fax: 1-202-493-2251.
    <bullet> Mail: Docket Operations, U.S. Department of 
Transportation, West Building, Ground Floor, Room W12-140, Routing 
Symbol M-30, 1200 New Jersey Avenue, SE., Washington, DC 20590.
    <bullet> Hand Delivery: To Docket Operations, Room W12-140 on the 
ground floor of the West Building, 1200 New Jersey Avenue, SE., 
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, 
except Federal Holidays.
    Instructions: Identify the agency and docket number (OST-2003-
15245) at the beginning of your submission. Except for comments that 
receive confidential treatment, all comments received will be posted 
without change to the Federal Docket Management System (FDMS), 
including any personal information provided. Detailed instructions for 
requesting confidential treatment are provided below, under the Privacy 
Act heading.
    Docket: For access to the dockets to read background documents or 
comments received, go to http://www.regulations.gov or DOT's Docket 
Operations Office (see ADDRESSES).
    Privacy Act: Anyone is able to search the electronic form of any 
written communications and comments received into any of our dockets by 
the name of the individual submitting the document (or signing the 
document, if submitted on behalf of an association, business, labor 
union, etc.). You may review DOT's complete Privacy Act Statement in 
the Federal Register published on April 11, 2000 (Volume 65, Number 70; 
Pages 19477-78), which may also be found at http://www.regulations.gov.
    You may request confidential treatment of comments or portions of 
comments under the procedures set forth in 49 CFR part 105. While all 
comments should be sent to the FDMS, OST will consider separately and 
not place in the public docket those comments or portions of comments 
OST determines to include trade secrets, other confidential commercial 
information, or sensitive security information (SSI). In accordance 
with 49 CFR 105.30, you may ask OST to keep information confidential 
using the following procedures: (1) Mark ``confidential'' on each page 
of the original document you would like to keep confidential; (2) send 
FDMS both the original document and a second copy of the original 
document with the confidential information redacted; and (3) explain 
why the information is confidential (as a trade secret, other 
confidential commercial information, or SSI). In your explanation, you 
should provide enough information to enable OST to determine whether 
the information provided is protected by law and must be handled 
separately.

FOR FURTHER INFORMATION CONTACT: For program issues, Jim Swart, 
Director, Office of Drug and Alcohol Policy and Compliance, 1200 New 
Jersey Avenue, SE., Washington, DC 20590; (202) 366-3784 (voice), (202) 
366-3897 (fax), or <a href="/cdn-cgi/l/email-protection#ed878480c39e9a8c9f99ad898299c38a829b"><span class="__cf_email__" data-cfemail="99f3f0f4b7eaeef8ebedd9fdf6edb7fef6ef">[email protected]</span></a> (e-mail). For legal issues, Robert 
C. Ashby, Deputy Assistant General Counsel for Regulations and 
Enforcement, 1200 New Jersey Avenue, SE., Washington, DC 20590; (202) 
366-9310 (voice); (202) 366-9313 (fax); or <a href="/cdn-cgi/l/email-protection#0b696469256a786369724b6f647f256c647d"><span class="__cf_email__" data-cfemail="1d7f727f337c6e757f645d797269337a726b">[email protected]</span></a> (e-mail).

SUPPLEMENTARY INFORMATION: This document responds to petitions and 
letters from several parties seeking to postpone the effective date of 
portions of the Department's June 25, 2008, final rule amending 49 CFR 
part 40 (73 FR 35961) and/or reconsider these provisions. The petitions 
concern the new section 40.67(b) and (i), described in more detail 
below. Petitioners include the Association of American Railroads (AAR), 
joined by the American Short Line and Regional Railroad Association; 
the Transportation Trades Department (TTD) of the AFCL-CIO; the 
International Brotherhood of Teamsters; and the Air Transport 
Association (ATA), joined by the Regional Airline Association (RAA).

Background

    On October 31, 2005, the Department of Transportation issued a 
notice of proposed rulemaking (NPRM) to amend 49 CFR part 40, the 
Department's drug and alcohol testing procedures rule (70 FR 62276). 
The primary purpose of the NPRM was to propose making specimen validity 
testing (SVT) mandatory. Mandatory SVT is an important step in 
combating the safety problem of cheating on drug tests. The two 
provisions that are the subject of the petitions concern direct 
observation (DO), another significant tool the Department uses to 
combat cheating.
    The history of DO testing under part 40 goes back to the beginnings 
of the Department's drug testing program. The principle that animates 
this history is that DO, because it is intrusive, is appropriate to 
use, not in the great mass of testing situations (e.g., all pre-
employment and random tests), but only in those situations in which 
there is a heightened incentive to cheat or circumstances demonstrating 
the likelihood of cheating. In this way, the Department has maintained 
the proper balance between the legitimate privacy expectations of 
employees and the safety and program integrity interests of the 
Department. As a result, DO tests constitute only a tiny percentage of 
the drug tests conducted each year under DOT drug testing rules.
    In the December 1, 1989, preamble to part 40 (54 FR 49854), we said 
that the limitations on using observed collections in only four 
circumstances would be maintained despite the fact that some comments 
requested that the Department allow greater discretion for observed 
collections. The Department decided that ``existing safeguards in part 
40 are adequate to prevent tampering and that direct observation, 
because of its increased intrusiveness, should be strictly limited.'' 
The Department considered that limiting the circumstances that would 
result in a DO is ``one factor in the balance between privacy and 
safety necessity considered by the courts.''
    The preamble went on to say that some comments specifically opposed 
direct observation ``as part of follow-up (i.e., post-positive) 
testing, while other commenters favored this practice.'' We said that 
the Department ``believes that direct observation may be a useful tool 
in follow-up testing.'' There was concern expressed about drug use 
relapses, especially for cocaine. We went on to say, ``An individual 
who has returned to work after rehabilitation but has suffered such a 
relapse may have a greater incentive to attempt to beat a

[[Page 50224]]

follow-up test, because the employer may not provide a second 
opportunity for rehabilitation.'' Regarding directly observed follow-up 
testing, the preamble concludes, ``If the employer or EAP counselor 
believes that this may be the case, the opportunity for direct 
observation should exist.''
    Currently, section 40.67(a) requires that employers direct an 
immediate collection under direct observations in three circumstances: 
(1) When the laboratory reported an invalid specimen and the MRO 
reported that there was not an adequate medical explanation for the 
result; (2) when the MRO reports to the employer that the original non-
negative result had to be cancelled because there was not a split 
specimen available for testing; and (3) when the MRO reports a 
negative-dilute specimen with a creatinine concentration greater than 
or equal to 2 mg/L or less than or equal to 5 mg/L. We added the third 
provision in 2003 in an interim final rule (68 FR 31624, May 28, 2003) 
and revised it in an interim final rule (69 FR 64865). Direct 
observation is also mandated at collection sites if the collector finds 
materials brought to the collection site to tamper with a specimen 
(section 40.61(f)(5)(i)), determines that a specimen is out of 
temperature range (section 40.65(b)(5)) or detects other evidence 
indicating an attempt to tamper with a specimen (section 40.65 (c)(1)). 
In addition, employers are currently allowed, but not required, to 
order a directly observed test under section 40.67(b) for return-to-
duty and follow-up tests.
    We acknowledge that DO collections are, and always have been, 
controversial. In the December 19, 2000 preamble to a major update to 
part 40 (65 FR 79462), about observed collections we said, ``Directly 
observed specimens are controversial because of their greater impact on 
employee privacy. They can be useful because they reduce the 
opportunity for tampering. On privacy grounds, some commenters, 
including unions and some service agents, would prefer not to conduct 
directly observed collections at all.'' (65 FR at 79489) These 
commenters opposed adding any situations in which direct observation 
was authorized or required.
    The 2000 preamble went on to say, ``Other commenters said that the 
benefit of greater protection against specimen tampering warranted 
direct observation in situations that suggested a heightened risk of 
tampering.'' (65 FR at 79489) The Department agreed with these 
commenters and increased the number of circumstances for which an 
observed collection was required or authorized. In circumstances that 
pose a higher risk or greater risk for tampering, ``the interests of 
the integrity of the testing process, with its safety implications, 
outweigh the additional privacy impact of the direct observation 
process.'' (65 FR at 79489-79490)
    More recently, there has been a sharply increased emphasis, at the 
level of national policy, on the problem of cheating and how to deal 
with it. The Department has been aware for several years of the 
increasing proliferation of products designed and sold to help workers 
who use drugs defeat drug tests. Not only was the Department working on 
the specimen validity testing rulemaking between 2005 and 2008, but the 
United States Congress was conducting its own inquiries on the issues.
    During a May 17, 2005 hearing before the Investigations Committee 
on Energy and Commerce, the Department of Health and Human Services 
provided the following testimony regarding prosthetic devices 
delivering synthetic or drug-free human urine:

    The most cumbersome, yet highly effective, way to beat a urine 
drug test is to use a physical belt-like device hidden under the 
clothing which contains a reservoir to unobtrusively hold real human 
urine from another person that is free from drugs, and deliver that 
bogus specimen into the collection container through a straw-like 
tube, or through a prosthetic device that looks like real human 
anatomy, color-matched. This last described device is heavily 
marketed for workplace drug testing and criminal justice urine 
collection situations that require directly observed urine specimens 
to be provided. Synthetic urine can be used in place of real human 
drug free urine. [Testimony before the Subcommittee on Oversight and 
Investigations Committee on Energy and Commerce United States House 
of Representatives Products Used to Thwart Detection in Drug Testing 
Programs, Statement of Robert L. Stephenson II, M.P.H. Director, 
Division of Workplace Programs Center for Substance Abuse 
Prevention, Substance Abuse and Mental Health Services 
Administration, U.S. Department of Health and Human Services at 
pages 4-5].

    Also at the 2005 hearing, the GAO testified that

    In summary, we found that products to defraud drug tests are 
easily obtained. They are brazenly marketed on Web sites by vendors 
who boast of periodically reformulating their products so that they 
will not be detected in the drug test process. In addition to an 
array of products designed to dilute, cleanse, or substitute urine 
specimens submitted to testers by drug users, approximately 400 
different products are available to adulterate urine samples. The 
sheer number of these products, and the ease with which they are 
marketed and distributed through the Internet, present formidable 
obstacles to the integrity of the drug testing process. [Testimony 
Statement of Robert J. Cramer, Managing Director, Office of Special 
Investigations, the United States Government Accountability Office 
(GAO), before the Chairman, Subcommittee on Oversight and 
Investigations, Committee on Energy and Commerce, House of 
Representatives, GAO-05-653T, May 1, 2005].

    On November 1, 2007, following media coverage regarding compromised 
collection integrity and security issues, the Congressional 
Subcommittee on Transportation and Infrastructure held a hearing on the 
problem of cheating on DOT-required tests. At the hearing, the GAO 
testified at the hearing about the threat to the integrity of the 
testing program posed by the devices being used to substitute urine in 
DO collections. In the final report the GAO issued in May of 2008, the 
GAO noted that the ease of subverting the testing process was a factor 
contributing to failures to detect drug use. Specifically, GAO noted 
that transportation employees ``are successfully adulterating or 
substituting their urine specimens with products that are widely 
available and marketed as * * * [ways to beat a test.]'' [GAO Report 
No. GAO-08-600, Motor Carrier Safety: Improvements to Drug Testing 
Programs Could Better Identify Illegal Drug Users and Keep them off the 
Road, May 2008 at pages 2-3.] The GAO further found that ``Several 
hundred products designed to dilute, cleanse, or substitute urine 
specimens can be easily obtained.'' [GAO Report No. GAO-08-600 at page 
20.]
    In light of the by-now well-recognized availability of substances 
and devices for substituting or adulterating specimens, the 
Department's premise for the changes it made to section 40.67 was that 
taking additional steps to combat cheating on drug tests was 
appropriate. Such steps are needed to avoid damage to the safety 
purposes of the program. Given the greater availability of means to 
cheat on tests, compared to the late 1980s, the Department took the 
position in the June 25 final rule that it is appropriate to strike the 
balance between the Department's interests in safety and program 
integrity and employees' interest in privacy at a different point than 
it did two decades ago.
    In the Omnibus Transportation Employee Testing Act of 1991, 
Congress recognized that, while privacy is a very important value in 
the drug testing process, it is not an absolute value. The Act directs 
the Department to ``promote, to the maximum extent practicable, 
individual privacy in the collection of specimens'' (49 U.S.C. 
20140(c)(1), emphasis added). In issuing the June 25

[[Page 50225]]

final rule, the Department, in effect, took the position that it is no 
longer ``practicable'' to operate a drug testing program without adding 
countermeasures to well-publicized cheating techniques and devices.

New Procedure To Check for Prosthetic Cheating Devices

    Based on what the Department viewed as the need for additional 
safeguards against prosthetic devices used to cheat on DO tests, the 
Department explicitly sought comment in its October 2005 NPRM (70 FR 
62281), on whether collectors should check to make sure that employees 
providing a specimen under DO are not using a prosthetic device to 
cheat on the test (e.g., by having an employee lower his pants and 
underwear so that the collector or observer could determine whether the 
employee was using such a device).
    In the preamble to the Department's final rule based on this NPRM 
(73 FR 35968), the Department responded to comments on this proposal. 
This response set forth the Department's rationale for adopting a new 
provision, found in section 40.67(i), requiring employees to raise and 
lower their clothing to show the collector or observer that the 
employee is not using a prosthetic device. The Department reaffirms 
this rationale, and the Department does not believe that any delay in 
the effective date of this provision is appropriate. The Department 
believes that there would be nothing to be gained by delaying this 
significant anti-cheating, pro-safety initiative.
    Consequently, this provision will go into effect, as scheduled, on 
August 25, 2008. The Department is not soliciting further comment on 
section 40.67(i). The effect of this decision is that, beginning August 
25, 2008, observers in all DO collections will be required to carry out 
the anti-prosthetic device procedure of section 40.67(i) in all 
directly observed collections, including FU and RTD tests where 
employers choose to use DO. There is no requirement to use the section 
40.67(i) procedure except in circumstances where DO tests otherwise are 
taking place.
    We do not believe that petitioners have made a persuasive case that 
a delay is necessary to train collectors in this new procedure, which 
is simple to carry out and easy to understand. Moreover, it is 
observers--who need not be trained collectors--who are to carry out the 
task of having employees raise and lower clothing to determine whether 
prosthetic cheating devices are present. Any individual of the 
appropriate gender should be able to perform this function with minimal 
instruction. In addition, having waited until mid-August to file their 
petitions saying they had insufficient time to train personnel, 
railroad and aviation employers appear to have missed the opportunity 
to begin training personnel during the several weeks since the June 
publication of the final rule, if they believed additional time to be 
necessary.
    It is important for employers to keep in mind, in view of the 
Department's decision to postpone the effective date of section 
40.67(b), that for the period between August 25 and October 31, 2008, 
there will be no need to recruit or train additional observers, because 
there will be no additional direct observation tests required beyond 
those the Department's rules required before August 25. All that will 
be required during this period is that employers and collection 
contractors instruct observers to follow the additional procedure to 
guard against the use of prosthetic devices.
    We also note that it is common for DOT operating administrations' 
enforcement personnel, in the initial months of a new requirement, to 
focus on information and education rather than the imposition of 
penalties. Employers who are making good faith efforts to comply with 
the provision should benefit from this typical enforcement practice.

Mandatory Use of Direct Observation in Return-to-Duty and Follow-up 
Testing

    At the end of the discussion of this provision on page 35968 of the 
final rule preamble, the Department said, in the context of taking 
additional steps to address the problem of cheating on drug tests, that 
DO would be required for all FU and RTD tests. The new requirement was 
included as section 40.67(b). Under part 40 as it existed before this 
amendment, employers had the discretion to require direct observation 
in FU and RTD tests, but were not mandated to do so.
    In the Department's view, this new requirement was a logical 
outgrowth of the development of the Department's increasing efforts to 
deal with the problem of cheating in drug tests. Even though we did not 
foresee [and few did] in 1989 the degree to which products designed to 
beat the drug test would be available, the Department was concerned 
about specimen tampering and about the heightened motivation of those 
employees returning to safety sensitive positions after positive tests 
to tamper with their specimens. That concern has increased in recent 
years as information about the widespread availability of cheating 
products has become available.
    As a consequence, the Department believed, in adding this 
provision, that it was important for us to be consistent with the other 
DO provisions, which make DO testing mandatory in circumstances 
involving heightened motivation for or evidence suggesting attempts to 
cheat (see sections 40.61(f)(5)(i); 40.65 (b)(5) and (c)(1); 40.67(a)). 
In all these cases, use of DO is mandatory. If safety necessitates a DO 
in one of these circumstances, then, the Department believed, safety 
likewise necessitates DO as part of FU and RTD tests. The Department 
was mindful that everyone who has to take an RTD or FU test had already 
violated the rule (e.g., by testing positive or refusing to test), 
showing that he or she has behaved in a way that presents an increased 
risk to transportation safety. Such employees will be acutely aware 
that that they must test negative on all RTD and FU tests in order to 
regain or retain their ability to perform safety-sensitive functions. 
These circumstances, the Department believed, present just the sort of 
heightened incentive for cheating on a test that DO testing is intended 
to combat.
    It was but a modest, incremental step from the current regulation's 
authorization of DO in FU and RTD situations to the June 25 final 
rule's requirement for DO in these situations. Consequently, the 
Department believed that taking this step was timely and appropriate.

Postponement of Effective Date of Section 40.67(b) and Request for 
Comment

    Petitioners pointed out that the Department's 2005 NPRM did not 
specifically raise for comment a proposal to make DO testing mandatory, 
rather than discretionary, in FU and RTD testing. While the Department 
believes, as discussed above, that section 40.67(b) is justified as a 
logical outgrowth of Part 40 rulemaking, even in the absence of a 
specific request for comment, the Department will seek comment on 
section 40.67(b) for 30 days.
    In order to accommodate this comment period, as well as to allow 
time for the Department to review and respond to any comments we 
receive, the Department will change the effective date of section 
40.67(b) to November 1, 2008, the date suggested by petitioners. We 
want all interested parties to realize that this change in the 
effective date affects ONLY section 40.67(b). The rest

[[Page 50226]]

of the June 25, 2008, final rule goes into effect on August 25, 2008, 
as scheduled.
    We will place the petitions we have received into the docket, and 
we will consider the arguments made in these petitions about the 
content of section 40.67(b) along with other comments that we receive. 
On the basis of the comments we receive and any other information 
available to the Department, the Department will reconsider section 
40.67(b) and may retain, eliminate, or modify it.
    Because this action and the decision not to take similar action 
with respect to section 40.67(i) also completely respond to the 
parallel petitions to the Federal Railroad Administration (FRA) by some 
of the same parties, which raise the same issues about the same 
provisions of part 40, FRA is not taking any separate action on the 
petitions concerning the implementation of the amendments to 40.67 in 
the railroad industry.

    Issued this 21st day of August, 2008, at Washington, DC.
Jim Swart,
Director, Office of Drug and Alcohol Policy and Compliance.
[FR Doc. E8-19816 Filed 8-22-08; 11:15 am]
BILLING CODE 4910-9X-P


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