
[Federal Register: August 26, 2008 (Volume 73, Number 166)]
[
Rules and Regulations]               
[Page 50222-50226]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au08-11]                         

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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:

     Federal eRulemaking Portal: Go to http://

www.regulations.gov. Follow the online instructions for submitting 

comments.

     Fax: 1-202-493-2251.

     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.

     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 jim.swart@dot.gov (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 bob.ashby@dot.gov (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
