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###### Department of Transportation

###### Office of the Secretary

          - 49 CFR Part 40
          - [Docket OST-2003-15245]
          - RIN 2105-AD55

# AGENCY:

Office of the Secretary, DOT.

      ( print page 50223)    

# ACTION:

Change in effective date; request for comments.

# 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 § 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                           ( print 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                           ( print 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                           ( print 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]

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