Procedures for Transportation Workplace Drug and Alcohol Testing Programs, 62910-62918 [E8-25102]

Agencies

• Office of the Secretary
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 73, Number 205 (Wednesday, October 22, 2008)]
[Rules and Regulations]
[Pages 62910-62918]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25102]


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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 and Alcohol Testing 
Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Response to comments.

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SUMMARY: The Department is issuing this notice to respond to comments 
on the amendment to 49 CFR 40.67(b) issued as part of a final rule on 
June 25, 2008. The Department is not changing this amendment, which 
will go into effect, as scheduled, on November 1, 2008. Beginning on 
that date, direct observation collections will be required for all 
return-to-duty and follow-up tests. When additional testing 
methodologies appropriate for use in return-to-duty and follow-up 
testing (e.g., oral fluid and sweat specimens) are approved by the 
Department of Health and Human Services and adopted by the Department, 
the Department intends to make these methods available to employers and 
employees as an alternative to direct observation urine testing in 
these situations.

DATES: The effective date of 49 CFR 40.67(b), as amended by the 
Department on June 25, 2008, and delayed on August 26, 2008, is 
November 1, 2008.

FOR FURTHER INFORMATION CONTACT: Jim L. Swart, Director, U.S. 
Department of Transportation, 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; or Robert 
C. Ashby, Deputy Assistant General Counsel for Regulation and 
Enforcement, U.S. Department of Transportation, same address, (202) 
366-9310 (voice), (202) 366-9313 (fax), or bob.ashby@dot.gov.

SUPPLEMENTARY INFORMATION: 

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. Based on this 
NPRM, the Department issued a final rule on June 25, 2008 (73 FR 
35961). The final rule included two provisions (49 CFR 40.67(b) and 
(i)) concerning the use of direct observation (DO) collections, another 
significant tool the Department uses to combat cheating.
    Petitioners, including the Association of American Railroads (AAR), 
joined by the American Short Line and Regional Railroad Association; 
the Transportation Trades Department (TTD) of the American Federation 
of Labor and Congress of Industrial Organizations (AFL-CIO); the 
International Brotherhood of Teamsters; and the Air Transport 
Association (ATA), joined by the Regional Airline Association (RAA), 
asked the Department to delay the effective date of these two 
provisions, seek further comment on them, and reconsider them. In 
response to these petitions, the Department issued a notice delaying 
the effective date of 49 CFR 40.67(b) until November 1, 2008 (73 FR 
50222; August 26, 2008). We opened a comment period on that provision, 
which closed on September 25, 2008. The Department did not delay the 
effective date of 49 CFR 40.67(i), which went into effect, as 
scheduled, on August 25, 2008.
    The history of DO collections 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 not 
appropriate to use 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

[[Page 62911]]

expectations of employees and the safety and program integrity 
interests of the Department. As a result, DO collections constitute 
only a tiny percentage of the drug collections conducted each year 
under DOT drug testing rules. DO collections have always required the 
use of a same-gender observer and for the observer to watch the flow of 
urine from the individual's body into the collection container.
    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 collection is ``one factor in the balance between 
privacy and safety necessity considered by the courts.''
    The preamble went on to say that some commenters 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 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 [employee assistance 
program] counselor believes that this may be the case, the opportunity 
for direct observation should exist.''
    Currently, section 40.67(a) requires that employers direct 
immediate collections under direct observation in three circumstances: 
(1) When the laboratory reported an invalid specimen (e.g., one that 
has an interfering substance preventing a normal result but the 
laboratory cannot identify a specific adulterant) and the Medical 
Review Officer (MRO) reported that there was not an adequate medical 
explanation for the result; (2) when the MRO reports to the employer 
that the original positive, adulterated, or substituted test 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/dL or less than 
or equal to 5 mg/dL. We added the third provision in 2003 in an interim 
final rule (68 FR 31624) and revised it in an interim final rule (69 FR 
64865). All these situations involve results indicating a heightened 
risk of cheating or that an attempt to cheat had taken place.
    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)). 
These are also situations involving evidence indicating an attempt to 
cheat. 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. The Department is well aware that they intrude on 
personal privacy to a greater extent than non-observed collection 
methods, and consequently we have limited the use of DO to situations 
where we believe using this approach is necessary to protect the 
integrity of the testing process and strengthen the safety objectives 
of the program. 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. 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. As a result we have worked on specimen 
validity testing rulemaking.
    Also, based upon our concerns and those expressed to us by 
collection site personnel and medical review officers about use of 
these products, we issued in July 2007 an interpretation outlining 
additional examples of an employee's failure to cooperate with the 
testing process that would cause a refusal to test. In that 
interpretation we said that one refusal to test would be: ``The 
employee is found to have a device--such as a prosthetic appliance--the 
purpose of which is to interfere with providing an actual urine 
specimen.'' We also gave instructions to collectors about how to handle 
this situation.
    Not only was the Department working on the specimen validity 
testing rulemaking between 2005 and 2008, but also 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 (HHS) 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 United States Government 
Accountability Office (GAO) testified that:

    In summary, we found that products to defraud drug tests are 
easily obtained. They

[[Page 62912]]

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 about the threat to the integrity of the testing program 
posed by the devices being used to substitute urine in DO collections. 
In its final report issued in May 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 placing the traveling 
public in danger of workers who try to cheat on their drug tests. 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 final rule, the 
Department, 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.
    With respect specifically to the new section 40.67(b), the 
Department, in the June 25 final rule, said that DO collections would 
be required for all follow-up and return-to-duty tests. The new 
requirement, aimed at counteracting cheating in these tests, was 
included as section 40.67(b). It read, ``As an employer, you must 
direct a collection under direct observation of an employee if the drug 
test is a return-to-duty test or a follow-up test.'' Under Part 40 as 
it existed before this amendment, employers had the discretion to 
require direct observation in follow-up and return-to-duty tests, but 
were not mandated to do so. It is significant that employers rarely 
exercised this important option.
    Notably, the November 1, 2007 GAO report indicated that even when 
collectors followed the appropriate procedures for integrity and 
security of specimens, the GAO inspectors were able to bring 
adulterants into the collection sites and successfully adulterate their 
specimens. These adulterants went undetected during laboratory testing. 
The GAO report said:

    Even in cases where the collector followed DOT protocol and 
asked our investigator to empty his pockets, our investigators 
simply hid these products in their pockets and elsewhere in their 
clothing.* * * Investigators determined that there is information on 
the Internet about concealing drug-masking products. For example, 
one Web site noted that ``although most testing sites will require 
you to remove items from your pockets, it is still possible to sneak 
in another specimen.''

    In the Department's view, this new requirement mandating DO for 
return-to-duty and follow-up testing 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 in 
1989 the degree to which products designed to beat the drug test would 
later become available, the Department was concerned about specimen 
tampering and about the heightened motivation of those employees 
returning to safety sensitive positions after positive tests or 
refusals 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 collection provisions, which make DO collections 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 collections as 
part of follow-up and return-to-duty tests. The Department was mindful 
that everyone who has to take a return-to-duty or follow-up test had 
already violated the rule (e.g., by testing positive or refusing to 
test), showing that he or she has knowingly chosen to act in a way that 
presents an increased risk to transportation safety. Such employees 
will be acutely aware that they must test negative on all return-to-
duty and follow-up 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 collections are intended to combat.
    It was but a modest, incremental step from the current regulation's 
authorization of DO in follow-up and return-to-duty 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. Nevertheless, the NPRM had not specifically requested 
comments on this subject, and the Department consequently opened a 
comment period on this provision and delayed its effective date until 
November 1, 2008.
    In considering all issues regarding drug testing, the Department 
keeps squarely in mind the vital safety purposes of its program. Recent 
multi-fatality transportation accidents in which drug use by safety-
sensitive personnel was involved underline the importance of deterring 
use of illegal drugs by transportation workers. When workers who use 
drugs believe they can get away with their misconduct by cheating, the 
deterrent effect of the

[[Page 62913]]

Department's rules is undermined. This is detrimental to public safety, 
and the Department cannot tolerate it.

Comments and DOT Responses

    The docket includes 86 comments. The breakdown of comments by 
source is the following:

Substance Abuse Professionals: 20
Unions or other employee organizations: 17
Collection sites or collection site organizations: 16
Individual employees: 10
Other individuals: 9
Employers or employer organizations: 9
Third-party Administrators: 3
Laboratories: 1
Medical Review Officers: 1

Some union and employer commenters are represented twice in this 
breakdown (e.g., because the docket includes a petition requesting an 
opportunity for further comment and an additional comment from the same 
organization once the docket was opened). Many of the individual 
comments from employees and others were submitted anonymously.

Comments on Direct Observation Procedure (Section 40.67(I))

    The August 26, 2008, notice opening a comment period sought 
comments only on the provision of section 40.67(b) that would make DO 
mandatory, rather than optional, in follow-up and return-to-duty 
testing. The notice specifically said that comments were not sought on 
the provisions of section 40.67(i). This section, which went into 
effect August 25, 2006, requires observers in directly observed 
collections to direct employees to raise and lower clothing and turn 
around, so that the observer can note any prosthetic or other device 
that the employee may possess in an attempt to cheat on the test.
    Nevertheless, a number of parties did comment on 40.67(i). One 
union and a comment from two employer organizations said that the 
Department should have postponed the effective date for this provision 
and opened a comment period, since in their view the notice of proposed 
rulemaking leading to the June 25 rule did not provide sufficient 
notice concerning the provision. Twenty commenters, mostly unions and 
individual employees, but also including a few collection sites, 
objected to the idea of the revised observation procedure, saying that 
it was too great an intrusion on employees' privacy. Many of these 
commenters also said that there was insufficient evidence that people 
in transportation industries were actually using prosthetic and other 
devices, and that therefore the Department's countermeasure was 
unnecessary. Two commenters expressed the concern that the rule could 
create confusion among collectors between cheating devices and 
medically-necessary prostheses, or devices used as a form of sexual 
expression, with the result that users of legitimate devices could 
unfairly be determined to have refused to test. Two Substance Abuse 
Professionals (SAPs) who commented on the provision and a Third Party 
Administrator (TPA) supported its inclusion, as a useful measure to 
counter attempts to cheat.

DOT Response

    Because matters concerning section 40.67(i) are outside the scope 
of the August 26 notice, these comments are not relevant to the 
decision the Department is making in this document: whether the 
provisions of section 40.67(b) should be retained, removed, or 
modified.
    We would note, however, that the basic procedure of body-to-bottle 
direct observation of certain tests involving a heightened risk of 
cheating, or evidence of a possible attempt to cheat, has been part of 
the Department's testing procedure since the program's beginnings in 
the 1980s. As attempts to cheat even on direct observation tests have 
become more sophisticated over the years--the Department's 1988-89 
testing procedure rules did not need to take prosthetic and other 
cheating devices into account, in particular--it is important for the 
Department's procedures to change to accommodate new circumstances. 
People who believe they can use cheating devices to get away with using 
illegal drugs while continuing to perform safety-sensitive functions 
are a threat to public safety.
    Some commenters argued that the Department has not provided data on 
how often prosthetic and other cheating devices are being used, so the 
Department need not take measures to prevent their use. The anecdotal 
evidence provided by several commenters to the docket, along with 
experience the Department has gained through the compliance activities 
of the DOT Agencies, provides sufficient justification to us that such 
devices are not only readily available, but are actually being used. 
The successful use of prosthetic and other cheating devices is, by 
nature, a matter of stealth. If someone uses such a device, and gets 
away with it, the drug test result will be a negative test result. 
Consequently, the cheater's action will never turn up in drug testing 
statistics. It is illogical to argue that the Department cannot take 
action to prevent cheating because successful cheating is absent from 
the program's statistics.
    The Department disagrees with commenters who said that there was 
insufficient notice of this anti-prosthetic provision in the NPRM. 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 or other 
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). This notice fully meets 
the requirement of the Administrative Procedure Act (APA) for a 
meaningful participation from the public by fairly apprising interested 
persons of the issues in the rulemaking. While DOT and agencies 
commonly do publish proposed rule text, there is no statutory 
requirement in the APA to do so, and doing so is not a mandatory 
prerequisite to issuing a final rule. A ``description of the subjects 
and issues involved'' (5 U.S.C. 553(b)(3)) is sufficient. That the 
notice did provide interested persons a meaningful opportunity to 
comment on this issue is evidenced by the comments that the Department 
in fact received.
    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 the 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 does not possess a prosthetic or other device designed to beat 
the test.
    The Department has fully explained in regulation text, guidelines, 
and supportive materials that the devices subject to the new procedures 
would be those expressly designed to interfere with the collection 
process (e.g., designed to carry ``clean'' urine or urine substitutes 
into the collection site). Likewise, our guidelines have always had 
provisions for those employees whose medical conditions require them to 
provide urine via indwelling catheters or external urine bags.

Comments Favoring Mandatory Direct Observation Testing on Return-to-
Duty and Follow-Up Tests

    The Department received 29 comments favoring the concept of DO 
collections in general and/or the mandatory application of DO to 
follow-up and return-to-duty testing. The

[[Page 62914]]

majority of these comments were from SAPs, though a few collection 
sites, a testing industry association, an MRO, an employer, and a few 
individuals took this view as well. The common theme among these 
commenters was that conducting direct observations on return-to-duty 
and follow-up tests is important to safety.
    SAP commenters generally said, based on their personal experience 
of working with individuals who had failed or refused drug tests, that 
people with addiction or other substance abuse problems had a great 
deal of difficulty in changing their behavior. They often exhibit 
denial of their problems and have a powerful drive to cheat in order to 
continue using the substances to which they are attached while 
continuing to work. One of the SAPs commented that for an individual 
who had failed or refused a drug test, being subject to DO and a 
return-to-duty or follow-up test is a consequence of substance abuse 
problems and/or a violation of Federal law, and as such was justified. 
Some commenters pointed to the fact that many treatment programs use 
direct observations for their own testing during rehabilitation, so 
many who have undergone treatment would expect direct observations.
    A number of SAPs indicated that when they recommended DO, employers 
responded by saying they would not have employees observed. Some 
employers were alleged to have stopped using SAPs who made these 
recommendations. In essence, SAPs said that employers were undermining 
the entire purpose of having the DO option. For this reason, one SAP 
recommended that any violation related to an employee's attempt to beat 
the test by adulteration, substitution, or other refusal should be met 
with long-term, if not permanent, removal from safety sensitive duties.
    The collection site organization that commented noted that DO 
collections make up a very small number of all DOT tests and can be an 
effective deterrent against cheating on return-to-duty and follow-up 
tests. One SAP commented that making DO mandatory in the return-to-duty 
and follow-up contexts would counteract what he viewed as hesitancy on 
the part of many employers under the present discretionary rule. This 
timidity, in his view, has led to a significant amount of cheating on 
these tests. Finally, some employer associations, while objecting to 
making DO mandatory for all follow-up and return-to-duty tests, 
supported requiring DO when the follow-up and return-to-duty tests 
resulted from a refusal to test, as distinct from a positive test.

DOT Response

    The Department believes that the expertise of SAPs--the individuals 
in the drug testing system who most often have first-hand, day-to-day 
observation of the individuals who violate DOT drug testing rules and 
the behaviors and motivations of these individuals--carries a great 
deal of weight in this discussion. They are the ``Gatekeepers'' of the 
return-to-duty process. SAPs have the education, qualifications, and 
experience that vest them with a significant role in evaluation, 
treatment, return-to-duty recommendations, and follow-up testing plans 
of the individuals who have violated Part 40 through their refusals 
and/or positive test results. Their nearly unanimous view that DO 
collections, particularly in the context of return-to-duty and follow-
up testing, is a necessary and appropriate response to the predictable 
behaviors of many violators strongly supports the Department's view 
that there is a heightened risk of cheating by individuals who are 
seeking to reclaim or retain the ability to perform safety-sensitive 
work after a violation.
    We also agree with SAPs who pointed out that individuals in 
recovery often need support to help them in their efforts to remain 
abstinent from drugs. They point out that people with substance abuse 
problems or who suffer from addiction are prone to having problems 
dealing with their drug use and in changing their drug use behavior, 
even after rehabilitation. In short, these employees are prone to 
relapse into drug use. We agree with SAPs who believe that DO 
collections would help these employees in their struggle to stop drug 
use.
    We also agree with SAPs comments indicating that drug treatment and 
education programs require DO collections during their program efforts. 
Therefore, most employees coming back into the workplace after testing 
positive or refusing a DOT test would be accustomed to having their 
collections observed.
    Employees who fail or refuse a drug test, and who are offered the 
opportunity by their employer to return to work, are frequently covered 
by a ``last chance agreement,'' a ``two strikes and out'' policy that 
means that a second violation will result in the individual being 
fired. In the aviation industry, the statutory ``permanent bar'' means 
that employees who fail a second test will never work in a particular 
occupation again. Where an individual cannot resist the powerful pull 
of drug dependence, and realizes that a positive result can cost him or 
her a job or even a career, cheating using one of the readily available 
techniques can prove an attractive option.
    We agree with the point that tests requiring DO collections make up 
only a small percentage of all DOT drug tests, and hence do not affect 
the vast majority of workers who take and pass DOT drug tests. We want 
to correct the misunderstanding of some commenters, who appeared to 
believe that all DOT tests would be directly observed under the new 
rules. To the contrary, people taking pre-employment, random, 
reasonable suspicion, and post-accident tests are not subject to DO, 
unless their actions trigger a suspicion that they are trying to cheat. 
The only workers who are affected by DO testing are those who by their 
conduct at the collection site or by the results of their tests have 
demonstrated that they are willing to endanger public safety through 
violating Federal law prohibiting illegal drug use. As a joint comment 
from two employer associations noted, the propensity to avoid 
accountability for drug use is particularly marked among individuals 
who refuse to take a drug test.

Comments Opposing Mandatory Direct Observation Testing on Return-to-
Duty and Follow-Up Tests

    Sixteen commenters, including several unions and a number of 
individuals, opposed DO in general. They said it was too intrusive, 
violated employees' privacy, and would work a particular hardship on 
people who had anxiety disorders that made it difficult for them to 
urinate when someone was watching. A number of union commenters also 
said that they believed that expanding the scope of mandatory DO 
testing to all follow-up and return-to-duty tests would exceed the 
Department's constitutional authority as outlined in the 1989 Supreme 
Court case (Skinner v. Railway Labor Executives' Association, 489 U.S. 
602 (1989)) that upheld the constitutionality of Federal Railroad 
Administration (FRA) drug testing requirements applying to the rail 
industry. In addition, some of these comments cited the provision of 
the Omnibus Transportation Employee Testing Act of 1991 directing the 
Department to ``promote, to the maximum extent practicable, individual 
privacy in the collection of specimens'' (see 49 U.S.C. 31306(c)(1) and 
parallel sections).
    Three unions suggested that DO testing was not needed for return-
to-duty and follow-up tests because employees who had tested positive 
had, in effect, shown themselves to be

[[Page 62915]]

willing to submit to testing without cheating. The unions reasoned that 
these employees were not the sort of people who had the motivation or 
propensity to cheat on tests. Moreover, one of the unions said, 
employees it represented must go through a detailed SAP evaluation 
process as well as vetting by DOT before returning to duty, so are 
likely to be drug-free.
    One of the most frequent comments made by commenters opposing the 
mandatory use of DO for return-to-duty and follow-up tests was that 
there was insufficient evidence of the need to take this step. Sixteen 
comments, mostly from unions and some employer groups, took this view. 
One union said that the low overall violation rate and the small number 
of recorded cases of adulteration and substitution showed that DO 
collections were not needed. In addition, the commenter said, 
individuals had shown a SAP that they were successfully rehabilitated 
by the time they got to the follow-up test stage of the process. Four 
other unions said that there was no evidence demonstrating a higher 
level of adulterated or substituted tests in the return-to-duty and 
follow-up contexts, and there was no documentation that transportation 
employees actually used prosthetic and other cheating devices, or that 
DOT agency personnel had not seen evidence of cheating.
    Eleven commenters, among which were unions, employers or employer 
associations, and collection sites or TPAs, urged the Department to 
retain the existing rule that makes the use of DO an employer option in 
the follow-up and return-to-duty contexts. One union said that DO 
should not be required for follow-up and return-to-duty tests unless 
there were specific findings or medical determinations backing the 
requirement for a given employee. Two other unions suggested that SAPs 
were in a good position to determine when DO was appropriate for an 
individual subject to return-to-duty and follow-up tests, and their 
findings could be a basis for such a decision. Another union suggested 
that the employer's designated employer representative (DER) could 
appropriately make this decision. On the other hand, two unions and a 
collection site operator said that, under existing DOT rules and 
guidance, DERs had too much discretion to direct that a test be 
conducted under DO.
    Twelve commenters, mostly collection sites, expressed the concern 
that they would be unable to find enough people to act as observers. 
The rule requires observers to be the same gender as the employee being 
tested, they noted, and their experience was that most or all 
collection site personnel were women while most employees reporting for 
testing were men.
    Seven commenters said that making DO mandatory in follow-up and 
return-to-duty testing would significantly increase the total number of 
DO collections. One employer association said that of the approximately 
4000 such tests in its industry, employers found it necessary to use DO 
only rarely. A large employer said it chose to use DO in only a small 
number of the approximately 1200 return-to-duty and follow-up tests it 
administered per year. Another employer association predicted that the 
number of DO collections would double. A union projected that there 
would be a dramatic increase in the number of employees subject to DO 
tests and the number of such tests conducted, if all follow-up and 
return-to-duty tests are directly observed. Some commenters said that 
there would be increased costs, since in many cases a second person, 
other than the collector, would have to be paid to observe the tests. 
Five commenters, including a TPA, two collection sites, an employer, 
and an individual, said they feared that mandatory DO in follow-up and 
return-to-duty testing would lead to a decrease in the availability of 
collection facilities. Two commenters said that the prospect of 
additional costs had already persuaded a few collection sites to stop 
doing DOT testing.
    In other comments, a TPA expressed concern that mandatory DO would 
lead employers to fire people rather than giving them a chance to 
return to work, because of extra costs of DO testing. A collection site 
said that only medical personnel should be observers in DO collections, 
while another collection site organization said that employer 
representatives should be able to act as observers.

DOT Response

    The Department agrees with commenters that DO collections are 
intrusive. The Department's rule has always recognized that there is a 
subset of cases in which this intrusion is justified in the interests 
of program integrity and public safety. When employees' conduct at the 
collection site shows the likelihood of an attempt to tamper with a 
specimen, when unexplained invalid test results come back from the 
laboratory, or when employees test positive or refuse to take a test, 
the Department's regulations have always recognized that there is a 
higher risk of cheating and a higher risk to safety. In these 
situations, the Department's existing rules require or permit the use 
of DO testing in order to deter and/or detect attempts to cheat.
    The Supreme Court's decision in Skinner held that the FRA's post-
accident drug testing program for railroad employees was 
constitutional, notwithstanding the absence of individualized suspicion 
of drug use by employees subject to testing. A companion case (National 
Treasury Employees' Union v. Von Raab, 489 U.S. 656 (1989)) concerning 
the testing of Federal customs personnel and a subsequent case 
concerning the Federal Aviation Administration's (FAA) drug testing 
program (Bluestein v. Skinner, 908 F.2d 451 (9th Cir., 1990), cert. 
denied 498 U.S. 1083 (1991)) made similar findings with respect to 
random testing programs. All of these cases found that Federally 
mandated drug testing was subject to 4th amendment scrutiny but that 
the Federal agencies involved had successfully struck a balance between 
the safety needs of the government and the privacy interests of 
employees.
    The courts in Skinner and Von Raab noted that the FRA's testing 
program avoided additional intrusion into employees' privacy by not 
using direct observation. Indeed, the FRA and Customs programs, like 
the current DOT program, did not use DO for all tests, as the 
Department of Defense program for military personnel does. Nothing in 
the decisions, however, suggests that the courts would regard any and 
all use of DO as unconstitutional on its face. In fact, Bluestein 
pertained to the FAA's drug testing program that was subject to 49 CFR 
Part 40 which, as noted above, has always made use of DO. In 
determining whether requiring, rather than merely permitting, the use 
of DO in return-to-duty and follow-up exceeds constitutional bounds, it 
is reasonable to believe that courts would continue to examine whether 
the Department had appropriately balanced the government's compelling 
safety interest with the legitimate privacy interests of employees. 
[See Gonzales v. Metropolitan Transportation Authority, 73 Fed. Appx. 
986, 2003 WL 22006014 (9th Cir. August 25, 2003) (compelling interest 
in public safety supports random testing of employees who only very 
rarely perform safety-sensitive functions).] Given that the precise 
place where the Department strikes this balance can properly be 
affected by changes in society, such as the greater prevalence of 
cheating devices and products now compared to the 1980s, the Department 
believes it likely that the courts would find that the Department had 
acted constitutionally.

[[Page 62916]]

    The privacy provision in the Omnibus Transportation Employee 
Testing Act gives discretion to the Department to determine the maximum 
extent to which the protection of individual privacy in the testing 
process is practicable. Part 40 has always contained extensive 
protections for individual privacy in the testing process. However, 
given the now-widespread availability and promotion of cheating devices 
and products, the purpose of which is to allow employees to conceal 
their illegal drug use while continuing to perform safety-sensitive 
functions, it is not practicable to turn a blind eye to the damage that 
cheating on drug tests can have on public safety. In the Department's 
judgment, it is essential to put into place additional countermeasures 
to deter and detect cheating, the likelihood of which has increased in 
the years since Part 40 was first adopted.
    The Department gives little weight to the unions' argument that 
people who have tested positive are unlikely to try to cheat, simply 
because they either apparently did not cheat while providing a positive 
specimen the first time around or have been through the SAP process. 
(This argument does not apply at all to people who have refused a test, 
since they have already demonstrated their determination to circumvent 
the testing process.) Employees in safety-sensitive positions who test 
positive have shown a willingness to knowingly disregard public safety 
and violate Federal law by using illegal drugs. Employees who know that 
they have duties that impact public safety and then engage in illegal 
drug use have, by their actions, demonstrated a lack of integrity that 
could readily manifest itself in an attempt to cheat on return-to-duty 
and follow-up tests.
    In this context, we note that DOT drug program statistics show that 
the violation (i.e., positives and refusals to test) rates for return-
to-duty and follow-up tests, in every regulated industry, are higher 
than the random testing violation rates. While a number of commenters 
asserted that employees who have previously violated the rules were 
seen by a SAP, participated in a program, and returned to duty were 
less likely to be prone to the temptation of continuing to use drugs or 
of adulterating or substituting their specimen on return-to-duty/
follow-up tests, the Management Information System (MIS) data submitted 
by all transportation modes indicates that the violation rate for 
return-to-duty and follow-up testing is two to four times higher than 
that of random testing.
    This situation is starkly illustrated in the aviation and rail 
industries, those most frequently represented in comments opposing DO 
in return-to-duty and follow-up testing. This data comes from the 
Department's MIS reports for 2007:

------------------------------------------------------------------------
                                                    Return-to-
                                           Random      duty    Follow-up
                                         (percent)  (percent)  (percent)
------------------------------------------------------------------------
Aviation...............................        .60       2.12       1.86
Rail...................................        .52        1.2        1.5
------------------------------------------------------------------------

    Put another way, the violation rate on return-to-duty tests is 
almost four times as high as the random violation rate in the aviation 
industry. The violation rate on follow-up tests is over three times the 
random violation rate. In the rail industry, the return-to-duty 
violation rate is over twice the random violation rate, while the 
follow-up violation rate is nearly three times the random violation 
rate. In addition, when employees in these two industries tested 
positive on their follow-up tests, the most prevalent drugs identified 
were--in order--cocaine, marijuana, and amphetamines/methamphetamines.
    This information supports SAP commenters' views of the motivation 
of previous violators to cheat. As SAP commenters pointed out, people 
who return to illegal drug use and realize that their jobs are at stake 
have strong motivation to take all necessary steps, including cheating, 
to avoid another positive result. The motive to cheat exists, widely 
advertised cheating devices and substances provide the means, and--in 
the absence of DO collections--current procedures for non-observed 
collections provide the opportunity. The Department stands by its view 
that return-to-duty and follow-up tests involve a heightened risk of 
cheating, compared to other testing occasions.
    As noted above in the discussion of section 40.67(i), the 
Department believes it is illogical to conclude that a lack of drug 
test result data showing use of prosthetic and other devices supports a 
conclusion that there is no need for DO tests in follow-up and return-
to-duty tests. Cheating attempts that evade detection, by definition, 
are not captured in program statistics. They are likely to be counted 
as normal negative test results, and not as adulterated or substituted 
tests. In any case, through experience in inspections, investigations, 
and during the course of its duties in assisting the public with 
complying with Part 40, the Department is aware of many instances of 
cheating. The FAA and the Federal Transit Administration, for example, 
have found hidden above ceiling tiles empty urine containers and 
plastic baggies brought into collection sites. Collectors have reported 
finding collection containers, baggies, bottles and plastic tubing 
hidden above ceiling tiles and in trash containers. MROs and collectors 
have told us about commercial vehicle drivers who used prosthetic 
cheating devices and accidentally revealed them to physicians and 
collectors shortly after providing their specimens. There are many more 
specific instances of cheating that we have become aware of over time.
    While this information is anecdotal rather than statistical, it is 
the Department's view that when well-publicized and advertised means of 
cheating exist, and we know these means are being used to thwart our 
testing program, it is clear that the Department's program is not 
immune. Thus, it is reasonable for the Department to take steps to 
deter and detect the use of cheating devices.
    At the time the Department initiated its drug testing program in 
the late 1980s, it was common for unions and other opponents of testing 
(including those whose challenges to the program were rejected by the 
courts in cases like Skinner, Bluestein, and Von Raab) to argue that 
the Department had no basis for its testing program because the 
Department had not proven by statistics or otherwise that there was 
really a drug abuse problem in the transportation industries. The 
Department replied that, when public safety was at stake, the 
Department could not take the risk of assuming that transportation 
workers were immune from a society-wide problem. Likewise, the 
Department cannot, in keeping with its public safety responsibilities, 
assume that means of cheating made widely available are somehow never 
used by transportation workers, especially when our experience 
demonstrates otherwise.
    The Department does not intend to depend solely on DO testing to 
combat the problem of cheating. The June 25 final rule made specimen 
validity testing (SVT) mandatory for all DOT specimens. The Department 
has provided additional guidance to collection sites on maintaining the 
appropriate safeguards against cheating, mailing to over 24,000 
collection sites ``DOT's 10 Steps to Collection Site Security and 
Integrity'' posters. The Department has explicitly supported 
legislation to strengthen program integrity, such as criminalizing the 
sale of cheating products and providing DOT agencies with civil penalty 
authority to sanction collection sites and other

[[Page 62917]]

service agents who do not carry out the rules properly. While these 
steps are important, they do not replace DO testing as a means of 
deterring and detecting cheating at the collection site when there is a 
heightened risk of cheating.
    Some comments said that large employers or groups of employers 
choose to conduct DO testing on only a few follow-up and return-to-duty 
tests. The employer option in previous versions of Part 40 was intended 
to give employers the chance to make careful, case-by-case, 
determinations of whether DO was appropriate for particular employees 
undergoing these post-violation tests, using their discretion wisely to 
protect against cheating that undermines the deterrent effect of the 
testing program (We note with interest that some union commenters 
suggested that, under present rules, it would be appropriate for an 
employer to require DO in follow-up and return-to-duty testing based on 
the findings of a SAP or a designated employer representative.) To the 
extent that employers are not taking responsibility for doing so, and 
are instead using the option to avoid using DO in all or most return-
to-duty and follow-up tests (e.g., for reasons of labor-management 
agreements, fear of upsetting employees, concern about costs), their 
behavior provides additional reason for the Department to mandate DO 
for these types of tests.
    For almost 20 years, the rules have required same-gender observers 
for DO collections. This requirement has not changed. If some 
collection sites are staffed mostly by women at the present time, while 
employees being tested are mostly men, the evident course of action for 
these sites to follow would be to hire additional men, at least on an 
on-call basis, to handle DO duties. Return-to-duty and follow-up tests 
are conducted at a day and time set by the employer, so the employer 
has ample time to notify the collection site in advance that a same-
gender observer will be needed for a DO collection. As a major drug and 
alcohol testing industry association responsible for training many 
collectors noted in their docket comment, collectors and collection 
facilities must have the ability to perform DO collections in order to 
be in compliance with 49 CFR part 40. Collection sites and employers 
have had to be ready with same gender observers for two decades.
    It should be noted that observers do not need to be trained 
collectors. They need only be able to carry out basic instructions for 
the observation process. Being male would be a bona fide occupational 
qualification for such a position, such that collection sites could 
specifically seek men to play this role without running afoul of equal 
employment opportunity laws because most employees requiring 
observation are men. We do not believe that people acting as observers 
need to be medically trained, as they are not performing any 
specifically medical tasks (even trained collectors do not need to be 
medical professionals). DOT has produced an instruction sheet about DO 
procedures and made it available to all collectors and collection 
sites, as well as collector and MRO training organizations.
    The Department also believes that, while there would be some 
increase in the number of DO tests, the increase would not be as 
dramatic as some commenters asserted. Therefore, the costs to 
collection sites and employers would not increase significantly.
    One major drug and alcohol testing association specializing in 
collection activities, in their docket comments, estimated that the 
Department's new rule would effect less than 2% of employees. Our MIS 
data for 2006 shows that return-to-duty and follow-up made up 2% of all 
DOT tests. HHS Data for 2006 indicated that there were approximately 
7.5 million tests conducted by HHS certified laboratories, of which we 
estimate that 7.32 million were DOT tests. That would mean that there 
could be approximately 146,400 return-to-duty and follow-up DOT tests 
annually. This figure includes those return-to-duty and follow-up tests 
already being conducted under DO by employer request.
    The Department estimates that there are more than 24,000 collection 
sites throughout the United States. Even if there had been no DO 
collections for return-to-duty and follow-up testing, this would 
average only an increase of 6 DO collections per site per year. This is 
certainly a manageable number. As one testing industry commenter noted, 
if a collection site facility is currently required to conduct DO 
collections at any time to be compliant with part 40, ``it should not 
matter whether they perform 1000 DO collections or 1020 (2% more).''
    The Department recognizes that some collection sites may have to 
collect more than that, but then there will be others who will collect 
fewer than the average, just as some employers will be responsible for 
more than an average number of employees in return-to-duty and follow-
up programs and others fewer than average.
    The Department believes that a wide variety of factors affect an 
employer's decision about whether to retain an employee who has 
violated the rules, and we consequently doubt that requiring DO in 
follow-up and return-to-duty tests will cause a major shift in 
employers' decisions about retention. In any case, the Department's 
interest is in safety, and we have always left personnel decisions to 
employers.
    The Department's experience is that there is a good deal of 
turnover in the collection site business, as some sites open and others 
close. Having to perform additional DO tests could lead some sites to 
leave the business; where there is a market demand for services, others 
are likely to take their place. Finally, we believe commenters did not 
correctly understand DOT guidance concerning the rule of employers and 
DERs in directing collection sites to conduct tests under DO. Employers 
and their DERs do not have unfettered discretion to direct collectors 
to use DO; they can only do so where the Department's rules require DO 
to be used. The Department will review its guidance documents to 
determine if any further clarification of this point should be made.

Use of Alternative Specimens

    Fourteen commenters said that, rather than making DO mandatory in 
follow-up and return-to-duty tests, the Department should take other, 
less intrusive, actions to reduce the likelihood of cheating. One 
testing industry association, a collection site, an employer, and a few 
individuals recommended that the Department adopt hair or saliva 
testing as an alternative to urine testing, believing that these 
methods were less vulnerable to cheating. Other suggestions included 
tighter supervision of the collection process and better training of 
collection personnel and support of anti-cheating legislative proposals 
in Congress.

DOT Response

    The Department is not opposed to the use of alternative, less 
intrusive, testing methods as a means of accomplishing the safety 
purposes of the program while preventing individuals from cheating. 
Under the Omnibus Transportation Employee Testing Act of 1991, however, 
the Department is authorized to use only testing methods that have been 
approved by the Department of Health and Human Services (HHS). To date, 
HHS has not approved any specimen testing except urine. To counteract 
serious concerns about potential cheating in urine testing, DOT must 
therefore rely for now on DO collections in the situations spelled out 
in Part 40; this is the tool we have available at this time to ensure 
that

[[Page 62918]]

cheating does not undermine the safety objectives of the Department's 
program.
    However, we know that HHS is in the process of working toward the 
approval of updates to the Mandatory Guidelines for urine testing which 
also supports use of some alternative testing methodologies. Based upon 
our discussions with HHS, oral fluids and sweat specimen testing are 
areas of promise which will receive maximum focus in HHS's next 
approval process. When they are approved by HHS, these methodologies 
will be forensically and scientifically suitable to be used in the DOT 
testing programs. Both oral fluid and sweat specimen testing are 
considerably less intrusive than DO of urine collections. Because of 
their drug use detection timetables, after approval by HHS oral fluids 
would be very suitable for return-to-duty testing and sweat specimens 
would be very suitable for follow-up testing.
    When HHS approves these specimens for testing, the Department 
intends to propose to amend Part 40 to provide for their use in 
appropriate testing situations. By doing so, the Department will 
provide a less intrusive alternative to DO urine testing in the return-
to-duty and/or follow-up situations.
    HHS is also considering the use of hair testing. There are a number 
of significant scientific and policy questions raised in public 
comments and Federal agency internal reviews of proposed revisions to 
the Mandatory Guidelines that must be answered before HHS and DOT could 
adopt the use of hair testing in the agencies' programs. The claimed 
90-day detection window for hair testing also makes its use problematic 
in RTD testing and for FU tests as well, depending on when they occur. 
Nevertheless, at such time as HHS approves hair testing, we are open to 
considering its use as part of the DOT testing program.
    Under authority separate from and predating the Omnibus Act, the 
FRA has long used blood testing and urine testing [as well as tissue 
and vitreous humor from cadavers] in its special post-accident testing. 
While blood testing is scientifically and forensically sound, its 
collection by needle is considered very intrusive. It also requires the 
use of medically-trained personnel as collectors. Importantly, blood 
affords a very brief window of detection. Consequently, while it can be 
used by the FRA appropriately in their special post-accident testing as 
a means of determining accident causative factors, it would not be a 
suitable methodology for return-to-duty and follow-up testing.

Other Agencies' Rules

    While the drug testing rules of other Federal agencies do not 
determine the way the Department responds to comments on section 
40.67(b), it is instructive to note that other agencies make 
significant use of DO in their testing programs. The Department of 
Defense, of course, has always used DO for all drug tests of military 
personnel, who generally are regarded, however, as having a lower 
expectation of privacy than civilian workers.
    In new final rules that go into effect in March 2009 (73 FR 16966; 
March 31, 2008), the Nuclear Regulatory Commission (NRC) will also 
afford less privacy for its DO collections for return-to-duty and 
follow-up tests for nuclear industry personnel, as well as tests in 
which collection site behavior or laboratory results indicate an 
attempt to cheat. The NRC regulation requires an anti-prosthetic 
procedure as part of all its DO tests, in which an individual must 
raise and lower his or her clothing from waist to knee not only before 
providing the specimen (as in the DOT procedure) but also during 
urination. NRC's rationale for this action was the following:

    More detailed procedures are necessary because devices and 
techniques to subvert the testing process have been developed since 
[the NRC rule was originally issued] that are difficult to detect in 
many collection circumstances, including direct observation, such as 
a false penis or other realistic urine delivery device containing a 
substitute urine specimen and heating element that may be used to 
replicate urination. Therefore, the agency has made these changes to 
increase the likelihood of detecting attempts to subvert the testing 
process and increase the effectiveness of directly observed 
collections in assuring that a valid specimen is obtained from the 
donor. 73 FR 17071; March 31, 2008.

    The HHS intends, in its upcoming Mandatory Guidelines for the 
Federal employee drug testing program, to require DO collections in all 
follow-up and return-to-duty tests. The HHS and NRC procedures are 
based on the same rationale as the DOT June 25 final rule: types of 
testing that present a heightened risk for cheating, given the ready 
availability of cheating products, call for appropriate 
countermeasures.

The Department's Decision

    Having considered the comments, the Department remains convinced 
that conducting all return-to-duty and follow-up tests under DO is the 
most prudent course from the viewpoint of safety. It is the method we 
have available today to deter and detect attempts to cheat, pending the 
availability of less intrusive alternative specimen testing methods.
    Under 40.67(b), there are no individuals who will be directly 
observed who have not already been subject to being directly observed 
under previous versions of Federal safety requirements by refusing to 
test, using illegal drugs, or otherwise breaching the rules. By this 
conduct, each of these individuals has shown a willingness to endanger 
public safety. Individuals in this category have a greater than average 
likelihood of using illegal drugs in the future and a higher than 
average motivation to cheat on a test. Under these circumstances, the 
Department is justified in regarding these individuals as having a 
reduced legitimate expectation of privacy, compared to covered 
employees in general. Given the increased availability of cheating 
products, compared to twenty years ago when Part 40 was first issued, 
the Department can properly adjust the balance between safety and 
privacy by making DO collections mandatory, rather than optional, in 
follow-up and return-to-duty testing.
    The Department realizes that there may need to be some adjustments 
necessary for employers, collection sites and others in order to begin 
implementing this requirement. However, by the time the rule goes into 
effect on November 1, affected parties will have had four months to 
address implementation issues, including labor-management relations, 
providing for the availability of same-gender observers etc. 
Consequently, we do not believe that any further delay in the effective 
date of this provision is warranted. We emphasize that conducting all 
future return-to-duty and follow-up tests under DO is a requirement of 
Federal law (including for employees whose initial violations of the 
rules occurred or whose series of follow-up tests began before November 
1).
    For the reasons set forth in this notice, section 40.67(b), as 
issue