[Federal Register: December 19, 2000 (Volume 65, Number 244)]
[Rules and Regulations]               
[Page 79461-79510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de00-13]                         
 

[[Page 79461]]

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Part II





Department of Transportation





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Office of the Secretary



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49 CFR Part 40



Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs; Final Rule


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-99-6578]
RIN 2105-AC49

 
Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

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SUMMARY: The Department of Transportation is revising its drug and 
alcohol testing procedures regulation. The purposes of the revision are 
to make the organization and language of the regulation clearer, to 
incorporate guidance and interpretations of the rule into its text, and 
to update the rule to include new provisions responding to changes in 
technology, the testing industry, and the Department's program.

EFFECTIVE DATES: The amendments to the current 49 CFR part 40 are 
effective January 18, 2001. The revised 49 CFR Part 40 is effective 
August 1, 2001.

FOR FURTHER INFORMATION CONTACT: Robert C. Ashby, Deputy Assistant 
General Counsel for Regulation and Enforcement, 400 7th Street, SW., 
Room 10424, Washington DC, 20590, 202-366-9310 (voice), 202-366-9313 
(fax), or bob.ashby@ost.dot.gov (e-mail); Mary Bernstein, Director, 
Office of Drug and Alcohol Policy and Compliance (ODAPC), 400 7th 
Street, SW., Room 10403, Washington DC, 20590, 202-366-3784 (voice), 
202-366-3897 (fax), or mary.bernstein@ost.dot.gov (e-mail); or Jim L. 
Swart, Drug and Alcohol Policy Advisor, ODAPC , same address and phone 
numbers as above, jim.swart@ost.dot.gov (e-mail).

SUPPLEMENTARY INFORMATION:

Background

    The Department of Transportation first published its drug testing 
procedures regulation (49 CFR part 40) on November 21, 1988 (53 FR 
47002), as an interim final rule. We based the rule on the Department 
of Health and Human Services (HHS) guidelines for Federal agency 
employee drug testing, with some changes to fit the transportation 
workplace. The Department published a final rule responding to comments 
on the interim rule a year later (54 FR 49854; December 1, 1989).
    The Department added alcohol testing procedures to Part 40 in a 
February 1994 final rule. This rule also made other changes to Part 40, 
including requirements for split samples in four operating 
administration rules. Since that time, the Department has amended 
specific provisions of Part 40 on various occasions (e.g., with respect 
to non-evidential alcohol screening devices and ``shy bladder'' 
procedures).
    In the years since Part 40 was first published, the Department 
issued a large volume of guidance and over 100 written interpretations, 
as well as a significant amount of informal advice. Most of this 
material has not previously been incorporated into the rule text. There 
have been changes in testing technology, the structure of the drug and 
alcohol testing business, and the functioning of the Department's drug 
and alcohol testing programs that make it desirable to update our 
regulatory provisions. Because the rule was originally based on that of 
another agency (i.e., HHS), there are some provisions that never were a 
close fit for the Department's programs. Moreover, the rule's 
organization and language do not meet the objectives of the Clinton 
Administration's current ``Plain Language'' policies. Under section 610 
of the Regulatory Flexibility Act, agencies are directed to review 
existing rules from time to time with an eye to their effects on small 
businesses and other small entities.
    For all these reasons, the Department decided to review Part 40. As 
a first step, we issued an advance notice of proposed rulemaking 
(ANPRM) on April 29, 1996 (61 FR 18713), asking for suggestions for 
change in the rule. We received 30 comments in response to this ANPRM. 
We then issued a notice of proposed rulemaking (NPRM) on December 9, 
1999 (64 FR 69076). This NPRM proposed a comprehensive revision to Part 
40. In response to the NPRM, we received letters from over 400 
commenters, making around 4000 individual suggestions concerning the 
rule. We also held three public listening sessions, at which numerous 
interested parties commented further on the Department's proposals, and 
we held an internet forum. The final rule responds to all the comments 
and makes significant alterations to the existing rules governing the 
Department's drug and alcohol testing programs.

Structure of the Rule

    Perhaps the first thing readers will notice about this final rule 
is that we have thoroughly restructured Part 40, with subparts 
organized by subject matter area. Like the NPRM, and in contrast to the 
existing rule, the text is divided into many more sections, with fewer 
paragraphs each on average, to make it easier to find regulatory 
provisions. The rule uses a question-answer format, with language 
specifically directing particular parties to take particular actions 
(e.g., ``As an employer, you must * * *''). We have also tried to 
express the requirements of the rule in plain language. Commenters were 
very complimentary about the reorganization of the rule, generally 
praising it as much clearer and easier to follow than the existing 
rule. The Department received a plain language award, known as the ``No 
Gobbledygook Award,'' from Vice President Gore's National Partnership 
for Reinventing Government in recognition of the improved clarity of 
the regulation. We have retained the NPRM's format and organization, 
which we believe will help drug and alcohol testing program 
participants understand and effectively carry out this rule.
    What matters most in a rulemaking is not the number of letters 
favoring or opposing a particular proposal. Our central concern is with 
the substance of the comments. In discussing comments on this rule and 
our response to them, we will focus on the substance of positions that 
commenters expressed, and on why we did or did not make changes in 
response to various comments. In writing the preamble, we have avoided 
counting up the number of comments supporting a given position except 
in the most general way, believing that doing so would distract from 
the discussion of substantive issues.

Effective Dates

    The Department has decided to establish an August 1, 2001, 
effective date for the revised Part 40. We recognize that there is 
always some difficulty for everyone involved in the transition between 
an existing rule and a new rule. We hope that this delayed effective 
date will ease the transition. During the period between publication 
and August 1, program participants will have the opportunity to learn 
about new provisions before having to implement them. During this 
period, the Department expects to develop and issue guidance (e.g., a 
revised medical review officer (MRO) manual) and make presentations at 
a significant number of conferences and training sessions. In addition, 
August 1 is the date on which use of the new Federal Drug Testing 
Custody and Control Form (CCF), to which the text of the revised Part 
40 refers, becomes mandatory.
    However, we believe it is important to begin implementing some new 
provisions sooner, since they enhance the fairness and integrity of the 
process. To do so, we must amend the existing

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Part 40 to include these provisions, so that they are in effect during 
the period before the August 1 effective date of the entire new version 
of the regulation. Come August 1, the existing Part 40 (including the 
amendments we are issuing today) will be replaced, in its entirety, by 
the new Part 40. Since the substance of today's amendments will be the 
same in both versions of the document, there will be no change in how 
we implement them after August 1.
    The provisions requiring MRO review and split specimen testing 
following adulteration and substitution findings will go into effect in 
30 days. The majority of laboratories already perform validity testing 
on a voluntary basis. Making the MRO review and split specimen 
procedures effective in 30 days will make these additional protections 
available in connection with this existing validity testing. At the 
same time, a provision explicitly authorizing the continuation of this 
existing practice under the new rule will go into effect. To the extent 
that the Department's September 1998 guidance memorandum concerning 
adulterated, substituted, dilute, and unsuitable tests is inconsistent 
with any provisions of these amendments, we regard that guidance as 
having been superseded on the effective date of the amendments.
    HHS is currently working mandatory requirements for validity 
testing. HHS is projecting completion of this project by August 1, 
2001. We believe that, to avoid any potential uncertainty about the 
standards and procedures for mandatory validity testing, DOT should put 
its mandate for validity testing into effect simultaneously with the 
new HHS requirements. Consequently, in the event HHS has not issued its 
new requirements by that date, we will publish a subsequent Federal 
Register notice postponing the Auust 1, 2001, effective date for 
mandatory validity testing.
    Another provision that we are including in the amendments to the 
existing Part 40, and that will go into effect in 30 days, is the 
public interest exclusion system. These provisions are very important 
to ensuring accountability in the provision of drug and alcohol 
testing. In addition, we are making the provisions of Sec. 40.5 
effective in 30 days as Sec. 40.203, since the Department expects to be 
issuing guidance materials on the new Part 40 before August 1, 2001.
    For readers' convenience, here is a table of the relationship 
between the section numbers in the amendments to current Part 40 that 
go into effect in 30 days and the section numbers of the corresponding 
sections of the new, revised Part 40 that goes into effect on August 1, 
2001:

------------------------------------------------------------------------
          Amended current part 40                New revised part 40
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40.201....................................    40.3
40.203....................................    40.5
40.205....................................    40.89
40.206....................................    40.91
40.209....................................    40.93
40.211....................................    40.95
40.213....................................    40.99
40.215....................................    40.145
40.217....................................    40.179
40.219....................................    40.181
40.221....................................    40.183
40.223....................................    40.187
40.225....................................    40.191
Subpart F (same section numbers)..........    Subpart R
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Principal Policy Issues

    In addition to often very detailed paragraph-by-paragraph comments 
on the text of the NPRM, commenters focused on several major policy 
issues. These included employee stand-down, validity testing, the 
public interest exclusion mechanism, the return-to-duty process, 
transmission of test results and other information through consortia 
and third-party administrators, reporting and storing information 
through electronic means, and reporting violations to DOT agencies. 
Issues also arose concerning confidentiality of information, conflicts 
of interest among service providers, training, and the collection 
process. In this preamble, we will discuss these policy issues first. 
After that, we will proceed to a section-by-section discussion of the 
rule, including the Department's responses to specific comments.

Stand-Down

    Stand-down refers to an employer practice of temporarily removing 
an employee from performance of safety-sensitive duties upon learning 
that the individual had a confirmed laboratory positive drug test, but 
before the MRO has completed the verification process. The existing 
regulation prohibits stand-down. MROs are not permitted to inform 
employers about the existence of a confirmed laboratory positive test 
pending verification, and employers are not allowed to take any action 
concerning an employee until they receive the MRO's notification of a 
verified positive test.
    The preamble to the NPRM noted the reasons for the current policy: 
stand-down undercuts the rationale for MRO review, can compromise the 
confidentiality of test results, and may result in unfair 
stigmatization of an employee as a drug user. While the rationale for 
stand-down is that it enhances safety, the Department has no evidence 
that the current policy has compromised safety. For example, we are not 
aware of any case in which an employee has had a drug-related accident 
while verification of a confirmed positive drug test was pending.
    The preamble also noted that some employers advocated the use of 
stand-down as a measure to enhance safety and reduce liability. They 
wanted to use this approach to eliminate, as far as possible, any risk 
that someone who had tested positive would be involved in an accident 
before the MRO could complete the verification process. We noted that, 
essentially for this reason, the Department's own internal drug testing 
program stood down some employees (e.g., air traffic controllers) in 
some circumstances following a report of a confirmed positive 
laboratory test.
    The NPRM regulatory text proposed two alternatives, one of which 
prohibited, and the other of which permitted, stand-down. The 
alternative that permitted stand-down included requirements to help 
safeguard employees' interests in confidentiality and fairness.

Comments

    Comments were sharply, and fairly evenly, divided on this issue. 
Some commenters, mostly employers and some service agents, supported 
stand-down. A few of these comments went further and urged that stand-
down be made mandatory, while a greater number said that it should be 
discretionary with each employer. A smaller number of commenters, 
including all unions and other employee organizations as well as some 
employers and service agents, opposed permitting stand-down.
    The most important argument cited by stand-down supporters was 
safety. Safety is a more important objective than confidentiality, many 
of them said. Even if there have not been documented cases of safety 
problems occurring in the absence of stand-down, no employer wants to 
be the first to face such a situation. Many employers may feel it so 
important to stand down employees on safety grounds that they would 
have an incentive to violate this prohibition. Avoiding unnecessary 
liability is also a consideration: It would be unwise, commenters said, 
to force a company to permit an employee it knew had a confirmed 
positive laboratory test to continue driving a commercial truck or 
flying a plane during the verification process.

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    Supporters also noted that, in most cases, there were very low 
rates of confirmed laboratory positive tests being verified negative 
(indeed, some drugs, like PCP, have no legitimate medical uses that 
would support a negative verification). Therefore, they said, stand-
down would not adversely affect more than the small number of drivers 
with confirmed positive laboratory results that an MRO later verified 
negative. Other commenters said that adverse consequences for employees 
could be minimized by employers choosing to keep employees in non-
safety-sensitive positions until verification or ensuring that 
employees whose tests were ultimately verified negative did not suffer 
any loss of pay or other adverse consequences.
    Opponents of stand-down said that the practice embodied a ``guilty 
until proved innocent'' approach that was manifestly unfair and ignored 
the purpose of having MRO review of positive tests. Confidentiality 
provisions would likely be inadequate. In practice, the ``word'' would 
get out that the employee had a confirmed laboratory test result and 
the employee--even if the MRO ultimately verified the test as 
negative--would be stigmatized in the workplace as a drug user. This 
would upset the regulatory balance between safety interests and the 
protection of employees from unfair consequences of the process. One 
motor carrier association said that this would be a particular problem 
in its industry. In large carriers, an employee cannot be taken out of 
service without involvement by multiple management employees. For 
unionized carriers in which assignments are made by seniority, it would 
be impossible to take a driver out of service without other drivers 
knowing it.
    Some commenters contested the safety rationale of stand-down by 
pointing out that a positive drug test does not indicate impairment. 
Other commenters said that the risk to the public from the current ``no 
stand-down'' policy was minimal, given that there were no known 
instances of accidents resulting from the absence of stand-down. 
Opponents also cited pay, privacy, and personnel consequences, as well 
as potential Americans with Disabilities Act and other issues 
potentially comploicating implementation of stand-down.
    An associated issue concerns pay status. If a company stands down 
an employee, should the company be required to pay the employee during 
this period, pending verification? Several commenters directly 
addressed this issue. About half of them, including a union and some 
employers and their associations, favored paying employees while they 
were in a stand-down status. The remainder said either that the 
regulation should be silent on the issue, with labor-management 
negotiations deciding the matter in each case, or that employees should 
not be paid while in stand-down status.
    While a number of comments addressed confidentiality and privacy 
issues, they provided little detail in the way of suggestions for how 
best to accomplish these objectives in a stand-down situation. 
Likewise, while a few commenters noted that confidentiality might be a 
more difficult issue in small companies, they did not provide any 
suggestions for how to address the issue. There was a suggestion that, 
to deal with the situation of owner-operators in the motor carrier 
industry, service agents be empowered to stand down these individuals.

DOT Response

    At the time of the NPRM, the Department recognized enough merit on 
both sides of this argument to propose alternative provisions. Having 
reviewed the comments, we remain convinced that advocates of both basic 
positions on the issue make some strong points. The Department is also 
aware that potential future changes in drug testing technology, such as 
the advent of HHS-approved on-site testing and alternative testing 
methods, may alter the response the Department's procedures take 
concerning stand-down in the future. Consequently, the Department is 
taking a middle-ground position on this difficult issue.
    The general rule will remain that stand-down is prohibited. The 
reasons for this general rule are the reasons articulated in the 
existing rule, the NPRM, and the comments from stand-down opponents. 
However, we believe it is necessary to respond to the genuine and 
plausible safety concerns of commenters favoring stand-down, the fact 
that safety is the Department's highest priority, and the fact that the 
Department's internal program uses a form of stand-down. Therefore, the 
Department will establish a waiver mechanism that permits employers, on 
a case-by-case basis, to request DOT agency approval for a specific, 
well-founded stand-down plan that effectively protect the interests of 
employees.
    This approach makes the Department's approach to its internal and 
external programs consistent with one another. When the Department, in 
its role as an employer, wanted to use a stand-down approach, it sought 
and received a waiver from HHS, whose drug testing guidelines also 
generally prohibit stand-down. Under the final rule, employers in the 
external program who wish to employ stand-down can, in an analogous 
way, seek a waiver from the Department of Transportation.
    We realize that some employers have employees that are regulated by 
more than one DOT agency. To avoid unnecessary administrative burdens 
in the waiver process, such an employer would have to submit only one 
waiver request, to the DOT agency that regulated the largest number of 
its employees. The various DOT agencies involved would coordinate 
internally before the lead agency responded to the employer.
    The Department intends to grant waivers only to employers who 
present a sound factual basis for their request and will have in place 
a number of provisions to protect employees' legitimate interests. The 
final rule (Sec. 40.21) lists several types of information that the 
employer would submit to the DOT agency in support of its request. This 
information is intended to give the DOT agency a picture of the 
employer's organization and safety situation. For example, the size or 
structure of the organization may affect the ability of an employer to 
carry out confidentiality requirements for the grant of a waiver. An 
organization that has an in-house MRO may be in a better position to 
control access to testing information than one that does not. An 
organization that stands employees down for reasons other than 
substance abuse testing may be in a better position to safeguard 
confidentiality than one that does not. Organizations' drug and alcohol 
testing history may be a relevant factor in determining whether stand-
down is useful in a particular company.
    None of these kinds of information is intended to establish a 
litmus test for granting a waiver. DOT agencies will make a case-by-
case decision about the merits of a stand-down petition with respect to 
each company that applies for one. DOT agencies will respond to each 
petition in writing, with reasons for the decision. DOT agencies are 
intended to have wide discretion in making these judgments. For 
example, two companies might present stand-down policies that are 
nearly identical on paper. However, contextual factors in one company 
may make its confidentiality assurances credible as a practical matter, 
while in the other case may suggest that confidentiality could not 
practically be maintained, despite the company's good faith efforts. 
DOT agencies could make different decisions in the two cases. We also 
point out that petitions for waivers

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will be considered on a company-by-company basis. DOT agencies will 
not, for example, consider a petition from a trade association or C/TPA 
on behalf of an industry or segment of an industry.
    As a condition for receiving a waiver, the rule requires the 
employer to submit its proposed written stand-down policy. These 
requirements pertain to confidentiality and protection of legitimate 
employee interests and are described in greater detail in the 
discussion of Sec. 40.21 below. One of these requirements is that an 
employer must continue to pay a worker who is in stand-down status, in 
the same way it would have in the absence of stand-down. This is a 
matter of fairness. To assume that the employee's test will be verified 
positive is to fall into the trap of presuming the employee guilty 
until proved innocent. In addition, continuing normal pay status for 
the employee should not be a major burden for employers, given the 
usually short interval before verification is completed. As a major 
employer association commented, most employers would not object to 
paying the employees for a reasonable amount of stand-down time if they 
believe they will gain a substantial safety benefit. An employer who 
articulated a safety rationale for stand-down but who objected to 
paying employees in the brief interim would seem to be an employer 
reluctant to expend resources commensurate with its expressed 
commitment to safety.
    These conditions are intentionally stringent. The Department wants 
to ensure that only employers who are able to maintain a successful 
balance between the potential safety benefits of stand-down and the 
legitimate privacy interests of employees are permitted to operate a 
stand-down policy. A DOT agency can impose additional conditions on a 
waiver or, if necessary, revoke a waiver it once granted. A DOT agency 
could also take enforcement action against an employer that violated 
the terms of its waiver.
    Some comments suggested that stand-down be permitted for confirmed 
laboratory tests for some drugs (e.g., PCP) but not others (e.g., 
opiates), based primarily on the lower or higher probabilities of 
verified negatives for these substances. The Department is not 
including such a provision as a general matter, out of concern that 
such a provision might lead to confusion.

Public Interest Exclusions (PIE)

    The NPRM proposed that service agents--persons and organizations 
that provide drug and alcohol testing services to employers, such as 
laboratories, MROs, substance abuse professionals (SAPs), collectors, 
breath alcohol technicians (BATs), screening test technicians (STTs), 
consortia and third-party administrators (C/TPAs)--should be 
accountable for serious noncompliance with Part 40. The NPRM proposed a 
mechanism based on the Department's existing non-procurement suspension 
and debarment rules (49 CFR part 29). This mechanism would permit the 
Department, following a series of procedures designed to ensure 
fairness, to impose a public interest exclusion (PIE). A PIE would 
direct DOT-regulated employers not to use the service agent for a 
period of time. The Department proposed to use this mechanism only in 
cases of serious misconduct where the service agent has not implemented 
prompt corrective action following notice by a DOT agency. The preamble 
noted that this mechanism rested on the Department's existing authority 
to establish requirements for the conduct of the drug and alcohol 
testing process and to direct employers to use only products and 
services that met these standards.

Comments

    The PIE proposal generated a good deal of comment. Almost a hundred 
written comments to the docket addressed the proposal, which was also 
the subject of extended discussion at the Department's three listening 
sessions, where the Department convened forums specifically on the 
subject. A strong majority of employers and all unions addressing the 
proposal favored it. Among service agents and their organizations, and 
other commenters submitting written comments, about 60 percent opposed 
the proposal, as written. Some service agent commenters urged 
postponing consideration of the provision and addressing it in a 
separate rulemaking.
    Even the commenters who opposed the proposal said that they 
believed service agents should be accountable for their conduct, at 
least in principle. Their reasons for opposing the proposal included 
doubting the need for such a mechanism and the Department's authority 
to implement it, a belief that the proposed process was insufficiently 
defined and did not provide enough procedural safeguards for service 
agents, a concern that DOT auditors and inspectors might initiate PIE 
proceedings arbitrarily, a preference for other alternatives (e.g., 
additional industry standards, certification, training programs, 
litigation), or support for other options mentioned in the preamble to 
the NPRM (e.g., certification or self-certification by all service 
agents with a DOT decertification process).
    Proponents of the proposal cited examples of misconduct by service 
agents for which there was no present remedy. They said that employers, 
especially small employers, often had to take on faith the quality of 
service agents, and the PIE process could help them to know which 
service agents to avoid. Employers also believed that it was unfair for 
them to be solely accountable for serious problems in the testing 
process. Service agents who supported the proposal said that it would 
enhance the overall quality of performance by service agents. Some 
service agents cut corners to reduce costs, putting more conscientious 
service agents at a competitive disadvantage, these commenters said, 
and then ``whined'' when the Department proposed a meaningful 
accountability mechanism.
    Commenters had a number of thoughts on specific aspects of the 
proposal. Many asked for greater specificity concerning the kinds of 
``offenses'' that would lead to a PIE proceeding. DOT staff pointed 
out, during the listening sessions and in writing, that the PIE 
mechanism was intended, both for policy and resource reasons, to be 
used only in the case of ``egregious'' misconduct. However, commenters 
pointed out that this statement was not made in the proposed regulatory 
text. They feared that differences in interpretation among inspectors 
and other DOT staff could lead to the inconsistent or arbitrary use of 
PIE proceedings. Some of these commenters desired a specific list of 
the actions that would lead to a PIE proceeding, while others suggested 
the Department should at least provide examples.
    Another frequently-made comment concerned the scope of PIEs. The 
NPRM said that a PIE would apply to all divisions, organizational 
elements, and types of services provided by a service agent, unless the 
ODAPC Director decided to limit its scope. Affiliates and individual 
officers and employees could also be subject to a PIE. A number of 
service agents and employers objected to this aspect of the proposal, 
saying it was too broad. It was unfair, they said, to prohibit 
employers from using a service agent's other services because of a 
problem in one area. If a TPA has violated the rule with respect to MRO 
services, for example, why should a PIE prevent an employer from using 
the TPA for collection or SAP services? Many commenters who made this 
point favored an approach that came to be known, in the listening 
sessions, as the

[[Page 79466]]

``slice of PIE.'' Under this approach, a PIE would apply only to the 
type of service in which noncompliance had taken place. Some commenters 
said the ``slice'' should be even narrower, applying only to the 
specific employer, facility, or individual service agent staff members 
who had been involved in the noncompliance. A few laboratories said 
that laboratories should not be subject to the PIE process, since HHS 
already regulates laboratories through its certification process. 
Another commenter thought that it would be better to fine erring 
service agents rather than issuing a PIE.
    Commenters raised two issues concerning the role of the ODAPC 
Director in the PIE process. A few service agents suggested that the 
Director would not be an objective decisionmaker, because he or she 
would be too sympathetic to the position of DOT staff. Others suggested 
that the ``firewall'' between the Director and other staff be made more 
explicit in the regulatory text. Several service agent commenters also 
asked for criteria for determining the length of a PIE, as well as a 
regulatory time frame for the Director's consideration of a service 
agent's petition to lift a PIE.
    Smaller numbers of commenters suggested other procedural changes in 
the PIE provisions. One recommendation was that the initiating 
official's burden of proof be ``clear and convincing evidence'' instead 
of a preponderance of the evidence. Others asked for specific rules of 
evidence to apply to PIE proceedings. Some asked that the Department 
contact the service agent first, to check on alleged facts, before 
initiating a proceeding. A number of employers asked for periods longer 
than the proposed 90 days to replace a service agent that was subject 
to a PIE, or for the possibility of extensions of that period. Some 
service agents asked to delay the effective date of the PIE provision 
by a year or two, to give organizations time to get used to the 
requirements of the new final rule. A commenter asked that the rule 
provide for a private right of action by employers against service 
agents. Other commenters disagreed with the statement in the proposed 
rule text that the purpose of a PIE was not punishment.

DOT Response

1. Basic Rationale for the PIE Provisions
    Service agents perform the bulk of drug and alcohol testing 
services for transportation employers. Employers, particularly small 
employers, necessarily rely on service agents to comply with their 
testing obligations. These employers often do not have the expertise in 
testing matters that would enable them to evaluate independently the 
quality, or even the regulatory compliance, of the work that service 
agents perform for them. Yet an employer's compliance with DOT 
regulations is largely dependent on its service agents' performance. If 
a service agent makes a serious mistake that results in the employer 
being out of compliance with a DOT rule, the employer alone is now 
accountable. The employer may be subject to civil penalties from a DOT 
agency. The employer can be subject to litigation resulting from 
personnel action it took on the basis of the service agent's 
noncomplying services. Most importantly, the employer's efforts to 
ensure the safety of its operations may be damaged, as when an employee 
who apparently uses drugs is returned to duty because of a service 
agent's noncompliance. In many cases, there are now no consequences to 
a service agent who creates such problems, even if the problems are 
serious.
    The experience of DOT agencies, which are responsible for reviewing 
employers' compliance, is that the vast majority of employer 
noncompliance results from service agent errors. (Given the pervasive 
role of service agents in performing testing functions, this is 
probably not a disproportionate effect.) FAA staff informally estimate, 
for example, that more than nine out of ten deficiencies their 
inspectors discover result from service agent errors. In addition, the 
Department's drug and alcohol testing office staff, from time to time, 
encounter serious noncompliance with DOT rules by service agents, for 
which there is no present remedy. Here are a few examples of actual 
cases we have encountered:
     An MRO verified many tests positive without conducting 
verification interviews. As a result, the tests had to be cancelled, 
and the employer had to return the employees to duty, incurring extra 
safety risks and costs.
     Another MRO, who had counterfeit medical credentials, 
verified several tests positive, bringing into question the integrity 
of the verification process.
     In defiance of the clear language of Part 40, a letter 
from the Department, and a finding by a court, a laboratory refused to 
provide an employee information to which she was entitled.
     A service agent made false claims that its personnel were 
certified by DOT. DOT wrote them a letter telling them to stop. Years 
later, the same service agent's letterhead continues to make the same 
claims.
     A consortium and a laboratory were engaged in a billing 
dispute with one another. As a result, numerous pre-employment results 
were not transmitted to employers for a number of months. No one 
informed the employers of the problem, and some of the employers, in 
the apparent belief that ``no news is good news,'' placed some of the 
workers--including one who tested positive--in safety-sensitive 
positions.
     A major employer used a service agent for SAP services. 
The SAPs provided by the service agent established a long-standing 
pattern of returning virtually all employees who have tested positive 
to work quickly, without education or treatment.
     Personnel of a major laboratory engaged in misconduct 
apparently involving the backdating and attempted destruction of 
documents relevant to litigation concerning a drug test result.
    Attempting to deal with service agent problems one employer at a 
time is both inefficient and potentially unfair. It is inefficient 
because service agents work for many employers. It is potentially 
unfair because employers may be unwitting victims of service agent 
misconduct. Conducting civil penalty proceedings against several 
employers because of the actions of one service agent, moreover, does 
little if anything to correct the conduct of the service agent or 
protect other employers from the consequences of its noncompliance. In 
addition, service agents often work for employers in more than one 
transportation industry. For example, if FRA takes action with respect 
to a railroad whose noncompliance is caused by service agent errors, 
this does nothing to protect a motor carrier who uses the same service 
agent.
    The Department believes that, in this situation, an accountability 
mechanism that protects the public interest, employers, and employees 
is appropriate and necessary. A few commenters appear to have 
misunderstood the nature of the PIE proposal. It is not an assertion of 
new regulatory authority over service agents. It makes use of the 
Department's long-standing authority to direct transportation employers 
not to use products and services that do not meet Federal standards. 
Employers may not use laboratories that are not HHS-certified. They may 
not use evidential breath testing devices (EBTs) that are not on the 
National Highway Traffic Safety Administration (NHTSA) conforming 
products list (CPL). They may not use SAPs and MROs who fail to meet 
regulatory qualifications. There is no difference in legal principle

[[Page 79467]]

between these well-established prohibitions and a requirement not to 
use a service agent who has been found to have seriously noncomplied 
with Part 40. A PIE is simply one additional directive to 
transportation employers to ensure that the employers use only service 
providers that meet regulatory requirements.
    Procedurally, the PIE process is modeled on a well-established 
procedure for handling non-procurement suspensions and debarments. 
While not identical to the non-procurement suspension and debarment 
rules of the Department (49 CFR part 29), the PIE process draws on Part 
29 for many of its details. Modeling PIE on an existing program that 
affords due process to participants ensures that PIE will be an 
effective and fair approach to serious noncompliance in the drug and 
alcohol testing program.
2. Legal Authority
    The Department looked carefully at the issue of legal authority 
before proposing the PIE process in the NPRM. As noted in the preamble 
to that document, there is ample legal authority to implement this 
proposal. First, there is specific statutory authority for rulemaking 
in this area. Section 322 of the DOT Act provides general rulemaking 
authority to the Secretary of Transportation. It states that ``[t]he 
Secretary of Transportation may prescribe regulations to carry out the 
duties and powers of the Secretary.'' Further, the 1991 Omnibus Act 
authorizes the Secretary of Transportation to continue in effect, 
amend, or further supplement regulations governing the use of alcohol 
or a controlled substance. See 49 U.S.C. 31306(i), 49 U.S.C. 20140(f), 
49 U.S.C. 5331(f)(3), and 49 U.S.C. 45106(c). Upon review of the Act, 
it is clear that Congress--while not explicitly mentioning a particular 
mechanism to ensure compliance--intended the Secretary to use his or 
her discretion to devise appropriate regulatory methods to carry out 
the Department's drug and alcohol testing responsibilities.
    Moreover, under well-settled case law, specific statutory authority 
is not needed in order for an agency to have authority to impose a 
reasonable requirement. There are many court decisions that support 
this point, particularly cases following Chevron v. Natural Resources 
Defense Council, 467 U.S. 837 (1984). Chevron stands for the 
proposition that courts will defer to ``permissible'' agency 
interpretations where the statute is ``silent or ambiguous''. In 
Chevron, the leading case on the regulatory and interpretive authority 
of agencies, the Supreme Court articulated the following standard:

    When a court reviews an agency's construction of the statute it 
administers, it is confronted with two questions. First, always, is 
the question of whether Congress has directly spoken to the precise 
question at issue. If the intent of Congress is clear, that is the 
end of the matter; for the court, as well as the agency, must give 
effect to the unambiguously expressed intent of Congress. If, 
however, the court determines Congress has not directly addressed 
the precise question at issue, the court does not simply impose its 
own construction of the statute, as would be necessary in the 
absence of an administrative interpretation. Rather, if the statute 
is silent or ambiguous with respect to the specific issue, the 
question for the court is whether the agency's answer is based on a 
permissible construction of the statute. (Id. at 842-43).

    Numerous cases have reaffirmed this standard. When courts have 
applied the Chevron analysis to strike down an agency regulation or 
interpretation, they have not done so on the basis that a statute did 
not speak to the issue at hand. Rather, they did so because something 
in the statute specifically precluded the action the agency had taken. 
It is clear that nothing in the Department's statutes precludes the 
Department from instituting a procedure like PIE.
    To the contrary, the most important statute authorizing the DOT 
drug and alcohol testing program, the Omnibus Transportation Employee 
Testing Act of 1991, confirms the Department's broad authority to carry 
out its drug and alcohol testing responsibilities. Congress intended 
that the Secretary use his or her discretion and issue supplementing 
regulations when necessary to carry out the Department's drug and 
alcohol testing responsibilities.
    The DOT agency drug testing regulations and Part 40 were originally 
adopted in 1988-89 without any specific statutory authority. These 
rules were based on the DOT agencies' general safety rulemaking 
authority and the Department's general rulemaking authority. These DOT 
agency safety statutes are silent with respect to drug and alcohol 
testing. They do not describe drugs to be tested, types of tests, 
random testing rates, laboratories, medical review officers, return-to-
duty procedures, testing equipment or personnel, or any of the other 
subjects addressed by DOT agency substance testing rules and Part 40. 
Before the Omnibus Act, these statutes provided the only authority for 
the DOT agency drug testing rules, and they still provide the only 
authority for the RSPA and Coast Guard rules. There was never any 
question--aside from the original transit rule--about the authority of 
the DOT agencies to issue these rules. When plaintiffs challenged these 
rules, they and the courts focused on the constitutional issues, 
mentioning the agency's authority for the rules only in passing, since 
it was so clear.
    Under Chevron, when the intent of Congress is clear, as is the case 
here, no further inquiry is necessary. This makes it unnecessary for 
any reviewing court to move on to the second prong of Chevron. If a 
court did examine the PIE provision under the second prong however, 
there is little doubt that the Department's action is based on a 
permissible construction of the statute. The Department 's decision to 
facilitate employer compliance and protect employers and employees from 
the consequences of services that are inconsistent with regulatory 
requirements is reasonable. Each of the requirements of Part 40 is 
important to ensure the accuracy, integrity, privacy and fairness of 
the testing process as well as the safety of the public. If a service 
agent fails or refuses to meet these requirements, then these important 
interests are adversely affected.
    As the testing program and the role of service agents have evolved 
over ten years, the Department has learned that additional measures are 
needed to ensure the proper provision of testing services to employers. 
In every respect, the proposed PIE process comes squarely within the 
range of agency actions which courts, applying Chevron, have approved.
3. Alternatives
    The Department believes that efforts by industry groups to 
establish certification programs, training programs, and industry 
standards are laudable and helpful. Such efforts, however, do not 
address the issue of accountability for service agents whose 
noncompliance is serious. These programs cannot respond, in a legally 
binding way, with real consequences, to protect employers and employees 
from the misconduct of a party who makes serious errors or chooses to 
noncomply to gain an economic advantage.
    An accountability mechanism like that proposed in the NPRM would 
effectively complement voluntary industry efforts. By attaching 
tangible consequences to serious noncompliance, an accountability 
mechanism would assist industry groups in getting service agents to 
take certification, training, and industry standards programs 
seriously.

[[Page 79468]]

    Some commenters favored one or more of the options discussed in the 
NPRM preamble, such as certification or self-certification followed by 
a DOT decertification procedure or a contract-based mechanism. With 
respect to the contract mechanism, comment was, however, very divided, 
with many commenters (in response to the PIE proposals or proposed 
Sec. 40.11) saying that the contract clause requirement was too 
burdensome or ineffective (i.e., with respect to parties who typically 
do not have written contracts). The Department does not have the 
resources to operate a Department-wide active certification program 
(especially with respect to the motor carrier industry). Maintaining a 
data base for a self-certification program would be difficult for the 
Department, and there are significant issues concerning keeping such a 
data base up to date. For these reasons, we do not believe that these 
options are preferable to the PIE provisions the NPRM proposed.
    A few commenters supported reliance on the legal system (i.e., 
court litigation) as a tool for employers to use to address problems 
caused by service agent noncompliance. Nothing prevents employers from 
resorting to private litigation now or in the future. By nature, 
however, such private litigation focuses on vindicating the private 
interests of the employer involved, not in more broadly protecting 
testing program participants and the public interest. For this reason, 
we do not view private litigation as a substitute for the PIE 
provisions.
4. How Does a PIE Proceeding Begin?
    Many service agent commenters asked for greater clarity and 
specificity concerning what ``offenses'' would be sufficient to warrant 
starting a PIE proceeding. They expressed the concern that the NPRM 
proposal would give DOT officials, including auditors and inspectors, 
too much discretion to start PIE proceedings based on minor problems, 
despite the Department's statements that PIEs were intended to be used 
in cases of ``egregious'' noncompliance.
    As DOT officials said during the listening sessions in PIE 
roundtables, we do not think it is a good idea to have a definitive 
list of offenses that would trigger a proceeding. The Department's 
experience with this program suggests that new situations will always 
arise. We cannot possibly specify them all at this time. A list that 
appeared definitive could lead to arguments that the Department was 
precluded from starting a PIE proceeding because the underlying conduct 
was not on a regulatory list.
    Nevertheless, the Department does believe it would make our intent 
and policy clearer to state in the regulatory text that this process is 
intended to be used only for serious noncompliance. We provide several 
examples of the kind of noncompliance that would, as a policy matter, 
have a level of seriousness sufficient to warrant starting a PIE 
proceeding. This regulatory text provision also states that the list is 
not exclusive or exhaustive: we retain the discretion to start PIE 
proceedings in situations not on the list and we are not required to 
start a PIE proceeding every time something on the list comes up.
    We also make clear that not everyone with a DOT ID card is 
authorized to start a PIE proceeding. Only certain officials, such as 
DOT agency drug and alcohol program managers, are authorized to do so. 
They may rely on credible information from any source, including but 
not limited to DOT auditors and inspectors, as the basis for starting a 
proceeding. As several commenters requested, the final rule text 
provides that the initiating official must contact the service agent to 
get its side of the story and any facts it can provide before taking 
further action, such as issuing a correction notice or a notice of 
proposed exclusion (NOPE).
    One issue on which commenters spoke concerns the relationship of 
the PIE process and the HHS certification process for laboratories. 
With respect to matters on which HHS takes certification action against 
a laboratory, the Department would defer to the HHS action. That is, as 
a policy matter, the Department would not start a PIE action is HHS had 
already taken a certification action against a laboratory on the same 
matter. We do not believe it would be an economical use of resources to 
have two Federal proceedings in progress with respect to the same 
laboratory, on the same issues, at the same time. However, if DHHS 
decided that it was not appropriate to begin certification action 
(e.g., because the laboratory's conduct did not trigger the HHS 
``imminent harm'' standard), DOT could consider whether to begin a PIE 
proceeding.
    One of the concerns that some commenters expressed was that the 
very existence of a PIE proceeding, regardless of its ultimate outcome, 
could have adverse economic effects on a service agent. They asked that 
such proceedings be kept confidential. The Department does not believe 
that it is possible to keep a PIE proceeding, or the events leading up 
to it (e.g., a factual inquiry, a correction notice) secret. For 
example, in seeking to establish whether there is a factual basis for a 
PIE proceeding, DOT personnel might well have to ask questions of a 
number of employers about the service agent's activities. On the other 
hand, the Department will not affirmatively seek to make pending 
proceedings public knowledge, prior to the issuance of a NOPE. For 
example, we do not intend to issue a press release or make other kinds 
of public announcements at the time that we send a correction notice to 
a service agent. The issuance of a NOPE and the Director's decision, 
however, are matters of public record.
5. Scope of PIE Proceedings
    Section 40.379 of the NPRM proposed that a PIE would apply to all 
the divisions, organizational elements, and types of services provided 
by the service agent involved, unless the Director limited the scope of 
the proceeding. Under some circumstances, affiliates and individuals 
could also be subject to a PIE. Many service agent commenters thought 
the scope of a PIE should be narrower, limited to a particular type of 
activity, affected employer, etc.
    The intent of the PIE proposal is to protect the public from the 
misconduct of an organization. Allowing the organization to segment its 
activities, and contend that the public should be protected only from 
some of what it does, is contrary to this objective. Nevertheless, the 
Department believes that it is appropriate to decide, on a case-by-case 
basis, whether a compliance problem is limited to one facet of a 
service agent's activities or pervades the service agent's 
organization. The Department is therefore making a procedural change 
from the NPRM. Instead of saying that a PIE would apply to everything a 
service agent does, the final rule makes the scope of the PIE an issue 
in the proceeding.
    That is, the initiating official would propose a scope for the 
proposed PIE, depending on that official's view of how pervasive the 
noncompliance was in the service agent's organization. It might be one 
activity or organizational element; it might be more than one; it might 
be the totality of the service agent's activities. The service agent 
could contest the initiating official's scope proposal, and the 
Director would make an explicit decision about scope. This is not quite 
the ``slice of pie'' proposal advanced by some service agents, since 
the Department would not necessarily be limited by rule to applying a 
PIE only to the type of activity or organizational element directly 
involved in the noncompliance. But the initiating official would have 
the burden of persuading the Director that the

[[Page 79469]]

proposed scope of the PIE was appropriate in light of the facts of the 
case. The final rule text provides several examples to illustrate the 
way this scope procedure is intended to work.
6. Procedural Issues
    Like the NPRM, the final rule requires initiating officials to send 
a correction notice to a service agent before starting a PIE 
proceeding. This notice gives the service agent 60 days to fix a 
problem or change its procedures before a more adversarial process 
begins. We have added greater specificity concerning the NOPE that 
begins a PIE proceeding (e.g., specifically requiring information on 
the proposed scope and duration of the PIE).
    We believe that the ODAPC Director is the appropriate person to 
make decisions in PIE cases. The ODAPC Director is someone who is 
knowledgeable about the DOT program and regulations but who is not 
directly involved in their enforcement by the DOT agencies. We disagree 
with contentions that the Director is inherently biased in potential 
PIE matters. It is the Director's job to consider such matters fairly 
and in accordance with the Department's rules, and nothing in the 
comments persuades us that the Director will be unable to do the job 
right.
    To reassure participants further about the objectivity of the 
process, we have added language to the final rule specifically 
prohibiting the ODAPC Director from playing any role in the initiation 
of a PIE and establishing a ``firewall'' between the initiating 
official and the Director. This firewall would prohibit any ex parte 
contacts between the two. In any situation in which it would be 
inappropriate for the Director to act as the decisionmaker (e.g., the 
Director had recent professional ties to the service agent who was the 
subject of the PIE proceeding, the Director has had substantial 
involvement in a matter before it becomes the subject of a PIE 
proceeding), the rule the Director would designate another person to 
decide the case. In addition, the final rule lists the elements of the 
Director's decision, including not only the basic decision about 
whether to issue a PIE but also decisions about disputed matters of 
material fact, the scope of a PIE, and the duration of a PIE.
    The standard of proof in a PIE proceeding will remain ``the 
preponderance of the evidence.'' There is no policy or legal basis 
apparent for raising this burden to the higher ``clear and convincing 
evidence'' level. Contrary to a few comments, there is no ``presumption 
of guilt'' on the part of a service agent in a PIE proceeding. The 
initiating official bears the burden of proof. Administrative 
proceedings in many kinds of matters, including suspension and 
debarment proceedings under Part 29, are conducted informally, without 
formal rules of evidence of the kind used in the court system, with 
evidence accepted on a general relevance standard. The final rule makes 
clear that PIE proceedings will be conducted in this way.
    The Department takes no position on whether Part 40 creates a 
private right of action, deferring to the courts or to DOT agency 
regulations on this issue. While the Department recognizes that a PIE 
will have adverse consequences for a service agent, we continue to 
believe that the purpose of a PIE is to protect the public interest, 
not punishment. This language, which is derived from Part 29, is an 
accurate statement of the intent of the PIE provision and we are 
retaining it. A few commenters asked for a time frame for PIE decisions 
by the Department. We have responded by saying that the Director will 
generally make a decision within 60 days of the completion of the 
record in the case, though the Director can extend this period for good 
cause.
    Some commenters requested additional clarification of the standards 
for determining the duration of a PIE. In response, we have added a new 
section listing examples of the kinds of factors that the Director will 
consider in determining the appropriateness, scope, and duration of a 
PIE. Since the proposed duration of a PIE is one of the elements of a 
proceeding that service agents can contest, service agents and 
initiating officials will have the opportunity to refer to these 
factors in their arguments about duration. In general, we say in the 
final regulatory text that a PIE stays in effect for one to five years. 
In deciding on the duration of a PIE, the Director will take into 
account the seriousness of the noncompliance and other factors listed 
in the rule. Nine months after the Director issues a PIE, the service 
agent can apply to the Director in writing to terminate or reduce a 
PIE. The rule spells out the grounds for such a request.
    As noted in the Effective Dates section of the preamble, the 
Department is making the PIE provisions of the rule 30 days from the 
date of publication. The effect of this action is to make PIE 
proceedings available to the Department with respect to noncompliance 
with the existing Part 40 rule between the publication date of this 
revision and the August 1 effective date of the complete revised Part 
40. We are doing so in order to emphasize to service agents that they 
are accountable for their actions. In some recent instances (e.g., the 
apparent laboratory evidence tampering incident referred to in ``Basic 
Rationale for PIE Provisions'' above), the Department would have had 
grounds for considering the use of PIE proceedings, had they been 
available to us.

Return-to-Duty Process

    The NPRM raised a number of issues surrounding the return-to-duty 
process. We proposed to consolidate this material in Part 40. One issue 
concerned the minimum number of follow-up tests that SAPs should 
prescribe. Should there be an increase over the current rule's 
requirement of six tests over the first 12 months following an 
employee's return to duty (e.g., to 12 tests over one or two years)? 
Another issue was ``aftercare.'' That is, SAPs often make 
recommendations for continuing assistance after the employee returns to 
work. The NPRM proposed that employers would have to monitor employees' 
compliance with these recommendations. A third issue was whether SAPs 
should routinely receive drug test quantitations.

Comments

    Comments from a mixture of employers, employees, and service agents 
directly addressed the question of whether the Department should 
increase the minimum number of follow-up tests. A substantial majority 
of these commenters opposed any change in the current requirement of a 
minimum of six tests over the first year following the employee's 
return to duty, and a few of these suggested reducing that minimum. 
These commenters did not oppose retaining the SAP's discretion to 
prescribe a higher number of tests or testing that went beyond the 
first year. Some additional commenters said that number of tests should 
be determined at the SAP's discretion, or in negotiation between the 
SAP and employer. On the other hand, a few commenters favored 
increasing the minimum to 12 tests.
    With respect to aftercare, several motor carriers and motor carrier 
associations opposed the proposal for employers to monitor employee 
compliance with SAP recommendations. They said it would be too 
burdensome and went beyond their expertise, which centered on running 
trucks, not aftercare. A few service agents supported the proposed 
change. There was also concern expressed, principally in discussions at 
the listening sessions, that some SAPs were reluctant to recommend 
assistance

[[Page 79470]]

even after employees tested positive, whether out of over-reliance on 
employee's excuses, claims that the testing process was flawed, or the 
SAP's personal opinions about the justification for or utility of the 
testing process. Some commenters asserted that the very fact of a 
violation showed that an individual was in need of some education or 
treatment, so it was inconsistent with the purpose of the rules to 
permit SAPs to find that an individual was not in need of assistance.
    Commenters were divided on the issue of whether SAPs should 
routinely receive reports of the quantitation of drugs in the specimens 
of individuals who tested positive. Those who favored this approach, 
including most of the employers who spoke to this issue and some of the 
SAPs, said that it would be useful to know the levels of drugs in the 
employees' specimens. This would be helpful to SAPs as they try to 
evaluate an employee's situation and determine what sort of treatment 
was appropriate. The majority of commenters opposed providing this 
information on a routine basis, saying that the quantitation of drugs 
in a specimen was usually irrelevant to evaluation and treatment and 
could sometimes be diagnostically misleading. Testing was never 
intended to diagnose addiction, and urine test quantitations rarely 
provide a good basis for evaluating an employee's drug problems. A 
laboratory added that requiring laboratories to report this information 
to SAPs would be burdensome.

DOT Response

    With respect to follow-up tests, the Department has decided that it 
is not necessary to increase the minimum number. We believe that 
follow-up tests are very important. They are the best tool we have to 
make sure that an individual who has returned to duty after a violation 
remains in compliance while experiencing the actual stresses and 
temptations of the work environment. However, requiring a greater 
number of tests could be unnecessarily burdensome in those cases in 
which SAPs are satisfied that six tests are sufficient. We will keep in 
place the basic provisions of the existing rule: a minimum of six such 
tests in the first year of safety-sensitive work following the 
employee's return to duty. SAPs will continue to have discretion to 
require a greater number of tests over a period of up to 60 months, as 
in the current rule.
    The Department has become convinced that there is no basis for a 
SAP ever determining that an individual who has tested positive or 
otherwise violated the drug and alcohol rules does not need education 
or treatment as well as follow up testing. For someone who performs 
safety-sensitive transportation functions, the very fact of a violation 
indicates a disregard of safety that must be addressed, corrected, and 
monitored in order to ensure safe performance of those functions in the 
future. Therefore, the final rule will require the SAP to mandate some 
level of assistance in every case, as well as to prescribe at least the 
minimum number of follow-up tests for each employee who returns to duty 
following any violation of the rules. We also clarify that the SAP must 
present a copy of his or her written follow-up testing plan to the 
designated employer representative (DER). The rule text also cautions 
SAPs against basing any decisions, even in part, on employee claims of 
flaws in the testing process or any private opinions of the SAP about 
the validity or utility of the testing process.
    In response to comments, the regulation clarifies that the follow-
up testing requirement follows the employee from one job to another and 
persists through a break in service. That is, if after returning to 
duty with an employer, the employee changes jobs before completing all 
required follow-up tests, the employee is responsible for completing 
the follow-up tests with his or her new employer. Likewise, if the 
employee returns to work, is laid off for several months, and then 
comes back to work with the same employer, the employee must complete 
the series of follow-up tests ordered by the SAP.
    With respect to employer monitoring of aftercare, the Department is 
persuaded by the objections of employer commenters that we should not 
require employers to take on this task. SAPs have the obligation to 
make recommendations for aftercare where they believe such assistance 
is needed to maintain sobriety or abstinence from illegal drugs. These 
recommendations should carry a good deal of weight, because they in 
effect declare that employee compliance with them is important to 
ensure safe performance of safety-sensitive functions. The rule states 
the employee's obligation to comply with these recommendations.
    Rather than requiring employer monitoring, however, the rule 
provides the employer discretion to take a variety of steps. These 
could include putting compliance with SAP recommendations into return-
to-duty agreements, disciplining employees for noncompliance, and using 
the services of SAPs or employee assistance programs (EAPs) to assist 
and monitor employees' aftercare activities. The rule notes that 
employers can choose to monitor these activities, and that employees 
who fail to carry out the recommendations can be subject to sanctions 
from their employers. We note that this discussion concerns employer 
discretion with respect to aftercare (e.g., treatment and education) 
activities only. Employers do not have discretion with respect to 
follow-up tests. Employers must carry out the follow-up test 
instructions they receive from SAPs.
    The Department believes that the commenters who opposed routinely 
providing drug test quantitations to SAPs have the better of the 
argument. SAPs take a variety of factors--including a face-to-face 
interview with the employee--into account when determining what 
assistance the employee needs. The amount of a particular drug in an 
employee's specimen at a particular time does not determine what sort 
of treatment is most appropriate for the individual. Consequently, we 
will not provide for quantitations to be given to SAPs on a routine 
basis. We do provide, however, that SAPs can consult with MROs (who 
must cooperate with SAPs) and receive information that the MRO has 
gathered as part of the verification process. Through this process, 
SAPs can get additional information that may be of use to them in the 
evaluation process.
    We want to emphasize that neither the rule nor the Department 
requires employers to fire employees who violate the Department's drug 
and alcohol testing rules. There is no national policy, and certainly 
no policy articulated by the Federal government, that commands this 
result. We would not have this detailed return-to-duty procedure if we 
believed that no one should be returned to duty after a violation.
    As has been true from the beginning, all the Department requires is 
that an employee who violates the rule not perform safety-sensitive 
functions until and unless he or she successfully completes the return-
to-duty process. Decisions about discipline and termination are left to 
the discretion of the employer or labor-management negotiations. Where 
employer policy, or labor-management negotiations, have delegated 
personnel decisions of this kind to an arbitrator, the Department 
intends that the arbitrator's decision determines the personnel action 
that the employer takes. The Supreme Court has recently affirmed these 
principles. Eastern Associated Coal Corporation v. United Mine Workers 
of America, District 17, et. al, 531 U.S. ____ (2000).
    Of course, an arbitrator cannot order an employer to return an 
employee to

[[Page 79471]]

the performance of safety-sensitive functions until the employee has 
successfully completed the return-to-duty process. Nor can an 
arbitrator or an employer change the laboratory's findings about a 
specimen or an MRO's decision about whether there is a legitimate 
medical explanation for a test result.

Collector Training

    Competent performance of drug and alcohol testing functions by 
collectors, BATs and STTs, MROs, SAPs and others involved in the 
testing process is obviously very important to the integrity and 
fairness of the Department's program. The Department's NPRM asked 
questions and offered proposals for the training and qualifications of 
these personnel. This discussion focuses on collector training, which 
was the subject of more comment than training for other personnel. 
Training and qualifications for other personnel are discussed in the 
section-by-section portion of the preamble.

Comments

    Training for collectors in the drug testing program was the subject 
of comment from a wide variety of parties, including service agents, 
employers, and unions. Commenters differed on most of the subjects 
under discussion, including the basic point of the extent of current 
problems in the collection area. Most commenters on the subject 
believed that collections were the weakest point of the testing 
process, though some argued that there was a low rate of collection 
errors in their experience. Some commenters said that it would reduce 
collection errors if the Federal Custody and Control Form (CCF) were 
simplified.
    Some commenters favored a formal instruction course for collectors, 
like the Department's BAT course. Most of these and some other 
commenters opposed the notions of self-instruction and self-
certification for collectors, saying that they were meaningless. They 
believed that there should be some sort of formal training, with an 
examination or other means of ensuring that a collector deserved to be 
certified. Some commenters also supported a ``train-the-trainer'' 
course requirement to certify trainers.
    Other commenters, however, opposed any formal training requirements 
for collectors, saying it was expensive, burdensome, and might make it 
harder to find collectors, especially in less densely populated areas. 
A maritime employer group asked for some exceptions to training 
requirements for people who were not regularly collectors but might 
occasionally have to conduct a collection, as in a post-accident 
situation.
    Commenters who thought the NPRM's training proposals were too 
extensive often objected to requirements for classroom training or 
other training modes involving a live instructor or monitor. They said 
the requirements should be more flexible, and provide for training 
through such approaches as videos, internet-based courses, or 
instruction and monitoring through telephone or interactive computer 
methods.
    A number of commenters objected to the term ``sufficiently 
knowledgeable,'' which the NPRM used to describe the personnel who 
trained collectors. The commenters said the term was too vague. Some of 
these commenters asked that the rule include more specific 
qualifications for trainers. Some commenters also objected to the 
proposal that trainees be required to complete five error-free mock 
collections, saying that the requirement was either too burdensome 
(some suggested the number of mock collections be reduced) or 
insufficient. Some commenters also took issue with the requirement that 
a collector who made a ``fatal flaw'' mistake should have to be 
retrained, particularly since they felt it might threaten the validity 
of subsequent collections the collector conducted prior to the 
retraining. Others thought it would be better to have a slower trigger 
for the retraining requirement (e.g., two fatal flaws in two years).

DOT Response

    The Department believes that making collector training more 
effective will be an important step in reducing errors in the drug 
testing process. The collection of urine specimens is the step in the 
process with the greatest potential for administrative error, and our 
own experience confirms the comments of persons who said that 
collections are a fertile source of mistakes. When our inspectors and 
program personnel visit collection sites in the field, they commonly 
find a wide variety of mistakes and misunderstandings in the collection 
process. We also agree that self-certification is inadequate. For these 
reasons, we will require additional training of collectors, compared to 
the present rule. We believe that this training should be provided in 
as flexible a manner as possible. Section 40.33 contains the 
Department's resolution of collector training issues.
    Part 40 contains much information about how collections must be 
conducted. It is essential that collectors become knowledgeable about 
the relevant portions of the new Part 40, DOT collections guidance and 
relevant DOT agency rule provisions, and we will require them to do so. 
We also believe that more formal training is needed to ensure that 
collectors understand and can carry out the requirements of this part. 
We believe that, as commenters noted, the training can be provided in a 
number of ways (e.g., classroom sessions, videos, internet courses). We 
are not prescribing a particular curriculum as we have for alcohol 
testing personnel, and we will not require that collectors be 
``certified.'' By taking this approach, we achieve the objective of 
additional training while allowing flexibility and minimizing costs. 
In-person involvement of a trainer is not required for this part of the 
training process.
    To demonstrate that they can practically apply what they have 
learned, collectors must conduct five consecutive error-free mock 
collections. We believe this is an extremely important requirement, 
because collectors must deal with real people and real specimens in 
their job, not just regulatory text or computer simulations. By mock 
collections, we mean collections that are not real collections of 
employees subject to testing under DOT regulations. The five 
collections must include both uneventful and ``problem'' testing 
scenarios. Another person must monitor and evaluate the mock 
collections to ensure that they are error-free. This part of the 
process does involve the in-person participation of someone to monitor 
and evaluate the trainee's performance (unless some technology is used 
that permits the real-time, step-by-step observation and evaluation of 
the trainee's performance without a person in the same room with the 
trainee).
    The monitor must be someone who has demonstrated necessary 
knowledge, skills, and experience (1) by regularly conducting DOT drug 
test collections for a period of at least a year, (2) by having 
conducted collector training under this part for a year, or (3) by 
successfully having completed a ``train-the-trainer'' course. The 
Department sets out these alternatives for qualifying as a trainer in 
response to comments that said ``sufficiently knowledgeable'' was too 
vague.
    All new collectors must meet these training requirements. In 
addition, current collectors must meet the requirement within 21/2 
years after the effective date of this rule (December 2003). This will 
provide adequate time for current collectors to get the

[[Page 79472]]

necessary qualification training, if they have not already done so.
    Collectors would have to get refresher training every five years. 
We believe that, just as other professionals in the drug and alcohol 
testing business need continuing education, it is important for 
collectors to brush up on the rules and techniques of their part of the 
drug testing process, in order to ensure that they perform at the 
highest level. This training would also focus on any changes in 
collection technology that had come into use in the meantime.
    One of the most important occasions for training is following a 
mistake that actually results in a test being cancelled. This 
requirement does not apply every time there is a cancelled test, only 
when the cancellation is the result of the collector's error. The 
training would focus on the subject matter that was involved with the 
error, and would also involve three monitored error-free mock 
collections. This training would have to take place within 30 days of 
the collector's being notified of the error. The reason for this 
training is obvious: if someone makes a mistake once, we want to make 
sure he or she does not make a similar mistake again.
    Commenters noted that it might be very burdensome for employers, or 
even some service agents, to keep training records for each of their 
possible many and widespread collectors. To avoid this problem, we are 
requiring that collectors (like other service providers) keep their own 
training records, which would have to be made available to employers, 
other service agents (e.g., C/TPAs) involved with the collector's 
provision of services, and DOT. In addition, we specify in Sec. 40.209 
that a test is not invalidated because a collector has not fulfilled a 
training requirement. For example, suppose someone collects a specimen 
correctly but has not completed required training or retraining. The 
test would not be cancelled because the training requirement was not 
met, though the collector, other service agents, and employer involved 
might be found in noncompliance as the result of the failure to meet 
training requirements.

Transmission of Information Through Consortia and Third-Party 
Administrators

    When the Department began the drug testing program in 1988-89, we 
had in mind a perhaps simplistic model of how the program would work. 
We imagined that most employers would have an in-house testing program 
that would perform most of the tasks the rules required, except that 
employers would contract directly with laboratories for specimen 
testing services and perhaps with MROs for medical review services. We 
thought that owner-operators and other very small employers might well 
band together in consortia to gain economies of scale in purchasing 
testing-related services.
    The program has developed in quite different directions, to the 
point where most employers' drug and alcohol testing programs are 
outsourced, often operated by C/TPAs. These organizations often bundle 
their services to employers. Only a minority of employers, usually 
large ones, operate their own programs.
    One of the Department's tasks in revising Part 40 is to make 
appropriate adaptations to the altered shape of the drug and alcohol 
testing business. We have no desire to stand as King Canute before the 
marketplace sea. Nor do we wish to surrender to purely economic 
considerations features of the program we regard as critical to its 
integrity. The goal of finding an appropriate balance has influenced 
our efforts in a number of areas as part of this rulemaking, including 
the functions of MROs and SAPs and the issue of how test results are 
reported to employers.
    In the NPRM, the Department proposed keeping sharp lines of 
demarcation between different participants in the program. 
Specifically, we proposed putting into regulatory text the 
interpretation we have maintained under the existing rule with respect 
to the transmission of drug test results from MROs to employers. That 
is, MROs must report the results directly to employers. C/TPAs could 
not act as intermediaries in this process. This position was based on 
the premise that indirect reporting was likely to be slower, and more 
prone to error and compromise of confidentiality, than direct 
reporting.

Comments

    The bulk of comments on this issue came from TPAs, who asserted 
that they should be permitted to act as intermediaries in the 
transmission of drug testing results. There were also comments from 
employers and unions, most of which supported the TPAs' position. 
During discussions of this issue in the listening sessions, DOT staff 
asked TPAs to address the question of how it was as or more efficient 
and effective to move a result from Point A (the MRO) to point B (the 
employer) through Point C (a TPA), rather than sending it directly from 
Point A to Point B. Many of the C/TPA comments did address this 
question.
    A common response was that many MROs do not have the staff or 
electronic capability to receive, process, and transmit results to 
clients. Indeed, many smaller doctors' offices would find it burdensome 
to handle all the paperwork. It is more efficient division of labor to 
have doctors concentrating on medical review and TPAs on information 
distribution, some said. TPAs, commenters said, are set up to act as 
electronic transfer points for data, allowing for the more efficient 
and timely delivery of results. Requiring the MRO to transmit the 
results directly would increase rather than decrease processing time 
and add costs.
    Commenters favoring change in this proposal also said that TPAs 
know the rules and regulations well, since this is their full-time 
business. Small employers find it easier to call one place--the TPA--
for all drug program information rather than having to deal with a 
variety of sources. Some of these commenters noted that, in the Coast 
Guard program, TPAs had played this role successfully for some time. 
They said there was no evidence of any detriment to public safety in 
this case, or in other cases where TPAs (contrary to existing rules) 
have transmitted results.
    Some MROs and TPAs disagreed with this point of view, citing 
concerns about delays, administrative errors, and risks to 
confidentiality. Commenters said that many MROs are fully capable of 
transmitting results information directly to employers, and that if an 
employer found that it was not receiving results in a timely fashion, 
it could change MROs. In addition, direct MRO transmission may provide 
greater value to employers, because MROs can answer questions about the 
result and help the employer resolve procedural issues.
    Comment on this issue focused on MRO transmission of verified drug 
testing results to employers. However, many commenters mentioned other 
areas in which similar issues arise, such as laboratory transmission of 
results to MROs, transmission of SAP reports to employers, and 
transmission of alcohol test results from BATs to employers.
    A related, but distinct, issue concerned who could appropriately 
play the role of the designated employer representative (DER). Some 
commenters said that C/TPAs should be able to act for employers as 
DERs, at least in small companies. Some of these comments alleged that 
the role of the DER was a complex, multifaceted one, and that it would 
be very costly, particularly for small companies, to hire a DER.

DOT Response

    The Department is persuaded by the comments on this subject that C/
TPAs

[[Page 79473]]

have the ability to transmit verified drug test results to employers as 
or more efficiently than MROs who transmit the information directly. 
While we understand, and to an extent share, concerns about potential 
delays, errors, and breaches of confidentiality when intermediaries are 
used, we do not have any evidence in the record that these problems 
actually occur in any significant way. The Coast Guard experience, as 
reported by commenters (including some employer and union commenters) 
and verified by Coast Guard staff, suggests that the parties concerned 
in that industry are satisfied with this approach.
    Consequently, the final rule (see --40.345) gives employers the 
choice of receiving drug test results directly from the MRO or via a C/
TPA. We emphasize that it is up to the employer--not the C/TPA--to make 
this choice. The employer can make this choice for any or all of the 
items listed in Appendix F (e.g., an employer may choose to receive 
some items via the TPA and others directly from an MRO). The rule 
authorizes C/TPAs to act as intermediaries in the transmittal of 
information to employers only with respect to the specific provisions 
of the rule listed in Appendix F. C/TPAs are prohibited from acting as 
an intermediary in transmitting information not listed in Appendix F.
    For example, C/TPAs are not allowed to act as an intermediary who 
transmits laboratory test results to MROs , SAP reports to employers, 
or medical information from MROs to employers. In the case of the 
laboratory reports, we believe that the direct link between 
laboratories and MROs is critical to the timely and independent medical 
review of those results. (Certainly laboratories have the electronic 
capability to readily transmit results directly to MROs in a timely and 
accurate fashion.) With respect to SAP reports, we are concerned that 
using an intermediary creates the opportunity and temptation to alter 
the SAP's recommendations (a problem that DOT staff have noted in the 
current program). With respect to medical information, we believe this 
is confidential medical data that should not pass through an additional 
hand on its way from the MRO to the employer.
    The discussion of this issue among commenters focused mainly, 
though not exclusively, on drug test information. A few commenters 
mentioned that similar considerations should apply to alcohol testing 
information. With respect to ``negative'' alcohol test results (i.e., 
results of less than 0.02), we agree. The same rationale that supports 
permitting drug testing information to be conveyed by C/TPAs applies to 
this information. However, we draw a distinction with respect to 
alcohol testing results of 0.02 or higher. These results--unlike 
positive drug test results or negative drug or alcohol test results--
mean that an employee is, to some extent, impaired by alcohol. As a 
safety matter, the employer must immediately remove the employee from 
performance of safety-sensitive functions. This is a situation where 
time is of the essence, and we therefore will continue to require BATs 
to transmit these results directly to employers. C/TPAs are not 
authorized to act as an intermediary in this situation.
    We believe that it is essential that someone employed by the actual 
transportation employer act as the DER. The DER's function is to 
receive information about certain kinds of test results and take 
required action, such as removing an employee from the performance of 
safety-sensitive functions. Someone who is an employee of a C/TPA, 
rather than of the actual transportation employer, is less well 
situated to perform these functions, especially since a C/TPA 
representative generally does not have line authority over a 
transportation employer's employees.
    Much of the comment on this issue appears based on a significant 
misunderstanding of the role of a DER. A DER is not a drug and alcohol 
program manager. A DER does not need extensive knowledge about the DOT 
drug and alcohol testing program and need not spend extensive time on 
DER duties. The DER is simply someone who can act immediately to remove 
an employee from safety-sensitive functions, or take other appropriate 
action, upon receipt of information that the employee has violated the 
rules or needs to be subject to certain testing requirements. 
Particularly for small companies (e.g., a 3-10 driver trucking 
company), the DER is likely to perform this function on a collateral 
duty basis, fielding a rare phone call (i.e., there are not many tests 
per year and only a small percentage of tests result in violations) and 
removing an employee from safety-sensitive functions on those 
occasions. This is not a time-or resources-intensive activity, and it 
would certainly not require hiring an extra human resources staff 
person.
    The one exception the final rule makes concerns owner-operators. 
Under the FMCSA rule, owner-operators are, in effect, required to get 
at least random testing services through a C/TPA. In an owner-operator, 
the driver is his or her own boss, so there is no one else in his or 
her own organization to direct him or her to stop performing safety-
sensitive functions. In this situation, we think it is probably better 
to permit the C/TPA to perform what otherwise would be a DER function.

Collection Process Issues

    Commenters were interested in a variety of issues in the drug 
testing collection process. These included dilution issues, the 
consequences of refusing to drink fluids and the length of the interval 
before the second collection attempt in ``shy bladder'' situations, 
retests under direct observation when a split specimen is unavailable 
for testing, using split specimen collections in all DOT modes, and 
having employees remove boots as part of the preparation for a 
collection.

Comments

    The first issue in this category is whether, when there is a 
specimen that is both negative and dilute, there should be an immediate 
recollection under direct observation. Commenters took a number of 
positions on the issue. Some employers and service agents favored 
making retests under direct observation mandatory, on the ground that a 
dilute specimen effectively formed a basis for a reasonable suspicion 
that the employee had tried to conceal drug use. Some unions and 
service agents opposed such a requirement because it would intrude on 
employees' privacy, might well result from innocent consumption of 
water, and was of dubious value in deterring and detecting illegal drug 
use.
    A plurality of commenters favored making a recollection, as well as 
the decision about whether to use direct observation, optional with the 
employer. This approach, they said, would recognize the variety of 
situations in which a dilute specimen may occur. It could be done in 
consultation with MROs, to ensure that there was some medical input 
into the employer's decision.
    The second, related issue is whether an employer should be able to 
disregard a negative dilute result. For example, suppose an employer 
receives such a result on an applicant's pre-employment test. Should 
the employer be able to require the applicant to take another test to 
get a ``real negative'' before beginning safety-sensitive work? Most 
employers, and some service agents, who commented on this issue favored 
this approach, especially in pre-employment testing. They did so in the 
belief that a negative dilute result was, at best, questionable. Even 
if it did not result from a deliberate attempt to cheat on a test, it 
was not as definite a

[[Page 79474]]

demonstration of compliance as a negative test from a more concentrated 
specimen. Unions and some service agents disagreed, saying that this 
would unnecessarily burden employees, including many who could achieve 
dilute (as distinct from substituted) results naturally, by drinking a 
lot of water (which some commenters made a point of noting was a legal 
substance). This approach would involve a ``guilty until proved 
innocent'' approach, in this view.
    Most, though not all, employers said that an employee who refuses 
to drink additional liquids after failing in his or her initial attempt 
to produce a sufficient specimen should be regarded as having refused 
to test. These commenters saw refusals to drink as attempts by 
employees who had used drugs to avoid a positive test. They also viewed 
it as a waste of up to three hours of time that the employee remained 
off the job (but presumably in paid status). Some service agents also 
shared this point of view. Unions and other service agents disagreed. 
They said that an employee could have legitimate health or other 
reasons for not wanting to drink additional fluids. Moreover, if an 
employee fails to drink fluids, and consequently fails to produce a 
sufficient specimen on the second try, the employee will be referred to 
a physician for an evaluation. If the physician does not find that a 
medical condition produced, or could have produced, the inability to 
provide a sufficient specimen, the employee will be treated as having 
refused the test. This consequence is sufficient, these commenters 
said.
    When an employee has a verified positive test, the Omnibus Employee 
Testing Act gives the employee the right to request a test of the split 
specimen. The Department has long taken the position that if the 
employee makes a timely request to test the split specimen, and the 
split specimen is unavailable for testing (e.g., the split specimen was 
never collected, leaked away, or was lost), the test must be cancelled. 
While we believe this outcome is necessary as a matter of law, it 
raises a safety concern. In such cases, we have an apparently valid, 
verified positive result, indicating that the employee used illegal 
drugs. However, because of the accidental unavailability of the split 
specimen, the employee can continue to perform safety-sensitive 
functions.
    In response to this concern, the NPRM sought comment on the idea of 
requiring a recollection under direct observation in these cases. This 
might detect drug use by the employee and result in his or her removal 
from the performance of safety-sensitive functions. The rationale for 
the direct observation aspect of the procedure reflects the belief that 
an employee, having recently tested positive, may have an additional 
incentive to cheat on the second test.
    Comment was divided on this issue. Employers generally supported 
the proposal to require recollection under direct observation on the 
safety rationale mentioned above. Unions and some service agents 
opposed the proposal, saying that it undermined the employee's right to 
a test of the split specimen. Some added that the second test would not 
really answer the question of whether the employee has tested positive 
on the first test. Opponents of the proposal particularly objected to 
the direct observation aspect of it, on intrusiveness and violation of 
privacy grounds. Why, they asked, should someone suffer a directly 
observed test because the collector made an error?
    Currently, those DOT agencies covered by the Omnibus Transportation 
Employee Testing Act--FRA, FAA, FTA, and FMCSA--are required to collect 
split specimens. RSPA and Coast Guard, whom the Act does not cover, 
give employers the choice of collecting single or split specimens. 
Commenters on this point almost unanimously favored requiring split 
specimens in all DOT agency programs. They said that this would be much 
simpler and less confusing, and likely would reduce the incidence of 
errors (e.g., failure to collect split specimens where required). Split 
specimen collections are not any more expensive than single specimens, 
one commenter said. One commenter questioned the Department's authority 
to require split specimen testing in RSPA and the Coast Guard absent 
legislation.
    The Department has heard concerns, over the years, that some 
employees have concealed adulterants or other means of tampering with 
tests in their boots (e.g., cowboy boots). For this reason, the NPRM 
proposed that collectors would ask employees to remove their boots, so 
that collectors could check them for such items. Commenters almost 
unanimously panned this proposal, asserting that it was intrusive, 
ineffective, and inconsistent (i.e., vis a vis the rule's treatment of 
other footwear and clothing). Commenters raised specters ranging from 
confrontations between employees and collectors to exposing collectors 
to unpleasant foot odors.

DOT Response

    With respect to the issue of negative dilute tests, the Department 
has decided to give employers discretion about how to handle these 
situations (see --40.197). There are reasonable arguments on both sides 
of this question, and the Department is not persuaded that that there 
is a single, across-the-board, right answer. The variety of 
circumstances among employers appears too wide to permit a unitary 
solution. In response to concerns about recollections being unduly 
burdensome on employees, the Department will require that a given 
employer treat all employees equally, to avoid the possibility of 
arbitrary selections of individuals for recollection. That is, an 
employer would have to treat all situations in a given category the 
same way (e.g., require recollections in all pre-employment test 
situations that had negative dilute results). This would prevent 
employers from singling out disfavored employees. In addition, 
employers would be limited to a total of two tests (the original 
negative dilute result and one recollection). They could not conduct 
additional tests if the recollection were also a negative dilute, for 
example. This provision limits the potential burden on employees.
    If an employer chooses to conduct another test, it could not be 
conducted under direct observation, unless one of the other 
circumstances permitting or requiring direct observation occurred. We 
use direct observation primarily to counter the likelihood of tampering 
at the collection site. This makes sense in situations where we are 
mostly concerned about adulteration or substitution. Most dilution 
cases, however, arise because an individual hydrates his or her system 
before going to the collection site. Privacy issues aside, then, direct 
observation seems off point in the dilution situation. What is useful 
is giving an employee the shortest possible interval between notice of 
the test and the conduct of the test, so that the individual does not 
have time to overhydrate. For this reason, the rule requires employers 
to provide no advance notice of the recollection to employees.
    The Department will not include any general provision requiring or 
authorizing employers to disregard the results of negative dilute 
tests. Given the structure of the rule, such a provision is 
unnecessary. Employers have the discretion to conduct one recollection 
following a negative dilute result. If the employer chooses not to 
conduct a recollection, then the negative result is the only result it 
has, and the employer will rely on the result just as is does in any 
other case. If the employer does conduct a recollection, then the 
result of

[[Page 79475]]

the recollection--not the original test--becomes the result on which 
the employer relies for all purposes. The original test would be 
cancelled in this situation, and not reported for management 
information system (MIS) purposes.
    The bottom line in any ``shy bladder'' situation is that, if, by 
the end of the collection process, the employee has not produced a 
sufficient specimen, the employee must be evaluated by a physician. 
Unless the physician finds that a medical condition resulted, or could 
have resulted, in the inability to provide a sufficient specimen, the 
employee is regarded as having refused to test (see --40.193). Given 
this provision, we believe it is unnecessary to say that a refusal to 
drink fluids, standing alone, is a refusal to test.
    As some commenters said, there may be legitimate reasons for an 
employee's decision not to drink fluids in this situation. In any case, 
if the employee declines to drink, subsequently does not produce a 
sufficient specimen, and cannot establish a medical condition 
explaining his or her inability to provide the specimen, a refusal to 
test will be established. While having employees waiting in a 
collection site for three hours, with or without drinking, may annoy 
employers and collectors, we do not believe this is a sufficient reason 
to terminate the shy bladder process because the employee does not 
choose to drink during that period.
    We believe that there is a strong safety rationale for requiring a 
recollection under direct observation following a verified positive, 
adulterated, or substituted test that is cancelled because the split 
specimen is unavailable for testing. In this situation, we know that 
there were drugs or an adulterant in, or substitution of, the primary 
specimen, and that there was no legitimate medical explanation. Split 
specimens fail to reconfirm the result of the test of the primary 
specimen in only a tiny minority of cases. If we do not collect another 
specimen in this case, there is a very high probability that we will be 
permitting an employee who has used illegal drugs, or tried to tamper 
with a test, to continue performing safety-sensitive functions. That is 
a significant safety concern.
    By recollecting another specimen, we have some possibility of 
detecting continuing drug use. Knowing that recollections will occur in 
this situation may also have some deterrent effect on employees. By 
recollecting another specimen under direct observation, we can limit 
the opportunities for tampering, for which there is a heightened 
incentive in this situation. We do not view this provision as 
penalizing an employee because a laboratory or collector erred. Rather, 
in the face of a laboratory or collector error, we view this provision 
as closing an inappropriate loophole for an employee who appears to 
have used illegal drugs or tried to defeat a test.
    We agree with commenters that it makes much more sense for all DOT 
agencies to have consistent requirements concerning split specimens. 
Therefore, Part 40 requires all collections to be split specimen 
collections, and RSPA and Coast Guard will amend their rules 
accordingly. We will delete from Part 40 all references to single 
specimen collections. There is no legal authority issue here: RSPA and 
Coast Guard base their rules on their statutory general safety 
authority, which does not contain specific requirements or prohibitions 
concerning how drug specimens are collected. There is no legal 
difference between these agencies using their discretion in 
implementing their general safety authorities by requiring split 
specimen testing and using it to give employers an option between split 
specimen or single specimen collections.
    We are persuaded by commenters that we should not go forward with 
the proposal to have collectors remove and inspect boots. The problems 
of this approach likely outweigh the benefits. Therefore, we have 
booted this provision out of the final rule.

Information Release Issues

    MROs sometimes find themselves in a dilemma. They verify a positive 
test result on an employee of Employer A. They also know that the same 
employee works in a DOT-regulated safety-sensitive position for 
Employer B. Consistent with safety and confidentiality 
responsibilities, what should the MRO do? The NPRM sought comment on 
this issue. The NPRM also asked for comment on whether MROs and other 
parties (e.g., C/TPAs) should report positive tests and other rule 
violations to DOT operating agencies, so that they could take 
enforcement action.

Comments

    There was a variety of comment on the idea of MROs sharing test 
information with other employers. Many employers, MROs, unions and 
other parties opposed allowing MROs to do so because it would breach 
employee confidentiality. Given the large data bases that some service 
agents maintain, this breach could be very wide, some commenters said. 
Some service agents questioned whether the proposed rule's language 
would have the effect of creating a duty on service agents to conduct 
searches of such data bases.
    Other MROs and employers favored giving MROs this discretion, in 
order to enhance safety and help MROs who find themselves in this 
dilemma. Commenters cited potential liability concerns on both sides of 
the question. Other commenters suggested that more systematic 
approaches to this problem might be more productive, such as creating a 
national data base of persons who had violated rules or requiring 
employers hiring new workers to check with previous employers about 
past test results (as FMCSA's rule already does). Canadian commenters 
also mentioned a concern that information release to third parties 
without individual employee consent may violate Canadian law.
    Commenters addressed the issue of release of information in legal 
proceedings. The existing rule and the NPRM focus on legal proceedings 
brought by an employee (e.g., an unjust termination suit). What about 
personal injury cases in which the employee's test result is a relevant 
issue, commenters asked.
    Some commenters thought that having service agents report rule 
violations to the DOT agencies was a good idea that would enhance 
safety. For example, if an owner-operator fails to show up for a test 
and continues to drive, only the C/TPA may know of the refusal. If the 
C/TPA does not report the problem to FMCSA, the likelihood of the 
owner-operator getting away with his or her refusal is heightened. 
Others raised confidentiality concerns and thought that there could be 
problems if service agents reported incomplete or erroneous information 
to the DOT agencies. Some service agents also feared that if they had 
authority to report violations to DOT agencies, even if this were not 
mandatory under the rule, they would be liable for not doing so. Others 
thought that this would create a difficult conflict of interest 
situation for service agents.

DOT Response

    The Department has decided to drop the proposal to permit or 
require MROs to pass on to third party employers information about the 
results of tests the employee took at the direction of another 
employer. The Department understands that confidentiality rules 
sometimes place MROs in a difficult position. Nevertheless, 
confidentiality is a cornerstone of the balance between safety and 
employee privacy that is crucial to the acceptance and 
constitutionality of the testing program. The Department is also 
concerned that

[[Page 79476]]

it would be very difficult to draft a provision that solved the 
``doctor's dilemma'' situation without opening the floodgates to 
widespread searching of large data bases for information on employee 
testing records that could severely compromise confidentiality. We do 
not think our NPRM language succeeded at this task. Consequently, as 
under the current rule, MROs will be prohibited from passing such 
information on to third party employers without the employee's consent. 
As described in the discussion of Sec. 40.25, we are adding a 
requirement to query previous employers for drug and alcohol test 
information in place of the proposed provision, based on an existing 
FMCSA provision.
    Another alternative to the proposal would be to create a Federal 
data base that would include all test results, which authorized 
employers could search to learn authorized information about current or 
prospective employees. This is a significant issue, but not one we are 
able to resolve at this time. We do believe that, in order to be 
effective, a data base of this sort would have to be national in scope 
under Federal supervision, rather than a mixture of state, local, and 
private data bases. It would also have to successfully solve security, 
access, due process, and updating issues. Creation of such a data base 
remains a matter for further study.
    The Department has decided to broaden the scope of release of 
information in the context of legal proceedings. We have added a 
provision (see Sec. 40.323) that would permit employers to release test 
information in a criminal or civil court proceeding resulting from an 
employee's performance of safety-sensitive duties, if the court orders 
it. For example, in personal injury litigation following a truck or bus 
collision, the court could determine that a post-accident drug test 
result of an employee is relevant to determining whether the driver or 
the driver's employer was negligent. The employer would be authorized 
to respond to the court's order to produce the records.
    There would be limits on the use of this information, however. The 
employer could release the information only to the decisionmaker, such 
as the judge in a lawsuit. It could be released only subject to a 
binding stipulation or protective order that the decisionmaker to whom 
it is released will make it available only to the parties to the 
proceeding, who could not disseminate it further or use it for other 
purposes. The Department believes that this approach provides for 
relevant use of test information without permitting the information to 
be spread about too widely. These limits also apply in situations where 
the information is made available in a proceeding brought by the 
employee (e.g., a grievance, arbitration, or lawsuit concerning 
personnel action following a violation).
    The Department has decided against requiring service agents to 
report apparent violations of the rules to the DOT agencies. Service 
agents can do so in any situation in which DOT agency rules already 
permit them to do so. The principal reason for this decision is that 
the Department's enforcement resources are limited. The DOT agencies 
must take great care in prioritizing the use of those resources, so 
that the greatest safety benefit is derived from their allocation.

Service Agent Contract Language

    The NPRM proposed that every contract or agreement between an 
employer and a service agent would have to include an assurance of 
compliance with DOT rules. The purpose of this proposal was to ensure 
that the obligation to comply with Part 40 and other DOT rules was not 
only a matter of regulation, but also a key part of the contractual 
relationship among participants in the testing program.

Comments

    Some employers and unions favored the proposed requirement, saying 
that it would help them ensure that services were provided properly. 
They said it would create universally understood contract remedies if 
service agents failed to provide appropriate services. Most of the 
commenters on this proposal were service agents, and they almost 
unanimously opposed the proposal. They said it would add substantially 
to the paperwork burden of the rule and would add costs (e.g., for 
attorney involvement in the contracting process). Moreover, opponents 
said, there are many times in which employers do not have written 
contracts with some service agents (e.g., collection sites remote from 
the employer's principal place of business), so there is no contract in 
which to incorporate such a clause. Requiring written contracts where 
none now exist would also be unnecessarily burdensome, they said. A 
mandatory contract clause could also lead to litigation, some 
commenters feared.

DOT Response

    The purpose of the proposed requirement was to ensure that 
compliance by service agents with this and other DOT rules was an 
enforceable contractual responsibility. The Department now believes 
that this purpose can be achieved by other means. We have replaced the 
proposed written contract clause requirement with a regulatory 
statement (see Sec. 40.11(c)). It provides that all agreements and 
arrangements, written or unwritten, between employers and service 
agents are deemed, as a matter of law, to require compliance with all 
applicable provisions of this part and DOT agency drug and alcohol 
testing regulations. The rule declares that compliance with these 
provisions is a material term of all such agreements and arrangements. 
Combined with the PIE provisions of Subpart R, this provision ensures 
that when a service agent is in noncompliance, DOT (through a PIE) or 
an employer (through a contract action) can respond effectively to 
service agent noncompliance. These provisions will achieve the 
Department's objective without incurring the paperwork burden and other 
problems cited by commenters with the NPRM provision. We also did not 
want to create potential compliance problems for service agents and 
employers based on the lack of a written agreement.

Electronic Technology Applications

    The NPRM asked for comment on how best to incorporate electronic 
technology into the drug and alcohol testing process to a greater 
extent.

Comments

    A substantial majority of all commenters on this issue strongly 
supported the wider use of electronic technology throughout the DOT 
drug and alcohol testing program. The suggested applications included 
such things as electronic signatures by various participants, an 
electronic CCF, and electronic storage and transmission of data. One of 
the goals mentioned in some comments was the ``paperless lab.'' 
Supporters emphasized the greater speed and efficiency of these 
applications, contrasted to a paper-based system. Some commenters noted 
that electronic applications of this kind were already in wide use in 
the private, non-regulated sector of drug and alcohol testing, and that 
the Food and Drug Administration had approved the use of electronic 
signatures in some contexts.
    Commenters mentioned that, in order to do the job right, electronic 
applications had to ensure the integrity and security of information, 
but many commenters also said that appropriate technological tools for 
this purpose already existed. Some commenters sounded cautionary notes, 
particularly with respect to the Department being assured of the 
effectiveness of system safeguards and the forensic acceptability

[[Page 79477]]

of electronic records and signatures before authorizing additional use 
of electronic applications in the program.

DOT Response

    The Department believes that the increased use of electronic 
methods in the program is both inevitable and beneficial. At the same 
time, we want to make sure that there are good, consistent minimum 
standards for the use of this technology, so that the integrity and 
confidentiality requirements of the program continue to be met. For 
this reason, the Department, in cooperation with HHS and the Office and 
Management and Budget (OMB), intend to form an advisory committee under 
the Federal Advisory Committee Act. Many of the interested parties 
began meeting this past summer to discuss the issues under the auspices 
of an OMB information technology initiative.
    This committee would be charged with making recommendations to DOT 
and HHS concerning changes in our regulations we could make to 
accommodate electronic technology. The committee would also make 
recommendations about consistent minimum standards for the technology 
used in Federal drug and alcohol testing programs. The Department 
anticipates that, following the receipt of the committee's 
recommendations, DOT and HHS will propose changes to Part 40 and the 
HHS Guidelines that will result in authorizing the more widespread use 
of electronic technology in the program.
    Meanwhile, the Department will make some modest changes to its 
requirements. For example, we will permit greater use of faxes and 
scanned computer images for reporting test results. Additionally, we 
are permitting laboratories to send electronic results reports to the 
MROs, provided that the laboratory and the MRO ensure that the 
information is accurate and can be transmitted in such a manner as to 
prevent unauthorized access or release of this information while it is 
transmitted or stored. The Department, at this point, is not requiring 
specific transmission or security standards, but as these are developed 
in the future, we will provide them as guidance for laboratories and 
MROs. Even when the Department has changed its regulations to permit 
greater use of electronic methods, we expect to retain the option to 
use a paper-based system, however. This is because many of the 
participants in our program, such as small transportation employers, 
may not be equipped to participate in a fully electronic system.

MRO/Laboratory Conflicts of Interest

    The Department has long believed that the MRO has a uniquely 
important responsibility for maintaining the integrity of the 
Department's drug testing system. For that reason, since the beginning 
of the Department's program, we have been concerned about the potential 
of conflicts of interest between MROs and other participants in the 
system, particularly the laboratory. For example, if an MRO is 
reviewing results of a laboratory with which the MRO has a financial 
relationship, it could happen, or appear to happen, that the MRO would 
be less likely to bring problems in the laboratory's test results to 
light. In the NPRM, the Department asked commenters for their thoughts 
on conflicts of interest, particularly whether the Department should 
state with greater specificity the kinds of relationship that involve 
conflicts or the appearance of conflicts.

Comments

    Some commenters questioned the NPRM's focus on the MRO-laboratory 
relationship, saying there were other relationships among participants 
that could be as or more troubling (e.g., laboratory-collection site 
relationships). Commenters also differed about what the rule should say 
about laboratory-MRO relationships. Some commenters favored a strict 
separation of roles, while others said that the program would be more 
efficient and less costly if MROs and laboratories could collaborate 
more closely. Some commenters, in response to a preamble question, 
supported adding more specific guidance to the rule on what sorts of 
relationships were considered inappropriate.
    A large majority of comments on this issue said it was important 
for the rule text to list the kinds of relationships that the 
Department regarded as creating conflicts of interest between MROs and 
laboratories. The comments acknowledged the significance of maintaining 
laboratory/MRO relationships that were free of such conflicts, in order 
to maintain the integrity of the program. In the absence of 
specificity, however, a general provision prohibiting conflicts or 
requiring a certification that there were none would be ineffective, 
they said. Commenters generally agreed with the list of conflicts 
listed in the NPRM preamble, as a means of ensuring the necessary 
separation of functions among participants. Commenters who dissented 
from this position usually argued that to prohibit close MRO/laboratory 
relationships would interfere with the integrated organizational 
arrangements that were most efficient in providing services to 
customers economically (e.g., one-stop shopping or ``turnkey'' 
programs).

DOT Response

    We agree that other relationships in the program might create 
conflict of interest issues. However, we continue to believe that the 
focus on the MRO-laboratory relationship is appropriate. In our view, 
the MRO is a key participant in the process, whose role is to be the 
most important protector of the accuracy and integrity of the process. 
A potential conflict of interest between an MRO and a laboratory, whose 
results the MRO must review, oversee, and, if necessary, question, is a 
particularly sensitive matter for the integrity of the program. We urge 
appropriate caution, use of firewalls, etc. to avoid potential 
conflicts of interest among all participants, but we believe that clear 
regulatory guidance is important in the MRO/laboratory relationship.
    While we recognize that commenters' views differ, we believe the 
program is best served by avoiding MRO/laboratory conflicts of interest 
or their appearance. We believe that a clear separation of their 
respective roles is necessary for this purpose. We have maintained this 
separation under the current rule, and we do not have evidence that 
this has unduly hampered the efficiency of the program.
    In response to comments, we have added list of actions that we view 
as creating the reality or appearance of a conflict of interest. These 
examples are not new creations: they codify guidance that the 
Department has given in several specific situations over the years. 
They are essentially the same examples listed in the preamble to the 
NPRM, with the clarification that they apply to MROs who actually 
review test results produced by the laboratory in question. This list 
of examples is not exclusive or exhaustive: other situations may arise 
that would constitute conflicts. The list is the following:
    (1) The laboratory employs an MRO who reviews test results produced 
by the laboratory.
    (2) The laboratory has a contract or retainer with the MRO for the 
review of test results produced by the laboratory.
    (3) The laboratory designates which MRO the employer is to use, 
recommends certain MROs, or gives the employer a slate of MROs from 
which to choose. We do not interpret this provision to prohibit 
laboratories from referring employers to a large, global list of MROs 
(e.g., a list of all MROs who have been certified by one of the

[[Page 79478]]

national MRO training organizations), so long as the laboratory does 
not edit the list or express a preference or recommendation among the 
MROs on the list.
    (4) The laboratory gives the employer a discount or other incentive 
to use a particular MRO.
    (5) The laboratory has its place of business co-located with that 
of an MRO or MRO staff who review test results produced by the 
laboratory;
    (6) The laboratory derives a financial or other benefit from having 
an employer use a particular MRO; or
    (7) The laboratory permits an MRO, or an MRO's organization, to 
have a significant financial interest in the laboratory.

Validity Testing

    By validity testing, we mean testing that laboratories conduct to 
deter and detect tampering with tests. The two most important 
categories of tampering are adulterating a specimen (e.g., putting a 
substance into a specimen designed to mask or destroy the drug or drug 
metabolite that the specimen may contain) or substituting a specimen 
(e.g., supplying water or some other substance in place of urine). The 
NPRM proposed to require laboratories to conduct validity testing on 
all specimens. It asked for comment on whether MRO review and split 
specimen testing should be applied to specimens that laboratories found 
to be adulterated or substituted, as they are to specimens that test 
positive for drugs. Validity testing is probably the most difficult and 
controversial issue in this rulemaking.

Comments

1. Adulteration
    A significant majority of commenters on the subject supported the 
idea of testing for adulterants. Commenters said that the purpose of 
such testing was to counteract tampering, which some said appeared to 
be on the rise in their experience. They cited the increased 
availability of substances and techniques claiming to protect drug 
users from testing positive for drugs, which are quite commonly 
advertised in publications and on the internet.
    Many commenters cited the volatility of the adulterant market, 
noting that the popularity of particular adulterants rise and fall. As 
countermeasures to one substance are found, other adulterants come into 
prominence, in a continuing ``arms race'' between those who try to 
facilitate and those who try to deter and detect ways of ``beating the 
test.'' Therefore, commenters said, there needs to be flexibility in 
the ``adulteration panels'' that laboratories use, to allow them to 
keep up with an ever-changing adulterant market. It is not helpful, in 
view of this need for flexibility, to mandate testing for specific 
substances such as nitrites, several commenters said.
    Two employee groups said that there was no evidence supporting the 
need for adulterant testing. They also said that adulterant testing was 
too burdensome. One laboratory suggested that adulterant testing should 
remain discretionary with laboratories, rather than mandated by the 
rule. Another commenter said that there should be standardized DHHS 
testing methodologies for adulterants, just as there are for drugs. 
Several commenters supported extending the blind testing program to 
adulterated and substituted specimens as a further safeguard. A few 
commenters addressed the issue of cost, but they did not agree with one 
another about whether adulterant testing would add significant costs to 
the program. Supporters of alternative testing methods (e.g., saliva, 
hair, on-site testing) argued that their methods would be quicker and 
more effective at detecting adulterants than the present laboratory-
based urine testing system.

2. Substitution

    Generally, commenters who supported testing for adulteration also 
supported testing for substitution. However, a number of commenters had 
greater concerns about substitution testing. Some comments, including 
one extensive comment submitted by a union, contended that the criteria 
for substitution developed by HHS, and incorporated in the NPRM, were 
faulty and based on inadequate studies. In particular, this comment 
criticized the HHS criteria because the literature on which the 
specific gravity and creatinine levels had been based included very few 
``paired studies'' looking at both criteria at once. Other comments 
criticized the studies because they had not specifically covered 
certain employee subgroups. A few comments suggested changing the name 
of this sort of specimen from ``substituted,'' which they found too 
conclusory, to ``hyper-dilute'' or something similar, which they 
believed to be more neutral and descriptive.
    During the listening sessions and in written comments, a number of 
individuals said they, or people they know, had been unfairly 
terminated on the basis of substitution. These individuals were not 
drug users, they said, but had consumed large quantities of water over 
a long work period. In addition, they were often small-framed minority 
women, vegetarians in some cases. They suggested that a combination of 
these circumstances could have resulted in the natural, innocent 
production of urine meeting the substitution criteria. They sought 
additional procedural protections and revision of the substitution 
criteria to prevent people from being unfairly found to have 
substituted a specimen.
3. Split Specimen Testing
    The Department presented three basic options for comment concerning 
the application of split specimen testing to findings of adulteration 
and substitution. The first option would have continued the 
Department's current policy of prohibiting split specimen testing in 
these cases. The second option would require split specimen testing in 
adulteration and substitution cases, on the same model as the current 
requirement for drug positives. The third option would add to the 
present system a requirement for the laboratory to test an additional 
aliquot of the specimen to ensure that the result could be replicated.
    All unions who commented favored the second option. They believed 
this was necessary if the system was to be fair and provide due process 
to employees whose specimens were found to be adulterated or 
substituted. They asserted that the scientific basis and technical 
standards for adulteration and substitution findings were weaker than 
in the case of drug positives, but pointed out that the consequences 
were equivalent (or more severe, in some cases). Employees should have 
the same chance to double-check the former as the latter. Some 
employers and service agents also supported this approach, principally 
on fairness grounds.
    Supporters of the first and third options, including a number of 
employers and service agents, opposed split specimen testing in 
adulteration and substitution as providing a second opportunity for an 
employee to beat the test. In addition, they said that the properties 
of many adulterants were unknown, and an adulterant might degrade in so 
short a time so that it would fail to reconfirm on a split specimen 
test. Variations in the findings about the urine could result from 
something as simple as the freezing and thawing of the split specimen, 
one commenter said. Among commenters in this group, a number supported 
Option 3 in preference to Option 1 because it would provide some 
additional protection for employees without having the disadvantages of 
opening the split specimen.

[[Page 79479]]

4. MRO Review
    Generally speaking, commenters lined up in the same way concerning 
whether MROs should review and verify adulterated and substituted test 
results as they did concerning split specimen testing for these 
results. Unions and other supporters said that MRO review, parallel to 
that for drug positives, should be made available as a matter of 
fairness. For example, if a small female flight attendant who has 
consumed a lot of water on a long flig