[Federal Register Volume 65, Number 244 (Tuesday, December 19, 2000)]
[Rules and Regulations]
[Pages 79462-79579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31251]



[[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

Federal Register / Vol. 65 , No. 244 / Tuesday, December 19, 2000 / 
Rules and Regulations

[[Page 79462]]


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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 <a href="/cdn-cgi/l/email-protection#74161b165a15071c160d341b07005a101b005a131b02"><span class="__cf_email__" data-cfemail="9dfff2ffb3fceef5ffe4ddf2eee9b3f9f2e9b3faf2eb">[email protected]</span></a> (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 <a href="/cdn-cgi/l/email-protection#6805091a11460a0d1a061b1c0d010628071b1c460c071c460f071e"><span class="__cf_email__" data-cfemail="761b17040f58141304180502131f18361905025812190258111900">[email protected]</span></a> (e-mail); or Jim L. 
Swart, Drug and Alcohol Policy Advisor, ODAPC , same address and phone 
numbers as above, <a href="/cdn-cgi/l/email-protection#97fdfefab9e4e0f6e5e3d7f8e4e3b9f3f8e3b9f0f8e1"><span class="__cf_email__" data-cfemail="cca6a5a1e2bfbbadbeb88ca3bfb8e2a8a3b8e2aba3ba">[email protected]</span></a> (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

[[Page 79463]]

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:

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          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.

[[Page 79464]]

    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

[[Page 79465]]

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:
    <bullet> 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.
    <bullet> Another MRO, who had counterfeit medical credentials, 
verified several tests positive, bringing into question the integrity 
of the verification process.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 2\1/2\ 
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 flight gets a substituted test 
result, she should have the opportunity to offer an explanation to the 
MRO. If she made her case, the MRO should verify the result negative, 
just as in the case of a drug positive with a legitimate medical 
explanation.
    Opponents of MRO review for adulteration and substitution cases 
said that it would be cumbersome. Also, there are not established 
standards for a ``legitimate medical explanation'' in the adulteration 
and substitution area as there are with respect to drugs, meaning that 
MROs would be acting in a less well informed way. Some commenters said 
that there were no legitimate medical explanations for the presence of 
adulterants, so the medical review process would be an empty exercise.
DOT Response
    We begin with the premise that tampering with drug tests is a bad 
thing and a serious safety concern. When people do so, it is probably 
because they want to continue using drugs while also continuing to 
perform safety-sensitive duties. Continuing to do both these things is 
precisely what the DOT drug testing program, in the interest of safety, 
is designed to prevent. To the extent that people believe that they can 
successfully beat a test, the deterrent effect of the program is 
diminished. One can oppose the concept of testing to catch tampering 
only if one believes that it is acceptable for people both to continue 
using drugs and to continue performing safety-sensitive duties.
    There were no commenters who said that they opposed the concept of 
testing to catch tampering with drug tests. Some commenters, however, 
said that it was not proven that tampering was so serious a problem as 
to warrant validity testing. The majority of commenters disagreed, and 
many were parties (laboratories, MROs, C/TPAs) who have significant 
experience in reviewing specimens and test results. Our own experience 
in working with participants in the program is consistent with that of 
commenters who believe that adulteration and substitution are 
relatively prevalent, serious issues requiring a regulatory response. 
The wide public advertising of substances and techniques to protect 
drug users from tests is further suggestive of a thriving cottage 
industry designed to help people beat drug tests.
    The Department consequently will make validity testing mandatory. 
Laboratories will test all incoming primary specimens for dilution, 
substitution, and adulteration. We believe that mandating that all 
laboratories test all primary specimens will result in greater 
uniformity of testing methods. Testing methods must be consistent with 
HHS requirements and guidance (HHS Program Documents 35 and 37 at the 
present time), upon which DOT will rely for purposes of this rule. As 
noted above, we will coordinate the effective date for mandatory 
validity testing with the issuance of HHS mandatory requirements on 
validity testing. The Department is convinced that testing in 
accordance with HHS requirements and guidance results in scientifically 
valid tests for pH, creatinine, specific gravity, and various 
adulterants.
    Consistent with comments that it was not advisable to list specific 
adulterants in the rule, since they change rapidly, the Department will 
simply rely on HHS rules and guidance, which can change to reflect new 
adulterants for laboratories to test. The Department's final rule also 
minimizes statements of requirements for laboratory testing 
methodology, since that is also an area in which we rely on HHS 
requirements and guidance. We do not believe that extensive duplication 
is necessary.
    The Department has thought a great deal about the HHS substitution 
criteria, which were the subject of extensive comment. HHS developed 
these criteria based on an extensive review of the literature (``NLCP: 
STATE OF THE SCIENCE--UPDATE # 1--Urine Specimen Validity Testing: 
Evaluation of the Scientific Data Used to Define a Urine Specimen as 
Substituted (February 14, 2000)''). We are aware that this literature 
review included only a few ``paired studies'' that simultaneously 
looked at both the specific gravity and creatinine criteria. 
Nevertheless, there is nothing in the HHS literature review that 
suggests any other criteria that would be more appropriate for 
determining substitution or that the existing criteria are erroneous. 
Notwithstanding the critique in the comment we received, no scientific 
paper of which we are aware has suggested criteria that it claimed was 
more appropriate. It is very significant that even the most vocal 
opponents of the substitution criteria were unable to provide a single 
documented instance of an individual meeting both substitution criteria 
through natural means in a controlled setting.
    We are also aware that most of the studies in the HHS literature 
review were studies of the general population that did not focus on 
specific subgroups. This is an acceptable practice in medical and 
scientific studies. Moreover, the Department does not believe that, to 
adopt generally applicable substitution criteria, it must demonstrate 
the suitability of the criteria over and over again for every 
conceivable subset of the population.
    To provide further information about these issues, the Department 
conducted its own study. The text of this study is available on the 
ODAPC web site (www.dot.gov/ost/dapc). The study was designed 
specifically to focus on two issues on which commenters criticized the 
HHS literature review, the absence of paired studies and insufficient 
study of female subjects. The DOT study made paired measurements of 
urine creatinine and specific gravity in a predominately female (40 of 
56) group of subjects.
    All participants in the study were of reasonable working age (19-
56). All participants volunteered to consume at least 80 ounces of 
fluid spread evenly over six consecutive hours. The protocol asked for 
40 ounces to be consumed within the first three hours of this six-hour 
test period. This would be immediately followed by the consumption of 
at least another 40 ounces in the last three hours of the six-hour test 
period. Urine specimens were collected prior to the start of the six-
hour period and at the end of each subsequent hour in the test period. 
Urine specimens were also collected on awakening the morning of the 
test day and on awakening the morning following the test day (this 
amounted to a total of nine urine specimens being requested from each 
participant).
    Each participant was asked to document the amount and type (water, 
coffee) of fluid consumed from awakening through completion of the six-
hour period, along with the total amount of urine produced from 
awakening through the six-hour period. Height, weight, age, gender, 
ethnicity, eating habits, and medications taken regularly and on the 
day of the collections were also documented. All urine specimens were 
sent to an HHS-certified laboratory where creatinine and specific 
gravity were measured using well-established laboratory techniques.
    The 56 subjects provided a total of 500 urine specimens. 504 
specimens

[[Page 79480]]

were expected; however, three individuals did not collect one of the 
specimens on awakening, and one person was unable to complete the 
second three hours of drinking per the test protocol. Two participants 
were unable to consume the minimum amount of fluid originally intended 
(total of 80 ounces, or approximately 2370 mL, spread evenly over the 
six hours). The remainder consumed at least the minimum requested. 
Twelve participants (five men and seven women) consumed over one gallon 
of fluid by the end of their test periods.
    Not one of the 500 specimens was identified as ``substituted'' 
based on the HHS criteria. This point deserves emphasis. The DOT 
research involved paired studies of predominately female subjects who 
drank copious quantities of water under controlled conditions. This 
examination of paired values of creatinine and specific gravity from 
500 specimens collected under water loading conditions strongly 
supports the criteria developed by HHS. There was no evidence that 
individuals, regardless of gender or other factors and despite 
consuming unusually large amounts of fluids, are capable of 
physiologically producing urine meeting the HHS substitution criteria. 
We do note that 113 of the specimens did meet the criteria for 
``dilute'' specimens, as defined by HHS. Under Part 40, a dilute 
specimen does not constitute a refusal to test.
    The propriety of the HHS substitution criteria was not the only 
area on which comments were received on validity testing. Several 
commenters questioned the tests used to determine validity as not being 
equivalent to the tests used in drug testing. Specifically at issue was 
whether or not the use of two different technologies is required for 
the initial and confirmatory tests.
    These comments, and their references to statements by two 
professional toxicology organizations--the American Academy of Forensic 
Sciences (AAFS) and the Society of Forensic Toxicologists (SOFT)--do 
not successfully make a case that the HHS-approved testing methods for 
adulteration and substitution are faulty.
    Not all types of tests are the same. In testing for the ``HHS 
five'' drugs, we are looking for chemically complex substances that we 
do not expect to find in most specimens. We use an immunoassay followed 
by gas chromatography/mass spectrometry (GC/MS). As applied, for 
example, to amphetamines, the immunossay test identifies a broader 
category of substances including, but not limited to, amphetamine and 
methamphetamine. The GC/MS test is used to increase the specificity of 
the testing process and accurately prove the presence of amphetamine or 
methamphetamine.
    By contrast, creatinine is a very simple substance that we always 
expect to find in urine. It is readily identified by colorimetric 
techniques, in which a chemical is added to urine to cause a color 
change and a special instrument measures light absorbed by the 
solution. It is not necessary with creatinine to differentiate specific 
complex substances from other substances that may be present in the 
specimen. Therefore, a second analytical technique to provide greater 
specificity is not needed. A single analytic technique repeated on a 
second specimen to ensure that we have a reproducible result is much 
more to the point.
    In the case of creatinine, the initial validity test result is 
analogous to that of a confirmation drug test result. It produces a 
quantified result suitable for use in determining whether the specimen 
is substituted or diluted. The second validity test performed on the 
specimen is sufficient to support fully the first validity test result. 
Because of the nature of the creatinine, it is not necessary to use two 
different testing technologies to establish a test result with 
certainty. (A similar point can be made about alcohol.) The quoted AAFS 
and SOFT statements, which apply principally to tests for drugs and 
drug metabolites, do not conflict with this analysis.
    We also point out that one important purpose of the initial 
immunoassay test for drugs is to eliminate negatives in a cost-
effective manner. It would be possible to run two consecutive GC/MS 
tests on a specimen and never use the separate immunoassay technique. 
Such an approach would lead to results that are completely accurate and 
reliable, but the reason we do not require this approach is that it 
would be much more expensive.
    In the case of substitution, the specific gravity test corroborates 
the creatinine result. This provides a level of forensic certainty 
equivalent to immunoassay followed by GC/MS in the drug testing case. 
Although the specific gravity tests appear to be based on simple 
technology, they have been established as reliable through extensive 
use over the many years in many clinical settings.
    One commenter suggested replacing specific gravity with osmolality, 
asserting that measurements of osmotic concentration of urine are 
considered more valid than specific gravity measurements. HHS and DOT 
believe that there is not a significant difference between osmolality 
and specific gravity for validity testing purposes. In fact, specific 
gravity is used clinically much more than osmometry. HHS-certified drug 
testing laboratories have 12 years of successful experience in testing 
for creatinine and specific gravity testing under the HHS guidelines, 
and we do not believe that commenters have made a compelling case for 
change.
    We also note that there are additional testing methods available 
for such substances as creatinine, nitrites, glutaraldehyde, chromium, 
and various possible adulterants. The fact that other tests exist does 
not mean that they must be used to produce an accurate result. The key 
point is that the methods we do use must be accurate and above 
reproach. DOT and HHS are convinced that the methods we use do produce 
the required accuracy for correct results.
    Contrary to one commenter's assertion, the Department's approach to 
validity testing does not create a ``presumption of guilt.'' A 
confirmed laboratory finding, whether for drugs, adulterants, or 
substitution, is a matter that calls for explanation. In the absence of 
a satisfactory explanation, we are justified in basing regulatory 
consequences on the finding.
    The Department, in short, has a rational and sound scientific basis 
for using the adulteration and substitution criteria we have chosen. 
Nonetheless, to ensure fairness and to provide safeguards parallel to 
those available in cases of positive drug tests, the Department will 
add split specimen testing and MRO review to its procedures in these 
cases.
    The Department is not legally compelled to include split specimen 
testing and MRO review in validity cases. As explained in the preamble 
to the NPRM (see 64 FR at 69081-82; December 9, 1999), these additional 
safeguards are required neither by the Constitution nor by statute. The 
Department's decision is a matter of policy, in the interest of 
providing greater fairness to employees in the drug testing program. 
The Department notes that situations in which an adulterant is 
naturally found or a substitution naturally occurs are likely to be 
extremely rare. At the present time, we do not know of any such 
situations. However, our policy to allow medical review and use of the 
split specimen will provide employees with an additional level of 
protection and an added degree of fairness.
    With respect to the use of split specimens in validity testing, the 
Department's process will parallel the existing split specimen 
procedure in the case of drug positives. Within 72 hours

[[Page 79481]]

of being notified by the MRO that his or her test has been verified 
adulterated or substituted, the employee may request a test of the 
split specimen. A second laboratory will test the split specimen.
    Laboratories will use the testing criteria set forth in HHS rules 
or guidance. Under current HHS criteria for adulterants, the test of 
the split specimen is for the presence of an adulterant, or, in the 
case of an adulteration finding based on pH, to ensure that the pH of 
the specimen meets the same regulatory criteria as for the primary 
specimen. In the case of substitution, the split specimen must meet the 
same regulatory criteria as for the primary specimen in order to be 
reconfirmed. As with drug positives, the consequence of a failure to 
reconfirm is a cancelled test.
    With respect to MRO review, the Department's process will also 
parallel the existing procedure for drug positives. The employee will 
have the opportunity to present a legitimate medical explanation. The 
employee, as is the case for all drugs except opiates, has the burden 
of proof to demonstrate to the MRO that a legitimate medical 
explanation exists. To meet this burden in the case of an adulterated 
specimen, the employee will have to demonstrate that the adulterant 
entered his or her specimen through physiological means. This will not 
be easy to do. Most adulterants are substances that do not naturally 
occur in urine. There is no way one can physiologically produce urine 
that includes such substances as bleach, glutaraldehyde, or soap, for 
example. There cannot be a legitimate medical explanation for the 
presence of these substances in urine, any more than there can be a 
legitimate medical explanation for the presence of PCP in a specimen.
    In cases where there is no reasonable apparent legitimate medical 
explanation, the MRO would verify the adulterated result. However, if 
an employee presents what the MRO believes could be a legitimate 
medical explanation, the MRO will tell the employee he or she may 
obtain additional evaluation from another physician, acceptable to the 
MRO, who has expertise relevant to the explanation. This would ensure 
that the MRO, standing alone, would not be called on to make a decision 
for which he or she lacked the needed expertise. The referral physician 
would make a recommendation about whether there was a legitimate 
medical explanation. The referral physician would evaluate any 
information presented by the employee in making his or her 
determination. If the referral physician found that there was a 
legitimate medical explanation, the MRO would review the referral 
physician's recommendation and, if appropriate in the MRO's judgment, 
cancel the test.
    MROs would follow the same process in the case of a substitution 
result. The MRO review provision for substitution emphasizes that it is 
not enough for the employee to show that he or she has a medical 
condition or has certain personal characteristics. The employee must 
establish the link between these facts and the ability to 
physiologically produce urine meeting the substitution criteria. For 
example, a replication of the employee's original test result, under 
carefully controlled conditions (including direct observation) could 
establish such a link.
    To meet our fairness objectives, we believe it is necessary to 
provide MRO review that can result in the cancellation of a test if the 
employee provides a legitimate medical explanation. Nevertheless, the 
Department emphasizes that it is the employee's burden to prove that 
such an explanation exists. The MRO is not responsible for disproving 
an employee's assertions.
    The Department will retain the word ``substitution,'' rather than 
changing to a term like ``hyper-dilute.'' Given the structure of the 
final rule, it seems clear that a laboratory ``substituted'' result is 
simply a confirmed result that must be verified by an MRO before 
becoming final, just like a confirmed drug positive. HHS uses this term 
in the Federal employee program, and it is useful to keep terms as 
consistent as possible between the two related programs.
    The Department works closely with HHS on validity testing issues, 
and the Department will use validity testing criteria set forth in HHS 
requirements and guidance. Validity testing is a subject that HHS, like 
DOT, takes very seriously, and HHS will issue additional guidance, as 
needed, to support the DOT validity testing program. We will work with 
HHS to ensure that validity testing remains as technically sound as the 
rest of the DOT program. The updated and clarified collection 
procedures in this final rule will help insure the integrity of the 
urine specimen. In addition, each laboratory will conduct validity 
testing under specific HHS guidance and quality control review, and the 
blind specimen quality control program will include adulterated and 
substituted specimens. Validity testing has now become a factor in the 
HHS evaluation of laboratories for certification and recertification. 
In addition, the application of split specimen testing and MRO review 
to validity tests will provide further safeguards for employees, 
parallel to the existing drug testing program.

Laboratory Problems

    In September 2000, the Department learned of a significant series 
of errors by one laboratory involved in validity testing. The first 
error that came to our attention involved apparent misconduct by 
laboratory personnel. Following a test result that met HHS substitution 
criteria, laboratory personnel apparently backdated documents 
explaining a minor irregularity in laboratory controls used to check 
the accuracy of testing machinery. These documents were then placed in 
the ``litigation package'' intended for use in an FAA certification 
proceeding involving the employee. To make matters worse, someone 
allegedly tore up a purported photocopy of the original of the 
backdated documents, and the laboratory official who signed the 
litigation package (no longer employed by the laboratory) allegedly had 
claimed credentials he did not have. These events undermined the 
credibility of the laboratory in this case so much that FAA enforcement 
attorneys felt compelled to settle the certification action.
    Second, the laboratory made significant errors in reading test 
results. One error was the practice of ``truncating'' creatinine 
measurements (i.e., expressing results only in whole numbers). This 
practice, which was not specifically mentioned in HHS Program Document 
35 but was specifically contrary to Program Document 37, causes any 
result in the 5 to 5.9 range to be reported as a 5. Since a result of 5 
or less is one of the criteria for substitution, this practice could 
have the effect of causing a specimen that was outside the creatinine 
criterion for substitution to be interpreted as meeting this criterion. 
This throws into question substitution results where the creatinine 
measurement was a 5. (It does not affect results where the creatinine 
result was below 5.) In addition, laboratory personnel apparently 
interpreted an error message (``LLL'') from a machine used to measure 
specific gravity as a measurement of 1.000. There is not a sound basis 
for making this interpretation.
    When we learned of these problems, we immediately involved HHS. The 
DOT and HHS Inspector Generals reviewed the apparent evidence-
tampering. In addition, this situation led us to add tampering with 
documentation by a laboratory as a type of noncompliance that can be 
subject to a PIE proceeding (see Sec. 40.365). The

[[Page 79482]]

employer who had used the laboratory in question terminated its 
contract with the laboratory and offered to rehire five employees whose 
test results had been thrown into question by the laboratory's errors. 
The laboratory director subsequently resigned.
    HHS promptly conducted a special inspection of the laboratory. 
Following the inspection, HHS determined that the laboratory had 
corrected the result-reading problems with substitution and had been, 
since January 2000, in full compliance with DOT and HHS requirements. 
HHS also surveyed all other laboratories to determine if any had made 
similar errors in reading results and to determine whether they were in 
compliance. No one else had made the error message interpretation 
mistake concerning specific gravity. However, HHS determined that, for 
varying periods of time (in many cases before the specific guidance on 
this point was issued in Program Document 37, but in some cases after), 
40 or more laboratories had engaged in ``truncating'' creatinine 
results. All the laboratories involved subsequently stopped this 
practice, and all are now reading these results properly.
    In addition to these problems, HHS also discovered that in some 
cases, laboratories had reported tests as substituted that did not meet 
both HHS substitution criteria. That is, the laboratories reported 
tests as substituted that met the creatinine criterion, even though 
they did not also meet the specific gravity criterion.
    HHS has examined each individual substitution and adulteration test 
result that a laboratory has reported since September 1998, when 
Program Document 35 took effect. In any case in which a substitution 
result was based on a creatinine reading of 5 at a laboratory that was 
truncating results at the time, or in which a substitution result was 
reported that did not meet all HHS criteria, HHS and DOT are working to 
remedy the problem as it may have affected individual employees. HHS is 
in the process of sending a letter to each MRO involved with one of the 
approximately 300 specimens involved informing the MRO that the test 
must be cancelled. The letter directs the MRO to inform the employer of 
the cancellation and to tell the employer to attempt to contact the 
employee with this information. The employer is also told to take any 
appropriate personnel action in light of the cancellation.
    HHS is also conducting special certification inspections of each 
laboratory that is performing validity testing to ensure that all its 
validity testing procedures are fully consistent with HHS guidance. 
These inspections will be completed this month. The laboratories 
involved full compliance with HHS validity testing requirements will 
now be a condition of maintaining their certification to participate in 
the Federal and DOT drug testing programs.
    We are deeply concerned about this situation, because laboratory 
problems of this kind can result in unfair treatment of employees and 
adversely affect the credibility and integrity of our program. We point 
out, however, that nothing in this situation suggests that there is 
anything wrong with the criteria and methods for validity testing. The 
problems in this case were human implementation errors, now corrected, 
involving the reading of results and the documentation and reporting of 
tests, not in the testing process itself or the scientific basis for 
it. The Department believes that it is appropriate to continue to 
implement validity testing as called for in this rule.

Section-by-Section Discussion

    The following part of the preamble discusses each of the final 
rule's sections, including responses to comments on each section.

Subpart A--Administrative Provisions

Section 40.1  Who Does This Regulation Cover?

    This section attracted little comment. One commenter expressed 
concern about potential coverage of volunteers in one FTA program, 
while another wanted to specify that contractors could also be covered. 
The final rule specifies that contractors, volunteers, and others would 
be covered by Part 40 to the extent that they are subject to other DOT 
agency drug and alcohol rules.
    The Federal Railroad Administration (FRA) operates a post-accident 
drug and alcohol testing program that antedates Part 40 and differs in 
a number of ways from the rest of the Department's programs (e.g., with 
respect to fluids tested, drugs that are tested for). We do not intend 
to interfere with the implementation of this long-standing program, and 
we have added a paragraph making this clear.

Section 40.3  What Do the Terms Used in This Regulation Mean?

    Commenters expressed interest in several of the definitions of 
terms in the NPRM. A commenter made a technical point that some kinds 
of evidential breath testing devices (EBTs) do not literally sample the 
ambient air, as the definition of ``air blank'' provides. We added a 
sentence to the definition noting that for some devices, the ``air 
blank'' is a reading of the device's internal standard.
    A commenter noted that the definition of ``alcohol use'' talks of 
``drinking or swallowing'' rather than ``consumption,'' as in the past. 
The reason for this change is to avoid interpretations by enforcement 
personnel that such actions as using an inhaler that contain alcohol 
are ``alcohol use'' for purposes of this part. For example, the use of 
rubbing alcohol, applied topically rather than imbibed, is not intended 
to be a violation of this part.
    Commenters interested in the role of service agents in the program 
asked for definitions of ``consortium'' and ``third party 
administrator.'' One commenter provided proposed definitions, which 
included a requirement for individuals with certain certifications to 
play key roles in the organization. We considered the possibility of 
separate definitions for ``consortium'' and ``third-party 
administrator,'' but we did not find any basis for defining the terms 
separately. There are no meaningful conceptual or operational 
distinctions between organizations that call themselves one thing or 
the other of which we are aware or which commenters explained. In the 
way the terms are used in the regulation, they are for all practical 
purposes interchangeable. Consequently, the final rule uses the term 
consortium/third party administrator (C/TPA) to refer to any 
organization, however structured, that provides or coordinates a 
variety of drug and alcohol testing services to employers. 
Organizations would not have to change their names to conform to this 
definition (i.e., a C/TPA that currently calls itself a ``consortium'' 
would not have to call itself something else).
    Some commenters asked that C/TPAs be regarded as ``employers'' 
(especially consortia that serve small transportation companies). (This 
comment is related to the issue of C/TPAs serving as DERs, discussed 
above in the ``Principal Policy Issues'' portion of the preamble.) 
While this rule broadens the authorized role of C/TPAs in a number of 
respects, we believe that the program works best when C/TPAs and 
employers stay within their respective roles. An employer is an 
organization like an airline, trucking company, transit authority, etc. 
that provides transportation services and employs safety-sensitive 
workers. C/TPAs do none of these things. They contract with employers 
to provide drug and alcohol testing services. We believe the 
distinction between ``employers'' and C/TPAs helps to avoid confusion 
and

[[Page 79483]]

counterproductive overlap in roles between the two types of 
organizations, and we are retaining the NPRM's statement that C/TPAs 
are not employers. Any statements to the contrary in DOT agency rules 
would be changed in the agencies' proposed conforming amendments to 
this rule.
    One commenter expressed concern that it was troublesome to have 
service agents contact a DER when there was another company 
representative on the scene of a testing event. This comment appeared 
to assume that an employer can have only one DER. This is not the case. 
An employer can designate as many DERs as it needs to carry out its 
program effectively.
    Several comments on the definitions of ``medical review officer'' 
(MRO) and ``substance abuse professional'' (SAP) asked that other 
professions or members of professional groups be included within the 
definitions. We will discuss these issues in connection with the MRO 
and SAP provisions of the rule. Training and qualification matters are 
found in substantive sections of the rule (e.g., Sec. 40.121 for MROs), 
and it is not necessary to duplicate them here. However, we have added 
to this section definitions of terms that are used to label different 
types of training for MROs, SAPs, collectors, and BATs/STTs (e.g., 
qualification training, refresher training).
    With respect to the term ``chain of custody,'' we note that the 
definition of this term is not intended to suggest that the MRO is 
responsible, as part of his or her chain of custody review, to examine 
the internal laboratory chain of custody. The MRO need only review the 
CCF itself.
    Commenters questioned the definitions of ``dilute'' and 
``substituted'' specimens. One commenter noted that it was unnecessary 
to suggest that a ``dilute'' specimen had been watered down by the 
improper action of an employee. We agree, and have expressed the 
definition, like that of ``substitution,'' in neutral, descriptive 
terms. These definitions are augmented later in the rule by 
quantitative criteria for dilute and substituted specimens.
    One commenter suggested slightly rewording several definitions of 
terms for the alcohol testing part of the program. These suggestions 
generally did not result in any significant substantive changes in 
these definitions, and we have left the definitions as they were in the 
NPRM. A few commenters asked for a different term in place of ``service 
agent,'' one suggesting ``substance abuse service professional 
(SASP).'' The Department believes the ``service agent'' term is short, 
easily understood, and inclusive, so we are retaining it. Finally, for 
greater clarity, we have added definitions of the ``Office of Drug and 
Alcohol Policy and Compliance (ODAPC)'' and ``validity testing'' to 
this section.

Section 40.5  Who Issues Authoritative Interpretations of This 
Regulation?

Section 40.7  How Can You Get an Exemption From a Requirement in This 
Regulation?

    There were few comments about these administrative provisions. One 
commenter asked how to obtain answers to interpretation questions, and 
another asked how one might object to interpretations of Part 40. We 
recommend calling or writing ODAPC. A commenter suggested publishing 
all interpretations in the Federal Register periodically. We believe 
that it is useful to make all interpretations widely available, and we 
will post them on the ODAPC web site (www.dot.gov/ost/dapc). We will 
also consider whether publication in the Federal Register would be a 
useful additional step.
    This interpretation authority applies to the application factual 
situations of the provisions of this rule. The Department is often 
asked whether, for example, the rule requires the cancellation of a 
test in a particular circumstance. The answer to this question is, in 
effect, an interpretation of the text of the rule as applied to the 
facts of the situation. ODAPC and the General Counsel's office work 
closely with the operating administrations to ensure consistency of all 
such interpretations with both Part 40 and the other DOT agency rules.
    We will retain the provision that makes only new guidance, issued 
after publication of this rule, valid. We have substantially rewritten 
Part 40. Much of the substance of interpretations of the former version 
of the rule is found in the text of the new rule. Other guidance 
pertains to a version of the rule that will no longer exist. We 
anticipate publishing additional guidance pertaining to the new Part 40 
(e.g., an MRO manual) before the effective date of the new rule.
    We want to emphasize that an exemption is not the same thing as a 
waiver. An exemption is, in effect, a rulemaking of particular 
applicability that responds to an unusual situation, not contemplated 
in the rulemaking and not having general application to a wide variety 
of situations. An agency cannot properly make de facto generally 
applicable amendments to a rule through exemptions, because this would 
circumvent the rulemaking process requirements of the Administrative 
Procedure Act. A waiver, on the other hand, is a generally applicable 
provision in a rule that permits regulated parties to comply through an 
alternative means, if certain conditions are met (e.g., Sec. 40.21).
    Part 40 is an Office of the Secretary (OST) rule. Consequently it 
is OST, and only OST, that has the authority to grant exemptions from 
it. Since Part 40 is applied to regulated employers through the other 
DOT agency drug and alcohol testing regulations, exemptions to Part 40 
are implemented via the other DOT agency regulations. There may be 
situations in which DOT agency regulations impose requirements that go 
beyond those of Part 40. In such a case, a regulated party might need 
to obtain an exemption from the additional DOT agency provision as well 
as from a Part 40 provision.

Subpart B--Employer Responsibilities

Section 40.11  What Are the General Responsibilities of Employers Under 
This Regulation?

    Most of the comments about this section concerned proposed 
paragraphs (d)-(f), which would have required contracts or written 
agreements between service agents and employers to include a clause 
making compliance with Part 40 a material term of the contract. These 
comments and the Department's response are discussed in the ``Principal 
Policy Issues'' portion of the preamble.
    A few commenters also objected to language in the proposed 
paragraph (b) saying that employers must ensure that service agents 
comply with their regulatory responsibilities. The thrust of these 
comments was that employers do not have the resources or expertise to 
monitor the compliance of their sometimes far-flung service agents. In 
response, we have merged language of paragraph (b) with Sec. 40.15(c). 
It no longer places an active compliance monitoring responsibility on 
employers, but simply says that the employer's good faith use of a 
service agent is not a defense to a DOT enforcement action. For 
example, if an employer's MRO fails to conduct verification interviews, 
the employer could be subject to civil penalties from a DOT agency (the 
MRO could independently be subject to a PIE proceeding). As an 
employer, you can contract out your drug and alcohol testing program 
functions, but you cannot contract away your compliance 
responsibilities.

[[Page 79484]]

Proposed Sec. 40.13  Nuclear Regulatory Commission (NRC) Program

    The NPRM proposed that there be reciprocity between the DOT and NRC 
drug and alcohol testing programs. A number of commenters favored this 
approach in principle, some asking that the notion of reciprocity be 
extended to other Federal testing programs. A few commenters opposed 
the proposal, saying that NRC rules did not measure up to DOT rules. 
Other commenters pointed to numerous differences between the two 
regulatory programs, with respect to program concepts, specific 
requirements, forms, and administration. Some suggested that a 
reciprocity agreement be created between the two agencies detailing how 
these differences would be handled. Others said that the more stringent 
of the two rules on each particular point should govern.
    The Department has concluded that the wide variety of program 
differences between the DOT and NRC regulations make it impractical to 
establish reciprocity between the two systems. These differences 
involve such matters as testing methods, consequences of some alcohol 
test results, alcohol testing forms, reporting and recordkeeping, 
inspection and enforcement procedures and responsibilities, and return-
to-duty procedures. We believe it would be very difficult to craft a 
provision that did justice to both programs and decreased, rather than 
increased, confusion among employers and employees. While we believe 
reciprocity and ``one-stop shopping'' are worthwhile objectives, we do 
not believe they are practically achievable in this case. In addition, 
the numbers of double-covered employees and employers (either with NRC 
or other Federal agencies) are quite small in comparison to the total 
number of parties covered by the DOT program. For these reasons, we are 
not making this proposed section part of the final rule.

Section 40.13  How Do DOT Drug and Alcohol Tests Relate to Non-DOT 
Tests?

    This section is based on proposed Sec. 40.15 of the NPRM. It 
continues to require that DOT and non-DOT tests be kept strictly 
separate. Comments were generally supportive of this concept, but some 
asked for clarification. Paragraph (b), for example, clearly concerns 
collections rather than other parts of the testing process, and the 
text has been changed to make this explicit. This provision does not, 
as one commenter wondered, mean that laboratories must process DOT and 
non-DOT specimens in separate batches. Another commenter suggested that 
the ``firewall'' between DOT and non-DOT tests would be stronger if we 
required that an employer use separate laboratories for the two types 
of tests. We have not become aware of any problems that use of the same 
laboratory has created, and we think that this idea would increase 
costs and administrative complexity for employers.
    A few commenters mentioned a desire to permit tests for other 
drugs, beyond the ``HHS five.'' This is a long-standing issue in the 
program, and DOT continues to take the position that we ought not go 
beyond the testing that HHS has authorized and for which HHS has 
certified laboratories. We agree with comments that inadvertent use of 
non-Federal forms should be a correctable flaw and that employers may 
appropriately use the CCF for Federally-regulated tests (i.e., under 
the HHS program for Federal agencies). The final text makes changes to 
these effects. The Department does not object to laboratories creating 
a standard form for non-DOT tests.
    One of the most important provisions of this section prohibits the 
use of DOT specimens for tests other than the ones explicitly 
authorized by this part. For example, the rule forbids laboratories and 
other parties from making a DOT specimen available for DNA testing. 
This incorporates in the rule text a long-standing DOT interpretation 
of Part 40. We say this for two main reasons. First, under these 
regulations, a properly completed chain of custody conclusively 
establishes the identity of a specimen. No additional tests are 
required for this purpose.
    Second, the only thing a DNA test can do is to determine, to a high 
level of probability, whether a specimen and a reference specimen were 
produced by the same individual. If the DNA test establishes a high 
probability that the original specimen tested for drugs and a reference 
specimen came from different individuals, this may mean one of four 
things. It could mean that there was an error in the collection, 
transmission, or handling of the specimen. It could mean that the 
employee provided a substituted specimen (e.g., someone else's urine) 
at the original collection and provided his or her own urine for the 
reference specimen. It could mean that the employee provided his or her 
own urine at the original collection and substituted someone else's 
urine for the reference specimen. It could mean that the individual 
provided substituted specimens from two different sources at the 
original collection and for the reference specimen. A DNA test cannot 
distinguish among these possibilities. Given a proper chain of custody, 
the last three possibilities are significantly more probable in 
practice than the first. A DNA finding of difference between the two 
specimens is not, then, a valid basis for canceling a test.
    Even if a DNA test is performed, contrary to these rules, this 
section prohibits employers from changing or disregarding a verified 
positive test. In such a case, regardless of the result of the 
unauthorized test, the employer cannot return the employee to the 
performance of safety-sensitive functions until and unless the employee 
successfully completes the return-to-duty process. The same point 
applies to other unauthorized tests (e.g., if the employee goes to his 
or her own doctor and gets a second urine test or a blood test).

Section 40.15  May an Employer Use a Service Agent to Meet DOT Drug and 
Alcohol Testing Requirements?

    This provision is based on Sec. 40.17 of the NPRM. It provides that 
an employer may use a service agent to carry out drug and alcohol 
testing program tasks. There were not many comments on this section, 
and they generally supported the provision. Some commenters sought to 
limit the responsibility of employers, saying they should not be 
accountable if they failed to comply with the rules because a service 
agent erred. As noted above, we disagree: employers always remain 
accountable for noncompliance, whether they run their own programs or 
outsource them. Another comment suggested laboratories should not be 
subject to DOT regulations, since they are regulated by HHS. It is 
certainly true that DOT relies on HHS for laboratory certification 
matters. However, laboratories have responsibilities under Part 40 
independent of their HHS responsibilities (e.g., with respect to 
relationships with MROs, release of information, and validity testing), 
and laboratories must be accountable to DOT in those matters.
    We agree, however, that we should not require employers to have 
active monitoring responsibilities with respect to service agents, 
though employers may choose to monitor their service agents' 
performance. Therefore, we have altered paragraph (b) to require 
employers simply to make sure that service agents meet regulatory 
qualifications. To this end, employers may ask to see documentation 
from service agents, who are obligated to provide it.

[[Page 79485]]

Section 40.17  Is an Employer Responsible for Obtaining Information 
From its Service Agents?

    This is a new section, responding to problems that the Department 
has encountered in the enforcement process. It is closely related to 
the point, made in previous sections, that an employer is responsible 
for its own compliance with DOT rules even in the face of mistakes by 
service agents. The section says that an employer has an affirmative 
responsibility to get information from service agents that is needed 
for compliance purposes. For example, suppose an applicant for a 
safety-sensitive job takes a pre-employment drug test, but there is a 
significant delay in the receipt of the test result from an MRO or C/
TPA. The employer must not assume that ``no news is good news'' and 
permit the applicant to perform safety-sensitive duties before 
receiving the result. Rather, the employer would have to seek out the 
information about the test result from the service agent before putting 
the employee to work.

Section 40.21  May an Employer Stand Down an Employee Before the MRO 
Has Completed the Verification Process?

    Proposed Secs. 40.19-40.21 have been relocated to Subpart Q, and we 
will respond to comments on them in the corresponding part of the 
preamble. There is no Sec. 40.19 in the final rule. Section 40.21 
concerns the issue of stand-down. This issue was raised by proposed 
Sec. 40.159(a) of the NPRM. We have relocated the section here since it 
pertains primarily to the responsibilities of the employer. We 
discussed the general policy issues surrounding stand-down in the 
``Principal Policy Issues'' portion of the preamble.
    The comments responding to proposed Sec. 40.159(a) focused almost 
exclusively on the pros and cons of stand-down as a policy. They did 
not address the details of how a stand-down policy would be 
implemented. In formulating Sec. 40. 21 of the final rule, we have 
crafted provisions specifically responsive both to the safely and 
privacy/employee protections sides of the issue that commenters raised.
    Paragraph (a) states the general policy prohibiting stand-down, 
except where a DOT agency grants a waiver. We note that this 
prohibition, and waivers of it, apply in adulteration and substitution 
cases as well as cases in which there is a confirmed test result for 
drugs or drug metabolites. Paragraph (b) tells employers to send their 
waiver requests to the DOT agency whose rules apply to the majority of 
the employer's covered employees. For many employers, whose employees 
are covered by only one DOT rule, the decision is obvious. An employer 
with covered employees in more than one DOT agency category would count 
the employees in each category. For example, an employer with 500 
aviation personnel and 1000 truck drivers would send its request to 
FMCSA. In such a case, FMCSA would coordinate with FAA before making a 
decision on the waiver request.
    Paragraph (c) lists the items that an employer must include in a 
waiver request. The first set of items are information that DOT 
agencies will use in determining whether to grant a waiver. It should 
be emphasized that none of the items in paragraphs (d)(1) are intended 
to create mandatory prerequisites to receiving a waiver. That is, we do 
not require that an organization be a particular size, or have an in-
house MRO, or have had an accident during the period before 
verification was completed, in order for its waiver request to be 
granted.
    Any organization that wants a waiver to do stand-down must have a 
written company policy on the subject. An employer must include its 
proposed policy with its waiver request, making sure that it covers 
seven mandatory elements. The first is distribution of the written 
policy to all covered employees. Each employee subject to stand-down 
must receive an individual copy of the policy: posting on bulletin 
boards or web sites is not sufficient. The second pertains to 
confidentiality. There must be an effective means of ensuring that only 
those persons with a need to know--the employee, the DER, and the MRO--
are told that the employee is being stood down because of a confirmed 
laboratory positive, adulterated, or substituted test result. We 
understand, of course, that the employee's supervisor will need to know 
that the employee is being removed from performance of safety-sensitive 
functions, but the supervisor must not be told the reason for the 
action. It is sufficient that the supervisor be given a general 
explanation (e.g., medical qualification reasons, personnel evaluation 
reasons).
    The third item is equality of treatment within a given job 
category. An employer cannot pick and choose the employees to whom it 
will apply a stand-down policy. That would be unfair. The employer must 
choose to stand-down all DOT-regulated employees in each job category 
or none. For example, an airline's policy could provide that all pilots 
would be subject to stand-down, but mechanics would not. However, the 
airline could not choose to stand down some pilots, but not others. 
When we use the term ``job categories'' in this paragraph, we mean 
broad, inclusive categories of employees, rather than narrower subsets 
of employee categories that might be used for pay or personnel 
purposes.
    The fourth item is a means of ensuring that stand-down is applied 
only with respect to the performance of safety-sensitive duties. For 
example, suppose a motor carrier's policy calls for stand-down with 
respect to drivers. The laboratory reports a confirmed positive drug 
test for Driver X. Driver X is scheduled to drive a commercial motor 
vehicle over the next few days. The company would stand Driver X down, 
so the driver would not be performing a safety-sensitive function 
during the verification period. The laboratory also reports a confirmed 
positive drug test for Driver Y. However, during the next few days, 
Driver Y is scheduled to be in training or to be on personal leave. The 
motor carrier would take no action with respect to Driver Y (including 
notification of a supervisor), because he or she would not be 
performing safety-sensitive duties during the verification period.
    The fifth item, concerning pay status of employees, is a very 
important matter of policy. As discussed above, employers who stand 
employees down must continue to pay them until and unless there is a 
verified adulterated, substituted, or positive test result. This 
obligation is to pay the employee in exactly the same way he or she 
would have been paid but for the stand-down. For example, suppose an 
employer stands down an employee from Monday through Thursday. If the 
employee would have been paid for 8 hours of work on each of the four 
days in the absence of the stand-down, then the employee would be paid 
for this amount of work. If the employee would only have worked on, and 
been paid for, only Tuesday and Wednesday, then the employer would pay 
the employee for these two days' work. We note that this obligation to 
pay the employee ends with a verification of a positive, adulterated, 
or substituted test, even if the employee subsequently asks for a test 
of the split specimen.
    For the sake of both employers and employees, it is very important 
that verifications proceed quickly when an employee is in a stand-down 
status. Therefore, the sixth condition is that the verification process 
must start at once and take no more than five days (a time period 
consistent with requirements for the verification process elsewhere in 
the rule). The process could exceed this five-day limit only for 
extenuating circumstances (i.e., the MRO provides a

[[Page 79486]]

written statement to the employer that a longer time is needed to 
complete verification).
    The seventh mandatory part of the employer policy is that, if an 
employee is stood down and the MRO verifies the test negative or 
cancels it, the employer must immediately return the employee to 
safety-sensitive duties. The employee must not suffer any adverse 
personnel or financial consequences. The employer must not maintain any 
individually identifiable records of the confirmed positive laboratory 
test. That is, the employer would have to expunge any individually 
identifiable record of the confirmed positive laboratory test and 
maintain only the record of the individual's verified negative or 
canceled test. This places both the employer and employee in the same 
position they would be in if the employer did not have a stand-down 
policy. The MRO will have a record of the laboratory test result that 
inspectors can access if necessary.
    This provision goes into effect on August 1, 2001. DOT agencies 
will not consider petitions for waivers before this effective date. In 
considering waivers, each DOT agency will use its own procedures 
applicable to waivers from its regulatory requirements. The concerned 
DOT agency Administrator, or his or her designee, will make each 
decision about whether to grant a waiver considering both the safety 
and the employee protection aspects of the matter. Administrators will 
informally coordinate proposed responses to waiver requests with ODAPC 
and other affected DOT agencies, in order to ensure intermodal 
consistency in the Department's responses. DOT agencies will respond to 
all waiver requests in writing, stating the reasons for their 
decisions.
    An Administrator can impose additional conditions on the grant of a 
waiver. The Administrator can also revoke a waiver if the employer 
fails to implement mandatory provisions of its stand-down policy or 
conditions the Administrator has placed on it. Finally, if an employer 
implements a stand-down policy without having a waiver, or violates the 
terms of the waiver (e.g., tests some employees but not others in a job 
category, fails to implement confidentiality safeguards, fails to pay 
employees during stand-down periods), the employer will be subject to 
DOT agency enforcement action (e.g., civil penalties), just as in any 
other case in which an employer violates DOT agency drug and alcohol 
regulations.

Section 40.23  What Actions Do Employers Take After Receiving Test 
Results?

    This section is based, in part, on Sec. 40.159(b)-(g) of the NPRM. 
We have added some material to it and placed it in Subpart B in order 
to provide employers with a convenient summary of their obligations 
when they receive various kinds of drug and alcohol test results. We 
believe that the regulatory text is self-explanatory, so we need not 
comment on it further here.
    There were very few comments on Sec. 40.159(b)-(g). One commenter 
said that the company should wait for the signed report from the MRO 
before taking action to remove an employee from safety-sensitive 
functions after a violation. We understand the usefulness of having 
paper in hand, but we believe that speed is more essential for safety 
reasons once the MRO or BAT informs the employer of a violation. Of 
course, the requirement to immediately remove an employee from the 
performance of safety-sensitive duties necessarily implies that 
employers may not ``stay'' this action pending any administrative or 
legal proceeding (e.g., grievance, arbitration, lawsuit) resulting from 
the outcome of the testing process.
    Paragraph (i) prohibits employers from changing test results (e.g., 
determining that the laboratory result was incorrect or that the MRO's 
judgment on a verification issue should be overturned). Obviously, 
there may be some cases in which a court or administrative hearing 
officer will require a test result to be expunged from the record, or a 
test cancelled, because of a problem in the testing process (e.g., a 
previously undiscovered fatal flaw). However, this action does not 
involve altering the laboratory finding or MRO determination, as such.

Section 40.25  Must an Employer Check on the Drug and Alcohol Testing 
Record of Employees It Is Intending To Use To Perform Safety-Sensitive 
Duties?

    The NPRM (proposed Sec. 40.329) would have required MROs to 
transmit drug test result information to additional employers in 
certain circumstances. If an MRO had personal knowledge that an 
employee whose test the MRO had verified positive worked in a safety-
sensitive position for another DOT-regulated employer, the MRO would, 
under certain conditions, tell the second employer about the positive 
test, without the employee's consent. As described in the ``Principal 
Policy Issues'' section of the preamble, we are not adopting this 
proposal as part of the final rule.
    In place of the proposed Sec. 40.329, and in the absence of a 
Federal data base, the Department is incorporating in the final rule a 
provision based on an existing FMCSA provision. This provision requires 
employers to check on the drug and alcohol testing background of new 
hires and other employees beginning safety-sensitive work. Employers 
would have to get written consent from the applicant (in the absence of 
which the employer would not hire the person). The employer sends the 
request for information and the employee's consent to all other DOT-
regulated employers for whom the employee had worked within the 
previous two years.
    The employer cannot let the employee perform safety-sensitive 
duties for more than 30 days unless the employer has obtained, or made 
and documented a good faith effort to obtain, the required information 
from previous employers (as well as from firms to whom the employee 
applied for safety-sensitive work, where there was a positive test 
result or a refusal). Of course, if the employer finds that the 
employee has a violation on his record, and the employee has not 
successfully completed the return-to-duty process, the employer must 
immediately stop using the employee to perform safety-sensitive 
functions.
    The Department believes that this section will help to achieve some 
of the purposes of the proposal to allow MROs to share test results, 
with fewer drawbacks. Admittedly, it affects only new employees rather 
than current safety-sensitive employees. However, FMCSA has had success 
implementing this provision, and it will help to screen out employees 
who are not eligible to perform safety-sensitive functions. It will 
also ensure that employees who violate the rules will have to go 
through the SAP/return-to-duty process before performing safety-
sensitive duties. It will therefore have safety benefits. Because a 
substantial majority of all DOT-regulated employees and employers are 
in the motor carrier industry, this provision will result in only a 
modest increase in the information collection burden of the DOT 
program. The written consent provision of the section avoids some of 
the privacy concerns of the MRO information sharing proposal.
    In addition to seeking information from previous employers, this 
section also requires employers to ask prospective employees if they 
have failed or refused a DOT drug or alcohol pre-employment test within 
the past two years from an employer who did not hire them. While we 
recognize that

[[Page 79487]]

applicants may not always tell the truth about such events, we believe 
that it is important to make this inquiry to help ensure that employees 
are not put to work in safety-sensitive positions following a pre-
employment test violation without having completed return-to-duty 
process requirements.

Section 40.27  Where Is Other Information on Employer Responsibilities 
Found in This Regulation?

    This is a new section, parallel to several sections (e.g., 
concerning MROs) in the NPRM. It is a list of other sections of the 
rule that touch on matters of particular interest to employers. We 
believe it will make the rule easier for employers to use if they have 
a quick guide to other references in the rule to employer 
responsibilities.

Subpart C--Urine Collection Personnel

Section 40.31  Who May Collect Urine Specimens for DOT Drug Testing?

    This introductory section to the urine collection personnel subpart 
states that only collectors meeting Subpart C requirements can collect 
specimens in DOT-regulated tests. They must meet Sec. 40.33 training 
requirements. The only subject of significant comment on this section 
had to do with the requirement that supervisors could not collect urine 
specimens from employees they supervise, unless no other qualified 
collector was available and DOT agency drug and alcohol regulations 
permitted the supervisor to act in this capacity.
    The intent of this provision is to prevent potential conflicts 
between supervisors and subordinates, as well as to avoid any claims 
that a supervisor was out to get an employee through manipulation of 
the testing process. However, commenters asked for clarification of who 
we meant to cover when we applied this prohibition to supervisors. 
Several suggested we should limit the prohibition to ``immediate 
supervisors,'' so that individuals higher in the organizational chain 
of command, who did not supervise the employee day-to-day, could act as 
collectors. The Department agrees, and we have added this language to 
the section.

Section 40.33  What Training Requirements Must a Collector Meet?

    There is a strong, though not unanimous, consensus among people 
familiar with the DOT drug testing program that collections is the area 
of the program where the most errors occur that cause tests to be 
cancelled. For this reason, the NPRM proposed several requirements to 
strengthen training for collectors, though it did not go so far as to 
propose an equivalent of the BAT course used for alcohol testing 
personnel. We discussed the key points of this issue in the ``Principal 
Policy Issues'' section of the preamble.
    We note here two additional changes we made to reduce paperwork 
burdens. In response to comments, we dropped the proposed requirement 
that called on collectors to ``attest in writing'' that they have read 
and understood the rules and DOT guidance. We also eliminated 
requirements (from proposed Sec. 40.35) requiring organizations 
employing collectors to maintain records of their training. Collectors 
will maintain their own training documentation, which they must show on 
request to DOT agency representatives as well as employers or C/TPAs 
who use their services.
    In this section and a number of others, the final rule makes 
reference to guidance documents being available on the ODAPC web site. 
These will be true statements by the time the rule becomes effective in 
August 2001. At the present time, however, these documents are ``under 
construction,'' and they have not yet made their debut in cyberspace.

Section 40.35  What Information About the DER Must Employers Provide to 
Collectors?

    This section is not based on proposed Sec. 40.35 of the NPRM which, 
as mentioned above, is not included in the final rule. It is a new 
section incorporating a brief statement that employers must make sure 
that collectors have the name of and contact information for the 
employer's DER, so that the collector can contact the employer 
concerning any problems that come up in the collection process (e.g., 
no shows, refusals). We recognize that there may be some situations 
(e.g., post-accident tests at locations remote from the employer's 
place of business) where this may not be feasible.

Section 40.37  Where Is Other Information on the Role of Collectors 
Found in This Regulation?

    This is a section listing other sections in the rule that 
collectors will find useful in understanding their functions in the 
drug testing program.

Subpart D--Collection Sites, Forms, Equipment and Supplies Used in 
DOT Urine Collections

Section 40.41  Where Does a Urine Collection for a DOT Drug Test Take 
Place?

    Most comments on this section focused on two issues. The first was 
the conditions on use of a multistall restroom. The NPRM proposed that 
a multistall restroom could be used only if a closed room for urination 
was not available, and could be used only for monitored collections. 
The proposed rule text also said that a multistall restroom must 
provide aural privacy to the extent practicable. Several commenters 
said these conditions were too restrictive and would effectively 
preclude employers from using multistall restrooms for collections. 
This was a problem, they said, because in some industries, this was the 
most readily available type of urination facility. Some commenters also 
noted what they viewed as an inconsistency between the aural privacy 
provision of this section and the provision in Sec. 40.69 that called 
on monitors to listen for sounds that might indicate tampering.
    Some commenters also thought that provisions of the proposal 
concerning closed room urination facilities were too restrictive, 
particularly the statement that the room should have an external water 
source, if practicable. They said that many such facilities (e.g., 
patient rest rooms in doctors' offices) had internal water sources, and 
the ``if practicable'' language could lead to legal challenges. They 
said it would be better simply to require collection sites to secure 
all water sources.
    The Department has modified this section in response to these 
comments. The final rule provides that either a closed room or 
multistall urination facility is acceptable. In the former, while it is 
preferable to have an external water source, the rule makes clear that 
a facility that has an internal water source is also acceptable, if all 
sources of water and potential adulterants are secured and moist 
towelettes are provided. This kind of urination facility must have a 
full-length privacy door. This means a door that is both opaque and 
solid. For example, a glass door, a door with a window or other means 
of viewing the interior of the room from outside, or a curtain is not 
adequate for this purpose. Nor would it be appropriate to have a video 
camera or microphone monitoring the room.
    If a multistall restroom is used as the urination facility, the 
facility must meet either of two requirements. First, a multistall 
restroom may be used without a monitor if all sources of water and 
potential adulterants are secured. Second, if these sources are not 
secured, the collection must be a monitored collection, meeting the 
requirements of Sec. 40.69. The facility must have a partial-length 
privacy door (i.e., for the stall in which urination takes place) to 
provide as much visual privacy as possible. We

[[Page 79488]]

have deleted the references in this section to aural privacy and in 
Sec. 40.69 to ``active listening'' by the monitor.
    Regardless of which type of urination facility a collection site 
uses, the employee is the only person permitted in the urination 
facility during the collection of a specimen. This requirement is 
intended to safeguard both the employee's privacy and the integrity of 
the process. The only exceptions to this rule are the observer in a 
directly observed collection or the monitor in a monitored collection.

Section 40.43  What Steps Must Operators of Collection Sites Take To 
Protect the Security and Integrity of Urine Collections?

    Commenters made a number of suggestions about this section. One 
commenter said that the requirement to ensure that the collection site 
is secure before each collection was too much work. We disagree. Making 
this check is vital to the integrity of the program. Several commenters 
suggested that we clarify the requirement that a collector can have 
only one collection going on at a time to allow a collector to continue 
other collections while another employee was drinking fluids in a ``shy 
bladder'' situation. We think this is a good idea that would avoid 
potential delays at collection sites, and we have added language to 
this effect.
    The NPRM proposed that the collector should keep the collection 
container within view ``to the greatest extent [he or she] can.'' A few 
commenters thought this requirement should be absolute, with the 
consequence being a fatal flaw if the collector let the container out 
of his or her sight. We do not believe that the requirement should be 
absolute. While it is important for the collector and the employee to 
keep the specimen in sight, a brief absence by the collector ought not 
be a reason for cancelling a test that otherwise meets Part 40 
requirements.
    As commenters suggested, we clarified that authorized personnel who 
may be present at the collection site may include employer 
representatives, that no one but direct observers and monitors could be 
in the urination facility with an employee, and that collectors can 
remove a disruptive person from the collection site.

Section 40.45  What Form Is Used To Document a DOT Urine Collection?

    Earlier this year (June 23, 2000), HHS issued a new CCF for use in 
both the Federal employee and DOT drug testing programs. The references 
to the CCF in this rule are to the new form. Most provisions of this 
rule become effective on August 1, 2001, the same date use of the HHS 
form becomes mandatory for use in the Federal employee program. (Before 
August 1, 2001, participants in both programs have the option of using 
either the old or the new form.) Consequently, there will be no 
disconnect between the HHS form requirements and the requirements of 
this rule.
    A few comments suggested allowing the collector to sign CCFs in 
advance, presumably to save time during collections. We think this idea 
is fraught with potential for misuse or theft of signed forms, and we 
will maintain the prohibition on this short cut. We have added a 
specific requirement for the MRO's phone and fax numbers, as a 
commenter suggested. A few commenters also suggested allowing the use 
of foreign-language versions of the form in the U.S., as well as in 
other countries. We have incorporated this suggestion, with the 
stipulation that use of a non-English version of the form that ODAPC 
has reviewed is allowable in any situation (here or in another country) 
only if both the employee and collector understand and can use the form 
in that language. For example, a collector who does not read French 
could not use a French language form, even for a French-speaking 
employee.

Section 40.47  May Employers Use the CCF for Non-DOT Collections or 
Non-Federal Forms for DOT Collections?

    Some commenters supported permitting the use of the Federal CCF for 
non-DOT collections. Some of these comments favored adding boxes to the 
form that collectors could check for ``DOT'' or ``non-DOT'' 
collections. We have believed since the beginnings of the DOT program 
that it is very important to maintain ``truth in testing.'' If a form 
says ``DOT'' or ``Federal'' on it, despite whatever fine print 
qualifications or check boxes might be included, the form may easily 
imply to the employee that he or she is being tested under Federal law. 
If this is not true, as in the case of a ``company policy'' test, then 
we are knowingly misinforming the employee. That is unfair. Moreover, 
``company policy'' tests that do not meet DOT requirements, but are 
conducted using the CCF, could implicate the DOT program in legal 
challenges to the non-DOT tests. We will maintain the existing 
prohibition.
    Generally, most commenters on the subject agreed with the NPRM's 
proposal to make use of a non-Federal form in a DOT test a 
``correctable flaw.'' A few comments questioned the need for the 
written correction. Correcting the flaw will ensure that there was an 
appropriate explanation for use of the non-DOT form (e.g., a post-
accident test where nothing else was available, a simple mistake) and 
will help to educate the collector involved about the need to use the 
correct form. We will also keep this provision in the final rule.

Section 40.49  What Materials Are Used To Collect Urine Specimens?

    There were few comments on this section, which requires the use of 
a ``DOT Kit'' (see Appendix A for details). Laboratories and MROs 
should treat as a ``red flag'' any situation in which a non-conforming 
kit is used. While use of a non-conforming kit is not a fatal or 
correctable flaw in the testing process, laboratories and MROs should, 
if they discover that a non-conforming kit was used for a collection, 
check to make sure that correct collection procedures were used and 
that no fatal flaws occurred. Use of a nonconforming kit is a rule 
violation that can subject the user to consequences under DOT agency 
rules.

Section 40.51  What Materials Are Used To Send Urine Specimens to the 
Laboratory?

    This provision concerns shipping containers. In response to a 
comment, we have omitted a reference to a standard ``box,'' leaving the 
provision as a performance standard requiring a container that 
adequately protects the specimen from damage during shipping.

Subpart E--Drug Test Collections

Section 40.61  What Are the Preliminary Steps in the Collection 
Process?

    Commenters responded to a variety of detailed issues in this 
section. With respect to employees who showed up late for a test or not 
at all, several commenters said it was common for employees not to have 
appointments. As a result, employees simply appeared at the collection 
site, and collection site people had no notion whether they were on 
time or not. Commenters suggested that the proposed ``no show'' 
provision be limited to situations in which the collection site was at 
the employee's worksite or an appointment had been scheduled. We agree, 
and have added language to this effect.
    Some commenters thought it was unreasonable to ask collection sites 
to do their work on a timely basis, and they therefore objected to the 
proposed requirement that the collection process begin without delay. 
We believe that, for the sake of both employers and employees, 
timeliness is essential for decent customer service. However, we

[[Page 79489]]

will respond to concerns about the flexibility of this provision by 
adding the modifier ``undue.'' We will also note in Sec. 40.209 that a 
collector delay is not a ``fatal flaw.''
    The NPRM stated that when alcohol and drug tests were being given 
to the same employee at the same site, the alcohol test should be given 
first. In response to comments concerned about backups in the testing 
process, we have provided additional flexibility and added an example 
of a situation in which an employee's urine collection might be 
conducted first.
    The NPRM would have prohibited the collection of urine from an 
unconscious employee by means of catheterization. A few comments asked 
for clarification in other situations involving catheters. Some also 
suggested testing by alternative means in these cases (e.g., hair, 
saliva). The Department is clarifying this section to prohibit 
collecting urine by catheterization not only from an unconscious 
employee, but also from a conscious employee. The former raises consent 
issues, and the latter, even given consent, raises safety issues. 
However, in the case of an employee who normally voids through self-
catheterization (e.g., for medical purposes), the collector must 
require the employee to provide a specimen in that manner.
    With respect to alternative testing technologies such as hair 
testing, saliva testing, and on-site testing, which commenters 
recommended in context of several sections of the NPRM, the Department 
will wait upon the action of HHS before proposing to incorporate 
additional methods. Approval of these or other methods, and 
establishment of requirements and procedures for them, are matters 
primarily within the expertise of HHS, which is currently considering 
them with the assistance of the Drug Testing Advisory Board (DTAB).
    Concerning identification of employees, commenters suggested that a 
driver's license or similar government-issued ID would be acceptable in 
lieu of an employer-issued credential. On the other hand, some comments 
pointed out that the credibility of employer-issued ID might be 
doubtful in the case of a self-employed individual. We have modified 
the section on both points. A driver's license or other government-
issued photo ID will be acceptable, and an employer-issued ID from an 
owner-operator or other self-employed person will not.
    Many of the same commenters who objected to the proposed 
requirement to have collectors search boots also objected, for similar 
reasons, to the proposed requirement (similar to that of the existing 
rule) to have employees empty their pockets. We believe that taking 
objects out of one's pockets is a minimal intrusion into the employee's 
privacy, which can help deter and detect some attempts to cheat on 
tests. In addition, this is a provision that is paralleled in HHS 
guidelines. The final rule retains the proposed requirement.
    A few commenters objected to the provision that would bar requiring 
employees to sign consent forms, waivers, releases, etc. concerning the 
collection and testing process. These comments did not explain the 
reason why exacting signatures on such documents was necessary for the 
DOT testing process, and we do not believe that it is. We have retained 
it, but moved it to Subpart Q and made it applicable to all service 
agents, not just collection sites. One comment suggested that 
collection sites be able to have employees sign consent forms with 
respect to non-DOT tests. This rule does not limit employers' or 
collection sites' actions concerning non-DOT tests, but the rule does 
require strict separation between DOT and non-DOT testing procedures. 
This includes separate paperwork for a DOT and non-DOT test conducted 
with respect to the same employee during his or her visit to a 
collection site. Such a consent form must not be part of the paperwork 
for a DOT test, and it could not apply to the DOT test or be filled out 
at the same time the employee was filling out the paperwork for the DOT 
test.

Section 40.63  What Steps Does the Collector Take in the Collection 
Process Before the Employee Provides a Urine Specimen?

    Commenters raised few issues concerning this section. A commenter 
wanted to eliminate the prohibition on the employee flushing the toilet 
after providing the sample, but we will retain this provision because 
it limits opportunities to flush away evidence of adulteration. 
(However, inadvertantly flushing the toilet does not create a ``fatal 
flaw.'') Another commenter suggested training collectors in how to 
detect attempts to tamper with specimens. We think this is a good idea, 
and our guidance will suggest it. However, we do not think it is 
necessary to incorporate it in rule text.

Section 40.65  What Does the Collector Check for When the Employee 
Presents a Specimen?

    Some commenters noted that the NPRM omitted the existing provision 
concerning taking an employee's body temperature when the specimen 
temperature was out of range. This was intended. Many collectors are 
not medically trained, and the accuracy of some thermometers is not 
certain. The provision has not been too useful under the existing rule, 
and we will not include it in the final rule. Other comments requested 
revision of the temperature range (e.g., to be between 94 and 100 
degrees). While this idea has some appeal, we believe we need to keep 
Part 40 consistent with HHS provisions on this matter.
    Other commenters asked for clarification whether, when one specimen 
has not met regulatory requirements (e.g., out of temperature range, 
insufficient volume), the specimen should be sent to the laboratory for 
testing, as well as any subsequent specimen that is collected. We 
agree, and have included specific directions on this point. For 
example, when the first specimen is out of temperature range, and a 
second specimen is collected under direct observation, both specimens 
would be sent to the laboratory and tested. On the other hand, if the 
first specimen were out of temperature range, and the employee refused 
to provide a second specimen under direct observation, the first 
specimen would be discarded and the event simply treated as a refusal.

Section 40.67  When and How Is a Directly Observed Collection 
Conducted?

    Directly observed specimens are controversial because of their 
greater impact on employee privacy. They can be useful because they 
reduce the opportunity for tampering. On privacy grounds, some 
commenters, including unions and some service agents, would prefer not 
to conduct directly observed collections at all. In any case, these 
commenters opposed adding any situations in which direct observation 
was required or authorized. Other commenters said that the benefit of 
greater protection against specimen tampering warranted direct 
observation in situations that suggested a heightened risk of 
tampering.
    The Department agrees with the latter comments. In situations that 
may create a higher risk or greater incentive for tampering (e.g., the 
previous collection was verified positive, adulterated, or substituted, 
but the test had to be cancelled because the split specimen was 
unavailable for testing; the previous specimen was invalid and there 
was no adequate medical explanation; temperature out of range; apparent 
tampering with the specimen at the collection site), the interests of 
the integrity of the testing process, with its

[[Page 79490]]

safety implications, outweigh the additional privacy impact of the 
direct observation process. On the other hand, dilute specimens may 
have a number of innocent causes (e.g., someone likes to drink a lot of 
water). A dilute specimen does not necessarily imply the same higher 
risk of tampering upon recollection, so the final rule does not 
authorize direct observation in this case.
    The existing rule and the NPRM both called for use of a same-gender 
direct observer. Some comments objected to this requirement, saying it 
created practical problems in collection sites that were staffed by 
only one collector. Other commenters insisted on retaining this 
requirement as a matter of privacy. We believe there is no alternative 
to retaining the same-gender observer requirement. Use of opposite 
gender observers would not only go counter to deeply held societal 
norms of privacy (i.e., the basic reason for separate men's and women's 
rest rooms in public places), but might raise genuine safety concerns, 
particularly on the part of female participants. We would point out 
that the observer need not be a trained collector, so that another 
same-gender person could be enlisted for the task.
    One commenter recommended we add a provision telling the collector 
or employer, as appropriate, to explain to the employee why a directly 
observed collection needs to be conducted. We believe that this is a 
good idea, and we have included a requirement in the rule to this 
effect.

Section 40.69  How Is a Monitored Collection Conducted?

    Much of the comment on this section echoed the comments on 
Sec. 40.41, supporting the use of multistall restrooms as urination 
facilities and urging the Department to permit the use of monitored 
collections at the collection sites at the employer's discretion. The 
discussion of multistall restrooms and monitored collections in 
Sec. 40.41 is the Department's resolution of these issues. This section 
sets forth the procedures to be used for monitored collections.
    A few commenters focused on the use of toilet bluing agents in 
monitored collections. They suggested that bluing not be required 
except in the toilet the employee is using while providing the 
specimen. We agree with this point with respect to a monitored 
collection. In a case in which a collection uses a multistall restroom 
as a urination facility but does not conduct monitored collections, 
however, all toilets must be secured, including the use of bluing.
    A number of commenters again objected to the requirement that the 
monitor be of the same gender as the employee, essentially for the same 
reasons that commenters objected to the same gender requirement for 
direct observers. They added that, in the case of monitors, there is a 
less intense privacy concern because the monitors do not actually watch 
the employee urinate. We agree that the privacy concern is less intense 
in this case, and for that reason we permit the use of opposite-gender 
monitors who are medical professionals. Medical professionals are 
trained to conduct themselves properly and are less likely than other 
persons to raise privacy and safety concerns among employees. But 
legitimate privacy and safety concerns still exist to a degree in the 
monitored collection situation, and we believe that monitors who are 
not medical professionals should continue to be the same gender as the 
employee, as under the current rule.

Section 40.71  How Does the Collector Prepare the Specimens?

    Proposed Sec. 40.71, concerning single specimen collection 
procedures, has been deleted, as all collections will now be split 
specimen collections. This section is based on proposed Sec. 40.73. 
There were few comments on this section. One suggested that the failure 
of the employee to initial the tamper-evident seals be regarded as a 
refusal to test. We do not think that that is the best solution to this 
problem. The individual has, after all, provided a specimen. By having 
the collector note the problem in the remarks line of the form, we 
preserve a record that the collection proceeded properly. In this 
section, we also clarify at several points that the collector, not the 
employee, performs several tasks.

Section 40.73  How Is the Collection Process Completed?

    This section is based on Sec. 40.75 of the NPRM. Commenters 
addressed a number of technical points. Some commenters wanted to put a 
time line in the section to expedite proceedings. We agree, and we have 
added a 24-hour/next business day requirement for transmittal of 
relevant copies of the CCF and the specimen itself. As another 
commenter suggested, we do encourage the immediate faxing of CCF copies 
to the MRO and DER.
    A commenter asked that we specifically prohibit employees from 
providing medical information on the CCF. We agree, and we have spelled 
out this point in Sec. 40.61(g). Another commenter suggested deleting 
the requirement for a ``box'' as the shipping container. We have 
deleted this requirement as a matter of flexibility, both here and in 
Appendix A, though we retain mention of a box as an example of 
something that can be a shipping container.
    A commenter suggested that we eliminate the proposed requirement to 
note the entry for a specific courier or shipping service on the CCF. 
This requirement is part of the HHS CCF and instructions, so for 
consistency's sake we will retain it. However, we also specify in 
Sec. 40.209 that omitting this information is not a fatal flaw.
    As indicated previously, the shipping container seal was used 
primarily to seal the shipping container (box). Laboratories still 
tested the specimens when the shipping container seal was broken, 
provided the seals on the bottles remained intact. Based on this fact, 
we have removed the requirement for a shipping container seal to be 
placed on a shipping container. The same rationale applies to placing a 
shipping container seal on the plastic bag. The construction of the 
plastic bag is such that any tampering will be evident, even without 
the seal. Consequently, the final rule does not include any requirement 
for placing a shipping container seal across the opening of the plastic 
bag or for the collector to sign or initial and date such a seal.

Subpart F--Drug Testing Laboratories

Section 40.81  What Laboratories May Be Used for DOT Drug Testing?

    The only comments on this section concerned the application of the 
PIE process to laboratories. Some laboratories and other commenters 
believed laboratories should not be subject to PIEs, since they are 
subject to HHS certification requirements. We believe that laboratories 
are service agents providing services to DOT-regulated employers no 
less than other parties subject to the PIE provision. Moreover, some 
Part 40 requirements affecting laboratories (e.g., information release, 
conflicts of interest, validity testing requirement) are not enforced 
by HHS through its certification procedures. For these reasons, we 
believe laboratories should remain subject to the PIE process. However, 
we specify in Sec. 40.365 that the Department does not intend, as a 
matter of policy, to initiate a PIE proceeding concerning a laboratory 
with respect to matters on which HHS has taken action under its 
certification process.

Section 40.83  How Do Laboratories Process Incoming Specimens?

    We have added a provision to this section specifically requiring

[[Page 79491]]

laboratories to comply with HHS guidelines concerning accessioning and 
processing specimens. We do not believe it is necessary to duplicate 
significant portions of the HHS guideline provisions concerning 
laboratory processing of specimens, and we have therefore eliminated 
some provisions of the proposed Subpart F, such as Sec. 40.87 and 
portions of this section and Sec. 40.95.
    Some commenters addressed the portion of the NPRM that discussed 
situations in which the color of the primary and split specimen differ. 
Because we will require a standardized collection kit using a single 
collection container, we believe that specimens failing to be color-
coordinated should no longer be a problem, so we have deleted this 
provision. This material is covered in the HHS guidelines, so we do not 
need to repeat it here. We did incorporate a commenter's suggestion to 
direct the laboratory to retain a specimen for five working days while 
waiting for the correction of a correctable flaw.
    A few commenters recommended that, when a laboratory notes that a 
split specimen is unavailable for testing, the laboratory should cancel 
the test then and there. We disagree. Most tests turn out to be 
negative, and employees do not request a test of the split specimen in 
all other cases. Therefore, there is a good probability that the test 
of the primary specimen will not turn out to be futile.

Section 40.85  What Drugs Do Laboratories Test for?

Section 40.87  What Are the Cutoff Concentrations for Initial and 
Confirmation Tests?

    These technical sections have changed very little from the existing 
rule. A few commenters supported, and a few others opposed, allowing to 
test for other drugs (e.g., barbiturates, benzodiazopenes, ``designer 
drugs'') in addition to the ``HHS five.'' This issue has been debated 
from the inception of the program. As the Department has said in the 
past, we believe the stability and reliability of the program are well 
served by limiting testing to the ``HHS five.'' HHS has established 
testing protocols and cutoffs for these drugs, and laboratories are 
subject to HHS certification for testing of these five drugs. This is 
not true for other drugs.

Section 40.89  Are Laboratories Required To Conduct Validity Testing?

Section 40.91  What Validity Tests Must Laboratories Conduct on Primary 
Specimens?

Section 40.93  What Criteria Do Laboratories Use To Establish That a 
Specimen Is Dilute or Substituted?

Section 40.95  What Criteria Do Laboratories Use To Establish That a 
Specimen Is Adulterated?

    These sections are the laboratory-related provisions concerning 
validity testing. We discussed validity testing extensively in the 
``Principal Policy Issues'' portion of the preamble, including issues 
pertaining to the scientific validity of adulteration and substitution 
criteria.
    Section 40.89(b) states that laboratories continue to be authorized 
to conduct validity testing. This sentence is included to avoid anyone 
mistakenly concluding that, until validity testing becomes mandatory, 
there is a question about whether it can remain a voluntary part of the 
DOT drug testing program, as it is today. (The parallel section of the 
amendments to current Part 40, Sec. 40.205(b), is for the same 
purpose.) When HHS issues its mandatory requirements on validity 
testing, DOT will amend Sec. 40.89(c) to insert a date on which DOT 
will require all DOT specimens to be subject to validity testing. We 
would not make this date earlier than August 1, 2001, even if HHS 
issues its requirements before that date.
    As noted in that discussion, this rule will not specify adulterants 
that must be tested, given the changes that can be expected in the 
popularity of various substances. However, we expect laboratories to be 
able to identify all those listed in up-to-date HHS guidance or rules. 
For example, we have not listed nitrites in this rule, but current HHS 
guidance calls on laboratories to test for nitrites. If nitrites cease 
to be a significant adulterant, and other substances arise to take its 
place, HHS guidance or rules will change as well.
    One point we believe to be quite important is that laboratories 
should remain vigilant for new adulterants. If a laboratory finds a 
substance it cannot identify that appears to act as an adulterant or 
interfering substance, the rule directs the laboratory, after checking 
with another laboratory, to inform ODAPC and HHS about it. Doing so 
will enable us to react as quickly as possible to new adulterants being 
marketed.
    We also note that, while the requirements for split specimen 
testing for adulterated and substituted specimens and MRO review will 
take effect within 30 days of the publication of this rule, mandatory 
validity testing is not required to begin until further notice from 
DOT. We will issue this notice in conjunction with the issuance by HHS 
of its mandatory requirements for validity testing. We hope that this 
will be on or before August 1, 2001. This should give those 
laboratories who currently are not conducting validity testing 
sufficient time to prepare to implement these requirements fully.

Section 40.97  What Do Laboratories Report and How Do They Report It?

    This section is based on parts of proposed Secs. 40.95 and 40.97. 
Some portions have been deleted as duplicative of HHS materials. The 
topic of greatest interest to commenters was the proposal to continue 
the current requirement that laboratories transmit test results 
directly to MROs, without using a C/TPA or some other party as an 
intermediary. C/TPAs made many of the same arguments on this point as 
they did with respect to the transmission of results from the MRO to 
the employer.
    There is only one party in the DOT drug testing system who is 
entitled to see a confirmed laboratory result. That is the MRO. Other 
parties, including collectors, employers (except in a limited way if a 
stand-down waiver is granted), SAPs, and C/TPAs are not. These other 
parties are entitled to learn of a result only after the MRO has 
verified it. To permit a C/TPA to receive a confirmed laboratory result 
and then transmit it to the MRO would directly violate this key 
principle. We do not think that, in the present state of the health 
care industry, there should be serious problems with MROs having 
appropriate technology to receive results.
    As discussed in the ``Primary Policy Issues'' part of the preamble, 
the Department has agreed to permit C/TPAs to act as intermediaries in 
transmitting results from MROs to employers. However, we believe that 
this situation is quite different from allowing C/TPAs to act as an 
intermediary in transmitting laboratory results to the MRO.
    A number of commenters supported allowing the electronic 
transmission of result reports, especially negatives. Paragraph (b) of 
this section does permit considerable use of electronic methods. Beyond 
that, the Department will consider additional use of electronic methods 
through the advisory committee process discussed in the ``Primary 
Policy Issues'' portion of the preamble.

[[Page 79492]]

    The NPRM mentioned transmitting negative results within 72 hours. 
Some commenters thought this period should be shortened to 24 or 48 
hours, while one laboratory thought it would be too burdensome to use 
couriers on weekends to meet this goal. The final rule says that 
results should be transmitted to the MRO on the same day or business 
day after review by the certifying scientist is complete. Besides 
taking care of any weekend worries, this provision, in tandem with the 
use of electronic methods permitted under the rule, should result in 
expeditious transmission of results.

Section 40.99  How Long Does the Laboratory Retain Specimens After 
Testing?

    We have simplified this section. Specimens which were positive, 
adulterated, substituted, or invalid must be kept for one year. In 
response to requests from commenters, we have provided that the 
laboratory must keep the specimens longer only if they receive a 
request from an employer, employee, MRO, C/TPA, or DOT agency 
representative. Absent such a request, the laboratory may discard the 
specimen. This rule applies to primary and split specimens alike. With 
respect to negative tests and specimens rejected for testing (e.g., 
because of a fatal or uncorrected flaw), the laboratory should follow 
HHS guidance. We do not believe it is necessary to restate the guidance 
here.

Section 40.101  What Relationship May a Laboratory Have With an MRO?

    This section focuses on potential conflicts of interest between 
MROs and laboratories. We discussed comments on this issue and the 
Department's responses in the ``Principal Policy Issues'' portion of 
the preamble.

Section 40.103  What Are the Requirements for Submitting Blind 
Specimens to a Laboratory?

    The NPRM proposed to reduce the number of blind specimens employers 
and other program participants were required to send to laboratories. 
We made this proposal because it would reduce costs and burdens and 
because the laboratory testing program appears to be running very 
smoothly. Comments were divided on this issue. A majority of 
commenters, especially from employers and their groups, supported the 
proposal. Some said they had never heard of a laboratory error. Others 
said that blind specimen testing had outlived its usefulness and should 
be eliminated. On the other hand, a number of commenters said that to 
reduce the number of blind specimens would endanger the accuracy and 
integrity of the laboratory testing program.
    We also received a number of comments saying that if we make 
validity testing mandatory, adulterated and substituted samples should 
also be included in the blind testing program. Some commenters 
expressed concern about being able to find adulterated blind specimens. 
A few comments from TPAs suggested that they should not have to send in 
blind specimens, even when they submitted more than 2000 specimens in 
the aggregate, because doing so should remain the individual employer's 
responsibility.
    The Department believes the NPRM proposed a good balance between 
considerations of reducing burdens and maintaining an effective check 
on laboratory performance. We have had few if any laboratory accuracy 
problems over the history of the program, and we believe that we can 
continue to ensure that this pattern continues while reducing burdens 
and costs on participants. We agree that adulterated and substituted 
specimens should be made part of the blind specimen testing program, 
and we have consequently changed the proportions of specimens in the 
program to be 75 percent negative, 15 percent positive, and 10 percent 
adulterated or substituted. This is particularly important given the 
recent problems at some laboratories concerning validity testing. Given 
that this provision will not take effect until next August, we think 
that producers will have time to market adulterated and substituted 
blind specimens.
    We believe that any organization that transmits to laboratories the 
requisite number of specimens in the aggregate should be responsible 
for participating in the blind testing program. This is true no matter 
whether the organization is an employer, a C/TPA, or some other service 
agent. The structure of the organization is irrelevant for this 
purpose. To decide otherwise would permit large gaps in the blind 
testing program. If 100 employers with 20 employees each are served by 
a C/TPA, and the C/TPA does not submit blind specimens, then no one 
will submit such specimens with respect to these employees, since each 
of the employers is too small on its own to be required to participate. 
Permitting this gap to exist would be disadvantageous from the program 
integrity standpoint.
    We would also point out that C/TPAs, in virtually every other area 
of program administration, assert that they can perform a multitude of 
functions for everyone involved in the program. We do not see any 
compelling reason for looking differently at their involvement in blind 
specimen testing.

Section 40.105  What Happens if the Laboratory Reports a Result 
Different From That Expected for a Blind Specimen?

    Some commenters objected to the proposed requirement for 
notification of DOT in the event of a laboratory error, or to the idea 
that ODAPC could direct laboratories to take corrective action. The 
main argument of these comments was that HHS had what they viewed as 
exclusive jurisdiction over testing matters, on which DOT should not 
infringe. We have refocused the section on unexpected blind specimen 
results.
    The Department would always coordinate closely with HHS on matters 
affecting laboratories, as indeed we have done in drafting this 
provision. The fact remains that many MROs and other participants in 
the DOT program have their primary Federal agency relationship with DOT 
agencies, and it makes sense to have them report problems to DOT. It is 
also important to realize that testing laboratories, while certified by 
HHS, receive significantly more specimens as a result of the DOT 
program than as a result of the Federal employee testing program. Under 
these circumstances, a DOT role in noting and helping to correct any 
laboratory-related problems affecting the DOT program seems most 
appropriate.
    Because we are requiring blind specimens in connection with 
validity testing, this section necessarily covers errors in validity 
testing.

Section 40.107  Who May Inspect Laboratories?

    In response to comments, we are clarifying that the employers who 
may inspect laboratories are those who use or are negotiating to use 
its services for DOT-regulated testing.

Section 40.109  What Documentation Must the Laboratory Keep, and for 
How Long?

    The Department has simplified this section and acted to reduce 
paperwork burdens, as a number of commenters recommended. All records 
supporting test results and those cited in Sec. 40.111 must be kept for 
two years, unless an MRO, employer, employee, or DOT agency 
representatives requests an extension within the two-year period (e.g., 
for litigation purposes). If no such request is received, the 
laboratory may discard the records.

[[Page 79493]]

Section 40.111  When and How Must a Laboratory Disclose Statistical 
Summaries and Other Information It Maintains?

    The NPRM proposed to reduce paperwork burdens by reducing the 
reporting frequency for this information from quarterly to semi-
annually. A number of comments supported this reduction. Other 
commenters favored eliminating the requirement altogether, or at least 
for small employers, on burden and cost reduction grounds. We believe 
that cutting the reporting burden in half is a sufficient burden 
reduction on this item and that even small employers will find 
summarized information on their workforce's participation useful. We 
underline the fact that the smallest employers, laboratories and C/TPAs 
will not experience the burden of sending ``non-reports,'' since there 
is no requirement to send a letter saying there is nothing to report 
unless specifically requested as part of a DOT audit. This will further 
reduce the paperwork burden of the rule.

Section 40.113  Where Is Other Information Concerning Laboratories 
Found in This Regulation?

    This is a cross-reference section to inform readers where they may 
find other material relevant to laboratories' participation in the 
program.

Subpart G--Medical Review Officers and the Verification Process

Section 40.121  Who Is Qualified To Act as an MRO?

    The Department believes that MROs play a key role in maintaining a 
fair and accurate drug testing program. Ensuring that MROs are in the 
best possible position to play this role requires, in our view, that 
they be well trained both in the substance of drug testing issues and 
the rules they are called on to apply. For these reasons, the NPRM 
proposed that MROs participate in a training course every two years or, 
in the alternative, self-certify that they have reviewed and understand 
these rules.
    Commenters raised a number of issues. First, some commenters said 
that groups of health professionals other than physicians, like 
chiropractors, nurse practitioners, and physicians' assistants, should 
be able to be MROs. They perform other functions like physicians (e.g., 
DOT physical examinations for commercial drivers) and are qualified to 
perform this one, commenters asserted. The Department does not agree 
with this assertion. That other health professionals have some training 
similar to that of physicians is undeniable, but the Department 
believes that the variety and depth of expertise needed to carry out 
MRO responsibilities effectively is unlikely to be found in other 
health professionals. There are clearly differences in the level of 
training needed to qualify for the various health professions, and we 
believe that only those professionals with the highest level of 
training should play this key role. Being qualified to perform routine 
physical examinations, for example, is not necessarily the same thing 
as being able to make capably the difficult judgment calls that MROs 
are called upon to make.
    Second, many commenters disagreed with the proposal to allow self-
certification of training. More formal training, including a 
certification program, was necessary, commenters said. Commenters 
pointed to three existing MRO training and certification programs as 
models for what the Department should require. These have a five-year 
retraining cycle, and a number of commenters thought that five years, 
as opposed to two, was sensible. On the other hand, a smaller number of 
commenters opposed additional training requirements for MROs, saying it 
would drive up the cost and difficulty of being an MRO, and hence 
reduce the supply of MROs available to employers.
    The Department is modifying this section in response to these 
comments. We are persuaded that MROs, given their critical role, should 
not only have the highest professional credentials to begin with, but 
also receive formal training in the rules and decision process of their 
critical role in this program. Therefore, we are dropping the self-
certification proposal of the NPRM. We will require MROs to take a 
formal training course, like one of the three national programs 
currently being offered. We will also require an examination 
administered by a nationally-recognized MRO professional certification 
board. We are not requiring ``certification'' of MROs, as such, 
however. While people who take the MRO courses typically get a 
``certificate'' from the program, DOT is not certifying doctors in a 
way analogous to the way that the FAA certificates pilots. We believe 
that certification by professional organizations is beneficial, but we 
believe that there are sufficient market incentives for certification 
that we do not need to require it in this rule. Finally, we are adding 
a continuing education requirement to ensure that MROs keep up with 
changes and developments in the field and the DOT program.
    The final rule establishes a phase-in period for this training 
requirement. For example, if a doctor is currently acting as an MRO, 
but has not yet had a formal training course, the doctor would have 
until January 2003 to meet the requirement. This should prevent any 
difficulty caused by lack of training sites or dates convenient for a 
particular physician.
    Costs for existing MRO training courses tend to average around 
$750, including the examination, and the courses take a weekend. This 
low cost and time commitment suggest that this training requirement 
should not dry up the supply of MROs.
    Like other participants, MROs would have to maintain their own 
documentation of training and qualification, which they must provide on 
request to representatives of the Department and employers and service 
agents who are using or negotiating to use their services.
    One issue about which the Department inquired in the preamble to 
the NPRM concerned issues of MRO work that goes across state lines. 
Commenters expressed the concern that some state medical regulatory 
organizations may attempt to assert that only doctors licensed in a 
particular state could perform MRO services with respect to employees 
located in that state. The Department shares these commenters' concern. 
This is a national program, and MROs often perform their duties for 
employees located in many states. Consequently, this section 
specifically provides that a physician licensed to practice in any 
jurisdiction (e.g., a state or province of the United States, Canada or 
Mexico, consistent with NAFTA requirements) and meeting other MRO 
requirements is authorized to act as an MRO with respect to employees 
located in any jurisdiction. We would regard any attempt by a state 
medical regulatory organization to limit the geographic scope of an 
MRO's work as pre-empted under the pre-emption provisions of DOT agency 
rules.

Section 40.123  What Are the MRO's Responsibilities in the DOT Drug 
Testing Program?

    There were a few comments on this section. One commenter liked, and 
another disliked, referring to the MRO as a gatekeeper for the accuracy 
and integrity of the process. Another suggested that the MRO should be 
an advocate for the accuracy and integrity of the process. We have kept 
the gatekeeper term and added the idea of being a program advocate. As 
other commenters agreed, independence and

[[Page 79494]]

impartiality are essential to the MRO's role.
    One commenter thought that the NPRM assumed, incorrectly, that MROs 
were solo practitioners. This commenter pointed out that there are MRO 
organizations with multiple MROs who perform drug testing program 
functions. We are very aware of this phenomenon, which is not 
surprising given the emphasis on group practice in today's health care 
industry. Nevertheless, each MRO retains individual responsibility for 
his or her actions. Groups don't verify test results; individual 
doctors do. It is the individual doctor who must make a decision and 
sign off on the result.
    One employer organization was concerned that the NPRM placed in the 
hands of MROs tasks that, in its view, properly belong to the employer, 
like providing feedback to collection sites and laboratories on 
performance issues. We have added ``employers'' to the list of persons 
with whom it is appropriate for MROs to communicate. At the same time, 
however, we do not believe that it is consistent with the independence 
and impartiality of the MRO for employers to limit the contact of MROs 
with other parties.
    In particular, we believe that no other party may legitimately 
attempt to interfere with the opportunity of an MRO to communicate with 
DOT agency representatives about drug testing program matters. For this 
reason, we have added language specifically prohibiting anyone from 
interfering with an MRO's access to DOT personnel or retaliating 
against an MRO for communicating with the Department.
    We became convinced of the necessity of this provision, in part, 
because of an instance in which an MRO raised an issue about a decision 
of a major transportation employer, who had in turn been given 
questionable advice by a service agent. The MRO brought the matter to 
the Department's attention. The Department wrote a letter to the 
employer correcting its understanding of the issue in question. The 
employer responded by directing the MRO not to communicate with DOT and 
subsequently terminated the MRO's services. The Department wants to put 
all parties on notice that conduct of this kind is not permitted by the 
new regulation and in future will subject violators to enforcement 
action by DOT agencies, in the case of employers, or PIE proceedings, 
in the case of service agents.
    As a number of commenters noted, since MROs will be involved in 
reviewing validity testing results, they will need to be prepared for 
the verification process in adulteration and substitution situations. 
This section now refers to this facet of the MRO's duties.
    In addition, the rule does not deem MROs, in working with employees 
under this program, to have established a doctor-patient relationship 
with them. Doctors are not diagnosing or treating employees they 
encounter in their role as MROs; they are using their medical expertise 
to make decisions in the context of a forensic program. In the 
Department's view, drug and alcohol tests are not properly viewed as 
medical examinations or procedures, notwithstanding the involvement of 
medically-trained personnel in their administration.

Section 40.125  What Relationship May an MRO Have With a Laboratory?

    This section is the reciprocal of Sec. 40.101, prohibiting improper 
MRO-laboratory relationships. It refers to the same improper 
relationships listed in Sec. 40.101 and directs MROs to sign a 
statement that they have no conflicts of interest or other improper 
relationships with laboratories.
    Commenters generally concurred with this provision, agreeing with 
the need to keep MRO and laboratory functions separate. One commenter 
said that MROs should be able to provide a list of laboratories to 
customers and laboratories should be able to refer customers to MRO 
certifying organizations. We do not endorse this practice, though the 
names of HHS-certified laboratories and groups that train MROs are 
matters of public record that no one can be forbidden from sharing. 
Another commenter asked how the provisions of this section would be 
enforced. The answer is through the PIE process. Another commenter 
asked that we specifically prohibit having MROs or MRO staff within a 
lab facility. The list of prohibited relationships in Sec. 40.101 
includes this item.

Section 40.127  What are the MRO's Functions in Reviewing Negative Test 
Results?

    Commenters raised two main issues concerning this section. While 
some commenters, mindful of the necessary role of the MRO in quality 
control for the testing process, supported MRO review of negative test 
results, most of those commenting said that the review requirements 
were too burdensome. It was not necessary for MROs to review 10 percent 
of negative results, they said, and this would raise costs that would 
be passed on to employers. These commenters appeared to view the 
processing of negative results as a simple administrative task that 
could safely be delegated to staff. If MROs were to review negative 
results at all, these commenters suggested, the amount of review should 
be reduced (e.g., to five percent or a numerical maximum).
    Reviewing negative test result records is an administrative task, 
to be sure, and we anticipate that MRO staffs will do most of the work 
involved. But quality control is an important function for which MROs 
themselves must remain responsible. In response to comments, we will 
reduce the number of reviews by MROs to five percent of results, 
including all that have required some corrective action (e.g., to fix a 
correctable flaw), to a maximum of 500 results per calendar quarter. 
This will reduce the potential burden on MROs, while retaining their 
oversight responsibility.
    The second major issue was the proposed language that required 
review of negative results to be done by staff under the direct 
personal supervision of MROs. Some commenters objected to this 
language, believing it meant that MROs would have to be co-located with 
all staff and provide face-to-face supervision. This would be contrary 
to common working arrangements of service agents, they said.
    The Department does not intend, through use of this language, to 
mandate that MROs must share the same physical space with all their 
staff members at all times. As commenters noted, direct personal 
supervision need not be physically face-to-face on an all-day, every 
day basis. Supervision can also take place through using a variety of 
electronic communications. However, the direct personal supervision 
must be meaningful. It involves personal oversight of staff members' 
work; personal involvement in evaluation, hiring, and firing; line 
authority over the staff for decisions, direction and control; and 
regular contact and oversight concerning drug testing program matters. 
It also means that the MRO's supervision and control of the staff 
members cannot be superseded by or delegated to anyone else with 
respect to test result review and other functions staff members perform 
for the MRO. In addition, CCFs may not contain fictitious addresses for 
MROs, and MROs must be personally involved with the review process when 
a confirmed positive, adulterated, or substituted result is received.
    There were also some comments advocating the use of electronic 
means of transmitting negative results from MROs to employers. We 
agree, and provide for this in Sec. 40.163. A number

[[Page 79495]]

of comments to this section also touted transmission of negative 
results to employers via C/TPAs, which we permit in Sec. 40.165 and 
Appendix F. Some commenters also supported eliminating a requirement 
that the MRO have any copies of the CCF before verifying a negative 
result. We do not believe it is advisable to make this change, because 
it is important that the MRO have the MRO copy of the CCF. This allows 
the MRO to double-check the accuracy of a result to ensure, for 
example, that an employer does not allow someone to begin work in a 
safety-sensitive position on the basis of a mistaken or misidentified 
negative result on a pre-employment test. Instead, we have tightened 
the requirements for appropriate copies of the CCF to reach the MRO in 
a more timely fashion.

Section 40.129  What are the MRO's Functions in Reviewing Laboratory 
Confirmed Positive, Adulterated, Substituted, or Invalid Drug Test 
Results?

    Virtually all the comment in this section concerned its references 
to the stand-down issue. The comments on this section were essentially 
the same with respect to proposed Sec. 40.159, and we discussed this 
issue in the ``Principal Policy Issues'' portion of the preamble. Since 
we decided to allow employers to ask for a waiver to have a stand-down 
policy, this section now tells MROs either to inform the DER that there 
is a confirmed laboratory adulterated, substituted, invalid or positive 
test result (if the employer has a stand-down waiver in place) or to 
avoid telling the employer about such a result, pending verification 
(if there is no such waiver in place). Since MRO review will now apply 
to adulterated and substituted results as well as invalid and positive 
results, this section and all those that follow reference all four 
kinds of results.

Section 40.131  How Does the MRO or DER Notify an Employee of the 
Verification Process After a Confirmed Positive, Adulterated, 
Substituted, or Invalid Test Result?

    Most of the discussion of this section concerned the proposed 
requirement, based on the Department's current rules and guidance, that 
MRO staff may make initial contacts with employees but not gather 
medical information or information pertaining to a legitimate medical 
explanation. A number of commenters said that staff, especially 
medically trained staff like physicians' assistants and nurses, should 
be able to perform these functions. This happens in the normal course 
of doctors' office and clinic work, they said, and would make the 
process less costly and more efficient. Other commenters thought the 
proposal was important for protecting employees' rights in the system.
    The Department believes that this situation is distinguishable from 
the day-to-day operation of a doctor's office. We are talking here 
about a key function in protecting the constitutional rights and 
livelihoods of employees, a function that has no parallel in daily 
clinical work. Our experience is that, if employees talk to staff about 
substantive matters, they sometimes think they have talked to the MRO 
and need not have further contact with the MRO. They therefore do not 
take full advantage of the protections the rule makes available for 
them. We also are concerned that clinic staff may not have the 
background to talk effectively with employees about legitimate medical 
explanations for confirmed positive, adulterated, substituted, or 
invalid test results. Staff can still play a useful role by advising 
employees to gather all prescriptions and other information together so 
as to be prepared to have a productive discussion with the MRO, as well 
as by scheduling the discussion with the MRO.
    We agree with commenters who pointed out that discussions with the 
MRO need not be in person. Most MRO operations use telephone contacts, 
and we have no objection to continuing that practice. We also agree 
with a commenter that, in instances where the MRO has been unable to 
contact the employee, MRO staff can contact the DER to take the next 
steps in the process.
    The NPRM proposed that the MRO make at least two attempts to 
contact the employee over a 24-hour period. There was disagreement 
about this point. Some union and other commenters thought the period 
was too brief, while some employer and other commenters thought it was 
too long. We believe 24 hours is a reasonable middle ground that will 
provide a fair chance to contact the employee to exercise an important 
right while not allowing a situation to drag on interminably.
    However, we have increased the minimum number of attempts to three, 
in order to provide a greater chance for attempts to contact the 
employee to be successful. These attempts need to be separated in time. 
It would be useless to call the employee, get no answer, and call back 
five minutes later to get no answer again. The attempts must be spread 
reasonably over the 24-hour period involved. There may also be 
circumstances in which the employee has provided incorrect phone 
numbers. If both phone numbers are ``bad numbers'' (disconnected, 
employee not known at that number), the MRO need not wait 24 hours to 
take the next actions the rules call for, since it would be futile to 
do so.

Section 40.133  Under What Circumstances May the MRO Verify a Test as 
Positive, or as a Refusal To Test Because of Adulteration or 
Substitution, Without Interviewing the Employee?

    Commenters on this section were mainly concerned about time frames. 
While there was relatively little disagreement with the idea that the 
MRO could verify a test after 72 hours had passed from an MRO or DER 
contact with an employee (one commenter suggested 48), many commenters 
said that 14 days was too long a time for the MRO to wait before 
verifying a test when no one was able to contact the employee. A number 
of these comments suggested 5 or 7 days.
    The Department will respond to these comments by shortening the 
time period to 10 days. We do not believe it is necessary to shorten 
the period further. Obviously, if the MRO or DER cannot contact the 
employee in that amount of time, either the employee is not performing 
safety-sensitive functions (e.g., is away on vacation without a 
forwarding phone number) or is as unreachable to be pulled off safety-
sensitive duties as he or she is with respect to talking to the MRO. 
There is no additional safety risk in either case.

Section 40.135  What Does the MRO Tell the Employee at the Beginning of 
the Verification Interview?

    Commenters generally supported this provision, which tells MROs to 
inform employees about the verification process, what will be expected 
of the employee, and about what information can later be made available 
to employers and others. One commenter requested that MROs make 
explicit what specific medications might be reported to employers. This 
is potentially a very comprehensive list, and we do not believe that 
this suggestion is practical.

Section 40.137  On What Basis Does the MRO Verify Test Results 
Involving Marijuana, Cocaine, Amphetamines, and PCP?

    One of the important provisions of this section, which the final 
rule makes explicit, is that employees bear the burden of proof that 
there is a legitimate medical explanation for the presence of these 
drugs in their specimens. One commenter asked that we not ``shift'' the 
burden of proof to the employee. There

[[Page 79496]]

is no ``shift.'' The employee has always had this responsibility.
    Consistent with similar provisions in the validity testing context, 
we are requiring employees to present their explanation and supporting 
evidence at the time of the verification interview. The MRO's staff 
will already have told the employee to gather prescription and other 
relevant information for this purpose. This should help to expedite the 
verification process. However, if the employee persuades the MRO that 
there is a reasonable basis to believe that the employee can produce 
additional relevant evidence, the MRO can grant up to five additional 
days to produce the evidence. This is not mandatory: The MRO should 
grant more time only if it appears that there is a good reason to do 
so.
    We agree with one comment that pointed out that there are no 
legitimate medical explanations for the use of PCP. This is also true 
of 6AM, a heroin-specific substance found in some opiate specimens. 
Section 40.151 now tells MROs not to accept any medical explanations 
for these substances.
    The NPRM mentioned that an MRO could consider the employee's use of 
legally obtained foreign medication. One commenter objected to this 
provision. We believe it is appropriate to consider the fact that an 
employee obtained medication legally in a foreign country, when 
medically appropriate, even if that medication is not legally available 
in the U.S. To do otherwise could penalize legal, innocent conduct. We 
have adopted, as part of the rule text, the principles underlying the 
Department's existing guidance on the foreign medications issue.
    We intend that, under this provision, MROs have broad discretion to 
determine whether the use of medications legally obtained within a 
foreign country should be viewed as a legitimate medical. In doing so, 
MROs must exercise their best professional judgment. MROs are neither 
required to find a legitimate medical explanation in any particular 
case nor prohibited from doing so (except to the extent that one of the 
principles set forth in this section requires the MRO to find that 
there was not a legitimate medical explanation). One of the reasons for 
the prominent position given MROs in the DOT drug testing program is 
precisely that we believe trained MROs are the best-equipped persons in 
the program to make these difficult medical judgment calls. We are 
confident that MROs will be thoughtful in considering the issues.
    The rule articulates three principles for MROs use in exercising 
their discretion. First, there can be a legitimate medical explanation 
only with respect to a medication that is legally obtained in a foreign 
country. Second there can be a legitimate medical explanation only with 
respect to a substance that has a legitimate medical use. Even if one 
obtains a substance abroad legally, it cannot form the basis of a 
legitimate medical explanation if it does not have a legitimate medical 
use. For example, drugs of abuse like heroin, marijuana, and PCP have 
no legitimate medical uses, and they cannot form the basis of a 
legitimate medical explanation in any case. Likewise, use of substance 
which--if obtained in the United States--would not form the basis of a 
legitimate medical explanation (e.g., hemp products, coca leaf teas) 
cannot form the basis of a legitimate medical explanation when obtained 
abroad.
    Third, a foreign medication can form the basis of a legitimate 
medical explanation only if it is used consistently with its proper and 
intended medical purpose. When someone uses a medication, the person 
has an obligation to use the substance for its appropriate purpose and 
in keeping with medical instructions for its use. In addressing this 
issue, the MRO should look at a number of factors. Did the employee 
have a genuine medical need for using the substance (e.g., an acute 
condition that arose while the employee was in the foreign country)? 
Did the employee use the medication for an appropriate medical purpose 
(e.g., as opposed to using a medication intended for one purpose for a 
different, and inappropriate, purpose)? Is the quantity of the 
substance in the individual's specimen consistent with its proper 
medical use?
    In applying these principles, it is very important for the employee 
to provide the MRO with adequate documentation. Travel documentation 
(visa, passport stamps, airline tickets, etc.) can help to check an 
employee's assertion that he or she was in the foreign country in 
question at the time he or she said the medication was obtained and/or 
consumed. Especially where a prescription drug is involved, discussions 
with a foreign physician or pharmacist are relevant to confirming the 
prescription for the foreign medication and the reason for it. It is 
important to note that, in some cases, drugs may be prescribed for 
purposes in foreign countries different from the purposes for which the 
medications are prescribed in the U.S. In the case of any foreign 
medication, the MRO should review documentation of purchase. 
Ultimately, it is the employee's burden to produce this information, 
though the MRO may need to be involved in some aspects of the effort, 
such as discussing medications with a foreign doctor.
    In assessing situations in which an employee obtains a medication 
abroad and consumes it after returning to the U.S., the MRO should take 
special care to ensure that the employee is using the medication for 
its intended, appropriate medical purpose. Import and use of some 
medications in the U.S. may be inconsistent with U.S. drug laws or 
Customs rules. This heightens the concern that an employee who is using 
such a medication in the U.S. may not be doing so consistent with its 
appropriate, intended medical purpose. In particular, routine or 
frequent use of such a medication in the U.S., as distinct from a one-
time or infrequent, inadvertent, or emergency use of the medication, 
may support an inference that an individual is not using the medication 
for its intended, appropriate medical purpose. If an employee should 
have consulted with a U.S. physician before using a foreign medication 
in the U.S., it can be relevant for the MRO to ask whether such a 
consultation took place. As a general matter, we view the U.S. use of 
foreign medication as more problematic than the use of the medication 
abroad, and we advise MROs to be more conservative in their 
determinations where U.S. use is involved.
    As in cases involving drugs obtained domestically, verification of 
a test as negative does not end the MRO's job. If use of a substance, 
even though not a violation of DOT agency drug and alcohol testing 
rules, creates safety or fitness-for-duty problems, MROs have a mandate 
to report this information to employers (see Sec. 40.327). An employee 
may be medically unfit for safety-sensitive duties because of the use 
of a legal medication, foreign or domestic.

Section 40.139  On What Basis Does the MRO Verify Test Results 
Involving Opiates?

    Most of the discussion on this section concerned the use of the 
15,000 ng/mL level of opiates in a specimen for shifting the burden of 
proof from the MRO (who in most opiate cases must show clinical 
evidence of unauthorized use) to the employee to show a legitimate 
medical explanation, as is the case in Sec. 40.137 for other drugs. As 
noted in the preamble to the NPRM (see 64 FR 60980; December 9, 1999), 
the Department has good reason to believe that this is an appropriate 
level (i.e., one high enough to avoid imposing an unfair burden on 
people who eat poppy seeds or otherwise engage in legal

[[Page 79497]]

activities for which there are not legitimate medical explanations).
    Some commenters appeared confused about the relationship of this 
threshold to the 2000 ng/mL cutoff for a confirmed positive test 
result. The two are different, and they are used for different 
purposes. The latter establishes a confirmed positive test; the former 
establishes that the employee, rather than the MRO, has the burden of 
proof in the verification process. In one Canadian commenter's example, 
codeine medications are legally available in Canada, and might produce 
test levels in excess of 15,000 ng/mL. In such a case, the employee 
would have the burden of proof with respect to a legitimate medical 
explanation, which the employee could meet through showing that he or 
she had used a legal over-the-counter medication.
    When an employee cannot establish a legitimate medical explanation 
for opiate levels (morphine or codeine) above the 15,000 ng/mL, then 
the MRO would verify the test positive. There would be no need for the 
MRO to find clinical evidence of unauthorized use.
    A commenter suggested, and we agree, that the MRO or other 
physician's encounter with an employee to determine if there is 
clinical evidence of unauthorized opiate use is better styled an 
``examination'' than an ``interview,'' and we have changed the language 
accordingly.
    The Department notes that a situation could arise in which the 
primary specimen is positive for opiates and 6-AM. The MRO verifies the 
test as positive, without determining whether there is a legitimate 
medical explanation or clinical signs of unauthorized use, since these 
steps are not necessary when a specimen is positive for 6-AM. The split 
specimen reconfirms the presence of opiates but not the presence of 6-
AM.
    In this case, the test would not be cancelled. Rather, the MRO 
would take additional verification steps. If the amount of morphine or 
codeine in the primary specimen were 15,000 ng/mL or more, the MRO 
would ask the employee to provide information on any legitimate medical 
explanation there might be for the presence of the opiates in the 
specimen. If the amount of morphine or coedine were less than 15,000 
ng/mL, the MRO would examine the employee for clinical signs of 
unauthorized use or refer him or her to another physician for this 
purpose. The MRO would then make a decision about whether to verify the 
result as positive. The MRO would make this decision without reference 
to 6-AM, since the specimen had failed to reconfirm for 6-AM.

Section 40.141  How Does the MRO Obtain Information for the 
Verification Decision?

    There were few comments to this section. One that we adopted 
suggested that in addition to reviewing evidence on its face, the MRO 
should take all reasonable and necessary steps to verify the 
authenticity of the evidence. We have deleted a provision authorizing 
the MRO to tell the laboratory to conduct a reanalysis of the primary 
specimen. Because this rule no longer provides for single specimen 
collections, we believe that this language is superfluous. Reanalysis 
of the primary specimen is no longer authorized.

Section 40.145  On What Basis Does the MRO Verify Test Results 
Involving Adulteration or Substitution?

    This section adds MRO review provisions concerning the results of 
validity tests. The basic policy issue of MRO review for validity 
testing was discussed in the ``Principal Policy Issues'' section of the 
preamble, which also describes the provisions of these sections. As 
noted above, MRO review of validity testing results will begin 30 days 
after the publication of this rule.
    One point we want to emphasize is that it is not enough for an 
employee to come up with a reason that allegedly accounts for the 
result (e.g., a medical condition, personal characteristics, proximity 
to a chemical). To meet his or her burden of proof, the employee must 
demonstrate a link between the alleged reason and the ability to 
physiologically produce the laboratory result obtained. For example, if 
an employee shows he has medical condition X, then he must also show a 
medical/scientific basis for getting from X to a creatinine result 
below 5 and a specific gravity below 1.001. If the employee shows he 
had topical exposure to chemical Z, he must also demonstrate medical/
scientific evidence that topical exposure to Z in the concentration he 
experienced leads to the physiological production of the levels of Z in 
his specimen that the laboratory found. Any such evidence must meet 
medical/scientific criteria for controls, methodology etc., in order to 
have credibility.
    In any case in which the MRO cancels an adulterated or substituted 
test result because the employee has established a legitimate medical 
explanation, the MRO must make a written report to ODAPC. The purpose 
of this report is to permit ODAPC and HHS to examine the circumstances. 
This examination could lead to additional guidance to MROs or 
laboratories concerning the matters that led to the cancellation. ODAPC 
would not, in such a case, act as a ``court of appeals'' that would 
overturn the results of the MRO review process.
    Under the final rule, the MRO reviewing an adulterated or 
substituted test result could direct the employee to obtain, within 5 
days, a further medical evaluation from someone with expertise in the 
medical issues raised by the employee's explanation. This individual 
could be a specialist in a particular field of practice, but need not 
be. What is important is that the referral physician have enough 
expertise to deal effectively with the particular issues in the case.
    The Department is aware that, in some cases, it may be difficult 
for an employee to secure, on his or her own, an appointment for this 
evaluation in a short period of time. Consequently, the Department does 
not regard it as a refusal to test if the employee is unable, after 
making good faith efforts, to get the appointment within the 5-day 
period. However, the MRO and the employer should do everything feasible 
to assist the employee in finding and getting an appointment with an 
appropriate physician.

Section 40.149  May the MRO Change a Verified Positive Drug Test Result 
or Refusal To Test?

    This provision is based on proposed Sec. 40.161. There were 
relatively few comments. A small number of commenters suggested that 
the employer should be able to change an MRO's action the employer 
believed to be erroneous, perhaps by referring the matter to another 
MRO for a second opinion. We do not believe that it would be advisable 
to authorize this sort of forum shopping. Under the new regulation, 
MROs will be even better trained in their duties. It would erode the 
finality of MRO's decisions and the protections the MRO system affords 
to employees to allow employers a second bite at the apple.
    Some commenters also believed the 60-day period during which an MRO 
could reverse a decision he or she had made was too long. One commenter 
thought that 14 days was a more reasonable time period. The point of 
this provision is to allow employees to present evidence that was not 
originally available. There need be no rush to foreclose this 
opportunity, which has no adverse safety implications, since the MRO 
will have already communicated the verification decision to the 
employer, who will have removed the employee from safety-sensitive 
duties. We will leave this provision unchanged, except to add a 
reference to adulteration and substitution cases.

[[Page 79498]]

    Here is a hypothetical case illustrating how the provision would 
work, in concert with the five-day extension provision of the 
Secs. 40.137 and 40.145. The MRO interviews the employee, who says she 
has a legitimate medical explanation. She asks for, and receives, a 3-
day extension to find evidence of the explanation, but is unable to do 
so. The MRO verifies the test as a refusal because of adulteration or 
substitution. The MRO reports the verified refusal result to the 
employer, who removes the employee from safety-sensitive duties.
    Six weeks later, she returns to the MRO with additional data, 
including a study performed by the referral physician, acceptable to 
the MRO, who she has retained. The study, performed under carefully 
controlled conditions, shows that the employee was able to replicate 
the laboratory result through physiological means. The MRO determines 
that this is a legitimate medical explanation and, after discussing the 
matter with ODAPC, reverses the original verification result. At this 
point, the employee no longer has an obligation to complete the return-
to-duty process before working again in a safety-sensitive position.

Section 40.151  What Are MROs Prohibited From Doing as Part of the 
Verification Process?

    This section is based on Sec. 40.143 of the NPRM. There was little 
comment. A few comments recommended that MROs should be able to 
consider evidence extrinsic to the testing process, such as procedural 
errors not reflected on the CCF, tests of additional specimens (e.g., a 
hair test), or use of ``medical marijuana'' in a state with a law 
authorizing such use. The Department is not adopting these suggestions, 
which would authorize collateral attacks on the validity of the testing 
process. This regulation prescribes the testing process; if the 
procedures in a given test meet this part's requirements, that is 
enough to make the test valid. The MRO should not go beyond the rule's 
requirements to accept other reasons to cancel a test.
    We do not believe it is appropriate to place MROs in the position 
of having to decide factual disputes between employees and collectors 
about what did or did not occur at the collection site (e.g., 
allegations that the collector left the area or left open urine 
containers where other people could access them) or about whether 
someone was properly selected for testing. Therefore, this section 
directs MROs not to become involved in issues extrinsic to the 
documents in reviewing the CCF. We do not intend, through this 
provision, to preclude MROs from taking action to cancel a test if the 
MRO determines that a fatal flaw has occurred in the testing process.
    We have, as some commenters suggested, added provisions related to 
validity testing. Certain substances cannot be produced physiologically 
in urine, and urine cannot have a zero creatinine content. Likewise, 
there is no legitimate medical explanation for PCP or 6-AM. The rule 
specifies that MROs cannot find that a legitimate medical explanation 
exists in these circumstances. Following a commenter's suggestion, we 
have also added coca leaf tea explanations to the same category of 
explanations (along with use of hemp products) that MROs may not 
accept.

Section 40.153  How Does the MRO Notify Employees of Their Right to a 
Test of the Split Specimen?

    Commenters said that if, as Sec. 40.145 of the NPRM proposed, MROs 
tell employees with verified positive, adulterated, and substituted 
tests (1) that they have a right to a test of the split specimen if 
they make a timely request, and (2) that they are not required to pay 
for the test from their own funds before the test takes place, then 
employees will frequently request tests of split specimens. This, in 
the view of a significant number of commenters, would be a bad thing: 
Few split specimens fail to reconfirm and testing them is an expensive 
annoyance that merely serves to delay the inevitable. On the other 
hand, as one commenter suggested, requiring advance payment from the 
employee's own funds would have the benefit of eliminating most split 
specimen tests, since they are most often a ploy used by a guilty 
employee in the hopes that the split is unavailable for testing or that 
the specimen will not reconfirm.
    The problem with these commenters' analysis is that a test of a 
split specimen is a right guaranteed to employees by the Omnibus 
Transportation Employee Testing Act. We agree with commenters that if 
we do not make employees aware of this right and permit employers to 
financially deter employees from exercising it, then fewer employees 
are likely to request a test of the split specimen. However, we must 
disagree with the proposition that reducing the frequency of requests 
of a test of the split specimen is an appropriate objective.
    When Congress guarantees a right to employees (and we believe we 
must treat all DOT-regulated employees in our program alike, even if 
they are not covered by the Omnibus Act), our obligation as a Federal 
agency is to faithfully execute that legislative decision. The statute 
provides a series of other protections to employees as a matter of 
right, such as the use of an HHS-certified laboratory and resort to MRO 
review for the five HHS drugs. An employer could not say that employees 
could have their specimen tested at an HHS laboratory only if they paid 
in advance a higher price to have their specimen tested there instead 
of a local hospital. Nor could an employer say that it would make MRO 
review available only if the employee paid in advance for the MRO's 
services. The same rationale applies to a test of the split specimen. 
When the statute and rule say that a certain procedure must be made 
available to an employee, then the employer is responsible for making 
it happen.
    Through collective bargaining or subsequent attempts at securing 
reimbursement, an employer may seek to have the employee ultimately pay 
part or all of the cost of a split specimen. But when the employee with 
a verified positive, adulterated, or substituted test result makes a 
timely request for a test of the split specimen, it is required that 
the test take place, and this requirement cannot be made contingent on 
advance payment by the employee. The Department will retain its NPRM 
language on this point. (This approach is consistent with the 
Department's longstanding interpretation of the current rule.)
    Another issue in the comments was how to define ``timely.'' The 
NPRM, like the present rule, says the right to a test of the split 
specimen is triggered if the employee makes the request within 72 hours 
of being notified by the MRO of a verified positive test. On request of 
a number of commenters, we are making explicit that it is the 
notification of the verified test result that starts this time period 
running. Some commenters pointed out that RSPA would have to change its 
rule (which currently permits up to 60 days for such a request) to be 
consistent with this provision. RSPA will propose such a change as part 
of its conforming amendments to this rule.
    Employers also asked whether they may take action during this 72-
hour period. In fact, employers must remove employees from safety-
sensitive duties as soon as they are notified of a verified positive, 
adulterated, or substituted test result. In addition, employers are 
free to take personnel action once they receive the verified result, 
although we believe it would be wise to avoid taking final action 
(e.g., termination) until the 72 hours are up or, where the employee 
requests a test of the split specimen, until the MRO reports the second

[[Page 79499]]

laboratory's split specimen test result to the employer. Nothing 
requires the employee to be in paid status during this period, in any 
case.
    A number of commenters noted that MROs sometimes authorize tests of 
the split specimen well after the 72-hour period has elapsed (e.g., 
weeks or months later). Nothing in the rule precludes an MRO from doing 
so. However, an employee has a right to a test of the split specimen 
only if he or she requests it within 72 hours. The employee cannot 
insist on having the split specimen tested after that time, and the 
employer is not obligated, financially or otherwise, to make the test 
happen.
    A few commenters suggested that the request for a test of the split 
specimen should be made in writing. It seems to us that a careful 
employee would make a written request, in order to have his timely 
request on the record. But we do not think it is necessary to require 
this action. Another commenter thought that the rule should not direct 
the MRO to tell employees that DNA or other tests are not authorized. 
The Department believes that this provision is beneficial as a means of 
avoiding unnecessary requests for these tests, and we have retained it.

Section 40.155  What Does the MRO Do When a Negative or Positive Test 
Result Is Also Dilute?

    This section is based on proposed Sec. 40.147 of the NPRM. There 
was little comment on this section, most of which concerned the issue 
of whether a dilute specimen should be an occasion for a recollection 
under direct observation. Such a recollection is not necessary in the 
case of a test result that is both positive and dilute. For a test that 
is both negative and dilute, we have decided (see Sec. 40.197(b)) to 
allow the employer the discretion to conduct an immediate recollection, 
but not under direct observation, since there can be many innocent 
reasons for a dilute specimen. This is a change from the existing rule, 
which permitted tests under direct observation on the next occasion 
when the individual would be tested (e.g., in the random program).

Section 40.159  What Does the MRO Do When a Drug Test Result Is 
Invalid?

    This section is based on Sec. 40.151 of the NPRM. Consistent with 
HHS guidelines, we are using the term ``invalid'' rather than 
``unsuitable for testing'' to describe such test results. There were a 
variety of comments on this section. Some commenters thought we should 
treat invalid tests as refusals to test, the same way we treat 
adulterated and substituted tests. Another commenter thought it would 
save time and effort if we simply cancelled invalid tests, with an 
unannounced recollection under direct observation, rather than going 
through the MRO inquiry process proposed in the NPRM.
    We believe that the Department chose a reasonable middle ground in 
the NPRM, and we will use this approach in the final rule. When an 
adulterant has not identified, it has not been conclusively shown that 
the employee has tampered with the specimen. Recollection under direct 
observation is an appropriate response to the suspicion of tampering 
that an invalid result raises. On the other hand, there may be medical 
reasons for an invalid result. Where these exist, it would be unfair to 
impose a directly observed collection on the employee.
    A commenter suggested that, when an employee admits to adulterating 
or substituting a specimen, the MRO get a written statement from the 
employee or make his own contemporaneous written statement of the 
employee's admission. We think that having the MRO document such 
admissions is a good idea, and we have added it to paragraph (c).

Section 40.161  What Does the MRO Do When a Drug Test Specimen Is 
Rejected for Testing?

    This section is based on Sec. 40.155 of the NPRM. Most comments 
were to the effect that it was unnecessary to have the MRO investigate 
the reason for the rejection, which commenters said was usually 
obvious. In response, we have removed this requirement and simplified 
this section. It now just recites the paperwork steps the MRO follows 
when he or she receives a rejected result.
    This section no longer calls for a recollection following a 
rejected result. There does not seem to be any strong reason for 
requiring a recollection because of what, in most cases, is an 
administrative error. Of course, in situations (e.g., pre-employment) 
where a negative test result is required, there will have to be another 
test in order to attempt to obtain the negative result.

Section 40.163  How Does the MRO Report Drug Test Results?

Section 40.165  To Whom Does the MRO Transmit Reports of Drug Test 
Results?

Section 40.167  How Are MRO Reports of Drug Results Transmitted to the 
Employer?

    These sections are all based on proposed Sec. 40.157. We split the 
proposed section into three parts to make it easier to understand. The 
greatest number of comments on the proposed section concerned the use 
of C/TPAs as intermediaries to transmit results from MROs to employers. 
We discussed this issue in the ``Principal Policy Issues'' portion of 
the preamble and incorporated our decision in Sec. 40.345. Section 
40.165 of the new rule references this decision, by saying that the MRO 
transmits results either to the DER or to a C/TPA acting as an 
intermediary. We emphasize that it is the employer's choice that 
determines whether the MRO transmits the information directly or 
permits a C/TPA to act as an intermediary.
    A number of comments concerned the electronic transmission of 
results (e.g., by fax or secure computer link). Electronic signature 
issues were also raised in this context. The Department's advisory 
committee will take up these issues in greater detail. For now, we will 
retain the NPRM language that telephone contact is the preferred means 
for transmitting non-negative results. We also note that one commenter 
appeared to misunderstand proposed Sec. 40.157(b)(3), which has become 
Sec. 40.167(c)(3) in the final rule. We do not require the MRO's verbal 
report to include all the points required in the documentation of the 
report, which must follow the verbal report. We have also decided to 
delete the information item concerning the address of the collection 
site, because we do not believe it is necessary for this report.
    Some commenters felt that the report format was too complex and 
would lead to practical difficulties. In connection with the new CCF, 
we have simplified these requirements. All reports can be made on a 
stamped (negatives) or signed (all other results) copy of Copy 2 of the 
CCF. Otherwise, the MRO must compose a letter with several information 
items for each result. We prefer that MROs use copies of Copy 2 of the 
CCF for this purpose, which will result in generating much less 
paperwork.

[[Page 79500]]

Section 40.169  Where is Other Information Concerning the Role of MROs 
Found in This Regulation?

    This is another in the series of sections providing, for readers' 
convenience, references to other sections of the regulation that 
concern, in this case, the role and activities of MROs.

Subpart H--Split Specimen Tests

Section 40.171  How Does an Employee Request a Test of a Split 
Specimen?

    There were few comments on this section. A number of commenters 
wanted to require that requests for tests of split specimens be in 
writing. One reason given for this request was that some employees, if 
the split specimen test reconfirmed, would deny asking for the test 
when the employer asked for reimbursement. We do not think it necessary 
to require these requests to be in writing, which in some instances 
could delay or burden the employee's right to have the split specimen 
retested. However, so that there is a written record of the request, 
the NPRM and this final rule direct MROs to document the date and time 
of the employee's request.

Section 40.173  Who Is Responsible for Paying for the Test of a Split 
Specimen?

    This section is related to the provision concerning payment for 
split specimen tests in Sec. 40.153, and commenters took very similar 
positions on the issues. Not surprisingly, unions and some service 
agents liked the proposal better than employers. The Department's 
rationale for incorporating this provision in the final rule is 
essentially the same as discussed under Sec. 40.153 above. Employers 
did want assurance that they could seek reimbursement from employees, 
and paragraph (c) of both the NPRM and final rule makes that point 
clear. We added an example of how employers could ensure that testing 
occurs on time (establishing accounts with laboratories, which they 
could do on their own or through a C/TPA).

Section 40.175  What Steps Does the First Laboratory Take With a Split 
Specimen?

    There were few comments concerning this section. Some commenters 
asked that tests be cancelled when a split specimen was unavailable. 
For reasons discussed above, the Department believes it is better to 
test the primary specimen in such cases. Some commenters addressed 
proposed Sec. 40.175(c), which we have deleted because it duplicated 
laboratory procedure matters in HHS guidance. Laboratories will follow 
this HHS guidance with respect to specimen retention requirements. 
Commenters asked for clarification of who gets to choose the laboratory 
that tests the split specimen. This is an issue on which the Department 
does not have a position. We are satisfied as long as the parties use 
an HHS-certified laboratory.

Section 40.177  What Does the Second Laboratory Do With the Split 
Specimen When It Is Being Tested To Reconfirm the Presence of a Drug or 
Drug Metabolite?

Section 40.179  What Does the Second Laboratory Do With the Split 
Specimen When It Is Being Tested To Reconfirm an Adulterated Test 
Result?

Section 40.181  What Does the Second Laboratory Do With the Split 
Specimen When It Is Being Tested To Reconfirm a Substituted Test 
Result?

    These sections are all based on proposed Sec. 40.177. Most of the 
comments on proposed Sec. 40.177 concerned the addition of validity 
testing to the split specimen portion of the program, discussed in 
greater detail in the ``Primary Policy Issues'' portion of the 
preamble.
    Existing HHS guidance (Program Documents 35 and 37) establish 
criteria for testing of the primary specimen for adulteration and 
substitution. These are the criteria referenced in Secs. 40.93 and 
40.95. These Program Documents do not, on their face, apply to testing 
of the split specimen. HHS is planning to incorporate split specimen 
testing criteria for adulteration in forthcoming mandatory requirements 
for validity testing. Pending completion of this formal HHS issuance, 
and because we believe it is important to begin split specimen testing 
in the validity testing program as soon as possible, the Department in 
Secs. 40.179 and 40.181 is requiring that the split specimen meet 
exactly the same criteria as the primary specimen in order to be 
considered reconfirmed. These criteria already exist in HHS guidance 
(Program Documents 35 and 37) and have a sound technical basis. When 
HHS issues its final mandatory requirements for split specimen tests in 
adulteration and substitution cases, the Department will, if necessary, 
amend these provisions to refer to the HHS issuance.

Section 40.183  What Information Do Laboratories Report to MROs 
Regarding Split Specimen Results?

    This section is based on proposed Sec. 40.181 of the NPRM. There 
were no substantive comments. We have adopted the section as proposed, 
except that we have added notations applicable to split specimen tests 
in adulteration and substitution situations. We also clarified that 
laboratories must sign and date the appropriate CCF copy.

Section 40.185  Through What Methods and to Whom Must a Laboratory 
Transmit Split Specimen Results?

    This section is based on proposed Sec. 40.179 of the NPRM. Comments 
focused on two issues: the use of electronic means of transmission and 
use of service agents as intermediaries between laboratories and MROs. 
In response to comments favoring greater use of electronic means, the 
final rule will permit results to be sent by electronic image, as well 
as other means. However, for the same reasons applicable to 
transmission of primary specimen test results, we will not permit C/
TPAs to receive split specimen results from laboratories.. Laboratories 
must promptly send split specimen results directly to MROs.

Section 40.187  What Does the MRO Do With Split Specimen Laboratory 
Results?

    This section is based on proposed Sec. 40.183 of the NPRM. Some 
commenters objected to a retest under direct observation as the 
consequence of a failure to reconfirm due to the unavailability of the 
split specimen for testing. As noted above, this situation involves 
strong evidence of a violation of the rules (e.g., a verified positive 
test), with the test being cancelled only because of a process problem 
(e.g., the split leaked away). In this situation, there is a stronger 
than usual incentive for the employee to attempt to beat the next test, 
hence the need for direct observation on the recollection.
    The Department deleted proposed Sec. 40.185, concerning retests of 
single specimen collections, since all collections under the new rule 
will be split specimen collections.

Section 40.189  Where Is Other Information Concerning Split Specimens 
Found in This Regulation?

    This is another in the series of cross-reference sections designed 
to help readers find related material.

Subpart I--Problems in Drug Tests

Section 40.191  What Is a Refusal To Take a DOT Drug Test, and What Are 
the Consequences?

    If an employee declines to take a drug test or takes a number of 
other actions that obstruct the drug testing process, the employee is 
deemed to have refused to test. For the most part, the consequences of 
a refusal are the same

[[Page 79501]]

or more severe as for any other violation of DOT agency drug and 
alcohol regulations.
    Commenters generally agreed with the list of actions in this 
section that constitute a refusal to test. One commenter wanted 
refusals on non-DOT tests to count as refusals under this part. They 
cannot, because this part does not require anyone to take a non-DOT 
test. A few comments also urged use of alternative testing 
technologies, such hair testing and on-site testing, in potential 
refusal situations. The Department will defer to HHS on alternative 
testing technology issues. HHS has not yet authorized these approaches 
to testing. We have added a specific reference to verified adulterated 
or substituted test results as a ground for determining that an 
employee has refused to test.

Section 40.193  What Happens When an Employee Does Not Provide a 
Sufficient Amount of Urine for a Drug Test?

    This is the so-called ``shy bladder'' provision of the rule. The 
proposed section would keep the core of the Department's current shy 
bladder procedures in place, and commenters did not question the 
direction of this provision. Commenters did address a number of 
specific issues concerning the section. Some commenters wanted to 
specify that the physician performing an evaluation of potential 
medical reasons for a shy bladder situation be a urologist or other 
specialist, on the theory that a non-specialist was not as well 
equipped for this function. The Department agrees, and, in parallel 
with the language concerning MRO review of adulteration and 
substitution provisions, the final rule calls for the use of a licensed 
physician with expertise in the medical issues surrounding a failure to 
provide a sufficient specimen.
    Commenters disagreed about who ought to select the physician for 
this evaluation. Some said the referral physician should be acceptable 
to the employer. Others said the referral physician should be 
acceptable to the employee. We take the view that the rule should not 
specify who makes the selection of the referral physician, but we do 
think that he or she should be acceptable to the MRO. The MRO is in a 
better position than either the employee or the employer to determine 
if a particular referral physician is appropriate to this task.
    Under the final rule, the an employee in a shy bladder situation 
would be directed to obtain within 5 days, a further medical evaluation 
from someone with expertise in the medical issues raised by the 
employee's situation. This physician could be a specialist (e.g., a 
urologist), but need not be. What is important is that the referral 
physician have sufficient expertise to deal effectively with the 
medical issues in the employee's case.
    The Department is aware that, in some cases, it may be difficult 
for an employee to secure, on his or her own, an appointment for this 
evaluation in a short period of time. Consequently, the Department does 
not regard it as a refusal to test if the employee is unable, after 
making good faith efforts, to get the appointment within the 5-day 
period. However, the MRO and the employer should do everything feasible 
to assist the employee in finding and getting an appointment with an 
appropriate referral physician.
    Commenters raised in this context the issue of whether a refusal to 
drink fluids in a shy bladder situation should constitute a refusal to 
test. We do not believe that a refusal to drink fluids should be 
considered a refusal to test, and we have incorporated this view into 
the text of this section.
    Some commenters suggested that, during the five days that may 
elapse between an employee's provision of an insufficient specimen and 
the determination of whether this constitutes a refusal to test, the 
employee should be stood down from performing safety-sensitive 
functions. We are not adopting this suggestion. Until and unless a 
refusal is determined to have occurred, there is no evidence of 
violation of the rules on which to base a temporary removal from 
performance of safety-sensitive duties (unlike the situation under a 
stand-down waiver, where there is the evidence of a confirmed positive 
test).
    A few comments questioned the three-hour waiting/fluid consumption 
period following an employee's provision of an insufficient specimen. 
One comment said blood should be drawn after two hours. Other comments 
said it made more sense to go immediately to an alternative specimen, 
such as saliva or hair. We believe that the three-hour period is by now 
well established in the DOT program, and comments did not make a 
compelling case for changing it. As noted above, we are waiting for HHS 
action before making any further decisions concerning alternative 
specimens.
    We incorporated in this section an existing DOT interpretation 
concerning psychological conditions alleged as reasons for a failure to 
provide a sufficient specimen. The meaning of this interpretation (see 
paragraph (e)) is that to be regarded as a pre-existing psychological 
disorder, it is not necessary that the condition be diagnosed before 
the time of the test, but the symptoms have to have been medically 
documented before the time of the test. For example, an individual may 
have brought urination problems to the attention of his urologist over 
a period of time, but the urologist did not enter a specific diagnosis 
of a psychological disorder into the medical records. In this 
situation, the examining physician has the discretion to determine that 
there was a pre-existing psychological condition, if the physician is 
convinced that the medically documented symptoms support such a 
diagnosis.

Section 40.195  What Happens When an Individual Is Unable To Provide a 
Sufficient Amount of Urine for a Pre-Employment or Return-to-Duty Drug 
Test Because of a Permanent or Long-Term Medical Condition?

    This section is intended to address a rare, but difficult, issue 
that may arise in these types of testing. In a pre-employment or 
return-to-duty test, an employee who is not now performing safety-
sensitive duties must have a negative test result in order to begin or 
resume performing safety-sensitive duties. In a ``shy bladder'' 
situation, if there is an adequate medical reason for the inability to 
provide a sufficient specimen, the test result is cancelled, not 
negative. If a permanent or long-term medical condition is the cause of 
the inability to provide a sufficient specimen, the employee might 
never be physically capable of obtaining a negative result. This could 
be very unfair to the employee, and it could raise Americans with 
Disabilities Act issues as well.
    Some commenters expressed the view that this provision should apply 
to other types of testing as well (e.g., random). We do not believe it 
is necessary to do so, because employees in these situations do not 
need a negative test result to perform safety-sensitive functions. A 
cancelled test is not a violation of DOT rules that compels employers 
to remove employees from safety-sensitive duties.
    In response to a comment, we added language that the MRO can 
conduct, or cause to be conducted, the further medical evaluation the 
section requires. We have also clarified that, as part of this 
evaluation, the physician may use alternative testing methods, 
including but not limited to blood testing, to help determine whether 
the employee shows clinical evidence of drug abuse. Particularly given 
that we do not apply

[[Page 79502]]

this procedure to random testing, we do not agree with a suggestion 
that an individual covered by this section should be taken out of the 
random testing pool. Doing so would also affect the probability that 
other individuals would be selected for testing. As in other situations 
calling for medical evaluations, the rule requires that the physician 
conducting the evaluation be acceptable to the MRO, rather than to the 
employer or employee.
    Under this section and Sec. 40.193, the referral physician reports 
to the MRO the basis for any conclusion that the individual has a 
permanent, long-term disability that prevents providing a sufficient 
specimen. However, for privacy reasons, neither the referral physician 
or the MRO passes on to the employer any information about the nature 
of the disability. The employer is simply told that there is a 
permanent, long-term condition.
    We have not included similar language in the rule concerning 
alcohol testing, because pre-employment alcohol testing is not 
mandatory. In the rare situation in which an employee is required to 
have a negative alcohol test in a return-to-duty or follow-up test 
situation, and could not produce sufficient breath because of a 
permanent, long-term disability, we would apply the reasoning of this 
section to that situation.

Section 40.197  What Happens When an Employer Receives a Report of a 
Dilute Specimen?

    This section is based on Secs. 40.147(a) and 40.159(d) of the NPRM. 
The NPRM, like the existing rule, would have given employers discretion 
to use direct observation the next time the employee was selected for 
testing (e.g., in random testing). Comments on this issue and the 
Department's responses are discussed under ``Collection Issues'' in the 
``Principal Policy Issues'' portion of this preamble. It should be 
noted that, unlike the existing rule and the NPRM, this provision 
authorizes a new collection immediately following a negative-dilute 
result, rather than on the next occasion when an employee is selected 
for testing. This recollection is not conducted under direct 
observation.

Section 40.199  What Problems Always Cause a Drug Test to be Cancelled?

    This section, listing ``fatal flaws'' that invariably result in the 
cancellation of a test, is based on Sec. 40.197 of the NPRM. The list 
of fatal flaws in the final rule is somewhat different from that in the 
proposed rule. Proposed paragraph (b), concerning the lack of a 
specimen ID number, is really an instance of the flaw cited in 
paragraph (a), a mismatch between the specimen ID numbers on the 
specimen bottle and the CCF. The former is included in the latter, so 
we have deleted the proposed paragraph (b). Consistent with HHS 
guidelines, we have added a new paragraph (b), concerning a situation 
in which the printed collector's name and collector's signature are 
both missing. This section's list of fatal flaws is now consistent with 
the HHS list of fatal flaws.
    A few comments suggested either that fatal flaws automatically 
cancel a test, without MRO involvement, or that the employer have the 
authority to cancel a test when a fatal flaw appears. We believe that, 
as the key ``gatekeeper'' and quality control person in the system, the 
MRO is the best party to make the actual pronouncement of a 
cancellation based on a fatal flaw. Another comment suggested that an 
error in the chain of custody documentation should result in the 
cancellation of a test. The problem here is that not all errors are 
created equal. Depending on the seriousness of an error and our ability 
to fix it, an error on the CCF can be a fatal flaw, a correctable flaw, 
or a de minimis error that does not result in cancellation.
    Finally, a commenter asked whether Bottle B may be redesignated as 
Bottle A, as the final paragraph of this section suggests. This has 
been an interpretation issue under the existing rule, but we are clear 
in this final rule that such redesignations can take place.

Section 40.201  What Problems Always Cause a Drug Test To Be Cancelled 
and May Result in a Requirement for Another Collection?

    This section is based on Sec. 40.199 of the NRPM. One commenter 
suggested treating invalid test results as refusals. As we have 
discussed above, the Department did not adopt this suggestion. There 
were no other substantive comments on this section, which we have 
adopted with some editorial changes and the addition of a paragraph 
pertaining to the failure of an adulterated or substituted result to 
reconfirm.

Section 40.203  What Problems Cause a Drug Test To Be Cancelled Unless 
They are Corrected?

    This section is based on Sec. 40.201 of the NPRM and concerns 
``correctable flaws.'' Commenters generally approved the proposed 
provision, but had varied suggestions. As in the case of fatal flaws, 
one suggestion was to allow employers to cancel tests in the case of an 
uncorrected flaw. As we said in that case, we believe that MROs are the 
best party to take all such actions in the drug testing program. Two 
commenters disagreed concerning the situation of a missing employee 
signature coupled with a lack of collector notation of the omission: 
one said it should be a fatal flaw and the other said it need not be 
even a correctable flaw. We believe that the NPRM formulation of making 
this situation a correctable flaw makes the most sense, giving due 
regard both to the need for completeness of the documentation and the 
ability to work around inadvertent administrative mistakes.
    A commenter suggested that an incorrect employee social security 
number (SSN) or other ID number (e.g., a transposition of numbers) 
should not be a fatal or correctable flaw. We agree with this comment. 
We also believe that a minor transposition error is the kind of 
irregularity that would not cause a test to be cancelled (see 
Sec. 40.209). If an ID number is completely wrong (e.g., appears to be 
a different number altogether) is too badly garbled to be useful in 
establishing the employee's identity, we view the number as having been 
omitted, which is a correctable flaw under paragraph (c). Another 
commenter suggested that the combination of a wrong ID number and a 
missing employee signature should be a fatal flaw. In our view, both of 
these items independently are correctable flaws, meaning that if either 
is left uncorrected the test is cancelled. This is a sufficient 
safeguard, we believe.

Section 40.205  How Are Drug Test Problems Corrected?

    This provision is based on proposed Sec. 40.203 and concerns how 
correctable flaws and other problems are corrected. There were few 
comments on this section. One commenter said there should be a time 
limit (e.g., five days) for making corrections, and that errors should 
be taken into account during verification. We agree that corrections 
should be timely, and while we do not believe that an absolute 
``statute of limitations'' is appropriate, we have added language 
directing parties to supply this information on the same business day 
on which they are notified of the problem, transmitting it by fax or 
courier. Aside from fatal or uncorrected flaws that cause a test to be 
cancelled, there is no role for consideration of these kinds of 
mistakes in the verification process, which focuses on whether there is 
a legitimate medical explanation for a test result.
    Another comment suggested that the use of a non-DOT form could be 
corrected by annotating the remarks

[[Page 79503]]

section of the non-DOT form with the needed information. We do not 
object to this form of correction in the situation where the form was 
used out of necessity (e.g., only form available for a post-accident 
test), though we do not think it is necessary to include this point in 
the rule text. It would obviously be contradictory to use this approach 
where the non-DOT form was allegedly used ``inadvertently,'' since a 
collector who noticed the use of the form sufficiently to make the 
annotation would clearly have been aware of what form he or she was 
using.

Section 40.207  What Is the Effect of a Cancelled Drug Test?

    This section is based on Sec. 40.205 of the NPRM. There was only 
one comment, which asked for guidance on what to do if an employee with 
a confirmed positive test had his or her test cancelled because of a 
fatal or uncorrected flaw. Other provisions of this part determine what 
action the employer is authorized or required to take. For example, 
following a cancellation of a verified positive test because a split 
specimen was unavailable for testing, there must be an immediate 
recollection under direct observation.

Section 40.209  What is the Effect of Procedural Problems That Are Not 
Sufficient to Cancel a Drug Test?

    There were few comments on this section, which is based on 
Sec. 40.207 of the NPRM. The NPRM version stated a general principle: 
tests cannot be cancelled based on an error that does not have a 
significant adverse effect on the right of the employee to have a fair 
and accurate test. The point of this proposal was to prevent 
administrative or judicial decisions invalidating drug tests that were 
fair and correct, but had certain de minimis irregularities. One 
commenter objected to this principle, saying that tests should be 
cancelled in these situations. Other commenters were supportive.
    Because of comments to other sections of the rule asking for 
clarification about whether certain mistakes in the process should be 
the basis for cancellation, and on the basis of the Department's 
experience in dealing with issues in many drug testing cases, we have 
decided to add to this section a list of matters that, consistent with 
this principle, never result in the cancellation of a test. This is not 
an exclusive or exhaustive list. These matters must be documented, and 
may result in corrective action for employers or service agents 
involved, but the proper remedy is not to cancel the test. This is a 
safety rule, and it is not consistent with safety to permit someone 
with a positive drug test to continue performing safety-sensitive 
functions because a collector made a minor paperwork error that does 
not compromise the fairness or accuracy of the test.
    One of the points we make in this section is that a urine 
collection or an alcohol test must not be cancelled solely because the 
collector, BAT, or STT has not met training requirements. Such a test 
would be cancelled only if there were a fatal flaw or other 
circumstances requiring cancellation. However, an organization that had 
a pattern or practice of using untrained collectors, BATs, or STTs 
would be subject to DOT enforcement action (in the case of an employer) 
or a PIE (in the case of a C/TPA or other service agent).

Subpart J--Alcohol Testing Personnel

    Generally speaking, there were far fewer comments on the alcohol 
testing portions of the rule than on the drug testing and other 
sections. Throughout much of the alcohol testing portion of the rule, 
one commenter provided extensive rewrites of the proposed regulatory 
text. These comments were clearly the product of substantial and 
thoughtful work on the commenter's part. For the most part, however, 
the suggested rewrites did not propose significant substantive changes 
in the proposed text. We will not discuss these rewrites on a 
paragraph-by-paragraph basis, except where they raise a substantive 
point that calls for a response.

Section 40.211  Who Conducts DOT Alcohol Tests?

    The only comments on this section had to do with the limitation on 
supervisors serving as BATs or STTs for their own subordinates. Some 
commenters said that this restriction should be modified, since many 
supervisors had been trained as BATs and there were some situations, 
such as ships at sea, where supervisors might be the only BATs or STTs 
available. We note that the proposed regulation already permitted 
supervisors to serve as BATs and STTs if no one else were available and 
DOT agency alcohol testing regulations allowed this practice. As in the 
case of collectors in the drug testing program, we have used the term 
``immediate'' supervisors to indicate that someone higher up in the 
chain of command was not limited by this restriction.

Section 40.213  What Training Requirements Must STTs and BATs Meet?

    The Department has revised this training both in response to 
comments and to parallel, as much as feasible, the training 
requirements for collectors in the drug testing program. One comment we 
adopted in both places was to permit use of a variety of training media 
(e.g., classroom instruction, internet, video, CD-ROM) for the academic 
portion of the training. For the proficiency demonstration part of the 
training, however, absent technological means of real-time monitoring 
and evaluation of actual proficiency demonstrations, in-person 
monitoring would be necessary. We also replaced the proposed 
``sufficiently knowledgeable'' language referring to trainers, which 
commenters said was too vague, with a series of criteria relating to 
experience or course work in the testing field.
    One commenter suggested a list of scenarios that should be randomly 
included in the three consecutive error-free collections needed to 
demonstrate proficiency for BATs. Without specifically endorsing the 
commenter's list, we believe that this is a useful suggestion. The 
Department's guidance on training will include a list of this type for 
use of persons conducting training.
    As in the case of collectors in the drug testing program, BATs and 
STTs would have to undergo refresher every five years, and error 
correction training when needed. Most commenters on the subject favored 
these kinds of training, though some had reservations about what they 
viewed as the higher costs of the training. In this matter, we believe 
that insistence on high training standards is no vice, and moderation 
in the pursuit of a well-trained work force is no virtue. Such a work 
force is vital to the integrity of the program.
    As in the drug testing collector training, some commenters favored 
waiting until more than one error resulting in cancellation of a test 
had occurred before requiring error correction training. As in that 
case, we believe that any such event creates an important training 
opportunity, to make sure that the individual does not make the same 
mistake in the future.

Section 40.215  What Information About the DER do Employers Have To 
Provide to BATs and STTs?

    Proposed Sec. 40.215 proposed various record retention and 
information requirements for organizations employing BATs and STTs. 
Because we believe it would relieve paperwork

[[Page 79504]]

burdens for employers and C/TPAs to have BATs and STTs maintain 
documentation of their training and qualifications (as Sec. 40.213 
provides), the only remaining portion of this section is proposed 
paragraph (c). This paragraph, on which there were no substantive 
comments, tells employers to provide to BATs and STTs the name and 
phone number of a DER.

Section 40.217  Where is Other Information on the Role of STTs and BATs 
Found in This Regulation?

    This is another in the series of cross-reference sections, pointing 
readers to other sections of the rule relevant to the functions of BATs 
and STTs.

Subpart K--Testing Sites, Forms, Equipment and Supplies Used in 
Alcohol Testing

Section 40.221  Where Does an Alcohol Test Take Place?

    We adopted this provision without substantive change.

Section 40.223  What Steps Must be Taken To Protect the Security of 
Alcohol Testing Sites?

    We adopted a comment to include ASDs in the requirement to secure 
testing devices when they are not being used. In response to another 
comment, we created an exception to the rule that BATs and STTs may not 
leave the testing site when a test is in progress. The exception is for 
a situation in which the BAT or STT must notify a supervisor or contact 
a DER for assistance in the case an employee or other person who 
obstructs, interferes with, or unnecessarily delays the testing 
process. Otherwise we have adopted the proposed section without 
substantive change.

Section 40.225  What Form Is Used for an Alcohol Test?

    Most of the comments on this section focused on changes commenters 
sought in the ATF. The form has been revised, and we have included it 
at Appendix F. Its use will become mandatory on August 1, 2001. We have 
also modified the language concerning foreign-language versions of the 
form to be consistent with the parallel provision concerning the CCF.

Section 40.227  May Employers Use the ATF for non-DOT Tests, or non-DOT 
Forms for DOT Tests?

    This section parallels the requirements for use of the CCF in the 
drug testing program. The few comments on the section were supportive 
of the Department's approach.

Section 40.229  What Devices Are Used To Conduct Alcohol Screening 
Tests?

    We adopted one comment, including a clarifying note in Sec. 40.231 
that only EBTs listed in the NHTSA CPL without an asterisk can be used 
in the DOT alcohol testing program.

Section 40.231  What Devices Are Used To Conduct Alcohol Confirmation 
Tests?

    We adopted one of several editorial comments we received on this 
section from a commenter, which is to remove the word ``sequential'' 
from the requirement that an EBT print a unique number on each copy of 
the result. As the commenter noted, the important thing is for the same 
unique test number to be displayed before the test and printed out on 
the result.

Section 40.233  What Are the Requirements for Proper Use and Care of 
EBTs?

    A number of commenters said it was unclear in the proposed version 
of this section who was responsible for what. To address this problem, 
we place responsibility on the user of the EBT, who could be an 
employer or a service agent. We asked in the preamble to the NPRM 
whether we should retain the requirement for quality assurance plans 
(QAPs). Most commenters favored retaining this requirement, and we have 
done so. We are not specifying in the rule, however, who is authorized 
to perform various maintenance, calibration, etc., functions, as one 
commenter suggested. We are not in a good position to determine who can 
best perform these functions.

Section 40.235  What Are the Requirements for Proper Use and Care of 
ASDs?

    Most of the comments on this section were editorial. One commenter 
expressed concern that the section appeared to focus on saliva ASDs to 
the exclusion of breath ASDs. This is not the case. These sections are 
derived from provisions of the existing regulation that apply to breath 
devices as well as saliva devices. Because the ``use and care'' 
requirements for EBTs of Sec. 40.233 also apply to breath ASDs, we have 
added a cross reference to Sec. 40.233 for clarity.

Subpart L--Alcohol Screening Tests

Section 40.241  What Are the First Steps in Any Alcohol Screening Test?

    Many comments on this section were parallel to the comments on 
Sec. 40.61. In response to the concern about tests not being scheduled 
in advance, we changed the language to refer to situations in which 
tests were scheduled. We also added language telling BATs and STTs to 
begin testing without ``undue'' delay. We did not adopt comments 
suggesting that it was appropriate for the testing process to wait upon 
the arrival of employer or employee representatives.
    One commenter noted an inconsistency between the way the NPRM 
treated refusals to sign the certification on the drug and alcohol 
testing forms, respectively. In the drug testing case, the collector is 
directed to note the problem in the remarks section of the form and 
continue with the test. In the alcohol testing case, the BAT or STT is 
directed to treat the problem as a refusal to test. We agree that these 
provisions should be consistent, and we have changed the alcohol 
procedure to be like the drug procedure.

Section 40.243  What Is the Procedure for an Alcohol Screening Test 
Using an EBT or Non-Evidential Breath ASD?

    Commenters had a variety of concerns about this section. One 
commenter asked if showing the employee the sequential number displayed 
on the device has been omitted from this provision. It has, and the 
omission was intended. We do not believe that this action is necessary 
to maintain the integrity of the process. In addition, these number 
displays are not available on all devices, such as some types of ASDs.
    Another commenter had several suggestions for elaborating on 
instructions to the BAT or STT as part of the preliminary portion of 
the testing process. We will consider including these suggestions in 
guidance. Another commenter asked us to specify the number of times an 
employee could blow into a breath device. We do not think that this is 
necessary. The point is to complete the test successfully. If it 
becomes apparent that the employee cannot provide sufficient breath to 
activate the device, then we expect the BAT or STT to use good judgment 
in determining when to begin the ``shy lung'' procedure.
    A commenter suggested allowing the result printout to be attached 
either to the front or the back of the ATF. We will adopt this comment 
in our pending revision of the ATF. Another suggestion was to use 
tamper-evident tapes that do not discolor over time. We think that this 
is a good idea, but not one that we need to mandate in rule text. We 
have adopted a commenter's suggestion that a self-adhesive label that 
is tamper-evident can be used to affix a result printout to the ATF.

[[Page 79505]]

Section 40.245  What Is the Procedure for an Alcohol Screening Test 
Using a Saliva ASD?

    The Department is adopting the proposed section without substantive 
change. One commenter asked to include material pertaining to new 
evidentiary saliva devices. At the time of the publication of this 
rule, NHTSA is looking at such devices, but NHTSA's review is not 
complete. NHTSA is considering modifying its model specifications for 
evidential breath testers to accommodate technologies that measure 
alcohol in other bodily fluids, such as saliva. If adopted, such 
changes would also require technical adjustments to Part 40 so that 
both the NHTSA action and Part 40 requirements worked smoothly in 
concert. Subsequent to this revision of Part 40, any proposed 
modifications to NHTSA model specifications or Part 40 to accommodate 
the above advances in technology would be published in the Federal 
Register, so that the public may comment on them before any changes are 
made final.
    Another commenter said that the ATF can get too sloppy when the STT 
attempts to use the same form for two separate devices. There is no 
mandate to use the same form. If one form is getting too cluttered, the 
STT can use a new form for the part of the process involving the second 
device. This commenter also said that, in the event the device does not 
activate on the first try, the STT should not have to place the device 
in the employee's mouth for the second attempt. We believe that 
maintaining this requirement is useful to ensure that the second 
attempt is more likely to succeed (e.g., in a situation in which the 
employee has used the device incorrectly at first). This commenter also 
suggested that there may be situations in which it is not possible to 
conduct a new test on an EBT, when the STT could not successfully 
follow ASD procedures. We agree with the commenter that the regulation 
should include language to address this situation, and we have added a 
provision to Sec. 40.271(a)(3) for this purpose.

Section 40.247  What Procedures Does the BAT or STT Follow After a 
Screening Test Result?

    This section is also substantively unchanged from the NPRM. One 
commenter preferred splitting the section into several sections, 
believing that this would make the requirements more clear. Paragraphs 
(a), (b), and (c) each are devoted to a single situation (test result 
of less than 0.02, result of 0.02 or greater, invalid result). We 
believe this organization is sufficiently clear. This commenter also 
suggested that we clarify that the employee must be observed during the 
waiting period in all circumstances. We agree, and we have added 
language to this effect to Sec. 40.251(a)(1). The purpose of this 
observation is to ensure that the employee remains under the control of 
responsible personnel during the waiting period and does not take any 
actions that could interfere with the successful completion of the 
testing process.
    Several comments asked that BATs be able to transmit test results 
to employers via C/TPAs, acting as intermediaries. Consistent with the 
Department's decisions in the drug testing part of the rule, the final 
rule will permit transmission of negative results by this means. (We 
will not permit positive results to be sent in this way. For safety's 
sake it is essential that these results be transmitted immediately and 
directly since, unlike drug test results, positive alcohol test results 
involve impairment.) Another commenter suggested that the ATF include a 
provision for a statement or check box to indicate that the employee 
had received instruction about the waiting period between the screening 
and confirmation tests. We will consider doing so as part of our 
pending revision of the ATF.

Subpart M--Alcohol Confirmation Tests

Section 40.251  What Are the First Steps in Any Alcohol Confirmation 
Test?

    One commenter suggested editorial changes to clarify the timing of 
the waiting period and the confirmation test, in paragraph (a)(1). We 
have adopted this language. We have not adopted other editorial 
suggestions for this section, because we believe they are not necessary 
to clarify the proposed language. We disagree with a comment suggesting 
that conducting a confirmation test more than 30 minutes after the 
screening test should not be permitted. While, as paragraph (a)(1) 
states, it is desirable that the confirmation test begin within 30 
minutes, we realize that circumstances (e.g., transportation from the 
screening test site to a different confirmation test site) could delay 
the test past this point. Better a delayed test than none at all.

Section 40.253  What Are the Procedures for Conducting an Alcohol 
Confirmation Test?

    At a commenter's suggesting, we added the word ``conducting'' to 
the first line of this section. Consistent with Sec. 40.243, we have 
added language saying that a self-adhesive label that is tamper-evident 
can be used to affix a result printout to the ATF. The section is 
otherwise unchanged from the NPRM version. We do not believe extensive 
editorial changes are needed. One commenter said that all test results 
of 0.02 or greater made on a defective machine before corrective action 
is taken must be cancelled. This point is covered by Sec. 40.267(c)(5). 
We will leave the word ``sequential'' in paragraph (f). This section 
involves the use of EBTs, all of which have sequential test number 
displays.

Section 40.255  What Happens Next After the Alcohol Confirmation Test 
Result?

    Aside from a few editorial changes and additional requests that C/
TPAs be able to act as intermediaries in the transmission of results, 
there were no comments on this sections. We have addressed the C/TPA 
transmission issue elsewhere. We have adopted the proposed section 
without change.

Subpart N--Problems in Alcohol Testing

Section 40.261  What Is a Refusal To Take an Alcohol Test, and What Are 
Its Consequences?

    In response to a comment, we added language clarifying that the 
failure to remain at a testing site until the testing process was 
complete constitutes a refusal to test. We have deleted the provision 
treating refusal of the employee to sign the ATF certification in Step 
4 as a refusal to test. Otherwise, the section is substantively 
unchanged from the NPRM. We have not made extensive editorial changes.

Section 40.263  What Happens When an Employee Does Not Provide a 
Sufficient Amount of Saliva for an Alcohol Screening Test?

    There was no substantive comment on this section, and we have 
adopted it unchanged from the NPRM.

Section 40.265  What Happens When an Employee Does Not Provide a 
Sufficient Amount of Breath for an Alcohol Test?

    We have revised this provision to be parallel, in many respects, 
with the ``shy bladder'' procedure in the drug testing portion of the 
rule. These changes

[[Page 79506]]

include providing that the evaluating physician must have expertise in 
the issues raised by the employee's failure to provide a sufficient 
amount of breath and that the employee must obtain the evaluation 
within five days. (The physician could be a specialist, but need not 
be. What is important is that the physician have sufficient expertise 
to deal effectively with the issues presented in the employee's case.) 
Three commenters suggested that this time period should be changed to 
one, three, or seven days rather than five days. We believe that the 
five-day period should be generally sufficient and is consistent with 
other medical evaluation provisions of the rule.
    However, the Department is aware that, in some cases, it may be 
difficult for an employee to secure, on his or her own, an appointment 
for this evaluation in a short period of time. Consequently, the 
Department does not regard it as a refusal to test if the employee is 
unable, after making good faith efforts, to get the appointment within 
the 5-day period. However, the employer should do everything feasible 
to assist the employee in finding and getting an appointment with an 
appropriate physician.
    A commenter suggested giving employees additional attempts to 
provide a sufficient amount of breath to complete a test. We have 
modified this section to permit an additional attempt, if the BAT or 
STT believes that it would be useful (e.g., because the employee came 
close on the second attempt or made a mistake in using the device that 
could be readily corrected). It is not mandatory for the BAT or STT to 
provide this third attempt. At this commenter's suggestion, we have 
also added language telling the BAT or STT to instruct the employee on 
the proper use of the device.

Section 40.267  What Problems Always Cause an Alcohol Test To Be 
Cancelled?

    One commenter disliked the use of the word ``cancelled,'' 
preferring ``invalid.'' The term ``invalid'' has a specific meaning in 
the drug testing part of the rule, so we think it better to avoid the 
word here. ``Cancelled'' has the same meaning here as it does in drug 
testing, and should not cause any confusion. A commenter suggested 
adding rule text requiring BATs and STTs to notify DERs within 48 hours 
of the discovery of a fatal flaw. We agree that prompt notification is 
important, and we have added language to Sec. 40.273 to this effect. We 
put this provision into Sec. 40.273 so that it applies to all 
cancellations.

Section 40.269  What Problems Cause an Alcohol Test To Be Cancelled 
Unless They Are Corrected?

    There were no substantive comments on this section, which is 
unchanged from the NPRM.

Section 40.271  How Are Alcohol Testing Problems Corrected?

    As discussed above, we have added a new paragraph (a)(3) to this 
section, concerning situations in which a new testing device is not 
available at the testing site. We have also added a new paragraph (c), 
clarifying that when a correctable flaw cannot be corrected, the test 
must be cancelled. We did not receive substantive comments on this 
section, which is otherwise unchanged from the NPRM.

Section 40.273  What Is the Effect of a Cancelled Alcohol Test?

    There were no substantive comments on this section, the proposed 
text of which is unchanged from the NPRM. We have added new paragraphs 
( c) and (d), which respectively call for notification of the DER and 
state that a cancelled test is not intended to provide a basis for a 
subsequent test under company policy,

Section 40.275  What Is the Effect of Procedural Problems That Are Not 
Sufficient To Cancel an Alcohol Test?

Section 40.277  Are Alcohol Tests Other Than Saliva or Breath for 
Screening and Breath for Confirmation Permitted Under These 
Regulations?

    There were no substantive comments on these sections, which are 
unchanged from the NPRM.

Subpart O--Substance Abuse Professionals and the Return-to-Duty 
Process

Section 40.281  Who Is Qualified To Act as a SAP?

Section 40.283  How Does a Certification Organization Obtain 
Recognition for Its Members as SAPs?

    These sections were both based on proposed Sec. 40.281. We received 
extensive comment on the question of who should be viewed as eligible 
to perform SAP functions. Many individuals, professional organizations, 
and certification organizations (e.g., for drug and alcohol counselors, 
marriage and family therapists, licensed professional counselors) 
asserted that their qualifications were as appropriate, if not more so, 
than groups and professions which the rule views as eligible. Without 
denigrating the qualifications of any individuals, professions, and 
organizations, the Department believes that the proposed rule continues 
to identify those professions and organizations that currently are best 
equipped to perform the SAP function in the DOT drug and alcohol 
testing program.
    This is a program that is national in scope, and we believe that, 
for persons who wish to act as SAPs based on membership in a licensed 
or certified profession, it is reasonable to require that the licensure 
or certification be available in all U.S. states. For persons who wish 
to act as SAPs based on an organizational certification, the Department 
has set forth criteria in Appendix E for the requirements that must lie 
behind such certifications. The Department developed these criteria 
under the existing rule as a means of evaluating applications to the 
Department for SAP eligibility, and they are consistent with the 
requirements of certification organizations that are already part of 
the SAP program.
    The NPRM proposed to require organizations that certify counselors 
to obtain National Commission for Certifying Agencies (NCCA) 
accreditation before submitting their requests to have the Department 
consider their certified counselors for inclusion in the SAP 
definition. The NPRM also proposed that the two certifying 
organizations whose counselors are already in the SAP definition (i.e., 
the National Association of Alcoholism and Drug Abuse Counselors 
Certification Commission (NAADAC) and the International Certification 
Reciprocity Consortium/Alcohol and Other Drug Abuse (ICRC)) would not 
be required to have NCCA accreditation because they have already been 
through a rigorous Department process prior to their inclusion.
    Commenters overwhelmingly supported the concept of having 
certification organizations obtain NCCA accreditation prior to 
submitting their requests to have their certified counselors considered 
for inclusion to the Department. A few organizations opposed any type 
of review by any organization, including the Department, prior to 
having their certified counselors added to the SAP definition. A few 
commenters wanted the Department to maintain total control of the 
review process--a process that proved entirely too burdensome and time 
consuming for us. Still other commenters wanted us to clarify that the 
NCCA accreditation requirement (and Appendix F of Part 40) applied 
solely to certifying organizations wishing to have their counselors 
included in the SAP definition and not to physicians, social

[[Page 79507]]

workers, psychologists, and employee assistance professionals; and not 
to NAADAC and ICRC. Those who commented on NAADAC and ICRC, did not 
believe NCCA accreditation was necessary for those two groups.
    Part 40 will require certification organizations wishing to have 
their certified counselors included in the SAP definition to meet the 
requirements (which includes NCCA accreditation) at Appendix F of Part 
40 prior to asking the Department to review their inclusion proposals. 
The Department will still receive and review all proposals for 
inclusion based upon Appendix F standards. It is important to note that 
NCCA accreditation is simply one of the prerequisites for inclusion, 
but it represents an area of review that the Department found to be the 
largest barrier to our streamlining the process for reviewing 
certification groups' application materials and for evaluating the 
quality of those groups' certification testing processes.
    Because NAADAC and ICRC excelled in the Department's previous 
review process, they will be compelled neither to have NCCA 
accreditation nor to complete the process again. Physicians, social 
workers, psychologists, and employee assistance professionals were 
never intended to have NCCA accreditation. This requirement is not for 
them: it is only for certification organizations wishing to have their 
certified counselors added to those of NAADAC and ICRC.
    A few commenters suggested that all SAPs be certified by the 
Department. One suggested that we support any future proposals by the 
Substance Abuse and Mental Health Services Administration to certify 
drug and alcohol counselors. While we support efforts to ensure that 
SAPs are better trained (and Part 40 has new training requirements for 
SAPs), the Department lacks the expertise, personnel, and time needed 
to establish and operate a SAP counselor certification effort. Like the 
lone commenter mentioned in this paragraph, we would support efforts by 
HHS to develop certification standards and subsequently certify all 
drug and alcohol counselors.
    As was the case with commenters on MRO training, most commenters on 
SAP training thought that self-certification was not adequate. Many 
comments favored more formal training requirements for SAPs, like those 
proposed for MROs. Some of these comments mentioned situations in which 
they believed SAPs had made poor decisions based on an incomplete 
understanding of their role under the DOT rules.
    The Department is persuaded that more formal SAP training is 
appropriate. Like MROs, SAPs are highly-qualified professionals. They 
play a key role in the return-to-duty process, which has important 
safety implications. In addition to their professional qualifications, 
they need to be very aware of their role in implementing DOT agency 
drug and alcohol testing rules. Consequently, the Department is 
revising SAP training requirements to parallel the training 
requirements for MROs. The Department is aware that there are not 
currently an array of SAP courses analogous to the MRO courses that 
medical groups currently present. For this reason, the SAP 
qualification training deadline has been extended to December 2003. 
However, the Department anticipates that, in the time permitted for new 
and current SAPs to meet this requirement (see Sec. 40.281(c)(3)), the 
demand for training will lead to a supply becoming available. We 
believe that organizations will take the opportunity to create 
appropriate training courses and materials.
    Like qualification training for MROs, SAP qualification training 
includes a requirement for an examination. However, the Department does 
not believe that this examination need be a formally designed and 
validated examination. SAP functions are narrower in scope and less 
complex than MRO functions, and the examination can therefore be 
simpler, in our view. The purpose of SAP training and the examination 
is not to teach people how to be clinicians, but rather to help SAPs 
learn how to operate in their specialized role within the DOT 
regulatory framework.
    As with MROs, we have added a continuing education requirement to 
keep SAPs current on program requirements and issues. This continuing 
education must involve a test or other assessment tool to help SAPs 
determine whether they have successfully learned the material.

Section 40.285  When Is a SAP Evaluation Required?

    This section is based on Sec. 40.283 of the NPRM. Consistent with 
other provisions of the rule, we have added adulteration and 
substitution results to the situations requiring SAP evaluations. We 
disagree with a commenter who said that an alcohol test result of 0.04 
or greater was not a violation of DOT agency alcohol regulations. It is 
a violation, and a SAP evaluation is a necessary part of the return-to-
duty process following such a violation. Some comments questioned 
whether a SAP evaluation was necessary in all cases (e.g., including 
pre-employment tests) following a violation. It is, and we have added 
some clarifying language to this effect. In the case of a pre-
employment test violation, the employer to whom the individual had 
applied would be responsible for providing the individual information 
about SAP resources and the return-to-duty process, even if the 
employer wanted no further relationship with the individual.
    A commenter asked whether a SAP evaluation would be needed for an 
employee who had a DUI/DWI charge against him or her in a private 
automobile. The answer is no: under Part 40 only a violation of DOT 
agency drug and alcohol testing rules triggers the requirement for a 
SAP evaluation (though DOT agency rules may impose additional 
requirements in some cases). Another commenter recommended that 
applicants who test positive on pre-employment tests should be required 
to present evidence of having completed the return-to-duty process 
before being able to work in a safety-sensitive position for another 
employer. We have addressed this issue in Sec. 40.25, concerning 
inquiries about previous test results.

Section 40.287  What Information Is an Employer Required To Provide 
Concerning SAP Services to an Employee Who Has a DOT Drug and Alcohol 
Regulation Violation?

    This section is based on proposed Sec. 40.285 of the NPRM. There 
were few comments. One asked whether the employer or the employee was 
to select the SAP. This section does not address selection of a SAP: it 
just says that the employer has to provide the employee a list of SAPs 
and how to reach them. The provision does clarify that this requirement 
applies to all violation situations, including pre-employment tests. If 
an applicant fails a pre-employment test, the employer must provide 
this information even if the employer intends not to hire the 
applicant.

Section 40.289  Are Employers Required To Provide SAP and Treatment 
Services to Employees?

    This provision is based on proposed Sec. 40.287 of the NPRM. 
Paragraphs (a) and (c) emphasize the employer's provision of SAP 
services. An employer may or may not provide SAP-related services to 
employees. An employer may or may not pay for such services. These are 
matters the Department leaves to employer discretion or labor-

[[Page 79508]]

management negotiations. One commenter suggested that employers be 
required to cover these services in their health plans. We believe 
that, as the commenter acknowledged, imposing coverage requirements on 
health care providers or insurers is outside the Department's 
jurisdiction.
    The proposed Sec. 40.287 included two paragraphs telling employers 
that they must ensure the SAPs used to evaluate employees before they 
return to duty meet certain qualifications. In view of the SAP training 
and qualification provisions of Sec. 40.281 of the final rule, we 
believe these paragraphs are duplicative, and we have deleted them. 
This section continues to emphasize that, before an employee who has 
violated a DOT agency drug and alcohol testing regulation may return to 
safety-sensitive duties, the employee must successfully complete the 
SAP evaluation/return-to-duty process.

Section 40.291  What Is the Role of the SAP in the Evaluation, 
Referral, and Treatment Process of an Employee Who Has Violated DOT 
Agency Drug and Alcohol Testing Regulations?

    The content of proposed Sec. 40.291 has been moved to 
Sec. 40.355(a). This section now concerns a different subject, stating 
the general duties of SAPs.

Section 40.293  What is the SAP's Function in Conducting the Initial 
Evaluation of an Employee?

    The final rule has no equivalent to proposed Sec. 40.289, the 
content of which duplicates other provisions in this subpart. There 
were few comments concerning Sec. 40.293, and they were mostly 
supportive. Some comments did favor allowing C/TPAs to transmit SAP 
reports to employers. As discussed in the ``Principal Policy Issues'' 
section of the preamble, we have chosen not to permit this, as a means 
of preventing anyone from having the opportunity to alter the SAP's 
report and recommendations.
    We have added three new points to this section. First, as discussed 
in the ``Principal Policy Issues'' section of the preamble, we believe 
that there are no circumstances in which it is appropriate for a SAP to 
find that a violator of our regulations is not in need of education 
and/or treatment. Therefore, paragraph (b) requires that SAPs make a 
recommendation for education and/or treatment in every case. Second, we 
have become concerned that we have not previously given SAPs guidance 
with respect to employees' stories that minimize the seriousness of 
their violations, analogous to the guidance we give MROs with respect 
to legitimate medical explanations. Therefore, paragraph (f) 
specifically forbids SAPs from taking certain kinds of factors into 
account in making their recommendations.
    Third, while we are not making quantitations routinely available to 
SAPs in drug testing cases (see discussion in ``Principal Policy 
Issues''), we believe it is very important for MROs and SAPs to have 
good communications about employees. Paragraph (g) explicitly 
authorizes SAPs to consult with MROs, and tells MROs they must 
cooperate with SAPs in these consultations.

Section 40.295  Can Employees or Employers Seek a Second SAP Evaluation 
if They Disagree With the First SAP's Recommendations?

    The purpose of this section is to prevent employers and employees 
from forum shopping until they get a SAP evaluation they like. Most 
comments supported the proposed prohibition on second opinions, though 
one commenter thought this should be permitted if the original SAP does 
a bad job. The difficulty with this suggestion is that a party's 
perception of the quality of the SAP's work is likely to be influenced 
on whether the SAP made a recommendation the party feels is in its 
interest. We believe that a prohibition on second opinions is the only 
way to prevent forum shopping.
    One commenter suggested that we remove the reference to the SAP 
being suitable to the employer. We believe the proposed language in 
this section is unnecessary, and we have deleted it. Also, to tighten 
the provision, we have added a sentence saying that if, notwithstanding 
the regulatory prohibition, an employee gets an evaluation from a 
second SAP, the employer must not pay any attention to it.

Section 40.297  Does Anyone Have the Authority To Change a SAP's 
Initial Evaluation?

    Several commenters noted that the language of the proposed section 
appeared to prevent even the SAP who originally made the recommendation 
from modifying his or her own recommendation. We did not intend to 
prevent SAPs from modifying their own recommendations, and we have 
added clarifying language that permits SAPs to do so when they receive 
new or additional information.

Section 40.299  What Is the SAP's Role and What Are the Limits on a 
SAP's Discretion in Referring Employees for Treatment and Education?

    A number of commenters appeared to prefer stating one of the 
exceptions to the rule against self-referral in terms of SAPs located 
in ``rural and remote areas'' rather than the NPRM's ``general 
commuting area'' language. The Department does not believe that this 
would improve the clarity of the section, since ``rural'' and 
``remote'' are rather subjective terms. The exception is intended to 
apply, in any case, to a situation in which there is no other source of 
services reasonably available in the vicinity. For example, if an 
employee had to make an overnight trip to get to another source of 
services, we would not consider it reasonably available.
    One commenter wanted to consider referrals to spouses as prohibited 
by this section. We believe this is covered by the prohibition on 
referrals to people with whom the SAP shares a financial interest. 
Another commenter wanted to create a fifth exception for in-house 
corporate SAPs. We believe that the second and third exceptions are 
adequate to cover this situation. We also received a suggestion to 
delete the signed statement requirement of proposed paragraph (d). 
Given the specificity of the other requirements of the section, we do 
not believe that this signed statement adds much of substance, and we 
have deleted it in the interest of reducing paperwork.

Section 40.301  What Is the SAP's Function in the Follow-Up Evaluation 
of an Employee?

    Comments were generally supportive of this section. A few comments 
pointed out that some current DOT agency regulations do not make use of 
the SAP process. This is true. However, DOT agencies will amend their 
regulations to conform to Part 40 before the effective date of this 
part. Another commenter asked for clarification of who makes a return-
to-duty determination. SAPs simply determine whether an employee has 
successfully demonstrated compliance with the SAP's recommendations. As 
this section and Sec. 40.305 make clear, only the employer decides 
whether, after all prerequisites have been met, the employee returns to 
safety-sensitive duties. In response to comments that employers should 
be notified if the SAP process is taking longer than expected (e.g., 
because the employee has not made expected progress in treatment), we 
have added a provision requiring the SAP to provide

[[Page 79509]]

written notice to the employer when the employee has not demonstrated 
successful compliance on follow-up evaluation.
    The Department understands that not every employee will make 
strides in dealing with a drug or alcohol problem sufficient to 
receiving a SAP follow-up report indicating that he or she has 
demonstrated successful compliance with the SAP's recommendation. When 
this happens, we believe that it is important that the employer receive 
a SAP follow-up report outlining the reason(s) why the employee has not 
demonstrated successful compliance. We understand that some employees 
may be actively involved in carrying out their education and/or 
treatment plan and simply need additional time to complete the work. 
Others may have been non-participants in a SAP-recommended program. 
Therefore, when the SAP determines that the employee has failed to 
demonstrate successful compliance, we have no objection to having the 
employer deciding to allow an additional SAP follow-up evaluation to be 
made consistent with the employee's progress (or lack of progress) and 
with employer policy and/or labor-management agreements. Nor will the 
Department object if the employer chooses instead to take other 
personnel actions consistent with employer policy and/or labor-
management agreements.

Section 40.303  What Happens if the SAP Believes the Employee Needs 
Additional Treatment, Aftercare, or Support Group Services Even After 
the Employee Returns to Safety-Sensitive Duties?

    As discussed in the ``Principal Policy Issues'' section of the 
preamble, we have deleted a proposed requirement that employers 
``monitor'' returned employees'' aftercare. This was the subject of the 
bulk of the comments on this section. The section now gives discretion 
to employers concerning their monitoring and enforcement of SAP 
aftercare recommendations. We strongly recommend that employers play an 
active role in ensuring that employees who have returned to work 
following a violation comply with aftercare recommendations. This is 
very important both for safety and the welfare of the employees. The 
rule also states that employees are obligated to comply with these SAP 
recommendations and are subject to employer discipline if they do not.

Section 40.305  How Does the Return-to-Duty Process Conclude?

    This section underlines the point that it is the employer, and the 
employer alone, who is responsible for deciding whether an employee who 
has violated DOT agency drug and alcohol testing rules will return to 
work. A determination by the SAP that the employee has successfully 
complied with the SAP's recommendations is a prerequisite to the 
employee's return to duty. So is a negative result on a subsequent 
return-to-duty test. But only the employer can decide whether or not to 
put the person back to work. SAPs do not make ``fitness for duty'' 
decisions, and employers should not ask them to do so. Commenters asked 
that we make these points clear. We think this section is as clear on 
this point as we can make it.

Section 40.307  What Is the SAP's Function in Prescribing the 
Employee's Follow-up Tests?

Section 40.309  What Are the Employer's Responsibilities With Respect 
to the SAP's Directions for Follow-up Tests?

    As discussed in the ``Principal Policy Issues'' section of the 
preamble, the Department has decided to retain the ``at least six 
follow-up tests in the first 12 months'' formulation for follow-up 
testing. In response to requests from commenters, we have clarified 
that this follow-up testing requirement ``follows the employee'' 
through job changes and breaks in safety-sensitive service. The six 
tests must occur during the first 12 months of safety-sensitive service 
after return-to-duty, regardless of for whom or when that service is 
performed.
    Of course, SAPs have the discretion to require more follow-up tests 
than the minimum. One commenter suggested that SAPs negotiate the 
number of follow-up tests over the minimum with the employer. We did 
not adopt this suggestion, because this is intended to be a clinical 
determination, not subject to economic or policy give-and-take. 
Employers are obligated to follow the SAP's follow-up testing plan. All 
parties involved should be aware that, under this rule, all employees 
who return to work after a violation will have a follow-up testing 
requirement with which employers and employees must comply.

Section 40.311  What Are Requirements Concerning SAP Reports?

    Most of the comment on this section concerned the issue of C/TPAs 
acting as intermediaries in the transmission of SAP reports to 
employers. As discussed above, the Department is not permitting C/TPAs 
to act in this capacity. SAPs must send their reports directly to the 
DER. The report must be on the SAP's own letterhead, not that of a C/
TPA or another service agent.
    In response to a comment on the content of the SAP report, we have 
used the term ``date(s)'' rather than ``date'' to cover the possibility 
that assessments will happen over a period of time longer than a single 
meeting. We have also clarified that ``reason for the assessment'' 
refers to the date and nature of the violation of DOT rules, as a 
commenter requested, and as DOT's SAP Guidelines outline.

Section 40.313  Where Is Other Information on SAP Functions Found in 
This Regulation?

    This is the last of the regulation's sections providing 
informational cross-references to other provisions concerning, in this 
case, SAP functions.

Subpart P--Confidentiality and Release of Information

Section 40.321  What Is the General Confidentiality Rule for Drug and 
Alcohol Test Information?

    Several commenters disagreed with the proposal to continue the 
Department's ban on blanket releases. These commenters believed that 
permitting blanket releases would facilitate the flow of information 
among parties who needed to know, for example, whether an applicant for 
a job had previously violated a DOT regulation. Other commenters 
favored retaining this proposal in order to protect employee privacy. 
The Department believes that the principle of specific written consent 
for any release of test result or medical information to third parties 
is critical to protect employees' legitimate expectations of privacy 
and confidentiality in the testing program. Permitting blanket releases 
is directly contrary to this principle. The Department will include the 
proposed provision in the final rule.

Section 40.323  May Program Participants Release Drug or Alcohol Test 
Information in Connection With Legal Proceedings?

    The existing rule and the NPRM both provide that in a proceeding 
brought by, or on behalf of, an employee, resulting from a positive 
test (e.g., a lawsuit or grievance), the employer may release employee 
test result information without the employee's consent. One commenter 
suggested that we add references to substituted and

[[Page 79510]]

adulterated tests and other refusals to test. We have done so.
    Another commenter raised the issue of a different kind of legal 
proceeding. The commenter asked whether otherwise confidential 
information could be released in a personal injury lawsuit where the 
employee's conduct was an issue (e.g., a truck or bus driver involved 
in a collision). We believe that, if a court orders the production of 
such information because it is relevant in such a proceeding, it is 
reasonable for the employer to provide it without getting the 
employee's consent. In this situation, the requirements of justice in 
the litigation outweigh the employee's privacy interest. We have added 
a paragraph to this effect. We also added a paragraph telling a service 
agent who is holding this information to provide it to the employer 
when the employer requests it for use in a legal proceeding covered by 
this section.

Section 40.327  When Must the MRO Report Medical Information Gathered 
in the Verification Process?

    This section provides that, under certain circumstances, MROs must 
provide certain otherwise confidential information to employers and 
certain other parties. The purpose of providing this information is to 
enhance safety. Commenters had a variety of concerns about this 
section. One comment suggested that the medical information be provided 
in writing in all cases. We think that a prudent MRO may choose to do 
so, but we do not believe that a regulatory requirement is needed.
    Some commenters objected to the paragraph that allows MROs to 
consult with the employee's own physician to see if alternate 
medication might be available that would be less likely to adversely 
affect safety, saying that MROs should stay out of what looks like a 
doctor-patient relationship with employees. A few commenters supported 
this proposal. Under the proposal, the MRO would take this step only 
with the employee's consent, and for the purpose of helping the 
employee find medication that would be compatible with safe job 
performance. From both the point of view of employee interests and 
safety, we believe that this proposal is sound, and we have retained 
it.
    One commenter said that Canadian law would preclude a doctor from 
releasing this information to an employer. We have added a provision 
saying that if the law of a foreign country, such as Canada, prohibits 
MROs from providing medical information to the employer, the MROs may 
comply with that prohibition.
    Another commenter pointed out that not only physicians, but also 
other medical professionals, may make determinations about whether an 
employee meets physical qualification standards. We have adopted the 
commenter's suggestion that the MRO can release information to the 
``health care provider'' involved in this activity. Consistent with the 
SAP provisions of the rule, we have included SAPs who are evaluating 
employees as part of the return-to-duty process as a party to whom the 
MRO can provide information under this section.
    Finally, as some commenters requested, we have made it mandatory 
for MROs to release information under this section if the information 
is likely to result in the employee being medically unqualified for 
performance of safety-sensitive duties under a DOT regulation or if the 
information indicates that continued performance by the employee of his 
or her safety-sensitive function is likely to pose a significant safety 
risk. In this case, the Department believes that the safety interest 
served by the information release outweighs the confidentiality 
interest of the employee.
    We point out that the medical information described in this section 
cannot be transmitted to employers or other parties using a C/TPA or 
other service agent as an intermediary. MROs must transmit this 
information directly to the employer.

Section 40.329  What Information Must Laboratories and Other Service 
Agents Release to Employees?

    Proposed Sec. 40.329, concerning release of information by MROs to 
third-party employers, has been deleted, for the reasons given in the 
``Principal Policy Issues'' section of the preamble. This section is 
based on proposed Sec. 40.331 of the NPRM.
    One commenter requested that the Department require that 
laboratories provide all records requested by an employee, as well as a 
laboratory person to testify in a legal proceeding who has firsthand 
knowledge of the laboratory, its records, and operating procedures. 
This commenter also requested that the rule require the laboratory to 
make records available within 10 days, rather than waiting for payment 
from the employee. This section does require that laboratories and 
other service agents provide a ``data package'' (sometimes referred to 
as a ``litigation package'') upon the employee's request. We do require 
that they provide it within 10 business days. The rule also limits the 
charge the service agent can make for the cost of copying and 
preparation. We believe these provisions adequately protect employee 
interests. We do not believe it is necessary, as another commenter 
suggested, to list the contents of a litigation package, which is quite 
standard and well understood among laboratories.
    We have not adopted the suggestion that laboratories be required to 
produce witnesses for appearances at legal proceedings. Such an open-
ended requirement would impose, in our view, unnecessary costs and 
burdens on laboratories and other service agents. There are adequate 
means (e.g., documentary evidence) through which employees can raise 
issues about the testing process.
    The NPRM proposed that laboratories provide to employees, on 
written request, information relating to the results of relevant HHS 
certification reviews. One comment supported this proposal, which is 
consistent with long-standing DOT interpretation of the existing Part 
40, while another commenter proposed that the laboratory's obligation 
be limited to the latest HHS Federal Register notice listing the 
laboratory as certified. Based on conversations with HHS staff, we have 
decided to delete this provision. HHS staff believe that providing this 
information would unnecessarily intrude on the HHS-laboratory 
relationship and could result in the introduction of misleading 
information about the laboratory certification process in legal 
proceedings involving drug test results.

Section 40.331  To What Additional Parties Must Employers and Service 
Agents Release Information?

    This section is based on Sec. 40.333 of the NPRM. Some commenters 
objected to being required to permit DOT representatives to see a broad 
array of drug and alcohol testing information. DOT has significant 
safety responsibilities for transportation industries, of which our 
drug and alcohol testing rules are an important part. As part of its 
safety mandate, DOT must be able to inspect regulated employers and 
those who carry out their drug and alcohol testing program 
responsibilities. DOT cannot do this job unless we have access to all 
relevant information. We believe it is vital to maintain this provision 
in the final rule. We would point out, particularly in response to a 
comment that Canadian MROs could not legally release certain 
information, that this paragraph focuses on the inspection and review 
of documents as part of the DOT oversight process, not on release of 
information to third parties.

[[Page 79511]]

    Commenters pointed out that, in some jurisdictions, state laws or 
rules require employers or service agents to provide drug test result 
information to state law enforcement or safety agencies. To ensure that 
there is no conflict between Part 40 and these state laws or rules, we 
have added language (already found in some DOT agency rules) to this 
section. It says that if requested by a state or local safety agency 
with regulatory authority over the employer or employee, employers and 
service agents must provide drug and alcohol test records concerning 
the employee to the agency. This paragraph also covers Federal agency 
requests (including requests by DOT, HHS, and the National 
Transportation Safety Board) for drug and alcohol test records. It 
should be noted that this paragraph applies only to testing records. It 
does not authorize provision of specimens.
    We have also added a paragraph stating in rule text the advice we 
have frequently given to employers and service agents faced with 
subpoenas or other orders directing them, contrary to Part 40 
requirements, to produce specimens where Part 40 does not permit. What 
is a laboratory or other party to do if it gets a request to produce a 
urine specimen or aliquot for an unauthorized test? The first thing the 
laboratory should do is to ``just say no,'' giving this DOT regulatory 
mandate as the reason. If someone seeks a subpoena or other court order 
directing the production of the specimen, the laboratory's attorneys 
should seek to quash or resist the action, asserting on the basis of 
this section that such an order is contrary to Federal law and subject 
to Federal pre-emption (under the existing pre-emption provisions of 
DOT agency drug and alcohol regulations). In such cases, we suggest 
that laboratories call the Department to consult about the matter. If a 
court ultimately issues a binding order requiring the production of the 
specimen, the laboratory may comply (we do not seek to make 
laboratories subject to contempt citations). However, as noted above, 
employers must continue to implement all consequences of a verified 
positive test required by DOT rules, regardless of the outcome of the 
unauthorized test or any personnel process decisions flowing from it.

Section 40.333  What Records Must Employers Keep?

    This section is based on Sec. 40.335 of the NPRM. In response to a 
number of comments and consistent with decisions reflected elsewhere in 
this document, proposed requirements for the retention of records 
concerning training of service agents and signed agreements with 
service agents have been deleted. Under the final rule, collectors, 
BATs, MROs etc. will maintain their own training records, and employers 
will not have this responsibility. The requirement to have signed 
agreements among employers and all service agents has been deleted.
    In response to a comment, we have deleted the word ``secure'' from 
paragraph (c), since we agree that control of access is the key point. 
One comment suggested that service agents should have up to five 
business days to get information to employers who are being audited. In 
our view, each DOT agency's rules and inspection practices should 
determine how quickly an employer must produce records. The service 
agent is responsible for meeting the employer's need to comply with DOT 
agency requirements.

Subpart Q--Roles and Responsibilities of Service Agents

Section 40.341  Must Service Agents Comply With DOT Drug and Alcohol 
Testing Requirements?

    There was only one comment on the proposed Sec. 40.341. AC/TPA 
wanted C/TPAs to be authorized to act as a DER and to be required to 
have a certified MRO or administrator in charge. For reasons we have 
discussed elsewhere, we are not permitting C/TPAs to act as DERs. While 
we think that training and certification programs for program 
administrators are a good idea, we do not believe that it is necessary 
to make them mandatory at this point.

Section 40.343  What Tasks May a Service Agent Perform for An Employer?

    This is a new section that makes the basic point that service 
agents can perform for employers those functions authorized by DOT 
rules. Proposed Sec. 40.343 dealt with a different issue. DOT has 
become aware of reports that, particularly in some industries, service 
agents have imposed requirements on covered entities that exceed the 
requirements of DOT rules. Some service agents have made compliance 
with these extra requirements a condition of approval of an employer's 
DOT drug and alcohol testing program. The proposed section was intended 
specifically to prevent excesses of this kind.
    There were few comments on the proposed section. One said that 
service agents work for employers in capacities other than compliance 
with DOT rules. This is doubtless true, but is an issue outside the 
scope of this rulemaking. One commenter suggested that there was a 
reverse problem, in that sometimes employers asked service agents 
(e.g., SAPs) to perform tasks beyond what DOT rules require (e.g., make 
fitness for duty decisions). We have strengthened language elsewhere in 
Part 40 to emphasize that it is inappropriate to call on SAPs to make 
these decisions for employers. A third commenter was concerned that the 
section might inhibit the ability of service agents to advise employers 
to recommend provisions not covered by DOT rules. Service agents can 
recommend provisions not covered by DOT rules, but they cannot make 
adoption of these recommendations a condition of approving employers' 
plans for DOT compliance purposes.
    The Department has relocated this provision to Sec. 40.355(l).

Section 40.345  In What Circumstances May a C/TPA Act as an 
Intermediary in the Transmission of Drug and Alcohol Testing 
Information to Employers?

    The proposed Sec. 40.345 made the point that a service agent that 
did not comply with DOT regulations was subject to PIE proceedings. 
Comments to this proposal were along the lines of comments on the PIE 
proposal itself, to which we responded in the ``Principal Policy 
Issues'' section of the preamble. The substance of this proposed 
section has been incorporated in Sec. 40.341 of the final rule.
    The new Sec. 40.345 incorporates the Department's decision, 
discussed at length under ``Principal Policy Issues,'' to permit 
employers to use C/TPAs for a variety of information transmission 
functions, such as passing drug and alcohol test results from MROs or 
BATs to employers. We emphasize four points. First, with respect to any 
and all of the functions that C/TPAs may perform, the employer has the 
choice of using a C/TPA as an intermediary or getting the information 
directly from the party (e.g., the MRO) who generates the information. 
Second, we direct readers' attention to Appendix F. C/TPAs may act as 
intermediaries only with respect to the functions listed in Appendix F.
    Third, when C/TPAs act as an intermediary, they must meet all 
requirements (e.g., concerning confidentiality and timing) that would 
apply if the party generating the information (e.g., an MRO or 
collector) sent the information directly to the employer. For example, 
if a C/TPA transmits the MRO's drug testing results to DERs, it must 
transmit each drug test result to the DER in compliance with the 
requirements for MROs set forth in Sec. 40.167. Fourth, as noted in 
connection with Sec. 40.15, employers remain fully

[[Page 79512]]

responsible for receiving all information and taking all actions 
required under Part 40 and other DOT agency rule.

Section 40.347  What Functions May 
C/TPAs Perform With Respect to Administering Testing?

    One comment on this section suggested that it refer to C/TPAs 
specifically, rather than service agents generally, because the content 
of the section covered functions that C/TPAs perform and other service 
agents (e.g., MROs, laboratories) either should not or typically do not 
perform. We agree with this comment, and we have changed the language 
of the section accordingly. Another commenter appeared to be confused 
about the provision telling service agents not to select employees 
randomly for testing from a ``follow-up'' pool. This point--which 
applies to employers as well as C/TPAs--is that follow-up tests are 
scheduled individually for employees who have returned to safety-
sensitive duties after a violation, consistent with the SAP's plan. It 
is never appropriate to put returned employees into a pool and select 
them randomly for follow-up testing. Employees never get advance notice 
of the time of a follow-up test, but follow-up testing is in no way 
random. On the other hand, in addition to being subject to follow-up 
testing, returned employees must be in the regular random testing pool, 
and are subject to selection for random testing on the same basis as 
all other covered employees.

Section 40.349  What Records May a Service Agent Receive and Maintain?

    Some commenters on this section were concerned that because the 
proposed rule used the general term ``service agent'' in this section, 
the section glossed over restrictions on the activities of MROs and 
laboratories. They suggested that, as in the case of Sec. 40.347, we 
limit the section to 
C/TPAs. While we agree that C/TPAs perform many record management 
functions, it does not appear to us that the provisions of this section 
apply only to C/TPAs. However, in response to the commenters' concerns, 
we are prefacing this section with an ``except where otherwise 
specified in this part'' statement (we did the same in Sec. 40.347). 
The import of this language is that, where MRO, laboratory, or other 
provisions of the rule impose requirements or restrictions beyond those 
of this section, those requirements or restrictions control.
    Another comment suggested clarifying that DOT access to service 
agent records and facilities does not apply to records and facilities 
not involved in the DOT drug and alcohol testing program. This point 
seems clear on the face of the proposed and final provisions, so we 
will not restate the obvious. Another comment objected to requiring 
this access, and asked for a justification. This is equally obvious: in 
order to maintain proper oversight of an important safety program, the 
Department needs access to the records and facilities of those who 
actually perform program tasks.

Section 40.351  What Confidentiality Requirements Apply to Service 
Agents?

    This section is also based on parts of proposed Sec. 40.349. A 
number of comments pertained to proposed Sec. 40.349(e), relating to 
handling of the CCF. There is no equivalent to this proposed paragraph 
in the final rule. A few comments also supported allowing ``blanket'' 
releases of information. As under the present rule, we believe that 
blanket releases compromise the confidentiality of employee-specific 
records and are subject to abuse. The final rule continues this 
prohibition.

Sec. 40.353  What Principles Govern the Interaction Between MROs and 
Other Service Agents?

    This section is based on Sec. 40.351 of the NPRM. Much of the 
comment concerned the discretion of C/TPAs, acting as an intermediary, 
to transmit laboratory results to MRO and MRO verification decisions to 
the employer. As discussed in ``Principal Policy Issues'' and in 
connection with Sec. 40.345, the final rule permits the latter and 
prohibits the former.
    Some commenters appeared to believe that the proposed section 
required MROs to exercise full-time, in-person, over-the-shoulder 
supervision of their staffs. This is not the case. As long as MROs 
really supervise their staff, this supervision need not always take 
place at the same site. We are aware that MRO operations may have more 
than one site and that an MRO cannot be everywhere at once. On the 
other hand, the rule is intended to prohibit C/TPA staff, working on 
their own or under C/TPA rather than MRO supervision, from performing 
MRO staff functions.
    To reduce paperwork, we have deleted a proposed requirement for 
written agreements between MROs and other service agents.

Sec. 40.355  What Limitations Apply to the Activities of Service 
Agents?

    Some commenters on this section favored allowing C/TPAs to act as 
DERs and to act as an intermediary in transmitting results from 
laboratories to MROs. Another commenter opposed any ``firewalls'' 
between C/TPAs and MROs. As we have explained above, the final rule 
does not permit C/TPAs to act as DERs or to transmit laboratory results 
to MROs. In our view, some firewalls between MROs and other 
participants in the testing process are essential to maintaining the 
necessary independence of MROs.
    Another commenter said that employers, not SAPs, should make 
follow-up testing determinations. SAPs are used in the return-to-duty 
process because of their expertise in evaluating individuals with drug 
and alcohol problems. We believe that their expertise should be used to 
determine follow-up testing requirements. Employers may know their 
workers, of course, but they are not typically experts in drug and 
alcohol abuse evaluation and treatment.
    One commenter suggested adding a sentence specifying that MROs 
could determine that an individual had refused a test, in the context 
of an adulteration or substitution finding. We agree, and we have added 
this language.
    We have added a paragraph concerning a problem that the Department 
has occasionally encountered. It states that service agents must not 
intentionally delay the transmission of drug or alcohol testing-related 
documents because of a payment dispute or other reasons. Parties can 
work out disputes among themselves, but it is essential to the safety 
purposes of this program that drug and alcohol testing results and 
other information flow freely. As a safety matter, this information 
must not be held hostage to business disagreements.

Subpart R--Public Interest Exclusions

    The Department discussed PIEs extensively in the ``Principal Policy 
Issues'' portion of the preamble. We will not repeat this discussion 
here, focusing instead on points in the individual sections of Subpart 
R that should be highlighted.

Sec. 40.361  What Is The Purpose of a Public Interest Exclusion (PIE)?

Section 40.363  On What Basis May the Department Issue a PIE?

Section 40.365  What Is the Department's Policy Concerning Starting a 
PIE Proceeding?

    These sections emphasize that the basic purpose of PIEs is to 
protect the public from serious noncompliance on the part of service 
agents. PIEs are not an exclusive remedy: We can take other actions 
(e.g., sanctions against employers, referral to the DOT Inspector

[[Page 79513]]

General) if circumstances warrant. The basic grounds for issuing a PIE 
are serious noncompliance with Part 40 or DOT agency drug and alcohol 
testing regulations and failure to cooperate with DOT oversight and 
enforcement efforts.
    Section 40.365 includes a list illustrating the kinds of misconduct 
that we believe warrant initiating a PIE proceeding. We emphasize that 
this is not an exhaustive or exclusive list. We can and will initiate 
PIEs on the basis of other fact situations, if warranted. However, this 
list should give interested persons a good idea of the Department's 
policy concerning the level of seriousness that we intend to be the 
basis for PIE actions. The items on the list all concern such matters 
as safety, the outcomes of test results, privacy and confidentiality, 
due process and fairness for employees, the honesty and integrity of 
the testing program, and cooperation with or provision of information 
to DOT agency representatives. Many of the items are drawn from 
problems the Department has noted under the existing Part 40.
    We note that the PIE provisions of the rule are not intended to 
have retroactive effect. That is, the Department would not initiate a 
PIE proceeding on the basis of conduct that occurred before the PIE 
provisions took effect.

Section 40.367  Who Initiates a PIE Proceeding?

Section 40.369  What Is the Discretion of an Initiating Official in 
Starting a PIE Proceeding?

Section 40.371  On What Information Does an Initiating Official Rely in 
Deciding Whether To Start a PIE Proceeding?

Section 40.411  What Is the Role of the DOT Inspector General's Office?

    These sections concern the Department's decision about whether to 
begin a PIE proceeding. Only selected DOT officials are authorized to 
begin such a proceeding: DOT agency drug and alcohol program managers, 
an official of ODAPC other than the Director (who, as the 
decisionmaker, is precluded from any role in initiating or prosecuting 
a PIE proceeding), or the designee of these officials. We emphasize 
that individual inspectors and subordinate staff members, while they 
may provide information to initiating officials, are not themselves 
authorized to initiate PIE proceedings.
    Initiating officials have broad discretion in deciding whether to 
start a PIE proceeding, though this discretion must be exercised with 
the policy expressed Sec. 40.365 in mind. DOT is never required to 
start a PIE proceeding. An initiating official can take into account 
such factors as his or her judgment of the seriousness of the matter 
and the availability of resources to investigate and prosecute a matter 
adequately.
    An initiating official can rely on credible information from any 
source in deciding whether to start a proceeding. As many commenters 
requested, the initiating official will make an informal contact with 
the service agent before sending a correction notice, in an attempt to 
determine if the service agent has any information that would help the 
initiating official make his or her decision to initiate a proceeding.
    While the DOT inspector general (IG) is not an initiating official 
in the PIE process, the IG can investigate complaints concerning waste, 
fraud, and abuse in the drug and alcohol testing program. The 
initiating official can use information from IG investigations and 
audits as the basis to begin a PIE proceeding. The IG can also take 
action leading to criminal or civil action against a service agent or 
employer if the facts warrant.

Section 40.373  Before Starting a PIE Proceeding, Does the Initiating 
Official Give the Service Agent an Opportunity To Correct Problems?

Section 40.375  How Does the Initiating Official Start a PIE 
Proceeding?

    These sections describe the first formal steps in any PIE 
proceeding. Before taking other action, the initiating official sends a 
correction notice, outlining the compliance problem and giving the 
service agent 60 days to correct it. If the service agent documents 
correction of the problem in this period, the official does not pursue 
a PIE proceeding. If not, the official sends a notice of proposed 
exclusion (NOPE) to the service agent, detailing the basis for the 
proposed exclusion and informing the service agent of the next 
procedural steps.
    There may be some problems that cannot be corrected, or some 
misconduct so serious that subsequent corrective steps are insufficient 
to make up for the effects of noncompliance. For example, an MRO who 
has counterfeit medical credentials probably cannot correct this 
problem. A laboratory that has demonstrated a significant lack of 
business integrity by falsifying evidence or a pattern or practice of 
careless conduct resulting in the cancellation of numerous tests might 
have great difficulty demonstrating that it has made adequate changes 
to make up for the problems it caused. The Department is not limited, 
in deciding whether to initiate a PIE proceeding, to purely prospective 
considerations (e.g., analogous to the ``imminent [future] harm'' 
standard HHS uses in deciding to take certification action against a 
laboratory). Nor is the Department required to accept, on face value, 
assurances from a service agent that it has learned its lesson and will 
comply in the future. The Department will make judgments of this kind 
on a case-by-case basis.

Section 40.377  Who Decides Whether To Issue a PIE?

    This sections focuses on the role of the ODAPC Director as 
decisionmaker. Section 40.377 articulates the firewall between the 
Director and the initiating official, to ensure impartiality. The 
Director can delegate the decisionmaking role to another official 
(e.g., in a case where the Director would be unavailable to decide the 
case or recused himself or herself because of a potential conflict of 
interest), who would then be subject to the same firewall requirements.

Section 40.379  How Do You Contest the Issuance of a PIE?

Section 40.381  What Information Do You Present to Contest the Proposed 
Issuance of a PIE?

Section 40.383  What Procedures Apply if You Contest the Issuance of a 
PIE?

Section 40.385  Who Bears the Burden of Proof in a PIE Proceeding?

    These sections cover an important part of the administrative due 
process protections built into the PIE provisions of the rule. Within 
30 days of getting a NOPE, a service agent must contact the Director 
and make arrangements to present information and arguments. If the 
service agent asks to meet with the Director, the Director will 
schedule a meeting. At this meeting, or in a written presentation, the 
service agent may provide any arguments or factual information it 
believes relevant to the proposed issuance of a PIE, its scope and 
duration. We emphasize that the opportunity to meet with the Director 
is not a ``hearing'' or ``trial,'' with formal rules of evidence. The 
Director will consider any relevant evidence and listen to any 
witnesses the initiating official or the service agent presents. 
Because the initiating official is the proponent of the PIE action, he 
or she bears the burden of proof (by a preponderance of the evidence) 
on all issues. To justify issuing a PIE, the Director must find that 
the service agent failed or refused to perform drug and/or alcohol 
testing services as required by this part or is in serious 
noncompliance

[[Page 79514]]

with a DOT agency drug and alcohol regulation.

Section 40.387  What Matters Does the Director Decide Concerning a 
Proposed PIE?

Section 40.389  What Factors May the Director Consider?

Section 40.391  What Is the Scope of a PIE?

Section 40.393  How Long Does a PIE Stay in Effect?

Section 40.407  May a Service Agent Ask To Have a PIE Reduced or 
Terminated?

    These sections concern what decisions the Director makes and which 
factors the Director considers in deciding on whether to issue a PIE, 
as well as the scope and duration of a PIE. When the Director receives 
the NOPE and the service agent's response to it, the Director can 
dismiss the proceeding (e.g., for not raising a sufficiently serious 
noncompliance issue to warrant issuing a PIE), remand it to the 
initiating official for more fact finding, or continue with the 
proceeding. Whenever a proceeding does go to decision, the Director 
would make determinations concerning disputed factual issues, whether 
the facts support issuing a PIE, and the scope and duration of a PIE. 
The factors the Director considers in making these decisions include 
the seriousness of the noncompliance, the pervasiveness of the 
noncompliance within the service agent's organization, and the 
compliance disposition of the service agent.
    The scope of a PIE was the subject of many comments. In the final 
rule, the initiating official proposes a scope for the PIE, the service 
agent can contest the proposal, and the Director decides what the scope 
should be. The general rule is that a PIE applies to parts of an 
organization or types of services that are affected by the service 
agent's noncompliance. The more pervasive the misconduct, the broader 
the scope of the PIE. The rule text provides several examples of the 
Department's thinking on how to view the proper scope of a PIE.
    There are also situations in which the PIE can apply to individual 
officers or employees of the service agent, if they are responsible for 
the noncompliance that formed the basis for the PIE. This provision is 
intended to prevent individuals from going into business under a 
different business or corporate name while a PIE remains in effect 
against the service agent they worked for. The same is true of 
businesses affiliated with the service agent concerning which the 
Department issued a PIE.
    A PIE stays in effect from one to five years. Like the scope of a 
PIE, the duration of a PIE is proposed by the initiating official, may 
be contested by the service agent, and is decided upon by the ODAPC 
Director. The Director's decision is based on such factors as the 
seriousness of the noncompliance on which the PIE is based and the 
continued need to protect employers and employees from the service 
agent's noncompliance. The Director considers factors such as those 
listed in Sec. 40.387 in making this decision.
    After a PIE has been in effect for nine months, the service agent 
can apply to have its duration shortened. If the Director verifies that 
the sources of noncompliance have been eliminated and that all drug or 
alcohol testing-related services the service agent would provide to 
DOT-regulated employers will be consistent with the requirements of 
this part, the Director may issue a notice terminating or reducing the 
PIE. We emphasize that this process is limited to the issues of 
duration and scope: it is not an appeal or reconsideration of the 
decision to issue the PIE.

Section 40.395  Can You Settle a PIE Proceeding?

Section 40.397  When Does the Director Make a PIE Decision?

Section 40.399  How Does the Department Notify Service Agents of Its 
Decision?

Section 40.401  How Does the Department Notify Employers and the Public 
About a PIE?

Section 40.403  Must a Service Agent Notify Its Clients When the 
Department Issues a PIE?

Section 40.405  May the Federal Courts Review PIE Decisions?

Section 40.413  How Are Notices Sent to Service Agents?

    The next group of provisions concern the mechanics of making PIE 
decisions and informing people about them. The initiating official and 
the service agent can settle a PIE proceeding at any time before the 
Director issues a decision. The Director must concur in the settlement, 
which could include, for example, provisions to ensure compliance or a 
period of voluntary exclusion during which the service agent agrees not 
to provide certain services to DOT-regulated employers while it fixes 
noncompliance problems.
    The Director is normally responsible for making a decision within 
60 days of the record of the proceeding being completed. The Director 
can extend this normal decision period for 30 days at a time for good 
cause. It is the Department's policy to expedite these important 
decisions, however. Once the Director issues a decision, it is a final 
administrative action of the Department, subject, like all such 
actions, to judicial review under the Administrative Procedure Act.
    The Director must provide written notice of a PIE to the service 
agent, including a statement of the basis for his or her decision and 
the scope and duration of the PIE. The Department also informs the 
public about the PIE though a web site posting and a Federal Register 
notice. We also anticipate informing employer and testing industry 
groups about the action, so that they can inform their members. The 
service agent also has an affirmative responsibility to inform 
customers about the PIE, so that they can obtain services from and 
transfer records to other service agents. Finally, Sec. 40.113 concerns 
the mechanics of how notices are sent to service agents and when they 
are deemed to have been received. As a policy matter, the initiating 
official will make reasonable efforts to follow up with the service 
agent to ensure that the service agent has received and understood the 
notice.

Section 40.409  What Does the Issuance of a PIE Mean to Transportation 
Employers?

    Employers have an affirmative responsibility to stop using the 
services of a service agent that is subject to a PIE. This obligation 
begins 90 days after the Director issues the PIE, to give the employer 
time to find another service provider. The obligation applies to 
services provided through an affiliate of the service agent subject to 
the PIE as well as the service agent itself, and it applies to 
employers in all DOT-regulated industries. It is important to note that 
a PIE does not invalidate otherwise proper drug and alcohol tests in 
which the service agent was involved before, and for 90 days after, the 
issuance of the PIE. The rule text spells out the operation of this 
provision in more detail.

Appendices

Appendix A

    During the last decade of drug testing, the Department has not 
regulated nor standardized the materials (i.e., collection containers, 
specimen bottles, etc.) used in DOT-mandated drug

[[Page 79515]]

testing. During the first few years of drug testing, only one specimen 
bottle was required. Subsequent to the Omnibus Act, split specimen 
collections became a requirement for four of the six DOT agencies. In 
general, each laboratory provided to the collection site or the 
employer laboratory specific collection kits, many of which differed in 
composition.
    The introduction of the split, the fact that in the pipeline and 
maritime industry split collection was an employer option, and the wide 
variance among the laboratories' kits, resulted in significant problems 
and numerous tests had to be cancelled based on collector error that, 
at times, was due to the differences in the makeup of the kits.
    Several years ago, the Department requested all laboratories to 
provide samples of their urine collection kits. These were reviewed 
against the then current regulatory requirements (e.g., tamper-evident 
seals on the bottles, availability and use of shipping container seals, 
collection instructions), and a majority of kits did not meet the 
regulatory requirements. Laboratories were notified and corrective 
action was recommended, but the Department did not take any specific 
action to standardize these kits at that time.
    The Department is convinced that the new requirement for all DOT 
agencies to use splits, and the development of a standard kit, will 
result in fewer mistakes and cancellations of drug tests. In that 
light, Appendix A spells out broad criteria for the composition of 
urine collection kits.
    The requirement for a collection container should minimize the need 
to give the employee both bottles, when there is no collection 
container in the kit, and request the employee to urinate into only one 
bottle. In some cases, employees fill both bottles and collectors 
submit these, resulting in splits that do not reconfirm. In some cases, 
the two bottles contained urine of different colors, but collectors 
submitted them anyway.
    The requirement that the collection container and the bottles be 
wrapped or sealed in a plastic bag was established earlier to prevent 
accusations by the employee that either the collector or someone at the 
collection site introduced some foreign substance into the containers, 
causing a positive result. The standards specifically spell out that 
the collection container needs to be securely wrapped separately from 
the specimen bottles and that the bottles must be either shrink wrapped 
or sealed in plastic bags or may be secured with other methodology 
provided that the tamper-evident mechanism is effective and easily 
discernable to the employee.
    For example, the use of a tiny filament between the bottle and the 
cap which breaks when the bottle is first opened may be effective in 
determining if the bottle was opened, but only if the employee has this 
pointed out to him or her. Even at that, the employee would have to 
look very closely to see if the filament is or is not attached. Most 
collectors will not spend the time to go through this process and 
employees can say they were not really able to tell if the filament was 
in place. It is much easier to defend and remember that a bottle was 
wrapped in a plastic bag, rather than argue that the employee was or 
was not specifically shown the filament or that he or she actually did 
or did not see the filament. Conversely, a bottle that has a paper 
label.
    The use of a leak-resistant plastic bag has been in place for a 
number of years, driven primarily by U.S. Postal Service and courier 
and shipping services requirements as a safety issue related to 
transportation of biological specimens. Under the new standards, the 
plastic bags must not only be leak-resistant (no zip locked bags), but 
must also be tamper-evident. In other words, once the bag is sealed it 
cannot be opened without the opening becoming obvious.
    Under current rules, there is a requirement that the shipping 
container be sealed with a shipping container seal that is initialed or 
signed and dated by the collector. In the NPRM, we proposed to use a 
tamper-evident seal on the plastic bag instead of the shipping 
container, since in many cases, collectors may collect several 
specimens in plastic bags and hold or store them until they have 
several which can then be placed into a shipping contained which is 
subsequently sealed. There were few comments related to the kit, but 
laboratories did indicate that when a shipping container, usually a 
box, arrives at the laboratory with a broken seal, the specimens are 
tested provided the specimen bottle seals are intact. To date, the 
Department is not aware of any problems related to this practice. 
However, it does call into question the purpose of the second (shipping 
container) seal. The Department's position is that if the leak-
resistant plastic bag is tamper-evident, that serves as the secondary 
protection, which is currently ensured by the shipping seal.
    The primary concern is, and always has been, the integrity of the 
specimen bottle seals. As long as the integrity of the specimen bottle 
seals is intact, the condition of the shipping container seal is not 
relevant. The standards listed in Appendix A, therefore, do not include 
a requirement for a shipping container or plastic bag seal.
    The current regulatory requirement is that the ``specimens shall be 
placed in shipping containers designed to minimize the possibility of 
damage during shipment (e.g., specimen boxes and/or padded mailers)''. 
In many cases, kits contain cardboard boxes designed to hold only two 
bottles for shipment. In some cases, collection sites may, and do, 
place a number of specimens in plastic bags and then into one large 
shipping container or box, and transport the specimens in that manner. 
With the advent of stronger plastics, some laboratories are requesting 
collection sites to transport bottles wrapped in leak-resistant plastic 
bags which are placed into larger plastic envelopes, contending that 
because the specimen bottles are constructed of stronger plastic, this 
is an acceptable practice.
    The Department has discussed this issue of transporting specimens 
with two of the largest courier services and both have expressed their 
concerns about leakage of urine specimens in transit and concern for 
the safety of their employees. Both courier services require a 
watertight primary receptacle (bottle) and a secondary watertight 
container, which in this case would be the leak-resistant plastic bag. 
One courier requires a sturdy outer package consisting of corrugated 
fiberboard, wood, metal, or rigid plastic; Styrofoam boxes, plastic 
bags, and paper envelopes are not acceptable as outer packaging. The 
second major courier requires that the primary container (bottle) meet 
a 150-pound crush test. If it meets that test, it may be placed in a 
leak-resistant plastic bag or container and then may be placed in a 
secondary leak-resistant plastic envelope without further packaging. 
Conversely, if the bottle(s) does not meet the crush test, it must be 
placed into a secondary package, which meets the 150-pound crush test. 
The secondary package may then be placed into a plastic shipping 
envelope.
    The Department has determined that current shipping regulations and 
requirements are sufficient to ensure that specimens are shipped in a 
manner that will protect them from damage. Therefore, the standards 
direct that the specimen bottles be shipped in containers that can 
sufficiently protect them from damage; the standards do not specify the 
type of material or the extent of weight (crush test) that the shipping 
containers should meet. The standards also permit the specimens to be 
transported to a laboratory in the leak-resistant plastic bag provided 
they are hand-carried by a laboratory courier. In other words, the 
courier picks the

[[Page 79516]]

specimens up in whatever is a convenient shipping or carrying container 
and does not subsequently place them into a system (automated 
transportation, another delivery courier, or on a plane, railroad, or 
truck), but personally delivers them to the laboratory.

Appendix B

    Appendix B is simply a list of the data elements and format for the 
semi-annual laboratory report provided to employers. Laboratories 
should follow this format when they compose these reports.

Appendix D

    This appendix identifies the format and type of information that 
the MRO needs to submit to DOT when a split specimen test fails to 
reconfirm the presence of the drug/drug metabolite, adulterant, or the 
substitution finding found in the primary specimen.
    There has been a long-standing practice under the current rule that 
when the employee requests a test of the split specimen and the test of 
the split fails to reconfirm the presence of the drug/drug metabolite 
that was found in the primary specimen, or if the split was not 
available (i.e., not collected or leaked in transit), the MRO was 
required to report this result to the Department. The purpose of this 
report was to determine if this was an administrative or collection 
error (e.g., the primary bottle and the split bottle were not the same 
urine) or if the failure to reconfirm was one of a technical nature, 
requiring review by HHS. Although the majority of ``failures to 
reconfirm'' have been due to the unavailability of the split specimen, 
some of the technical problems led to the discovery of the various 
adulterants that are currently used to circumvent the testing process. 
Based on this, the Department will continue to require this reporting 
by the MRO.
    The Department has also decided to permit an employee to request 
the test of the split specimen when the primary specimen is reported as 
adulterated or substituted. Based on that decision, we have determined 
that should the split fail to indicate the adulterant or the 
substitution is not supported by the test of the split or the MRO 
cancels the test based on medical evidence, the MRO needs to report 
this cancellation to the Department in the same manner as if it was a 
positive result which failed to reconfirm.
    There is not a standard ``report'' that the MRO needs to fill out. 
However, for consistency of information, Appendix D provides the format 
for the information that the Department needs to fully assess if there 
are any technical problems in the testing process. For ease of use, the 
same format can be used for reporting cancellation of a positive as 
well as for adulteration and substitution.

Appendix E

    This Appendix lists the 12 criteria the Department examines in 
determining whether certification organizations should be accepted 
under Secs. 40.281-40.283 for participation in the SAP program. The 
first eleven items are the same criteria the Department has used in 
evaluating other certification organizations that are already part of 
the program (e.g., ICRC). The twelfth item is NCCA accreditation, 
discussed in the preamble to Sec. 40.281.

Appendix F

    This Appendix is a list of the drug and alcohol testing information 
transmission functions that C/TPAs are authorized to perform (see 
Sec. 40.345) C/TPAs may, acting as an intermediary, transmit the 
information in the listed regulatory sections to the DER for an 
employer, if the employer chooses to have the C/TPA do so. These are 
the only items that C/TPAs are permitted to transmit to the employer as 
an intermediary. The use of service agent intermediaries is prohibited 
in all other cases, such as transmission of laboratory drug test 
results to MROs, the transmission of SAP reports to employers, and the 
transmission of positive alcohol test results.
    In every case, the C/TPA must ensure that, in transmitting the 
information, it meets all requirements (e.g., concerning 
confidentiality and timing) that would apply if the party originating 
the information (e.g., an MRO or collector) sent the information 
directly to the employer. For example, if a C/TPA transmits MROs' drug 
testing results to DERs, you must transmit each drug test result to the 
DER in compliance with the requirements for MROs set forth in 
Sec. 40.157.

Appendix G

    The ATF included in Appendix G is a slight modification of the 
existing alcohol testing form. One commenter suggested that a new 
alcohol testing form be developed that incorporated requirements 
proposed by the NPRM (e.g., the name of the DER, whether an STT used a 
saliva device). We believe that a revised form will serve the program 
better by allowing us to capture the necessary information. At the same 
time, it will no longer require the employee to sign in Step 4 if the 
alcohol concentration is less than 0.02. This signature will only be 
necessary if the alcohol concentration is 0.02 or higher on the 
confirmation test. Consistent with the CCF, all pages of the form may 
be white, with the distribution legend at the bottom of pages 2 and 3 
following the colors of the current form. The OMB control number of the 
new form will be OMB 2105-0529, the same as for the current form. 
Program participants may start using the form January 18, 2001. Use of 
the form will become mandatory on August 1, 2001.

Regulatory Analyses and Notices

Executive Order 12866 and DOT Regulatory Policies and Procedures

    This rule is a significant rule for purposes of Executive Order 
12866. It is significant because of its policy importance and its 
impact upon sizeable industries. It is not, however, an economically 
significant regulation. It is a reworking of existing requirements, 
imposing few new mandates, and should not have significant incremental 
costs. Because of its multimodal impact and policy interest to 
regulated parties and service agents, it is a significant rule for 
purposes of the DOT Regulatory Policies and Procedures. Throughout this 
regulation, we have attempted to balance the costs of new requirements 
with the cost savings accrued through the elimination of some current 
requirements.

Economic Impacts

    There are two features of the regulation that would add new 
requirements having economic impacts. The first is the requirement for 
validity testing. As the result of work by HHS and the laboratories, 
these protocols are already in place and are being used by most 
laboratories, so we expect the incremental costs of this requirement to 
be modest. The Department believes that public safety is well-served by 
these steps to identify and hold accountable employees in safety-
sensitive positions who attempt to tamper with the testing process.
    Second, the rule includes additional training requirements for some 
service agents. Errors in the testing process resulting from lack of 
training can lead to increased employer program costs and increased 
paperwork required to document the errors and repeat the testing 
process. The rule upgrades requirements for collectors, MROs, and SAPs. 
Well-attended training courses for MROs already exist, as do some 
collector and SAP courses.
    At the same time, the Department anticipates cost savings from some 
provisions of the regulation, such as the

[[Page 79517]]

reductions in blind specimen requirements and mitigation of some 
reporting requirements. The additional training requirements discussed 
in the previous paragraphs will help to reduce costs from errors in the 
system. For example, every time a better-trained collector conducts a 
collection properly instead of making a mistake, the costs of 
developing memorandums for correction, preparing laboratory litigation 
packages, arbitration or court proceedings, and reversing personnel 
actions are avoided.
    The Department has estimated cost increases and decreases that 
could be expected if the proposed rule's provisions are made final. It 
is important to understand that this is a big program, touching some 
8.34 million employees working for about 673,413 employers. Around 
30,000 individuals and organizations work as service agents.
    In terms of new costs, the Department estimates an annual cost of 
about $1.4 million for validity testing. With respect to training for 
SAPs. MROs, BATs, STTs, and collectors, we anticipate that annual costs 
will run about $4 million. In addition, we estimate that there will be 
one-time costs for a variety of administrative requirements in the 
first year of implementation of approximately $1.93 million.
    On the other hand, we anticipate saving at least $4.3 million per 
year from the reduction in blind specimen testing (the savings will 
probably be somewhat greater, because fewer organizations will be 
required to submit blind specimens). By changing the current quarterly 
laboratory report requirement to require a semiannual report, we 
anticipate saving another $2.5 million annually. By permitting 
positive, adulterated, and substituted test results to be faxed rather 
than sent by overnight express, we project an annual $3.3 million 
saving. These annual savings are greater than the additional annual 
costs we anticipate for the proposed rule. In total, then, we estimate 
that the new rule will result in about $7.4 million in incremental 
costs versus $10.1 million in incremental savings, compared to the 
existing rule.
    The Department has placed in the docket for this rulemaking a 
document describing the basis for these estimates in greater detail.

Executive Order 13132 and Federalism

    This final rule does not have sufficient Federalism impacts to 
warrant further action under Executive Order 13132. The Department 
notes that the provisions of Part 40 are incorporated by reference in 
the other DOT agency drug and alcohol testing regulations, which have 
existing pre-emption provisions in them. Consequently, for example, a 
provision of a state or local law or regulation that conflicted with a 
provision of Part 40 could be subject to pre-emption on the basis of 
this existing operating administration authority.

Regulatory Flexibility Act

    With respect to the Regulatory Flexibility Act, the Department 
certifies that this rule does not have a significant economic impact on 
a substantial number of small entities, so a Regulatory Flexibility 
analysis has not been prepared. It is clear that the rule affects large 
numbers of small entities. Many thousands of covered employers are 
small businesses (e.g., small trucking companies, small transit 
authorities), as are many service agents (e.g., occupational health 
clinics). Given the small, and overall favorable, net change in 
regulatory costs compared to the present rule, spread over these 
thousands of small entitites, the cost impact per entity is expected to 
be negligible.
    We have also taken some steps, such as the reduction in blind 
specimens, the reduced frequency of some reports, and the discretion we 
have given C/TPAs to act as intermediaries in some situations, that 
should assist small entities in complying and reduce their burdens. For 
the smallest entities (e.g., owner-operators), we have also permitted 
C/TPAs to perform some additional functions. The PIE provision should 
reduce costs to small employers as the result of noncompliance by 
service agents. Our ability to create special provisions for small 
entities is limited by the need to have uniform requirements to ensure 
safety and fairness to employees. There must be a single standard for 
the accuracy and integrity of the program and the protection of 
legitimate employee interests that cannot vary with the size of the 
employer or service agent.
    This rulemaking resulted from a ``610 Review'' under the Regulatory 
Flexibility Act. We have reviewed the existing program to identify 
areas in which the rule can be improved with the effect of assisting 
small businesses to comply in a rational and cost-effective manner. In 
addition to the general clarification of the program this rule 
provides, we have identified some specific areas (e.g., blind specimen 
requirements, the addition of the public interest exclusion provision, 
the reduction in reporting frequencies, the discretionary use of C/TPAs 
to transmit information) that should be particularly helpful to small 
regulated employers.

Paperwork Reduction Act

    Since the inception of the Department's drug and alcohol testing 
program, each individual DOT agency has complied with the requirements 
of the Paperwork Reduction Act (PRA) by submitting a justification to 
the Office of Management and Budget (OMB). These PRA submissions 
reflected requirements derived from the respective DOT agency drug and 
alcohol regulations as well as from Part 40. The submissions were never 
presented to OMB in a coordinated fashion, nor were they reviewed 
together to ensure that all drug and alcohol program requirements were 
reflected in a manner that was consistent, accurate, and non-
duplicative.
    In January 2000, the Department began an effort to evaluate prior 
PRA submissions in an attempt to address disparities between DOT agency 
estimates as well as the aggregate burden and cost estimates. A One-DOT 
group was formed. Its goals were to bring consistency and simplicity to 
DOT's PRA submissions; eliminate PRA submission duplication between and 
among DOT agencies, OST, and other Federal agencies; eliminate PRA 
submission discrepancies; and, more importantly perhaps, ensure 
accuracy of submissions. In addition, the group decided to standardize 
cost, hour, and wage indicators, where possible, and to identify task 
commonalities in DOT agency regulations and standardize how they are 
reported to OMB. The group sought to determine where program PRA 
responsibilities for specific drug and alcohol program elements lie--
with the DOT agencies, OST, or other Federal agencies.
    The group identified a total of 37 PRA tasks contained in one or 
more of the regulations of six DOT agencies (i.e., that properly reside 
in the operating administration rules rather than in Part 40). Some 
tasks were shared by all or some DOT agencies, while other tasks were 
peculiar to only one DOT agency. The operating administrations 
subsequently made PRA submissions to OMB for these items, which OMB 
approved. These submissions resulted in a reduction in the paperwork 
burden attributable to operating administration rules, both because 
Part 40-related burdens were kept separate and because a significant 
overestimate of the burden connected with one of the operating 
administration programs was corrected. The total reduction was over 50 
million hours.
    Next, the Department constructed a baseline for the information 
collection burden attributable to the existing Part

[[Page 79518]]

40 (most of which had not previously been accounted for in PRA 
submissions or had been subsumed under operating administration 
submissions). This baseline is approximately 2.23 million hours. The 
Department submitted a PRA request to OMB concerning this material, 
which OMB has approved.
    Third, the Department compared the information collection burden of 
the existing Part 40 baseline to the estimated burden for the new Part 
40. Comparing the existing rule to the new rule, there are some items 
that increase (e.g., obtaining test results from previous employers, 
MRO review of negative test documentation, employer SAP lists being 
provided to employees), in part because they previously were accounted 
for under operating administration rules. Other items decreased (e.g., 
changing from quarterly to semi-annual laboratory reports). The largest 
decrease resulted from the drug testing form's burden hours being 
accounted for under the PRA responsibility of HHS. Cumulatively, the 
new Part 40's information collection burden is approximately about 842 
thousand hours, or about 1.39 million hours less than that of the 
existing Part 40.
    For informational purposes, the Department has placed its entire 
Paperwork Reduction Act package on the internet, on the same Docket 
Management System web site on which comments on this rulemaking are 
posted. Interested persons may review this material electronically. The 
following web address provides instructions and access to the DOT 
electronic docket: http://dms.dot.gov/search/. To find the material on 
the Part 40 rulemaking, just enter the number 6578 in the ``docket 
number'' search dialog box.
    In addition, we note that Sec. 40.25, which requires employers to 
obtain information from applicants about previous drug and alcohol test 
results, was not previously the subject of PRA-related comment. While 
this section is part of the PRA package OMB has approved in connection 
with Part 40, you may comment about the information collection aspects 
of the section. Please send any comments to Jim L. Swart, Drug and 
Alcohol Policy Advisor, 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 
<a href="/cdn-cgi/l/email-protection#b9d3d0d497caced8cbcdf9d6cacd97ddd6cd97ded6cf"><span class="__cf_email__" data-cfemail="503a393d7e2327312224103f23247e343f247e373f26">[email protected]</span></a> (e-mail).

Other Executive Orders

    There are a number of other Executive Orders that can affect 
rulemakings. These include Executive Orders 13084 (Consultation and 
Coordination with Indian Tribal Governments), 12988 (Civil Justice 
Reform), 12875 (Enhancing the Intergovernmental Partnership), 12630 
(Governmental Actions and Interference with Constitutionally Protected 
Property Rights), 12898 (Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations), 13045 
(Protection of Children from Environmental Health Risks and Safety 
Risks), and 12889 (Implementation of North American Free Trade 
Agreement). We have considered these Executive Orders in the context of 
this rule, and we believe that the rule does not directly affect the 
matters that the Executive Orders cover. We have prepared this 
rulemaking in accordance with the Presidential Directive on Plain 
Language.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedures, Alcohol abuse, Alcohol 
testing, Drug abuse, Drug testing, Laboratories, Reporting and 
recordkeeping requirements, Safety, Transportation.

    Issued this 1st day of December 2000, at Washington, DC.
Rodney E. Slater,
Secretary of Transportation.

    For the reasons set forth in the preamble, the Department of 
Transportation amends 49 CFR subtitle A as follows:
    1. Effective January 18, 2001, amend the current 49 CFR part 40 as 
follows:

PART 40--[AMENDED]

    a. The authority citation for Part 40 is revised to read as 
follows:

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
45101 et seq.

    b. Add Subparts E and F to read as follows:
Subpart E--Additional Administrative Provisions and Validity Testing
Sec.
40.201   Additional definitions.
40.203   Who issues authoritative interpretations of this 
regulation?
40.205   What is validity testing, and are laboratories authorized 
to conduct it?
40.207   What validity tests must laboratories conduct on primary 
specimens?
40.209   What criteria do laboratories use to establish that a 
specimen is dilute or substituted?
40.211   What criteria do laboratories use to establish that a 
specimen is adulterated?
40.213   How long does the laboratory retain specimens after 
testing?
40.215   On what basis does the MRO verify test results involving 
adulteration or substitution?
40.217   What does the second laboratory do with the split specimen 
when it is tested to reconfirm an adulterated test result?
40.219   What does the second laboratory do with the split specimen 
when it is tested to reconfirm a substituted test result?
40.221   What information do laboratories report to MROs regarding 
split specimen results?
40.223   What does the MRO do with split specimen laboratory 
results?
40.225   What is a refusal to take a DOT drug test, and what are the 
consequences?
Subpart F--Public Interest Exclusions
40.301-40.359  [Reserved]
40.361   What is the purpose of a public interest exclusion (PIE)?
40.363   On what basis may the Department issue a PIE?
40.365   What is the Department's policy concerning starting a PIE 
proceeding?
40.367   Who initiates a PIE proceeding?
40.369   What is the discretion of an initiating official in 
starting a PIE proceeding?
40.371   On what information does an initiating official rely in 
deciding whether to start a PIE proceeding?
40.373   Before starting a PIE proceeding, does the initiating 
official give the service agent an opportunity to correct problems?
40.375   How does the initiating official start a PIE proceeding?
40.377   Who decides whether to issue a PIE?
40.379   How do you contest the issuance of a PIE?
40.381   What information do you present to contest the proposed 
issuance of a PIE?
40.383   What procedures apply if you contest the issuance of a PIE?
40.385   Who bears the burden of proof in a PIE proceeding?
40.387   What matters does the Director decide concerning a proposed 
PIE?
40.389   What factors may the Director consider?
40.391   What is the scope of a PIE?
40.393   How long does a PIE stay in effect?
40.395   Can you settle a PIE proceeding?
40.397   When does the Director make a PIE decision?
40.399   How does the Department notify service agents of its 
decision?
40.401   How does the Department notify employers and the public 
about a PIE?
40.403   Must a service agent notify its clients when the Department 
issues a PIE?
40.405   May the Federal courts review PIE decisions?
40.407   May a service agent ask to have a PIE reduced or 
terminated?
40.409   What does the issuance of a PIE mean to transportation 
employers?
40.411   What is the role of the DOT Inspector General's office?
40.413   How are notices sent to service agents?

[[Page 79519]]

Subpart E--Additional Administrative Provisions and Validity 
Testing


Sec. 40.201  Additional definitions.

    The following definitions apply to the provisions of this subpart E 
and subpart F of this part:
    Adulterated specimen. A specimen that contains a substance that is 
not expected to be present in human urine, or contains a substance 
expected to be present but is at a concentration so high that it is not 
consistent with human urine.
    Affiliate. Persons are affiliates of one another if, directly or 
indirectly, one controls or has the power to control the other, or a 
third party controls or has the power to control both. Indicators of 
control include, but are not limited to: interlocking management or 
ownership; shared interest among family members; shared facilities or 
equipment; or common use of employees. Following the issuance of a 
public interest exclusion, an organization having the same or similar 
management, ownership, or principal employees as the service agent 
concerning whom a public interest exclusion is in effect is regarded as 
an affiliate. This definition is used in connection with the public 
interest exclusion procedures of Subpart F of this part.
    Confirmation (or confirmatory) validity test. A second test 
performed on a urine specimen to further support a validity test 
result.
    Dilute specimen. A specimen with creatinine and specific gravity 
values that are lower than expected for human urine.
    Initial validity test. The first test used to determine if a 
specimen is adulterated, diluted, or substituted.
    Office of Drug and Alcohol Policy and Compliance (ODAPC). The 
office in the Office of the Secretary, DOT, that is responsible for 
coordinating drug and alcohol testing program matters within the 
Department and providing information concerning the implementation of 
this part.
    Split specimen. In drug testing, a part of the urine specimen that 
is sent to a first laboratory and retained unopened, and which is 
transported to a second laboratory in the event that the employee 
requests that it be tested following a verified positive test of the 
primary specimen or a verified adulterated or substituted test result.
    Substituted specimen. A specimen with creatinine and specific 
gravity values that are so diminished that they are not consistent with 
human urine.


Sec. 40.203  Who issues authoritative interpretations of this 
regulation?

    ODAPC and the DOT Office of General Counsel (OGC) provide written 
interpretations of the provisions of this part. These written DOT 
interpretations are the only official and authoritative interpretations 
concerning the provisions of this part. DOT agencies may incorporate 
ODAPC/OGC interpretations in written guidance they issue concerning 
drug and alcohol testing matters.


Sec. 40.205  What is validity testing, and are laboratories authorized 
to conduct it?

    (a) Specimen validity testing is the evaluation of the specimen to 
determine if it is consistent with normal human urine. The purpose of 
validity testing is to determine whether certain adulterants or foreign 
substances were added to the urine, if the urine was diluted, or if the 
specimen was substituted.
    (b) As a laboratory, you are authorized to conduct validity 
testing.


Sec. 40.207  What validity tests must laboratories conduct on primary 
specimens?

    As a laboratory, if you conduct validity testing under the 
authorization of Sec. 40.205(b), you must conduct it in accordance with 
the requirements of this section.
    (a) You must test each primary specimen for creatinine. You must 
also determine its specific gravity if you find that the creatinine 
concentration is less than 20 mg/dL.
    (b) You must measure the pH of each primary specimen.
    (c) You must test each primary specimen to determine if it contains 
substances that may be used to adulterate the specimen. Your tests must 
have the capability of determining whether any substance identified in 
current HHS requirements or specimen validity guidance is present in 
the specimen.
    (d) If you suspect the presence of an interfering substance/
adulterant that could make a test result invalid, but you are unable to 
identify it (e.g., a new adulterant), you may, as the first laboratory, 
send the specimen to another HHS certified laboratory that has the 
capability of doing so.
    (e) If you identify a substance in a specimen that appears to be an 
adulterant, but which is not listed in current HHS requirements or 
guidance, you must report the finding in writing to ODAPC and the 
Division of Workplace Programs, HHS, within three business days. You 
must also complete testing of the specimen for drugs, to the extent 
technically feasible.
    (f) You must conserve as much as possible of the specimen for 
possible future testing.


Sec. 40.209  What criteria do laboratories use to establish that a 
specimen is dilute or substituted?

    (a) As a laboratory you must consider the primary specimen to be 
dilute if the creatinine concentration is less than 20 mg/dL and the 
specific gravity is less than 1.003, unless the criteria for a 
substituted specimen are met.
    (b) As a laboratory you must consider the primary specimen to be 
substituted if the creatinine concentration is less than or equal to 5 
mg/dL and the specific gravity is less than or equal to 1.001 or 
greater than or equal to 1.020.


Sec. 40.211  What criteria do laboratories use to establish that a 
specimen is adulterated?

    (a) As a laboratory, you must consider the primary specimen to be 
adulterated if you determine that--
    (1) A substance that is not expected to be present in human urine 
is identified in the specimen;
    (2) A substance that is expected to be present in human urine is 
identified at a concentration so high that it is not consistent with 
human urine; or
    (3) The physical characteristics of the specimen are outside the 
normal expected range for human urine.
    (b) In making your determination under paragraph (a) of this 
section, you must apply the criteria in current HHS requirements or 
specimen validity guidance.


Sec. 40.213  How long does the laboratory retain specimens after 
testing?

    (a) As a laboratory testing the primary specimen, you must retain a 
specimen that was reported with positive, adulterated, substituted, or 
invalid results for a minimum of one year.
    (b) You must keep such a specimen in secure, long-term, frozen 
storage in accordance with HHS requirements.
    (c) Within the one-year period, the MRO, the employee, the 
employer, or a DOT agency may request in writing that you retain a 
specimen for an additional period of time (e.g., for the purpose of 
preserving evidence for litigation or a safety investigation). If you 
receive such a request, you must comply with it. If you do not receive 
such a request, you may discard the specimen at the end of the year.
    (d) If you have not sent the split specimen to another laboratory 
for testing, you must retain the split specimen for an employee's test 
for the same period of time that you retain the primary specimen and 
under the same storage conditions.

[[Page 79520]]

    (e) As the laboratory testing the split specimen, you must meet the 
requirements of paragraphs (a) through (c) of this section with respect 
to the split specimen.


Sec. 40.215  On what basis does the MRO verify test results involving 
adulteration or substitution?

    (a) As an MRO, when you receive a laboratory report that a specimen 
is adulterated or substituted, you must treat that report in the same 
way you treat the laboratory's report of a confirmed positive test for 
a drug or drug metabolite.
    (b) You must follow the same procedures used for verification of a 
confirmed positive test for a drug or drug except as otherwise provided 
in this section.
    (c) In the verification interview, you must explain the laboratory 
findings to the employee and address technical questions or issues the 
employee may raise.
    (d) You must offer the employee the opportunity to present a 
legitimate medical explanation for the laboratory findings with respect 
to presence of the adulterant in, or the creatinine and specific 
gravity findings for, the specimen.
    (e) The employee has the burden of proof that there is a legitimate 
medical explanation.
    (1) To meet this burden in the case of an adulterated specimen, the 
employee must demonstrate that the adulterant found by the laboratory 
entered the specimen through physiological means.
    (2) To meet this burden in the case of a substituted specimen, the 
employee must demonstrate that he or she did produce or could have 
produced urine, through physiological means, meeting the creatinine and 
specific gravity criteria of Sec. 40.209(b).
    (3) The employee must present information meeting this burden at 
the time of the verification interview. As the MRO, you have discretion 
to extend the time available to the employee for this purpose for up to 
five days before verifying the specimen, if you determine that there is 
a reasonable basis to believe that the employee will be able to produce 
relevant evidence supporting a legitimate medical explanation within 
that time.
    (f) As the MRO or the employer, you are not responsible for 
arranging, conducting, or paying for any studies, examinations or 
analyses to determine whether a legitimate medical explanation exists.
    (g) As the MRO, you must exercise your best professional judgment 
in deciding whether the employee has established a legitimate medical 
explanation.
    (1) If you determine that the employee's explanation does not 
present a reasonable basis for concluding that there may be a 
legitimate medical explanation, you must report the test to the DER as 
a verified refusal to test because of adulteration or substitution, as 
applicable.
    (2) If you believe that the employee's explanation may present a 
reasonable basis for concluding that there is a legitimate medical 
explanation, you must direct the employee to obtain, within the five-
day period set forth in paragraph (e)(3) of this section, a further 
medical evaluation. This evaluation must be performed by a licensed 
physician (the ``referral physician''), acceptable to you, with 
expertise in the medical issues raised by the employee's explanation. 
(The MRO may perform this evaluation if the MRO has appropriate 
expertise.)
    (i) As the MRO or employer, you are not responsible for finding or 
paying a referral physician. However, on request of the employee, you 
must provide reasonable assistance to the employee's efforts to find 
such a physician. The final choice of the referral physician is the 
employee's, as long as the physician is acceptable to you.
    (ii) As the MRO, you must consult with the referral physician, 
providing guidance to him or her concerning his or her responsibilities 
under this section. As part of this consultation, you must provide the 
following information to the referral physician:
    (A) That the employee was required to take a DOT drug test, but the 
laboratory reported that the specimen was adulterated or substituted, 
which is treated as a refusal to test;
    (B) The consequences of the appropriate DOT agency regulation for 
refusing to take the required drug test;
    (C) That the referral physician must agree to follow the 
requirements of paragraphs (g)(3) through (g)(4) of this section; and
    (D) That the referral physician must provide you with a signed 
statement of his or her recommendations.
    (3) As the referral physician, you must evaluate the employee and 
consider any evidence the employee presents concerning the employee's 
medical explanation. You may conduct additional tests to determine 
whether there is a legitimate medical explanation. Any additional urine 
tests must be performed in an HHS-certified laboratory.
    (4) As the referral physician, you must then make a written 
recommendation to the MRO about whether the MRO should determine that 
there is a legitimate medical explanation. As the MRO, you must 
seriously consider and assess the referral physician's recommendation 
in deciding whether there is a legitimate medical explanation.
    (5) As the MRO, if you determine that there is a legitimate medical 
explanation, you must cancel the test and inform ODAPC in writing of 
the determination and the basis for it (e.g., referral physician's 
findings, evidence produced by the employee).
    (6) As the MRO, if you determine that there is not a legitimate 
medical explanation, you must report the test to the DER as a verified 
refusal to test because of adulteration or substitution.
    (h) The following are examples of types of evidence an employee 
could present to support an assertion of a legitimate medical 
explanation for a substituted result:
    (1) Medically valid evidence demonstrating that the employee is 
capable of physiologically producing urine meeting the creatinine and 
specific gravity criteria of Sec. 40.209(b).
    (i) To be regarded as medically valid, the evidence must have been 
gathered using appropriate methodology and controls to ensure its 
accuracy and reliability.
    (ii) Assertion by the employee that his or her personal 
characteristics (e.g., with respect to race, gender, weight, diet, 
working conditions) are responsible for the substituted result does 
not, in itself, constitute a legitimate medical explanation. To make a 
case that there is a legitimate medical explanation, the employee must 
present evidence showing that the cited personal characteristics 
actually result in the physiological production of urine meeting the 
creatinine and specific gravity criteria of Sec. 40.209 (b).
    (2) Information from a medical evaluation under paragraph (g) of 
this section that the individual has a medical condition that has been 
demonstrated to cause the employee to physiologically produce urine 
meeting the creatinine and specific gravity criteria of Sec. 40.209(b).
    (i) A finding or diagnosis by the physician that an employee has a 
medical condition, in itself, does not constitute a legitimate medical 
explanation.
    (ii) To establish there is a legitimate medical explanation, the 
employee must demonstrate that the cited medical condition actually 
results in the physiological production of urine meeting the creatinine 
and specific gravity criteria of Sec. 40.209(b).

[[Page 79521]]

Sec. 40.217  What does the second laboratory do with the split specimen 
when it is tested to reconfirm an adulterated test result?

    As the laboratory testing the split specimen, you must test the 
split specimen for the adulterant detected in the primary specimen 
using the same criteria that were used for the primary specimen or HHS 
guidance, as applicable. The result of the primary specimen is 
reconfirmed if the split specimen meets these criteria.


Sec. 40.219  What does the second laboratory do with the split specimen 
when it is tested to reconfirm a substituted test result?

    As the laboratory testing the split specimen, you must test the 
split specimen using the criteria of Sec. 40.209(b), just as you would 
do for a primary specimen. The result of the primary specimen is 
reconfirmed if the split specimen meets these criteria.


Sec. 40.221  What information do laboratories report to MROs regarding 
split specimen results?

    (a) As the laboratory responsible for testing the split specimen, 
and you are using the Federal Testing Custody and Control Form (CCF) 
issued by HHS on June 23, 2000, you must report split specimen test 
results in adulteration and substitution situations by checking the 
``Reconfirmed'' box or the ``Failed to Reconfirm'' box (Step 5(b)) on 
Copy 1 of the CCF.
    (b) If you check the ``Failed to Reconfirm'' box, one of the 
following statements must be included (as appropriate) on the 
``Reason'' line (Step 5(b)):
    (1) Drug(s)/metabolite(s) not detected.''
    (2) ``Adulterant not found within criteria.''
    (3) ``Specimen not consistent with substitution criteria [specify 
creatinine, specific gravity, or both]''
    (4) ``Specimen not available for testing.''
    (c ) If you are using the CCF issued by HHS prior to June 23, 2000, 
enter the information referenced in paragraph (b) (2), (3), or (4) of 
this section on the ``remarks'' line.
    (d) As the laboratory certifying scientist, enter your name, sign, 
and date the CCF.


Sec. 40.223  What does the MRO do with split specimen laboratory 
results?

    As an MRO, you must take the following actions when a laboratory 
reports the following results of split specimen tests concerning 
adulterated or substituted specimens:
    (a) Reconfirmed. (1) In the case of a reconfirmed positive test for 
a drug or drug metabolite, report the reconfirmation to the DER and the 
employee.
    (2) In the case of a reconfirmed adulterated or substituted result, 
report to the DER and the employee that the specimen was adulterated or 
substituted, either of which constitutes a refusal to test. Therefore, 
``refusal to test'' is the final result.
    (b) Failed to Reconfirm: Drug(s)/Drug Metabolite(s) Not Detected. 
(1) Report to the DER and the employee that both tests must be 
cancelled.
    (2) Inform ODAPC of the failure to reconfirm.
    (c) Failed to Reconfirm: Adulterated or Substituted (as 
appropriate); Criteria Not Met. (1) Report to the DER and the employee 
that both tests must be cancelled.
    (2) Inform ODAPC of the failure to reconfirm.
    (d) Failed to Reconfirm: Specimen not Available for Testing. (1) 
Report to the DER and the employee that both tests must be cancelled 
and the reason for cancellation.
    (2) Direct the DER to ensure the immediate collection of another 
specimen from the employee under direct observation, with no notice 
given to the employee of this collection requirement until immediately 
before the collection.
    (3) Inform ODAPC of the failure to reconfirm.
    (e) Enter your name, sign and date the appropriate copy of the CCF.
    (f) Send a legible copy of the appropriate copy of the CCF (or a 
signed and dated letter) to the employer and keep a copy for your 
records.


Sec. 40.225  What is a refusal to take a DOT drug test, and what are 
the consequences?

    (a) [Reserved]
    (b) As an employee, if the MRO reports that you have a verified 
adulterated or substituted test result, you have refused to take a drug 
test.
    (c) As an employee, if you refuse to take a drug test, you incur 
the consequences specified under DOT agency regulations for a violation 
of those DOT agency regulations.
    (d) [Reserved]
    (e) [Reserved]

Subpart F--Public Interest Exclusions


Secs. 40.301-40.359  [Reserved]


Sec. 40.361  What is the purpose of a public interest exclusion (PIE)?

    (a) To protect the public interest, including protecting 
transportation employers and employees from serious noncompliance with 
DOT drug and alcohol testing rules, the Department's policy is to 
ensure that employers conduct business only with responsible service 
agents.
    (b) The Department therefore uses PIEs to exclude from 
participation in DOT's drug and alcohol testing program any service 
agent who, by serious noncompliance with this part or other DOT agency 
drug and alcohol testing regulations, has shown that it is not 
currently acting in a responsible manner.
    (c) A PIE is a serious action that the Department takes only to 
protect the public interest. We intend to use PIEs only to remedy 
situations of serious noncompliance. PIEs are not used for the purpose 
of punishment.
    (d) Nothing in this subpart precludes a DOT agency or the Inspector 
General from taking other action authorized by its regulations with 
respect to service agents or employers that violate its regulations.


Sec. 40.363  On what basis may the Department issue a PIE?

    (a) If you are a service agent, the Department may issue a PIE 
concerning you if we determine that you have failed or refused to 
provide drug or alcohol testing services consistent with the 
requirements of this part or a DOT agency drug and alcohol regulation.
    (b) The Department also may issue a PIE if you have failed to 
cooperate with DOT agency representatives concerning inspections, 
complaint investigations, compliance and enforcement reviews, or 
requests for documents and other information about compliance with this 
part or DOT agency drug and alcohol regulations.


Sec. 40.365  What is the Department's policy concerning starting a PIE 
proceeding?

    (a) It is the Department's policy to start a PIE proceeding only in 
cases of serious, uncorrected noncompliance with the provisions of this 
part, affecting such matters as safety, the outcomes of test results, 
privacy and confidentiality, due process and fairness for employees, 
the honesty and integrity of the testing program, and cooperation with 
or provision of information to DOT agency representatives.
    (b) The following are examples of the kinds of serious 
noncompliance that, as a matter of policy, the Department views as 
appropriate grounds for starting a PIE proceeding. These examples are 
not intended to be an exhaustive or exclusive list of the grounds for 
starting a PIE proceeding. We intend them to illustrate the level of 
seriousness that the Department believes supports starting a PIE 
proceeding. The examples follow:
    (1) For an MRO, verifying tests positive without interviewing the

[[Page 79522]]

employees as required by this part or providing MRO services without 
meeting the qualifications for an MRO required by this part;
    (2) For a laboratory, refusing to provide information to the 
Department, an employer, or an employee as required by this part; or a 
pattern or practice of testing errors that result in the cancellation 
of tests. (As a general matter of policy, the Department does not 
intend to initiate a PIE proceeding concerning a laboratory with 
respect to matters on which HHS initiates certification actions under 
its laboratory guidelines.);
    (3) For a collector, a pattern or practice of directly observing 
collections when doing so is unauthorized, or failing or refusing to 
directly observe collections when doing so is mandatory;
    (4) For collectors, BATs, or STTs, a pattern or practice of using 
forms, testing equipment, or collection kits that do not meet the 
standards in this part;
    (5) For a collector, BAT, or STT, a pattern or practice of ``fatal 
flaws'' or other significant uncorrected errors in the collection 
process;
    (6) For a laboratory, MRO or C/TPA, failing or refusing to report 
tests results as required by this part or DOT agency regulations;
    (7) For a laboratory, falsifying, concealing, or destroying 
documentation concerning any part of the drug testing process, 
including, but not limited to, documents in a ``litigation package'';
    (8) For SAPs, providing SAP services while not meeting SAP 
qualifications required by this part or performing evaluations without 
face-to-face interviews;
    (9) For any service agent, maintaining a relationship with another 
party that constitutes a conflict of interest under this part (e.g., a 
laboratory that derives a financial benefit from having an employer use 
a specific MRO);
    (10) For any service agent, representing falsely that the service 
agent or its activities is approved or certified by the Department or a 
DOT agency;
    (11) For any service agent, disclosing an employee's test result 
information to any party this part or a DOT agency regulation does not 
authorize, including by obtaining a ``blanket'' consent from employees 
or by creating a data base from which employers or others can retrieve 
an employee's DOT test results without the specific consent of the 
employee;
    (12) For any service agent, interfering or attempting to interfere 
with the ability of an MRO to communicate with the Department, or 
retaliating against an MRO for communicating with the Department;
    (13) For any service agent, directing or recommending that an 
employer fail or refuse to implement any provision of this part; or
    (14) With respect to noncompliance with a DOT agency regulation, 
conduct that affects important provisions of Department-wide concern 
(e.g., failure to properly conduct the selection process for random 
testing).


Sec. 40.367  Who initiates a PIE proceeding?

    The following DOT officials may initiate a PIE proceeding:
    (a) The drug and alcohol program manager of a DOT agency;
    (b) An official of ODAPC, other than the Director; or
    (c) The designee of any of these officials.


Sec. 40.369  What is the discretion of an initiating official in 
starting a PIE proceeding?

    (a) Initiating officials have broad discretion in deciding whether 
to start a PIE proceeding.
    (b) In exercising this discretion, the initiating official must 
consider the Department's policy regarding the seriousness of the 
service agent's conduct (see Sec. 40.365) and all information he or she 
has obtained to this point concerning the facts of the case. The 
initiating official may also consider the availability of the resources 
needed to pursue a PIE proceeding.
    (c) A decision not to initiate a PIE proceeding does not 
necessarily mean that the Department regards a service agent as being 
in compliance or that the Department may not use other applicable 
remedies in a situation of noncompliance.


Sec. 40.371  On what information does an initiating official rely in 
deciding whether to start a PIE proceeding?

    (a) An initiating official may rely on credible information from 
any source as the basis for starting a PIE proceeding.
    (b) Before sending a correction notice (see Sec. 40.373), the 
initiating official informally contacts the service agent to determine 
if there is any information that may affect the initiating official's 
determination about whether it is necessary to send a correction 
notice. The initiating official may take any information resulting from 
this contact into account in determining whether to proceed under this 
subpart.


Sec. 40.373  Before starting a PIE proceeding, does the initiating 
official give the service agent an opportunity to correct problems?

    (a) If you are a service agent, the initiating official must send 
you a correction notice before starting a PIE proceeding.
    (b) The correction notice identifies the specific areas in which 
you must come into compliance in order to avoid being subject to a PIE 
proceeding.
    (c) If you make and document changes needed to come into compliance 
in the areas listed in the correction notice to the satisfaction of the 
initiating official within 60 days of the date you receive the notice, 
the initiating official does not start a PIE proceeding. The initiating 
official may conduct appropriate fact finding to verify that you have 
made and maintained satisfactory corrections. When he or she is 
satisfied that you are in compliance, the initiating official sends you 
a notice that the matter is concluded.


Sec. 40.375  How does the initiating official start a PIE proceeding?

    (a) As a service agent, if your compliance matter is not 
correctable (see Sec. 40.373(a)), or if have not resolved compliance 
matters as provided in Sec. 40.373(c), the initiating official starts a 
PIE proceeding by sending you a notice of proposed exclusion (NOPE). 
The NOPE contains the initiating official's recommendations concerning 
the issuance of a PIE, but it is not a decision by the Department to 
issue a PIE.
    (b) The NOPE includes the following information:
    (1) A statement that the initiating official is recommending that 
the Department issue a PIE concerning you;
    (2) The factual basis for the initiating official's belief that you 
are not providing drug and/or alcohol testing services to DOT-regulated 
employers consistent with the requirements of this part or are in 
serious noncompliance with a DOT agency drug and alcohol regulation;
    (3) The factual basis for the initiating official's belief that 
your noncompliance has not been or cannot be corrected;
    (4) The initiating official's recommendation for the scope of the 
PIE;
    (5) The initiating official's recommendation for the duration of 
the PIE; and
    (6) A statement that you may contest the issuance of the proposed 
PIE, as provided in Sec. 40.379.
    (c) The initiating official sends a copy of the NOPE to the ODAPC 
Director at the same time he or she sends the NOPE to you.


Sec. 40.377  Who decides whether to issue a PIE?

    (a) The ODAPC Director, or his or her designee, decides whether to 
issue a PIE. If a designee is acting as the

[[Page 79523]]

decisionmaker, all references in this subpart to the Director refer to 
the designee.
    (b) To ensure his or her impartiality, the Director plays no role 
in the initiating official's determination about whether to start a PIE 
proceeding.
    (c) There is a ``firewall'' between the initiating official and the 
Director. This means that the initiating official and the Director are 
prohibited from having any discussion, contact, or exchange of 
information with one another about the matter, except for documents and 
discussions that are part of the record of the proceeding.


Sec. 40.379  How do you contest the issuance of a PIE?

    (a) If you receive a NOPE, you may contest the issuance of the PIE.
    (b) If you want to contest the proposed PIE, you must provide the 
Director information and argument in opposition to the proposed PIE in 
writing, in person, and/or through a representative. To contest the 
proposed PIE, you must take one or more of the steps listed in this 
paragraph (b) within 30 days after you receive the NOPE.
    (1) You may request that the Director dismiss the proposed PIE 
without further proceedings, on the basis that it does not concern 
serious noncompliance with this part or DOT agency regulations, 
consistent with the Department's policy as stated in Sec. 40.365.
    (2) You may present written information and arguments, consistent 
with the provisions of Sec. 40.381, contesting the proposed PIE.
    (3) You may arrange with the Director for an informal meeting to 
present your information and arguments.
    (c) If you do not take any of the actions listed in paragraph (b) 
of this section within 30 days after you receive the NOPE, the matter 
proceeds as an uncontested case. In this event, the Director makes his 
or her decision based on the record provided by the initiating official 
(i.e., the NOPE and any supporting information or testimony) and any 
additional information the Director obtains.


Sec. 40.381  What information do you present to contest the proposed 
issuance of a PIE?

    (a) As a service agent who wants to contest a proposed PIE, you 
must present at least the following information to the Director:
    (1) Specific facts that contradict the statements contained in the 
NOPE (see Sec. 40.375(b)(2) and (3)). A general denial is insufficient 
to raise a genuine dispute over facts material to the issuance of a 
PIE;
    (2) Identification of any existing, proposed or prior PIE; and
    (3) Identification of your affiliates, if any.
    (b) You may provide any information and arguments you wish 
concerning the proposed issuance, scope and duration of the PIE (see 
Sec. 40.375(b)(4) and (5).
    (c) You may provide any additional relevant information or 
arguments concerning any of the issues in the matter.


Sec. 40.383  What procedures apply if you contest the issuance of a 
PIE?

    (a) DOT conducts PIE proceedings in a fair and informal manner. The 
Director may use flexible procedures to allow you to present matters in 
opposition. The Director is not required to follow formal rules of 
evidence or procedure in creating the record of the proceeding.
    (b) The Director will consider any information or argument he or 
she determines to be relevant to the decision on the matter.
    (c) You may submit any documentary evidence you want the Director 
to consider. In addition, if you have arranged an informal meeting with 
the Director, you may present witnesses and confront any person the 
initiating official presents as a witness against you.
    (d) In cases where there are material factual issues in dispute, 
the Director or his or her designee may conduct additional fact-
finding.
    (e) If you have arranged a meeting with the Director, the Director 
will make a transcribed record of the meeting available to you on your 
request. You must pay the cost of transcribing and copying the meeting 
record.


Sec. 40.385  Who bears the burden of proof in a PIE proceeding?

    (a) As the proponent of issuing a PIE, the initiating official 
bears the burden of proof.
    (b) This burden is to demonstrate, by a preponderance of the 
evidence, that the service agent was in serious noncompliance with the 
requirements of this part for drug and/or alcohol testing-related 
services or with the requirements of another DOT agency drug and 
alcohol testing regulation.


Sec. 40.387  What matters does the Director decide concerning a 
proposed PIE?

    (a) Following the service agent's response (see Sec. 40.379(b)) or, 
if no response is received, after 30 days have passed from the date on 
which the service agent received the NOPE, the Director may take one of 
the following steps:
    (1) In response to a request from the service agent (see 
Sec. 40.379(b)(1)) or on his or her own motion, the Director may 
dismiss a PIE proceeding if he or she determines that it does not 
concern serious noncompliance with this part or DOT agency regulations, 
consistent with the Department's policy as stated in Sec. 40.365.
    (i) If the Director dismisses a proposed PIE under this paragraph 
(a), the action is closed with respect to the noncompliance alleged in 
the NOPE.
    (ii) The Department may initiate a new PIE proceeding against you 
on the basis of different or subsequent conduct that is in 
noncompliance with this part or other DOT drug and alcohol testing 
rules.
    (2) If the Director determines that the initiating official's 
submission does not have complete information needed for a decision, 
the Director may remand the matter to the initiating official. The 
initiating official may resubmit the matter to the Director when the 
needed information is complete. If the basis for the proposed PIE has 
changed, the initiating official must send an amended NOPE to the 
service agent.
    (b) The Director makes determinations concerning the following 
matters in any PIE proceeding that he or she decides on the merits:
    (1) Any material facts that are in dispute;
    (2) Whether the facts support issuing a PIE;
    (3) The scope of any PIE that is issued; and
    (4) The duration of any PIE that is issued.


Sec. 40.389  What factors may the Director consider?

    This section lists examples of the kind of mitigating and 
aggravating factors that the Director may consider in determining 
whether to issue a PIE concerning you, as well as the scope and 
duration of a PIE. This list is not exhaustive or exclusive. The 
Director may consider other factors if appropriate in the circumstances 
of a particular case. The list of examples follows:
    (a) The actual or potential harm that results or may result from 
your noncompliance;
    (b) The frequency of incidents and/or duration of the 
noncompliance;
    (c) Whether there is a pattern or prior history of noncompliance;
    (d) Whether the noncompliance was pervasive within your 
organization, including such factors as the following:
    (1) Whether and to what extent your organization planned, 
initiated, or carried out the noncompliance;
    (2) The positions held by individuals involved in the 
noncompliance, and

[[Page 79524]]

whether your principals tolerated their noncompliance; and
    (3) Whether you had effective standards of conduct and control 
systems (both with respect to your own organization and any contractors 
or affiliates) at the time the noncompliance occurred;
    (e) Whether you have demonstrated an appropriate compliance 
disposition, including such factors as the following:
    (1) Whether you have accepted responsibility for the noncompliance 
and recognize the seriousness of the conduct that led to the cause for 
issuance of the PIE;
    (2) Whether you have cooperated fully with the Department during 
the investigation. The Director may consider when the cooperation began 
and whether you disclosed all pertinent information known to you;
    (3) Whether you have fully investigated the circumstances of the 
noncompliance forming the basis for the PIE and, if so, have made the 
result of the investigation available to the Director;
    (4) Whether you have taken appropriate disciplinary action against 
the individuals responsible for the activity that constitutes the 
grounds for issuance of the PIE; and
    (5) Whether your organization has taken appropriate corrective 
actions or remedial measures, including implementing actions to prevent 
recurrence;
    (f) With respect to noncompliance with a DOT agency regulation, the 
degree to which the noncompliance affects matters common to the DOT 
drug and alcohol testing program;
    (g) Other factors appropriate to the circumstances of the case.


Sec. 40.391  What is the scope of a PIE?

    (a) The scope of a PIE is the Department's determination about the 
divisions, organizational elements, types of services, affiliates, and/
or individuals (including direct employees of a service agent and its 
contractors) to which a PIE applies.
    (b) If, as a service agent, the Department issues a PIE concerning 
you, the PIE applies to all your divisions, organizational elements, 
and types of services that are involved with or affected by the 
noncompliance that forms the factual basis for issuing the PIE.
    (c) In the NOPE (see Sec. 40.375(b)(4)), the initiating official 
sets forth his or her recommendation for the scope of the PIE. The 
proposed scope of the PIE is one of the elements of the proceeding that 
the service agent may contest (see Sec. 40.381(b)) and about which the 
Director makes a decision (see Sec. 40.387(b)(3)).
    (d) In recommending and deciding the scope of the PIE, the 
initiating official and Director, respectively, must take into account 
the provisions of paragraphs (e) through (j) of this section.
    (e) The pervasiveness of the noncompliance within a service agent's 
organization (see Sec. 40.389(d)) is an important consideration in 
determining the scope of a PIE. The appropriate scope of a PIE grows 
broader as the pervasiveness of the noncompliance increases.
    (f) The application of a PIE is not limited to the specific 
location or employer at which the conduct that forms the factual basis 
for issuing the PIE was discovered.
    (g) A PIE applies to your affiliates, if the affiliate is involved 
with or affected by the conduct that forms the factual basis for 
issuing the PIE.
    (h) A PIE applies to individuals who are officers, employees, 
directors, shareholders, partners, or other individuals associated with 
your organization in the following circumstances:
    (1) Conduct forming any part of the factual basis of the PIE 
occurred in connection with the individual's performance of duties by 
or on behalf of your organization; or
    (2) The individual knew of, had reason to know of, approved, or 
acquiesced in such conduct. The individual's acceptance of benefits 
derived from such conduct is evidence of such knowledge, acquiescence, 
or approval.
    (i) If a contractor to your organization is solely responsible for 
the conduct that forms the factual basis for a PIE, the PIE does not 
apply to the service agent itself unless the service agent knew or 
should have known about the conduct and did not take action to correct 
it.
    (j) PIEs do not apply to drug and alcohol testing that DOT does not 
regulate.
    (k) The following examples illustrate how the Department intends 
the provisions of this section to work:

    Example 1 to Sec. 40.391. Service Agent P provides a variety of 
drug testing services. P's SAP services are involved in a serious 
violation of this Part 40. However, P's other services fully comply 
with this part, and P's overall management did not plan or concur in 
the noncompliance, which in fact was contrary to P's articulated 
standards. Because the noncompliance was isolated in one area of the 
organization's activities, and did not pervade the entire 
organization, the scope of the PIE could be limited to SAP services.
    Example 2 to Sec. 40.391. Service Agent Q provides a similar 
variety of services. The conduct forming the factual basis for a PIE 
concerns collections for a transit authority. As in Example 1, the 
noncompliance is not pervasive throughout Q's organization. The PIE 
would apply to collections at all locations served by Q, not just 
the particular transit authority or not just in the state in which 
the transit authority is located.
    Example 3 to Sec. 40.391. Service Agent R provides a similar 
array of services. One or more of the following problems exists: R's 
activities in several areas--collections, MROs, SAPs, protecting the 
confidentiality of information--are involved in serious 
noncompliance; DOT determines that R's management knew or should 
have known about serious noncompliance in one or more areas, but 
management did not take timely corrective action; or, in response to 
an inquiry from DOT personnel, R's management refuses to provide 
information about its operations. In each of these three cases, the 
scope of the PIE would include all aspects of R's services.
    Example 4 to Sec. 40.391. Service Agent W provides only one kind 
of service (e.g., laboratory or MRO services). The Department issues 
a PIE concerning these services. Because W only provides this one 
kind of service, the PIE necessarily applies to all its operations.
    Example 5 to Sec. 40.391. Service Agent X, by exercising 
reasonably prudent oversight of its collection contractor, should 
have known that the contractor was making numerous ``fatal flaws'' 
in tests. Alternatively, X received a correction notice pointing out 
these problems in its contractor's collections. In neither case did 
X take action to correct the problem. X, as well as the contractor, 
would be subject to a PIE with respect to collections.
    Example 6 to Sec. 40.391. Service Agent Y could not reasonably 
have known that one of its MROs was regularly failing to interview 
employees before verifying tests positive. When it received a 
correction notice, Y immediately dismissed the erring MRO. In this 
case, the MRO would be subject to a PIE but Y would not.
    Example 7 to Sec. 40.391. The Department issues a PIE with 
respect to Service Agent Z. Z provides services for DOT-regulated 
transportation employers, a Federal agency under the HHS-regulated 
Federal employee testing program, and various private businesses and 
public agencies that DOT does not regulate. The PIE applies only to 
the DOT-regulated transportation employers with respect to their 
DOT-mandated testing, not to the Federal agency or the other public 
agencies and private businesses. The PIE does not prevent the non-
DOT regulated entities from continuing to use Z's services.


Sec. 40.393  How long does a PIE stay in effect?

    (a) In the NOPE (see Sec. 40.375(b)(5)), the initiating official 
proposes the duration of the PIE. The duration of the PIE is one of the 
elements of the proceeding that the service agent may contest (see 
Sec. 40.381(b)) and about which the Director makes a decision (see 
Sec. 40.387(b)(4)).
    (b) In deciding upon the duration of the PIE, the Director 
considers the

[[Page 79525]]

seriousness of the conduct on which the PIE is based and the continued 
need to protect employers and employees from the service agent's 
noncompliance. The Director considers factors such as those listed in 
Sec. 40.389 in making this decision.
    (c) The duration of a PIE will be between one and five years, 
unless the Director reduces its duration under Sec. 40.407.


Sec. 40.395  Can you settle a PIE proceeding?

    At any time before the Director's decision, you and the initiating 
official can, with the Director's concurrence, settle a PIE proceeding.


Sec. 40.397  When does the Director make a PIE decision?

    The Director makes his or her decision within 60 days of the date 
when the record of a PIE proceeding is complete (including any meeting 
with the Director and any additional fact-finding that is necessary). 
The Director may extend this period for good cause for additional 
periods of up to 30 days.


Sec. 40.399  How does the Department notify service agents of its 
decision?

    If you are a service agent involved in a PIE proceeding, the 
Director provides you written notice as soon as he or she makes a PIE 
decision. The notice includes the following elements:
    (a) If the decision is not to issue a PIE, a statement of the 
reasons for the decision, including findings of fact with respect to 
any material factual issues that were in dispute.
    (b) If the decision is to issue a PIE--
    (1) A reference to the NOPE;
    (2) A statement of the reasons for the decision, including findings 
of fact with respect to any material factual issues that were in 
dispute;
    (3) A statement of the scope of the PIE; and
    (4) A statement of the duration of the PIE.


Sec. 40.401  How does the Department notify employers and the public 
about a PIE?

    (a) The Department maintains a document called the ``List of 
Excluded Drug and Alcohol Service Agents.'' This document may be found 
on the Department's web site (http://www.dot.gov/ost/dapc). You may 
also request a copy of the document from ODAPC.
    (b) When the Director issues a PIE, he or she adds to the List the 
name and address of the service agent, and any other persons or 
organizations, to whom the PIE applies and information about the scope 
and duration of the PIE.
    (c) When a service agent ceases to be subject to a PIE, the 
Director removes this information from the List.
    (d) The Department also publishes a Federal Register notice to 
inform the public on any occasion on which a service agent is added to 
or taken off the List.


Sec. 40.403  Must a service agent notify its clients when the 
Department issues a PIE?

    (a) As a service agent, if the Department issues a PIE concerning 
you, you must notify each of your DOT-regulated employer clients, in 
writing, about the issuance, scope, duration, and effect of the PIE. 
You may meet this requirement by sending a copy of the Director's PIE 
decision or by a separate notice. You must send this notice to each 
client within three working days of receiving from the Department the 
notice provided for in Sec. 40.399(b).
    (b) As part of the notice you send under paragraph (a) of this 
section, you must offer to transfer immediately all records pertaining 
to the employer and its employees to the employer or to any other 
service agent the employer designates. You must carry out this transfer 
as soon as the employer requests it.


Sec. 40.405  May the Federal courts review PIE decisions?

    The Director's decision is a final administrative action of the 
Department. Like all final administrative actions of Federal agencies, 
the Director's decision is subject to judicial review under the 
Administrative Procedure Act (5 U.S.C. 551 et seq.).


Sec. 40.407  May a service agent ask to have a PIE reduced or 
terminated?

    (a) Yes, as a service agent concerning whom the Department has 
issued a PIE, you may request that the Director terminate a PIE or 
reduce its duration and/or scope. This process is limited to the issues 
of duration and scope. It is not an appeal or reconsideration of the 
decision to issue the PIE.
    (b) Your request must be in writing and supported with 
documentation.
    (c) You must wait at least nine months from the date on which the 
Director issued the PIE to make this request.
    (d) The initiating official who was the proponent of the PIE may 
provide information and arguments concerning your request to the 
Director.
    (e) If the Director verifies that the sources of your noncompliance 
have been eliminated and that all drug or alcohol testing-related 
services you would provide to DOT-regulated employers will be 
consistent with the requirements of this part, the Director may issue a 
notice terminating or reducing the PIE.


Sec. 40.409  What does the issuance of a PIE mean to transportation 
employers?

    (a) As an employer, you are deemed to have notice of the issuance 
of a PIE when it appears on the List mentioned in Sec. 40.401(a) or the 
notice of the PIE appears in the Federal Register as provided in 
Sec. 40.401(d). You should check this List to ensure that any service 
agents you are using or planning to use are not subject to a PIE.
    (b) As an employer who is using a service agent concerning whom a 
PIE is issued, you must stop using the services of the service agent no 
later than 90 days after the Department has published the decision in 
the Federal Register or posted it on its web site. You may apply to the 
ODAPC Director for an extension of 30 days if you demonstrate that you 
cannot find a substitute service agent within 90 days.
    (c) Except during the period provided in paragraph (b) of this 
section, you must not, as an employer, use the services of a service 
agent that are covered by a PIE that the Director has issued under this 
subpart. If you do so, you are in violation of the Department's 
regulations and subject to applicable DOT agency sanctions (e.g., civil 
penalties, withholding of Federal financial assistance).
    (d) You also must not obtain drug or alcohol testing services 
through a contractor or affiliate of the service agent to whom the PIE 
applies.

    Example to Paragraph (d). Service Agent R was subject to a PIE 
with respect to SAP services. As an employer, not only must you not 
use R's own SAP services, but you also must not use SAP services you 
arrange through R, such as services provided by a subcontractor or 
affiliate of R or a person or organization that receives financial 
gain from its relationship with R.

    (e) This section's prohibition on using the services of a service 
agent concerning which the Director has issued a PIE applies to 
employers in all industries subject to DOT drug and alcohol testing 
regulations.

    Example to Paragraph (e). The initiating official for a PIE was 
the FAA drug and alcohol program manager, and the conduct forming 
the basis of the PIE pertained to the aviation industry. As a motor 
carrier, transit authority, pipeline, railroad, or maritime 
employer, you are also prohibited from using the services of the 
service agent involved in connection with the DOT drug and alcohol 
testing program.

    (f) The issuance of a PIE does not result in the cancellation of 
drug or alcohol tests conducted using the service agent involved before 
the

[[Page 79526]]

issuance of the Director's decision or up to 90 days following its 
publication in the Federal Register or posting on the Department's web 
site, unless otherwise specified in the Director's PIE decision or the 
Director grants an extension as provided in paragraph (b) of this 
section.

    Example to Paragraph (f). The Department issues a PIE concerning 
Service Agent N on September 1. All tests conducted using N's 
services before September 1, and through November 30, are valid for 
all purposes under DOT drug and alcohol testing regulations, 
assuming they meet all other regulatory requirements.


Sec. 40.411  What is the role of the DOT Inspector General's office?

    (a) Any person may bring concerns about waste, fraud, or abuse on 
the part of a service agent to the attention of the DOT Office of 
Inspector General.
    (b) In appropriate cases, the Office of Inspector General may 
pursue criminal or civil remedies against a service agent.
    (c) The Office of Inspector General may provide factual information 
to other DOT officials for use in a PIE proceeding.


Sec. 40.413  How are notices sent to service agents?

    (a) If you are a service agent, DOT sends notices to you, including 
correction notices, notices of proposed exclusion, decision notices, 
and other notices, in any of the ways mentioned in paragraph (b) or (c) 
of this section.
    (b) DOT may send a notice to you, your identified counsel, your 
agent for service of process, or any of your partners, officers, 
directors, owners, or joint venturers to the last known street address, 
fax number, or e-mail address. DOT deems the notice to have been 
received by you if sent to any of these persons.
    (c) DOT considers notices to be received by you--
    (1) When delivered, if DOT mails the notice to the last known 
street address, or five days after we send it if the letter is 
undeliverable;
    (2) When sent, if DOT sends the notice by fax or five days after we 
send it if the fax is undeliverable; or
    (3) When delivered, if DOT sends the notice by e-mail or five days 
after DOT sends it if the e-mail is undeliverable.

    2. Effective August 1, 2001, revise 49 CFR Part 40 to read as 
follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

Subpart A--Administrative Provisions
Sec.
40.1   Who does this regulation cover?
40.3   What do the terms used in this regulation mean?
40.5   Who issues authoritative interpretations of this regulation?
40.7   How can you get an exemption from a requirement in this 
regulation?
Subpart B--Employer Responsibilities
40.11  What are the general responsibilities of employers under this 
regulation?
40.13  How do DOT drug and alcohol tests relate to non-DOT tests?
40.15  May an employer use a service agent to meet DOT drug and 
alcohol testing requirements?
40.17  Is an employer responsible for obtaining information from its 
service agents?
40.19  [Reserved]
40.21  May an employer stand down an employee before the MRO has 
completed the verification process?
40.23  What actions do employers take after receiving verified test 
results?
40.25  Must an employer check on the drug and alcohol testing record 
of employees it is intending to use to perform safety-sensitive 
duties?
40.27  Where is other information on employer responsibilities found 
in this regulation?
Subpart C--Urine Collection Personnel
40.31  Who may collect urine specimens for DOT drug testing?
40.33  What training requirements must a collector meet?
40.35  What information about the DER must employers provide to 
collectors?
40.37  Where is other information on the role of collectors found in 
this regulation?
Subpart D--Collection Sites, Forms, Equipment and Supplies Used in DOT 
Urine Collections
40.41  Where does a urine collection for a DOT drug test take place?
40.43  What steps must operators of collection sites take to protect 
the security and integrity of urine collections?
40.45  What form is used to document a DOT urine collection?
40.47  May employers use the CCF for non-DOT collections or non-
Federal forms for DOT collections?
40.49  What materials are used to collect urine specimens?
40.51  What materials are used to send urine specimens to the 
laboratory?
Subpart E--Urine Specimen Collections
40.61  What are the preliminary steps in the collection process?
40.63  What steps does the collector take in the collection process 
before the employee provides a urine specimen?
40.65  What does the collector check for when the employee presents 
a specimen?
40.67  When and how is a directly observed collection conducted?
40.69  How is a monitored collection conducted?
40.71  How does the collector prepare the specimens?
40.73  How is the collection process completed?
Subpart F--Drug Testing Laboratories
40.81  What laboratories may be used for DOT drug testing?
40.83  How do laboratories process incoming specimens?
40.85  What drugs do laboratories test for?
40.87  What are the cutoff concentrations for initial and 
confirmation tests?
40.89  What is validity testing, and are laboratories required to 
conduct it?
40.91  What validity tests must laboratories conduct on primary 
specimens?
40.93  What criteria do laboratories use to establish that a 
specimen is dilute or substituted?
40.95  What criteria do laboratories use to establish that a 
specimen is adulterated?
40.97  What do laboratories report and how do they report it?
40.99  How long does the laboratory retain specimens after testing?
40.101  What relationship may a laboratory have with an MRO?
40.103  What are the requirements for submitting blind specimens to 
a laboratory?
40.105   What happens if the laboratory reports a result different 
from that expected for a blind specimen?
40.107   Who may inspect laboratories?
40.109   What documentation must the laboratory keep, and for how 
long?
40.111   When and how must a laboratory disclose statistical 
summaries and other information it maintains?
40.113   Where is other information concerning laboratories found in 
this regulation?
Subpart G--Medical Review Officers and the Verification Process
40.121  Who is qualified to act as an MRO?
40.123   What are the MRO's responsibilities in the DOT drug testing 
program?
40.125   What relationship may an MRO have with a laboratory?
40.127   What are the MRO's functions in reviewing negative test 
results?
40.129   What are the MRO's functions in reviewing laboratory 
confirmed positive, adulterated, substituted, or invalid drug test 
results?
40.131   How does the MRO or DER notify an employee of the 
verification process after a confirmed positive, adulterated, 
substituted, or invalid test result?
40.133   Under what circumstances may the MRO verify a test as 
positive, or as a refusal to test because of adulteration or 
substitution, without interviewing the employee?
40.135   What does the MRO tell the employee at the beginning of the 
verification interview?
40.137   On what basis does the MRO verify test results involving 
marijuana, cocaine, amphetamines, or PCP?
40.139   On what basis does the MRO verify test results involving 
opiates?
40.141   How does the MRO obtain information for the verification 
decision?
40.143   [Reserved]

[[Page 79527]]

40.145   On what basis does the MRO verify test results involving 
adulteration or substitution?
40.147   [Reserved]
40.149   May the MRO change a verified positive drug test result or 
refusal to test?
40.151   What are MROs prohibited from doing as part of the 
verification process?
40.153   How does the MRO notify employees of their right to a test 
of the split specimen?
40.155   What does the MRO do when a negative or positive test 
result is also dilute?
40.157   [Reserved]
40.159   What does the MRO do when a drug test result is invalid?
40.161   What does the MRO do when a drug test specimen is rejected 
for testing?
40.163   How does the MRO report drug test results?
40.165   To whom does the MRO transmit reports of drug test results?
40.167   How are MRO reports of drug results transmitted to the 
employer?
40.169   Where is other information concerning the role of MROs and 
the verification process found in this regulation?
Subpart H--Split Specimen Tests
40.171   How does an employee request a test of a split specimen?
40.173   Who is responsible for paying for the test of a split 
specimen?
40.175   What steps does the first laboratory take with a split 
specimen?
40.177   What does the second laboratory do with the split specimen 
when it is tested to reconfirm the presence of a drug or drug 
metabolite?
40.179   What does the second laboratory do with the split specimen 
when it is tested to reconfirm an adulterated test result?
40.181   What does the second laboratory do with the split specimen 
when it is tested to reconfirm a substituted test result?
40.183   What information do laboratories report to MROs regarding 
split specimen results?
40.185   Through what methods and to whom must a laboratory report 
split specimen results?
40.187   What does the MRO do with split specimen laboratory 
results?
40.189   Where is other information concerning split specimens found 
in this regulation?
Subpart I--Problems in Drug Tests
40.191   What is a refusal to take a DOT drug test, and what are the 
consequences?
40.193   What happens when an employee does not provide a sufficient 
amount of urine for a drug test?
40.195   What happens when an individual is unable to provide a 
sufficient amount of urine for a pre-employment or return-to-duty 
test because of a permanent or long-term medical condition?
40.197   What happens when an employer receives a report of a dilute 
specimen?
40.199   What problems always cause a drug test to be cancelled?
40.201   What problems always cause a drug test to be cancelled and 
may result in a requirement for another collection?
40.203   What problems cause a drug test to be cancelled unless they 
are corrected?
40.205   How are drug test problems corrected?
40.207   What is the effect of a cancelled drug test?
40.209   What is the effect of procedural problems that are not 
sufficient to cancel a drug test?
Subpart J--Alcohol Testing Personnel
40.211   Who conducts DOT alcohol tests?
40.213   What training requirements must STTs and BATs meet?
40.215   What information about the DER do employers have to provide 
to BATs and STTs?
40.217   Where is other information on the role of STTs and BATs 
found in this regulation?
Subpart K--Testing Sites, Forms, Equipment and Supplies Used in Alcohol 
Testing
40.221   Where does an alcohol test take place?
40.223   What steps must be taken to protect the security of alcohol 
testing sites?
40.225   What form is used for an alcohol test?
40.227   May employers use the ATF for non-DOT tests, or non-DOT 
forms for DOT tests?
40.229   What devices are used to conduct alcohol screening tests?
40.231   What devices are used to conduct alcohol confirmation 
tests?
40.233   What are the requirements for proper use and care of EBTs?
40.235   What are the requirements for proper use and care of ASDs?
Subpart L--Alcohol Screening Tests
40.241   What are the first steps in any alcohol screening test?
40.243   What is the procedure for an alcohol screening test using 
an EBT or non-evidential breath ASD?
40.245   What is the procedure for an alcohol screening test using a 
saliva ASD?
40.247   What procedures does the BAT or STT follow after a 
screening test result?
Subpart M--Alcohol Confirmation Tests
40.251   What are the first steps in an alcohol confirmation test?
40.253   What are the procedures for conducting an alcohol 
confirmation test?
40.255   What happens next after the alcohol confirmation test 
result?
Subpart N--Problems in Alcohol Testing
40.261   What is a refusal to take an alcohol test, and what are the 
consequences?
40.263   What happens when an employee is unable to provide a 
sufficient amount of saliva for an alcohol screening test?
40.265   What happens when an employee is unable to provide a 
sufficient amount of breath for an alcohol test?
40.267   What problems always cause an alcohol test to be cancelled?
40.269   What problems cause an alcohol test to be cancelled unless 
they are corrected?
40.271   How are alcohol testing problems corrected?
40.273   What is the effect of a cancelled alcohol test?
40.275   What is the effect of procedural problems that are not 
sufficient to cancel an alcohol test?
40.277   Are alcohol tests other than saliva or breath permitted 
under these regulations?
Subpart O--Substance Abuse Professionals and the Return-to-Duty Process
40.281   Who is qualified to act as a SAP?
40.283   How does a certification organization obtain recognition 
for its members as SAPs?
40.285   When is a SAP evaluation required?
40.287   What information is an employer required to provide 
concerning SAP services to an employee who has a DOT drug and 
alcohol regulation violation?
40.289   Are employers required to provide SAP and treatment 
services to employees?
40.291   What is the role of the SAP in the evaluation, referral, 
and treatment process of an employee who has violated DOT agency 
drug and alcohol testing regulations?
40.293   What is the SAP's function in conducting the initial 
evaluation of an employee?
40.295   May employees or employers seek a second SAP evaluation if 
they disagree with the first SAP's recommendations?
40.297   Does anyone have the authority to change a SAP's initial 
evaluation?
40.299   What is the SAP's role and what are the limits on a SAP's 
discretion in referring employees for education and treatment?
40.301   What is the SAP's function in the follow-up evaluation of 
an employee?
40.303   What happens if the SAP believes the employee needs 
additional treatment, aftercare, or support group services even 
after the employee returns to safety-sensitive duties?
40.305   How does the return-to-duty process conclude?
40.307   What is the SAP's function in prescribing the employee's 
follow-up tests?
40.309   What are the employer's responsibilities with respect to 
the SAP's directions for follow-up tests?
40.311   What are requirements concerning SAP reports?
40.313   Where is other information on SAP functions and the return-
to-duty process found in this regulation?
Subpart P--Confidentiality and Release of Information
40.321   What is the general confidentiality rule for drug and 
alcohol test information?
40.323   May program participants release drug or alcohol test 
information in connection with legal proceedings?
40.325   [Reserved]
40.327   When must the MRO report medical information gathered in 
the verification process?
40.329   What information must laboratories, MROs, and other service 
agents release to employees?

[[Page 79528]]

40.331   To what additional parties must employers and service 
agents release information?
40.333   What records must employers keep?
Subpart Q--Roles And Responsibilities of Service Agents
40.341   Must service agents comply with DOT drug and alcohol 
testing requirements?
40.343   What tasks may a service agent perform for an employer?
40.345   In what circumstances may a C/TPA act as an intermediary in 
the transmission of drug and alcohol testing information to 
employers?
40.347   What functions may C/TPAs perform with respect 
administering testing?
40.349   What records may a service agent receive and maintain?
40.351   What confidentiality requirements apply to service agents?
40.353   What principles govern the interaction between MROs and 
other service agents?
40.355   What limitations apply to the activities of service agents?
Subpart R--Public Interest Exclusions
40.361   What is the purpose of a public interest exclusion (PIE)?
40.363   On what basis may the Department issue a PIE?
40.365   What is the Department's policy concerning starting a PIE 
proceeding?
40.367   Who initiates a PIE proceeding?
40.369   What is the discretion of an initiating official in 
starting a PIE proceeding?
40.371   On what information does an initiating official rely in 
deciding whether to start a PIE proceeding?
40.373   Before starting a PIE proceeding, does the initiating 
official give the service agent an opportunity to correct problems?
40.375   How does the initiating official start a PIE proceeding?
40.377   Who decides whether to issue a PIE?
40.379   How do you contest the issuance of a PIE?
40.381   What information do you present to contest the proposed 
issuance of a PIE?
40.383   What procedures apply if you contest the issuance of a PIE?
40.385   Who bears the burden of proof in a PIE proceeding?
40.387   What matters does the Director decide concerning a proposed 
PIE?
40.389   What factors may the Director consider?
40.391   What is the scope of a PIE?
40.393   How long does a PIE stay in effect?
40.395   Can you settle a PIE proceeding?
40.397   When does the Director make a PIE decision?
40.399   How does the Department notify service agents of its 
decision?
40.401   How does the Department notify employers and the public 
about a PIE?
40.403   Must a service agent notify its clients when the Department 
issues a PIE?
40.405   May the Federal courts review PIE decisions?
40.407   May a service agent ask to have a PIE reduced or 
terminated?
40.409   What does the issuance of a PIE mean to transportation 
employers?
40.411   What is the role of the DOT Inspector General's office?
40.413   How are notices sent to service agents?
Appendix A to Part 40--DOT Standards for Urine Collection Kits
Appendix B to Part 40--DOT Drug Testing Semi-annual Laboratory 
Report
Appendix C to Part 40--[Reserved]
Appendix D to Part 40--Report Format: Split Specimen Failure to 
Reconfirm
Appendix E to Part 40--SAP Equivalency Requirements for 
Certification Organizations
Appendix F to Part 40--Drug and Alcohol Testing Information that C/
TPAs May Transmit to Employers
Appendix G to Part 40--Alcohol Testing Form (ATF)

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
45101 et seq.

Subpart A--Administrative Provisions


Sec. 40.1  Who does this regulation cover?

    (a) This part tells all parties who conduct drug and alcohol tests 
required by Department of Transportation (DOT) agency regulations how 
to conduct these tests and what procedures to use.
    (b) This part concerns the activities of transportation employers, 
safety-sensitive transportation employees (including self-employed 
individuals, contractors and volunteers as covered by DOT agency 
regulations), and service agents.
    (c) Nothing in this part is intended to supersede or conflict with 
the implementation of the Federal Railroad Administration's post-
accident testing program (see 49 CFR 219.200).


Sec. 40.3  What do the terms used in this regulation mean?

    In this part, the terms listed in this section have the following 
meanings:
    Adulterated specimen. A specimen that contains a substance that is 
not expected to be present in human urine, or contains a substance 
expected to be present but is at a concentration so high that it is not 
consistent with human urine.
    Affiliate. Persons are affiliates of one another if, directly or 
indirectly, one controls or has the power to control the other, or a 
third party controls or has the power to control both. Indicators of 
control include, but are not limited to: interlocking management or 
ownership; shared interest among family members; shared facilities or 
equipment; or common use of employees. Following the issuance of a 
public interest exclusion, an organization having the same or similar 
management, ownership, or principal employees as the service agent 
concerning whom a public interest exclusion is in effect is regarded as 
an affiliate. This definition is used in connection with the public 
interest exclusion procedures of Subpart R of this part.
    Air blank. In evidential breath testing devices (EBTs) using gas 
chromatography technology, a reading of the device's internal standard. 
In all other EBTs, a reading of ambient air containing no alcohol.
    Alcohol. The intoxicating agent in beverage alcohol, ethyl alcohol 
or other low molecular weight alcohols, including methyl or isopropyl 
alcohol.
    Alcohol concentration. The alcohol in a volume of breath expressed 
in terms of grams of alcohol per 210 liters of breath as indicated by a 
breath test under this part.
    Alcohol confirmation test. A subsequent test using an EBT, 
following a screening test with a result of 0.02 or greater, that 
provides quantitative data about the alcohol concentration.
    Alcohol screening device (ASD). A breath or saliva device, other 
than an EBT, that is approved by the National Highway Traffic Safety 
Administration (NHTSA) and placed on a conforming products list (CPL) 
for such devices.
    Alcohol screening test. An analytic procedure to determine whether 
an employee may have a prohibited concentration of alcohol in a breath 
or saliva specimen.
    Alcohol testing site. A place selected by the employer where 
employees present themselves for the purpose of providing breath or 
saliva for an alcohol test.
    Alcohol use. The drinking or swallowing of any beverage, liquid 
mixture or preparation (including any medication), containing alcohol.
    Blind specimen or blind performance test specimen. A specimen 
submitted to a laboratory for quality control testing purposes, with a 
fictitious identifier, so that the laboratory cannot distinguish it 
from an employee specimen.
    Breath Alcohol Technician (BAT). A person who instructs and assists 
employees in the alcohol testing process and operates an evidential 
breath testing device.
    Cancelled test. A drug or alcohol test that has a problem 
identified that cannot be or has not been corrected, or which this part 
otherwise requires to be cancelled. A cancelled test is neither a 
positive nor a negative test.
    Chain of custody. The procedure used to document the handling of 
the urine specimen from the time the employee gives the specimen to the 
collector until the specimen is destroyed. This

[[Page 79529]]

procedure uses the Federal Drug Testing Custody and Control Form (CCF).
    Collection container. A container into which the employee urinates 
to provide the specimen for a drug test.
    Collection site. A place selected by the employer where employees 
present themselves for the purpose of providing a urine specimen for a 
drug test.
    Collector. A person who instructs and assists employees at a 
collection site, who receives and makes an initial inspection of the 
specimen provided by those employees, and who initiates and completes 
the CCF.
    Confirmation (or confirmatory) drug test. A second analytical 
procedure performed on a urine specimen to identify and quantify the 
presence of a specific drug or drug metabolite.
    Confirmation (or confirmatory) validity test. A second test 
performed on a urine specimen to further support a validity test 
result.
    Confirmed drug test. A confirmation test result received by an MRO 
from a laboratory.
    Consortium/Third-party administrator (C/TPA). A service agent that 
provides or coordinates the provision of a variety of drug and alcohol 
testing services to employers. C/TPAs typically perform administrative 
tasks concerning the operation of the employers' drug and alcohol 
testing programs. This term includes, but is not limited to, groups of 
employers who join together to administer, as a single entity, the DOT 
drug and alcohol testing programs of its members. C/TPAs are not 
``employers'' for purposes of this part.
    Continuing education. Training for medical review officers (MROs) 
and substance abuse professionals (SAPs) who have completed 
qualification training and are performing MRO or SAP functions, 
designed to keep MROs and SAPs current on changes and developments in 
the DOT drug and alcohol testing program.
    Designated employer representative (DER). An employee authorized by 
the employer to take immediate action(s) to remove employees from 
safety-sensitive duties and to make required decisions in the testing 
and evaluation processes. The DER also receives test results and other 
communications for the employer, consistent with the requirements of 
this part. Service agents cannot act as DERs.
    Dilute specimen. A specimen with creatinine and specific gravity 
values that are lower than expected for human urine.
    DOT, The Department, DOT agency. These terms encompass all DOT 
agencies, including, but not limited to, the United States Coast Guard 
(USCG), the Federal Aviation Administration (FAA), the Federal Railroad 
Administration (FRA), the Federal Motor Carrier Safety Administration 
(FMCSA), the Federal Transit Administration (FTA), the National Highway 
Traffic Safety Administration (NHTSA), the Research and Special 
Programs Administration (RSPA), and the Office of the Secretary (OST). 
These terms include any designee of a DOT agency.
    Drugs. The drugs for which tests are required under this part and 
DOT agency regulations are marijuana, cocaine, amphetamines, 
phencyclidine (PCP), and opiates.
    Employee. Any person who is designated in a DOT agency regulation 
as subject to drug testing and/or alcohol testing. The term includes 
individuals currently performing safety-sensitive functions designated 
in DOT agency regulations and applicants for employment subject to pre-
employment testing. For purposes of drug testing under this part, the 
term employee has the same meaning as the term ``donor'' as found on 
CCF and related guidance materials produced by the Department of Health 
and Human Services.
    Employer. A person or entity employing one or more employees 
(including an individual who is self-employed) subject to DOT agency 
regulations requiring compliance with this part. The term includes an 
employer's officers, representatives, and management personnel. Service 
agents are not employers for the purposes of this part.
    Error Correction Training. Training provided to BATs, collectors, 
and screening test technicians (STTs) following an error that resulted 
in the cancellation of a drug or alcohol test. Error correction 
training must be provided in person or by a means that provides real-
time observation and interaction between the instructor and trainee.
    Evidential Breath Testing Device (EBT). A device approved by NHTSA 
for the evidential testing of breath at the .02 and .04 alcohol 
concentrations, placed on NHTSA's Conforming Products List (CPL) for 
``Evidential Breath Measurement Devices'' and identified on the CPL as 
conforming with the model specifications available from NHTSA's Traffic 
Safety Program.
    HHS. The Department of Health and Human Services or any designee of 
the Secretary, Department of Health and Human Services.
    Initial drug test. The test used to differentiate a negative 
specimen from one that requires further testing for drugs or drug 
metabolites.
    Initial validity test. The first test used to determine if a 
specimen is adulterated, diluted, or substituted.
    Laboratory. Any U.S. laboratory certified by HHS under the National 
Laboratory Certification Program as meeting the minimum standards of 
Subpart C of the HHS Mandatory Guidelines for Federal Workplace Drug 
Testing Programs; or, in the case of foreign laboratories, a laboratory 
approved for participation by DOT under this part. (The HHS Mandatory 
Guidelines for Federal Workplace Drug Testing Programs are available on 
the internet at http://www.health.org/workpl.htm or from the Division 
of Workplace Programs, 5600 Fishers Lane, Rockwall II Building, Suite 
815, Rockville, MD 20857.)
    Medical Review Officer (MRO). A person who is a licensed physician 
and who is responsible for receiving and reviewing laboratory results 
generated by an employer's drug testing program and evaluating medical 
explanations for certain drug test results.
    Office of Drug and Alcohol Policy and Compliance (ODAPC). The 
office in the Office of the Secretary, DOT, that is responsible for 
coordinating drug and alcohol testing program matters within the 
Department and providing information concerning the implementation of 
this part.
    Primary specimen. In drug testing, the urine specimen bottle that 
is opened and tested by a first laboratory to determine whether the 
employee has a drug or drug metabolite in his or her system; and for 
the purpose of validity testing. The primary specimen is distinguished 
from the split specimen, defined in this section.
    Qualification Training. The training required in order for a 
collector, BAT, MRO, SAP, or STT to be qualified to perform their 
functions in the DOT drug and alcohol testing program. Qualification 
training may be provided by any appropriate means (e.g., classroom 
instruction, internet application, CD-ROM, video).
    Refresher Training. The training required periodically for 
qualified collectors, BATs, and STTs to review basic requirements and 
provide instruction concerning changes in technology (e.g., new testing 
methods that may be authorized) and amendments, interpretations, 
guidance, and issues concerning this part and DOT agency drug and 
alcohol testing regulations. Refresher training can be provided by any 
appropriate means (e.g., classroom instruction, internet application, 
CD-ROM, video).
    Screening Test Technician (STT). A person who instructs and assists

[[Page 79530]]

employees in the alcohol testing process and operates an ASD.
    Secretary. The Secretary of Transportation or the Secretary's 
designee.
    Service agent. Any person or entity, other than an employee of the 
employer, who provides services specified under this part to employers 
and/or employees in connection with DOT drug and alcohol testing 
requirements. This includes, but is not limited to, collectors, BATs 
and STTs, laboratories, MROs, substance abuse professionals, and C/
TPAs. To act as service agents, persons and organizations must meet the 
qualifications set forth in applicable sections of this part. Service 
agents are not employers for purposes of this part.
    Shipping container. A container that is used for transporting and 
protecting urine specimen bottles and associated documents from the 
collection site to the laboratory.
    Specimen bottle. The bottle that, after being sealed and labeled 
according to the procedures in this part, is used to hold the urine 
specimen during transportation to the laboratory.
    Split specimen. In drug testing, a part of the urine specimen that 
is sent to a first laboratory and retained unopened, and which is 
transported to a second laboratory in the event that the employee 
requests that it be tested following a verified positive test of the 
primary specimen or a verified adulterated or substituted test result.
    Stand-down. The practice of temporarily removing an employee from 
the performance of safety-sensitive functions based only on a report 
from a laboratory to the MRO of a confirmed positive test for a drug or 
drug metabolite, an adulterated test, or a substituted test, before the 
MRO has completed verification of the test result.
    Substance Abuse Professional (SAP). A person who evaluates 
employees who have violated a DOT drug and alcohol regulation and makes 
recommendations concerning education, treatment, follow-up testing, and 
aftercare.
    Substituted specimen. A specimen with creatinine and specific 
gravity values that are so diminished that they are not consistent with 
human urine.
    Verified test. A drug test result or validity testing result from 
an HHS-certified laboratory that has undergone review and final 
determination by the MRO.


Sec. 40.5  Who issues authoritative interpretations of this regulation?

    ODAPC and the DOT Office of General Counsel (OGC) provide written 
interpretations of the provisions of this part. These written DOT 
interpretations are the only official and authoritative interpretations 
concerning the provisions of this part. DOT agencies may incorporate 
ODAPC/OGC interpretations in written guidance they issue concerning 
drug and alcohol testing matters. Only Part 40 interpretations issued 
after August 1, 2001, are considered valid.


Sec. 40.7  How can you get an exemption from a requirement in this 
regulation?

    (a) If you want an exemption from any provision of this part, you 
must request it in writing from the Office of the Secretary of 
Transportation, under the provisions and standards of 49 CFR part 5. 
You must send requests for an exemption to the following address: 
Department of Transportation, Deputy Assistant General Counsel for 
Regulation and Enforcement, 400 7th Street, SW., Room 10424, 
Washington, DC 20590.
    (b) Under the standards of 49 CFR part 5, we will grant the request 
only if the request documents special or exceptional circumstances, not 
likely to be generally applicable and not contemplated in connection 
with the rulemaking that established this part, that make your 
compliance with a specific provision of this part impracticable.
    (c) If we grant you an exemption, you must agree to take steps we 
specify to comply with the intent of the provision from which an 
exemption is granted.
    (d) We will issue written responses to all exemption requests.

Subpart B--Employer Responsibilities


Sec. 40.11  What are the general responsibilities of employers under 
this regulation?

    (a) As an employer, you are responsible for meeting all applicable 
requirements and procedures of this part.
    (b) You are responsible for all actions of your officials, 
representatives, and agents (including service agents) in carrying out 
the requirements of the DOT agency regulations.
    (c) All agreements and arrangements, written or unwritten, between 
and among employers and service agents concerning the implementation of 
DOT drug and alcohol testing requirements 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. Compliance with 
these provisions is a material term of all such agreements and 
arrangements.


Sec. 40.13  How do DOT drug and alcohol tests relate to non-DOT tests?

    (a) DOT tests must be completely separate from non-DOT tests in all 
respects.
    (b) DOT tests must take priority and must be conducted and 
completed before a non-DOT test is begun. For example, you must discard 
any excess urine left over from a DOT test and collect a separate void 
for the subsequent non-DOT test.
    (c) Except as provided in paragraph (d) of this section, you must 
not perform any tests on DOT urine or breath specimens other than those 
specifically authorized by this part or DOT agency regulations. For 
example, you may not test a DOT urine specimen for additional drugs, 
and a laboratory is prohibited from making a DOT urine specimen 
available for a DNA test or other types of specimen identity testing.
    (d) The single exception to paragraph (c) of this section is when a 
DOT drug test collection is conducted as part of a physical examination 
required by DOT agency regulations. It is permissible to conduct 
required medical tests related to this physical examination (e.g., for 
glucose) on any urine remaining in the collection container after the 
drug test urine specimens have been sealed into the specimen bottles.
    (e) No one is permitted to change or disregard the results of DOT 
tests based on the results of non-DOT tests. For example, as an 
employer you must not disregard a verified positive DOT drug test 
result because the employee presents a negative test result from a 
blood or urine specimen collected by the employee's physician or a DNA 
test result purporting to question the identity of the DOT specimen.
    (f) As an employer, you must not use the CCF or the ATF in your 
non-DOT drug and alcohol testing programs. This prohibition includes 
the use of the DOT forms with references to DOT programs and agencies 
crossed out. You also must always use the CCF and ATF for all your DOT-
mandated drug and alcohol tests.


Sec. 40.15  May an employer use a service agent to meet DOT drug and 
alcohol testing requirements?

    (a) As an employer, you may use a service agent to perform the 
tasks needed to comply with this part and DOT agency drug and alcohol 
testing regulations, consistent with the requirements of Subpart Q and 
other applicable provisions of this part.
    (b) As an employer, you are responsible for ensuring that the 
service agents you use meet the qualifications set forth in this part 
(e.g., Sec. 40.121 for MROs). You may require service agents

[[Page 79531]]

to show you documentation that they meet the requirements of this part 
(e.g., documentation of MRO qualifications required by Sec. 40.121(e)).
    (c) You remain responsible for compliance with all applicable 
requirements of this part and other DOT drug and alcohol testing 
regulations, even when you use a service agent. If you violate this 
part or other DOT drug and alcohol testing regulations because a 
service agent has not provided services as our rules require, a DOT 
agency can subject you to sanctions. Your good faith use of a service 
agent is not a defense in an enforcement action initiated by a DOT 
agency in which your alleged noncompliance with this part or a DOT 
agency drug and alcohol regulation may have resulted from the service 
agent's conduct.
    (d) As an employer, you must not permit a service agent to act as 
your DER.


Sec. 40.17  Is an employer responsible for obtaining information from 
its service agents?

    Yes, as an employer, you are responsible for obtaining information 
required by this part from your service agents. This is true whether or 
not you choose to use a C/TPA as an intermediary in transmitting 
information to you. For example, suppose an applicant for a safety-
sensitive job takes a pre-employment drug test, but there is a 
significant delay in your receipt of the test result from an MRO or C/
TPA. You must not assume that ``no news is good news'' and permit the 
applicant to perform safety-sensitive duties before receiving the 
result. This is a violation of the Department's regulations.


Sec. 40.19  [Reserved]


Sec. 40.21  May an employer stand down an employee before the MRO has 
completed the verification process?

    (a) As an employer, you are prohibited from standing employees 
down, except consistent with a waiver a DOT agency grants under this 
section.
    (b) You may make a request to the concerned DOT agency for a waiver 
from the prohibition of paragraph (a) of this section. Such a waiver, 
if granted, permits you to stand an employee down following the MRO's 
receipt of a laboratory report of a confirmed positive test for a drug 
or drug metabolite, an adulterated test, or a substituted test 
pertaining to the employee.
    (1) For this purpose, the concerned DOT agency is the one whose 
drug and alcohol testing rules apply to the majority of the covered 
employees in your organization. The concerned DOT agency uses its 
applicable procedures for considering requests for waivers.
    (2) Before taking action on a waiver request, the concerned DOT 
agency coordinates with other DOT agencies that regulate the employer's 
other covered employees.
    (3) The concerned DOT agency provides a written response to each 
employer that petitions for a waiver, setting forth the reasons for the 
agency's decision on the waiver request.
    (c) Your request for a waiver must include, as a minimum, the 
following elements:
    (1) Information about your organization:
    (i) Your determination that standing employees down is necessary 
for safety in your organization and a statement of your basis for it, 
including any data on safety problems or incidents that could have been 
prevented if a stand-down procedure had been in place;
    (ii) Data showing the number of confirmed laboratory positive, 
adulterated, and substituted test results for your employees over the 
two calendar years preceding your waiver request, and the number and 
percentage of those test results that were verified positive, 
adulterated, or substituted by the MRO;
    (iii) Information about the work situation of the employees subject 
to stand-down, including a description of the size and organization of 
the unit(s) in which the employees work, the process through which 
employees will be informed of the stand-down, whether there is an in-
house MRO, and whether your organization has a medical disqualification 
or stand-down policy for employees in situations other than drug and 
alcohol testing; and
    (iv) A statement of which DOT agencies regulate your employees.
    (2) Your proposed written company policy concerning stand-down, 
which must include the following elements:
    (i) Your assurance that you will distribute copies of your written 
policy to all employees that it covers;
    (ii) Your means of ensuring that no information about the confirmed 
positive, adulterated, or substituted test result or the reason for the 
employee's temporary removal from performance of safety-sensitive 
functions becomes available, directly or indirectly, to anyone in your 
organization (or subsequently to another employer) other than the 
employee, the MRO and the DER;
    (iii) Your means of ensuring that all covered employees in a 
particular job category in your organization are treated the same way 
with respect to stand-down;
    (iv) Your means of ensuring that a covered employee will be subject 
to stand-down only with respect to the actual performance of safety-
sensitive duties;
    (v) Your means of ensuring that you will not take any action 
adversely affecting the employee's pay and benefits pending the 
completion of the MRO's verification process. This includes continuing 
to pay the employee during the period of the stand-down in the same way 
you would have paid him or her had he or she not been stood down;
    (vi) Your means of ensuring that the verification process will 
commence no later than the time an employee is temporarily removed from 
the performance of safety-sensitive functions and that the period of 
stand-down for any employee will not exceed five days, unless you are 
informed in writing by the MRO that a longer period is needed to 
complete the verification process; and
    (vii) Your means of ensuring that, in the event that the MRO 
verifies the test negative or cancels it--
    (A) You return the employee immediately to the performance of 
safety-sensitive duties;
    (B) The employee suffers no adverse personnel or financial 
consequences as a result; and
    (C) You maintain no individually identifiable record that the 
employee had a confirmed laboratory positive, adulterated, or 
substituted test result (i.e., you maintain a record of the test only 
as a negative or cancelled test).
    (d) The Administrator of the concerned DOT agency, or his or her 
designee, may grant a waiver request only if he or she determines that, 
in the context of your organization, there is a high probability that 
the procedures you propose will effectively enhance safety and protect 
the interests of employees in fairness and confidentiality.
    (1) The Administrator, or his or her designee, may impose any 
conditions he or she deems appropriate on the grant of a waiver.
    (2) The Administrator, or his or her designee, may immediately 
suspend or revoke the waiver if he or she determines that you have 
failed to protect effectively the interests of employees in fairness 
and confidentiality, that you have failed to comply with the 
requirements of this section, or that you have failed to comply with 
any other conditions the DOT agency has attached to the waiver.
    (e) You must not stand employees down in the absence of a waiver, 
or inconsistent with the terms of your waiver. If you do, you are in 
violation

[[Page 79532]]

of this part and DOT agency drug testing regulations, and you are 
subject to enforcement action by the DOT agency just as you are for 
other violations of this part and DOT agency rules.


Sec. 40.23  What actions do employers take after receiving verified 
test results?

    (a) As an employer who receives a verified positive drug test 
result, you must immediately remove the employee involved from 
performing safety-sensitive functions. You must take this action upon 
receiving the initial report of the verified positive test result. Do 
not wait to receive the written report or the result of a split 
specimen test.
    (b) As an employer who receives a verified adulterated or 
substituted drug test result, you must consider this a refusal to test 
and immediately remove the employee involved from performing safety-
sensitive functions. You must take this action on receiving the initial 
report of the verified adulterated or substituted test result. Do not 
wait to receive the written report or the result of a split specimen 
test.
    (c) As an employer who receives an alcohol test result of 0.04 or 
higher, you must immediately remove the employee involved from 
performing safety-sensitive functions. If you receive an alcohol test 
result of 0.02--0.39, you must temporarily remove the employee involved 
from performing safety-sensitive functions, as provided in applicable 
DOT agency regulations. Do not wait to receive the written report of 
the result of the test.
    (d) As an employer, when an employee has a verified positive, 
adulterated, or substituted test result, or has otherwise violated a 
DOT agency drug and alcohol regulation, you must not return the 
employee to the performance of safety-sensitive functions until or 
unless the employee successfully completes the return-to-duty process 
of Subpart O of this part.
    (e) As an employer who receives a drug test result indicating that 
the employee's specimen was dilute, take action as provided in 
Sec. 40.197.
    (f) As an employer who receives a drug test result indicating that 
the employee's specimen was invalid and that a second collection must 
take place under direct observation--
    (1) You must immediately direct the employee to provide a new 
specimen under direct observation.
    (2) You must not attach consequences to the finding that the test 
was invalid other than collecting a new specimen under direct 
observation.
    (3) You must not give any advance notice of this test requirement 
to the employee.
    (4) You must instruct the collector to note on the CCF the same 
reason (e.g. random test, post-accident test) as for the original 
collection.
    (g) As an employer who receives a cancelled test result when a 
negative result is required (e.g., pre-employment, return-to-duty, or 
follow-up test), you must direct the employee to provide another 
specimen immediately.
    (h) As an employer, you may also be required to take additional 
actions required by DOT agency regulations (e.g., FAA rules require 
some positive drug tests to be reported to the Federal Air Surgeon).
    (i) As an employer, you must not alter a drug or alcohol test 
result transmitted to you by an MRO, BAT, or C/TPA.


Sec. 40.25  Must an employer check on the drug and alcohol testing 
record of employees it is intending to use to perform safety-sensitive 
duties?

    (a) Yes, as an employer, you must, after obtaining an employee's 
written consent, request the information about the employee listed in 
paragraph (b) of this section. This requirement applies only to 
employees seeking to begin performing safety-sensitive duties for you 
for the first time (i.e., a new hire, an employee transfers into a 
safety-sensitive position). If the employee refuses to provide this 
written consent, you must not permit the employee to perform safety-
sensitive functions.
    (b) You must request the information listed in this paragraph (b) 
from DOT-regulated employers who have employed the employee during any 
period during the two years before the date of the employee's 
application or transfer:
    (1) Alcohol tests with a result of 0.04 or higher alcohol 
concentration;
    (2) Verified positive drug tests;
    (3) Refusals to be tested (including verified adulterated or 
substituted drug test results);
    (4) Other violations of DOT agency drug and alcohol testing 
regulations; and
    (5) With respect to any employee who violated a DOT drug and 
alcohol regulation, documentation of the employee's successful 
completion of DOT return-to-duty requirements (including follow-up 
tests). If the previous employer does not have information about the 
return-do-duty process (e.g., an employer who did not hire an employee 
who tested positive on a pre-employment test), you must seek to obtain 
this information from the employee.
    (c) The information obtained from a previous employer includes any 
drug or alcohol test information obtained from previous employers under 
this section or other applicable DOT agency regulations.
    (d) If feasible, you must obtain and review this information before 
the employee first performs safety-sensitive functions. If this is not 
feasible, you must obtain and review the information as soon as 
possible. However, you must not permit the employee to perform safety-
sensitive functions after 30 days from the date on which the employee 
first performed safety-sensitive functions, unless you have obtained or 
made and documented a good faith effort to obtain this information.
    (e) If you obtain information that the employee has violated a DOT 
agency drug and alcohol regulation, you must not use the employee to 
perform safety-sensitive functions unless you also obtain information 
that the employee has subsequently complied with the return-to-duty 
requirements of Subpart O of this part and DOT agency drug and alcohol 
regulations.
    (f) You must provide to each of the employers from whom you request 
information under paragraph (b) of this section written consent for the 
release of the information cited in paragraph (a) of this section.
    (g) The release of information under this section must be in any 
written form (e.g., fax, e-mail, letter) that ensures confidentiality. 
As the previous employer, you must maintain a written record of the 
information released, including the date, the party to whom it was 
released, and a summary of the information provided.
    (h) If you are an employer from whom information is requested under 
paragraph (b) of this section, you must, after reviewing the employee's 
specific, written consent, immediately release the requested 
information to the employer making the inquiry.
    (i) As the employer requesting the information required under this 
section, you must maintain a written, confidential record of the 
information you obtain or of the good faith efforts you made to obtain 
the information. You must retain this information for three years from 
the date of the employee's first performance of safety-sensitive duties 
for you.
    (j) As the employer, you must also ask the employee whether he or 
she has tested positive, or refused to test, on any pre-employment drug 
or alcohol test administered by an employer to which the employee 
applied for, but did not obtain, safety-sensitive transportation work 
covered by DOT agency drug and alcohol testing rules during the past 
two years. If the employee admits that he or she had a positive test or 
a refusal to

[[Page 79533]]

test, you must not use the employee to perform safety-sensitive 
functions for you, until and unless the employee documents successful 
completion of the return-to-duty process (see paragraphs (b)(5) and (e) 
of this section).


Sec. 40.27  Where is other information on employer responsibilities 
found in this regulation?

    You can find other information on the responsibilities of employers 
in the following sections of this part:

Sec. 40.3--Definition.
Sec. 40.35--Information about DERs that employers must provide 
collectors.
Sec. 40.45--Modifying CCFs, Use of foreign-language CCFs.
Sec. 40.47--Use of non-Federal forms for DOT tests or Federal CCFs 
for non-DOT tests.
Sec. 40.67--Requirements for direct observation.
Secs. 40.103-40.105--Blind specimen requirements.
Sec. 40. 173--Responsibility to ensure test of split specimen.
Sec. 40.193--Action in ``shy bladder'' situations.
Sec. 40.197--Actions following report of a dilute specimen.
Sec. 40.207--Actions following a report of a cancelled drug test.
Sec. 40.209--Actions following and consequences of non-fatal flaws 
in drug tests.
Sec. 40.215--Information about DERs that employers must provide BATs 
and STTs.
Sec. 40.225--Modifying ATFs; use of foreign-language ATFs.
Sec. 40.227--Use of non-DOT forms for DOT tests or DOT ATFs for non-
DOT tests.
Sec. 40.235 (c) and (d)--responsibility to follow instructions for 
ASDs.
Sec. 40.255 (b)--receipt and storage of alcohol test information.
Sec. 40.265 (c)-(e)--actions in ``shy lung'' situations.
Sec. 40.267--Cancellation of alcohol tests.
Sec. 40.271--Actions in ``correctable flaw'' situations in alcohol 
tests.
Sec. 40.273--Actions following cancelled tests in alcohol tests.
Sec. 40.275--Actions in ``non-fatal flaw'' situations in alcohol 
tests.
Secs. 40.287-40.289--Responsibilities concerning SAP services.
Secs. 40.295-40.297--Prohibition on seeking second SAP evaluation or 
changing SAP recommendation.
Sec. 40.303--Responsibilities concerning aftercare recommendations.
Sec. 40.305--Responsibilities concerning return-to-duty decision.
Sec. 40.309--Responsibilities concerning follow-up tests.
Sec. 40.321--General confidentiality requirement.
Sec. 40.323--Release of confidential information in litigation.
Sec. 40.331--Other circumstances for the release of confidential 
information.
Sec. 40.333--Record retention requirements.
Sec. 40.345--Choice of who reports drug testing information to 
employers.

Subpart C--Urine Collection Personnel


Sec. 40.31  Who may collect urine specimens for DOT drug testing?

    (a) Collectors meeting the requirements of this subpart are the 
only persons authorized to collect urine specimens for DOT drug 
testing.
    (b) A collector must meet training requirements of Sec. 40.33.
    (c) As the immediate supervisor of an employee being tested, you 
may not act as the collector when that employee is tested, unless no 
other collector is available and you are permitted to do so under DOT 
agency drug and alcohol regulations.
    (d) You must not act as the collector for the employee being tested 
if you work for a HHS-certified laboratory (e.g., as a technician or 
accessioner) and could link the employee with a urine specimen, drug 
testing result, or laboratory report.


Sec. 40.33  What training requirements must a collector meet?

    To be permitted to act as a collector in the DOT drug testing 
program, you must meet each of the requirements of this section:
    (a) Basic information. You must be knowledgeable about this part, 
the current ``DOT Urine Specimen Collection Procedures Guidelines,'' 
and DOT agency regulations applicable to the employers for whom you 
perform collections, and you must keep current on any changes to these 
materials. The DOT Urine Specimen Collection Procedures Guidelines 
document is available from ODAPC (Department of Transportation, 400 7th 
Street, SW., Room 10403, Washington DC, 20590, 202-366-3784, or on the 
ODAPC web site (http://www.dot.gov/ost/dapc).
    (b) Qualification training. You must receive qualification training 
meeting the requirements of this paragraph. Qualification training must 
provide instruction on the following subjects:
    (1) All steps necessary to complete a collection correctly and the 
proper completion and transmission of the CCF;
    (2) ``Problem'' collections (e.g., situations like ``shy bladder'' 
and attempts to tamper with a specimen);
    (3) Fatal flaws, correctable flaws, and how to correct problems in 
collections; and
    (4) The collector's responsibility for maintaining the integrity of 
the collection process, ensuring the privacy of employees being tested, 
ensuring the security of the specimen, and avoiding conduct or 
statements that could be viewed as offensive or inappropriate;
    (c) Initial Proficiency Demonstration. Following your completion of 
qualification training under paragraph (b) of this section, you must 
demonstrate proficiency in collections under this part by completing 
five consecutive error-free mock collections.
    (1) The five mock collections must include two uneventful 
collection scenarios, one insufficient quantity of urine scenario, one 
temperature out of range scenario, and one scenario in which the 
employee refuses to sign the CCF and initial the specimen bottle 
tamper-evident seal.
    (2) Another person must monitor and evaluate your performance, in 
person or by a means that provides real-time observation and 
interaction between the instructor and trainee, and attest in writing 
that the mock collections are ``error-free.'' This person must be an 
individual who has demonstrated necessary knowledge, skills, and 
abilities by--
    (i) Regularly conducting DOT drug test collections for a period of 
at least a year;
    (ii) Conducting collector training under this part for a year; or
    (iii) Successfully completing a ``train the trainer'' course.
    (d) Schedule for qualification training and initial proficiency 
demonstration. The following is the schedule for qualification training 
and the initial proficiency demonstration you must meet:
    (1) If you became a collector before August 1, 2001, and you have 
already met the requirements of paragraphs (b) and (c) of this section, 
you do not have to meet them again.
    (2) If you became a collector before August 1, 2001, and have yet 
to meet the requirements of paragraphs (b) and (c) of this section, you 
must do so no later than January 31, 2003.
    (3) If you become a collector on or after August 1, 2001, you must 
meet the requirements of paragraphs (b) and (c) of this section before 
you begin to perform collector functions.
    (e) Refresher training. No less frequently than every five years 
from the date on which you satisfactorily complete the requirements of 
paragraphs (b) and (c) of this section, you must complete refresher 
training that meets all the requirements of paragraphs (b) and (c) of 
this section.
    (f) Error Correction Training. If you make a mistake in the 
collection process that causes a test to be cancelled (i.e., a fatal or 
uncorrected flaw), you must undergo error correction training. This 
training must occur within 30 days of the date you are notified of the 
error that led to the need for retraining.
    (i) Error correction training must be provided and your proficiency

[[Page 79534]]

documented in writing by a person who meets the requirements of 
paragraph (c)(2) of this section.
    (ii) Error correction training is required to cover only the 
subject matter area(s) in which the error that caused the test to be 
cancelled occurred.
    (iii) As part of the error correction training, you must 
demonstrate your proficiency in the collection procedures of this part 
by completing three consecutive error-free mock collections. The mock 
collections must include one uneventful scenario and two scenarios 
related to the area(s) in which your error(s) occurred. The person 
providing the training must monitor and evaluate your performance and 
attest in writing that the mock collections were ``error-free.''
    (g) Documentation. You must maintain documentation showing that you 
currently meet all requirements of this section. You must provide this 
documentation on request to DOT agency representatives and to employers 
and C/TPAs who are using or negotiating to use your services.


Sec. 40.35  What information about the DER must employers provide to 
collectors?

    As an employer, you must provide to collectors the name and 
telephone number of the appropriate DER (and C/TPA, where applicable) 
to contact about any problems or issues that may arise during the 
testing process.


Sec. 40.37  Where is other information on the role of collectors found 
in this regulation?

    You can find other information on the role and functions of 
collectors in the following sections of this part:

Sec. 40.3--Definition.
Sec. 40.43--Steps to prepare and secure collection sites.
Secs. 40.45-40.47--Use of CCF.
Secs. 40.49-40.51--Use of collection kit and shipping materials.
Secs. 40.61-40.63--Preliminary steps in collections.
Sec. 40.65--Role in checking specimens.
Sec. 40.67--Role in directly observed collections.
Sec. 40.69--Role in monitored collections.
Sec. 40.71--Role in split specimen collections.
Sec. 40.73--Chain of custody completion and finishing the collection 
process.
Sec. 40.103--Processing blind specimens.
Sec. 40.191--Action in case of refusals to take test.
Sec. 40.193--Action in ``shy bladder'' situations.
Sec. 40.199-40.205--Collector errors in tests, effects, and means of 
correction.

Subpart D--Collection Sites, Forms, Equipment and Supplies Used in 
DOT Urine Collections


Sec. 40.41  Where does a urine collection for a DOT drug test take 
place?

    (a) A urine collection for a DOT drug test must take place in a 
collection site meeting the requirements of this section.
    (b) If you are operating a collection site, you must ensure that it 
meets the security requirements of Sec. 40.43.
    (c) If you are operating a collection site, you must have all 
necessary personnel, materials, equipment, facilities and supervision 
to provide for the collection, temporary storage, and shipping of urine 
specimens to a laboratory, and a suitable clean surface for writing.
    (d) Your collection site must include a facility for urination 
described in either paragraph (e) or paragraph (f) of this section.
    (e) The first, and preferred, type of facility for urination that a 
collection site may include is a single-toilet room, having a full-
length privacy door, within which urination can occur.
    (1) No one but the employee may be present in the room during the 
collection, except for the observer in the event of a directly observed 
collection.
    (2) You must have a source of water for washing hands, that, if 
practicable, should be external to the closed room where urination 
occurs. If an external source is not available, you may meet this 
requirement by securing all sources of water and other substances that 
could be used for adulteration and substitution (e.g., water faucets, 
soap dispensers) and providing moist towelettes outside the closed 
room.
    (f) The second type of facility for urination that a collection 
site may include is a multistall restroom.
    (1) Such a site must provide substantial visual privacy (e.g., a 
toilet stall with a partial-length door) and meet all other applicable 
requirements of this section.
    (2) If you use a multi-stall restroom, you must either--
    (i) Secure all sources of water and other substances that could be 
used for adulteration and substitution (e.g., water faucets, soap 
dispensers) and place bluing agent in all toilets or secure the toilets 
to prevent access; or
    (ii) Conduct all collections in the facility as monitored 
collections (see Sec. 40.69 for procedures). This is the only 
circumstance in which you may conduct a monitored collection.
    (3) No one but the employee may be present in the multistall 
restroom during the collection, except for the monitor in the event of 
a monitored collection or the observer in the event of a directly 
observed collection.
    (g) A collection site may be in a medical facility, a mobile 
facility (e.g., a van), a dedicated collection facility, or any other 
location meeting the requirements of this section.


Sec. 40.43  What steps must operators of collection sites take to 
protect the security and integrity of urine collections?

    (a) Collectors and operators of collection sites must take the 
steps listed in this section to prevent unauthorized access that could 
compromise the integrity of collections.
    (b) As a collector, you must do the following before each 
collection to deter tampering with specimens:
    (1) Secure any water sources or otherwise make them unavailable to 
employees (e.g., turn off water inlet, tape handles to prevent opening 
faucets);
    (2) Ensure that the water in the toilet is blue;
    (3) Ensure that no soap, disinfectants, cleaning agents, or other 
possible adulterants are present;
    (4) Inspect the site to ensure that no foreign or unauthorized 
substances are present;
    (5) Tape or otherwise secure shut any movable toilet tank top, or 
put bluing in the tank;
    (6) Ensure that undetected access (e.g., through a door not in your 
view) is not possible;
    (7) Secure areas and items (e.g., ledges, trash receptacles, paper 
towel holders, under-sink areas) that appear suitable for concealing 
contaminants; and
    (8) Recheck items in paragraphs (b)(1) through (7) of this section 
following each collection to ensure the site's continued integrity.
    (c) If the collection site uses a facility normally used for other 
purposes, like a public rest room or hospital examining room, you must, 
as a collector, also ensure before the collection that:
    (1) Access to collection materials and specimens is effectively 
restricted; and
    (2) The facility is secured against access during the procedure to 
ensure privacy to the employee and prevent distraction of the 
collector. Limited-access signs must be posted.
    (d) As a collector, you must take the following additional steps to 
ensure security during the collection process:
    (1) To avoid distraction that could compromise security, you are 
limited to conducting a collection for only one employee at a time. 
However, during the time one employee is in the period for drinking 
fluids in a ``shy bladder''

[[Page 79535]]

situation (see Sec. 40.193(b)), you may conduct a collection for 
another employee.
    (2) To the greatest extent you can, keep an employee's collection 
container within view of both you and the employee between the time the 
employee has urinated and the specimen is sealed.
    (3) Ensure you are the only person in addition to the employee who 
handles the specimen before it is poured into the bottles and sealed 
with tamper-evident seals.
    (4) In the time between when the employee gives you the specimen 
and when you seal the specimen, remain within the collection site.
    (5) Maintain personal control over each specimen and CCF throughout 
the collection process.
    (e) If you are operating a collection site, you must implement a 
policy and procedures to prevent unauthorized personnel from entering 
any part of the site in which urine specimens are collected or stored.
    (1) Only employees being tested, collectors and other collection 
site workers, DERs, employee and employer representatives authorized by 
the employer (e.g., employer policy, collective bargaining agreement), 
and DOT agency representatives are authorized persons for purposes of 
this paragraph (e).
    (2) Except for the observer in a directly observed collection or 
the monitor in the case of a monitored collection, you must not permit 
anyone to enter the urination facility in which employees provide 
specimens.
    (3) You must ensure that all authorized persons are under the 
supervision of a collector at all times when permitted into the site.
    (4) You or the collector may remove any person who obstructs, 
interferes with, or causes a delay in the collection process.
    (f) If you are operating a collection site, you must minimize the 
number of persons handling specimens.


Sec. 40.45  What form is used to document a DOT urine collection?

    (a) The Federal Drug Testing Custody and Control Form (CCF) must be 
used to document every urine collection required by the DOT drug 
testing program. The CCF must be a five-part carbonless manifold form. 
You may view this form on the Department's web site (http://www.dot.gov/ost/dapc) or the HHS web site (http://www.health.org/workpl.htm).
    (b) As a participant in the DOT drug testing program, you are not 
permitted to modify or revise the CCF except as follows:
    (1) You may include, in the area outside the border of the form, 
other information needed for billing or other purposes necessary to the 
collection process.
    (2) The CCF must include the names, addresses, telephone numbers 
and fax numbers of the employer and the MRO, which may be preprinted, 
typed, or handwritten. The MRO information must include the specific 
physician's name and address, as opposed to only a generic clinic, 
health care organization, or company name. This information is 
required, and it is prohibited for an employer, collector, service 
agent or any other party to omit it. In addition, a C/TPA's name, 
address, fax number, and telephone number may be included, but is not 
required.
    (3) As an employer, you may add the name of the DOT agency under 
whose authority the test occurred as part of the employer information.
    (4) As a collector, you may use a CCF with your name, address, 
telephone number, and fax number preprinted, but under no circumstances 
may you sign the form before the collection event.
    (c) Under no circumstances may the CCF transmit personal 
identifying information about an employee (other than a social security 
number (SSN) or other employee identification (ID) number) to a 
laboratory.
    (d) As an employer, you may use an equivalent foreign-language 
version of the CCF approved by ODAPC. You may use such a non-English 
language form only in a situation where both the employee and collector 
understand and can use the form in that language.


Sec. 40.47  May employers use the CCF for non-DOT collections or non-
Federal forms for DOT collections?

    (a) No, as an employer, you are prohibited from using the CCF for 
non-DOT urine collections. You are also prohibited from using non-
Federal forms for DOT urine collections. Doing either subjects you to 
enforcement action under DOT agency regulations.
    (b) (1) In the rare case where the collector, either by mistake or 
as the only means to conduct a test under difficult circumstances 
(e.g., post-accident or reasonable suspicion test with insufficient 
time to obtain the CCF), uses a non-Federal form for a DOT collection, 
the use of a non-Federal form does not present a reason for the 
laboratory to reject the specimen for testing or for an MRO to cancel 
the result.
    (2) The use of the non-DOT form is a ``correctable flaw.'' As an 
MRO, to correct the problem you must follow the procedures of 
Sec. 40.205(b)(2).


Sec. 40.49  What materials are used to collect urine specimens?

    For each DOT drug test, you must use a collection kit meeting the 
requirements of Appendix A of this part.


Sec. 40.51  What materials are used to send urine specimens to the 
laboratory?

    (a) Except as provided in paragraph (b) of this section, you must 
use a shipping container that adequately protects the specimen bottles 
from shipment damage in the transport of specimens from the collection 
site to the laboratory.
    (b) You are not required to use a shipping container if a 
laboratory courier hand-delivers the specimens from the collection site 
to the laboratory.

Subpart E--Urine Specimen Collections


Sec. 40.61  What are the preliminary steps in the collection process?

    As the collector, you must take the following steps before actually 
beginning a collection:
    (a) When a specific time for an employee's test has been scheduled, 
or the collection site is at the employee's work site, and the employee 
does not appear at the collection site at the scheduled time, contact 
the DER to determine the appropriate interval within which the DER has 
determined the employee is authorized to arrive. If the employee's 
arrival is delayed beyond that time, you must notify the DER that the 
employee has not reported for testing. In a situation where a C/TPA has 
notified an owner/operator or other individual employee to report for 
testing and the employee does not appear, the C/TPA must notify the 
employee that he or she has refused to test (see Sec. 40.191(a)(1)).
    (b) Ensure that, when the employee enters the collection site, you 
begin the testing process without undue delay. For example, you must 
not wait because the employee says he or she is not ready or is unable 
to urinate or because an authorized employer or employee representative 
is delayed in arriving.
    (1) If the employee is also going to take a DOT alcohol test, you 
must, to the greatest extent practicable, ensure that the alcohol test 
is completed before the urine collection process begins.

    Example to Paragraph (b)(1): An employee enters the test site 
for both a drug and an alcohol test. Normally, the collector would 
wait until the BAT had completed the alcohol test process before 
beginning the drug test process. However, there are some situations 
in which an exception to this normal practice would be reasonable. 
One

[[Page 79536]]

such situation might be if several people were waiting for the BAT 
to conduct alcohol tests, but a drug testing collector in the same 
facility were free. Someone waiting might be able to complete a drug 
test without unduly delaying his or her alcohol test. Collectors and 
BATs should work together, however, to ensure that post-accident and 
reasonable suspicion alcohol tests happen as soon as possible (e.g., 
by moving the employee to the head of the line for alcohol tests).

    (2) If the employee needs medical attention (e.g., an injured 
employee in an emergency medical facility who is required to have a 
post-accident test), do not delay this treatment to collect a specimen.
    (3) You must not collect, by catheterization or other means, urine 
from an unconscious employee to conduct a drug test under this part. 
Nor may you catheterize a conscious employee. However, you must inform 
an employee who normally voids through self-catheterization that the 
employee is required to provide a specimen in that manner.
    (4) If, as an employee, you normally void through self-
catheterization, and decline to do so, this constitutes a refusal to 
test.
    (c) Require the employee to provide positive identification. You 
must see a photo ID issued by the employer (other than in the case of 
an owner-operator or other self-employed individual) or a Federal, 
state, or local government (e.g., a driver's license). You may not 
accept faxes or photocopies of identification. Positive identification 
by an employer representative (not a co-worker or another employee 
being tested) is also acceptable. If the employee cannot produce 
positive identification, you must contact a DER to verify the identity 
of the employee.
    (d) If the employee asks, provide your identification to the 
employee. Your identification must include your name and your 
employer's name, but does not have to include your picture, address, or 
telephone number.
    (e) Explain the basic collection procedure to the employee, 
including showing the employee the instructions on the back of the CCF.
    (f) Direct the employee to remove outer clothing (e.g., coveralls, 
jacket, coat, hat) that could be used to conceal items or substances 
that could be used to tamper with a specimen. You must also direct the 
employee to leave these garments and any briefcase, purse, or other 
personal belongings with you or in a mutually agreeable location. You 
must advise the employee that failure to comply with your directions 
constitutes a refusal to test.
    (1) If the employee asks for a receipt for any belongings left with 
you, you must provide one.
    (2) You must allow the employee to keep his or her wallet.
    (3) You must not ask the employee to remove other clothing (e.g., 
shirts, pants, dresses, underwear), to remove all clothing, or to 
change into a hospital or examination gown (unless the urine collection 
is being accomplished simultaneously with a DOT agency-authorized 
medical examination).
    (4) You must direct the employee to empty his or her pockets and 
display the items in them to ensure that no items are present which 
could be used to adulterate the specimen. If nothing is there that can 
be used to adulterate a specimen, the employee can place the items back 
into his or her pockets. As the employee, you must allow the collector 
to make this observation.
    (5) If, in your duties under paragraph (f)(4) of this section, you 
find any material that could be used to tamper with a specimen, you 
must:
    (i) Determine if the material appears to be brought to the 
collection site with the intent to alter the specimen, and, if it is, 
conduct a directly observed collection using direct observation 
procedures (see Sec. 40.67); or
    (ii) Determine if the material appears to be inadvertently brought 
to the collection site (e.g., eye drops), secure and maintain it until 
the collection process is completed and conduct a normal (i.e., 
unobserved) collection.
    (g) You must instruct the employee not to list medications that he 
or she is currently taking on the CCF. (The employee may make notes of 
medications on the back of the employee copy of the form for his or her 
own convenience, but these notes must not be transmitted to anyone 
else.)


Sec. 40.63  What steps does the collector take in the collection 
process before the employee provides a urine specimen?

    As the collector, you must take the following steps before the 
employee provides the urine specimen:
    (a) Complete Step 1 of the CCF.
    (b) Instruct the employee to wash and dry his or her hands at this 
time. You must tell the employee not to wash his or her hands again 
until after delivering the specimen to you. You must not give the 
employee any further access to water or other materials that could be 
used to adulterate or dilute a specimen.
    (c) Select, or allow the employee to select, an individually 
wrapped or sealed collection container from collection kit materials. 
Either you or the employee, with both of you present, must unwrap or 
break the seal of the collection container. You must not unwrap or 
break the seal on any specimen bottle at this time. You must not allow 
the employee to take anything from the collection kit into the room 
used for urination except the collection container.
    (d) Direct the employee to go into the room used for urination, 
provide a specimen of at least 45 mL, not flush the toilet, and return 
to you with the specimen as soon as the employee has completed the 
void.
    (1) Except in the case of an observed or a monitored collection 
(see Secs. 40.67 and 40.69 ), neither you nor anyone else may go into 
the room with the employee.
    (2) As the collector, you may set a reasonable time limit for 
voiding.
    (e) You must pay careful attention to the employee during the 
entire collection process to note any conduct that clearly indicates an 
attempt to tamper with a specimen (e.g., substitute urine in plain view 
or an attempt to bring into the collection site an adulterant or urine 
substitute). If you detect such conduct, you must require that a 
collection take place immediately under direct observation (see 
Sec. 40.67 ) and note the conduct and the fact that the collection was 
observed in the ``Remarks'' line of the CCF (Step 2). You must also, as 
soon as possible, inform the DER and collection site supervisor that a 
collection took place under direct observation and the reason for doing 
so.


Sec. 40.65   What does the collector check for when the employee 
presents a specimen?

    As a collector, you must check the following when the employee 
gives the collection container to you:
    (a) Sufficiency of specimen. You must check to ensure that the 
specimen contains at least 45 mL of urine.
    (1) If it does not, you must follow ``shy bladder'' procedures (see 
Sec. 40.193(b)).
    (2) When you follow ``shy bladder'' procedures, you must discard 
the original specimen, unless another problem (i.e., temperature out of 
range, signs of tampering) also exists.
    (3) You are never permitted to combine urine collected from 
separate voids to create a specimen.
    (4) You must discard any excess urine.
    (b) Temperature. You must check the temperature of the specimen no 
later than four minutes after the employee has given you the specimen.
    (1) The acceptable temperature range is 32-38  deg.C/90-100  deg.F.
    (2) You must determine the temperature of the specimen by reading 
the temperature strip attached to the collection container.

[[Page 79537]]

    (3) If the specimen temperature is within the acceptable range, you 
must mark the ``Yes'' box on the CCF (Step 2).
    (4) If the specimen temperature is outside the acceptable range, 
you must mark the ``No'' box and enter in the ``Remarks'' line (Step 2) 
your findings about the temperature.
    (5) If the specimen temperature is outside the acceptable range, 
you must immediately conduct a new collection using direct observation 
procedures (see Sec. 40.67).
    (6) In a case where a specimen is collected under direct 
observation because of the temperature being out of range, you must 
process both the original specimen and the specimen collected using 
direct observation and send the two sets of specimens to the 
laboratory. This is true even in a case in which the original specimen 
has insufficient volume but the temperature is out of range. You must 
also, as soon as possible, inform the DER and collection site 
supervisor that a collection took place under direct observation and 
the reason for doing so.
    (7) In a case where the employee refuses to provide another 
specimen (see Sec. 40.191(a)(3)) or refuses to provide another specimen 
under direct observation (see Sec. 40.191(a)(4)), you must notify the 
DER. As soon as you have notified the DER, you must discard any 
specimen the employee has provided previously during the collection 
procedure.
    (c) Signs of tampering. You must inspect the specimen for unusual 
color, presence of foreign objects or material, or other signs of 
tampering (e.g., if you notice any unusual odor).
    (1) If it is apparent from this inspection that the employee has 
tampered with the specimen (e.g., blue dye in the specimen, excessive 
foaming when shaken, smell of bleach), you must immediately conduct a 
new collection using direct observation procedures (see Sec. 40.67 ).
    (2) In a case where a specimen is collected under direct 
observation because of showing signs of tampering, you must process 
both the original specimen and the specimen collected using direct 
observation and send the two sets of specimens to the laboratory. This 
is true even in a case in which the original specimen has insufficient 
volume but it shows signs of tampering. You must also, as soon as 
possible, inform the DER and collection site supervisor that a 
collection took place under direct observation and the reason for doing 
so.
    (3) In a case where the employee refuses to provide another 
specimen (see Sec. 40.191(a)(3)) or refuses to provide a specimen under 
direct observation (see Sec. 40.193(a)(4)), you must notify the DER. As 
soon as you have notified the DER, you must discard any specimen the 
employee has provided previously during the collection procedure.


Sec. 40.67  When and how is a directly observed collection conducted?

    (a) As an employer you must direct an immediate collection under 
direct observation with no advance notice to the employee, if:
    (1) The laboratory reported to the MRO that a specimen is invalid, 
and the MRO reported to you that there was not an adequate medical 
explanation for the result; or
    (2) The MRO reported to you that the original positive, 
adulterated, or substituted test result had to be cancelled because the 
test of the split specimen could not be performed.
    (b) As an employer, you may direct a collection under direct 
observation of an employee if the drug test is a return-to-duty test or 
a follow-up test.
    (c) As a collector, you must immediately conduct a collection under 
direct observation if:
    (1) You are directed by the DER to do so (see paragraphs (a) and 
(c) of this section); or
    (2) You observed materials brought to the collection site or the 
employee's conduct clearly indicates an attempt to tamper with a 
specimen (see Secs. 40.61(f)(5)(i) and 40.63(e)); or
    (3) The temperature on the original specimen was out of range (see 
Sec. 40.65(b)(5)); or (4) The original specimen appeared to have been 
tampered with (see Sec. 40.65(c)(1)).
    (d)(1) As the employer, you must explain to the employee the reason 
for a directly observed collection under paragraph (a) or (b) of this 
section.
    (2) As the collector, you must explain to the employee the reason 
under this part for a directly observed collection under paragraphs 
(c)(2) through (4) of this section.
    (e) As the collector, you must complete a new CCF for the directly 
observed collection.
    (1) You must mark the ``reason for test'' block (Step 1) the same 
as for the first collection.
    (2) You must check the ``Observed, (Enter Remark)'' box and enter 
the reason (see Sec. 40.67(b)) in the ``Remarks'' line (Step 2).
    (f) In a case where two sets of specimens are being sent to the 
laboratory because of suspected tampering with the specimen at the 
collection site, enter on the ``Remarks'' line of the CCF (Step 2) for 
each specimen a notation to this effect (e.g., collection 1 of 2, or 2 
of 2) and the specimen ID number of the other specimen.
    (g) As the collector, you must ensure that the observer is the same 
gender as the employee. You must never permit an opposite gender person 
to act as the observer. The observer can be a different person from the 
collector and need not be a qualified collector.
    (h) As the collector, if someone else is to observe the collection 
(e.g., in order to ensure a same gender observer), you must verbally 
instruct that person to follow procedures at paragraphs (i) and (j) of 
this section. If you, the collector, are the observer, you too must 
follow these procedures.
    (i) As the observer, you must watch the employee urinate into the 
collection container. Specifically, you are to watch the urine go from 
the employee's body into the collection container.
    (j) As the observer but not the collector, you must not take the 
collection container from the employee, but you must observe the 
specimen as the employee takes it to the collector.
    (k) As the collector, when someone else has acted as the observer, 
you must include the observer's name in the ``Remarks'' line of the CCF 
(Step 2).
    (l) As the employee, if you decline to allow a directly observed 
collection required or permitted under this section to occur, this is a 
refusal to test.


Sec. 40.69  How is a monitored collection conducted?

    (a) As the collector, you must secure the room being used for the 
monitored collection so that no one except the employee and the monitor 
can enter it until after the collection has been completed.
    (b) As the collector, you must ensure that the monitor is the same 
gender as the employee, unless the monitor is a medical professional 
(e.g., nurse, doctor, physician's assistant). The monitor can be a 
different person from the collector and need not be a qualified 
collector.
    (c) As the collector, if someone else is to monitor the collection 
(e.g., in order to ensure a same gender monitor), you must verbally 
instruct that person to follow procedures at paragraphs (d) and (e) of 
this section. If you, the collector, are the observer, you too must 
follow these procedures.
    (d) As the monitor, you must not watch the employee urinate into 
the collection container. If you hear sounds or make other observations 
indicating an attempt to tamper with a specimen, there must be an 
additional collection under direct observation (see Secs. 40.63(e), 
40.65(c), and 40.67(b)).

[[Page 79538]]

    (e) As the monitor, you must ensure that the employee takes the 
collection container directly to the collector as soon as the employee 
has exited the enclosure.
    (f) As the collector, when someone else has acted as the monitor, 
you must note that person's name in the ``Remarks'' line of the CCF 
(Step 2).
    (g) As the employee being tested, if you decline to permit a 
collection authorized under this section to be monitored, it is a 
refusal to test.


Sec. 40.71  How does the collector prepare the specimens?

    (a) All collections under DOT agency drug testing regulations must 
be split specimen collections.
    (b) As the collector, you must take the following steps, in order, 
after the employee brings the urine specimen to you. You must take 
these steps in the presence of the employee.
    (1) Check the box on the CCF (Step 2) indicating that this was a 
split specimen collection.
    (2) You, not the employee, must first pour at least 30 mL of urine 
from the collection container into one specimen bottle, to be used for 
the primary specimen.
    (3) You, not the employee, must then pour at least 15 mL of urine 
from the collection container into the second specimen bottle to be 
used for the split specimen.
    (4) You, not the employee, must place and secure (i.e., tighten or 
snap) the lids/caps on the bottles.
    (5) You, not the employee, must seal the bottles by placing the 
tamper-evident bottle seals over the bottle caps/lids and down the 
sides of the bottles.
    (6) You, not the employee, must then write the date on the tamper-
evident bottle seals.
    (7) You must then ensure that the employee initials the tamper-
evident bottle seals for the purpose of certifying that the bottles 
contain the specimens he or she provided. If the employee fails or 
refuses to do so, you must note this in the ``Remarks'' line of the CCF 
(Step 2) and complete the collection process.


Sec. 40.73  How is the collection process completed?

    (a) As the collector, you must do the following things to complete 
the collection process. You must complete the steps called for in 
paragraphs (a)(1) through (a)(7) of this section in the employee's 
presence.
    (1) Direct the employee to read and sign the certification 
statement on Copy 2 (Step 5) of the CCF and provide date of birth, 
printed name, and day and evening contact telephone numbers. If the 
employee refuses to sign the CCF or to provide date of birth, printed 
name, or telephone numbers, you must note this in the ``Remarks'' line 
(Step 2) of the CCF, and complete the collection. If the employee 
refuses to fill out any information, you must, as a minimum, print the 
employee's name in the appropriate place.
    (2) Complete the chain of custody on the CCF (Step 5) by printing 
your name (note: you may pre-print your name), recording the time and 
date of the collection, signing the statement, and entering the name of 
the delivery service transferring the specimen to the laboratory,
    (3) Ensure that all copies of the CCF are legible and complete.
    (4) Remove Copy 5 of the CCF and give it to the employee.
    (5) Place the specimen bottles and Copy 1 of the CCF in the 
appropriate pouches of the plastic bag.
    (6) Secure both pouches of the plastic bag.
    (7) Advise the employee that he or she may leave the collection 
site.
    (8) To prepare the sealed plastic bag containing the specimens and 
CCF for shipment you must:
    (i) Place the sealed plastic bag in a shipping container (e.g., 
standard courier box) designed to minimize the possibility of damage 
during shipment. (More than one sealed plastic bag can be placed into a 
single shipping container if you are doing multiple collections.)
    (ii) Seal the container as appropriate.
    (iii) If a laboratory courier hand-delivers the specimens from the 
collection site to the laboratory, prepare the sealed plastic bag for 
shipment as directed by the courier service.
    (9) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You 
must fax or otherwise transmit these copies to the MRO and DER within 
24 hours or during the next business day. Keep Copy 3 for at least 30 
days, unless otherwise specified by applicable DOT agency regulations.
    (b) As a collector or collection site, you must ensure that each 
specimen you collect is shipped to a laboratory as quickly as possible, 
but in any case within 24 hours or during the next business day.

Subpart F--Drug Testing Laboratories


Sec. 40.81  What laboratories may be used for DOT drug testing?

    (a) As a drug testing laboratory located in the U.S., you are 
permitted to participate in DOT drug testing only if you are certified 
by HHS under the National Laboratory Certification Program (NLCP) for 
all testing required under this part.
    (b) As a drug testing laboratory located in Canada or Mexico which 
is not certified by HHS under the NLCP, you are permitted to 
participate in DOT drug testing only if:
    (1) The DOT, based on a written recommendation from HHS, has 
approved your laboratory as meeting HHS laboratory certification 
standards or deemed your laboratory fully equivalent to a laboratory 
meeting HHS laboratory certification standards for all testing required 
under this part; or
    (2) The DOT, based on a written recommendation from HHS, has 
recognized a Canadian or Mexican certifying organization as having 
equivalent laboratory certification standards and procedures to those 
of HHS, and the Canadian or Mexican certifying organization has 
certified your laboratory under those equivalent standards and 
procedures.
    (c) As a laboratory participating in the DOT drug testing program, 
you must comply with the requirements of this part. You must also 
comply with all applicable requirements of HHS in testing DOT 
specimens, whether or not the HHS requirements are explicitly stated in 
this part.
    (d) If DOT determines that you are in noncompliance with this part, 
you could be subject to PIE proceedings under Subpart R of this part. 
If the Department issues a PIE with respect to you, you are ineligible 
to participate in the DOT drug testing program even if you continue to 
meet the requirements of paragraph (a) or (b) of this section.


Sec. 40.83  How do laboratories process incoming specimens?

    As the laboratory, you must do the following when you receive a DOT 
specimen:
    (a) You are authorized to receive only the laboratory copy of the 
CCF. You are not authorized to receive other copies of the CCF nor any 
copies of the alcohol testing form.
    (b) You must comply with applicable provisions of the HHS 
Guidelines concerning accessioning and processing urine drug specimens.
    (c) You must inspect each specimen and CCF for the following 
``fatal flaws:''
    (1) The specimen ID numbers on the specimen bottle and the CCF do 
not match;
    (2) The specimen bottle seal is broken or shows evidence of 
tampering, unless a split specimen can be redesignated (see paragraph 
(g) of this section);
    (3) The collector's printed name and signature are omitted from the 
CCF; and
    (4) There is an insufficient amount of urine in the primary bottle 
for analysis, unless the specimens can be

[[Page 79539]]

redesignated (see paragraph (g) of this section).
    (d) When you find a specimen meeting the criteria of paragraph (c) 
of this section, you must document your findings and stop the testing 
process. Report the result in accordance with Sec. 40.97(a)(3) .
    (e) You must inspect each specimen and CCF for the following 
``correctable flaws'':
    (1) The specimen temperature was not checked and the ``Remarks'' 
line did not contain an entry regarding the temperature being outside 
of range; and
    (2) The collector's signature is omitted on the certification 
statement on the CCF.
    (f) Upon finding that a specimen meets the criteria of paragraph 
(e) of this section, document the flaw and continue the testing 
process.
    (1) In such a case, you must retain the specimen for a minimum of 5 
business days from the date on which you initiated action to correct 
the flaw.
    (2) You must then attempt to correct the flaw by following the 
procedures of Sec. 40.205(b).
    (3) If the flaw is not corrected, report the result in accordance 
with Sec. 40.97(a)(3).
    (g) If the CCF is marked indicating that a split specimen 
collection was collected and if the split specimen does not accompany 
the primary, has leaked, or is otherwise unavailable for testing, you 
must still test the primary specimen and follow appropriate procedures 
outlined in Sec. 40.175(b) regarding the unavailability of the split 
specimen for testing.
    (1) The primary specimen and the split specimen can be redesignated 
(i.e., Bottle B is redesignated as Bottle A, and vice-versa) if:
    (i) The primary specimen appears to have leaked out of its sealed 
bottle and the laboratory believes a sufficient amount of urine exists 
in the split specimen to conduct all appropriate primary laboratory 
testing; or
    (ii) The primary specimen is labeled as Bottle B, and the split 
specimen as Bottle A; or
    (iii) The laboratory opens the split specimen instead of the 
primary specimen, the primary specimen remains sealed, and the 
laboratory believes a sufficient amount of urine exists in the split 
specimen to conduct all appropriate primary laboratory testing; or
    (iv) The primary specimen seal is broken but the split specimen 
remains sealed and the laboratory believes a sufficient amount of urine 
exists in the split specimen to conduct all appropriate primary 
laboratory testing.
    (2) In situations outlined in paragraph (g)(1) of this section, the 
laboratory shall mark through the ``A'' and write ``B,'' then initial 
and date the change. A corresponding change shall be made to the other 
bottle by marking through the ``B'' and writing ``A,'' and initialing 
and dating the change.
    (h) A notation shall be made on Copy 1 of the CCF (Step 5a) and on 
any laboratory internal chain of custody documents, as appropriate, for 
any fatal or correctable flaw.


Sec. 40.85  What drugs do laboratories test for?

    As a laboratory, you must test for the following five drugs or 
classes of drugs in a DOT drug test. You must not test ``DOT 
specimens'' for any other drugs.
    (a) Marijuana metabolites.
    (b) Cocaine metabolites.
    (c) Amphetamines.
    (d) Opiate metabolites.
    (e) Phencyclidine (PCP).


Sec. 40.87  What are the cutoff concentrations for initial and 
confirmation tests?

    (a) As a laboratory, you must use the cutoff concentrations 
displayed in the following table for initial and confirmation drug 
tests. All cutoff concentrations are expressed in nanograms per 
milliliter (ng/mL). The table follows:

------------------------------------------------------------------------
                                     Initial
    Type of drug or metabolite         test         Confirmation test
------------------------------------------------------------------------
(1) Marijuana metabolites........           50  ........................
(i) Delta-9-tetrahydrocanna-binol-              15
 9-carboxylic acid (THC).
(2) Cocaine metabolites                    300  150
 (Benzoylecgonine).
(3) Phencyclidine (PCP)..........           25  25
(4) Amphetamines.................         1000  ........................
(i) Amphetamine..................  ...........  500
(ii) Methamphetamine.............  ...........  500 (Specimen must also
                                                 contain amphetamine at
                                                 a concentration of
                                                 greater than or equal
                                                 to 200 ng/mL.)
(5) Opiate metabolites...........         2000  ........................
(i) Codeine......................  ...........  2000
(ii) Morphine....................  ...........  2000
(iii) 6-acetylmorphine (6-AM)....  ...........  10 (Test for 6-AM in the
                                                 specimen. Conduct this
                                                 test only when specimen
                                                 contains morphine at a
                                                 concentration greater
                                                 than or equal to 2000
                                                 ng/mL.)
------------------------------------------------------------------------

    (b) On an initial drug test, you must report a result below the 
cutoff concentration as negative. If the result is at or above the 
cutoff concentration, you must conduct a confirmation test.
    (c) On a confirmation drug test, you must report a result below the 
cutoff concentration as negative and a result at or above the cutoff 
concentration as confirmed positive.
    (d) You must report quantitative values for morphine or codeine at 
15,000 ng/mL or above.


Sec. 40.89  What is validity testing, and are laboratories required to 
conduct it?

    (a) Specimen validity testing is the evaluation of the specimen to 
determine if it is consistent with normal human urine. The purpose of 
validity testing is to determine whether certain adulterants or foreign 
substances were added to the urine, if the urine was diluted, or if the 
specimen was substituted.
    (b) As a laboratory, you must conduct validity testing.


Sec. 40.91  What validity tests must laboratories conduct on primary 
specimens?

    As a laboratory, when you conduct validity testing under 
Sec. 40.89, you must conduct it in accordance with the requirements of 
this section.
    (a) You must test each primary specimen for creatinine. You must 
also determine its specific gravity if you find that the creatinine 
concentration is less than 20 mg/dL.
    (b) You must measure the pH of each primary specimen.
    (c) You must test each primary specimen to determine if it contains

[[Page 79540]]

substances that may be used to adulterate the specimen. Your tests must 
have the capability of determining whether any substance identified in 
current HHS requirements or specimen validity guidance is present in 
the specimen.
    (d) If you suspect the presence of an interfering substance/
adulterant that could make a test result invalid, but you are unable to 
identify it (e.g., a new adulterant), you must, as the first 
laboratory, send the specimen to another HHS certified laboratory that 
has the capability of doing so.
    (e) If you identify a substance in a specimen that appears to be an 
adulterant, but which is not listed in current HHS requirements or 
guidance, you must report the finding in writing to ODAPC and the 
Division of Workplace Programs, HHS, within three business days. You 
must also complete testing of the specimen for drugs, to the extent 
technically feasible.
    (f) You must conserve as much as possible of the specimen for 
possible future testing.


Sec. 40.93  What criteria do laboratories use to establish that a 
specimen is dilute or substituted?

    (a) As a laboratory you must consider the primary specimen to be 
dilute if the creatinine concentration is less than 20 mg/dL and the 
specific gravity is less than 1.003, unless the criteria for a 
substituted specimen are met.
    (b) As a laboratory you must consider the primary specimen to be 
substituted if the creatinine concentration is less than or equal to 5 
mg/dL and the specific gravity is less than or equal to 1.001 or 
greater than or equal to 1.020.


Sec. 40.95  What criteria do laboratories use to establish that a 
specimen is adulterated?

    (a) As a laboratory, you must consider the primary specimen to be 
adulterated if you determine that--
    (1) A substance that is not expected to be present in human urine 
is identified in the specimen;
    (2) A substance that is expected to be present in human urine is 
identified at a concentration so high that it is not consistent with 
human urine; or
    (3) The physical characteristics of the specimen are outside the 
normal expected range for human urine.
    (b) In making your determination under paragraph (a) of this 
section, you must apply the criteria in current HHS requirements or 
specimen validity guidance.


Sec. 40.97  What do laboratories report and how do they report it?

    (a) As a laboratory, you must report the results for each primary 
specimen tested as one of the following:
    (1) Negative;
    (2) Negative--dilute;
    (3) Rejected for testing, with remark(s);
    (4) Positive, with drug(s)/metabolite(s) noted;
    (5) Positive, with drug(s)/metabolite(s) noted--dilute;
    (6) Adulterated, with remark(s);
    (7) Substituted, with remark(s); or
    (8) Invalid result, with remark(s).
    (b) As a laboratory, you must report laboratory results directly, 
and only, to the MRO at his or her place of business. You must not 
report results to or through the DER or a service agent (e.g., C/TPA).
    (1) Negative results: You must fax, courier, mail, or 
electronically transmit a legible image or copy of the fully-completed 
Copy 1 of the CCF which has been signed by the certifying scientist, or 
you may provide the laboratory results report electronically (i.e., 
computer data file).
    (i) If you elect to provide the laboratory results report, you must 
include the following elements, as a minimum, in the report format:
    (A) Laboratory name;
    (B) Employer's name (you may include I.D. or account number;
    (C) Specimen I.D. number;
    (D) Donor's SSN or employee I.D. number, if provided; `
    (E) Reason for test, if provided;
    (F) Date of the collection;
    (G) Date received at the laboratory;
    (H) Date certifying scientist released the results;
    (I) Results (e.g., positive, adulterated) as listed in paragraph 
(a) of this section; and
    (J) Remarks section, with an explanation of any situation in which 
a correctable flaw has been corrected.
    (ii) The laboratory results report may be released only after 
review and approval by the certifying scientist and must reflect the 
same test result information as contained on the CCF signed by the 
certifying scientist.
    (iii) The results report may be transmitted through any means that 
ensures accuracy and confidentiality. You, as the laboratory, together 
with the MRO, must ensure that the information is adequately protected 
from unauthorized access or release, both during transmission and in 
storage.
    (2) Non-negative results: You must fax, courier, mail, or 
electronically transmit a legible image or copy of the fully-completed 
Copy 1 of the CCF that has been signed by the certifying scientist. In 
addition, you may provide the electronic laboratory results report 
following the format and procedures set forth in paragraphs (b)(1)(i) 
and (ii) of this section.
    (c) In transmitting laboratory results to the MRO, you, as the 
laboratory, together with the MRO, must ensure that the information is 
adequately protected from unauthorized access or release, both during 
transmission and in storage. If the results are provided by fax, the 
fax connection must have a fixed telephone number accessible only to 
authorized individuals.
    (d) You must transmit test results to the MRO in a timely manner, 
preferably the same day that review by the certifying scientist is 
completed.
    (e) You must provide quantitative values for confirmed positive 
drug, adulterated, and substituted test results to the MRO when the MRO 
requests you to do so in writing. The MRO's request may either be a 
general request covering all such results you send to the MRO or a 
specific case-by-case request.
    (f) You must provide quantitative values for confirmed opiate 
results for morphine or codeine at 15,000 ng/mL or above, even if the 
MRO has not requested quantitative values for the test result.


Sec. 40.99  How long does the laboratory retain specimens after 
testing?

    (a) As a laboratory testing the primary specimen, you must retain a 
specimen that was reported with positive, adulterated, substituted, or 
invalid results for a minimum of one year.
    (b) You must keep such a specimen in secure, long-term, frozen 
storage in accordance with HHS requirements.
    (c) Within the one-year period, the MRO, the employee, the 
employer, or a DOT agency may request in writing that you retain a 
specimen for an additional period of time (e.g., for the purpose of 
preserving evidence for litigation or a safety investigation). If you 
receive such a request, you must comply with it. If you do not receive 
such a request, you may discard the specimen at the end of the year.
    (d) If you have not sent the split specimen to another laboratory 
for testing, you must retain the split specimen for an employee's test 
for the same period of time that you retain the primary specimen and 
under the same storage conditions.
    (e) As the laboratory testing the split specimen, you must meet the 
requirements of paragraphs (a) through (d) of this section with respect 
to the split specimen.

[[Page 79541]]

Sec. 40.101  What relationship may a laboratory have with an MRO?

    (a) As a laboratory, you may not enter into any relationship with 
an MRO that creates a conflict of interest or the appearance of a 
conflict of interest with the MRO's responsibilities for the employer. 
You may not derive any financial benefit by having an employer use a 
specific MRO.
    (b) The following are examples of relationships between 
laboratories and MROs that the Department regards as creating conflicts 
of interest, or the appearance of such conflicts. This following list 
of examples is not intended to be exclusive or exhaustive:
    (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, 
gives the employer a slate of MROs from which to choose, or recommends 
certain MROs;
    (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; or
    (6) The laboratory permits an MRO, or an MRO's organization, to 
have a financial interest in the laboratory.


Sec. 40.103  What are the requirements for submitting blind specimens 
to a laboratory?

    (a) As an employer or C/TPA with an aggregate of 2000 or more DOT-
covered employees, you must send blind specimens to laboratories you 
use. If you have an aggregate of fewer than 2000 DOT-covered employees, 
you are not required to provide blind specimens.
    (b) To each laboratory to which you send at least 100 specimens in 
a year, you must transmit a number of blind specimens equivalent to one 
percent of the specimens you send to that laboratory, up to a maximum 
of 50 blind specimens in each quarter (i.e., January-March, April-June, 
July-September, October-December). As a C/TPA, you must apply this 
percentage to the total number of DOT-covered employees' specimens you 
send to the laboratory. Your blind specimen submissions must be evenly 
spread throughout the year. The following examples illustrate how this 
requirement works:

    Example 1 to Paragraph (b). You send 2500 specimens to Lab X in 
Year 1. In this case, you would send 25 blind specimens to Lab X in 
Year 1. To meet the even distribution requirement, you would send 6 
in each of three quarters and 7 in the other.
    Example 2 to Paragraph (b).  You send 2000 specimens to Lab X 
and 1000 specimens to Lab Y in Year 1. In this case, you would send 
20 blind specimens to Lab X and 10 to Lab Y in Year 1. The even 
distribution requirement would apply in a similar way to that 
described in Example 1.
    Example 3 to Paragraph (b). Same as Example 2, except that you 
also send 20 specimens to Lab Z. In this case, you would send blind 
specimens to Labs X and Y as in Example 2. You would not have to 
send any blind specimens to Lab Z, because you sent fewer than 100 
specimens to Lab Z.
    Example 4 to Paragraph (b).  You are a C/TPA sending 2000 
specimens to Lab X in Year 1. These 2000 specimens represent 200 
small employers who have an average of 10 covered employees each. In 
this case you--not the individual employers--send 20 blind specimens 
to Lab X in Year 1, again ensuring even distribution. The individual 
employers you represent are not required to provide any blind 
specimens on their own.
    Example 5 to Paragraph (b).  You are a large C/TPA that sends 
40,000 specimens to Lab Y in Year 1. One percent of that figure is 
400. However, the 50 blind specimen per quarter ``cap'' means that 
you need send only 50 blind specimens per quarter, rather than the 
100 per quarter you would have to send to meet the one percent rate. 
Your annual total would be 200, rather than 400, blind specimens.

    (c) Approximately 75 percent of the specimens you submit must be 
blank (i.e., containing no drugs, nor adulterated or substituted). 
Approximately 15 percent must be positive for one or more of the five 
drugs involved in DOT tests, and approximately 10 percent must either 
be adulterated with a substance cited in HHS guidance or substituted 
(i.e., having specific gravity and creatinine meeting the criteria of 
Sec. 40.93(b)).
    (1) The blind specimens that you submit that contain drugs, that 
are adulterated with a substance cited in HHS guidance, or that are 
substituted must be validated as to their contents by the supplier 
using initial and confirmatory tests.
    (2) The supplier must provide information regarding the shelf life 
of the blind specimens.
    (3) If the blind specimen is drug positive, the concentration of 
drug it contains must be between 1.5 and 2 times the initial drug test 
cutoff concentration.
    (4) If the blind specimen is adulterated with nitrite, the 
concentration of nitrite it contains must be between 1.5 and 2 times 
the initial validity test cutoff concentration.
    (5) If the blind specimen is adulterated by altering pH, the pH 
must be less than or equal to 2, or greater than or equal to 12.
    (6) If the blind specimen is substituted, the creatinine must be 
less than or equal to 2, and the specific gravity must be 1.000.
    (d) You must ensure that each blind specimen is indistinguishable 
to the laboratory from a normal specimen.
    (1) You must submit blind specimens to the laboratory using the 
same channels (e.g., via a regular collection site) through which 
employees' specimens are sent to the laboratory.
    (2) You must ensure that the collector uses a CCF, places fictional 
initials on the specimen bottle label/seal, indicates for the MRO on 
Copy 2 that the specimen is a blind specimen, and discards Copies 4 and 
5 (employer and employee copies).
    (3) You must ensure that all blind specimens include split 
specimens.


Sec. 40.105  What happens if the laboratory reports a result different 
from that expected for a blind specimen?

    (a) If you are an employer, MRO, or C/TPA who submits a blind 
specimen, and if the result reported to the MRO is different from the 
result expected, you must investigate the discrepancy.
    (b) If the unexpected result is a false negative, you must provide 
the laboratory with the expected results (obtained from the supplier of 
the blind specimen), and direct the laboratory to determine the reason 
for the discrepancy.
    (c) If the unexpected result is a false positive, you must provide 
the laboratory with the expected results (obtained from the supplier of 
the blind specimen), and direct the laboratory to determine the reason 
for the discrepancy. You must also notify ODAPC of the discrepancy by 
telephone (202-366-3784) or e-mail (addresses are listed on the ODAPC 
web site, http://www.dot.gov/ost/dapc). ODAPC will notify HHS who will 
take appropriate action.


Sec. 40.107  Who may inspect laboratories?

    As a laboratory, you must permit an inspection, with or without 
prior notice, by ODAPC, a DOT agency, or a DOT-regulated employer that 
contracts with the laboratory for drug testing under the DOT drug 
testing program, or the designee of such an employer.


Sec. 40.109  What documentation must the laboratory keep, and for how 
long?

    (a) As a laboratory, you must retain all records pertaining to each 
employee urine specimen for a minimum of two years.
    (b) As a laboratory, you must also keep for two years employer-
specific data required in Sec. 40.111.

[[Page 79542]]

    (c) Within the two-year period, the MRO, the employee, the 
employer, or a DOT agency may request in writing that you retain the 
records for an additional period of time (e.g., for the purpose of 
preserving evidence for litigation or a safety investigation). If you 
receive such a request, you must comply with it. If you do not receive 
such a request, you may discard the records at the end of the two-year 
period.


Sec. 40.111  When and how must a laboratory disclose statistical 
summaries and other information it maintains?

    (a) As a laboratory, you must transmit an aggregate statistical 
summary, by employer, of the data listed in Appendix B to this part to 
the employer on a semi-annual basis.
    (1) The summary must not reveal the identity of any employee.
    (2) In order to avoid sending data from which it is likely that 
information about an employee's test result can be readily inferred, 
you must not send a summary if the employer has fewer than five 
aggregate tests results.
    (3) The summary must be sent by January 20 of each year for July 1 
through December 31 of the prior year.
    (4) The summary must also be sent by July 20 of each year for 
January 1 through June 30 of the current year.
    (b) When the employer requests a summary in response to an 
inspection, audit, or review by a DOT agency, you must provide it 
unless the employer had fewer than five aggregate test results. In that 
case, you must send the employer a report indicating that not enough 
testing was conducted to warrant a summary. You may transmit the 
summary or report by hard copy, fax, or other electronic means.
    (c) You must also release information to appropriate parties as 
provided in Secs. 40.329 and 40.331.


Sec. 40.113  Where is other information concerning laboratories found 
in this regulation?

    You can find more information concerning laboratories in several 
sections of this part:

Sec. 40.3--Definition.
Sec. 40.13--Prohibition on making specimens available for other 
purposes.
Sec. 40.31--Conflicts of interest concerning collectors.
Sec. 40.47--Laboratory rejections of test for improper form.
Sec. 40.125--Conflicts of interest concerning MROs.
Sec. 40.175--Role of first laboratory in split specimen tests.
Sec. 40.177--Role of second laboratory in split specimen tests 
(drugs).
Sec. 40.179--Role of second laboratory in split specimen tests 
(adulterants).
Sec. 40.181--Role of second laboratory in split specimen tests 
(substitution).
Secs. 40.183-40.185--Transmission of split specimen test results to 
MRO.
Secs. 40.201-40.205--Role in correcting errors.
Sec. 40.329--Release of information to employees.
Sec. 40.331--Limits on release of information.
Sec. 40.355--Role with respect to other service agents.

Subpart G--Medical Review Officers and the Verification Process


Sec. 40.121  Who is qualified to act as an MRO?

    To be qualified to act as an MRO in the DOT drug testing program, 
you must meet each of the requirements of this section:
    (a) Credentials. You must be a licensed physician (Doctor of 
Medicine or Osteopathy). If you are a licensed physician in any U.S., 
Canadian, or Mexican jurisdiction and meet the other requirements of 
this section, you are authorized to perform MRO services with respect 
to all covered employees, wherever they are located. For example, if 
you are licensed as an M.D. in one state or province in the U.S., 
Canada, or Mexico, you are not limited to performing MRO functions in 
that state or province, and you may perform MRO functions for employees 
in other states or provinces without becoming licensed to practice 
medicine in the other jurisdictions.
    (b) Basic knowledge. You must be knowledgeable in the following 
areas:
    (1) You must be knowledgeable about and have clinical experience in 
controlled substances abuse disorders, including detailed knowledge of 
alternative medical explanations for laboratory confirmed drug test 
results.
    (2) You must be knowledgeable about issues relating to adulterated 
and substituted specimens as well as the possible medical causes of 
specimens having an invalid result.
    (3) You must be knowledgeable about this part, the DOT MRO 
Guidelines, and the DOT agency regulations applicable to the employers 
for whom you evaluate drug test results, and you must keep current on 
any changes to these materials. The DOT MRO Guidelines document is 
available from ODAPC (Department of Transportation, 400 7th Street, 
SW., Room 10403, Washington, DC 20590, 202-366-3784, or on the ODAPC 
web site (http://www.dot.gov/ost/dapc ost/dapc)).
    (c) Qualification training. You must receive qualification training 
meeting the requirements of this paragraph (c).
    (1) Qualification training must provide instruction on the 
following subjects:
    (i) Collection procedures for urine specimens;
    (ii) Chain of custody, reporting, and recordkeeping;
    (iii) Interpretation of drug and validity tests results;
    (iv) The role and responsibilities of the MRO in the DOT drug 
testing program;
    (v) The interaction with other participants in the program (e.g., 
DERs, SAPs); and
     (vi) Provisions of this part and DOT agency rules applying to 
employers for whom you review test results, including changes and 
updates to this part and DOT agency rules, guidance, interpretations, 
and policies affecting the performance of MRO functions, as well as 
issues that MROs confront in carrying out their duties under this part 
and DOT agency rules.
    (2) Following your completion of qualification training under 
paragraph (c)(1) of this section, you must satisfactorily complete an 
examination administered by a nationally-recognized MRO certification 
board or subspecialty board for medical practitioners in the field of 
medical review of DOT-mandated drug tests. The examination must 
comprehensively cover all the elements of qualification training listed 
in paragraph (c)(1) of this section.
    (3) The following is the schedule for qualification training you 
must meet:
    (i) If you became an MRO before August 1, 2001, and have already 
met the qualification training requirement, you do not have to meet it 
again.
    (ii) If you became an MRO before August 1, 2001, but have not yet 
met the qualification training requirement, you must do so no later 
than January 31, 2003.
    (iii) If you become an MRO on or after August 1, 2001, you must 
meet the qualification training requirement before you begin to perform 
MRO functions.
    (d) Continuing Education. During each three-year period from the 
date on which you satisfactorily complete the examination under 
paragraph (c)(2) of this section, you must complete continuing 
education consisting of at least 12 professional development hours 
(e.g., Continuing Education Medical Units) relevant to performing MRO 
functions.
    (1) This continuing education must include material concerning new 
technologies, interpretations, recent guidance, rule changes, and other 
information about developments in MRO practice, pertaining to the DOT 
program, since the time you met the qualification training requirements 
of this section.

[[Page 79543]]

    (2) Your continuing education activities must include assessment 
tools to assist you in determining whether you have adequately learned 
the material.
    (e) Documentation. You must maintain documentation showing that you 
currently meet all requirements of this section. You must provide this 
documentation on request to DOT agency representatives and to employers 
and C/TPAs who are using or negotiating to use your services.


Sec. 40.123  What are the MRO's responsibilities in the DOT drug 
testing program?

    As an MRO, you have the following basic responsibilities:
    (a) Acting as an independent and impartial ``gatekeeper'' and 
advocate for the accuracy and integrity of the drug testing process.
    (b) Providing a quality assurance review of the drug testing 
process for the specimens under your purview. This includes, but is not 
limited to:
    (1) Ensuring the review of the CCF on all specimen collections for 
the purposes of determining whether there is a problem that may cause a 
test to be cancelled (see Secs. 40.199-40.203 ). As an MRO, you are not 
required to review laboratory internal chain of custody documentation. 
No one is permitted to cancel a test because you have not reviewed this 
documentation;
    (2) Providing feedback to employers, collection sites and 
laboratories regarding performance issues where necessary; and
    (3) Reporting to and consulting with the ODAPC or a relevant DOT 
agency when you wish DOT assistance in resolving any program issue. As 
an employer or service agent, you are prohibited from limiting or 
attempting to limit the MRO's access to DOT for this purpose and from 
retaliating in any way against an MRO for discussing drug testing 
issues with DOT.
    (c) You must determine whether there is a legitimate medical 
explanation for confirmed positive, adulterated, substituted, and 
invalid drug tests results from the laboratory.
    (d) While you provide medical review of employees' test results, 
this part does not deem that you have established a doctor-patient 
relationship with the employees whose tests you review.
    (e) You must act to investigate and correct problems where possible 
and notify appropriate parties (e.g., HHS, DOT, employers, service 
agents) where assistance is needed, (e.g., cancelled or problematic 
tests, incorrect results, problems with blind specimens).
    (f) You must ensure the timely flow of test results and other 
information to employers.
    (g) You must protect the confidentiality of the drug testing 
information.
    (h) You must perform all your functions in compliance with this 
part and other DOT agency regulations.


Sec. 40.125  What relationship may an MRO have with a laboratory?

    As an MRO, you may not enter into any relationship with an 
employer's laboratory that creates a conflict of interest or the 
appearance of a conflict of interest with your responsibilities to that 
employer. You may not derive any financial benefit by having an 
employer use a specific laboratory. For examples of relationships 
between laboratories and MROs that the Department views as creating a 
conflict of interest or the appearance of such a conflict, see 
Sec. 40.101(b).


Sec. 40.127  What are the MRO's functions in reviewing negative test 
results?

    As the MRO, you must do the following with respect to negative drug 
test results you receive from a laboratory, prior to verifying the 
result and releasing it to the DER:
    (a) Review Copy 2 of the CCF to determine if there are any fatal or 
correctable errors that may require you to initiate corrective action 
or to cancel the test (see Secs. 40.199 and 40.203).
    (b) Review the negative laboratory test result and ensure that it 
is consistent with the information contained on the CCF.
    (c) Before you report a negative test result, you must have in your 
possession the following documents:
    (1) Copy 2 of the CCF, a legible copy of it, or any other CCF copy 
containing the employee's signature; and
    (2) A legible copy (fax, photocopy, image) of Copy 1 of the CCF or 
the electronic laboratory results report that conveys the negative 
laboratory test result.
    (d) If the copy of the documentation provided to you by the 
collector or laboratory appears unclear, you must request that the 
collector or laboratory send you a legible copy.
    (e) On Copy 2 of the CCF, place a check mark in the ``Negative'' 
box (Step 6), provide your name, and sign, initial, or stamp and date 
the verification statement.
    (f) Report the result in a confidential manner (see Secs. 40.163-
40.167).
    (g) Staff under your direct, personal supervision may the 
administrative functions of this section for you, but only you can 
cancel a test.
    (1) On specimen results that are reviewed by your staff, you are 
responsible for assuring the quality of their work.
    (2) You are required to personally review at least 5 percent of all 
CCFs reviewed by your staff on a quarterly basis, including all results 
that required a corrective action. However, you need not review more 
than 500 negative results in any quarter.
    (3) Your review must, as a minimum, include the CCF, negative 
laboratory test result, any accompanying corrective documents, and the 
report sent to the employer. You must correct any errors that you 
discover. You must take action as necessary to ensure compliance by 
your staff with this part and document your corrective action. You must 
attest to the quality assurance review by initialing the CCFs that you 
review.
    (4) You must make these CCFs easily identifiable and retrievable by 
you for review by DOT agencies.


Sec. 40.129  What are the MRO's functions in reviewing laboratory 
confirmed positive, adulterated, substituted, or invalid drug test 
results?

    (a) As the MRO, you must do the following with respect to confirmed 
positive, adulterated, substituted, or invalid drug tests you receive 
from a laboratory, before you verify the result and release it to the 
DER:
    (1) Review Copy 2 of the CCF to determine if there are any fatal or 
correctable errors that may require you to cancel the test (see 
Secs. 40.199 and 40.203). Staff under your direct, personal supervision 
may conduct this administrative review for you, but only you may verify 
or cancel a test.
    (2) Review Copy 1 of the CCF and ensure that it is consistent with 
the information contained on Copy 2, that the test result is legible, 
and that the certifying scientist signed the form. You are not required 
to review any other documentation generated by the laboratory during 
their analysis or handling of the specimen (e.g., the laboratory 
internal chain of custody).
    (3) If the copy of the documentation provided to you by the 
collector or laboratory appears unclear, you must request that the 
collector or laboratory send you a legible copy.
    (4) Except in the circumstances spelled out in Sec. 40.133 , 
conduct a verification interview. This interview must include direct 
contact in person or by telephone between you and the employee. You may 
initiate the verification process based on the laboratory results 
report.
    (5) Verify the test result as either negative, positive, test 
cancelled, or

[[Page 79544]]

refusal to test because of adulteration or substitution, consistent 
with the requirements of Secs. 40.135-40.145 and 40.159 .
    (b) Before you report a verified negative, positive, test 
cancelled, refusal to test because of adulteration or substitution, you 
must have in your possession the following documents:
    (1) Copy 2 of the CCF, a legible copy of it, or any other CCF copy 
containing the employee's signature; and
    (2) A legible copy (fax, photocopy, image) of Copy 1 of the CCF, 
containing the certifying scientist's signature.
    (c) With respect to verified positive test results, place a check 
mark in the ``Positive'' box (Step 6) on Copy 2 of the CCF, indicate 
the drug(s)/ metabolite(s) detected on the ``Remarks'' line, sign and 
date the verification statement.
    (d) Report the result in a confidential manner (see Secs. 40.163-
40.167 ).
    (e) With respect to adulteration or substitution test results, 
check the ``refusal to test because:'' box (Step 6) on Copy 2 of the 
CCF, check the ``Adulterated'' or ``Substituted'' box, as appropriate, 
make appropriate annotation in the ``Remarks'' line, sign and date the 
verification statement.
    (f) As the MRO, your actions concerning reporting confirmed 
positive, adulterated, or substituted results to the employer before 
you have completed the verification process are also governed by the 
stand-down provisions of Sec. 40.21 .
    (1) If an employer has a stand-down policy that meets the 
requirements of Sec. 40.21 , you may report to the DER that you have 
received an employee's laboratory confirmed positive, adulterated, or 
substituted test result, consistent with the terms of the waiver the 
employer received. You must not provide any further details about the 
test result (e.g., the name of the drug involved).
    (2) If the employer does not have a stand-down policy that meets 
the requirements of Sec. 40.21 , you must not inform the employer that 
you have received an employee's laboratory confirmed positive, 
adulterated, or substituted test result until you verify the test 
result. For example, as an MRO employed directly by a company, you must 
not tell anyone on the company's staff or management that you have 
received an employee's laboratory confirmed test result.


Sec. 40.131  How does the MRO or DER notify an employee of the 
verification process after a confirmed positive, adulterated, 
substituted, or invalid test result?

    (a) When, as the MRO, you receive a confirmed positive, 
adulterated, substituted, or invalid test result from the laboratory, 
you must contact the employee directly (i.e., actually talk to the 
employee), on a confidential basis, to determine whether the employee 
wants to discuss the test result. In making this contact, you must 
explain to the employee that, if he or she declines to discuss the 
result, you will verify the test as positive or as a refusal to test 
because of adulteration or substitution, as applicable.
    (b) As the MRO, staff under your personal supervision may conduct 
this initial contact for you.
    (1) This staff contact must be limited to scheduling the discussion 
between you and the employee and explaining the consequences of the 
employee's declining to speak with you (i.e., that the MRO will verify 
the test without input from the employee). If the employee declines to 
speak with you, the staff person must document the employee's decision, 
including the date and time.
    (2) A staff person must not gather any medical information or 
information concerning possible explanations for the test result.
    (3) A staff person may advise an employee to have medical 
information (e.g., prescriptions, information forming the basis of a 
legitimate medical explanation for a confirmed positive test result) 
ready to present at the interview with the MRO.
    (4) Since you are required to speak personally with the employee, 
face-to-face or on the phone, your staff must not inquire if the 
employee wishes to speak with you.
    (c) As the MRO, you or your staff must make reasonable efforts to 
reach the employee at the day and evening telephone numbers listed on 
the CCF. Reasonable efforts include, as a minimum, three attempts, 
spaced reasonably over a 24-hour period, to reach the employee at the 
day and evening telephone numbers listed on the CCF. If you or your 
staff cannot reach the employee directly after making these efforts, 
you or your staff must take the following steps:
    (1) Document the efforts you made to contact the employee, 
including dates and times. If both phone numbers are incorrect (e.g., 
disconnected, wrong number), you may take the actions listed in 
paragraph (c)(2) of this section without waiting the full 24-hour 
period.
    (2) Contact the DER, instructing the DER to contact the employee.
    (i) You must simply direct the DER to inform the employee to 
contact you.
    (ii) You must not inform the DER that the employee has a confirmed 
positive, adulterated, substituted, or invalid test result.
    (iii) You must document the dates and times of your attempts to 
contact the DER, and you must document the name of the DER you 
contacted and the date and time of the contact.
    (d) As the DER, you must attempt to contact the employee 
immediately, using procedures that protect, as much as possible, the 
confidentiality of the MRO's request that the employee contact the MRO. 
If you successfully contact the employee (i.e., actually talk to the 
employee), you must document the date and time of the contact, and 
inform the MRO. You must inform the employee that he or she must 
contact the MRO within the next 72 hours and tell the employee the 
consequences of failing to do so (see Sec. 40.133(a)(2)).
    (1) As the DER, you must not inform anyone else working for the 
employer that you are seeking to contact the employee on behalf of the 
MRO.
    (2) If, as the DER, you have made all reasonable efforts to contact 
the employee but failed to do so, you may place the employee on 
temporary medically unqualified status or medical leave. Reasonable 
efforts include, as a minimum, three attempts, spaced reasonably over a 
24-hour period, to reach the employee at the day and evening telephone 
numbers listed on the CCF.
    (i) As the DER, you must document the dates and times of these 
efforts.
    (ii) If, as the DER, you are unable to contact the employee within 
this 24-hour period, you must leave a message for the employee by any 
practicable means (e.g., voice mail, e-mail, letter) to contact the MRO 
and inform the MRO of the date and time of this attempted contact.


Sec. 40.133  Under what circumstances may the MRO verify a test as 
positive, or as a refusal to test because of adulteration or 
substitution, without interviewing the employee?

    (a) As the MRO, you normally may verify a confirmed positive test 
(for any drug or drug metabolite, including opiates), or as a refusal 
to test because of adulteration or substitution, only after 
interviewing the employee as provided in Secs. 40.135-40.145 . However, 
there are three circumstances in which you may verify such a result 
without an interview:
    (1) You may verify a test result as a positive or refusal to test, 
as applicable, if the employee expressly declines the opportunity to 
discuss the test with you. You must maintain complete documentation of 
this occurrence, including notation of informing, or

[[Page 79545]]

attempting to inform, the employee of the consequences of not 
exercising the option to speak with the you.
    (2) You may verify a test result as a positive or refusal to test, 
as applicable, if the DER has successfully made and documented a 
contact with the employee and instructed the employee to contact you 
and more than 72 hours have passed since the time the DER contacted the 
employee.
    (3) You may verify a test result as a positive or refusal to test, 
as applicable, if neither you nor the DER, after making and documenting 
all reasonable efforts, has been able to contact the employee within 
ten days of the date on which the MRO receives the confirmed test 
result from the laboratory.
    (b) As the MRO, when you verify a test result as a positive or 
refusal to test under this section, you must document the date, time 
and reason, following the instructions in Sec. 40.163 .
    (c) As the MRO, after you have verified a test result as a positive 
or refusal to test under this section and reported the result to the 
DER, you must allow the employee to present information to you within 
60 days of the verification documenting that serious illness, injury, 
or other circumstances unavoidably precluded contact with the MRO and/
or DER in the times provided. On the basis of such information, you may 
reopen the verification, allowing the employee to present information 
concerning whether there is a legitimate medical explanation for the 
confirmed test result.


Sec. 40.135  What does the MRO tell the employee at the beginning of 
the verification interview?

    (a) As the MRO, you must tell the employee that the laboratory has 
determined that the employee's test result was positive, adulterated, 
substituted, or invalid, as applicable. You must also tell the employee 
of the drugs for which his or her specimen tested positive, or the 
basis for the finding of adulteration or substitution.
    (b) You must explain the verification interview process to the 
employee and inform the employee that your decision will be based on 
information the employee provides in the interview.
    (c) You must explain that, if further medical evaluation is needed 
for the verification process, the employee must comply with your 
request for this evaluation and that failure to do so is equivalent of 
expressly declining to discuss the test result.
    (d) As the MRO, you must warn an employee who has a confirmed 
positive, adulterated, substituted or invalid test that you are 
required to provide to third parties drug test result information and 
medical information affecting the performance of safety-sensitive 
duties that the employee gives you in the verification process without 
the employee's consent (see Sec. 40.327).
    (1) You must give this warning to the employee before obtaining any 
medical information as part of the verification process.
    (2) For purposes of this paragraph (d), medical information 
includes information on medications or other substances affecting the 
performance of safety-sensitive duties that the employee reports using 
or medical conditions the employee reports having.
    (3) For purposes of this paragraph (d), the persons to whom this 
information may be provided include the employer, a SAP evaluating the 
employee as part of the return to duty process (see Sec. 40.293(g)), 
DOT, another Federal safety agency (e.g., the NTSB), or any state 
safety agency as required by state law.
    (e) You must also advise the employee that, before informing any 
third party about any medication the employee is using pursuant to a 
legally valid prescription under the Controlled Substances Act, you 
will, if the employee consents, contact the prescribing physician to 
determine if the medication can be changed to one that does not make 
the employee medically unqualified or does not pose a significant 
safety risk.


Sec. 40.137  On what basis does the MRO verify test results involving 
marijuana, cocaine, amphetamines, or PCP?

    (a) As the MRO, you must verify a confirmed positive test result 
for marijuana, cocaine, amphetamines, and/or PCP unless the employee 
presents a legitimate medical explanation for the presence of the 
drug(s)/metabolite(s) in his or her system.
    (b) You must offer the employee an opportunity to present a 
legitimate medical explanation in all cases.
    (c) The employee has the burden of proof that a legitimate medical 
explanation exists. The employee must present information meeting this 
burden at the time of the verification interview. As the MRO, you have 
discretion to extend the time available to the employee for this 
purpose for up to five days before verifying the test result, if you 
determine that there is a reasonable basis to believe that the employee 
will be able to produce relevant evidence concerning a legitimate 
medical explanation within that time.
    (d) If you determine that there is a legitimate medical 
explanation, you must verify the test result as negative. Otherwise, 
you must verify the test result as positive.
    (e) In determining whether a legitimate medical explanation exists, 
you may consider the employee's use of a medication from a foreign 
country. You must exercise your professional judgment consistently with 
the following principles:
    (1) There can be a legitimate medical explanation only with respect 
to a substance that is obtained legally in a foreign country.
    (2) There can be a legitimate medical explanation only with respect 
to a substance that has a legitimate medical use. Use of a drug of 
abuse (e.g., heroin, PCP, marijuana) or any other substance (see 
Sec. 40.151(f) and (g)) that cannot be viewed as having a legitimate 
medical use can never be the basis for a legitimate medical 
explanation, even if the substance is obtained legally in a foreign 
country.
    (3) Use of the substance can form the basis of a legitimate medical 
explanation only if it is used consistently with its proper and 
intended medical purpose.
    (4) Even if you find that there is a legitimate medical explanation 
under this paragraph (e) and verify a test negative, you may have a 
responsibility to raise fitness-for-duty considerations with the 
employer (see Sec. 40.327).


Sec. 40.139  On what basis does the MRO verify test results involving 
opiates?

    As the MRO, you must proceed as follows when you receive a 
laboratory confirmed positive opiate result:
    (a) If the laboratory detects the presence of 6-acetylmorphine (6-
AM) in the specimen, you must verify the test result positive.
    (b) In the absence of 6-AM, if the laboratory detects the presence 
of either morphine or codeine at 15,000 ng/mL or above, you must verify 
the test result positive unless the employee presents a legitimate 
medical explanation for the presence of the drug or drug metabolite in 
his or her system, as in the case of other drugs (see Sec. 40.137). 
Consumption of food products (e.g., poppy seeds) must not be considered 
a legitimate medical explanation for the employee having morphine or 
codeine at these concentrations.
    (c) For all other opiate positive results, you must verify a 
confirmed positive test result for opiates only if you determine that 
there is clinical evidence, in addition to the urine test, of 
unauthorized use of any opium, opiate, or opium derivative (i.e., 
morphine, heroin, or codeine).
    (1) As an MRO, it is your responsibility to use your best

[[Page 79546]]

professional and ethical judgement and discretion to determine whether 
there is clinical evidence of unauthorized use of opiates. Examples of 
information that you may consider in making this judgement include, but 
are not limited to, the following:
    (i) Recent needle tracks;
    (ii) Behavioral and psychological signs of acute opiate 
intoxication or withdrawal;
    (iii) Clinical history of unauthorized use recent enough to have 
produced the laboratory test result;
    (iv) Use of a medication from a foreign country. See Sec. 40.137(e) 
for guidance on how to make this determination.
    (2) In order to establish the clinical evidence referenced in 
paragraphs (c)(1)(i) and (ii) of this section, personal observation of 
the employee is essential.
    (i) Therefore, you, as the MRO, must conduct, or cause another 
physician to conduct, a face-to-face examination of the employee.
    (ii) No face-to-face examination is needed in establishing the 
clinical evidence referenced in paragraph (c)(1)(iii) or (iv) of this 
section.
    (3) To be the basis of a verified positive result for opiates, the 
clinical evidence you find must concern a drug that the laboratory 
found in the specimen. (For example, if the test confirmed the presence 
of codeine, and the employee admits to unauthorized use of hydrocodone, 
you do not have grounds for verifying the test positive. The admission 
must be for the substance that was found).
    (4) As the MRO, you have the burden of establishing that there is 
clinical evidence of unauthorized use of opiates referenced in this 
paragraph (c). If you cannot make this determination (e.g., there is 
not sufficient clinical evidence or history), you must verify the test 
as negative. The employee does not need to show you that a legitimate 
medical explanation exists if no clinical evidence is established.


Sec. 40.141  How does the MRO obtain information for the verification 
decision?

    As the MRO, you must do the following as you make the 
determinations needed for a verification decision:
    (a) You must conduct a medical interview. You must review the 
employee's medical history and any other relevant biomedical factors 
presented to you by the employee. You may direct the employee to 
undergo further medical evaluation by you or another physician.
    (b) If the employee asserts that the presence of a drug or drug 
metabolite in his or her specimen results from taking prescription 
medication, you must review and take all reasonable and necessary steps 
to verify the authenticity of all medical records the employee 
provides. You may contact the employee's physician or other relevant 
medical personnel for further information.


Sec. 40.143  [Reserved]


Sec. 40.145  On what basis does the MRO verify test results involving 
adulteration or substitution?

    (a) As an MRO, when you receive a laboratory report that a specimen 
is adulterated or substituted, you must treat that report in the same 
way you treat the laboratory's report of a confirmed positive test for 
a drug or drug metabolite.
    (b) You must follow the same procedures used for verification of a 
confirmed positive test for a drug or drug metabolite (see 
Secs. 40.129-40.135, 40.141, 40.151), except as otherwise provided in 
this section.
    (c) In the verification interview, you must explain the laboratory 
findings to the employee and address technical questions or issues the 
employee may raise.
    (d) You must offer the employee the opportunity to present a 
legitimate medical explanation for the laboratory findings with respect 
to presence of the adulterant in, or the creatinine and specific 
gravity findings for, the specimen.
    (e) The employee has the burden of proof that there is a legitimate 
medical explanation.
    (1) To meet this burden in the case of an adulterated specimen, the 
employee must demonstrate that the adulterant found by the laboratory 
entered the specimen through physiological means.
    (2) To meet this burden in the case of a substituted specimen, the 
employee must demonstrate that he or she did produce or could have 
produced urine, through physiological means, meeting the creatinine and 
specific gravity criteria of Sec. 40.93(b).
    (3) The employee must present information meeting this burden at 
the time of the verification interview. As the MRO, you have discretion 
to extend the time available to the employee for this purpose for up to 
five days before verifying the specimen, if you determine that there is 
a reasonable basis to believe that the employee will be able to produce 
relevant evidence supporting a legitimate medical explanation within 
that time.
    (f) As the MRO or the employer, you are not responsible for 
arranging, conducting, or paying for any studies, examinations or 
analyses to determine whether a legitimate medical explanation exists.
    (g) As the MRO, you must exercise your best professional judgment 
in deciding whether the employee has established a legitimate medical 
explanation.
    (1) If you determine that the employee's explanation does not 
present a reasonable basis for concluding that there may be a 
legitimate medical explanation, you must report the test to the DER as 
a verified refusal to test because of adulteration or substitution, as 
applicable.
    (2) If you believe that the employee's explanation may present a 
reasonable basis for concluding that there is a legitimate medical 
explanation, you must direct the employee to obtain, within the five-
day period set forth in paragraph (e)(3) of this section, a further 
medical evaluation. This evaluation must be performed by a licensed 
physician (the ``referral physician''), acceptable to you, with 
expertise in the medical issues raised by the employee's explanation. 
(The MRO may perform this evaluation if the MRO has appropriate 
expertise.)
    (i) As the MRO or employer, you are not responsible for finding or 
paying a referral physician. However, on request of the employee, you 
must provide reasonable assistance to the employee's efforts to find 
such a physician. The final choice of the referral physician is the 
employee's, as long as the physician is acceptable to you.
    (ii) As the MRO, you must consult with the referral physician, 
providing guidance to him or her concerning his or her responsibilities 
under this section. As part of this consultation, you must provide the 
following information to the referral physician:
    (A) That the employee was required to take a DOT drug test, but the 
laboratory reported that the specimen was adulterated or substituted, 
which is treated as a refusal to test;
    (B) The consequences of the appropriate DOT agency regulation for 
refusing to take the required drug test;
    (C) That the referral physician must agree to follow the 
requirements of paragraphs (g)(3) through (g)(4) of this section; and
    (D) That the referral physician must provide you with a signed 
statement of his or her recommendations.
    (3) As the referral physician, you must evaluate the employee and 
consider any evidence the employee presents concerning the employee's 
medical explanation. You may conduct additional tests to determine 
whether

[[Page 79547]]

there is a legitimate medical explanation. Any additional urine tests 
must be performed in an HHS-certified laboratory.
    (4) As the referral physician, you must then make a written 
recommendation to the MRO about whether the MRO should determine that 
there is a legitimate medical explanation. As the MRO, you must 
seriously consider and assess the referral physician's recommendation 
in deciding whether there is a legitimate medical explanation.
    (5) As the MRO, if you determine that there is a legitimate medical 
explanation, you must cancel the test and inform ODAPC in writing of 
the determination and the basis for it (e.g., referral physician's 
findings, evidence produced by the employee).
    (6) As the MRO, if you determine that there is not a legitimate 
medical explanation, you must report the test to the DER as a verified 
refusal to test because of adulteration or substitution.
    (h) The following are examples of types of evidence an employee 
could present to support an assertion of a legitimate medical 
explanation for a substituted result.
    (1) Medically valid evidence demonstrating that the employee is 
capable of physiologically producing urine meeting the creatinine and 
specific gravity criteria of Sec. 40.93(b) .
    (i) To be regarded as medically valid, the evidence must have been 
gathered using appropriate methodology and controls to ensure its 
accuracy and reliability.
    (ii) Assertion by the employee that his or her personal 
characteristics (e.g., with respect to race, gender, weight, diet, 
working conditions) are responsible for the substituted result does 
not, in itself, constitute a legitimate medical explanation. To make a 
case that there is a legitimate medical explanation, the employee must 
present evidence showing that the cited personal characteristics 
actually result in the physiological production of urine meeting the 
creatinine and specific gravity criteria of Sec. 40.93(b) .
    (2) Information from a medical evaluation under paragraph (g) of 
this section that the individual has a medical condition that has been 
demonstrated to cause the employee to physiologically produce urine 
meeting the creatinine and specific gravity criteria of Sec. 40.93(b) .
    (i) A finding or diagnosis by the physician that an employee has a 
medical condition, in itself, does not constitute a legitimate medical 
explanation.
    (ii) To establish there is a legitimate medical explanation, the 
employee must demonstrate that the cited medical condition actually 
results in the physiological production of urine meeting the creatinine 
and specific gravity criteria of Sec. 40.93(b) .


Sec. 40.147  [Reserved]


Sec. 40.149  May the MRO change a verified positive drug test result or 
refusal to test?

    (a) As the MRO, you may change a verified positive or refusal to 
test drug test result only in the following situations:
    (1) When you have reopened a verification that was done without an 
interview with an employee (see Sec. 40.133(c)).
    (2) If you receive information, not available to you at the time of 
the original verification, demonstrating that the laboratory made an 
error in identifying (e.g., a paperwork mistake) or testing (e.g., a 
false positive or negative) the employee's primary or split specimen. 
For example, suppose the laboratory originally reported a positive test 
result for Employee X and a negative result for Employee Y. You 
verified the test results as reported to you. Then the laboratory 
notifies you that it mixed up the two test results, and X was really 
negative and Y was really positive. You would change X's test result 
from positive to negative and contact Y to conduct a verification 
interview.
    (3) If, within 60 days of the original verification decision--
    (i) You receive information that could not reasonably have been 
provided to you at the time of the decision demonstrating that there is 
a legitimate medical explanation for the presence of drug(s)/
metabolite(s) in the employee's specimen; or
    (ii) You receive credible new or additional evidence that a 
legitimate medical explanation for an adulterated or substituted result 
exists.

    Example to Paragraph (a)(3): If the employee's physician 
provides you a valid prescription that he or she failed to find at 
the time of the original verification, you may change the test 
result from positive to negative if you conclude that the 
prescription provides a legitimate medical explanation for the 
drug(s)/ metabolite(s) in the employee's specimen.

    (4) If you receive the information in paragraph (a)(3) of this 
section after the 60-day period, you must consult with ODAPC prior to 
changing the result.
    (5) When you have made an administrative error and reported an 
incorrect result.
    (b) If you change the result, you must immediately notify the DER 
in writing, as provided in Secs. 40.163-40.165.
    (c) You are the only person permitted to change a verified test 
result.


Sec. 40.151  What are MROs prohibited from doing as part of the 
verification process?

    As an MRO, you are prohibited from doing the following as part of 
the verification process:
    (a) You must not consider any evidence from tests of urine samples 
or other body fluids or tissues (e.g., blood or hair samples) that are 
not collected or tested in accordance with this part. For example, if 
an employee tells you he went to his own physician, provided a urine 
specimen, sent it to a laboratory, and received a negative test result 
or a DNA test result questioning the identity of his DOT specimen, you 
are required to ignore this test result.
    (b) In reviewing the CCF, you must not consider evidence extrinsic 
to the CCF in determining whether the test is valid. For example, you 
must review only what is on the face of the CCF for this purpose, not 
assertions by the employee that the CCF does not accurately reflect 
what happened at the collection site.
    (c) It is not your function to determine whether the employer 
should have directed that a test occur. For example, if an employee 
tells you that the employer misidentified her as the subject of a 
random test, or directed her to take a reasonable suspicion or post-
accident test without proper grounds under a DOT agency drug or alcohol 
regulation, you must inform the employee that you cannot play a role in 
deciding these issues.
    (d) It is not your function to consider explanations of confirmed 
positive, adulterated, or substituted test results that would not, even 
if true, constitute a legitimate medical explanation. For example, an 
employee may tell you that someone slipped amphetamines into her drink 
at a party, that she unknowingly ingested a marijuana brownie, or that 
she traveled in a closed car with several people smoking crack. MROs 
are unlikely to be able to verify the facts of such passive or 
unknowing ingestion stories. Even if true, such stories do not present 
a legitimate medical explanation. Consequently, you must not declare a 
test as negative based on an explanation of this kind.
    (e) You must not verify a test negative based on information that a 
physician recommended that the employee use a drug listed in Schedule I 
of the Controlled Substances Act. (e.g., under a state law that 
purports to authorize such recommendations, such as the

[[Page 79548]]

``medical marijuana'' laws that some states have adopted).
    (f) You must not accept an assertion of consumption or other use of 
a hemp or other non-prescription marijuana-related product as a basis 
for verifying a marijuana test negative. You also must not accept such 
an explanation related to consumption of coca teas as a basis for 
verifying a cocaine test result as negative. Consuming or using such a 
product is not a legitimate medical explanation.
    (g) You must not accept an assertion that there is a legitimate 
medical explanation for the presence of PCP or 6-AM in a specimen. 
There are no legitimate medical explanations for the presence of these 
substances.
    (h) You must not accept, as a legitimate medical explanation for an 
adulterated specimen, an assertion that soap, bleach, or glutaraldehyde 
entered a specimen through physiological means. There are no 
physiological means through which these substances can enter a 
specimen.
    (i) You must not accept, as a legitimate medical explanation for a 
substituted specimen, an assertion that an employee can produce urine 
with no detectable creatinine. There are no physiological means through 
which a person can produce a urine specimen having this characteristic.


Sec. 40.153  How does the MRO notify employees of their right to a test 
of the split specimen?

    (a) As the MRO, when you have verified a drug test as positive for 
a drug or drug metabolite, or as a refusal to test because of 
adulteration or substitution, you must notify the employee of his or 
her right to have the split specimen tested. You must also notify the 
employee of the procedures for requesting a test of the split specimen.
    (b) You must inform the employee that he or she has 72 hours from 
the time you provide this notification to him or her to request a test 
of the split specimen.
    (c) You must tell the employee how to contact you to make this 
request. You must provide telephone numbers or other information that 
will allow the employee to make this request. As the MRO, you must have 
the ability to receive the employee's calls at all times during the 72 
hour period (e.g., by use of an answering machine with a ``time stamp'' 
feature when there is no one in your office to answer the phone).
    (d) You must tell the employee that if he or she makes this request 
within 72 hours, the employer must ensure that the test takes place, 
and that the employee is not required to pay for the test from his or 
her own funds before the test takes place. You must also tell the 
employee that the employer may seek reimbursement for the cost of the 
test (see Sec. 40.173 ).
    (e) You must tell the employee that additional tests of the 
specimen e.g., DNA tests) are not authorized.


Sec. 40.155  What does the MRO do when a negative or positive test 
result is also dilute?

    (a) When the laboratory reports that a specimen is dilute, you 
must, as the MRO, report to the DER that the specimen, in addition to 
being negative or positive, is dilute.
    (b) You must check the ``dilute'' box (Step 6) on Copy 2 of the 
CCF.
    (c) You may only report a dilute test result when you are in 
possession of a legible copy of Copy 1 of the CCF. In addition, you 
must have Copy 2 of the CCF, a legible copy of it, or any other copy of 
the CCF containing the employee's signature.
    (d) When you report a dilute specimen to the DER, you must explain 
to the DER the employer's obligations and choices under Sec. 40.197.


Sec. 40.157  [Reserved]


Sec. 40.159  What does the MRO do when a drug test result is invalid?

    (a) As the MRO, when the laboratory reports that the test result is 
an invalid result, you must do the following:
    (1) Discuss the laboratory results with a certifying scientist to 
obtain more specific information.
    (2) Contact the employee and inform the employee that the specimen 
was invalid or contained an unexplained interfering substance. In 
contacting the employee, use the procedures set forth in Sec. 40.131.
    (3) After explaining the limits of disclosure (see Secs. 40.135(d) 
and 40.327), you should inquire as to medications the employee may have 
taken that may interfere with some immunoassay tests.
    (4) If the employee gives an explanation that is acceptable, you 
must:
    (i) Place a check mark in the ``Test Cancelled'' box (Step 6) on 
Copy 2 of the CCF and enter ``Invalid Result'' and ``direct observation 
collection not required'' on the ``Remarks'' line.
    (ii) Report to the DER that the test is cancelled, the reason for 
cancellation, and that no further action is required unless a negative 
test result is required (i.e., pre-employment, return-to-duty, or 
follow-up tests).
    (5) If the employee is unable to provide an explanation and/or a 
valid prescription for a medication that interfered with the 
immunoassay test but denies having adulterated the specimen, you must:
    (i) Place a check mark in the ``Test Cancelled'' box (Step 6) on 
Copy 2 of the CCF and enter ``Invalid Result'' and ``direct observation 
collection required'' on the ``Remarks'' line.
    (ii) Report to the DER that the test is cancelled, the reason for 
cancellation, and that a second collection must take place immediately 
under direct observation.
    (iii) Instruct the employer to ensure that the employee has the 
minimum possible advance notice that he or she must go to the 
collection site.
    (b) You may only report an invalid test result when you are in 
possession of a legible copy of Copy 1 of the CCF. In addition, you 
must have Copy 2 of the CCF, a legible copy of it, or any other copy of 
the CCF containing the employee's signature.
    (c) If the employee admits to having adulterated or substituted the 
specimen, you must, on the same day, write and sign your own statement 
of what the employee told you. You must then report a refusal to test 
in accordance with Sec. 40.163 .


Sec. 40.161  What does the MRO do when a drug test specimen is rejected 
for testing?

    As the MRO, when the laboratory reports that the specimen is 
rejected for testing (e.g., because of a fatal or uncorrected flaw), 
you must do the following:
    (a) Place a check mark in the ``Test Cancelled'' box (Step 6) on 
Copy 2 of the CCF and enter the reason on the ``Remarks'' line.
    (b) Report to the DER that the test is cancelled and the reason for 
cancellation, and that no further action is required unless a negative 
test is required (e.g., in the case of a pre-employment, return-to-
duty, or follow-up test).
    (c) You may only report a test cancelled because of a rejected for 
testing test result when you are in possession of a legible copy of 
Copy 1 of the CCF. In addition, you must have Copy 2 of the CCF, a 
legible copy of it, or any other copy of the CCF containing the 
employee's signature.


Sec. 40.163  How does the MRO report drug test results?

    (a) As the MRO, it is your responsibility to report the drug test 
results to the employer in writing.
    (1) You or a staff member may rubber stamp a report of negative 
results. If you use a rubber stamp, you or your staff must also initial 
the stamp to identify who affixed the stamp to the report.
    (2) You, as the MRO, must sign reports of all other results.

[[Page 79549]]

    (b) You may use a signed or stamped and dated legible photocopy of 
Copy 2 of the CCF to report test results.
    (c) If you do not report test results using Copy 2 of the CCF for 
this purpose, you must provide a written report (e.g., a letter) for 
each test result. This report must, as a minimum, include the following 
information:
    (1) Full name, as indicated on the CCF, of the employee tested;
    (2) Specimen ID number from the CCF and the donor SSN or employee 
ID number;
    (3) Reason for the test as indicated on the CCF (e.g., random, 
post-accident);
    (4) Date of the collection;
    (5) Result of the test (i.e., positive, negative, dilute, refusal 
to test, test cancelled) and the date the result was verified by the 
MRO;
    (6) For verified positive tests, the drug(s)/metabolite(s) for 
which the test was positive;
    (7) For cancelled tests, the reason for cancellation; and
    (8) For refusals to test, the reason for the refusal determination 
(e.g., in the case of an adulterated test result, the name of the 
adulterant).
    (d) You must retain a signed or stamped and dated copy of Copy 2 of 
the CCF in your records. If you do not use Copy 2 for reporting 
results, you must maintain a copy of the signed or stamped and dated 
letter in addition to the signed or stamped and dated Copy 2.
    (e) You must not use Copy 1 of the CCF to report drug test results.
    (f) You must not provide quantitative values to the DER or C/TPA 
for drug or validity test results. However, you must provide the test 
information in your possession to a SAP who consults with you (see 
Sec. 40.293(g)).


Sec. 40.165  To whom does the MRO transmit reports of drug test 
results?

    (a) As the MRO, you must report all drug test results to the DER, 
except in the circumstances provided for in Sec. 40.345 .
    (b) If the employer elects to receive reports of results through a 
C/TPA, acting as an intermediary as provided in Sec. 40.345 , you must 
report the results through the designated C/TPA.


Sec. 40.167  How are MRO reports of drug results transmitted to the 
employer?

    As the MRO or C/TPA who transmits drug test results to the 
employer, you must comply with the following requirements:
    (a) You must report the results in a confidential manner.
    (b) You must transmit to the DER on the same day the MRO verifies 
the result or the next business day all verified positive test results, 
results requiring an immediate collection under direct observation, 
adulterated or substituted specimen results, and other refusals to 
test.
    (1) Direct telephone contact with the DER is the preferred method 
of immediate reporting. Follow up your phone call with appropriate 
documentation (see Sec. 40.163).
    (2) You are responsible for identifying yourself to the DER, and 
the DER must have a means to confirm your identification.
    (3) The MRO's report that you transmit to the employer must contain 
all of the information required by Sec. 40.163 .
    (c) You must transmit the MRO's written report of verified test to 
the DER so that the DER receives them within two days of verification 
by the MRO.
    (d) In transmitting test results, you or the C/TPA and the employer 
must ensure the security of the transmission and limit access to any 
transmission, storage, or retrieval systems.


Sec. 40.169  Where is other information concerning the role of MROs and 
the verification process found in this regulation?

    You can find more information concerning the role of MROs in 
several sections of this part:

Sec. 40.3--Definition.
Sec. Sec. 40.47-40.49--Correction of form and kit errors.
Sec. 40.67--Role in direct observation and other atypical test 
situations.
Sec. 40.83--Laboratory handling of fatal and correctable flaws.
Sec. 40.97--Laboratory handling of test results and quantitative 
values.
Sec. 40.99--Authorization of longer laboratory retention of 
specimens.
Sec. 40.101--Relationship with laboratories; avoidance of conflicts 
of interest.
Sec. 40.105--Notification of discrepancies in blind specimen 
results.
Sec. 40.171--Request for test of split specimen.
Sec. 40.187--Action concerning split specimen test results.
Sec. 40.193--Role in ``shy bladder'' situations.
Sec. 40.195--Role in cancelling tests.
Secs. 40.199-40.203--Documenting errors in tests.
Sec. 40.327--Confidentiality and release of information.
Sec. 40.347--Transfer of records.
Sec. 40.353--Relationships with service agents.

Subpart H--Split Specimen Tests


Sec. 40.171  How does an employee request a test of a split specimen?

    (a) As an employee, when the MRO has notified you that you have a 
verified positive drug test or refusal to test because of adulteration 
or substitution, you have 72 hours from the time of notification to 
request a test of the split specimen. The request may be verbal or in 
writing. If you make this request to the MRO within 72 hours, you 
trigger the requirements of this section for a test of the split 
specimen.
    (b)(1) If, as an employee, you have not requested a test of the 
split specimen within 72 hours, you may present to the MRO information 
documenting that serious injury, illness, lack of actual notice of the 
verified test result, inability to contact the MRO (e.g., there was no 
one in the MRO's office and the answering machine was not working), or 
other circumstances unavoidably prevented you from making a timely 
request.
    (2) As the MRO, if you conclude from the employee's information 
that there was a legitimate reason for the employee's failure to 
contact you within 72 hours, you must direct that the test of the split 
specimen take place, just as you would when there is a timely request.
    (c) When the employee makes a timely request for a test of the 
split specimen under paragraphs (a) and (b) of this section, you must, 
as the MRO, immediately provide written notice to the laboratory that 
tested the primary specimen, directing the laboratory to forward the 
split specimen to a second HHS-certified laboratory. You must also 
document the date and time of the employee's request.


Sec. 40.173  Who is responsible for paying for the test of a split 
specimen?

    (a) As the employer, you are responsible for making sure (e.g., by 
establishing appropriate accounts with laboratories for testing split 
specimens) that the MRO, first laboratory, and second laboratory 
perform the functions noted in Secs. 40.175-40.185 in a timely manner, 
once the employee has made a timely request for a test of the split 
specimen.
    (b) As the employer, you must not condition your compliance with 
these requirements on the employee's direct payment to the MRO or 
laboratory or the employee's agreement to reimburse you for the costs 
of testing. For example, if you ask the employee to pay for some or all 
of the cost of testing the split specimen, and the employee is 
unwilling or unable to do so, you must ensure that the test takes place 
in a timely manner, even though this means that you pay for it.
    (c) As the employer, you may seek payment or reimbursement of all 
or part of the cost of the split specimen from the employee (e.g., 
through your written company policy or a collective bargaining 
agreement). This part takes

[[Page 79550]]

no position on who ultimately pays the cost of the test, so long as the 
employer ensures that the testing is conducted as required and the 
results released appropriately.


Sec. 40.175  What steps does the first laboratory take with a split 
specimen?

    (a) As the laboratory at which the primary and split specimen first 
arrive, you must check to see whether the split specimen is available 
for testing.
    (b) If the split specimen is unavailable or appears insufficient, 
you must then do the following:
    (1) Continue the testing process for the primary specimen as you 
would normally. Report the results for the primary specimen without 
providing the MRO information regarding the unavailable split specimen.
    (2) Upon receiving a letter from the MRO instructing you to forward 
the split specimen to another laboratory for testing, report to the MRO 
that the split specimen is unavailable for testing. Provide as much 
information as you can about the cause of the unavailability.
    (c) As the laboratory that tested the primary specimen, you are not 
authorized to open the split specimen under any circumstances (except 
when the split specimen is redesignated as provided in Sec. 40.83).
    (d) When you receive written notice from the MRO instructing you to 
send the split specimen to another HHS-certified laboratory, you must 
forward the following items to the second laboratory:
    (1) The split specimen in its original specimen bottle, with the 
seal intact;
    (2) A copy of the MRO's written request; and
    (3) A copy of Copy 1 of the CCF, which identifies the drug(s)/
metabolite(s) or the validity criteria to be tested for.
    (e) You must not send to the second laboratory any information 
about the identity of the employee. Inadvertent disclosure does not, 
however, cause a fatal flaw.
    (f) This subpart does not prescribe who gets to decide which HHS-
certified laboratory is used to test the split specimen. That decision 
is left to the parties involved.


Sec. 40.177  What does the second laboratory do with the split specimen 
when it is tested to reconfirm the presence of a drug or drug 
metabolite?

    (a) As the laboratory testing the split specimen, you must test the 
split specimen for the drug(s)/drug metabolite(s) detected in the 
primary specimen.
    (b) You must conduct this test without regard to the cutoff 
concentrations of Sec. 40.87 .
    (c) If the test fails to reconfirm the presence of the drug(s)/drug 
metabolite(s) that were reported positive in the primary specimen, you 
must conduct validity tests in an attempt to determine the reason for 
being unable to reconfirm the presence of the drug(s)/metabolite(s). 
You should conduct the same validity tests as you would conduct on a 
primary specimen set forth in Sec. 40.91 .
    (d) In addition, if the test fails to reconfirm the presence of the 
drugs/drugs metabolites or validity criteria that were reported in the 
primary specimen, you may transmit the specimen or an aliquot of it to 
another HHS-certified laboratory that will conduct another 
reconfirmation test.


Sec. 40.179  What does the second laboratory do with the split specimen 
when it is tested to reconfirm an adulterated test result?

    As the laboratory testing the split specimen, you must test the 
split specimen for the adulterant detected in the primary specimen, 
using the criteria of Sec. 40.95 just as you would do for a primary 
specimen. The result of the primary specimen is reconfirmed if the 
split specimen meets these criteria.


Sec. 40.181  What does the second laboratory do with the split specimen 
when it is tested to reconfirm a substituted test result?

    As the laboratory testing the split specimen, you must test the 
split specimen using the criteria of Sec. 40.93(b), just as you would 
do for a primary specimen. The result of the primary specimen is 
reconfirmed if the split specimen meets these criteria.


Sec. 40.183  What information do laboratories report to MROs regarding 
split specimen results?

    (a) As the laboratory responsible for testing the split specimen, 
you must report split specimen test results by checking the 
``Reconfirmed'' box or the ``Failed to Reconfirm'' box (Step 5(b)) on 
Copy 1 of the CCF.
    (b) If you check the ``Failed to Reconfirm'' box, one of the 
following statements must be included (as appropriate) on the 
``Reason'' line (Step 5(b)):
    (1) ``Drug(s)/Drug Metabolite(s) Not Detected.''
    (2) ``Adulterant not found within criteria.''
    (3) ``Specimen not consistent with substitution criteria [specify 
creatinine, specific gravity, or both]''
    (4) ``Specimen not available for testing.''
    (c) As the laboratory certifying scientist, enter your name, sign, 
and date the CCF.


Sec. 40.185  Through what methods and to whom must a laboratory report 
split specimen results?

    (a) As the laboratory testing the split specimen, you must report 
laboratory results directly, and only, to the MRO at his or her place 
of business. You must not report results to or through the DER or 
another service agent (e.g., a C/TPA).
    (b) You must fax, courier, mail, or electronically transmit a 
legible image or copy of the fully-completed Copy 1 of the CCF, which 
has been signed by the certifying scientist.
    (c) You must transmit the laboratory result to the MRO immediately, 
preferably on the same day or next business day as the result is signed 
and released.


Sec. 40.187  What does the MRO do with split specimen laboratory 
results?

    As an MRO, you must take the following actions when a laboratory 
reports the following results of split specimen tests:
    (a) Reconfirmed. (1) In the case of a reconfirmed positive test for 
a drug or drug metabolite, report the reconfirmation to the DER and the 
employee.
    (2) In the case of a reconfirmed adulterated or substituted result, 
report to the DER and the employee that the specimen was adulterated or 
substituted, either of which constitutes a refusal to test. Therefore, 
``refusal to test'' is the final result.
    (b) Failed to Reconfirm: Drug(s)/Drug Metabolite(s) Not Detected. 
(1) Report to the DER and the employee that both tests must be 
cancelled.
    (2) Using the format in Appendix D to this part, inform ODAPC of 
the failure to reconfirm.
    (c) Failed to Reconfirm: Adulteration or Substitution (as 
appropriate) Criteria Not Met. (1) Report to the DER and the employee 
that both tests must be cancelled.
    (2) Using the format in Appendix D to this part, inform ODAPC of 
the failure to reconfirm.
    (d) Failed to Reconfirm: Specimen not Available for Testing. (1) 
Report to the DER and the employee that both tests must be cancelled 
and the reason for cancellation.
    (2) Direct the DER to ensure the immediate collection of another 
specimen from the employee under direct observation, with no notice 
given to the employee of this collection requirement until immediately 
before the collection.

[[Page 79551]]

    (3) Using the format in Appendix D to this part, notify ODAPC of 
the failure to reconfirm.
    (e) Enter your name, sign and date (Step 7) of Copy 2 of the CCF.
    (f) Send a legible copy of Copy 2 of the CCF (or a signed and dated 
letter, see Sec. 40.163 ) to the employer and keep a copy for your 
records. Transmit the document as provided in Sec. 40.167.


Sec. 40.189  Where is other information concerning split specimens 
found in this regulation?

    You can find more information concerning split specimens in several 
sections of this part:

Sec. 40.3--Definition.
Sec. 40.65--Quantity of split specimen.
Sec. 40.67--Directly observed test when split specimen is 
unavailable.
Secs. 40.71-40.73--Collection process for split specimens.
Sec. 40.83--Laboratory accessioning of split specimens.
Sec. 40.99--Laboratory retention of split specimens.
Sec. 40.103--Blind split specimens.
Sec. 40.153--MRO notice to employees on tests of split specimen.
Secs. 40.193 and 40.201--MRO actions on insufficient or unavailable 
split specimens.
Appendix D to Part 40--Report format for split specimen failure to 
reconfirm.

Subpart I--Problems in Drug Tests


Sec. 40.191  What is a refusal to take a DOT drug test, and what are 
the consequences?

    (a) As an employee, you have refused to take a drug test if you:
    (1) Fail to appear for any test within a reasonable time, as 
determined by the employer, after being directed to do so by the 
employer. This includes the failure of an employee (including an owner-
operator) to appear for a test when called by C/TPA (see 
Sec. 40.61(a));
    (2) Fail to remain at the testing site until the testing process is 
complete;
    (3) Fail to provide a urine specimen for any drug test required by 
this part or DOT agency regulations;
    (4) In the case of a directly observed or monitored collection in a 
drug test, fail to permit the observation or monitoring of your 
provision of a specimen (see Secs. 40.67(l) and 40.69(g));
    (5) Fail to provide a sufficient amount of urine when directed, and 
it has been determined, through a required medical evaluation, that 
there was no adequate medical explanation for the failure (see 
Sec. 40.193(d)(2));
    (6) Fail or decline to take a second test the employer or collector 
has directed you to take;
    (7) Fail to undergo a medical examination or evaluation, as 
directed by the MRO as part of the verification process, or as directed 
by the DER as part of the ``shy bladder'' procedures of this part (see 
Sec. 40.193(d)); or
    (8) Fail to cooperate with any part of the testing process (e.g., 
refuse to empty pockets when so directed by the collector, behave in a 
confrontational way that disrupts the collection process).
    (b) As an employee, if the MRO reports that you have a verified 
adulterated or substituted test result, you have refused to take a drug 
test.
    (c) As an employee, if you refuse to take a drug test, you incur 
the consequences specified under DOT agency regulations for a violation 
of those DOT agency regulations.
    (d) As a collector or an MRO, when an employee refuses to 
participate in the part of the testing process in which you are 
involved, you must terminate the portion of the testing process in 
which you are involved, document the refusal on the CCF (or in a 
separate document which you cause to be attached to the form), 
immediately notify the DER by any means (e.g., telephone or secure fax 
machine) that ensures that the refusal notification is immediately 
received. As a referral physician (e.g., physician evaluating a ``shy 
bladder'' condition or a claim of a legitimate medical explanation in a 
validity testing situation), you must notify the MRO, who in turn will 
notify the DER.
    (1) As the collector, you must note the refusal in the ``Remarks'' 
line (Step 2), and sign and date the CCF.
    (2) As the MRO, you must note the refusal by checking the ``refused 
to test because'' box (Step 6) on Copy 2 of the CCF, and add the reason 
on the ``Remarks'' line. You must then sign and date the CCF.
    (e) As an employee, when you refuse to take a non-DOT test or to 
sign a non-DOT form, you have not refused to take a DOT test. There are 
no consequences under DOT agency regulations for refusing to take a 
non-DOT test.


Sec. 40.193  What happens when an employee does not provide a 
sufficient amount of urine for a drug test?

    (a) This section prescribes procedures for situations in which an 
employee does not provide a sufficient amount of urine to permit a drug 
test (i.e., 45 mL of urine).
    (b) As the collector, you must do the following:
    (1) Discard the insufficient specimen, except where the 
insufficient specimen was out of temperature range or showed evidence 
of adulteration or tampering (see Sec. 40.65(b) and (c)).
    (2) Urge the employee to drink up to 40 ounces of fluid, 
distributed reasonably through a period of up to three hours, or until 
the individual has provided a sufficient urine specimen, whichever 
occurs first. It is not a refusal to test if the employee declines to 
drink.
    (3) If the employee refuses to make the attempt to provide a new 
urine specimen, you must discontinue the collection, note the fact on 
the ``Remarks'' line of the CCF (Step 2), and immediately notify the 
DER. This is a refusal to test.
    (4) If the employee has not provided a sufficient specimen within 
three hours of the first unsuccessful attempt to provide the specimen, 
you must discontinue the collection, note the fact on the ``Remarks'' 
line of the CCF (Step 2), and immediately notify the DER.
    (5) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You 
must send or fax these copies to the MRO and DER within 24 hours or the 
next business day.
    (c) As the DER, when the collector informs you that the employee 
has not provided a sufficient amount of urine (see paragraph (b)(4) of 
this section), you must, after consulting with the MRO, direct the 
employee to obtain, within five working days, an evaluation from a 
licensed physician, acceptable to the MRO, who has expertise in the 
medical issues raised by the employee's failure to provide a sufficient 
specimen. (The MRO may perform this evaluation if the MRO has 
appropriate expertise.)
    (1) As the MRO, if another physician will perform the evaluation, 
you must provide the other physician with the following information and 
instructions:
    (i) That the employee was required to take a DOT drug test, but was 
unable to provide a sufficient amount of urine to complete the test;
    (ii) The consequences of the appropriate DOT agency regulation for 
refusing to take the required drug test;
    (iii) That the referral physician must agree to follow the 
requirements of paragraphs (d) through (g) of this section.
    (d) As the referral physician conducting this evaluation, you must 
recommend that the MRO make one of the following determinations:
    (1) A medical condition has, or with a high degree of probability 
could have, precluded the employee from providing a sufficient amount 
of urine. As the MRO, if you accept this recommendation, you must:
    (i) Check ``Test Cancelled'' (Step 6) on the CCF; and
    (ii) Sign and date the CCF.
    (2) There is not an adequate basis for determining that a medical 
condition has, or with a high degree of probability could have, 
precluded the employee

[[Page 79552]]

from providing a sufficient amount of urine. As the MRO, if you accept 
this recommendation, you must:
    (i) Check ``Refusal to test because'' (Step 6) on the CCF and enter 
reason in the remarks line; and
    (ii) Sign and date the CCF.
    (e) For purposes of this paragraph, a medical condition includes an 
ascertainable physiological condition (e.g., a urinary system 
dysfunction) or a medically documented pre-existing psychological 
disorder, but does not include unsupported assertions of ``situational 
anxiety'' or dehydration.
    (f) As the referral physician making the evaluation, after 
completing your evaluation, you must provide a written statement of 
your recommendations and the basis for them to the MRO. You must not 
include in this statement detailed information on the employee's 
medical condition beyond what is necessary to explain your conclusion.
    (g) If, as the referral physician making this evaluation in the 
case of a pre-employment test, you determine that the employee's 
medical condition is a serious and permanent or long-term disability 
that is highly likely to prevent the employee from providing a 
sufficient amount of urine for a very long or indefinite period of 
time, you must set forth your determination and the reasons for it in 
your written statement to the MRO. As the MRO, upon receiving such a 
report, you must follow the requirements of Sec. 40.195, where 
applicable.
    (h) As the MRO, you must seriously consider and assess the referral 
physician's recommendations in making your determination about whether 
the employee has a medical condition that has, or with a high degree of 
probability could have, precluded the employee from providing a 
sufficient amount of urine. You must report your determination to the 
DER in writing as soon as you make it.
    (i) As the employer, when you receive a report from the MRO 
indicating that a test is cancelled as provided in paragraph (d)(1) of 
this section, you take no further action with respect to the employee. 
The employee remains in the random testing pool.


Sec. 40.195  What happens when an individual is unable to provide a 
sufficient amount of urine for a pre-employment or return-to-duty test 
because of a permanent or long-term medical condition?

    (a) This section concerns a situation in which an employee has a 
medical condition that precludes him or her from providing a sufficient 
specimen for a pre-employment or return-to-duty test and the condition 
involves a permanent or long-term disability. As the MRO in this 
situation, you must do the following:
    (1) You must determine if there is clinical evidence that the 
individual is an illicit drug user. You must make this determination by 
personally conducting, or causing to be conducted, a medical evaluation 
and through consultation with the employee's physician and/or the 
physician who conducted the evaluation under Sec. 40.193(d).
    (2) If you do not personally conduct the medical evaluation, you 
must ensure that one is conducted by a licensed physician acceptable to 
you.
    (3) For purposes of this section, the MRO or the physician 
conducting the evaluation may conduct an alternative test (e.g., blood) 
as part of the medically appropriate procedures in determining clinical 
evidence of drug use.
    (b) If the medical evaluation reveals no clinical evidence of drug 
use, as the MRO, you must report the result to the employer as a 
negative test with written notations regarding results of both the 
evaluation conducted under Sec. 40.193(d) and any further medical 
examination. This report must state the basis for the determination 
that a permanent or long-term medical condition exists, making 
provision of a sufficient urine specimen impossible, and for the 
determination that no signs and symptoms of drug use exist.
    (1) Check ``Negative'' (Step 6) on the CCF.
    (2) Sign and date the CCF.
    (c) If the medical evaluation reveals clinical evidence of drug 
use, as the MRO, you must report the result to the employer as a 
cancelled test with written notations regarding results of both the 
evaluation conducted under Sec. 40.193(d) and any further medical 
examination. This report must state that a permanent or long-term 
medical condition exists, making provision of a sufficient urine 
specimen impossible, and state the reason for the determination that 
signs and symptoms of drug use exist. Because this is a cancelled test, 
it does not serve the purposes of a negative test (i.e., the employer 
is not authorized to allow the employee to begin or resume performing 
safety-sensitive functions, because a negative test is needed for that 
purpose).
    (d) For purposes of this section, permanent or long-term medical 
conditions are those physiological, anatomic, or psychological 
abnormalities documented as being present prior to the attempted 
collection, and considered not amenable to correction or cure for an 
extended period of time, if ever.
    (1) Examples would include destruction (any cause) of the 
glomerular filtration system leading to renal failure; unrepaired 
traumatic disruption of the urinary tract; or a severe psychiatric 
disorder focused on genito-urinary matters.
    (2) Acute or temporary medical conditions, such as cystitis, 
urethritis or prostatitis, though they might interfere with collection 
for a limited period of time, cannot receive the same exceptional 
consideration as the permanent or long-term conditions discussed in 
paragraph (d)(1) of this section.


Sec. 40.197  What happens when an employer receives a report of a 
dilute specimen?

    (a) As the employer, if the MRO informs you that a positive drug 
test was dilute, you simply treat the test as a verified positive test. 
You must not direct the employee to take another test based on the fact 
that the specimen was dilute.
    (b) If the MRO informs you that a negative drug test was dilute, 
you may, but are not required to, direct the employee to take another 
test immediately. Such recollections must not be collected under direct 
observation, unless there is another basis for use of direct 
observation (see Sec. 40.67(b) and (c)).
    (c) You must treat all employees the same for this purpose. For 
example, you must not retest some employees and not others. You may, 
however, establish different policies for different types of tests 
(e.g., conduct retests in pre-employment test situations, but not in 
random test situations). You must inform your employees in advance of 
your decisions on these matters.
    (d) If you direct the employee to take another test, you must 
ensure that the employee is given the minimum possible advance notice 
that he or she must go to the collection site.
    (e) If you direct the employee to take another test, the result of 
the second test--not that of the original test--becomes the test of 
record, on which you rely for purposes of this part.
    (f) If you require employees to take another test, and the second 
test is also negative and dilute, you are not permitted to make the 
employee take a third test because the second test was dilute.
    (g) If you direct the employee to take another test and the 
employee declines to do so, the employee has refused the test for 
purpose of this part and DOT agency regulations.

[[Page 79553]]

Sec. 40.199  What problems always cause a drug test to be cancelled?

    (a) As the MRO, when the laboratory discovers a ``fatal flaw'' 
during its processing of incoming specimens (see Sec. 40.83), the 
laboratory will report to you that the specimen has been ``Rejected for 
Testing'' (with the reason stated). You must always cancel such a test.
    (b) The following are ``fatal flaws'':
    (1) There is no printed collector's name and no collector's 
signature;
    (2) The specimen ID numbers on the specimen bottle and the CCF do 
not match;
    (3) The specimen bottle seal is broken or shows evidence of 
tampering (and a split specimen cannot be redesignated, see 
Sec. 40.83(g)); and
    (4) Because of leakage or other causes, there is an insufficient 
amount of urine in the primary specimen bottle for analysis and the 
specimens cannot be redesignated (see Sec. 40.83(g)).
    (c) You must report the result as provided in Sec. 40.161 .


Sec. 40.201    What problems always cause a drug test to be cancelled 
and may result in a requirement for another collection?

    As the MRO, you must cancel a drug test when a laboratory reports 
that any of the following problems have occurred. You must inform the 
DER that the test was cancelled. You must also direct the DER to ensure 
that an additional collection occurs immediately, if required by the 
applicable procedures specified in paragraphs (a) through (e) of this 
section.
    (a) The laboratory reports an ``Invalid Result.'' You must follow 
applicable procedures in Sec. 40.159 (recollection under direct 
observation may be required).
    (b) The laboratory reports the result as ``Rejected for Testing.'' 
You must follow applicable procedures in Sec. 40.161 (a recollection 
may be required).
    (c) The laboratory's test of the primary specimen is positive and 
the split specimen is reported by the laboratory as ``Failure to 
Reconfirm: Drug(s)/Drug Metabolite(s) Not Detected.'' You must follow 
applicable procedures in Sec. 40.187(b) (no recollection is required in 
this case).
    (d) The laboratory's test result for the primary specimen is 
adulterated or substituted and the split specimen is reported by the 
laboratory as ``Adulterant not found within criteria,'' or `` specimen 
not consistent with substitution criteria, as applicable. You must 
follow applicable procedures in Sec. 40.187(c) (no recollection is 
required in this case).
    (e) The laboratory's test of the primary specimen is positive, 
adulterated, or substituted and the split specimen is unavailable for 
testing. You must follow applicable procedures in Sec. 40.187(d) 
(recollection under direct observation is required in this case).
    (f) The examining physician has determined that there is an 
acceptable medical explanation of the employee's failure to provide a 
sufficient amount of urine. You must follow applicable procedures in 
Sec. 40.193(d)(1) (no recollection is required in this case).


Sec. 40.203    What problems cause a drug test to be cancelled unless 
they are corrected?

    (a) As the MRO, when a laboratory discovers a ``correctable flaw'' 
during its processing of incoming specimens (see Sec. 40.83), the 
laboratory will attempt to correct it. If the laboratory is 
unsuccessful in this attempt, it will report to you that the specimen 
has been ``Rejected for Testing'' (with the reason stated).
    (b) The following are ``correctable flaws'' that laboratories must 
attempt to correct:
    (1) The collector's signature is omitted on the certification 
statement on the CCF.
    (2) The specimen temperature was not checked and the ``Remarks'' 
line did not contain an entry regarding the temperature being out of 
range.
    (c) As the MRO, when you discover a ``correctable flaw'' during 
your review of the CCF, you must cancel the test unless the flaw is 
corrected.
    (d) The following are correctable flaws that you must attempt to 
correct:
    (1) The employee's signature is omitted from the certification 
statement, unless the employee's failure or refusal to sign is noted on 
the ``Remarks'' line of the CCF.
    (2) The certifying scientist's signature is omitted on the 
laboratory copy of the CCF for a positive, adulterated, substituted, or 
invalid test result.
    (3) The collector uses a non-DOT form for the test, provided that 
the collection and testing process is conducted in accordance with DOT 
procedures in an HHS-certified laboratory following DOT initial and 
confirmation test criteria.


Sec. 40.205    How are drug test problems corrected?

    (a) As a collector, you have the responsibility of trying to 
successfully complete a collection procedure for each employee.
    (1) If, during or shortly after the collection process, you become 
aware of any event that prevents the completion of a valid test or 
collection (e.g., a procedural or paperwork error), you must try to 
correct the problem promptly, if doing so is practicable. You may 
conduct another collection as part of this effort.
    (2) If another collection is necessary, you must begin the new 
collection procedure as soon as possible, using a new CCF and a new 
collection kit.
    (b) If, as a collector, laboratory, MRO, employer, or other person 
implementing these drug testing regulations, you become aware of a 
problem that can be corrected (see Sec. 40.203 ), but which has not 
already been corrected under paragraph (a) of this section, you must 
take all practicable action to correct the problem so that the test is 
not cancelled.
    (1) If the problem resulted from the omission of required 
information, you must, as the person responsible for providing that 
information, supply in writing the missing information and a statement 
that it is true and accurate. For example, suppose you are a collector, 
and you forgot to make a notation on the ``Remarks'' line of the CCF 
that the employee did not sign the certification. You would, when the 
problem is called to your attention, supply a signed statement that the 
employee failed or refused to sign the certification and that your 
statement is true and accurate. You must supply this information on the 
same business day on which you are notified of the problem, 
transmitting it by fax or courier.
    (2) If the problem is the use of a non-Federal form, you must, as 
the person responsible for the use of the incorrect form, provide a 
signed statement that the incorrect form contains all the information 
needed for a valid DOT drug test, that the incorrect form was used 
inadvertently or as the only means of conducting a test, in 
circumstances beyond your control. The statement must also list the 
steps you have taken to prevent future use of non-Federal forms for DOT 
tests. For this flaw to have been corrected, the test of the specimen 
must have occurred at a HHS-certified laboratory where it was tested 
using the testing protocol in this part. You must supply this 
information on the same business day on which you are notified of the 
problem, transmitting it by fax or courier.
    (3) You must maintain the written documentation of a correction 
with the CCF.
    (4) You must mark the CCF in such a way (e.g., stamp noting 
correction) as to make it obvious on the face of the CCF that you 
corrected the flaw.
    (c) If the correction does not take place, as the MRO you must 
cancel the test.

[[Page 79554]]

Sec. 40.207  What is the effect of a cancelled drug test?

    (a) A cancelled drug test is neither positive nor negative.
    (1) As an employer, you must not attach to a cancelled test the 
consequences of a positive test or other violation of a DOT drug 
testing regulation (e.g., removal from a safety-sensitive position).
    (2) As an employer, you must not use a cancelled test for the 
purposes of a negative test to authorize the employee to perform 
safety-sensitive functions (i.e., in the case of a pre-employment, 
return-to-duty, or follow-up test).
    (3) However, as an employer, you must not direct a recollection for 
an employee because a test has been cancelled, except in the situations 
cited in paragraph (a)(2) of this section or other provisions of this 
part that require another test to be conducted (e.g., 
Secs. 40.159(a)(5) and 40.187(b)).
    (b) A cancelled test does not count toward compliance with DOT 
requirements (e.g., being applied toward the number of tests needed to 
meet the employer's minimum random testing rate).
    (c) A cancelled DOT test does not provide a valid basis for an 
employer to conduct a non-DOT test (i.e., a test under company 
authority).


Sec. 40.209  What is the effect of procedural problems that are not 
sufficient to cancel a drug test?

    (a) As a collector, laboratory, MRO, employer or other person 
administering the drug testing process, you must document any errors in 
the testing process of which you become aware, even if they are not 
considered problems that will cause a test to be cancelled as listed in 
this subpart. Decisions about the ultimate impact of these errors will 
be determined by other administrative or legal proceedings, subject to 
the limitations of paragraph (b) of this section.
    (b) No person concerned with the testing process may declare a test 
cancelled based on an error that does not have a significant adverse 
effect on the right of the employee to have a fair and accurate test. 
Matters that do not result in the cancellation of a test include, but 
are not limited to, the following:
    (1) A minor administrative mistake (e.g., the omission of the 
employee's middle initial, a transposition of numbers in the employee's 
social security number);
    (2) An error that does not affect employee protections under this 
part (e.g., the collector's failure to add bluing agent to the toilet 
bowl, which adversely affects only the ability of the collector to 
detect tampering with the specimen by the employee);
    (3) The collection of a specimen by a collector who is required to 
have been trained (see Sec. 40.33), but who has not met this 
requirement;
    (4) A delay in the collection process (see Sec. 40.61(a));
    (5) Verification of a test result by an MRO who has the basic 
credentials to be qualified as an MRO (see Sec. 40.121(a) through (b)) 
but who has not met training and/or documentation requirements (see 
Sec. 40.121(c) through (e));
    (6) The failure to directly observe or monitor a collection that 
the rule requires or permits to be directly observed or monitored, or 
the unauthorized use of direct observation or monitoring for a 
collection;
    (7) The fact that a test was conducted in a facility that does not 
meet the requirements of Sec. 40.41;
    (8) If the specific name of the courier on the CCF is omitted or 
erroneous;
    (9) Personal identifying information is inadvertently contained on 
the CCF (e.g., the employee signs his or her name on the laboratory 
copy); or
    (10) Claims that the employee was improperly selected for testing.
    (c) As an employer, these types of errors, even though not 
sufficient to cancel a drug test result, may subject you to enforcement 
action under DOT agency regulations.

Subpart J--Alcohol Testing Personnel


Sec. 40.211  Who conducts DOT alcohol tests?

    (a) Screening test technicians (STTs) and breath alcohol 
technicians (BATs) meeting their respective requirements of this 
subpart are the only people authorized to conduct DOT alcohol tests.
    (b) An STT can conduct only alcohol screening tests, but a BAT can 
conduct alcohol screening and confirmation tests.
    (c) As a BAT- or STT-qualified immediate supervisor of a particular 
employee, you may not act as the STT or BAT when that employee is 
tested, unless no other STT or BAT is available and DOT agency 
regulations do not prohibit you from doing so.


Sec. 40.213  What training requirements must STTs and BATs meet?

    To be permitted to act as a BAT or STT in the DOT alcohol testing 
program, you must meet each of the requirements of this section:
    (a) Basic information. You must be knowledgeable about the alcohol 
testing procedures in this part and the current DOT guidance. These 
documents and information are available from ODAPC (Department of 
Transportation, 400 7th Street, SW., Room 10403, Washington DC, 20590, 
202-366-3784, or on the ODAPC web site, http://www.dot.gov/ost/dapc)).
    (b) Qualification training. You must receive qualification training 
meeting the requirements of this paragraph (b).
    (1) Qualification training must be in accordance with the DOT Model 
BAT or STT Course, as applicable. The DOT Model Courses are available 
from ODAPC (Department of Transportation, 400 7th Street, SW., Room 
10403, Washington DC, 20590, 202-366-3784, or on the ODAPC web site, 
http://www.dot.gov/ost/dapc). The training can also be provided using a 
course of instruction equivalent to the DOT Model Courses. On request, 
ODAPC will review BAT and STT instruction courses for equivalency.
    (2) Qualification training must include training to proficiency in 
using the alcohol testing procedures of this part and in the operation 
of the particular alcohol testing device(s) (i.e., the ASD(s) or 
EBT(s)) you will be using.
    (3) The training must emphasize that you are responsible for 
maintaining the integrity of the testing process, ensuring the privacy 
of employees being tested, and avoiding conduct or statements that 
could be viewed as offensive or inappropriate.
    (4) The instructor must be an individual who has demonstrated 
necessary knowledge, skills, and abilities by regularly conducting DOT 
alcohol tests as an STT or BAT, as applicable, for a period of at least 
a year, who has conducted STT or BAT training, as applicable, under 
this part for a year, or who has successfully completed a ``train the 
trainer'' course.
    (c) Initial Proficiency Demonstration. Following your completion of 
qualification training under paragraph (b) of this section, you must 
demonstrate proficiency in alcohol testing under this part by 
completing three consecutive error-free mock tests.
    (1) Another person must monitor and evaluate your performance, in 
person or by a means that provides real-time observation and 
interaction between the instructor and trainee, and attest in writing 
that the mock collections are ``error-free.'' This person must be an 
individual who meets the requirements of paragraph (b)(4) of this 
section.
    (2) These tests must use the alcohol testing devices (e.g., EBT(s) 
or ASD(s)) that you will use as a BAT or STT.
    (3) If you are an STT who will be using an ASD that indicates 
readings by

[[Page 79555]]

changes, contrasts, or other readings in color, you must demonstrate as 
part of the mock test that you are able to discern changes, contrasts, 
or readings correctly.
    (d) Schedule for qualification training and initial proficiency 
demonstration. The following is the schedule for qualification training 
and the initial proficiency demonstration you must meet:
    (1) If you became a BAT or STT before August 1, 2001, you were 
required to have met the requirements set forth in paragraphs (b) and 
(c) of this section, and you do not have to meet them again.
    (2) If you become a BAT or STT on or after August 1, 2001, you must 
meet the requirements of paragraphs (b) and (c) of this section before 
you begin to perform BAT or STT functions.
    (e) Refresher training. No less frequently than every five years 
from the date on which you satisfactorily complete the requirements of 
paragraphs (b) and (c) of this section, you must complete refresher 
training that meets all the requirements of paragraphs (b) and (c) of 
this section.
    (f) Error Correction Training. If you make a mistake in the alcohol 
testing process that causes a test to be cancelled (i.e., a fatal or 
uncorrected flaw), you must undergo error correction training. This 
training must occur within 30 days of the date you are notified of the 
error that led to the need for retraining.
    (1) Error correction training must be provided and your proficiency 
documented in writing by a person who meets the requirements of 
paragraph (b)(4) of this section.
    (2) Error correction training is required to cover only the subject 
matter area(s) in which the error that caused the test to be cancelled 
occurred.
    (3) As part of the error correction training, you must demonstrate 
your proficiency in the alcohol testing procedures of this part by 
completing three consecutive error-free mock tests. The mock tests must 
include one uneventful scenario and two scenarios related to the 
area(s) in which your error(s) occurred. The person providing the 
training must monitor and evaluate your performance and attest in 
writing that the mock tests were error-free.
    (g) Documentation. You must maintain documentation showing that you 
currently meet all requirements of this section. You must provide this 
documentation on request to DOT agency representatives and to employers 
and C/TPAs who are negotiating to use your services.
    (h) Other persons who may serve as BATs or STTs. (1) Anyone meeting 
the requirements of this section to be a BAT may act as an STT, 
provided that the individual has demonstrated initial proficiency in 
the operation of the ASD that he or she is using, as provided in 
paragraph (c) of this section.
    (2) Law enforcement officers who have been certified by state or 
local governments to conduct breath alcohol testing are deemed to be 
qualified as BATs. They are not required to also complete the training 
requirements of this section in order to act as BATs. In order for a 
test conducted by such an officer to be accepted under DOT alcohol 
testing requirements, the officer must have been certified by a state 
or local government to use the EBT or ASD that was used for the test.


Sec. 40.215  What information about the DER do employers have to 
provide to BATs and STTs?

    As an employer, you must provide to the STTs and BATs the name and 
telephone number of the appropriate DER (and C/TPA, where applicable) 
to contact about any problems or issues that may arise during the 
testing process.


Sec. 40.217  Where is other information on the role of STTs and BATs 
found in this regulation?

    You can find other information on the role and functions of STTs 
and BATs in the following sections of this part:

Sec. 40.3--Definitions.
Sec. 40.223--Responsibility for supervising employees being tested.
Secs. 40.225-40.227--Use of the alcohol testing form.
Secs. 40.241-40.245--Screening test procedures with ASDs and EBTs.
Secs. 40.251-40.255--Confirmation test procedures.
Sec. 40.261--Refusals to test.
Secs. 40.263-40.265--Insufficient saliva or breath.
Sec. 40.267--Problems requiring cancellation of tests.
Secs. 40.269-40.271--Correcting problems in tests.

Subpart K--Testing Sites, Forms, Equipment and Supplies Used in 
Alcohol Testing


Sec. 40.221  Where does an alcohol test take place?

    (a) A DOT alcohol test must take place at an alcohol testing site 
meeting the requirements of this section.
    (b) If you are operating an alcohol testing site, you must ensure 
that it meets the security requirements of Sec. 40.223.
    (c) If you are operating an alcohol testing site, you must ensure 
that it provides visual and aural privacy to the employee being tested, 
sufficient to prevent unauthorized persons from seeing or hearing test 
results.
    (d) If you are operating an alcohol testing site, you must ensure 
that it has all needed personnel, materials, equipment, and facilities 
to provide for the collection and analysis of breath and/or saliva 
samples, and a suitable clean surface for writing.
    (e) If an alcohol testing site fully meeting all the visual and 
aural privacy requirements of paragraph (c) is not readily available, 
this part allows a reasonable suspicion or post-accident test to be 
conducted at a site that partially meets these requirements. In this 
case, the site must afford visual and aural privacy to the employee to 
the greatest extent practicable.
    (f) An alcohol testing site can be in a medical facility, a mobile 
facility (e.g., a van), a dedicated collection facility, or any other 
location meeting the requirements of this section.


Sec. 40.223  What steps must be taken to protect the security of 
alcohol testing sites?

    (a) If you are a BAT, STT, or other person operating an alcohol 
testing site, you must prevent unauthorized personnel from entering the 
testing site.
    (1) The only people you are to treat as authorized persons are 
employees being tested, BATs, STTs, and other alcohol testing site 
workers, DERs, employee representatives authorized by the employer 
(e.g., on the basis of employer policy or labor-management agreement), 
and DOT agency representatives.
    (2) You must ensure that all persons are under the supervision of a 
BAT or STT at all times when permitted into the site.
    (3) You may remove any person who obstructs, interferes with, or 
causes unnecessary delay in the testing process.
    (b) As the BAT or STT, you must not allow any person other than 
you, the employee, or a DOT agency representative to actually witness 
the testing process (see Secs. 40.241-40.255).
    (c) If you are operating an alcohol testing site, you must ensure 
that when an EBT or ASD is not being used for testing, you store it in 
a secure place.
    (d) If you are operating an alcohol testing site, you must ensure 
that no one other than BATs or other employees of the site have access 
to the site when an EBT is unsecured.
    (e) As a BAT or STT, to avoid distraction that could compromise 
security, you are limited to conducting an alcohol test for only one 
employee at a time.
    (1) When an EBT screening test on an employee indicates an alcohol

[[Page 79556]]

concentration of 0.02 or higher, and the same EBT will be used for the 
confirmation test, you are not allowed to use the EBT for a test on 
another employee before completing the confirmation test on the first 
employee.
    (2) As a BAT who will conduct both the screening and the 
confirmation test, you are to complete the entire screening and 
confirmation process on one employee before starting the screening 
process on another employee.
    (3) You are not allowed to leave the alcohol testing site while the 
testing process for a given employee is in progress, except to notify a 
supervisor or contact a DER for assistance in the case an employee or 
other person who obstructs, interferes with, or unnecessarily delays 
the testing process.


Sec. 40.225  What form is used for an alcohol test?

    (a) The DOT Alcohol Testing Form (ATF) must be used for every DOT 
alcohol test. The ATF must be a three-part carbonless manifold form. 
The ATF is found in Appendix G to this part. You may view this form on 
the ODAPC web site (http://www.dot.gov/ost/dapc).
    (b) As an employer in the DOT alcohol testing program, you are not 
permitted to modify or revise the ATF except as follows:
    (1) You may include other information needed for billing purposes, 
outside the boundaries of the form.
    (2) You may use a ATF directly generated by an EBT which omits the 
space for affixing a separate printed result to the ATF, provided the 
EBT prints the result directly on the ATF.
    (3) You may use an ATF that has the employer's name, address, and 
telephone number preprinted. In addition, a C/TPA's name, address, and 
telephone number may be included, to assist with negative results.
    (4) You may use an ATF in which all pages are printed on white 
paper. The white pages must have either clearly discernible borders in 
the specified color for each page or designation statements for each 
copy in the specified color.
    (5) As a BAT or STT, you may add, on the ``Remarks'' line of the 
ATF, the name of the DOT agency under whose authority the test 
occurred.
    (6) As a BAT or STT, you may use a ATF that has your name, address, 
and telephone number preprinted, but under no circumstances can your 
signature be preprinted.
    (c) As an employer, you may use an equivalent foreign-language 
version of the ATF approved by ODAPC. You may use such a non-English 
language form only in a situation where both the employee and BAT/STT 
understand and can use the form in that language.


Sec. 40.227  May employers use the ATF for non-DOT tests, or non-DOT 
forms for DOT tests?

    (a) No, as an employer, BAT, or STT, you are prohibited from using 
the ATF for non-DOT alcohol tests. You are also prohibited from using 
non-DOT forms for DOT alcohol tests. Doing either subjects you to 
enforcement action under DOT agency regulations.
    (b) If the STT or BAT, either by mistake, or as the only means to 
conduct a test under difficult circumstances (e.g., post-accident test 
with insufficient time to obtain the ATF), uses a non-DOT form for a 
DOT test, the use of a non-DOT form does not, in and of itself, require 
the employer or service agent to cancel the test. However, in order for 
the test to be considered valid, a signed statement must be obtained 
from the STT or BAT in accordance with Sec. 40.271(b) .


Sec. 40.229  What devices are used to conduct alcohol screening tests?

    EBTs and ASDs on the NHTSA conforming products lists (CPL) for 
evidential and non-evidential devices are the only devices you are 
allowed to use to conduct alcohol screening tests under this part. An 
ASD can be used only for screening tests for alcohol, and may not be 
used for confirmation tests.


Sec. 40.231  What devices are used to conduct alcohol confirmation 
tests?

    (a) EBTs on the NHTSA CPL for evidential devices that meet the 
requirements of paragraph (b) of this section are the only devices you 
may use to conduct alcohol confirmation tests under this part. Note 
that, among devices on the CPL for EBTs, only those devices listed 
without an asterisk (*) are authorized for use in confirmation testing 
in the DOT alcohol testing program.
    (b) To conduct a confirmation test, you must use an EBT that has 
the following capabilities:
    (1) Provides a printed triplicate result (or three consecutive 
identical copies of a result) of each breath test;
    (2) Assigns a unique number to each completed test, which the BAT 
and employee can read before each test and which is printed on each 
copy of the result;
    (3) Prints, on each copy of the result, the manufacturer's name for 
the device, its serial number, and the time of the test;
    (4) Distinguishes alcohol from acetone at the 0.02 alcohol 
concentration level;
    (5) Tests an air blank; and
    (6) Performs an external calibration check.


Sec. 40.233  What are the requirements for proper use and care of EBTs?

    (a) As an EBT manufacturer, you must submit, for NHTSA approval, a 
quality assurance plan (QAP) for your EBT before NHTSA places the EBT 
on the CPL.
    (1) Your QAP must specify the methods used to perform external 
calibration checks on the EBT, the tolerances within which the EBT is 
regarded as being in proper calibration, and the intervals at which 
these checks must be performed. In designating these intervals, your 
QAP must take into account factors like frequency of use, environmental 
conditions (e.g., temperature, humidity, altitude) and type of 
operation (e.g., stationary or mobile).
    (2) Your QAP must also specify the inspection, maintenance, and 
calibration requirements and intervals for the EBT.
    (b) As the manufacturer, you must include, with each EBT, 
instructions for its use and care consistent with the QAP.
    (c) As the user of the EBT (e.g., employer, service agent), you 
must do the following:
    (1) You must follow the manufacturer's instructions (see paragraph 
(b) of this section), including performance of external calibration 
checks at the intervals the instructions specify.
    (2) In conducting external calibration checks, you must use only 
calibration devices appearing on NHTSA's CPL for ``Calibrating Units 
for Breath Alcohol Tests.''
    (3) If an EBT fails an external check of calibration, you must take 
the EBT out of service. You may not use the EBT again for DOT alcohol 
testing until it is repaired and passes an external calibration check.
    (4) You must maintain records of the inspection, maintenance, and 
calibration of EBTs as provided in Sec. 40.333(a)(2) .
    (5) You must ensure that inspection, maintenance, and calibration 
of the EBT are performed by its manufacturer or a maintenance 
representative certified either by the manufacturer or by a state 
health agency or other appropriate state agency.


Sec. 40.235  What are the requirements for proper use and care of ASDs?

    (a) As an ASD manufacturer, you must submit, for NHTSA approval, a 
QAP for your ASD before NHTSA places the ASD on the CPL. Your QAP must

[[Page 79557]]

specify the methods used for quality control checks, temperatures at 
which the ASD must be stored and used, the shelf life of the device, 
and environmental conditions (e.g., temperature, altitude, humidity) 
that may affect the ASD's performance.
    (b) As a manufacturer, you must include with each ASD instructions 
for its use and care consistent with the QAP. The instructions must 
include directions on the proper use of the ASD, and, where applicable 
the time within which the device must be read, and the manner in which 
the reading is made.
    (c) As the user of the ADS (e.g., employer, STT), you must follow 
the QAP instructions.
    (d) You are not permitted to use an ASD that does not pass the 
specified quality control checks or that has passed its expiration 
date.
    (e) As an employer, with respect to breath ASDs, you must also 
follow the device use and care requirements of Sec. 40.233 .

Subpart L--Alcohol Screening Tests


Sec. 40.241  What are the first steps in any alcohol screening test?

    As the BAT or STT you will take the following steps to begin all 
alcohol screening tests, regardless of the type of testing device you 
are using:
    (a) When a specific time for an employee's test has been scheduled, 
or the collection site is at the employee's worksite, and the employee 
does not appear at the collection site at the scheduled time, contact 
the DER to determine the appropriate interval within which the DER has 
determined the employee is authorized to arrive. If the employee's 
arrival is delayed beyond that time, you must notify the DER that the 
employee has not reported for testing. In a situation where a C/TPA has 
notified an owner/operator or other individual employee to report for 
testing and the employee does not appear, the C/TPA must notify the 
employee that he or she has refused to test.
    (b) Ensure that, when the employee enters the alcohol testing site, 
you begin the alcohol testing process without undue delay. For example, 
you must not wait because the employee says he or she is not ready or 
because an authorized employer or employee representative is delayed in 
arriving.
    (1) If the employee is also going to take a DOT drug test, you 
must, to the greatest extent practicable, ensure that the alcohol test 
is completed before the urine collection process begins.
    (2) If the employee needs medical attention (e.g., an injured 
employee in an emergency medical facility who is required to have a 
post-accident test), do not delay this treatment to conduct a test.
    (c) Require the employee to provide positive identification. You 
must see a photo ID issued by the employer (other than in the case of 
an owner-operator or other self-employer individual) or a Federal, 
state, or local government (e.g., a driver's license). You may not 
accept faxes or photocopies of identification. Positive identification 
by an employer representative (not a co-worker or another employee 
being tested) is also acceptable. If the employee cannot produce 
positive identification, you must contact a DER to verify the identity 
of the employee.
    (d) If the employee asks, provide your identification to the 
employee. Your identification must include your name and your 
employer's name but is not required to include your picture, address, 
or telephone number.
    (e) Explain the testing procedure to the employee, including 
showing the employee the instructions on the back of the ATF.
    (f) Complete Step 1 of the ATF.
    (g) Direct the employee to complete Step 2 on the ATF and sign the 
certification. If the employee refuses to sign this certification, you 
must document this refusal on the ``Remarks'' line of the ATF and 
immediately notify the DER. This is a refusal to test.


Sec. 40.243  What is the procedure for an alcohol screening test using 
an EBT or non-evidential breath ASD?

    As the BAT or STT, you must take the following steps:
    (a) Select, or allow the employee to select, an individually 
wrapped or sealed mouthpiece from the testing materials.
    (b) Open the individually wrapped or sealed mouthpiece in view of 
the employee and insert it into the device in accordance with the 
manufacturer's instructions.
    (c) Instruct the employee to blow steadily and forcefully into the 
mouthpiece for at least six seconds or until the device indicates that 
an adequate amount of breath has been obtained.
    (d) Show the employee the displayed test result.
    (e) If the device is one that prints the test number, testing 
device name and serial number, time, and result directly onto the ATF, 
you must check to ensure that the information has been printed 
correctly onto the ATF.
    (f) If the device is one that prints the test number, testing 
device name and serial number, time and result, but on a separate 
printout rather than directly onto the ATF, you must affix the printout 
of the information to the designated space on the ATF with tamper-
evident tape or use a self-adhesive label that is tamper-evident.
    (g) If the device is one that does not print the test number, 
testing device name and serial number, time, and result, or it is a 
device not being used with a printer, you must record this information 
in Step 3 of the ATF.


Sec. 40.245  What is the procedure for an alcohol screening test using 
a saliva ASD?

    As the STT, you must take the following steps:
    (a) Check the expiration date on the device and show it to the 
employee. You may not use the device after its expiration date.
    (b) Open an individually wrapped or sealed package containing the 
device in the presence of the employee.
    (c) Offer the employee the opportunity to use the device. If the 
employee uses it, you must instruct the employee to insert it into his 
or her mouth and use it in a manner described by the device's 
manufacturer.
    (d) If the employee chooses not to use the device, or in all cases 
in which a new test is necessary because the device did not activate 
(see paragraph (g) of this section), you must insert the device into 
the employee's mouth and gather saliva in the manner described by the 
device's manufacturer. You must wear single-use examination or similar 
gloves while doing so and change them following each test.
    (e) When the device is removed from the employee's mouth, you must 
follow the manufacturer's instructions regarding necessary next steps 
in ensuring that the device has activated.
    (f)(1) If you were unable to successfully follow the procedures of 
paragraphs (c) through (e) of this section (e.g., the device breaks, 
you drop the device on the floor), you must discard the device and 
conduct a new test using a new device.
    (2) The new device you use must be one that has been under your 
control or that of the employer before the test.
    (3) You must note on the ``Remarks'' line of the ATF the reason for 
the new test. (Note: You may continue using the same ATF with which you 
began the test.)
    (4) You must offer the employee the choice of using the device or 
having you use it unless the employee, in the opinion of the STT or 
BAT, was responsible (e.g., the employee dropped the device) for the 
new test needing to be conducted.
    (5) If you are unable to successfully follow the procedures of 
paragraphs (c)

[[Page 79558]]

through (e) of this section on the new test, you must end the 
collection and put an explanation on the ``Remarks'' line of the ATF.
    (6) You must then direct the employee to take a new test 
immediately, using an EBT for the screening test.
    (g) If you are able to successfully follow the procedures of 
paragraphs (c)-(e) of this section, but the device does not activate, 
you must discard the device and conduct a new test, in the same manner 
as provided in paragraph (f) of this section. In this case, you must 
place the device into the employee's mouth to collect saliva for the 
new test.
    (h) You must read the result displayed on the device no sooner than 
the device's manufacturer instructs. In all cases the result displayed 
must be read within 15 minutes of the test. You must then show the 
device and its reading to the employee and enter the result on the ATF.
    (i) You must never re-use devices, swabs, gloves or other materials 
used in saliva testing.
    (j) You must note the fact that you used a saliva ASD in Step 3 of 
the ATF.


Sec. 40.247  What procedures does the BAT or STT follow after a 
screening test result?

    (a) If the test result is an alcohol concentration of less than 
0.02, as the BAT or STT, you must do the following:
    (1) Sign and date Step 3 of the ATF; and
    (2) Transmit the result to the DER in a confidential manner, as 
provided in Sec. 40.255 .
    (b) If the test result is an alcohol concentration of 0.02 or 
higher, as the BAT or STT, you must direct the employee to take a 
confirmation test.
    (1) If you are the BAT who will conduct the confirmation test, you 
must then conduct the test using the procedures beginning at 
Sec. 40.251 .
    (2) If you are not the BAT who will conduct the confirmation test, 
direct the employee to take a confirmation test, sign and date Step 3 
of the ATF, and give the employee Copy 2 of the ATF.
    (3) If the confirmation test will be performed at a different site 
from the screening test, you must take the following additional steps:
    (i) Advise the employee not to eat, drink, put anything (e.g., 
cigarette, chewing gum) into his or her mouth, or belch;
    (ii) Tell the employee the reason for the waiting period required 
by Sec. 40.251(a) (i.e., to prevent an accumulation of mouth alcohol 
from leading to an artificially high reading);
    (iii) Explain that following your instructions concerning the 
waiting period is to the employee's benefit;
    (iv) Explain that the confirmation test will be conducted at the 
end of the waiting period, even if the instructions have not been 
followed;
    (v) Note on the ``Remarks'' line of the ATF that the waiting period 
instructions were provided;
    (vi) Instruct the person accompanying the employee to carry a copy 
of the ATF to the BAT who will perform the confirmation test; and
    (vii) Ensure that you or another BAT, STT, or employer 
representative observe the employee as he or she is transported to the 
confirmation testing site. You must direct the employee not to attempt 
to drive a motor vehicle to the confirmation testing site.
    (c) If the screening test is invalid, you must, as the BAT or STT, 
tell the employee the test is cancelled and note the problem on the 
``Remarks'' line of the ATF. If practicable, repeat the testing process 
(see Sec. 40. 271).

Subpart M--Alcohol Confirmation Tests


Sec. 40.251  What are the first steps in an alcohol confirmation test?

    As the BAT for an alcohol confirmation test, you must follow these 
steps to begin the confirmation test process:
    (a) You must carry out a requirement for a waiting period before 
the confirmation test, by taking the following steps:
    (1) You must ensure that the waiting period lasts at least 15 
minutes, starting with the completion of the screening test. After the 
waiting period has elapsed, you should begin the confirmation test as 
soon as possible, but not more than 30 minutes after the completion of 
the screening test.
    (i) If the confirmation test is taking place at a different 
location from the screening test (see Sec. 40.247(b)(3)) the time of 
transit between sites counts toward the waiting period if the STT or 
BAT who conducted the screening test provided the waiting period 
instructions.
    (ii) If you cannot verify, through review of the ATF, that waiting 
period instructions were provided, then you must carry out the waiting 
period requirement.
    (iii) You or another BAT or STT, or an employer representative, 
must observe the employee during the waiting period.
    (2) Concerning the waiting period, you must tell the employee:
    (i) Not to eat, drink, put anything (e.g., cigarette, chewing gum) 
into his or her mouth, or belch;
    (ii) The reason for the waiting period (i.e., to prevent an 
accumulation of mouth alcohol from leading to an artificially high 
reading);
    (iii) That following your instructions concerning the waiting 
period is to the employee's benefit; and
    (iv) That the confirmation test will be conducted at the end of the 
waiting period, even if the instructions have not been followed.
    (3) If you become aware that the employee has not followed the 
instructions, you must note this on the ``Remarks'' line of the ATF.
    (b) If you did not conduct the screening test for the employee, you 
must require positive identification of the employee, explain the 
confirmation procedures, and use a new ATF. You must note on the 
``Remarks'' line of the ATF that a different BAT or STT conducted the 
screening test.
    (c) Complete Step 1 of the ATF.
    (d) Direct the employee to complete Step 2 on the ATF and sign the 
certification. If the employee refuses to sign this certification, you 
must document this refusal on the ``Remarks'' line of the ATF and 
immediately notify the DER. This is a refusal to test.
    (e) Even if more than 30 minutes have passed since the screening 
test result was obtained, you must begin the confirmation test 
procedures in Sec. 40.253, not another screening test.
    (f) You must note on the ``Remarks'' line of the ATF the time that 
elapsed between the two events, and if the confirmation test could not 
begin within 30 minutes of the screening test, the reason why.
    (g) Beginning the confirmation test procedures after the 30 minutes 
have elapsed does not invalidate the screening or confirmation tests, 
but it may constitute a regulatory violation subject to DOT agency 
sanction.


Sec. 40.253  What are the procedures for conducting an alcohol 
confirmation test?

    As the BAT conducting an alcohol confirmation test, you must follow 
these steps in order to complete the confirmation test process:
    (a) In the presence of the employee, you must conduct an air blank 
on the EBT you are using before beginning the confirmation test and 
show the reading to the employee.
    (1) If the reading is 0.00, the test may proceed. If the reading is 
greater than 0.00, you must conduct another air blank.
    (2) If the reading on the second air blank is 0.00, the test may 
proceed. If the reading is greater than 0.00, you must take the EBT out 
of service.
    (3) If you take an EBT out of service for this reason, no one may 
use it for testing until the EBT is found to be

[[Page 79559]]

within tolerance limits on an external check of calibration.
    (4) You must proceed with the test of the employee using another 
EBT, if one is available.
    (b) You must open a new individually wrapped or sealed mouthpiece 
in view of the employee and insert it into the device in accordance 
with the manufacturer's instructions.
    (c) You must ensure that you and the employee read the sequential 
test number displayed on the EBT.
    (d) You must instruct the employee to blow steadily and forcefully 
into the mouthpiece for at least six seconds or until the device 
indicates that an adequate amount of breath has been obtained.
    (e) You must show the employee the result displayed on the EBT.
    (f) You must show the employee the result and unique test number 
that the EBT prints out either directly onto the ATF or onto a separate 
printout.
    (g) If the EBT provides a separate printout of the result, you must 
attach the printout to the designated space on the ATF with tamper-
evident tape, or use a self-adhesive label that is tamper-evident.


Sec. 40.255  What happens next after the alcohol confirmation test 
result?

    (a) After the EBT has printed the result of an alcohol confirmation 
test, you must, as the BAT, take the following additional steps:
    (1) Sign and date Step 3 of the ATF.
    (2) If the alcohol confirmation test result is lower than 0.02, 
nothing further is required of the employee. As the BAT, you must sign 
and date Step 3 of the ATF.
    (3) If the alcohol confirmation test result is 0.02 or higher, 
direct the employee to sign and date Step 4 of the ATF. If the employee 
does not do so, you must note this on the ``Remarks'' line of the ATF. 
However, this is not considered a refusal to test.
    (4) If the test is invalid, tell the employee the test is cancelled 
and note the problem on the ``Remarks'' line of the ATF. If 
practicable, conduct a re-test. (see Sec. 40.271).
    (5) Immediately transmit the result directly to the DER in a 
confidential manner.
    (i) You may transmit the results using Copy 1 of the ATF, in 
person, by telephone, or by electronic means. In any case, you must 
immediately notify the DER of any result of 0.02 or greater by any 
means (e.g., telephone or secure fax machine) that ensures the result 
is immediately received by the DER. You must not transmit these results 
through C/TPAs or other service agents.
    (ii) If you do not make the initial transmission in writing, you 
must follow up the initial transmission with Copy 1 of the ATF.
    (b) As an employer, you must take the following steps with respect 
to the receipt and storage of alcohol test result information:
    (1) If you receive any test results that are not in writing (e.g., 
by telephone or electronic means), you must establish a mechanism to 
establish the identity of the BAT sending you the results.
    (2) You must store all test result information in a way that 
protects confidentiality.

Subpart N--Problems in Alcohol Testing


Sec. 40.261  What is a refusal to take an alcohol test, and what are 
the consequences?

    (a) As an employee, you are considered to have refused to take an 
alcohol test if you:
    (1) Fail to appear for any test within a reasonable time, as 
determined by the employer, after being directed to do so by the 
employer. This includes the failure of an employee (including an owner-
operator) to appear for a test when called by C/TPA (see 
Sec. 40.241(b)(1));
    (2) Fail to remain at the testing site until the testing process is 
complete;
    (3) Fail to attempt to provide a saliva or breath specimen, as 
applicable, for any test required by this part or DOT agency 
regulations;
    (4) Fail to provide a sufficient breath specimen, and the physician 
has determined, through a required medical evaluation, that there was 
no adequate medical explanation for the failure (see Sec. 40.265(c));
    (5) Fail to undergo a medical examination or evaluation, as 
directed by the employer as part of the insufficient breath procedures 
outlined at Sec. 40.265(c);
    (6) Fail to sign the certification at Step 2 of the ATF (see 
Sec. 40.241(b)(7)); or
    (7) Fail to cooperate with any part of the testing process.
    (b) As an employee, if you refuse to take an alcohol test, you 
incur the same consequences specified under DOT agency regulations for 
a violation of those DOT agency regulations.
    (c) As a BAT or an STT, or as the physician evaluating a ``shy 
lung'' situation, when an employee refuses to test as provided in 
paragraph (a) of this section, you must terminate the portion of the 
testing process in which you are involved, document the refusal on the 
ATF (or in a separate document which you cause to be attached to the 
form), immediately notify the DER by any means (e.g., telephone or 
secure fax machine) that ensures the refusal notification is 
immediately received. You must make this notification directly to the 
DER (not using a C/TPA as an intermediary).
    (d) As an employee, when you refuse to take a non-DOT test or to 
sign a non-DOT form, you have not refused to take a DOT test. There are 
no consequences under DOT agency regulations for such a refusal.


Sec. 40.263  What happens when an employee is unable to provide a 
sufficient amount of saliva for an alcohol screening test?

    (a) As the STT, you must take the following steps if an employee is 
unable to provide sufficient saliva to complete a test on a saliva 
screening device (e.g., the employee does not provide sufficient saliva 
to activate the device).
    (1) You must conduct a new screening test using a new screening 
device.
    (2) If the employee refuses to make the attempt to complete the new 
test, you must discontinue testing, note the fact on the ``Remarks'' 
line of the ATF, and immediately notify the DER. This is a refusal to 
test.
    (3) If the employee has not provided a sufficient amount of saliva 
to complete the new test, you must note the fact on the ``Remarks'' 
line of the ATF and immediately notify the DER.
    (b) As the DER, when the STT informs you that the employee has not 
provided a sufficient amount of saliva (see paragraph (a)(3) of this 
section), you must immediately arrange to administer an alcohol test to 
the employee using an EBT or other breath testing device.


Sec. 40.265  What happens when an employee is unable to provide a 
sufficient amount of breath for an alcohol test?

    (a) If an employee does not provide a sufficient amount of breath 
to permit a valid breath test, you must take the steps listed in this 
section.
    (b) As the BAT or STT, you must instruct the employee to attempt 
again to provide a sufficient amount of breath and about the proper way 
to do so.
    (1) If the employee refuses to make the attempt, you must 
discontinue the test, note the fact on the ``Remarks'' line of the ATF, 
and immediately notify the DER. This is a refusal to test.
    (2) If the employee again attempts and fails to provide a 
sufficient amount of breath, you may provide another opportunity to the 
employee to do so if you believe that there is a strong likelihood that 
it could result in providing a sufficient amount of breath.
    (3) When the employee's attempts under paragraph (b)(2) of this 
section

[[Page 79560]]

have failed to produce a sufficient amount of breath, you must note the 
fact on the ``Remarks'' line of the ATF and immediately notify the DER.
    (4) If you are using an EBT that has the capability of operating 
manually, you may attempt to conduct the test in manual mode.
    (5) If you are qualified to use a saliva ASD and you are in the 
screening test stage, you may change to a saliva ASD only to complete 
the screening test.
    (c) As the employer, when the BAT or STT informs you that the 
employee has not provided a sufficient amount of breath, you must 
direct the employee to obtain, within five days, an evaluation from a 
licensed physician who is acceptable to you and who has expertise in 
the medical issues raised by the employee's failure to provide a 
sufficient specimen.
    (1) You are required to provide the physician who will conduct the 
evaluation with the following information and instructions:
    (i) That the employee was required to take a DOT breath alcohol 
test, but was unable to provide a sufficient amount of breath to 
complete the test;
    (ii) The consequences of the appropriate DOT agency regulation for 
refusing to take the required alcohol test;
    (iii) That the physician must provide you with a signed statement 
of his or her conclusions; and
    (iv) That the physician, in his or her reasonable medical judgment, 
must base those conclusions on one of the following determinations:
    (A) A medical condition has, or with a high degree of probability 
could have, precluded the employee from providing a sufficient amount 
of breath. The physician must not include in the signed statement 
detailed information on the employee's medical condition. In this case, 
the test is cancelled.
    (B) There is not an adequate basis for determining that a medical 
condition has, or with a high degree of probability could have, 
precluded the employee from providing a sufficient amount of breath. 
This constitutes a refusal to test.
    (C) For purposes of paragraphs (c)(1)(iv)(A) and (B) of this 
section, a medical condition includes an ascertainable physiological 
condition (e.g., a respiratory system dysfunction) or a medically 
documented pre-existing psychological disorder, but does not include 
unsupported assertions of ``situational anxiety'' or hyperventilation.
    (2) As the physician making the evaluation, after making your 
determination, you must provide a written statement of your conclusions 
and the basis for them to the DER directly (and not through a C/TPA 
acting as an itermediary). You must not include in this statement 
detailed information on the employee's medical condition beyond what is 
necessary to explain your conclusion.
    (3) Upon receipt of the report from the examining physician, as the 
DER you must immediately inform the employee and take appropriate 
action based upon your DOT agency regulations.


Sec. 40.267  What problems always cause an alcohol test to be 
cancelled?

    As an employer, a BAT, or an STT, you must cancel an alcohol test 
if any of the following problems occur. These are ``fatal flaws.'' You 
must inform the DER that the test was cancelled and must be treated as 
if the test never occurred. These problems are:
    (a) In the case of a screening test conducted on a saliva ASD:
    (1) The STT reads the result either sooner than or later than the 
time allotted by the manufacturer (see Sec. 40.245(h));
    (2) The device does not activate (see Sec. 40.245(g)); or
    (3) The device is used for a test after the expiration date printed 
on its package (see Sec. 40.245(a)).
    (b) In the case of a screening or confirmation test conducted on an 
EBT, the sequential test number or alcohol concentration displayed on 
the EBT is not the same as the sequential test number or alcohol 
concentration on the printed result (see Sec. 40.253(c), (e) and (f)).
    (c) In the case of a confirmation test:
    (1) The BAT conducts the confirmation test before the end of the 
minimum 15-minute waiting period (see Sec. 40.251(a)(1));
    (2) The BAT does not conduct an air blank before the confirmation 
test (see Sec. 40.253(a));
    (3) There is not a 0.00 result on the air blank conducted before 
the confirmation test (see Sec. 40.253(a)(1) and (2));
    (4) The EBT does not print the result (see Sec. 40.253(f)); or
    (5) The next external calibration check of the EBT produces a 
result that differs by more than the tolerance stated in the QAP from 
the known value of the test standard. In this case, every result of 
0.02 or above obtained on the EBT since the last valid external 
calibration check is cancelled (see Sec. 40.233(a)(1) and (d)).


Sec. 40.269  What problems cause an alcohol test to be cancelled unless 
they are corrected?

    As a BAT or STT, or employer, you must cancel an alcohol test if 
any of the following problems occur, unless they are corrected. These 
are ``correctable flaws.'' These problems are:
    (a) The BAT or STT does not sign the ATF (see 
Sec. Sec. 40.247(a)(1) and 40.255(a)(1)).
    (b) The BAT or STT fails to note on the ``Remarks'' line of the ATF 
that the employee has not signed the ATF after the result is obtained 
(see Sec. 40.255(a)(2)).
    (c) The BAT or STT uses a non-DOT form for the test (see 
Sec. 40.225(a)).


Sec. 40.271  How are alcohol testing problems corrected?

    (a) As a BAT or STT, you have the responsibility of trying to 
complete successfully an alcohol test for each employee.
    (1) If, during or shortly after the testing process, you become 
aware of any event that will cause the test to be cancelled (see 
Sec. 40.267 ), you must try to correct the problem promptly, if 
practicable. You may repeat the testing process as part of this effort.
    (2) If repeating the testing process is necessary, you must begin a 
new test as soon as possible. You must use a new ATF, a new sequential 
test number, and, if needed, a new ASD and/or a new EBT. It is 
permissible to use additional technical capabilities of the EBT (e.g., 
manual operation) if you have been trained to do so in accordance with 
Sec. 40.213(c) .
    (3) If repeating the testing process is necessary, you are not 
limited in the number of attempts to complete the test, provided that 
the employee is making a good faith effort to comply with the testing 
process.
    (4) If another testing device is not available for the new test at 
the testing site, you must immediately notify the DER and advise the 
DER that the test could not be completed. As the DER who receives this 
information, you must make all reasonable efforts to ensure that the 
test is conducted at another testing site as soon as possible.
    (b) If, as an STT, BAT, employer or other service agent 
administering the testing process, you become aware of a ``correctable 
flaw'' (see Sec. 40.269 ) that has not already been corrected, you must 
take all practicable action to correct the problem so that the test is 
not cancelled.
    (1) If the problem resulted from the omission of required 
information, you must, as the person responsible for providing that 
information, supply in writing the missing information and a signed 
statement that it is true and accurate. For example, suppose you are a 
BAT and you forgot to make a notation on the ``Remarks'' line of the 
ATF that

[[Page 79561]]

the employee did not sign the certification. You would, when the 
problem is called to your attention, supply a signed statement that the 
employee failed or refused to sign the certification after the result 
was obtained, and that your signed statement is true and accurate.
    (2) If the problem is the use of a non-DOT form, you must, as the 
person responsible for the use of the incorrect form, certify in 
writing that the incorrect form contains all the information needed for 
a valid DOT alcohol test. You must also provide a signed statement that 
the incorrect form was used inadvertently or as the only means of 
conducting a test, in circumstances beyond your control, and the steps 
you have taken to prevent future use of non-DOT forms for DOT tests. 
You must supply this information on the same business day on which you 
are notified of the problem, transmitting it by fax or courier.
    (c) If you cannot correct the problem, you must cancel the test.


Sec. 40.273  What is the effect of a cancelled alcohol test?

    (a) A cancelled alcohol test is neither positive nor negative.
    (1) As an employer, you must not attach to a cancelled test the 
consequences of a test result that is 0.02 or greater (e.g., removal 
from a safety-sensitive position).
    (2) As an employer, you must not use a cancelled test in a 
situation where an employee needs a test result that is below 0.02 
(e.g., in the case of a return-to-duty or follow-up test to authorize 
the employee to perform safety-sensitive functions).
    (3) As an employer, you must not direct a recollection for an 
employee because a test has been cancelled, except in the situations 
cited in paragraph (a)(2) of this section or other provisions of this 
part.
    (b) A cancelled test does not count toward compliance with DOT 
requirements, such as a minimum random testing rate.
    (c) When a test must be cancelled, if you are the BAT, STT, or 
other person who determines that the cancellation is necessary, you 
must inform the affected DER within 48 hours of the cancellation.
    (d) A cancelled DOT test does not provide a valid basis for an 
employer to conduct a non-DOT test (i.e., a test under company 
authority).


Sec. 40.275  What is the effect of procedural problems that are not 
sufficient to cancel an alcohol test?

    (a) As an STT, BAT, employer, or a service agent administering the 
testing process, you must document any errors in the testing process of 
which you become aware, even if they are not ``fatal flaws'' or 
``correctable flaws'' listed in this subpart. Decisions about the 
ultimate impact of these errors will be determined by administrative or 
legal proceedings, subject to the limitation of paragraph (b) of this 
section.
    (b) No person concerned with the testing process may declare a test 
cancelled based on a mistake in the process that does not have a 
significant adverse effect on the right of the employee to a fair and 
accurate test. For example, it is inconsistent with this part to cancel 
a test based on a minor administrative mistake (e.g., the omission of 
the employee's middle initial) or an error that does not affect 
employee protections under this part. Nor does the failure of an 
employee to sign in Step 4 of the ATF result in the cancellation of the 
test. Nor is a test to be cancelled on the basis of a claim by an 
employee that he or she was improperly selected for testing.
    (c) As an employer, these errors, even though not sufficient to 
cancel an alcohol test result, may subject you to enforcement action 
under DOT agency regulations.


Sec. 40.277  Are alcohol tests other than saliva or breath permitted 
under these regulations?

    No, other types of alcohol tests (e,g., blood and urine) are not 
authorized for testing done under this part. Only saliva or breath for 
screening tests and breath for confirmation tests using approved 
devices are permitted.

Subpart O--Substance Abuse Professionals and the Return-to-Duty 
Process


Sec. 40.281  Who is qualified to act as a SAP?

    To be permitted to act as a SAP in the DOT drug testing program, 
you must meet each of the requirements of this section:
    (a) Credentials. You must have one of the following credentials:
    (1) You are a licensed physician (Doctor of Medicine or 
Osteopathy);
    (2) You are a licensed or certified social worker;
    (3) You are a licensed or certified psychologist;
    (4) You are a licensed or certified employee assistance 
professional; or
    (5) You are a drug and alcohol counselor certified by the National 
Association of Alcoholism and Drug Abuse Counselors Certification 
Commission (NAADAC) or by the International Certification Reciprocity 
Consortium/Alcohol and Other Drug Abuse (ICRC).
    (b) Basic knowledge. You must be knowledgeable in the following 
areas:
    (1) You must be knowledgeable about and have clinical experience in 
the diagnosis and treatment of alcohol and controlled substances-
related disorders.
    (2) You must be knowledgeable about the SAP function as it relates 
to employer interests in safety-sensitive duties.
    (3) You must be knowledgeable about this part, the DOT agency 
regulations applicable to the employers for whom you evaluate 
employees, and the DOT SAP Guidelines, and you keep current on any 
changes to these materials. These documents are available from ODAPC 
(Department of Transportation, 400 7th Street, SW., Room 10403, 
Washington DC, 20590 (202-366-3784), or on the ODAPC web site (http://www.dot.gov/ost/dapc).
    (c) Qualification training. You must receive qualification training 
meeting the requirements of this paragraph (c).
    (1) Qualification training must provide instruction on the 
following subjects:
    (i) Background, rationale, and coverage of the Department's drug 
and alcohol testing program;
    (ii) 49 CFR Part 40 and DOT agency drug and alcohol testing rules;
    (iii) Key DOT drug testing requirements, including collections, 
laboratory testing, MRO review, and problems in drug testing;
    (iv) Key DOT alcohol testing requirements, including the testing 
process, the role of BATs and STTs, and problems in alcohol tests;
    (v) SAP qualifications and prohibitions;
    (vi) The role of the SAP in the return-to-duty process, including 
the initial employee evaluation, referrals for education and/or 
treatment, the follow-up evaluation, continuing treatment 
recommendations, and the follow-up testing plan;
    (vii) SAP consultation and communication with employers, MROs, and 
treatment providers;
    (viii) Reporting and recordkeeping requirements;
    (ix) Issues that SAPs confront in carrying out their duties under 
the program.
    (2) Following your completion of qualification training under 
paragraph (c)(1) of this section, you must satisfactorily complete an 
examination administered by a nationally-recognized professional or 
training organization. The examination must comprehensively cover all 
the elements of qualification training listed in paragraph (c)(1) of 
this section.
    (3) The following is the schedule for qualification training you 
must meet:

[[Page 79562]]

    (i) If you became a SAP before August 1, 2001, you must meet the 
qualification training requirement no later than December 31, 2003.
    (ii) If you become a SAP between August 1, 2001, and December 31, 
2003, you must meet the qualification training requirement no later 
than December 31, 2003.
    (iii) If you become a SAP on or after January 1, 2004, you must 
meet the qualification training requirement before you begin to perform 
SAP functions.
    (d) Continuing education. During each three-year period from the 
date on which you satisfactorily complete the examination under 
paragraph (c)(2) of this section, you must complete continuing 
education consisting of at least 12 professional development hours 
(e.g., CEUs) relevant to performing SAP functions.
    (1) This continuing education must include material concerning new 
technologies, interpretations, recent guidance, rule changes, and other 
information about developments in SAP practice, pertaining to the DOT 
program, since the time you met the qualification training requirements 
of this section.
    (2) Your continuing education activities must include documentable 
assessment tools to assist you in determining whether you have 
adequately learned the material.
    (e) Documentation. You must maintain documentation showing that you 
currently meet all requirements of this section. You must provide this 
documentation on request to DOT agency representatives and to employers 
and C/TPAs who are using or contemplating using your services.


Sec. 40.283  How does a certification organization obtain recognition 
for its members as SAPs?

    (a) If you represent a certification organization that wants DOT to 
authorize its certified drug and alcohol counselors to be added to 
Sec. 40.281(a)(5), you may submit a written petition to DOT requesting 
a review of your petition for inclusion.
    (b) You must obtain the National Commission for Certifying Agencies 
(NCCA) accreditation before DOT will act on your petition.
    (c) You must also meet the minimum requirements of Appendix E to 
this part before DOT will act on your petition.


Sec. 40.285  When is a SAP evaluation required?

    (a) As an employee, when you have violated DOT drug and alcohol 
regulations, you cannot again perform any DOT safety-sensitive duties 
for any employer until and unless you complete the SAP evaluation, 
referral, and education/treatment process set forth in this subpart and 
in applicable DOT agency regulations. The first step in this process is 
a SAP evaluation.
    (b) For purposes of this subpart, a verified positive DOT drug test 
result, a DOT alcohol test with a result indicating an alcohol 
concentration of 0.04 or greater, a refusal to test (including by 
adulterating or substituting a urine specimen) or any other violation 
of the prohibition on the use of alcohol or drugs under a DOT agency 
regulation constitutes a DOT drug and alcohol regulation violation.


Sec. 40.287  What information is an employer required to provide 
concerning SAP services to an employee who has a DOT drug and alcohol 
regulation violation?

    As an employer, you must provide to each employee (including an 
applicant or new employee) who violates a DOT drug and alcohol 
regulation a listing of SAPs readily available to the employee and 
acceptable to you, with names, addresses, and telephone numbers. You 
cannot charge the employee any fee for compiling or providing this 
list. You may provide this list yourself or through a C/TPA or other 
service agent.


Sec. 40.289  Are employers required to provide SAP and treatment 
services to employees?

    (a) As an employer, you are not required to provide a SAP 
evaluation or any subsequent recommended education or treatment for an 
employee who has violated a DOT drug and alcohol regulation.
    (b) However, if you offer that employee an opportunity to return to 
a DOT safety-sensitive duty following a violation, you must, before the 
employee again performs that duty, ensure that the employee receives an 
evaluation by a SAP meeting the requirements of Sec. 40.281 and that 
the employee successfully complies with the SAP's evaluation 
recommendations.
    (c) Payment for SAP evaluations and services is left for employers 
and employees to decide and may be governed by existing management-
labor agreements and health care benefits.


Sec. 40.291  What is the role of the SAP in the evaluation, referral, 
and treatment process of an employee who has violated DOT agency drug 
and alcohol testing regulations?

    (a) As a SAP, you are charged with:
    (1) Making a face-to-face clinical assessment and evaluation to 
determine what assistance is needed by the employee to resolve problems 
associated with alcohol and/or drug use;
    (2) Referring the employee to an appropriate education and/or 
treatment program;
    (3) Conducting a face-to-face follow-up evaluation to determine if 
the employee has actively participated in the education and/or 
treatment program and has demonstrated successful compliance with the 
initial assessment and evaluation recommendations;
    (4) Providing the DER with a follow-up drug and/or alcohol testing 
plan for the employee; and
    (5) Providing the employee and employer with recommendations for 
continuing education and/or treatment.
    (b) As a SAP, you are not an advocate for the employer or employee. 
Your function is to protect the public interest in safety by 
professionally evaluating the employee and recommending appropriate 
education/treatment, follow-up tests, and aftercare.


Sec. 40.293  What is the SAP's function in conducting the initial 
evaluation of an employee?

    As a SAP, for every employee who comes to you following a DOT drug 
and alcohol regulation violation, you must accomplish the following:
    (a) Provide a comprehensive face-to-face assessment and clinical 
evaluation.
    (b) Recommend a course of education and/or treatment with which the 
employee must demonstrate successful compliance prior to returning to 
DOT safety-sensitive duty.
    (1) You must make such a recommendation for every individual who 
has violated a DOT drug and alcohol regulation.
    (2) You must make a recommendation for education and/or treatment 
that will, to the greatest extent possible, protect public safety in 
the event that the employee returns to the performance of safety-
sensitive functions.
    (c) Appropriate education may include, but is not limited to, self-
help groups (e.g., Alcoholics Anonymous) and community lectures, where 
attendance can be independently verified, and bona fide drug and 
alcohol education courses.
    (d) Appropriate treatment may include, but is not limited to, in-
patient hospitalization, partial in-patient treatment, out-patient 
counseling programs, and aftercare.
    (e) You must provide a written report directly to the DER 
highlighting your specific recommendations for assistance (see 
Sec. 40.311(c)).
    (f) For purposes of your role in the evaluation process, you must 
assume that a verified positive test result has conclusively 
established that the employee committed a DOT drug and

[[Page 79563]]

alcohol regulation violation. You must not take into consideration in 
any way, as a factor in determining what your recommendation will be, 
any of the following:
    (1) A claim by the employee that the test was unjustified or 
inaccurate;
    (2) Statements by the employee that attempt to mitigate the 
seriousness of a violation of a DOT drug or alcohol regulation (e.g., 
related to assertions of use of hemp oil, ``medical marijuana'' use, 
``contact positives,'' poppy seed ingestion, job stress); or
    (3) Personal opinions you may have about the justification or 
rationale for drug and alcohol testing.
    (g) In the course of gathering information for purposes of your 
evaluation in the case of a drug-related violation, you may consult 
with the MRO. As the MRO, you are required to cooperate with the SAP 
and provide available information the SAP requests. It is not necessary 
to obtain the consent of the employee to provide this information.


Sec. 40.295  May employees or employers seek a second SAP evaluation if 
they disagree with the first SAP's recommendations?

    (a) As an employee with a DOT drug and alcohol regulation 
violation, when you have been evaluated by a SAP, you must not seek a 
second SAP's evaluation in order to obtain another recommendation.
    (b) As an employer, you must not seek a second SAP's evaluation if 
the employee has already been evaluated by a qualified SAP. If the 
employee, contrary to paragraph (a) of this section, has obtained a 
second SAP evaluation, as an employer you may not rely on it for any 
purpose under this part.


Sec. 40.297  Does anyone have the authority to change a SAP's initial 
evaluation?

    (a) Except as provided in paragraph (b) of this section, no one 
(e.g., an employer, employee, a managed-care provider, any service 
agent) may change in any way the SAP's evaluation or recommendations 
for assistance. For example, a third party is not permitted to make 
more or less stringent a SAP's recommendation by changing the SAP's 
evaluation or seeking another SAP's evaluation.
    (b) The SAP who made the initial evaluation may modify his or her 
initial evaluation and recommendations based on new or additional 
information (e.g., from an education or treatment program).


Sec. 40.299  What is the SAP's role and what are the limits on a SAP's 
discretion in referring employees for education and treatment?

    (a) As a SAP, upon your determination of the best recommendation 
for assistance, you will serve as a referral source to assist the 
employee's entry into a education and/or treatment program.
    (b) To prevent the appearance of a conflict of interest, you must 
not refer an employee requiring assistance to your private practice or 
to a person or organization from which you receive payment or to a 
person or organization in which you have a financial interest. You are 
precluded from making referrals to entities with which you are 
financially associated.
    (c) There are four exceptions to the prohibitions contained in 
paragraph (b) of this section. You may refer an employee to any of the 
following providers of assistance, regardless of your relationship with 
them:
    (1) A public agency (e.g., treatment facility) operated by a state, 
county, or municipality;
    (2) The employer or a person or organization under contract to the 
employer to provide alcohol or drug treatment and/or education services 
(e.g., the employer's contracted treatment provider);
    (3) The sole source of therapeutically appropriate treatment under 
the employee's health insurance program (e.g., the single substance 
abuse in-patient treatment program made available by the employee's 
insurance coverage plan); or
    (4) The sole source of therapeutically appropriate treatment 
reasonably available to the employee (e.g., the only treatment facility 
or education program reasonably located within the general commuting 
area).


Sec. 40.301  What is the SAP's function in the follow-up evaluation of 
an employee?

    (a) As a SAP, after you have prescribed assistance under 
Sec. 40.293, you must re-evaluate the employee to determine if the 
employee has successfully carried out your education and/or treatment 
recommendations.
    (1) This is your way to gauge for the employer the employee's 
ability to demonstrate successful compliance with the education and/or 
treatment plan.
    (2) Your evaluation may serve as one of the reasons the employer 
decides to return the employee to safety-sensitive duty.
    (b) As the SAP making the follow-up evaluation determination, you 
must:
    (1) Confer with or obtain appropriate documentation from the 
appropriate education and/or treatment program professionals where the 
employee was referred; and
    (2) Conduct a face-to-face clinical interview with the employee to 
determine if the employee demonstrates successful compliance with your 
initial evaluation recommendations.
    (c) (1) If the employee has demonstrated successful compliance, you 
must provide a written report directly to the DER highlighting your 
clinical determination that the employee has done so with your initial 
evaluation recommendation (see Sec. 40.311(d)).
    (2) You may determine that an employee has successfully 
demonstrated compliance even though the employee has not yet completed 
the full regimen of education and/or treatment you recommended or needs 
additional asssitance. For example, if the employee has successfully 
completed the 30-day in-patient program you prescribed, you may make a 
``successful compliance'' determination even though you conclude that 
the employee has not yet completed the out-patient counseling you 
recommended or should continue in an aftercare program.
    (d)(1) As the SAP, if you believe, as a result of the follow-up 
evaluation, that the employee has not demonstrated successful 
compliance with your recommendations, you must provide written notice 
directly to the DER (see Sec. 40.311(e)).
    (2) As an employer who receives the SAP's written notice that the 
employee has not successfully complied with the SAP's recommendations, 
you must not return the employee to the performance of safety-sensitive 
duties.
    (3) As the SAP, you may conduct additional follow-up evaluation(s) 
if the employer determines that doing so is consistent with the 
employee's progress as you have reported it and with the employer's 
policy and/or labor-management agreements.
    (4) As the employer, following a SAP report that the employee has 
not demonstrated successful compliance, you may take personnel action 
consistent with your policy and/or labor-management agreements.


Sec. 40.303  What happens if the SAP believes the employee needs 
additional treatment, aftercare, or support group services even after 
the employee returns to safety-sensitive duties?

    (a) As a SAP, if you believe that ongoing services (in addition to 
follow-up tests) are needed to assist an employee to maintain sobriety 
or abstinence from drug use after the

[[Page 79564]]

employee resumes the performance of safety-sensitive duties, you must 
provide recommendations for these services in your follow-up evaluation 
report (see Sec. 40.311(d)(10)).
    (b) As an employer receiving a recommendation for these services 
from a SAP, you may, as part of a return-to-duty agreement with the 
employee, require the employee to participate in the recommended 
services. You may monitor and document the employee's participation in 
the recommended services. You may also make use of SAP and employee 
assistance program (EAP) services in assisting and monitoring 
employees' compliance with SAP recommendations. Nothing in this section 
permits an employer to fail to carry out its obligations with respect 
to follow-up testing (see Sec. 40.309 ).
    (c) As an employee, you are obligated to comply with the SAP's 
recommendations for these services. If you fail or refuse to do so, you 
may be subject to disciplinary action by your employer.


Sec. 40.305   How does the return-to-duty process conclude?

    (a) As the employer, if you decide that you want to permit the 
employee to return to the performance of safety-sensitive functions, 
you must ensure that the employee takes a return-to-duty test. This 
test cannot occur until after the SAP has determined that the employee 
has successfully complied with prescribed education and/or treatment. 
The employee must have a negative drug test result and/or an alcohol 
test with an alcohol concentration of less than 0.02 before resuming 
performance of safety-sensitive duties.
    (b) As an employer, you must not return an employee to safety-
sensitive duties until the employee meets the conditions of paragraph 
(a) of this section. However, you are not required to return an 
employee to safety-sensitive duties because the employee has met these 
conditions. That is a personnel decision that you have the discretion 
to make, subject to collective bargaining agreements or other legal 
requirements.
    (c) As a SAP or MRO, you must not make a ``fitness for duty'' 
determination as part of this re-evaluation unless required to do so 
under an applicable DOT agency regulation. It is the employer, rather 
than you, who must decide whether to put the employee back to work in a 
safety-sensitive position.


Sec. 40.307   What is the SAP's function in prescribing the employee's 
follow-up tests?

    (a) As a SAP, for each employee who has committed a DOT drug or 
alcohol regulation violation, and who seeks to resume the performance 
of safety-sensitive functions, you must establish a written follow-up 
testing plan. You do not establish this plan until after you determine 
that the employee has successfully complied with your recommendations 
for education and/or treatment.
    (b) You must present a copy of this plan directly to the DER (see 
Sec. 40.311(d)(9)).
    (c) You are the sole determiner of the number and frequency of 
follow-up tests and whether these tests will be for drugs, alcohol, or 
both, unless otherwise directed by the appropriate DOT agency 
regulation. For example, if the employee had a positive drug test, but 
your evaluation or the treatment program professionals determined that 
the employee had an alcohol problem as well, you should require that 
the employee have follow-up tests for both drugs and alcohol.
    (d) However, you must, at a minimum, direct that the employee be 
subject to six unannounced follow-up tests in the first 12 months of 
safety-sensitive duty following the employee's return to safety-
sensitive functions.
    (1) You may require a greater number of follow-up tests during the 
first 12-month period of safety-sensitive duty (e.g., you may require 
one test a month during the 12-month period; you may require two tests 
per month during the first 6-month period and one test per month during 
the final 6-month period).
    (2) You may also require follow-up tests during the 48 months of 
safety-sensitive duty following this first 12-month period.
    (3) You are not to establish the actual dates for the follow-up 
tests you prescribe. The decision on specific dates to test is the 
employer's.
    (4) As the employer, you must not impose additional testing 
requirements (e.g., under company authority) on the employee that go 
beyond the SAP's follow-up testing plan.
    (e) The requirements of the SAP's follow-up testing plan ``follow 
the employee'' to subsequent employers or through breaks in service.

    Example 1 to Paragraph (e): The employee returns to duty with 
Employer A. Two months afterward, after completing the first two of 
six follow-up tests required by the SAP's plan, the employee quits 
his job with Employer A and begins to work in a similar position for 
Employer B. The employee remains obligated to complete the four 
additional tests during the next 10 months of safety-sensitive duty, 
and Employer B is responsible for ensuring that the employee does 
so. Employer B learns of this obligation through the inquiry it 
makes under Sec. 40.25.
    Example 2 to Paragraph (e): The employee returns to duty with 
Employer A. Three months later, after the employee completes the 
first two of six follow-up tests required by the SAP's plan, 
Employer A lays the employee off for economic or seasonal employment 
reasons. Four months later, Employer A recalls the employee. 
Employer A must ensure that the employee completes the remaining 
four follow-up tests during the next nine months.

    (f) As the SAP, you may modify the determinations you have made 
concerning follow-up tests. For example, even if you recommended 
follow-up testing beyond the first 12-months, you can terminate the 
testing requirement at any time after the first year of testing. You 
must not, however, modify the requirement that the employee take at 
least six follow-up tests within the first 12 months after returning to 
the performance of safety-sensitive functions.


Sec. 40.309   What are the employer's responsibilities with respect to 
the SAP's directions for follow-up tests?

    (a) As the employer, you must carry out the SAP's follow-up testing 
requirements. You may not allow the employee to continue to perform 
safety-sensitive functions unless follow-up testing is conducted as 
directed by the SAP.
    (b) You should schedule follow-up tests on dates of your own 
choosing, but you must ensure that the tests are unannounced with no 
discernable pattern as to their timing, and that the employee is given 
no advance notice.
    (c) You cannot substitute any other tests (e.g., those carried out 
under the random testing program) conducted on the employee for this 
follow-up testing requirement.
    (d) You cannot count a follow-up test that has been cancelled as a 
completed test. A cancelled follow-up test must be recollected.


Sec. 40.311  What are the requirements concerning SAP reports?

    (a) As the SAP conducting the required evaluations, you must send 
the written reports required by this section in writing directly to the 
DER and not to a third party or entity for forwarding to the DER 
(except as provided in Sec. 40.355(e)). You may, however, forward the 
document simultaneously to the DER and to a C/TPA.
    (b) As an employer, you must ensure that you receive SAP written 
reports directly from the SAP performing the evaluation and that no 
third party or

[[Page 79565]]

entity changed the SAP's report in any way.
    (c) The SAP's written report, following an initial evaluation that 
determines what level of assistance is needed to address the employee's 
drug and/or alcohol problems, must be on the SAP's own letterhead (and 
not the letterhead of another service agent) signed and dated by the 
SAP, and must contain the following delineated items:
    (1) Employee's name and SSN;
    (2) Employer's name and address;
    (3) Reason for the assessment (specific violation of DOT 
regulations and violation date);
    (4) Date(s) of the assessment;
    (5) SAP's education and/or treatment recommendation; and
    (6) SAP's telephone number.
    (d) The SAP's written report concerning a follow-up evaluation that 
determines the employee has demonstrated successful compliance must be 
on the SAP's own letterhead (and not the letterhead of another service 
agent), signed by the SAP and dated, and must contain the following 
items:
    (1) Employee's name and SSN;
    (2) Employer's name and address;
    (3) Reason for the initial assessment (specific violation of DOT 
regulations and violation date);
    (4) Date(s) of the initial assessment and synopsis of the treatment 
plan;
    (5) Name of practice(s) or service(s) providing the recommended 
education and/or treatment;
    (6) Inclusive dates of employee's program participation;
    (7) Clinical characterization of employee's program participation;
    (8) SAP's clinical determination as to whether the employee has 
demonstrated successful compliance;
    (9) Follow-up testing plan;
    (10) Employee's continuing care needs with specific treatment, 
aftercare, and/or support group services recommendations; and
    (11) SAP's telephone number.
    (e) The SAP's written report concerning a follow-up evaluation that 
determines the employee has not demonstrated successful compliance must 
be on the SAP's own letterhead (and not the letterhead of another 
service agent), signed by the SAP and dated, and must contain the 
following items:
    (1) Employee's name and SSN;
    (2) Employer's name and address;
    (3) Reason for the initial assessment (specific DOT violation and 
date);
    (4) Date(s) of initial assessment and synopsis of treatment plan;
    (5) Name of practice(s) or service(s) providing the recommended 
education and/or treatment;
    (6) Inclusive dates of employee's program participation;
    (7) Clinical characterization of employee's program participation;
    (8) Date(s) of the first follow-up evaluation;
    (9) Date(s) of any further follow-up evaluation the SAP has 
scheduled;
    (10) SAP's clinical reasons for determining that the employee has 
not demonstrated successful compliance; and
    (11) SAP's telephone number.
    (f) As a SAP, you must also provide these written reports directly 
to the employee if the employee has no current employer and to the 
gaining DOT regulated employer in the event the employee obtains 
another transportation industry safety-sensitive position.
    (g) As a SAP, you are to maintain copies of your reports to 
employers for 5 years, and your employee clinical records in accordance 
with Federal, state, and local laws regarding record maintenance, 
confidentiality, and release of information. You must make these 
records available, on request, to DOT agency representatives (e.g., 
inspectors conducting an audit or safety investigation) and 
representatives of the NTSB in an accident investigation.
    (h) As an employer, you must maintain your reports from SAPs for 5 
years from the date you received them.


Sec. 40.313  Where is other information on SAP functions and the 
return-to-duty process found in this regulation?

    You can find other information on the role and functions of SAPs in 
the following sections of this part:

Sec. 40.3--Definition.
Sec. 40.347--Service agent assistance with SAP-required follow-up 
testing.
Sec. 40.355--Transmission of SAP reports.
Sec. 40.329(c)--Making SAP reports available to employees on 
request.

Appendix E to Part 40--SAP Equivalency Requirements for Certification 
Organizations.

Subpart P--Confidentiality and Release of Information


Sec. 40.321  What is the general confidentiality rule for drug and 
alcohol test information?

    Except as otherwise provided in this subpart, as a service agent or 
employer participating in the DOT drug or alcohol testing process, you 
are prohibited from releasing individual test results or medical 
information about an employee to third parties without the employee's 
specific written consent.
    (a) A ``third party'' is any person or organization to whom other 
subparts of this regulation do not explicitly authorize or require the 
transmission of information in the course of the drug or alcohol 
testing process.
    (b) ``Specific written consent'' means a statement signed by the 
employee that he or she agrees to the release of a particular piece of 
information to a particular, explicitly identified, person or 
organization at a particular time. ``Blanket releases,'' in which an 
employee agrees to a release of a category of information (e.g., all 
test results) or to release information to a category of parties (e.g., 
other employers who are members of a C/TPA, companies to which the 
employee may apply for employment), are prohibited under this part.


Sec. 40.323   May program participants release drug or alcohol test 
information in connection with legal proceedings?

    (a) As an employer, you may release information pertaining to an 
employee's drug or alcohol test without the employee's consent in 
certain legal proceedings.
    (1) These proceedings include a lawsuit (e.g., a wrongful discharge 
action), grievance (e.g., an arbitration concerning disciplinary action 
taken by the employer), or administrative proceeding (e.g., an 
unemployment compensation hearing) brought by, or on behalf of, an 
employee and resulting from a positive DOT drug or alcohol test or a 
refusal to test (including, but not limited to, adulterated or 
substituted test results).
    (2) These proceedings also include a criminal or civil action 
resulting from an employee's performance of safety-sensitive duties, in 
which a court of competent jurisdiction determines that the drug or 
alcohol test information sought is relevant to the case and issues an 
order directing the employer to produce the information. 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 is authorized to respond to the 
court's order to produce the records.
    (b) In such a proceeding, you may release the information to the 
decisionmaker in the proceeding (e.g., the court in a lawsuit). You may 
release the information only with a binding stipulation that the 
decisionmaker to whom it is released will make it available only to 
parties to the proceeding.
    (c) If you are a service agent, and the employer requests its 
employee's drug or alcohol testing information from you to use in a 
legal proceeding as authorized in paragraph (a) of this

[[Page 79566]]

section (e.g., the laboratory's data package), you must provide the 
requested information to the employer.
    (d) As an employer or service agent, you must immediately notify 
the employee in writing of any information you release under this 
section.


Sec. 40.325  [Reserved]


Sec. 40.327  When must the MRO report medical information gathered in 
the verification process?

    (a) As the MRO, you must, except as provided in paragraph (c) of 
this section, report drug test results and medical information you 
learned as part of the verification process to third parties without 
the employee's consent if you determine, in your reasonable medical 
judgment, that:
    (1) The information is likely to result in the employee being 
determined to be medically unqualified under an applicable DOT agency 
regulation; or
    (2) The information indicates that continued performance by the 
employee of his or her safety-sensitive function is likely to pose a 
significant safety risk.
    (b) The third parties to whom you are authorized to provide 
information by this section include the employer, a physician or other 
health care provider responsible for determining the medical 
qualifications of the employee under an applicable DOT agency safety 
regulation, a SAP evaluating the employee as part of the return to duty 
process (see Sec. 40.293(g)), a DOT agency, or the National 
Transportation Safety Board in the course of an accident investigation.
    (c) If the law of a foreign country (e.g., Canada) prohibits you 
from providing medical information to the employer, you may comply with 
that prohibition.


Sec. 40.329  What information must laboratories, MROs, and other 
service agents release to employees?

    (a) As an MRO or service agent you must provide, within 10 business 
days of receiving a written request from an employee, copies of any 
records pertaining to the employee's use of alcohol and/or drugs, 
including records of the employee's DOT-mandated drug and/or alcohol 
tests. You may charge no more than the cost of preparation and 
reproduction for copies of these records.
    (b) As a laboratory, you must provide, within 10 business days of 
receiving a written request from an employee, and made through the MRO, 
the records relating to the results of the employee's drug test (i.e., 
laboratory report and data package). You may charge no more than the 
cost of preparation and reproduction for copies of these records.
    (c) As a SAP, you must make available to an employee, on request, a 
copy of all SAP reports (see Sec. 40.311).


Sec. 40.331  To what additional parties must employers and service 
agents release information?

    As an employer or service agent you must release information under 
the following circumstances:
    (a) If you receive a specific, written consent from an employee 
authorizing the release of information about that employee's drug or 
alcohol tests to an identified person, you must provide the information 
to the identified person. For example, as an employer, when you receive 
a written request from a former employee to provide information to a 
subsequent employer, you must do so. In providing the information, you 
must comply with the terms of the employee's consent.
    (b) If you are an employer, you must, upon request of DOT agency 
representatives, provide the following:
    (1) Access to your facilities used for this part and DOT agency 
drug and alcohol program functions.
    (2) All written, printed, and computer-based drug and alcohol 
program records and reports (including copies of name-specific records 
or reports), files, materials, data, documents/documentation, 
agreements, contracts, policies, and statements that are required by 
this part and DOT agency regulations.
    (c) If you are a service agent, you must, upon request of DOT 
agency representatives, provide the following:
    (1) Access to your facilities used for this part and DOT agency 
drug and alcohol program functions.
    (2) All written, printed, and computer-based drug and alcohol 
program records and reports (including copies of name-specific records 
or reports), files, materials, data, documents/documentation, 
agreements, contracts, policies, and statements that are required by 
this part and DOT agency regulations.
    (d) If requested by the National Transportation Safety Board as 
part of an accident investigation, you must provide information 
concerning post-accident tests administered after the accident.
    (e) If requested by a Federal, state or local safety agency with 
regulatory authority over you or the employee, you must provide drug 
and alcohol test records concerning the employee.
    (f) Except as otherwise provided in this part, as a laboratory you 
must not release or provide a specimen or a part of a specimen to a 
requesting party, without first obtaining written consent from ODAPC. 
If a party seeks a court order directing you to release a specimen or 
part of a specimen contrary to any provision of this part, you must 
take necessary legal steps to contest the issuance of the order (e.g., 
seek to quash a subpoena, citing the requirements of Sec. 40.13 ). This 
part does not require you to disobey a court order, however.


Sec. 40.333  What records must employers keep?

    (a) As an employer, you must keep the following records for the 
following periods of time:
    (1) You must keep the following records for five years:
    (i) Records of employee alcohol test results indicating an alcohol 
concentration of 0.02 or greater;
    (ii) Records of employee verified positive drug test results;
    (iii) Documentation of refusals to take required alcohol and/or 
drug tests (including substituted or adulterated drug test results);
    (iv) SAP reports; and
    (v) All follow-up tests and schedules for follow-up tests.
    (2) You must keep records for three years of information obtained 
from previous employers under Sec. 40.25 concerning drug and alcohol 
test results of employees.
    (3) You must keep records of the inspection, maintenance, and 
calibration of EBTs, for two years.
    (4) You must keep records of negative and cancelled drug test 
results and alcohol test results with a concentration of less than 0.02 
for one year.
    (b) You do not have to keep records related to a program 
requirement that does not apply to you (e.g., a maritime employer who 
does not have a DOT-mandated random alcohol testing program need not 
maintain random alcohol testing records).
    (c) You must maintain the records in a location with controlled 
access.
    (d) A service agent may maintain these records for you. However, 
you must ensure that you can produce these records at your principal 
place of business in the time required by the DOT agency. For example, 
as a motor carrier, when an FMCSA inspector requests your records, you 
must ensure that you can provide them within two working days.

Subpart Q--Roles and Responsibilities of Service Agents


Sec. 40.341  Must service agents comply with DOT drug and alcohol 
testing requirements?

    (a) As a service agent, the services you provide to transportation 
employers must meet the requirements of this part

[[Page 79567]]

and the DOT agency drug and alcohol testing regulations.
    (b) If you do not comply, DOT may take action under the Public 
Interest Exclusions procedures of this part (see Subpart R of this 
part) or applicable provisions of other DOT agency regulations.


Sec. 40.343  What tasks may a service agent perform for an employer?

    As a service agent, you may perform for employers the tasks needed 
to comply with DOT agency drug and alcohol testing regulations, subject 
to the requirements and limitations of this part.


Sec. 40.345  In what circumstances may a C/TPA act as an intermediary 
in the transmission of drug and alcohol testing information to 
employers?

    (a) As a C/TPA or other service agent, you may act as an 
intermediary in the transmission of drug and alcohol testing 
information in the circumstances specified in this section only if the 
employer chooses to have you do so. Each employer makes the decision 
about whether to receive some or all of this information from you, 
acting as an intermediary, rather than directly from the service agent 
who originates the information (e.g., an MRO or BAT).
    (b) The specific provisions of this part concerning which you may 
act as an intermediary are listed in Appendix F to this part. These are 
the only situations in which you may act as an intermediary. You are 
prohibited from doing so in all other situations.
    (c) In every case, you must ensure that, in transmitting 
information to employers, you meet all requirements (e.g., concerning 
confidentiality and timing) that would apply if the service agent 
originating the information (e.g., an MRO or collector) sent the 
information directly to the employer. For example, if you transmit drug 
testing results from MROs to DERs, you must transmit each drug test 
result to the DER in compliance with the MRO requirements set forth in 
Sec. 40.167 .


Sec. 40.347  What functions may C/TPAs perform with respect to 
administering testing?

    As a C/TPA, except as otherwise specified in this part, you may 
perform the following functions for employers concerning random 
selection and other selections for testing.
    (a) You may operate random testing programs for employers and may 
assist (i.e., through contracting with laboratories or collection 
sites, conducting collections) employers with other types of testing 
(e.g., pre-employment, post-accident, reasonable suspicion, return-to-
duty, and follow-up).
    (b) You may combine employees from more than one employer or one 
transportation industry in a random pool if permitted by all the DOT 
agency drug and alcohol testing regulations involved.
    (1) If you combine employees from more than one transportation 
industry, you must ensure that the random testing rate is at least 
equal to the highest rate required by each DOT agency.
    (2) Employees not covered by DOT agency regulations may not be part 
of the same random pool with DOT covered employees.
    (c) You may assist employers in ensuring that follow-up testing is 
conducted in accordance with the plan established by the SAP. However, 
neither you nor the employer are permitted to randomly select employees 
from a ``follow-up pool'' for follow-up testing.


Sec. 40.349  What records may a service agent receive and maintain?

    (a) Except where otherwise specified in this part, as a service 
agent you may receive and maintain all records concerning DOT drug and 
alcohol testing programs, including positive, negative, and refusal to 
test individual test results. You do not need the employee's consent to 
receive and maintain these records.
    (b) You may maintain all information needed for operating a drug/
alcohol program (e.g., CCFs, ATFs, names of employees in random pools, 
random selection lists, copies of notices to employers of selected 
employees) on behalf of an employer.
    (c) If a service agent originating drug or alcohol testing 
information, such as an MRO or BAT, sends the information directly to 
the DER, he or she may also provide the information simultaneously to 
you, as a C/TPA or other service agent who maintains this information 
for the employer.
    (d) If you are serving as an intermediary in transmitting 
information that is required to be provided to the employer, you must 
ensure that it reaches the employer in the same time periods required 
elsewhere in this part.
    (e) You must ensure that you can make available to the employer 
within two days any information the employer is asked to produce by a 
DOT agency representative.
    (f) On request of an employer, you must, at any time on the request 
of an employer, transfer immediately all records pertaining to the 
employer and its employees to the employer or to any other service 
agent the employer designates. You must carry out this transfer as soon 
as the employer requests it. You are not required to obtain employee 
consent for this transfer. You must not charge more than your 
reasonable administrative costs for conducting this transfer. You may 
not charge a fee for the release of these records.
    (g) If you are planning to go out of business or your organization 
will be bought by or merged with another organization, you must 
immediately notify all employers and offer to transfer all records 
pertaining to the employer and its employees to the employer or to any 
other service agent the employer designates. You must carry out this 
transfer as soon as the employer requests it. You are not required to 
obtain employee consent for this transfer. You must not charge more 
than your reasonable administrative costs for conducting this transfer. 
You may not charge a fee for the release of these records.


Sec. 40.351  What confidentiality requirements apply to service agents?

    Except where otherwise specified in this part, as a service agent 
the following confidentiality requirements apply to you:
    (a) When you receive or maintain confidential information about 
employees (e.g., individual test results), you must follow the same 
confidentiality regulations as the employer with respect to the use and 
release of this information.
    (b) You must follow all confidentiality and records retention 
requirements applicable to employers.
    (c) You may not provide individual test results or other 
confidential information to another employer without a specific, 
written consent from the employee. For example, suppose you are a C/TPA 
that has employers X and Y as clients. Employee Jones works for X, and 
you maintain Jones' drug and alcohol test for X. Jones wants to change 
jobs and work for Y. You may not inform Y of the result of a test 
conducted for X without having a specific, written consent from Jones. 
Likewise, you may not provide this information to employer Z, who is 
not a C/TPA member, without this consent.
    (d) You must not use blanket consent forms authorizing the release 
of employee testing information.
    (e) You must establish adequate confidentiality and security 
measures to ensure that confidential employee records are not available 
to unauthorized persons. This includes protecting the physical security 
of

[[Page 79568]]

records, access controls, and computer security measures to safeguard 
confidential data in electronic data bases.


Sec. 40.353  What principles govern the interaction between MROs and 
other service agents?

    As a service agent other than an MRO (e.g., a C/TPA), the following 
principles govern your interaction with MROs:
    (a) You may provide MRO services to employers, directly or through 
contract, if you meet all applicable provisions of this part.
    (b) If you employ or contract for an MRO, the MRO must perform 
duties independently and confidentially. When you have a relationship 
with an MRO, you must structure the relationship to ensure that this 
independence and confidentiality are not compromised. Specific means 
(including both physical and operational measures, as appropriate) to 
separate MRO functions and other service agent functions are essential.
    (c) Only your staff who are actually under the day-to-day 
supervision and control of an MRO with respect to MRO functions may 
perform these functions. This does not mean that those staff may not 
perform other functions at other times. However, the designation of 
your staff to perform MRO functions under MRO supervision must be 
limited and not used as a subterfuge to circumvent confidentiality and 
other requirements of this part and DOT agency regulations. You must 
ensure that MRO staff operate under controls sufficient to ensure that 
the independence and confidentiality of the MRO process are not 
compromised.
    (d) Like other MROs, an MRO you employ or contract with must 
personally conduct verification interviews with employees and must 
personally make all verification decisions. Consequently, your staff 
cannot perform these functions.


Sec. 40.355  What limitations apply to the activities of service 
agents?

    As a service agent, you are subject to the following limitations 
concerning your activities in the DOT drug and alcohol testing program.
    (a) You must not require an employee to sign a consent, release, 
waiver of liability, or indemnification agreement with respect to any 
part of the drug or alcohol testing process covered by this part 
(including, but not limited to, collections, laboratory testing, MRO, 
and SAP services).
    (b) You must not act as an intermediary in the transmission of drug 
test results from the laboratory to the MRO. That is, the laboratory 
may not send results to you, with you in turn sending them to the MRO 
for verification. For example, a practice in which the laboratory 
transmits results to your computer system, and you then assign the 
results to a particular MRO, is not permitted.
    (c) You must not transmit drug test results directly from the 
laboratory to the employer (by electronic or other means) or to a 
service agent who forwards them to the employer. All confirmed 
laboratory results must be processed by the MRO before they are 
released to any other party.
    (d) You must not act as an intermediary in the transmission of 
alcohol test results of 0.02 or higher from the STT or BAT to the DER.
    (e) Except as provided in paragraph (f) of this section, you must 
not act as an intermediary in the transmission of individual SAP 
reports to the actual employer. That is, the SAP may not send such 
reports to you, with you in turn sending them to the actual employer. 
However, you may maintain individual SAP summary reports and follow-up 
testing plans after they are sent to the DER, and the SAP may transmit 
such reports to you simultaneously with sending them to the DER.
    (f) As an exception to paragraph (e) of this section, you may act 
as an intermediary in the transmission of SAP report from the SAP to an 
owner-operator or other self-employed individual.
    (g) Except as provided in paragraph (h) of this section, you must 
not make decisions to test an employee based upon reasonable suspicion, 
post-accident, return-to-duty, and follow-up determination criteria. 
These are duties the actual employer cannot delegate to a C/TPA. You 
may, however, provide advice and information to employers regarding 
these testing issues and how the employer should schedule required 
testing.
    (h) As an exception to paragraph (g) of this section, you may make 
decisions to test an employee based upon reasonable suspicion, post-
accident, return-to-duty, and follow-up determination criteria with 
respect to an owner-operator or other self-employed individual.
    (i) Except as provided in paragraph (j) of this section, you must 
not make a determination that an employee has refused a drug or alcohol 
test. This is a non-delegable duty of the actual employer. You may, 
however, provide advice and information to employers regarding refusal-
to-test issues.
    (j) As an exception to paragraph (i) of this section, you may make 
a determination that an employee has refused a drug or alcohol test, 
if:
    (1) You are authorized by a DOT agency regulation to do so, you 
schedule a required test for an owner-operator or other self-employed 
individual, and the individual fails to appear for the test without a 
legitimate reason; or
    (2) As an MRO, you determine that an individual has refused to test 
on the basis of adulteration or substitution.
    (k) You must not act as a DER. For example, while you may be 
responsible for transmitting information to the employer about test 
results, you must not act on behalf of the employer in actions to 
remove employees from safety-sensitive duties.
    (l) In transmitting documents to laboratories, you must ensure that 
you send to the laboratory that conducts testing only the laboratory 
copy of the CCF. You must not transmit other copies of the CCF or any 
ATFs to the laboratory.
    (m) You must not impose conditions or requirements on employers 
that DOT regulations do not authorize. For example, as a C/TPA serving 
employers in the pipeline or motor carrier industry, you must not 
require employers to have provisions in their DOT plans that RSPA or 
FMCSA regulations do not require.
    (n) You must not intentionally delay the transmission of drug or 
alcohol testing-related documents concerning actions you have 
performed, because of a payment dispute or other reasons.

    Example 1 to Paragraph (n): A laboratory that has tested a 
specimen must not delay transmitting the documentation of the test 
result to an MRO because of a billing or payment dispute with the 
MRO or a C/TPA.
    Example 2 to Paragraph (n): An MRO or SAP who has interviewed an 
employee must not delay sending a verified test result or SAP report 
to the employer because of such a dispute with the employer or 
employee.
    Example 3 to Paragraph (n): A collector who has performed a 
urine specimen collection must not delay sending the drug specimen 
and CCF to the laboratory because of a payment or other dispute with 
the laboratory or a C/TPA.
    Example 4 to Paragraph (n): A BAT who has conducted an alcohol 
test must not delay sending test result information to an employer 
or C/TPA because of a payment or other dispute with the employer or 
C/TPA.

    (o) While you must follow the DOT agency regulations, the actual 
employer remains accountable to DOT for compliance, and your failure to 
implement any aspect of the program as required in this part and other 
applicable DOT agency regulations makes the employer subject to 
enforcement action by the Department.

[[Page 79569]]

Subpart R--Public Interest Exclusions


Sec. 40.361  What is the purpose of a public interest exclusion (PIE)?

    (a) To protect the public interest, including protecting 
transportation employers and employees from serious noncompliance with 
DOT drug and alcohol testing rules, the Department's policy is to 
ensure that employers conduct business only with responsible service 
agents.
    (b) The Department therefore uses PIEs to exclude from 
participation in DOT's drug and alcohol testing program any service 
agent who, by serious noncompliance with this part or other DOT agency 
drug and alcohol testing regulations, has shown that it is not 
currently acting in a responsible manner.
    (c) A PIE is a serious action that the Department takes only to 
protect the public interest. We intend to use PIEs only to remedy 
situations of serious noncompliance. PIEs are not used for the purpose 
of punishment.
    (d) Nothing in this subpart precludes a DOT agency or the Inspector 
General from taking other action authorized by its regulations with 
respect to service agents or employers that violate its regulations.


Sec. 40.363  On what basis may the Department issue a PIE?

    (a) If you are a service agent, the Department may issue a PIE 
concerning you if we determine that you have failed or refused to 
provide drug or alcohol testing services consistent with the 
requirements of this part or a DOT agency drug and alcohol regulation.
    (b) The Department also may issue a PIE if you have failed to 
cooperate with DOT agency representatives concerning inspections, 
complaint investigations, compliance and enforcement reviews, or 
requests for documents and other information about compliance with this 
part or DOT agency drug and alcohol regulations.


Sec. 40.365  What is the Department's policy concerning starting a PIE 
proceeding?

    (a) It is the Department's policy to start a PIE proceeding only in 
cases of serious, uncorrected noncompliance with the provisions of this 
part, affecting such matters as safety, the outcomes of test results, 
privacy and confidentiality, due process and fairness for employees, 
the honesty and integrity of the testing program, and cooperation with 
or provision of information to DOT agency representatives.
    (b) The following are examples of the kinds of serious 
noncompliance that, as a matter of policy, the Department views as 
appropriate grounds for starting a PIE proceeding. These examples are 
not intended to be an exhaustive or exclusive list of the grounds for 
starting a PIE proceeding. We intend them to illustrate the level of 
seriousness that the Department believes supports starting a PIE 
proceeding. The examples follow:
    (1) For an MRO, verifying tests positive without interviewing the 
employees as required by this part or providing MRO services without 
meeting the qualifications for an MRO required by this part;
    (2) For a laboratory, refusing to provide information to the 
Department, an employer, or an employee as required by this part; 
failing or refusing to conduct a validity testing program when required 
by this part; or a pattern or practice of testing errors that result in 
the cancellation of tests. (As a general matter of policy, the 
Department does not intend to initiate a PIE proceeding concerning a 
laboratory with respect to matters on which HHS initiates certification 
actions under its laboratory guidelines.);
    (3) For a collector, a pattern or practice of directly observing 
collections when doing so is unauthorized, or failing or refusing to 
directly observe collections when doing so is mandatory;
    (4) For collectors, BATs, or STTs, a pattern or practice of using 
forms, testing equipment, or collection kits that do not meet the 
standards in this part;
    (5) For a collector, BAT, or STT, a pattern or practice of ``fatal 
flaws'' or other significant uncorrected errors in the collection 
process;
    (6) For a laboratory, MRO or C/TPA, failing or refusing to report 
tests results as required by this part or DOT agency regulations;
    (7) For a laboratory, falsifying, concealing, or destroying 
documentation concerning any part of the drug testing process, 
including, but not limited to, documents in a ``litigation package'';
    (8) For SAPs, providing SAP services while not meeting SAP 
qualifications required by this part or performing evaluations without 
face-to-face interviews;
    (9) For any service agent, maintaining a relationship with another 
party that constitutes a conflict of interest under this part (e.g., a 
laboratory that derives a financial benefit from having an employer use 
a specific MRO);
    (10) For any service agent, representing falsely that the service 
agent or its activities is approved or certified by the Department or a 
DOT agency;
    (11) For any service agent, disclosing an employee's test result 
information to any party this part or a DOT agency regulation does not 
authorize, including by obtaining a ``blanket'' consent from employees 
or by creating a data base from which employers or others can retrieve 
an employee's DOT test results without the specific consent of the 
employee;
    (12) For any service agent, interfering or attempting to interfere 
with the ability of an MRO to communicate with the Department, or 
retaliating against an MRO for communicating with the Department;
    (13) For any service agent, directing or recommending that an 
employer fail or refuse to implement any provision of this part; or
    (14) With respect to noncompliance with a DOT agency regulation, 
conduct that affects important provisions of Department-wide concern 
(e.g., failure to properly conduct the selection process for random 
testing).


Sec. 40.367  Who initiates a PIE proceeding?

    The following DOT officials may initiate a PIE proceeding:
    (a) The drug and alcohol program manager of a DOT agency;
    (b) An official of ODAPC, other than the Director; or
    (c) The designee of any of these officials.


Sec. 40.369  What is the discretion of an initiating official in 
starting a PIE proceeding?

    (a) Initiating officials have broad discretion in deciding whether 
to start a PIE proceeding.
    (b) In exercising this discretion, the initiating official must 
consider the Department's policy regarding the seriousness of the 
service agent's conduct (see Sec. 40.365) and all information he or she 
has obtained to this point concerning the facts of the case. The 
initiating official may also consider the availability of the resources 
needed to pursue a PIE proceeding.
    (c) A decision not to initiate a PIE proceeding does not 
necessarily mean that the Department regards a service agent as being 
in compliance or that the Department may not use other applicable 
remedies in a situation of noncompliance.


Sec. 40.371  On what information does an initiating official rely in 
deciding whether to start a PIE proceeding?

    (a) An initiating official may rely on credible information from 
any source as the basis for starting a PIE proceeding.
    (b) Before sending a correction notice (see Sec. 40.373), the 
initiating official informally contacts the service agent to determine 
if there is any information that may affect the initiating official's

[[Page 79570]]

determination about whether it is necessary to send a correction 
notice. The initiating official may take any information resulting from 
this contact into account in determining whether to proceed under this 
subpart.


Sec. 40.373  Before starting a PIE proceeding, does the initiating 
official give the service agent an opportunity to correct problems?

    (a) If you are a service agent, the initiating official must send 
you a correction notice before starting a PIE proceeding.
    (b) The correction notice identifies the specific areas in which 
you must come into compliance in order to avoid being subject to a PIE 
proceeding.
    (c) If you make and document changes needed to come into compliance 
in the areas listed in the correction notice to the satisfaction of the 
initiating official within 60 days of the date you receive the notice, 
the initiating official does not start a PIE proceeding. The initiating 
official may conduct appropriate fact finding to verify that you have 
made and maintained satisfactory corrections. When he or she is 
satisfied that you are in compliance, the initiating official sends you 
a notice that the matter is concluded.


Sec. 40.375  How does the initiating official start a PIE proceeding?

    (a) As a service agent, if your compliance matter is not 
correctable (see Sec. 40.373(a)), or if have not resolved compliance 
matters as provided in Sec. 40.373(c), the initiating official starts a 
PIE proceeding by sending you a notice of proposed exclusion (NOPE). 
The NOPE contains the initiating official's recommendations concerning 
the issuance of a PIE, but it is not a decision by the Department to 
issue a PIE.
    (b) The NOPE includes the following information:
    (1) A statement that the initiating official is recommending that 
the Department issue a PIE concerning you;
    (2) The factual basis for the initiating official's belief that you 
are not providing drug and/or alcohol testing services to DOT-regulated 
employers consistent with the requirements of this part or are in 
serious noncompliance with a DOT agency drug and alcohol regulation;
    (3) The factual basis for the initiating official's belief that 
your noncompliance has not been or cannot be corrected;
    (4) The initiating official's recommendation for the scope of the 
PIE;
    (5) The initiating official's recommendation for the duration of 
the PIE; and
    (6) A statement that you may contest the issuance of the proposed 
PIE, as provided in Sec. 40.379.
    (c) The initiating official sends a copy of the NOPE to the ODAPC 
Director at the same time he or she sends the NOPE to you.


Sec. 40.377  Who decides whether to issue a PIE?

    (a) The ODAPC Director, or his or her designee, decides whether to 
issue a PIE. If a designee is acting as the decisionmaker, all 
references in this subpart to the Director refer to the designee.
    (b) To ensure his or her impartiality, the Director plays no role 
in the initiating official's determination about whether to start a PIE 
proceeding.
    (c) There is a ``firewall'' between the initiating official and the 
Director. This means that the initiating official and the Director are 
prohibited from having any discussion, contact, or exchange of 
information with one another about the matter, except for documents and 
discussions that are part of the record of the proceeding.


Sec. 40.379  How do you contest the issuance of a PIE?

    (a) If you receive a NOPE, you may contest the issuance of the PIE.
    (b) If you want to contest the proposed PIE, you must provide the 
Director information and argument in opposition to the proposed PIE in 
writing, in person, and/or through a representative. To contest the 
proposed PIE, you must take one or more of the steps listed in this 
paragraph (b) within 30 days after you receive the NOPE.
    (1) You may request that the Director dismiss the proposed PIE 
without further proceedings, on the basis that it does not concern 
serious noncompliance with this part or DOT agency regulations, 
consistent with the Department's policy as stated in Sec. 40.365.
    (2) You may present written information and arguments, consistent 
with the provisions of Sec. 40.381, contesting the proposed PIE.
    (3) You may arrange with the Director for an informal meeting to 
present your information and arguments.
    (c) If you do not take any of the actions listed in paragraph (b) 
of this section within 30 days after you receive the NOPE, the matter 
proceeds as an uncontested case. In this event, the Director makes his 
or her decision based on the record provided by the initiating official 
(i.e., the NOPE and any supporting information or testimony) and any 
additional information the Director obtains.


Sec. 40.381  What information do you present to contest the proposed 
issuance of a PIE?

    (a) As a service agent who wants to contest a proposed PIE, you 
must present at least the following information to the Director:
    (1) Specific facts that contradict the statements contained in the 
NOPE (see Sec. 40.375(b)(2) and (3)). A general denial is insufficient 
to raise a genuine dispute over facts material to the issuance of a 
PIE;
    (2) Identification of any existing, proposed or prior PIE; and
    (3) Identification of your affiliates, if any.
    (b) You may provide any information and arguments you wish 
concerning the proposed issuance, scope and duration of the PIE (see 
Sec. 40.375(b)(4) and (5)).
    (c) You may provide any additional relevant information or 
arguments concerning any of the issues in the matter.


Sec. 40.383  What procedures apply if you contest the issuance of a 
PIE?

    (a) DOT conducts PIE proceedings in a fair and informal manner. The 
Director may use flexible procedures to allow you to present matters in 
opposition. The Director is not required to follow formal rules of 
evidence or procedure in creating the record of the proceeding.
    (b) The Director will consider any information or argument he or 
she determines to be relevant to the decision on the matter.
    (c) You may submit any documentary evidence you want the Director 
to consider. In addition, if you have arranged an informal meeting with 
the Director, you may present witnesses and confront any person the 
initiating official presents as a witness against you.
    (d) In cases where there are material factual issues in dispute, 
the Director or his or her designee may conduct additional fact-
finding.
    (e) If you have arranged a meeting with the Director, the Director 
will make a transcribed record of the meeting available to you on your 
request. You must pay the cost of transcribing and copying the meeting 
record.


Sec. 40.385   Who bears the burden of proof in a PIE proceeding?

    (a) As the proponent of issuing a PIE, the initiating official 
bears the burden of proof.
    (b) This burden is to demonstrate, by a preponderance of the 
evidence, that the service agent was in serious noncompliance with the 
requirements of this part for drug and/or alcohol testing-related 
services or with the requirements of another DOT agency drug and 
alcohol testing regulation.

[[Page 79571]]

Sec. 40.387  What matters does the Director decide concerning a 
proposed PIE?

    (a) Following the service agent's response (see Sec. 40.379(b)) or, 
if no response is received, after 30 days have passed from the date on 
which the service agent received the NOPE, the Director may take one of 
the following steps:
    (1) In response to a request from the service agent (see 
Sec. 40.379(b)(1)) or on his or her own motion, the Director may 
dismiss a PIE proceeding if he or she determines that it does not 
concern serious noncompliance with this part or DOT agency regulations, 
consistent with the Department's policy as stated in Sec. 40.365.
    (i) If the Director dismisses a proposed PIE under this paragraph 
(a), the action is closed with respect to the noncompliance alleged in 
the NOPE.
    (ii) The Department may initiate a new PIE proceeding against you 
on the basis of different or subsequent conduct that is in 
noncompliance with this part or other DOT drug and alcohol testing 
rules.
    (2) If the Director determines that the initiating official's 
submission does not have complete information needed for a decision, 
the Director may remand the matter to the initiating official. The 
initiating official may resubmit the matter to the Director when the 
needed information is complete. If the basis for the proposed PIE has 
changed, the initiating official must send an amended NOPE to the 
service agent.
    (b) The Director makes determinations concerning the following 
matters in any PIE proceeding that he or she decides on the merits:
    (1) Any material facts that are in dispute;
    (2) Whether the facts support issuing a PIE;
    (3) The scope of any PIE that is issued; and
    (4) The duration of any PIE that is issued.


Sec. 40.389  What factors may the Director consider?

    This section lists examples of the kind of mitigating and 
aggravating factors that the Director may consider in determining 
whether to issue a PIE concerning you, as well as the scope and 
duration of a PIE. This list is not exhaustive or exclusive. The 
Director may consider other factors if appropriate in the circumstances 
of a particular case. The list of examples follows:
    (a) The actual or potential harm that results or may result from 
your noncompliance;
    (b) The frequency of incidents and/or duration of the 
noncompliance;
    (c) Whether there is a pattern or prior history of noncompliance;
    (d) Whether the noncompliance was pervasive within your 
organization, including such factors as the following:
    (1) Whether and to what extent your organization planned, 
initiated, or carried out the noncompliance;
    (2) The positions held by individuals involved in the 
noncompliance, and whether your principals tolerated their 
noncompliance; and
    (3) Whether you had effective standards of conduct and control 
systems (both with respect to your own organization and any contractors 
or affiliates) at the time the noncompliance occurred;
    (e) Whether you have demonstrated an appropriate compliance 
disposition, including such factors as the following:
    (1) Whether you have accepted responsibility for the noncompliance 
and recognize the seriousness of the conduct that led to the cause for 
issuance of the PIE;
    (2) Whether you have cooperated fully with the Department during 
the investigation. The Director may consider when the cooperation began 
and whether you disclosed all pertinent information known to you;
    (3) Whether you have fully investigated the circumstances of the 
noncompliance forming the basis for the PIE and, if so, have made the 
result of the investigation available to the Director;
    (4) Whether you have taken appropriate disciplinary action against 
the individuals responsible for the activity that constitutes the 
grounds for issuance of the PIE; and
    (5) Whether your organization has taken appropriate corrective 
actions or remedial measures, including implementing actions to prevent 
recurrence;
    (f) With respect to noncompliance with a DOT agency regulation, the 
degree to which the noncompliance affects matters common to the DOT 
drug and alcohol testing program;
    (g) Other factors appropriate to the circumstances of the case.


Sec. 40.391   What is the scope of a PIE?

    (a) The scope of a PIE is the Department's determination about the 
divisions, organizational elements, types of services, affiliates, and/
or individuals (including direct employees of a service agent and its 
contractors) to which a PIE applies.
    (b) If, as a service agent, the Department issues a PIE concerning 
you, the PIE applies to all your divisions, organizational elements, 
and types of services that are involved with or affected by the 
noncompliance that forms the factual basis for issuing the PIE.
    (c) In the NOPE (see Sec. 40.375(b)(4)), the initiating official 
sets forth his or her recommendation for the scope of the PIE. The 
proposed scope of the PIE is one of the elements of the proceeding that 
the service agent may contest (see Sec. 40.381(b)) and about which the 
Director makes a decision (see Sec. 40.387(b)(3)).
    (d) In recommending and deciding the scope of the PIE, the 
initiating official and Director, respectively, must take into account 
the provisions of paragraphs (e) through (j) of this section.
    (e) The pervasiveness of the noncompliance within a service agent's 
organization (see Sec. 40.389(d)) is an important consideration in 
determining the scope of a PIE. The appropriate scope of a PIE grows 
broader as the pervasiveness of the noncompliance increases.
    (f) The application of a PIE is not limited to the specific 
location or employer at which the conduct that forms the factual basis 
for issuing the PIE was discovered.
    (g) A PIE applies to your affiliates, if the affiliate is involved 
with or affected by the conduct that forms the factual basis for 
issuing the PIE.
    (h) A PIE applies to individuals who are officers, employees, 
directors, shareholders, partners, or other individuals associated with 
your organization in the following circumstances:
    (1) Conduct forming any part of the factual basis of the PIE 
occurred in connection with the individual's performance of duties by 
or on behalf of your organization; or
    (2) The individual knew of, had reason to know of, approved, or 
acquiesced in such conduct. The individual's acceptance of benefits 
derived from such conduct is evidence of such knowledge, acquiescence, 
or approval.
    (i) If a contractor to your organization is solely responsible for 
the conduct that forms the factual basis for a PIE, the PIE does not 
apply to the service agent itself unless the service agent knew or 
should have known about the conduct and did not take action to correct 
it.
    (j) PIEs do not apply to drug and alcohol testing that DOT does not 
regulate.
    (k) The following examples illustrate how the Department intends 
the provisions of this section to work:

    Example 1 to Sec. 40.391. Service Agent P provides a variety of 
drug testing services. P's SAP services are involved in a serious 
violation of this Part 40. However, P's other

[[Page 79572]]

services fully comply with this part, and P's overall management did 
not plan or concur in the noncompliance, which in fact was contrary 
to P's articulated standards. Because the noncompliance was isolated 
in one area of the organization's activities, and did not pervade 
the entire organization, the scope of the PIE could be limited to 
SAP services.
    Example 2 to Sec. 40.391. Service Agent Q provides a similar 
variety of services. The conduct forming the factual basis for a PIE 
concerns collections for a transit authority. As in Example 1, the 
noncompliance is not pervasive throughout Q's organization. The PIE 
would apply to collections at all locations served by Q, not just 
the particular transit authority or not just in the state in which 
the transit authority is located.
    Example 3 to Sec. 40.391. Service Agent R provides a similar 
array of services. One or more of the following problems exists: R's 
activities in several areas--collections, MROs, SAPs, protecting the 
confidentiality of information--are involved in serious 
noncompliance; DOT determines that R's management knew or should 
have known about serious noncompliance in one or more areas, but 
management did not take timely corrective action; or, in response to 
an inquiry from DOT personnel, R's management refuses to provide 
information about its operations. In each of these three cases, the 
scope of the PIE would include all aspects of R's services.
    Example 4 to Sec. 40.391. Service Agent W provides only one kind 
of service (e.g., laboratory or MRO services). The Department issues 
a PIE concerning these services. Because W only provides this one 
kind of service, the PIE necessarily applies to all its operations.
    Example 5 to Sec. 40.391. Service Agent X, by exercising 
reasonably prudent oversight of its collection contractor, should 
have known that the contractor was making numerous ``fatal flaws'' 
in tests. Alternatively, X received a correction notice pointing out 
these problems in its contractor's collections. In neither case did 
X take action to correct the problem. X, as well as the contractor, 
would be subject to a PIE with respect to collections.
    Example 6 to Sec. 40.391. Service Agent Y could not reasonably 
have known that one of its MROs was regularly failing to interview 
employees before verifying tests positive. When it received a 
correction notice, Y immediately dismissed the erring MRO. In this 
case, the MRO would be subject to a PIE but Y would not.
    Example 7 to Sec. 40.391. The Department issues a PIE with 
respect to Service Agent Z. Z provides services for DOT-regulated 
transportation employers, a Federal agency under the HHS-regulated 
Federal employee testing program, and various private businesses and 
public agencies that DOT does not regulate. The PIE applies only to 
the DOT-regulated transportation employers with respect to their 
DOT-mandated testing, not to the Federal agency or the other public 
agencies and private businesses. The PIE does not prevent the non-
DOT regulated entities from continuing to use Z's services.

Sec. 40.393  How long does a PIE stay in effect?

    (a) In the NOPE (see Sec. 40.375(b)(5)), the initiating official 
proposes the duration of the PIE. The duration of the PIE is one of the 
elements of the proceeding that the service agent may contest (see 
Sec. 40.381(b)) and about which the Director makes a decision (see 
Sec. 40.387(b)(4)).
    (b) In deciding upon the duration of the PIE, the Director 
considers the seriousness of the conduct on which the PIE is based and 
the continued need to protect employers and employees from the service 
agent's noncompliance. The Director considers factors such as those 
listed in Sec. 40.389 in making this decision.
    (c) The duration of a PIE will be between one and five years, 
unless the Director reduces its duration under Sec. 40.407.


Sec. 40.395  Can you settle a PIE proceeding?

    At any time before the Director's decision, you and the initiating 
official can, with the Director's concurrence, settle a PIE proceeding.


Sec. 40.397  When does the Director make a PIE decision?

    The Director makes his or her decision within 60 days of the date 
when the record of a PIE proceeding is complete (including any meeting 
with the Director and any additional fact-finding that is necessary). 
The Director may extend this period for good cause for additional 
periods of up to 30 days.


Sec. 40.399  How does the Department notify service agents of its 
decision?

    If you are a service agent involved in a PIE proceeding, the 
Director provides you written notice as soon as he or she makes a PIE 
decision. The notice includes the following elements:
    (a) If the decision is not to issue a PIE, a statement of the 
reasons for the decision, including findings of fact with respect to 
any material factual issues that were in dispute.
    (b) If the decision is to issue a PIE--
    (1) A reference to the NOPE;
    (2) A statement of the reasons for the decision, including findings 
of fact with respect to any material factual issues that were in 
dispute;
    (3) A statement of the scope of the PIE; and
    (4) A statement of the duration of the PIE.


Sec. 40.401  How does the Department notify employers and the public 
about a PIE?

    (a) The Department maintains a document called the ``List of 
Excluded Drug and Alcohol Service Agents.'' This document may be found 
on the Department's web site (http://www.dot.gov/ost/dapc). You may 
also request a copy of the document from ODAPC.
    (b) When the Director issues a PIE, he or she adds to the List the 
name and address of the service agent, and any other persons or 
organizations, to whom the PIE applies and information about the scope 
and duration of the PIE.
    (c) When a service agent ceases to be subject to a PIE, the 
Director removes this information from the List.
    (d) The Department also publishes a Federal Register notice to 
inform the public on any occasion on which a service agent is added to 
or taken off the List.


Sec. 40.403  Must a service agent notify its clients when the 
Department issues a PIE?

    (a) As a service agent, if the Department issues a PIE concerning 
you, you must notify each of your DOT-regulated employer clients, in 
writing, about the issuance, scope, duration, and effect of the PIE. 
You may meet this requirement by sending a copy of the Director's PIE 
decision or by a separate notice. You must send this notice to each 
client within three working days of receiving from the Department the 
notice provided for in Sec. 40.399(b).
    (b) As part of the notice you send under paragraph (a) of this 
section, you must offer to transfer immediately all records pertaining 
to the employer and its employees to the employer or to any other 
service agent the employer designates. You must carry out this transfer 
as soon as the employer requests it.


Sec. 40.405  May the Federal courts review PIE decisions?

    The Director's decision is a final administrative action of the 
Department. Like all final administrative actions of Federal agencies, 
the Director's decision is subject to judicial review under the 
Administrative Procedure Act (5 U.S.C. 551 et. seq).


Sec. 40.407  May a service agent ask to have a PIE reduced or 
terminated?

    (a) Yes, as a service agent concerning whom the Department has 
issued a PIE, you may request that the Director terminate a PIE or 
reduce its duration and/or scope. This process is limited to the issues 
of duration and scope. It is not an appeal or reconsideration of the 
decision to issue the PIE.
    (b) Your request must be in writing and supported with 
documentation.
    (c) You must wait at least nine months from the date on which the 
Director issued the PIE to make this request.

[[Page 79573]]

    (d) The initiating official who was the proponent of the PIE may 
provide information and arguments concerning your request to the 
Director.
    (e) If the Director verifies that the sources of your noncompliance 
have been eliminated and that all drug or alcohol testing-related 
services you would provide to DOT-regulated employers will be 
consistent with the requirements of this part, the Director may issue a 
notice terminating or reducing the PIE.


Sec. 40.409  What does the issuance of a PIE mean to transportation 
employers?

    (a) As an employer, you are deemed to have notice of the issuance 
of a PIE when it appears on the List mentioned in Sec. 40.401(a) or the 
notice of the PIE appears in the Federal Register as provided in 
Sec. 40.401(d). You should check this List to ensure that any service 
agents you are using or planning to use are not subject to a PIE.
    (b) As an employer who is using a service agent concerning whom a 
PIE is issued, you must stop using the services of the service agent no 
later than 90 days after the Department has published the decision in 
the Federal Register or posted it on its web site. You may apply to the 
ODAPC Director for an extension of 30 days if you demonstrate that you 
cannot find a substitute service agent within 90 days.
    (c) Except during the period provided in paragraph (b) of this 
section, you must not, as an employer, use the services of a service 
agent that are covered by a PIE that the Director has issued under this 
subpart. If you do so, you are in violation of the Department's 
regulations and subject to applicable DOT agency sanctions (e.g., civil 
penalties, withholding of Federal financial assistance).
    (d) You also must not obtain drug or alcohol testing services 
through a contractor or affiliate of the service agent to whom the PIE 
applies.

    Example to Paragraph (d): Service Agent R was subject to a PIE 
with respect to SAP services. As an employer, not only must you not 
use R's own SAP services, but you also must not use SAP services you 
arrange through R, such as services provided by a subcontractor or 
affiliate of R or a person or organization that receives financial 
gain from its relationship with R.

    (e) This section's prohibition on using the services of a service 
agent concerning which the Director has issued a PIE applies to 
employers in all industries subject to DOT drug and alcohol testing 
regulations.

    Example to Paragraph (e): The initiating official for a PIE was 
the FAA drug and alcohol program manager, and the conduct forming 
the basis of the PIE pertained to the aviation industry. As a motor 
carrier, transit authority, pipeline, railroad, or maritime 
employer, you are also prohibited from using the services of the 
service agent involved in connection with the DOT drug and alcohol 
testing program.

    (f) The issuance of a PIE does not result in the cancellation of 
drug or alcohol tests conducted using the service agent involved before 
the issuance of the Director's decision or up to 90 days following its 
publication in the Federal Register or posting on the Department's web 
site, unless otherwise specified in the Director's PIE decision or the 
Director grants an extension as provided in paragraph (b) of this 
section.

    Example to Paragraph (f): The Department issues a PIE concerning 
Service Agent N on September 1. All tests conducted using N's 
services before September 1, and through November 30, are valid for 
all purposes under DOT drug and alcohol testing regulations, 
assuming they meet all other regulatory requirements.

Sec. 40.411  What is the role of the DOT Inspector General's office?

    (a) Any person may bring concerns about waste, fraud, or abuse on 
the part of a service agent to the attention of the DOT Office of 
Inspector General.
    (b) In appropriate cases, the Office of Inspector General may 
pursue criminal or civil remedies against a service agent.
    (c) The Office of Inspector General may provide factual information 
to other DOT officials for use in a PIE proceeding.


Sec. 40.413  How are notices sent to service agents?

    (a) If you are a service agent, DOT sends notices to you, including 
correction notices, notices of proposed exclusion, decision notices, 
and other notices, in any of the ways mentioned in paragraph (b) or (c) 
of this section.
    (b) DOT may send a notice to you, your identified counsel, your 
agent for service of process, or any of your partners, officers, 
directors, owners, or joint venturers to the last known street address, 
fax number, or e-mail address. DOT deems the notice to have been 
received by you if sent to any of these persons.
    (c) DOT considers notices to be received by you--
    (1) When delivered, if DOT mails the notice to the last known 
street address, or five days after we send it if the letter is 
undeliverable;
    (2) When sent, if DOT sends the notice by fax or five days after we 
send it if the fax is undeliverable; or
    (3) When delivered, if DOT sends the notice by e-mail or five days 
after DOT sends it if the e-mail is undeliverable.

Appendix A to Part 40--DOT Standards for Urine Collection Kits

The Collection Kit Contents

    1. Collection Container
    a. Single-use container, made of plastic, large enough to easily 
catch and hold at least 55 mL of urine voided from the body.
    b. Must have graduated volume markings clearly noting levels of 
45 mL and above.
    c. Must have a temperature strip providing graduated temperature 
readings 32-38  deg.C/90-100  deg.F, that is affixed or can be 
affixed at a proper level on the outside of the collection 
container. Other methodologies (e.g., temperature device built into 
the wall of the container) are acceptable provided the temperature 
measurement is accurate and such that there is no potential for 
contamination of the specimen.
    d. Must be individually wrapped in a sealed plastic bag or 
shrink wrapping; or must have a peelable, sealed lid or other easily 
visible tamper-evident system.
    e. May be made available separately at collection sites to 
address shy bladder situations when several voids may be required to 
complete the testing process.
    2. Plastic Specimen Bottles
    a. Each bottle must be large enough to hold at least 35 mL; or 
alternatively, they may be two distinct sizes of specimen bottles 
provided that the bottle designed to hold the primary specimen holds 
at least 35 mL of urine and the bottle designed to hold the split 
specimen holds at least 20 mL.
    b. Must have screw-on or snap-on caps that prevent seepage of 
the urine from the bottles during shipment.
    c. Must have markings clearly indicating the appropriate levels 
(30 mL for the primary specimen and 15 mL for the split) of urine 
that must be poured into the bottles.
    d. Must be designed so that the required tamper-evident bottle 
seals made available on the CCF fit with no damage to the seal when 
the employee initials it nor with the chance that the seal overlap 
would conceal printed information.
    e. Must be wrapped (with caps) together in a sealed plastic bag 
or shrink wrapping separate from the collection container; or must 
be wrapped (with cap) individually in sealed plastic bags or shrink 
wrapping; or must have peelable, sealed lid or other easily visible 
tamper-evident system.
    f. Plastic material must be leach resistant.
    3. Leak-Resistant Plastic Bag
    a. Must have two sealable compartments or pouches which are 
leak-resistant; one large enough to hold two specimen bottles and 
the other large enough to hold the CCF paperwork.
    b. The sealing methodology must be such that once the 
compartments are sealed, any tampering or attempts to open either 
compartment will be evident.
    4. Absorbent material
    Each kit must contain enough absorbent material to absorb the 
entire contents of both specimen bottles. Absorbent material must be 
designed to fit inside the leak-resistant

[[Page 79574]]

plastic bag pouch into which the specimen bottles are placed.
    5. Shipping Container
    a. Must be designed to adequately protect the specimen bottles 
from shipment damage in the transport of specimens from the 
collection site to the laboratory (e.g., standard courier box, small 
cardboard box, plastic container).
    b. May be made available separately at collection sites rather 
than being part of an actual kit sent to collection sites.
    c. A shipping container is not necessary if a laboratory courier 
hand-delivers the specimen bottles in the plastic leak-proof bags 
from the collection site to the laboratory.

Appendix B to Part 40--DOT Drug Testing Semi-Annual Laboratory Report

    The following items are required on each report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include billing code or ID code)
C/C/TPA Identification: (where applicable; name and address)
1. Number of specimen results reported: (total number)
    By test type:

    (a) Pre-employment testing: (number)
    (b) Post-accident testing: (number)
    (c) Random testing: (number)
    (d) Reasonable suspicion/cause testing: (number)
    (e) Return-to-duty testing: (number)
    (f) Follow-up testing: (number)
    (g) Type not noted on CCF: (number)
2. Number of specimens reported as
    (a) Negative: (total number)
    (b) Negative-dilute: (number)
3. Number of specimens reported as Rejected for Testing: (total 
number)
By reason:
    (a) Fatal flaw: (number)
    (b) Uncorrected flaw: (number)
4. Number of specimens reported as Positive: (total number)
    By drug:
    (a) Marijuana Metabolite: (number)
    (b) Cocaine Metabolite: (number)
    (c) Opiates:
    (1) Codeine: (number)
    (2) Morphine: (number)
    (3) 6-AM: (number)
    (d) Phencyclidine: (number)
    (e) Amphetamines: (number)
    (1) Amphetamine: (number)
    (2) Methamphetamine: (number):
5. Adulterated: (number)
6. Substituted: (number)
7. Invalid results: (number)

Appendix C to Part 40--[Reserved]

Appendix D to Part 40--Report Format: Split Specimen Failure to 
Reconfirm

    Fax or mail to: Department of Transportation, Office of Drug and 
Alcohol Policy and Compliance, 400 7th Street, SW., Room 10403, 
Washington, DC 20590 (fax) 202-366-3897.
    1. MRO name, address, phone number, and fax number.
    2. Collection site name, address, and phone number.
    3. Date of collection.
    4. Specimen I.D. number.
    5. Laboratory accession number.
    6. Primary specimen laboratory name, address, and phone number.
    7. Date result reported or certified by primary laboratory.
    8. Split specimen laboratory name, address, and phone number.
    9. Date split specimen result reported or certified by split 
specimen laboratory.
    10. Primary specimen results (e.g., name of drug, adulterant) in 
the primary specimen.
    11. Reason for split specimen failure-to-reconfirm result (e.g., 
drug or adulterant not present, specimen invalid, split not 
collected, insufficient volume).
    12. Actions taken by the MRO (e.g., notified employer of failure 
to reconfirm and requirement for recollection).
    13. Additional information explaining the reason for 
cancellation.
    14. Name of individual submitting the report (if not the MRO).

Appendix E to Part 40--SAP Equivalency Requirements for Certification 
Organizations

    1. Experience: Minimum requirements are for three years of full-
time supervised experience or 6,000 hours of supervised experience 
as an alcoholism and/or drug abuse counselor. The supervision must 
be provided by a licensed or certified practitioner. Supervised 
experience is important if the individual is to be considered a 
professional in the field of alcohol and drug abuse evaluation and 
counseling.
    2. Education: There exists a requirement of 270 contact hours of 
education and training in alcoholism and/or drug abuse or related 
training. These hours can take the form of formal education, in-
service training, and professional development courses. Part of any 
professional counselor's development is participation in formal and 
non-formal education opportunities within the field.
    3. Continuing Education: The certified counselor must receive at 
least 40-60 hours of continuing education units (CEU) during each 
two year period. These CEUs are important to the counselor's keeping 
abreast of changes and improvements in the field.
    4. Testing: A passing score on a national test is a requirement. 
The test must accurately measure the application of the knowledge, 
skills, and abilities possessed by the counselor. The test 
establishes a national standard that must be met to practice.
    5. Testing Validity: The certification examination must be 
reviewed by an independent authority for validity (examination 
reliability and relationship to the knowledge, skills, and abilities 
required by the counseling field). The reliability of the exam is 
paramount if counselor attributes are to be accurately measured. The 
examination passing score point must be placed at an appropriate 
minimal level score as gauged by statistically reliable methodology.
    6. Measurable Knowledge Base: The certification process must be 
based upon measurable knowledge possessed by the applicant and 
verified through collateral data and testing. That level of 
knowledge must be of sufficient quantity to ensure a high quality of 
SAP evaluation and referral services.
    7. Measurable Skills Base: The certification process must be 
based upon measurable skills possessed by the applicant and verified 
through collateral data and testing. That level of skills must be of 
sufficient quality to ensure a high quality of SAP evaluation and 
referral services.
    8. Quality Assurance Plan: The certification agency must ensure 
that a means exists to determine that applicant records are verified 
as being true by the certification staff. This is an important check 
to ensure that true information is being accepted by the certifying 
agency.
    9. Code of Ethics: Certified counselors must pledge to adhere to 
an ethical standard for practice. It must be understood that code 
violations could result in de-certification. These standards are 
vital in maintaining the integrity of practitioners. High ethical 
standards are required to ensure quality of client care and 
confidentiality of client information as well as to guard against 
inappropriate referral practices.
    10. Re-certification Program: Certification is not just a one-
time event. It is a continuing privilege with continuing 
requirements. Among these are continuing education, continuing state 
certification, and concomitant adherence to the code of ethics. Re-
certification serves as a protector of client interests by removing 
poor performers from the certified practice.
    11. Fifty State Coverage: Certification must be available to 
qualified counselors in all 50 states and, therefore, the test must 
be available to qualified applicants in all 50 states. Because many 
companies are multi-state operators, consistency in SAP evaluation 
quality and opportunities is paramount. The test need not be given 
in all 50 states but should be accessible to candidates from all 
states.
    12. National Commission for Certifying Agencies (NCCA) 
Accreditation: Having NCCA accreditation is a means of demonstrating 
to the Department of Transportation that your certification has been 
reviewed by a panel of impartial experts that have determined that 
your examination(s) has met stringent and appropriate testing 
standards.

Appendix F to Part 40--Drug and Alcohol Testing Information that C/TPAs 
May Transmit to Employers

    1. If you are a C/TPA, you may, acting as an intermediary, 
transmit the information in the following sections of this part to 
the DER for an employer, if the employer chooses to have you do so. 
These are the only items that you are permitted to transmit to the 
employer as an intermediary. The use of C/TPA intermediaries is 
prohibited in all other cases, such as transmission of laboratory 
drug test results to MROs, the transmission of medical information 
from MROs to employers, the transmission of SAP reports to 
employers, the transmission of positive alcohol test results, and 
the transmission of medical information from MROs to employers.
    2. In every case, you must ensure that, in transmitting the 
information, you meet all

[[Page 79575]]

requirements (e.g., concerning confidentiality and timing) that 
would apply if the party originating the information (e.g., an MRO 
or collector) sent the information directly to the employer. For 
example, if you transmit MROs' drug testing results to DERs, you 
must transmit each drug test result to the DER in compliance with 
the requirements for MROs set forth in Sec. 40.167.

Drug Testing Information

Sec. 40.25: Previous two years' test results
Sec. 40.35: Notice to collectors of contact information for DER
Sec. 40.61(a): Notification to DER that an employee is a ``no show'' 
for a drug test
Sec. 40.63(e): Notification to DER of a collection under direct 
observation
Sec. 40.65(b)(6) and (7) and (c)(2) and (3): Notification to DER of 
a refusal to provide a specimen or an insufficient specimen
Sec. 40.73(a)(9): Transmission of CCF copies to DER (However, MRO 
copy of CCF must be sent by collector directly to the MRO, not 
through the C/TPA.)
Sec. 40.111(a): Transmission of laboratory statistical report to 
employer
Sec. 40.129 (d): Report of test results to DER
Sec. 40.129(f)(1): Report to DER of confirmed positive test in 
stand-down situation
Sec. 40.149(b): Report to DER of changed test result
Sec. 40.155(a): Report to DER of dilute specimen
Secs. 40.159(a)(4)(ii); 40.161(b): Reports to DER that test is 
cancelled
Sec. 40.167(b) and (c): Reports of test results to DER
Sec. 40.187(a), (b)(1), (c)(1), (d)(1) and (2): Reports to DER 
concerning the reconfirmation of tests
Sec. 40.191(d): Notice to DER concerning refusals to test
Sec. 40.193(b)(3): Notification to DER of refusal in shy bladder 
situation
Sec. 40.193(b)(4): Notification to DER of insufficient specimen
Sec. 40.193(b)(5): Transmission of CCF copies to DER (not to MRO)
Sec. 40.199: Report to DER of cancelled test and direction to DER 
for additional collection
Sec. 40.201: Report to DER of cancelled test

Alcohol Testing Information

Sec. 40.215: Notice to BATs and STTs of contact information for DER
Sec. 40.241(b)(1): Notification to DER that an employee is a ``no 
show'' for an alcohol test
Sec. 40.247(a)(2): Transmission of alcohol screening test results 
only when the test result is less than 0.02
Sec. 40.255(a)(4): Transmission of alcohol confirmation test results 
only when the test result is less than 0.02
Sec. 40.263(a)(3) and 263(b)(3): Notification of insufficient saliva 
and failure to provide sufficient amount of breath

Appendix G to Part 40--Alcohol Testing Form

    The following form is the alcohol testing form required for use 
in the DOT alcohol testing program beginning August 1, 2001. Use of 
the form is authorized beginning January 18, 2001.

BILLING CODE 4910-62-P

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[FR Doc. 00-31251 Filed 12-14-00; 2:49 pm]
BILLING CODE 4910-62-C


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