[Federal Register: December 19, 2000 (Volume 65, Number 244)]
[Rules and Regulations]
[Page 79511-79560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de00-14]
[[pp. 79511-79560]] Procedures for Transportation Workplace Drug and Alcohol Testing
Programs
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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
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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
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
jim.swart@ost.dot.gov (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