[Federal Register: December 19, 2000 (Volume 65, Number 244)]
[Rules and Regulations]
[Page 79461-79510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de00-13]
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Part II
Department of Transportation
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Office of the Secretary
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49 CFR Part 40
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs; Final Rule
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DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[Docket OST-99-6578]
RIN 2105-AC49
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs
AGENCY: Office of the Secretary, DOT.
ACTION: Final rule.
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SUMMARY: The Department of Transportation is revising its drug and
alcohol testing procedures regulation. The purposes of the revision are
to make the organization and language of the regulation clearer, to
incorporate guidance and interpretations of the rule into its text, and
to update the rule to include new provisions responding to changes in
technology, the testing industry, and the Department's program.
EFFECTIVE DATES: The amendments to the current 49 CFR part 40 are
effective January 18, 2001. The revised 49 CFR Part 40 is effective
August 1, 2001.
FOR FURTHER INFORMATION CONTACT: Robert C. Ashby, Deputy Assistant
General Counsel for Regulation and Enforcement, 400 7th Street, SW.,
Room 10424, Washington DC, 20590, 202-366-9310 (voice), 202-366-9313
(fax), or bob.ashby@ost.dot.gov (e-mail); Mary Bernstein, Director,
Office of Drug and Alcohol Policy and Compliance (ODAPC), 400 7th
Street, SW., Room 10403, Washington DC, 20590, 202-366-3784 (voice),
202-366-3897 (fax), or mary.bernstein@ost.dot.gov (e-mail); or Jim L.
Swart, Drug and Alcohol Policy Advisor, ODAPC , same address and phone
numbers as above, jim.swart@ost.dot.gov (e-mail).
SUPPLEMENTARY INFORMATION:
Background
The Department of Transportation first published its drug testing
procedures regulation (49 CFR part 40) on November 21, 1988 (53 FR
47002), as an interim final rule. We based the rule on the Department
of Health and Human Services (HHS) guidelines for Federal agency
employee drug testing, with some changes to fit the transportation
workplace. The Department published a final rule responding to comments
on the interim rule a year later (54 FR 49854; December 1, 1989).
The Department added alcohol testing procedures to Part 40 in a
February 1994 final rule. This rule also made other changes to Part 40,
including requirements for split samples in four operating
administration rules. Since that time, the Department has amended
specific provisions of Part 40 on various occasions (e.g., with respect
to non-evidential alcohol screening devices and ``shy bladder''
procedures).
In the years since Part 40 was first published, the Department
issued a large volume of guidance and over 100 written interpretations,
as well as a significant amount of informal advice. Most of this
material has not previously been incorporated into the rule text. There
have been changes in testing technology, the structure of the drug and
alcohol testing business, and the functioning of the Department's drug
and alcohol testing programs that make it desirable to update our
regulatory provisions. Because the rule was originally based on that of
another agency (i.e., HHS), there are some provisions that never were a
close fit for the Department's programs. Moreover, the rule's
organization and language do not meet the objectives of the Clinton
Administration's current ``Plain Language'' policies. Under section 610
of the Regulatory Flexibility Act, agencies are directed to review
existing rules from time to time with an eye to their effects on small
businesses and other small entities.
For all these reasons, the Department decided to review Part 40. As
a first step, we issued an advance notice of proposed rulemaking
(ANPRM) on April 29, 1996 (61 FR 18713), asking for suggestions for
change in the rule. We received 30 comments in response to this ANPRM.
We then issued a notice of proposed rulemaking (NPRM) on December 9,
1999 (64 FR 69076). This NPRM proposed a comprehensive revision to Part
40. In response to the NPRM, we received letters from over 400
commenters, making around 4000 individual suggestions concerning the
rule. We also held three public listening sessions, at which numerous
interested parties commented further on the Department's proposals, and
we held an internet forum. The final rule responds to all the comments
and makes significant alterations to the existing rules governing the
Department's drug and alcohol testing programs.
Structure of the Rule
Perhaps the first thing readers will notice about this final rule
is that we have thoroughly restructured Part 40, with subparts
organized by subject matter area. Like the NPRM, and in contrast to the
existing rule, the text is divided into many more sections, with fewer
paragraphs each on average, to make it easier to find regulatory
provisions. The rule uses a question-answer format, with language
specifically directing particular parties to take particular actions
(e.g., ``As an employer, you must * * *''). We have also tried to
express the requirements of the rule in plain language. Commenters were
very complimentary about the reorganization of the rule, generally
praising it as much clearer and easier to follow than the existing
rule. The Department received a plain language award, known as the ``No
Gobbledygook Award,'' from Vice President Gore's National Partnership
for Reinventing Government in recognition of the improved clarity of
the regulation. We have retained the NPRM's format and organization,
which we believe will help drug and alcohol testing program
participants understand and effectively carry out this rule.
What matters most in a rulemaking is not the number of letters
favoring or opposing a particular proposal. Our central concern is with
the substance of the comments. In discussing comments on this rule and
our response to them, we will focus on the substance of positions that
commenters expressed, and on why we did or did not make changes in
response to various comments. In writing the preamble, we have avoided
counting up the number of comments supporting a given position except
in the most general way, believing that doing so would distract from
the discussion of substantive issues.
Effective Dates
The Department has decided to establish an August 1, 2001,
effective date for the revised Part 40. We recognize that there is
always some difficulty for everyone involved in the transition between
an existing rule and a new rule. We hope that this delayed effective
date will ease the transition. During the period between publication
and August 1, program participants will have the opportunity to learn
about new provisions before having to implement them. During this
period, the Department expects to develop and issue guidance (e.g., a
revised medical review officer (MRO) manual) and make presentations at
a significant number of conferences and training sessions. In addition,
August 1 is the date on which use of the new Federal Drug Testing
Custody and Control Form (CCF), to which the text of the revised Part
40 refers, becomes mandatory.
However, we believe it is important to begin implementing some new
provisions sooner, since they enhance the fairness and integrity of the
process. To do so, we must amend the existing
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Part 40 to include these provisions, so that they are in effect during
the period before the August 1 effective date of the entire new version
of the regulation. Come August 1, the existing Part 40 (including the
amendments we are issuing today) will be replaced, in its entirety, by
the new Part 40. Since the substance of today's amendments will be the
same in both versions of the document, there will be no change in how
we implement them after August 1.
The provisions requiring MRO review and split specimen testing
following adulteration and substitution findings will go into effect in
30 days. The majority of laboratories already perform validity testing
on a voluntary basis. Making the MRO review and split specimen
procedures effective in 30 days will make these additional protections
available in connection with this existing validity testing. At the
same time, a provision explicitly authorizing the continuation of this
existing practice under the new rule will go into effect. To the extent
that the Department's September 1998 guidance memorandum concerning
adulterated, substituted, dilute, and unsuitable tests is inconsistent
with any provisions of these amendments, we regard that guidance as
having been superseded on the effective date of the amendments.
HHS is currently working mandatory requirements for validity
testing. HHS is projecting completion of this project by August 1,
2001. We believe that, to avoid any potential uncertainty about the
standards and procedures for mandatory validity testing, DOT should put
its mandate for validity testing into effect simultaneously with the
new HHS requirements. Consequently, in the event HHS has not issued its
new requirements by that date, we will publish a subsequent Federal
Register notice postponing the Auust 1, 2001, effective date for
mandatory validity testing.
Another provision that we are including in the amendments to the
existing Part 40, and that will go into effect in 30 days, is the
public interest exclusion system. These provisions are very important
to ensuring accountability in the provision of drug and alcohol
testing. In addition, we are making the provisions of Sec. 40.5
effective in 30 days as Sec. 40.203, since the Department expects to be
issuing guidance materials on the new Part 40 before August 1, 2001.
For readers' convenience, here is a table of the relationship
between the section numbers in the amendments to current Part 40 that
go into effect in 30 days and the section numbers of the corresponding
sections of the new, revised Part 40 that goes into effect on August 1,
2001:
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Amended current part 40 New revised part 40
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40.201.................................... 40.3
40.203.................................... 40.5
40.205.................................... 40.89
40.206.................................... 40.91
40.209.................................... 40.93
40.211.................................... 40.95
40.213.................................... 40.99
40.215.................................... 40.145
40.217.................................... 40.179
40.219.................................... 40.181
40.221.................................... 40.183
40.223.................................... 40.187
40.225.................................... 40.191
Subpart F (same section numbers).......... Subpart R
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Principal Policy Issues
In addition to often very detailed paragraph-by-paragraph comments
on the text of the NPRM, commenters focused on several major policy
issues. These included employee stand-down, validity testing, the
public interest exclusion mechanism, the return-to-duty process,
transmission of test results and other information through consortia
and third-party administrators, reporting and storing information
through electronic means, and reporting violations to DOT agencies.
Issues also arose concerning confidentiality of information, conflicts
of interest among service providers, training, and the collection
process. In this preamble, we will discuss these policy issues first.
After that, we will proceed to a section-by-section discussion of the
rule, including the Department's responses to specific comments.
Stand-Down
Stand-down refers to an employer practice of temporarily removing
an employee from performance of safety-sensitive duties upon learning
that the individual had a confirmed laboratory positive drug test, but
before the MRO has completed the verification process. The existing
regulation prohibits stand-down. MROs are not permitted to inform
employers about the existence of a confirmed laboratory positive test
pending verification, and employers are not allowed to take any action
concerning an employee until they receive the MRO's notification of a
verified positive test.
The preamble to the NPRM noted the reasons for the current policy:
stand-down undercuts the rationale for MRO review, can compromise the
confidentiality of test results, and may result in unfair
stigmatization of an employee as a drug user. While the rationale for
stand-down is that it enhances safety, the Department has no evidence
that the current policy has compromised safety. For example, we are not
aware of any case in which an employee has had a drug-related accident
while verification of a confirmed positive drug test was pending.
The preamble also noted that some employers advocated the use of
stand-down as a measure to enhance safety and reduce liability. They
wanted to use this approach to eliminate, as far as possible, any risk
that someone who had tested positive would be involved in an accident
before the MRO could complete the verification process. We noted that,
essentially for this reason, the Department's own internal drug testing
program stood down some employees (e.g., air traffic controllers) in
some circumstances following a report of a confirmed positive
laboratory test.
The NPRM regulatory text proposed two alternatives, one of which
prohibited, and the other of which permitted, stand-down. The
alternative that permitted stand-down included requirements to help
safeguard employees' interests in confidentiality and fairness.
Comments
Comments were sharply, and fairly evenly, divided on this issue.
Some commenters, mostly employers and some service agents, supported
stand-down. A few of these comments went further and urged that stand-
down be made mandatory, while a greater number said that it should be
discretionary with each employer. A smaller number of commenters,
including all unions and other employee organizations as well as some
employers and service agents, opposed permitting stand-down.
The most important argument cited by stand-down supporters was
safety. Safety is a more important objective than confidentiality, many
of them said. Even if there have not been documented cases of safety
problems occurring in the absence of stand-down, no employer wants to
be the first to face such a situation. Many employers may feel it so
important to stand down employees on safety grounds that they would
have an incentive to violate this prohibition. Avoiding unnecessary
liability is also a consideration: It would be unwise, commenters said,
to force a company to permit an employee it knew had a confirmed
positive laboratory test to continue driving a commercial truck or
flying a plane during the verification process.
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Supporters also noted that, in most cases, there were very low
rates of confirmed laboratory positive tests being verified negative
(indeed, some drugs, like PCP, have no legitimate medical uses that
would support a negative verification). Therefore, they said, stand-
down would not adversely affect more than the small number of drivers
with confirmed positive laboratory results that an MRO later verified
negative. Other commenters said that adverse consequences for employees
could be minimized by employers choosing to keep employees in non-
safety-sensitive positions until verification or ensuring that
employees whose tests were ultimately verified negative did not suffer
any loss of pay or other adverse consequences.
Opponents of stand-down said that the practice embodied a ``guilty
until proved innocent'' approach that was manifestly unfair and ignored
the purpose of having MRO review of positive tests. Confidentiality
provisions would likely be inadequate. In practice, the ``word'' would
get out that the employee had a confirmed laboratory test result and
the employee--even if the MRO ultimately verified the test as
negative--would be stigmatized in the workplace as a drug user. This
would upset the regulatory balance between safety interests and the
protection of employees from unfair consequences of the process. One
motor carrier association said that this would be a particular problem
in its industry. In large carriers, an employee cannot be taken out of
service without involvement by multiple management employees. For
unionized carriers in which assignments are made by seniority, it would
be impossible to take a driver out of service without other drivers
knowing it.
Some commenters contested the safety rationale of stand-down by
pointing out that a positive drug test does not indicate impairment.
Other commenters said that the risk to the public from the current ``no
stand-down'' policy was minimal, given that there were no known
instances of accidents resulting from the absence of stand-down.
Opponents also cited pay, privacy, and personnel consequences, as well
as potential Americans with Disabilities Act and other issues
potentially comploicating implementation of stand-down.
An associated issue concerns pay status. If a company stands down
an employee, should the company be required to pay the employee during
this period, pending verification? Several commenters directly
addressed this issue. About half of them, including a union and some
employers and their associations, favored paying employees while they
were in a stand-down status. The remainder said either that the
regulation should be silent on the issue, with labor-management
negotiations deciding the matter in each case, or that employees should
not be paid while in stand-down status.
While a number of comments addressed confidentiality and privacy
issues, they provided little detail in the way of suggestions for how
best to accomplish these objectives in a stand-down situation.
Likewise, while a few commenters noted that confidentiality might be a
more difficult issue in small companies, they did not provide any
suggestions for how to address the issue. There was a suggestion that,
to deal with the situation of owner-operators in the motor carrier
industry, service agents be empowered to stand down these individuals.
DOT Response
At the time of the NPRM, the Department recognized enough merit on
both sides of this argument to propose alternative provisions. Having
reviewed the comments, we remain convinced that advocates of both basic
positions on the issue make some strong points. The Department is also
aware that potential future changes in drug testing technology, such as
the advent of HHS-approved on-site testing and alternative testing
methods, may alter the response the Department's procedures take
concerning stand-down in the future. Consequently, the Department is
taking a middle-ground position on this difficult issue.
The general rule will remain that stand-down is prohibited. The
reasons for this general rule are the reasons articulated in the
existing rule, the NPRM, and the comments from stand-down opponents.
However, we believe it is necessary to respond to the genuine and
plausible safety concerns of commenters favoring stand-down, the fact
that safety is the Department's highest priority, and the fact that the
Department's internal program uses a form of stand-down. Therefore, the
Department will establish a waiver mechanism that permits employers, on
a case-by-case basis, to request DOT agency approval for a specific,
well-founded stand-down plan that effectively protect the interests of
employees.
This approach makes the Department's approach to its internal and
external programs consistent with one another. When the Department, in
its role as an employer, wanted to use a stand-down approach, it sought
and received a waiver from HHS, whose drug testing guidelines also
generally prohibit stand-down. Under the final rule, employers in the
external program who wish to employ stand-down can, in an analogous
way, seek a waiver from the Department of Transportation.
We realize that some employers have employees that are regulated by
more than one DOT agency. To avoid unnecessary administrative burdens
in the waiver process, such an employer would have to submit only one
waiver request, to the DOT agency that regulated the largest number of
its employees. The various DOT agencies involved would coordinate
internally before the lead agency responded to the employer.
The Department intends to grant waivers only to employers who
present a sound factual basis for their request and will have in place
a number of provisions to protect employees' legitimate interests. The
final rule (Sec. 40.21) lists several types of information that the
employer would submit to the DOT agency in support of its request. This
information is intended to give the DOT agency a picture of the
employer's organization and safety situation. For example, the size or
structure of the organization may affect the ability of an employer to
carry out confidentiality requirements for the grant of a waiver. An
organization that has an in-house MRO may be in a better position to
control access to testing information than one that does not. An
organization that stands employees down for reasons other than
substance abuse testing may be in a better position to safeguard
confidentiality than one that does not. Organizations' drug and alcohol
testing history may be a relevant factor in determining whether stand-
down is useful in a particular company.
None of these kinds of information is intended to establish a
litmus test for granting a waiver. DOT agencies will make a case-by-
case decision about the merits of a stand-down petition with respect to
each company that applies for one. DOT agencies will respond to each
petition in writing, with reasons for the decision. DOT agencies are
intended to have wide discretion in making these judgments. For
example, two companies might present stand-down policies that are
nearly identical on paper. However, contextual factors in one company
may make its confidentiality assurances credible as a practical matter,
while in the other case may suggest that confidentiality could not
practically be maintained, despite the company's good faith efforts.
DOT agencies could make different decisions in the two cases. We also
point out that petitions for waivers
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will be considered on a company-by-company basis. DOT agencies will
not, for example, consider a petition from a trade association or C/TPA
on behalf of an industry or segment of an industry.
As a condition for receiving a waiver, the rule requires the
employer to submit its proposed written stand-down policy. These
requirements pertain to confidentiality and protection of legitimate
employee interests and are described in greater detail in the
discussion of Sec. 40.21 below. One of these requirements is that an
employer must continue to pay a worker who is in stand-down status, in
the same way it would have in the absence of stand-down. This is a
matter of fairness. To assume that the employee's test will be verified
positive is to fall into the trap of presuming the employee guilty
until proved innocent. In addition, continuing normal pay status for
the employee should not be a major burden for employers, given the
usually short interval before verification is completed. As a major
employer association commented, most employers would not object to
paying the employees for a reasonable amount of stand-down time if they
believe they will gain a substantial safety benefit. An employer who
articulated a safety rationale for stand-down but who objected to
paying employees in the brief interim would seem to be an employer
reluctant to expend resources commensurate with its expressed
commitment to safety.
These conditions are intentionally stringent. The Department wants
to ensure that only employers who are able to maintain a successful
balance between the potential safety benefits of stand-down and the
legitimate privacy interests of employees are permitted to operate a
stand-down policy. A DOT agency can impose additional conditions on a
waiver or, if necessary, revoke a waiver it once granted. A DOT agency
could also take enforcement action against an employer that violated
the terms of its waiver.
Some comments suggested that stand-down be permitted for confirmed
laboratory tests for some drugs (e.g., PCP) but not others (e.g.,
opiates), based primarily on the lower or higher probabilities of
verified negatives for these substances. The Department is not
including such a provision as a general matter, out of concern that
such a provision might lead to confusion.
Public Interest Exclusions (PIE)
The NPRM proposed that service agents--persons and organizations
that provide drug and alcohol testing services to employers, such as
laboratories, MROs, substance abuse professionals (SAPs), collectors,
breath alcohol technicians (BATs), screening test technicians (STTs),
consortia and third-party administrators (C/TPAs)--should be
accountable for serious noncompliance with Part 40. The NPRM proposed a
mechanism based on the Department's existing non-procurement suspension
and debarment rules (49 CFR part 29). This mechanism would permit the
Department, following a series of procedures designed to ensure
fairness, to impose a public interest exclusion (PIE). A PIE would
direct DOT-regulated employers not to use the service agent for a
period of time. The Department proposed to use this mechanism only in
cases of serious misconduct where the service agent has not implemented
prompt corrective action following notice by a DOT agency. The preamble
noted that this mechanism rested on the Department's existing authority
to establish requirements for the conduct of the drug and alcohol
testing process and to direct employers to use only products and
services that met these standards.
Comments
The PIE proposal generated a good deal of comment. Almost a hundred
written comments to the docket addressed the proposal, which was also
the subject of extended discussion at the Department's three listening
sessions, where the Department convened forums specifically on the
subject. A strong majority of employers and all unions addressing the
proposal favored it. Among service agents and their organizations, and
other commenters submitting written comments, about 60 percent opposed
the proposal, as written. Some service agent commenters urged
postponing consideration of the provision and addressing it in a
separate rulemaking.
Even the commenters who opposed the proposal said that they
believed service agents should be accountable for their conduct, at
least in principle. Their reasons for opposing the proposal included
doubting the need for such a mechanism and the Department's authority
to implement it, a belief that the proposed process was insufficiently
defined and did not provide enough procedural safeguards for service
agents, a concern that DOT auditors and inspectors might initiate PIE
proceedings arbitrarily, a preference for other alternatives (e.g.,
additional industry standards, certification, training programs,
litigation), or support for other options mentioned in the preamble to
the NPRM (e.g., certification or self-certification by all service
agents with a DOT decertification process).
Proponents of the proposal cited examples of misconduct by service
agents for which there was no present remedy. They said that employers,
especially small employers, often had to take on faith the quality of
service agents, and the PIE process could help them to know which
service agents to avoid. Employers also believed that it was unfair for
them to be solely accountable for serious problems in the testing
process. Service agents who supported the proposal said that it would
enhance the overall quality of performance by service agents. Some
service agents cut corners to reduce costs, putting more conscientious
service agents at a competitive disadvantage, these commenters said,
and then ``whined'' when the Department proposed a meaningful
accountability mechanism.
Commenters had a number of thoughts on specific aspects of the
proposal. Many asked for greater specificity concerning the kinds of
``offenses'' that would lead to a PIE proceeding. DOT staff pointed
out, during the listening sessions and in writing, that the PIE
mechanism was intended, both for policy and resource reasons, to be
used only in the case of ``egregious'' misconduct. However, commenters
pointed out that this statement was not made in the proposed regulatory
text. They feared that differences in interpretation among inspectors
and other DOT staff could lead to the inconsistent or arbitrary use of
PIE proceedings. Some of these commenters desired a specific list of
the actions that would lead to a PIE proceeding, while others suggested
the Department should at least provide examples.
Another frequently-made comment concerned the scope of PIEs. The
NPRM said that a PIE would apply to all divisions, organizational
elements, and types of services provided by a service agent, unless the
ODAPC Director decided to limit its scope. Affiliates and individual
officers and employees could also be subject to a PIE. A number of
service agents and employers objected to this aspect of the proposal,
saying it was too broad. It was unfair, they said, to prohibit
employers from using a service agent's other services because of a
problem in one area. If a TPA has violated the rule with respect to MRO
services, for example, why should a PIE prevent an employer from using
the TPA for collection or SAP services? Many commenters who made this
point favored an approach that came to be known, in the listening
sessions, as the
[[Page 79466]]
``slice of PIE.'' Under this approach, a PIE would apply only to the
type of service in which noncompliance had taken place. Some commenters
said the ``slice'' should be even narrower, applying only to the
specific employer, facility, or individual service agent staff members
who had been involved in the noncompliance. A few laboratories said
that laboratories should not be subject to the PIE process, since HHS
already regulates laboratories through its certification process.
Another commenter thought that it would be better to fine erring
service agents rather than issuing a PIE.
Commenters raised two issues concerning the role of the ODAPC
Director in the PIE process. A few service agents suggested that the
Director would not be an objective decisionmaker, because he or she
would be too sympathetic to the position of DOT staff. Others suggested
that the ``firewall'' between the Director and other staff be made more
explicit in the regulatory text. Several service agent commenters also
asked for criteria for determining the length of a PIE, as well as a
regulatory time frame for the Director's consideration of a service
agent's petition to lift a PIE.
Smaller numbers of commenters suggested other procedural changes in
the PIE provisions. One recommendation was that the initiating
official's burden of proof be ``clear and convincing evidence'' instead
of a preponderance of the evidence. Others asked for specific rules of
evidence to apply to PIE proceedings. Some asked that the Department
contact the service agent first, to check on alleged facts, before
initiating a proceeding. A number of employers asked for periods longer
than the proposed 90 days to replace a service agent that was subject
to a PIE, or for the possibility of extensions of that period. Some
service agents asked to delay the effective date of the PIE provision
by a year or two, to give organizations time to get used to the
requirements of the new final rule. A commenter asked that the rule
provide for a private right of action by employers against service
agents. Other commenters disagreed with the statement in the proposed
rule text that the purpose of a PIE was not punishment.
DOT Response
1. Basic Rationale for the PIE Provisions
Service agents perform the bulk of drug and alcohol testing
services for transportation employers. Employers, particularly small
employers, necessarily rely on service agents to comply with their
testing obligations. These employers often do not have the expertise in
testing matters that would enable them to evaluate independently the
quality, or even the regulatory compliance, of the work that service
agents perform for them. Yet an employer's compliance with DOT
regulations is largely dependent on its service agents' performance. If
a service agent makes a serious mistake that results in the employer
being out of compliance with a DOT rule, the employer alone is now
accountable. The employer may be subject to civil penalties from a DOT
agency. The employer can be subject to litigation resulting from
personnel action it took on the basis of the service agent's
noncomplying services. Most importantly, the employer's efforts to
ensure the safety of its operations may be damaged, as when an employee
who apparently uses drugs is returned to duty because of a service
agent's noncompliance. In many cases, there are now no consequences to
a service agent who creates such problems, even if the problems are
serious.
The experience of DOT agencies, which are responsible for reviewing
employers' compliance, is that the vast majority of employer
noncompliance results from service agent errors. (Given the pervasive
role of service agents in performing testing functions, this is
probably not a disproportionate effect.) FAA staff informally estimate,
for example, that more than nine out of ten deficiencies their
inspectors discover result from service agent errors. In addition, the
Department's drug and alcohol testing office staff, from time to time,
encounter serious noncompliance with DOT rules by service agents, for
which there is no present remedy. Here are a few examples of actual
cases we have encountered:
An MRO verified many tests positive without conducting
verification interviews. As a result, the tests had to be cancelled,
and the employer had to return the employees to duty, incurring extra
safety risks and costs.
Another MRO, who had counterfeit medical credentials,
verified several tests positive, bringing into question the integrity
of the verification process.
In defiance of the clear language of Part 40, a letter
from the Department, and a finding by a court, a laboratory refused to
provide an employee information to which she was entitled.
A service agent made false claims that its personnel were
certified by DOT. DOT wrote them a letter telling them to stop. Years
later, the same service agent's letterhead continues to make the same
claims.
A consortium and a laboratory were engaged in a billing
dispute with one another. As a result, numerous pre-employment results
were not transmitted to employers for a number of months. No one
informed the employers of the problem, and some of the employers, in
the apparent belief that ``no news is good news,'' placed some of the
workers--including one who tested positive--in safety-sensitive
positions.
A major employer used a service agent for SAP services.
The SAPs provided by the service agent established a long-standing
pattern of returning virtually all employees who have tested positive
to work quickly, without education or treatment.
Personnel of a major laboratory engaged in misconduct
apparently involving the backdating and attempted destruction of
documents relevant to litigation concerning a drug test result.
Attempting to deal with service agent problems one employer at a
time is both inefficient and potentially unfair. It is inefficient
because service agents work for many employers. It is potentially
unfair because employers may be unwitting victims of service agent
misconduct. Conducting civil penalty proceedings against several
employers because of the actions of one service agent, moreover, does
little if anything to correct the conduct of the service agent or
protect other employers from the consequences of its noncompliance. In
addition, service agents often work for employers in more than one
transportation industry. For example, if FRA takes action with respect
to a railroad whose noncompliance is caused by service agent errors,
this does nothing to protect a motor carrier who uses the same service
agent.
The Department believes that, in this situation, an accountability
mechanism that protects the public interest, employers, and employees
is appropriate and necessary. A few commenters appear to have
misunderstood the nature of the PIE proposal. It is not an assertion of
new regulatory authority over service agents. It makes use of the
Department's long-standing authority to direct transportation employers
not to use products and services that do not meet Federal standards.
Employers may not use laboratories that are not HHS-certified. They may
not use evidential breath testing devices (EBTs) that are not on the
National Highway Traffic Safety Administration (NHTSA) conforming
products list (CPL). They may not use SAPs and MROs who fail to meet
regulatory qualifications. There is no difference in legal principle
[[Page 79467]]
between these well-established prohibitions and a requirement not to
use a service agent who has been found to have seriously noncomplied
with Part 40. A PIE is simply one additional directive to
transportation employers to ensure that the employers use only service
providers that meet regulatory requirements.
Procedurally, the PIE process is modeled on a well-established
procedure for handling non-procurement suspensions and debarments.
While not identical to the non-procurement suspension and debarment
rules of the Department (49 CFR part 29), the PIE process draws on Part
29 for many of its details. Modeling PIE on an existing program that
affords due process to participants ensures that PIE will be an
effective and fair approach to serious noncompliance in the drug and
alcohol testing program.
2. Legal Authority
The Department looked carefully at the issue of legal authority
before proposing the PIE process in the NPRM. As noted in the preamble
to that document, there is ample legal authority to implement this
proposal. First, there is specific statutory authority for rulemaking
in this area. Section 322 of the DOT Act provides general rulemaking
authority to the Secretary of Transportation. It states that ``[t]he
Secretary of Transportation may prescribe regulations to carry out the
duties and powers of the Secretary.'' Further, the 1991 Omnibus Act
authorizes the Secretary of Transportation to continue in effect,
amend, or further supplement regulations governing the use of alcohol
or a controlled substance. See 49 U.S.C. 31306(i), 49 U.S.C. 20140(f),
49 U.S.C. 5331(f)(3), and 49 U.S.C. 45106(c). Upon review of the Act,
it is clear that Congress--while not explicitly mentioning a particular
mechanism to ensure compliance--intended the Secretary to use his or
her discretion to devise appropriate regulatory methods to carry out
the Department's drug and alcohol testing responsibilities.
Moreover, under well-settled case law, specific statutory authority
is not needed in order for an agency to have authority to impose a
reasonable requirement. There are many court decisions that support
this point, particularly cases following Chevron v. Natural Resources
Defense Council, 467 U.S. 837 (1984). Chevron stands for the
proposition that courts will defer to ``permissible'' agency
interpretations where the statute is ``silent or ambiguous''. In
Chevron, the leading case on the regulatory and interpretive authority
of agencies, the Supreme Court articulated the following standard:
When a court reviews an agency's construction of the statute it
administers, it is confronted with two questions. First, always, is
the question of whether Congress has directly spoken to the precise
question at issue. If the intent of Congress is clear, that is the
end of the matter; for the court, as well as the agency, must give
effect to the unambiguously expressed intent of Congress. If,
however, the court determines Congress has not directly addressed
the precise question at issue, the court does not simply impose its
own construction of the statute, as would be necessary in the
absence of an administrative interpretation. Rather, if the statute
is silent or ambiguous with respect to the specific issue, the
question for the court is whether the agency's answer is based on a
permissible construction of the statute. (Id. at 842-43).
Numerous cases have reaffirmed this standard. When courts have
applied the Chevron analysis to strike down an agency regulation or
interpretation, they have not done so on the basis that a statute did
not speak to the issue at hand. Rather, they did so because something
in the statute specifically precluded the action the agency had taken.
It is clear that nothing in the Department's statutes precludes the
Department from instituting a procedure like PIE.
To the contrary, the most important statute authorizing the DOT
drug and alcohol testing program, the Omnibus Transportation Employee
Testing Act of 1991, confirms the Department's broad authority to carry
out its drug and alcohol testing responsibilities. Congress intended
that the Secretary use his or her discretion and issue supplementing
regulations when necessary to carry out the Department's drug and
alcohol testing responsibilities.
The DOT agency drug testing regulations and Part 40 were originally
adopted in 1988-89 without any specific statutory authority. These
rules were based on the DOT agencies' general safety rulemaking
authority and the Department's general rulemaking authority. These DOT
agency safety statutes are silent with respect to drug and alcohol
testing. They do not describe drugs to be tested, types of tests,
random testing rates, laboratories, medical review officers, return-to-
duty procedures, testing equipment or personnel, or any of the other
subjects addressed by DOT agency substance testing rules and Part 40.
Before the Omnibus Act, these statutes provided the only authority for
the DOT agency drug testing rules, and they still provide the only
authority for the RSPA and Coast Guard rules. There was never any
question--aside from the original transit rule--about the authority of
the DOT agencies to issue these rules. When plaintiffs challenged these
rules, they and the courts focused on the constitutional issues,
mentioning the agency's authority for the rules only in passing, since
it was so clear.
Under Chevron, when the intent of Congress is clear, as is the case
here, no further inquiry is necessary. This makes it unnecessary for
any reviewing court to move on to the second prong of Chevron. If a
court did examine the PIE provision under the second prong however,
there is little doubt that the Department's action is based on a
permissible construction of the statute. The Department 's decision to
facilitate employer compliance and protect employers and employees from
the consequences of services that are inconsistent with regulatory
requirements is reasonable. Each of the requirements of Part 40 is
important to ensure the accuracy, integrity, privacy and fairness of
the testing process as well as the safety of the public. If a service
agent fails or refuses to meet these requirements, then these important
interests are adversely affected.
As the testing program and the role of service agents have evolved
over ten years, the Department has learned that additional measures are
needed to ensure the proper provision of testing services to employers.
In every respect, the proposed PIE process comes squarely within the
range of agency actions which courts, applying Chevron, have approved.
3. Alternatives
The Department believes that efforts by industry groups to
establish certification programs, training programs, and industry
standards are laudable and helpful. Such efforts, however, do not
address the issue of accountability for service agents whose
noncompliance is serious. These programs cannot respond, in a legally
binding way, with real consequences, to protect employers and employees
from the misconduct of a party who makes serious errors or chooses to
noncomply to gain an economic advantage.
An accountability mechanism like that proposed in the NPRM would
effectively complement voluntary industry efforts. By attaching
tangible consequences to serious noncompliance, an accountability
mechanism would assist industry groups in getting service agents to
take certification, training, and industry standards programs
seriously.
[[Page 79468]]
Some commenters favored one or more of the options discussed in the
NPRM preamble, such as certification or self-certification followed by
a DOT decertification procedure or a contract-based mechanism. With
respect to the contract mechanism, comment was, however, very divided,
with many commenters (in response to the PIE proposals or proposed
Sec. 40.11) saying that the contract clause requirement was too
burdensome or ineffective (i.e., with respect to parties who typically
do not have written contracts). The Department does not have the
resources to operate a Department-wide active certification program
(especially with respect to the motor carrier industry). Maintaining a
data base for a self-certification program would be difficult for the
Department, and there are significant issues concerning keeping such a
data base up to date. For these reasons, we do not believe that these
options are preferable to the PIE provisions the NPRM proposed.
A few commenters supported reliance on the legal system (i.e.,
court litigation) as a tool for employers to use to address problems
caused by service agent noncompliance. Nothing prevents employers from
resorting to private litigation now or in the future. By nature,
however, such private litigation focuses on vindicating the private
interests of the employer involved, not in more broadly protecting
testing program participants and the public interest. For this reason,
we do not view private litigation as a substitute for the PIE
provisions.
4. How Does a PIE Proceeding Begin?
Many service agent commenters asked for greater clarity and
specificity concerning what ``offenses'' would be sufficient to warrant
starting a PIE proceeding. They expressed the concern that the NPRM
proposal would give DOT officials, including auditors and inspectors,
too much discretion to start PIE proceedings based on minor problems,
despite the Department's statements that PIEs were intended to be used
in cases of ``egregious'' noncompliance.
As DOT officials said during the listening sessions in PIE
roundtables, we do not think it is a good idea to have a definitive
list of offenses that would trigger a proceeding. The Department's
experience with this program suggests that new situations will always
arise. We cannot possibly specify them all at this time. A list that
appeared definitive could lead to arguments that the Department was
precluded from starting a PIE proceeding because the underlying conduct
was not on a regulatory list.
Nevertheless, the Department does believe it would make our intent
and policy clearer to state in the regulatory text that this process is
intended to be used only for serious noncompliance. We provide several
examples of the kind of noncompliance that would, as a policy matter,
have a level of seriousness sufficient to warrant starting a PIE
proceeding. This regulatory text provision also states that the list is
not exclusive or exhaustive: we retain the discretion to start PIE
proceedings in situations not on the list and we are not required to
start a PIE proceeding every time something on the list comes up.
We also make clear that not everyone with a DOT ID card is
authorized to start a PIE proceeding. Only certain officials, such as
DOT agency drug and alcohol program managers, are authorized to do so.
They may rely on credible information from any source, including but
not limited to DOT auditors and inspectors, as the basis for starting a
proceeding. As several commenters requested, the final rule text
provides that the initiating official must contact the service agent to
get its side of the story and any facts it can provide before taking
further action, such as issuing a correction notice or a notice of
proposed exclusion (NOPE).
One issue on which commenters spoke concerns the relationship of
the PIE process and the HHS certification process for laboratories.
With respect to matters on which HHS takes certification action against
a laboratory, the Department would defer to the HHS action. That is, as
a policy matter, the Department would not start a PIE action is HHS had
already taken a certification action against a laboratory on the same
matter. We do not believe it would be an economical use of resources to
have two Federal proceedings in progress with respect to the same
laboratory, on the same issues, at the same time. However, if DHHS
decided that it was not appropriate to begin certification action
(e.g., because the laboratory's conduct did not trigger the HHS
``imminent harm'' standard), DOT could consider whether to begin a PIE
proceeding.
One of the concerns that some commenters expressed was that the
very existence of a PIE proceeding, regardless of its ultimate outcome,
could have adverse economic effects on a service agent. They asked that
such proceedings be kept confidential. The Department does not believe
that it is possible to keep a PIE proceeding, or the events leading up
to it (e.g., a factual inquiry, a correction notice) secret. For
example, in seeking to establish whether there is a factual basis for a
PIE proceeding, DOT personnel might well have to ask questions of a
number of employers about the service agent's activities. On the other
hand, the Department will not affirmatively seek to make pending
proceedings public knowledge, prior to the issuance of a NOPE. For
example, we do not intend to issue a press release or make other kinds
of public announcements at the time that we send a correction notice to
a service agent. The issuance of a NOPE and the Director's decision,
however, are matters of public record.
5. Scope of PIE Proceedings
Section 40.379 of the NPRM proposed that a PIE would apply to all
the divisions, organizational elements, and types of services provided
by the service agent involved, unless the Director limited the scope of
the proceeding. Under some circumstances, affiliates and individuals
could also be subject to a PIE. Many service agent commenters thought
the scope of a PIE should be narrower, limited to a particular type of
activity, affected employer, etc.
The intent of the PIE proposal is to protect the public from the
misconduct of an organization. Allowing the organization to segment its
activities, and contend that the public should be protected only from
some of what it does, is contrary to this objective. Nevertheless, the
Department believes that it is appropriate to decide, on a case-by-case
basis, whether a compliance problem is limited to one facet of a
service agent's activities or pervades the service agent's
organization. The Department is therefore making a procedural change
from the NPRM. Instead of saying that a PIE would apply to everything a
service agent does, the final rule makes the scope of the PIE an issue
in the proceeding.
That is, the initiating official would propose a scope for the
proposed PIE, depending on that official's view of how pervasive the
noncompliance was in the service agent's organization. It might be one
activity or organizational element; it might be more than one; it might
be the totality of the service agent's activities. The service agent
could contest the initiating official's scope proposal, and the
Director would make an explicit decision about scope. This is not quite
the ``slice of pie'' proposal advanced by some service agents, since
the Department would not necessarily be limited by rule to applying a
PIE only to the type of activity or organizational element directly
involved in the noncompliance. But the initiating official would have
the burden of persuading the Director that the
[[Page 79469]]
proposed scope of the PIE was appropriate in light of the facts of the
case. The final rule text provides several examples to illustrate the
way this scope procedure is intended to work.
6. Procedural Issues
Like the NPRM, the final rule requires initiating officials to send
a correction notice to a service agent before starting a PIE
proceeding. This notice gives the service agent 60 days to fix a
problem or change its procedures before a more adversarial process
begins. We have added greater specificity concerning the NOPE that
begins a PIE proceeding (e.g., specifically requiring information on
the proposed scope and duration of the PIE).
We believe that the ODAPC Director is the appropriate person to
make decisions in PIE cases. The ODAPC Director is someone who is
knowledgeable about the DOT program and regulations but who is not
directly involved in their enforcement by the DOT agencies. We disagree
with contentions that the Director is inherently biased in potential
PIE matters. It is the Director's job to consider such matters fairly
and in accordance with the Department's rules, and nothing in the
comments persuades us that the Director will be unable to do the job
right.
To reassure participants further about the objectivity of the
process, we have added language to the final rule specifically
prohibiting the ODAPC Director from playing any role in the initiation
of a PIE and establishing a ``firewall'' between the initiating
official and the Director. This firewall would prohibit any ex parte
contacts between the two. In any situation in which it would be
inappropriate for the Director to act as the decisionmaker (e.g., the
Director had recent professional ties to the service agent who was the
subject of the PIE proceeding, the Director has had substantial
involvement in a matter before it becomes the subject of a PIE
proceeding), the rule the Director would designate another person to
decide the case. In addition, the final rule lists the elements of the
Director's decision, including not only the basic decision about
whether to issue a PIE but also decisions about disputed matters of
material fact, the scope of a PIE, and the duration of a PIE.
The standard of proof in a PIE proceeding will remain ``the
preponderance of the evidence.'' There is no policy or legal basis
apparent for raising this burden to the higher ``clear and convincing
evidence'' level. Contrary to a few comments, there is no ``presumption
of guilt'' on the part of a service agent in a PIE proceeding. The
initiating official bears the burden of proof. Administrative
proceedings in many kinds of matters, including suspension and
debarment proceedings under Part 29, are conducted informally, without
formal rules of evidence of the kind used in the court system, with
evidence accepted on a general relevance standard. The final rule makes
clear that PIE proceedings will be conducted in this way.
The Department takes no position on whether Part 40 creates a
private right of action, deferring to the courts or to DOT agency
regulations on this issue. While the Department recognizes that a PIE
will have adverse consequences for a service agent, we continue to
believe that the purpose of a PIE is to protect the public interest,
not punishment. This language, which is derived from Part 29, is an
accurate statement of the intent of the PIE provision and we are
retaining it. A few commenters asked for a time frame for PIE decisions
by the Department. We have responded by saying that the Director will
generally make a decision within 60 days of the completion of the
record in the case, though the Director can extend this period for good
cause.
Some commenters requested additional clarification of the standards
for determining the duration of a PIE. In response, we have added a new
section listing examples of the kinds of factors that the Director will
consider in determining the appropriateness, scope, and duration of a
PIE. Since the proposed duration of a PIE is one of the elements of a
proceeding that service agents can contest, service agents and
initiating officials will have the opportunity to refer to these
factors in their arguments about duration. In general, we say in the
final regulatory text that a PIE stays in effect for one to five years.
In deciding on the duration of a PIE, the Director will take into
account the seriousness of the noncompliance and other factors listed
in the rule. Nine months after the Director issues a PIE, the service
agent can apply to the Director in writing to terminate or reduce a
PIE. The rule spells out the grounds for such a request.
As noted in the Effective Dates section of the preamble, the
Department is making the PIE provisions of the rule 30 days from the
date of publication. The effect of this action is to make PIE
proceedings available to the Department with respect to noncompliance
with the existing Part 40 rule between the publication date of this
revision and the August 1 effective date of the complete revised Part
40. We are doing so in order to emphasize to service agents that they
are accountable for their actions. In some recent instances (e.g., the
apparent laboratory evidence tampering incident referred to in ``Basic
Rationale for PIE Provisions'' above), the Department would have had
grounds for considering the use of PIE proceedings, had they been
available to us.
Return-to-Duty Process
The NPRM raised a number of issues surrounding the return-to-duty
process. We proposed to consolidate this material in Part 40. One issue
concerned the minimum number of follow-up tests that SAPs should
prescribe. Should there be an increase over the current rule's
requirement of six tests over the first 12 months following an
employee's return to duty (e.g., to 12 tests over one or two years)?
Another issue was ``aftercare.'' That is, SAPs often make
recommendations for continuing assistance after the employee returns to
work. The NPRM proposed that employers would have to monitor employees'
compliance with these recommendations. A third issue was whether SAPs
should routinely receive drug test quantitations.
Comments
Comments from a mixture of employers, employees, and service agents
directly addressed the question of whether the Department should
increase the minimum number of follow-up tests. A substantial majority
of these commenters opposed any change in the current requirement of a
minimum of six tests over the first year following the employee's
return to duty, and a few of these suggested reducing that minimum.
These commenters did not oppose retaining the SAP's discretion to
prescribe a higher number of tests or testing that went beyond the
first year. Some additional commenters said that number of tests should
be determined at the SAP's discretion, or in negotiation between the
SAP and employer. On the other hand, a few commenters favored
increasing the minimum to 12 tests.
With respect to aftercare, several motor carriers and motor carrier
associations opposed the proposal for employers to monitor employee
compliance with SAP recommendations. They said it would be too
burdensome and went beyond their expertise, which centered on running
trucks, not aftercare. A few service agents supported the proposed
change. There was also concern expressed, principally in discussions at
the listening sessions, that some SAPs were reluctant to recommend
assistance
[[Page 79470]]
even after employees tested positive, whether out of over-reliance on
employee's excuses, claims that the testing process was flawed, or the
SAP's personal opinions about the justification for or utility of the
testing process. Some commenters asserted that the very fact of a
violation showed that an individual was in need of some education or
treatment, so it was inconsistent with the purpose of the rules to
permit SAPs to find that an individual was not in need of assistance.
Commenters were divided on the issue of whether SAPs should
routinely receive reports of the quantitation of drugs in the specimens
of individuals who tested positive. Those who favored this approach,
including most of the employers who spoke to this issue and some of the
SAPs, said that it would be useful to know the levels of drugs in the
employees' specimens. This would be helpful to SAPs as they try to
evaluate an employee's situation and determine what sort of treatment
was appropriate. The majority of commenters opposed providing this
information on a routine basis, saying that the quantitation of drugs
in a specimen was usually irrelevant to evaluation and treatment and
could sometimes be diagnostically misleading. Testing was never
intended to diagnose addiction, and urine test quantitations rarely
provide a good basis for evaluating an employee's drug problems. A
laboratory added that requiring laboratories to report this information
to SAPs would be burdensome.
DOT Response
With respect to follow-up tests, the Department has decided that it
is not necessary to increase the minimum number. We believe that
follow-up tests are very important. They are the best tool we have to
make sure that an individual who has returned to duty after a violation
remains in compliance while experiencing the actual stresses and
temptations of the work environment. However, requiring a greater
number of tests could be unnecessarily burdensome in those cases in
which SAPs are satisfied that six tests are sufficient. We will keep in
place the basic provisions of the existing rule: a minimum of six such
tests in the first year of safety-sensitive work following the
employee's return to duty. SAPs will continue to have discretion to
require a greater number of tests over a period of up to 60 months, as
in the current rule.
The Department has become convinced that there is no basis for a
SAP ever determining that an individual who has tested positive or
otherwise violated the drug and alcohol rules does not need education
or treatment as well as follow up testing. For someone who performs
safety-sensitive transportation functions, the very fact of a violation
indicates a disregard of safety that must be addressed, corrected, and
monitored in order to ensure safe performance of those functions in the
future. Therefore, the final rule will require the SAP to mandate some
level of assistance in every case, as well as to prescribe at least the
minimum number of follow-up tests for each employee who returns to duty
following any violation of the rules. We also clarify that the SAP must
present a copy of his or her written follow-up testing plan to the
designated employer representative (DER). The rule text also cautions
SAPs against basing any decisions, even in part, on employee claims of
flaws in the testing process or any private opinions of the SAP about
the validity or utility of the testing process.
In response to comments, the regulation clarifies that the follow-
up testing requirement follows the employee from one job to another and
persists through a break in service. That is, if after returning to
duty with an employer, the employee changes jobs before completing all
required follow-up tests, the employee is responsible for completing
the follow-up tests with his or her new employer. Likewise, if the
employee returns to work, is laid off for several months, and then
comes back to work with the same employer, the employee must complete
the series of follow-up tests ordered by the SAP.
With respect to employer monitoring of aftercare, the Department is
persuaded by the objections of employer commenters that we should not
require employers to take on this task. SAPs have the obligation to
make recommendations for aftercare where they believe such assistance
is needed to maintain sobriety or abstinence from illegal drugs. These
recommendations should carry a good deal of weight, because they in
effect declare that employee compliance with them is important to
ensure safe performance of safety-sensitive functions. The rule states
the employee's obligation to comply with these recommendations.
Rather than requiring employer monitoring, however, the rule
provides the employer discretion to take a variety of steps. These
could include putting compliance with SAP recommendations into return-
to-duty agreements, disciplining employees for noncompliance, and using
the services of SAPs or employee assistance programs (EAPs) to assist
and monitor employees' aftercare activities. The rule notes that
employers can choose to monitor these activities, and that employees
who fail to carry out the recommendations can be subject to sanctions
from their employers. We note that this discussion concerns employer
discretion with respect to aftercare (e.g., treatment and education)
activities only. Employers do not have discretion with respect to
follow-up tests. Employers must carry out the follow-up test
instructions they receive from SAPs.
The Department believes that the commenters who opposed routinely
providing drug test quantitations to SAPs have the better of the
argument. SAPs take a variety of factors--including a face-to-face
interview with the employee--into account when determining what
assistance the employee needs. The amount of a particular drug in an
employee's specimen at a particular time does not determine what sort
of treatment is most appropriate for the individual. Consequently, we
will not provide for quantitations to be given to SAPs on a routine
basis. We do provide, however, that SAPs can consult with MROs (who
must cooperate with SAPs) and receive information that the MRO has
gathered as part of the verification process. Through this process,
SAPs can get additional information that may be of use to them in the
evaluation process.
We want to emphasize that neither the rule nor the Department
requires employers to fire employees who violate the Department's drug
and alcohol testing rules. There is no national policy, and certainly
no policy articulated by the Federal government, that commands this
result. We would not have this detailed return-to-duty procedure if we
believed that no one should be returned to duty after a violation.
As has been true from the beginning, all the Department requires is
that an employee who violates the rule not perform safety-sensitive
functions until and unless he or she successfully completes the return-
to-duty process. Decisions about discipline and termination are left to
the discretion of the employer or labor-management negotiations. Where
employer policy, or labor-management negotiations, have delegated
personnel decisions of this kind to an arbitrator, the Department
intends that the arbitrator's decision determines the personnel action
that the employer takes. The Supreme Court has recently affirmed these
principles. Eastern Associated Coal Corporation v. United Mine Workers
of America, District 17, et. al, 531 U.S. ____ (2000).
Of course, an arbitrator cannot order an employer to return an
employee to
[[Page 79471]]
the performance of safety-sensitive functions until the employee has
successfully completed the return-to-duty process. Nor can an
arbitrator or an employer change the laboratory's findings about a
specimen or an MRO's decision about whether there is a legitimate
medical explanation for a test result.
Collector Training
Competent performance of drug and alcohol testing functions by
collectors, BATs and STTs, MROs, SAPs and others involved in the
testing process is obviously very important to the integrity and
fairness of the Department's program. The Department's NPRM asked
questions and offered proposals for the training and qualifications of
these personnel. This discussion focuses on collector training, which
was the subject of more comment than training for other personnel.
Training and qualifications for other personnel are discussed in the
section-by-section portion of the preamble.
Comments
Training for collectors in the drug testing program was the subject
of comment from a wide variety of parties, including service agents,
employers, and unions. Commenters differed on most of the subjects
under discussion, including the basic point of the extent of current
problems in the collection area. Most commenters on the subject
believed that collections were the weakest point of the testing
process, though some argued that there was a low rate of collection
errors in their experience. Some commenters said that it would reduce
collection errors if the Federal Custody and Control Form (CCF) were
simplified.
Some commenters favored a formal instruction course for collectors,
like the Department's BAT course. Most of these and some other
commenters opposed the notions of self-instruction and self-
certification for collectors, saying that they were meaningless. They
believed that there should be some sort of formal training, with an
examination or other means of ensuring that a collector deserved to be
certified. Some commenters also supported a ``train-the-trainer''
course requirement to certify trainers.
Other commenters, however, opposed any formal training requirements
for collectors, saying it was expensive, burdensome, and might make it
harder to find collectors, especially in less densely populated areas.
A maritime employer group asked for some exceptions to training
requirements for people who were not regularly collectors but might
occasionally have to conduct a collection, as in a post-accident
situation.
Commenters who thought the NPRM's training proposals were too
extensive often objected to requirements for classroom training or
other training modes involving a live instructor or monitor. They said
the requirements should be more flexible, and provide for training
through such approaches as videos, internet-based courses, or
instruction and monitoring through telephone or interactive computer
methods.
A number of commenters objected to the term ``sufficiently
knowledgeable,'' which the NPRM used to describe the personnel who
trained collectors. The commenters said the term was too vague. Some of
these commenters asked that the rule include more specific
qualifications for trainers. Some commenters also objected to the
proposal that trainees be required to complete five error-free mock
collections, saying that the requirement was either too burdensome
(some suggested the number of mock collections be reduced) or
insufficient. Some commenters also took issue with the requirement that
a collector who made a ``fatal flaw'' mistake should have to be
retrained, particularly since they felt it might threaten the validity
of subsequent collections the collector conducted prior to the
retraining. Others thought it would be better to have a slower trigger
for the retraining requirement (e.g., two fatal flaws in two years).
DOT Response
The Department believes that making collector training more
effective will be an important step in reducing errors in the drug
testing process. The collection of urine specimens is the step in the
process with the greatest potential for administrative error, and our
own experience confirms the comments of persons who said that
collections are a fertile source of mistakes. When our inspectors and
program personnel visit collection sites in the field, they commonly
find a wide variety of mistakes and misunderstandings in the collection
process. We also agree that self-certification is inadequate. For these
reasons, we will require additional training of collectors, compared to
the present rule. We believe that this training should be provided in
as flexible a manner as possible. Section 40.33 contains the
Department's resolution of collector training issues.
Part 40 contains much information about how collections must be
conducted. It is essential that collectors become knowledgeable about
the relevant portions of the new Part 40, DOT collections guidance and
relevant DOT agency rule provisions, and we will require them to do so.
We also believe that more formal training is needed to ensure that
collectors understand and can carry out the requirements of this part.
We believe that, as commenters noted, the training can be provided in a
number of ways (e.g., classroom sessions, videos, internet courses). We
are not prescribing a particular curriculum as we have for alcohol
testing personnel, and we will not require that collectors be
``certified.'' By taking this approach, we achieve the objective of
additional training while allowing flexibility and minimizing costs.
In-person involvement of a trainer is not required for this part of the
training process.
To demonstrate that they can practically apply what they have
learned, collectors must conduct five consecutive error-free mock
collections. We believe this is an extremely important requirement,
because collectors must deal with real people and real specimens in
their job, not just regulatory text or computer simulations. By mock
collections, we mean collections that are not real collections of
employees subject to testing under DOT regulations. The five
collections must include both uneventful and ``problem'' testing
scenarios. Another person must monitor and evaluate the mock
collections to ensure that they are error-free. This part of the
process does involve the in-person participation of someone to monitor
and evaluate the trainee's performance (unless some technology is used
that permits the real-time, step-by-step observation and evaluation of
the trainee's performance without a person in the same room with the
trainee).
The monitor must be someone who has demonstrated necessary
knowledge, skills, and experience (1) by regularly conducting DOT drug
test collections for a period of at least a year, (2) by having
conducted collector training under this part for a year, or (3) by
successfully having completed a ``train-the-trainer'' course. The
Department sets out these alternatives for qualifying as a trainer in
response to comments that said ``sufficiently knowledgeable'' was too
vague.
All new collectors must meet these training requirements. In
addition, current collectors must meet the requirement within 21/2
years after the effective date of this rule (December 2003). This will
provide adequate time for current collectors to get the
[[Page 79472]]
necessary qualification training, if they have not already done so.
Collectors would have to get refresher training every five years.
We believe that, just as other professionals in the drug and alcohol
testing business need continuing education, it is important for
collectors to brush up on the rules and techniques of their part of the
drug testing process, in order to ensure that they perform at the
highest level. This training would also focus on any changes in
collection technology that had come into use in the meantime.
One of the most important occasions for training is following a
mistake that actually results in a test being cancelled. This
requirement does not apply every time there is a cancelled test, only
when the cancellation is the result of the collector's error. The
training would focus on the subject matter that was involved with the
error, and would also involve three monitored error-free mock
collections. This training would have to take place within 30 days of
the collector's being notified of the error. The reason for this
training is obvious: if someone makes a mistake once, we want to make
sure he or she does not make a similar mistake again.
Commenters noted that it might be very burdensome for employers, or
even some service agents, to keep training records for each of their
possible many and widespread collectors. To avoid this problem, we are
requiring that collectors (like other service providers) keep their own
training records, which would have to be made available to employers,
other service agents (e.g., C/TPAs) involved with the collector's
provision of services, and DOT. In addition, we specify in Sec. 40.209
that a test is not invalidated because a collector has not fulfilled a
training requirement. For example, suppose someone collects a specimen
correctly but has not completed required training or retraining. The
test would not be cancelled because the training requirement was not
met, though the collector, other service agents, and employer involved
might be found in noncompliance as the result of the failure to meet
training requirements.
Transmission of Information Through Consortia and Third-Party
Administrators
When the Department began the drug testing program in 1988-89, we
had in mind a perhaps simplistic model of how the program would work.
We imagined that most employers would have an in-house testing program
that would perform most of the tasks the rules required, except that
employers would contract directly with laboratories for specimen
testing services and perhaps with MROs for medical review services. We
thought that owner-operators and other very small employers might well
band together in consortia to gain economies of scale in purchasing
testing-related services.
The program has developed in quite different directions, to the
point where most employers' drug and alcohol testing programs are
outsourced, often operated by C/TPAs. These organizations often bundle
their services to employers. Only a minority of employers, usually
large ones, operate their own programs.
One of the Department's tasks in revising Part 40 is to make
appropriate adaptations to the altered shape of the drug and alcohol
testing business. We have no desire to stand as King Canute before the
marketplace sea. Nor do we wish to surrender to purely economic
considerations features of the program we regard as critical to its
integrity. The goal of finding an appropriate balance has influenced
our efforts in a number of areas as part of this rulemaking, including
the functions of MROs and SAPs and the issue of how test results are
reported to employers.
In the NPRM, the Department proposed keeping sharp lines of
demarcation between different participants in the program.
Specifically, we proposed putting into regulatory text the
interpretation we have maintained under the existing rule with respect
to the transmission of drug test results from MROs to employers. That
is, MROs must report the results directly to employers. C/TPAs could
not act as intermediaries in this process. This position was based on
the premise that indirect reporting was likely to be slower, and more
prone to error and compromise of confidentiality, than direct
reporting.
Comments
The bulk of comments on this issue came from TPAs, who asserted
that they should be permitted to act as intermediaries in the
transmission of drug testing results. There were also comments from
employers and unions, most of which supported the TPAs' position.
During discussions of this issue in the listening sessions, DOT staff
asked TPAs to address the question of how it was as or more efficient
and effective to move a result from Point A (the MRO) to point B (the
employer) through Point C (a TPA), rather than sending it directly from
Point A to Point B. Many of the C/TPA comments did address this
question.
A common response was that many MROs do not have the staff or
electronic capability to receive, process, and transmit results to
clients. Indeed, many smaller doctors' offices would find it burdensome
to handle all the paperwork. It is more efficient division of labor to
have doctors concentrating on medical review and TPAs on information
distribution, some said. TPAs, commenters said, are set up to act as
electronic transfer points for data, allowing for the more efficient
and timely delivery of results. Requiring the MRO to transmit the
results directly would increase rather than decrease processing time
and add costs.
Commenters favoring change in this proposal also said that TPAs
know the rules and regulations well, since this is their full-time
business. Small employers find it easier to call one place--the TPA--
for all drug program information rather than having to deal with a
variety of sources. Some of these commenters noted that, in the Coast
Guard program, TPAs had played this role successfully for some time.
They said there was no evidence of any detriment to public safety in
this case, or in other cases where TPAs (contrary to existing rules)
have transmitted results.
Some MROs and TPAs disagreed with this point of view, citing
concerns about delays, administrative errors, and risks to
confidentiality. Commenters said that many MROs are fully capable of
transmitting results information directly to employers, and that if an
employer found that it was not receiving results in a timely fashion,
it could change MROs. In addition, direct MRO transmission may provide
greater value to employers, because MROs can answer questions about the
result and help the employer resolve procedural issues.
Comment on this issue focused on MRO transmission of verified drug
testing results to employers. However, many commenters mentioned other
areas in which similar issues arise, such as laboratory transmission of
results to MROs, transmission of SAP reports to employers, and
transmission of alcohol test results from BATs to employers.
A related, but distinct, issue concerned who could appropriately
play the role of the designated employer representative (DER). Some
commenters said that C/TPAs should be able to act for employers as
DERs, at least in small companies. Some of these comments alleged that
the role of the DER was a complex, multifaceted one, and that it would
be very costly, particularly for small companies, to hire a DER.
DOT Response
The Department is persuaded by the comments on this subject that C/
TPAs
[[Page 79473]]
have the ability to transmit verified drug test results to employers as
or more efficiently than MROs who transmit the information directly.
While we understand, and to an extent share, concerns about potential
delays, errors, and breaches of confidentiality when intermediaries are
used, we do not have any evidence in the record that these problems
actually occur in any significant way. The Coast Guard experience, as
reported by commenters (including some employer and union commenters)
and verified by Coast Guard staff, suggests that the parties concerned
in that industry are satisfied with this approach.
Consequently, the final rule (see --40.345) gives employers the
choice of receiving drug test results directly from the MRO or via a C/
TPA. We emphasize that it is up to the employer--not the C/TPA--to make
this choice. The employer can make this choice for any or all of the
items listed in Appendix F (e.g., an employer may choose to receive
some items via the TPA and others directly from an MRO). The rule
authorizes C/TPAs to act as intermediaries in the transmittal of
information to employers only with respect to the specific provisions
of the rule listed in Appendix F. C/TPAs are prohibited from acting as
an intermediary in transmitting information not listed in Appendix F.
For example, C/TPAs are not allowed to act as an intermediary who
transmits laboratory test results to MROs , SAP reports to employers,
or medical information from MROs to employers. In the case of the
laboratory reports, we believe that the direct link between
laboratories and MROs is critical to the timely and independent medical
review of those results. (Certainly laboratories have the electronic
capability to readily transmit results directly to MROs in a timely and
accurate fashion.) With respect to SAP reports, we are concerned that
using an intermediary creates the opportunity and temptation to alter
the SAP's recommendations (a problem that DOT staff have noted in the
current program). With respect to medical information, we believe this
is confidential medical data that should not pass through an additional
hand on its way from the MRO to the employer.
The discussion of this issue among commenters focused mainly,
though not exclusively, on drug test information. A few commenters
mentioned that similar considerations should apply to alcohol testing
information. With respect to ``negative'' alcohol test results (i.e.,
results of less than 0.02), we agree. The same rationale that supports
permitting drug testing information to be conveyed by C/TPAs applies to
this information. However, we draw a distinction with respect to
alcohol testing results of 0.02 or higher. These results--unlike
positive drug test results or negative drug or alcohol test results--
mean that an employee is, to some extent, impaired by alcohol. As a
safety matter, the employer must immediately remove the employee from
performance of safety-sensitive functions. This is a situation where
time is of the essence, and we therefore will continue to require BATs
to transmit these results directly to employers. C/TPAs are not
authorized to act as an intermediary in this situation.
We believe that it is essential that someone employed by the actual
transportation employer act as the DER. The DER's function is to
receive information about certain kinds of test results and take
required action, such as removing an employee from the performance of
safety-sensitive functions. Someone who is an employee of a C/TPA,
rather than of the actual transportation employer, is less well
situated to perform these functions, especially since a C/TPA
representative generally does not have line authority over a
transportation employer's employees.
Much of the comment on this issue appears based on a significant
misunderstanding of the role of a DER. A DER is not a drug and alcohol
program manager. A DER does not need extensive knowledge about the DOT
drug and alcohol testing program and need not spend extensive time on
DER duties. The DER is simply someone who can act immediately to remove
an employee from safety-sensitive functions, or take other appropriate
action, upon receipt of information that the employee has violated the
rules or needs to be subject to certain testing requirements.
Particularly for small companies (e.g., a 3-10 driver trucking
company), the DER is likely to perform this function on a collateral
duty basis, fielding a rare phone call (i.e., there are not many tests
per year and only a small percentage of tests result in violations) and
removing an employee from safety-sensitive functions on those
occasions. This is not a time-or resources-intensive activity, and it
would certainly not require hiring an extra human resources staff
person.
The one exception the final rule makes concerns owner-operators.
Under the FMCSA rule, owner-operators are, in effect, required to get
at least random testing services through a C/TPA. In an owner-operator,
the driver is his or her own boss, so there is no one else in his or
her own organization to direct him or her to stop performing safety-
sensitive functions. In this situation, we think it is probably better
to permit the C/TPA to perform what otherwise would be a DER function.
Collection Process Issues
Commenters were interested in a variety of issues in the drug
testing collection process. These included dilution issues, the
consequences of refusing to drink fluids and the length of the interval
before the second collection attempt in ``shy bladder'' situations,
retests under direct observation when a split specimen is unavailable
for testing, using split specimen collections in all DOT modes, and
having employees remove boots as part of the preparation for a
collection.
Comments
The first issue in this category is whether, when there is a
specimen that is both negative and dilute, there should be an immediate
recollection under direct observation. Commenters took a number of
positions on the issue. Some employers and service agents favored
making retests under direct observation mandatory, on the ground that a
dilute specimen effectively formed a basis for a reasonable suspicion
that the employee had tried to conceal drug use. Some unions and
service agents opposed such a requirement because it would intrude on
employees' privacy, might well result from innocent consumption of
water, and was of dubious value in deterring and detecting illegal drug
use.
A plurality of commenters favored making a recollection, as well as
the decision about whether to use direct observation, optional with the
employer. This approach, they said, would recognize the variety of
situations in which a dilute specimen may occur. It could be done in
consultation with MROs, to ensure that there was some medical input
into the employer's decision.
The second, related issue is whether an employer should be able to
disregard a negative dilute result. For example, suppose an employer
receives such a result on an applicant's pre-employment test. Should
the employer be able to require the applicant to take another test to
get a ``real negative'' before beginning safety-sensitive work? Most
employers, and some service agents, who commented on this issue favored
this approach, especially in pre-employment testing. They did so in the
belief that a negative dilute result was, at best, questionable. Even
if it did not result from a deliberate attempt to cheat on a test, it
was not as definite a
[[Page 79474]]
demonstration of compliance as a negative test from a more concentrated
specimen. Unions and some service agents disagreed, saying that this
would unnecessarily burden employees, including many who could achieve
dilute (as distinct from substituted) results naturally, by drinking a
lot of water (which some commenters made a point of noting was a legal
substance). This approach would involve a ``guilty until proved
innocent'' approach, in this view.
Most, though not all, employers said that an employee who refuses
to drink additional liquids after failing in his or her initial attempt
to produce a sufficient specimen should be regarded as having refused
to test. These commenters saw refusals to drink as attempts by
employees who had used drugs to avoid a positive test. They also viewed
it as a waste of up to three hours of time that the employee remained
off the job (but presumably in paid status). Some service agents also
shared this point of view. Unions and other service agents disagreed.
They said that an employee could have legitimate health or other
reasons for not wanting to drink additional fluids. Moreover, if an
employee fails to drink fluids, and consequently fails to produce a
sufficient specimen on the second try, the employee will be referred to
a physician for an evaluation. If the physician does not find that a
medical condition produced, or could have produced, the inability to
provide a sufficient specimen, the employee will be treated as having
refused the test. This consequence is sufficient, these commenters
said.
When an employee has a verified positive test, the Omnibus Employee
Testing Act gives the employee the right to request a test of the split
specimen. The Department has long taken the position that if the
employee makes a timely request to test the split specimen, and the
split specimen is unavailable for testing (e.g., the split specimen was
never collected, leaked away, or was lost), the test must be cancelled.
While we believe this outcome is necessary as a matter of law, it
raises a safety concern. In such cases, we have an apparently valid,
verified positive result, indicating that the employee used illegal
drugs. However, because of the accidental unavailability of the split
specimen, the employee can continue to perform safety-sensitive
functions.
In response to this concern, the NPRM sought comment on the idea of
requiring a recollection under direct observation in these cases. This
might detect drug use by the employee and result in his or her removal
from the performance of safety-sensitive functions. The rationale for
the direct observation aspect of the procedure reflects the belief that
an employee, having recently tested positive, may have an additional
incentive to cheat on the second test.
Comment was divided on this issue. Employers generally supported
the proposal to require recollection under direct observation on the
safety rationale mentioned above. Unions and some service agents
opposed the proposal, saying that it undermined the employee's right to
a test of the split specimen. Some added that the second test would not
really answer the question of whether the employee has tested positive
on the first test. Opponents of the proposal particularly objected to
the direct observation aspect of it, on intrusiveness and violation of
privacy grounds. Why, they asked, should someone suffer a directly
observed test because the collector made an error?
Currently, those DOT agencies covered by the Omnibus Transportation
Employee Testing Act--FRA, FAA, FTA, and FMCSA--are required to collect
split specimens. RSPA and Coast Guard, whom the Act does not cover,
give employers the choice of collecting single or split specimens.
Commenters on this point almost unanimously favored requiring split
specimens in all DOT agency programs. They said that this would be much
simpler and less confusing, and likely would reduce the incidence of
errors (e.g., failure to collect split specimens where required). Split
specimen collections are not any more expensive than single specimens,
one commenter said. One commenter questioned the Department's authority
to require split specimen testing in RSPA and the Coast Guard absent
legislation.
The Department has heard concerns, over the years, that some
employees have concealed adulterants or other means of tampering with
tests in their boots (e.g., cowboy boots). For this reason, the NPRM
proposed that collectors would ask employees to remove their boots, so
that collectors could check them for such items. Commenters almost
unanimously panned this proposal, asserting that it was intrusive,
ineffective, and inconsistent (i.e., vis a vis the rule's treatment of
other footwear and clothing). Commenters raised specters ranging from
confrontations between employees and collectors to exposing collectors
to unpleasant foot odors.
DOT Response
With respect to the issue of negative dilute tests, the Department
has decided to give employers discretion about how to handle these
situations (see --40.197). There are reasonable arguments on both sides
of this question, and the Department is not persuaded that that there
is a single, across-the-board, right answer. The variety of
circumstances among employers appears too wide to permit a unitary
solution. In response to concerns about recollections being unduly
burdensome on employees, the Department will require that a given
employer treat all employees equally, to avoid the possibility of
arbitrary selections of individuals for recollection. That is, an
employer would have to treat all situations in a given category the
same way (e.g., require recollections in all pre-employment test
situations that had negative dilute results). This would prevent
employers from singling out disfavored employees. In addition,
employers would be limited to a total of two tests (the original
negative dilute result and one recollection). They could not conduct
additional tests if the recollection were also a negative dilute, for
example. This provision limits the potential burden on employees.
If an employer chooses to conduct another test, it could not be
conducted under direct observation, unless one of the other
circumstances permitting or requiring direct observation occurred. We
use direct observation primarily to counter the likelihood of tampering
at the collection site. This makes sense in situations where we are
mostly concerned about adulteration or substitution. Most dilution
cases, however, arise because an individual hydrates his or her system
before going to the collection site. Privacy issues aside, then, direct
observation seems off point in the dilution situation. What is useful
is giving an employee the shortest possible interval between notice of
the test and the conduct of the test, so that the individual does not
have time to overhydrate. For this reason, the rule requires employers
to provide no advance notice of the recollection to employees.
The Department will not include any general provision requiring or
authorizing employers to disregard the results of negative dilute
tests. Given the structure of the rule, such a provision is
unnecessary. Employers have the discretion to conduct one recollection
following a negative dilute result. If the employer chooses not to
conduct a recollection, then the negative result is the only result it
has, and the employer will rely on the result just as is does in any
other case. If the employer does conduct a recollection, then the
result of
[[Page 79475]]
the recollection--not the original test--becomes the result on which
the employer relies for all purposes. The original test would be
cancelled in this situation, and not reported for management
information system (MIS) purposes.
The bottom line in any ``shy bladder'' situation is that, if, by
the end of the collection process, the employee has not produced a
sufficient specimen, the employee must be evaluated by a physician.
Unless the physician finds that a medical condition resulted, or could
have resulted, in the inability to provide a sufficient specimen, the
employee is regarded as having refused to test (see --40.193). Given
this provision, we believe it is unnecessary to say that a refusal to
drink fluids, standing alone, is a refusal to test.
As some commenters said, there may be legitimate reasons for an
employee's decision not to drink fluids in this situation. In any case,
if the employee declines to drink, subsequently does not produce a
sufficient specimen, and cannot establish a medical condition
explaining his or her inability to provide the specimen, a refusal to
test will be established. While having employees waiting in a
collection site for three hours, with or without drinking, may annoy
employers and collectors, we do not believe this is a sufficient reason
to terminate the shy bladder process because the employee does not
choose to drink during that period.
We believe that there is a strong safety rationale for requiring a
recollection under direct observation following a verified positive,
adulterated, or substituted test that is cancelled because the split
specimen is unavailable for testing. In this situation, we know that
there were drugs or an adulterant in, or substitution of, the primary
specimen, and that there was no legitimate medical explanation. Split
specimens fail to reconfirm the result of the test of the primary
specimen in only a tiny minority of cases. If we do not collect another
specimen in this case, there is a very high probability that we will be
permitting an employee who has used illegal drugs, or tried to tamper
with a test, to continue performing safety-sensitive functions. That is
a significant safety concern.
By recollecting another specimen, we have some possibility of
detecting continuing drug use. Knowing that recollections will occur in
this situation may also have some deterrent effect on employees. By
recollecting another specimen under direct observation, we can limit
the opportunities for tampering, for which there is a heightened
incentive in this situation. We do not view this provision as
penalizing an employee because a laboratory or collector erred. Rather,
in the face of a laboratory or collector error, we view this provision
as closing an inappropriate loophole for an employee who appears to
have used illegal drugs or tried to defeat a test.
We agree with commenters that it makes much more sense for all DOT
agencies to have consistent requirements concerning split specimens.
Therefore, Part 40 requires all collections to be split specimen
collections, and RSPA and Coast Guard will amend their rules
accordingly. We will delete from Part 40 all references to single
specimen collections. There is no legal authority issue here: RSPA and
Coast Guard base their rules on their statutory general safety
authority, which does not contain specific requirements or prohibitions
concerning how drug specimens are collected. There is no legal
difference between these agencies using their discretion in
implementing their general safety authorities by requiring split
specimen testing and using it to give employers an option between split
specimen or single specimen collections.
We are persuaded by commenters that we should not go forward with
the proposal to have collectors remove and inspect boots. The problems
of this approach likely outweigh the benefits. Therefore, we have
booted this provision out of the final rule.
Information Release Issues
MROs sometimes find themselves in a dilemma. They verify a positive
test result on an employee of Employer A. They also know that the same
employee works in a DOT-regulated safety-sensitive position for
Employer B. Consistent with safety and confidentiality
responsibilities, what should the MRO do? The NPRM sought comment on
this issue. The NPRM also asked for comment on whether MROs and other
parties (e.g., C/TPAs) should report positive tests and other rule
violations to DOT operating agencies, so that they could take
enforcement action.
Comments
There was a variety of comment on the idea of MROs sharing test
information with other employers. Many employers, MROs, unions and
other parties opposed allowing MROs to do so because it would breach
employee confidentiality. Given the large data bases that some service
agents maintain, this breach could be very wide, some commenters said.
Some service agents questioned whether the proposed rule's language
would have the effect of creating a duty on service agents to conduct
searches of such data bases.
Other MROs and employers favored giving MROs this discretion, in
order to enhance safety and help MROs who find themselves in this
dilemma. Commenters cited potential liability concerns on both sides of
the question. Other commenters suggested that more systematic
approaches to this problem might be more productive, such as creating a
national data base of persons who had violated rules or requiring
employers hiring new workers to check with previous employers about
past test results (as FMCSA's rule already does). Canadian commenters
also mentioned a concern that information release to third parties
without individual employee consent may violate Canadian law.
Commenters addressed the issue of release of information in legal
proceedings. The existing rule and the NPRM focus on legal proceedings
brought by an employee (e.g., an unjust termination suit). What about
personal injury cases in which the employee's test result is a relevant
issue, commenters asked.
Some commenters thought that having service agents report rule
violations to the DOT agencies was a good idea that would enhance
safety. For example, if an owner-operator fails to show up for a test
and continues to drive, only the C/TPA may know of the refusal. If the
C/TPA does not report the problem to FMCSA, the likelihood of the
owner-operator getting away with his or her refusal is heightened.
Others raised confidentiality concerns and thought that there could be
problems if service agents reported incomplete or erroneous information
to the DOT agencies. Some service agents also feared that if they had
authority to report violations to DOT agencies, even if this were not
mandatory under the rule, they would be liable for not doing so. Others
thought that this would create a difficult conflict of interest
situation for service agents.
DOT Response
The Department has decided to drop the proposal to permit or
require MROs to pass on to third party employers information about the
results of tests the employee took at the direction of another
employer. The Department understands that confidentiality rules
sometimes place MROs in a difficult position. Nevertheless,
confidentiality is a cornerstone of the balance between safety and
employee privacy that is crucial to the acceptance and
constitutionality of the testing program. The Department is also
concerned that
[[Page 79476]]
it would be very difficult to draft a provision that solved the
``doctor's dilemma'' situation without opening the floodgates to
widespread searching of large data bases for information on employee
testing records that could severely compromise confidentiality. We do
not think our NPRM language succeeded at this task. Consequently, as
under the current rule, MROs will be prohibited from passing such
information on to third party employers without the employee's consent.
As described in the discussion of Sec. 40.25, we are adding a
requirement to query previous employers for drug and alcohol test
information in place of the proposed provision, based on an existing
FMCSA provision.
Another alternative to the proposal would be to create a Federal
data base that would include all test results, which authorized
employers could search to learn authorized information about current or
prospective employees. This is a significant issue, but not one we are
able to resolve at this time. We do believe that, in order to be
effective, a data base of this sort would have to be national in scope
under Federal supervision, rather than a mixture of state, local, and
private data bases. It would also have to successfully solve security,
access, due process, and updating issues. Creation of such a data base
remains a matter for further study.
The Department has decided to broaden the scope of release of
information in the context of legal proceedings. We have added a
provision (see Sec. 40.323) that would permit employers to release test
information in a criminal or civil court proceeding resulting from an
employee's performance of safety-sensitive duties, if the court orders
it. For example, in personal injury litigation following a truck or bus
collision, the court could determine that a post-accident drug test
result of an employee is relevant to determining whether the driver or
the driver's employer was negligent. The employer would be authorized
to respond to the court's order to produce the records.
There would be limits on the use of this information, however. The
employer could release the information only to the decisionmaker, such
as the judge in a lawsuit. It could be released only subject to a
binding stipulation or protective order that the decisionmaker to whom
it is released will make it available only to the parties to the
proceeding, who could not disseminate it further or use it for other
purposes. The Department believes that this approach provides for
relevant use of test information without permitting the information to
be spread about too widely. These limits also apply in situations where
the information is made available in a proceeding brought by the
employee (e.g., a grievance, arbitration, or lawsuit concerning
personnel action following a violation).
The Department has decided against requiring service agents to
report apparent violations of the rules to the DOT agencies. Service
agents can do so in any situation in which DOT agency rules already
permit them to do so. The principal reason for this decision is that
the Department's enforcement resources are limited. The DOT agencies
must take great care in prioritizing the use of those resources, so
that the greatest safety benefit is derived from their allocation.
Service Agent Contract Language
The NPRM proposed that every contract or agreement between an
employer and a service agent would have to include an assurance of
compliance with DOT rules. The purpose of this proposal was to ensure
that the obligation to comply with Part 40 and other DOT rules was not
only a matter of regulation, but also a key part of the contractual
relationship among participants in the testing program.
Comments
Some employers and unions favored the proposed requirement, saying
that it would help them ensure that services were provided properly.
They said it would create universally understood contract remedies if
service agents failed to provide appropriate services. Most of the
commenters on this proposal were service agents, and they almost
unanimously opposed the proposal. They said it would add substantially
to the paperwork burden of the rule and would add costs (e.g., for
attorney involvement in the contracting process). Moreover, opponents
said, there are many times in which employers do not have written
contracts with some service agents (e.g., collection sites remote from
the employer's principal place of business), so there is no contract in
which to incorporate such a clause. Requiring written contracts where
none now exist would also be unnecessarily burdensome, they said. A
mandatory contract clause could also lead to litigation, some
commenters feared.
DOT Response
The purpose of the proposed requirement was to ensure that
compliance by service agents with this and other DOT rules was an
enforceable contractual responsibility. The Department now believes
that this purpose can be achieved by other means. We have replaced the
proposed written contract clause requirement with a regulatory
statement (see Sec. 40.11(c)). It provides that all agreements and
arrangements, written or unwritten, between employers and service
agents are deemed, as a matter of law, to require compliance with all
applicable provisions of this part and DOT agency drug and alcohol
testing regulations. The rule declares that compliance with these
provisions is a material term of all such agreements and arrangements.
Combined with the PIE provisions of Subpart R, this provision ensures
that when a service agent is in noncompliance, DOT (through a PIE) or
an employer (through a contract action) can respond effectively to
service agent noncompliance. These provisions will achieve the
Department's objective without incurring the paperwork burden and other
problems cited by commenters with the NPRM provision. We also did not
want to create potential compliance problems for service agents and
employers based on the lack of a written agreement.
Electronic Technology Applications
The NPRM asked for comment on how best to incorporate electronic
technology into the drug and alcohol testing process to a greater
extent.
Comments
A substantial majority of all commenters on this issue strongly
supported the wider use of electronic technology throughout the DOT
drug and alcohol testing program. The suggested applications included
such things as electronic signatures by various participants, an
electronic CCF, and electronic storage and transmission of data. One of
the goals mentioned in some comments was the ``paperless lab.''
Supporters emphasized the greater speed and efficiency of these
applications, contrasted to a paper-based system. Some commenters noted
that electronic applications of this kind were already in wide use in
the private, non-regulated sector of drug and alcohol testing, and that
the Food and Drug Administration had approved the use of electronic
signatures in some contexts.
Commenters mentioned that, in order to do the job right, electronic
applications had to ensure the integrity and security of information,
but many commenters also said that appropriate technological tools for
this purpose already existed. Some commenters sounded cautionary notes,
particularly with respect to the Department being assured of the
effectiveness of system safeguards and the forensic acceptability
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of electronic records and signatures before authorizing additional use
of electronic applications in the program.
DOT Response
The Department believes that the increased use of electronic
methods in the program is both inevitable and beneficial. At the same
time, we want to make sure that there are good, consistent minimum
standards for the use of this technology, so that the integrity and
confidentiality requirements of the program continue to be met. For
this reason, the Department, in cooperation with HHS and the Office and
Management and Budget (OMB), intend to form an advisory committee under
the Federal Advisory Committee Act. Many of the interested parties
began meeting this past summer to discuss the issues under the auspices
of an OMB information technology initiative.
This committee would be charged with making recommendations to DOT
and HHS concerning changes in our regulations we could make to
accommodate electronic technology. The committee would also make
recommendations about consistent minimum standards for the technology
used in Federal drug and alcohol testing programs. The Department
anticipates that, following the receipt of the committee's
recommendations, DOT and HHS will propose changes to Part 40 and the
HHS Guidelines that will result in authorizing the more widespread use
of electronic technology in the program.
Meanwhile, the Department will make some modest changes to its
requirements. For example, we will permit greater use of faxes and
scanned computer images for reporting test results. Additionally, we
are permitting laboratories to send electronic results reports to the
MROs, provided that the laboratory and the MRO ensure that the
information is accurate and can be transmitted in such a manner as to
prevent unauthorized access or release of this information while it is
transmitted or stored. The Department, at this point, is not requiring
specific transmission or security standards, but as these are developed
in the future, we will provide them as guidance for laboratories and
MROs. Even when the Department has changed its regulations to permit
greater use of electronic methods, we expect to retain the option to
use a paper-based system, however. This is because many of the
participants in our program, such as small transportation employers,
may not be equipped to participate in a fully electronic system.
MRO/Laboratory Conflicts of Interest
The Department has long believed that the MRO has a uniquely
important responsibility for maintaining the integrity of the
Department's drug testing system. For that reason, since the beginning
of the Department's program, we have been concerned about the potential
of conflicts of interest between MROs and other participants in the
system, particularly the laboratory. For example, if an MRO is
reviewing results of a laboratory with which the MRO has a financial
relationship, it could happen, or appear to happen, that the MRO would
be less likely to bring problems in the laboratory's test results to
light. In the NPRM, the Department asked commenters for their thoughts
on conflicts of interest, particularly whether the Department should
state with greater specificity the kinds of relationship that involve
conflicts or the appearance of conflicts.
Comments
Some commenters questioned the NPRM's focus on the MRO-laboratory
relationship, saying there were other relationships among participants
that could be as or more troubling (e.g., laboratory-collection site
relationships). Commenters also differed about what the rule should say
about laboratory-MRO relationships. Some commenters favored a strict
separation of roles, while others said that the program would be more
efficient and less costly if MROs and laboratories could collaborate
more closely. Some commenters, in response to a preamble question,
supported adding more specific guidance to the rule on what sorts of
relationships were considered inappropriate.
A large majority of comments on this issue said it was important
for the rule text to list the kinds of relationships that the
Department regarded as creating conflicts of interest between MROs and
laboratories. The comments acknowledged the significance of maintaining
laboratory/MRO relationships that were free of such conflicts, in order
to maintain the integrity of the program. In the absence of
specificity, however, a general provision prohibiting conflicts or
requiring a certification that there were none would be ineffective,
they said. Commenters generally agreed with the list of conflicts
listed in the NPRM preamble, as a means of ensuring the necessary
separation of functions among participants. Commenters who dissented
from this position usually argued that to prohibit close MRO/laboratory
relationships would interfere with the integrated organizational
arrangements that were most efficient in providing services to
customers economically (e.g., one-stop shopping or ``turnkey''
programs).
DOT Response
We agree that other relationships in the program might create
conflict of interest issues. However, we continue to believe that the
focus on the MRO-laboratory relationship is appropriate. In our view,
the MRO is a key participant in the process, whose role is to be the
most important protector of the accuracy and integrity of the process.
A potential conflict of interest between an MRO and a laboratory, whose
results the MRO must review, oversee, and, if necessary, question, is a
particularly sensitive matter for the integrity of the program. We urge
appropriate caution, use of firewalls, etc. to avoid potential
conflicts of interest among all participants, but we believe that clear
regulatory guidance is important in the MRO/laboratory relationship.
While we recognize that commenters' views differ, we believe the
program is best served by avoiding MRO/laboratory conflicts of interest
or their appearance. We believe that a clear separation of their
respective roles is necessary for this purpose. We have maintained this
separation under the current rule, and we do not have evidence that
this has unduly hampered the efficiency of the program.
In response to comments, we have added list of actions that we view
as creating the reality or appearance of a conflict of interest. These
examples are not new creations: they codify guidance that the
Department has given in several specific situations over the years.
They are essentially the same examples listed in the preamble to the
NPRM, with the clarification that they apply to MROs who actually
review test results produced by the laboratory in question. This list
of examples is not exclusive or exhaustive: other situations may arise
that would constitute conflicts. The list is the following:
(1) The laboratory employs an MRO who reviews test results produced
by the laboratory.
(2) The laboratory has a contract or retainer with the MRO for the
review of test results produced by the laboratory.
(3) The laboratory designates which MRO the employer is to use,
recommends certain MROs, or gives the employer a slate of MROs from
which to choose. We do not interpret this provision to prohibit
laboratories from referring employers to a large, global list of MROs
(e.g., a list of all MROs who have been certified by one of the
[[Page 79478]]
national MRO training organizations), so long as the laboratory does
not edit the list or express a preference or recommendation among the
MROs on the list.
(4) The laboratory gives the employer a discount or other incentive
to use a particular MRO.
(5) The laboratory has its place of business co-located with that
of an MRO or MRO staff who review test results produced by the
laboratory;
(6) The laboratory derives a financial or other benefit from having
an employer use a particular MRO; or
(7) The laboratory permits an MRO, or an MRO's organization, to
have a significant financial interest in the laboratory.
Validity Testing
By validity testing, we mean testing that laboratories conduct to
deter and detect tampering with tests. The two most important
categories of tampering are adulterating a specimen (e.g., putting a
substance into a specimen designed to mask or destroy the drug or drug
metabolite that the specimen may contain) or substituting a specimen
(e.g., supplying water or some other substance in place of urine). The
NPRM proposed to require laboratories to conduct validity testing on
all specimens. It asked for comment on whether MRO review and split
specimen testing should be applied to specimens that laboratories found
to be adulterated or substituted, as they are to specimens that test
positive for drugs. Validity testing is probably the most difficult and
controversial issue in this rulemaking.
Comments
1. Adulteration
A significant majority of commenters on the subject supported the
idea of testing for adulterants. Commenters said that the purpose of
such testing was to counteract tampering, which some said appeared to
be on the rise in their experience. They cited the increased
availability of substances and techniques claiming to protect drug
users from testing positive for drugs, which are quite commonly
advertised in publications and on the internet.
Many commenters cited the volatility of the adulterant market,
noting that the popularity of particular adulterants rise and fall. As
countermeasures to one substance are found, other adulterants come into
prominence, in a continuing ``arms race'' between those who try to
facilitate and those who try to deter and detect ways of ``beating the
test.'' Therefore, commenters said, there needs to be flexibility in
the ``adulteration panels'' that laboratories use, to allow them to
keep up with an ever-changing adulterant market. It is not helpful, in
view of this need for flexibility, to mandate testing for specific
substances such as nitrites, several commenters said.
Two employee groups said that there was no evidence supporting the
need for adulterant testing. They also said that adulterant testing was
too burdensome. One laboratory suggested that adulterant testing should
remain discretionary with laboratories, rather than mandated by the
rule. Another commenter said that there should be standardized DHHS
testing methodologies for adulterants, just as there are for drugs.
Several commenters supported extending the blind testing program to
adulterated and substituted specimens as a further safeguard. A few
commenters addressed the issue of cost, but they did not agree with one
another about whether adulterant testing would add significant costs to
the program. Supporters of alternative testing methods (e.g., saliva,
hair, on-site testing) argued that their methods would be quicker and
more effective at detecting adulterants than the present laboratory-
based urine testing system.
2. Substitution
Generally, commenters who supported testing for adulteration also
supported testing for substitution. However, a number of commenters had
greater concerns about substitution testing. Some comments, including
one extensive comment submitted by a union, contended that the criteria
for substitution developed by HHS, and incorporated in the NPRM, were
faulty and based on inadequate studies. In particular, this comment
criticized the HHS criteria because the literature on which the
specific gravity and creatinine levels had been based included very few
``paired studies'' looking at both criteria at once. Other comments
criticized the studies because they had not specifically covered
certain employee subgroups. A few comments suggested changing the name
of this sort of specimen from ``substituted,'' which they found too
conclusory, to ``hyper-dilute'' or something similar, which they
believed to be more neutral and descriptive.
During the listening sessions and in written comments, a number of
individuals said they, or people they know, had been unfairly
terminated on the basis of substitution. These individuals were not
drug users, they said, but had consumed large quantities of water over
a long work period. In addition, they were often small-framed minority
women, vegetarians in some cases. They suggested that a combination of
these circumstances could have resulted in the natural, innocent
production of urine meeting the substitution criteria. They sought
additional procedural protections and revision of the substitution
criteria to prevent people from being unfairly found to have
substituted a specimen.
3. Split Specimen Testing
The Department presented three basic options for comment concerning
the application of split specimen testing to findings of adulteration
and substitution. The first option would have continued the
Department's current policy of prohibiting split specimen testing in
these cases. The second option would require split specimen testing in
adulteration and substitution cases, on the same model as the current
requirement for drug positives. The third option would add to the
present system a requirement for the laboratory to test an additional
aliquot of the specimen to ensure that the result could be replicated.
All unions who commented favored the second option. They believed
this was necessary if the system was to be fair and provide due process
to employees whose specimens were found to be adulterated or
substituted. They asserted that the scientific basis and technical
standards for adulteration and substitution findings were weaker than
in the case of drug positives, but pointed out that the consequences
were equivalent (or more severe, in some cases). Employees should have
the same chance to double-check the former as the latter. Some
employers and service agents also supported this approach, principally
on fairness grounds.
Supporters of the first and third options, including a number of
employers and service agents, opposed split specimen testing in
adulteration and substitution as providing a second opportunity for an
employee to beat the test. In addition, they said that the properties
of many adulterants were unknown, and an adulterant might degrade in so
short a time so that it would fail to reconfirm on a split specimen
test. Variations in the findings about the urine could result from
something as simple as the freezing and thawing of the split specimen,
one commenter said. Among commenters in this group, a number supported
Option 3 in preference to Option 1 because it would provide some
additional protection for employees without having the disadvantages of
opening the split specimen.
[[Page 79479]]
4. MRO Review
Generally speaking, commenters lined up in the same way concerning
whether MROs should review and verify adulterated and substituted test
results as they did concerning split specimen testing for these
results. Unions and other supporters said that MRO review, parallel to
that for drug positives, should be made available as a matter of
fairness. For example, if a small female flight attendant who has
consumed a lot of water on a long flig