[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
[[Page 79477]]
of electronic records and signatures before authorizing additional use
of electronic applications in the program.
DOT Response
The Department believes that the increased use of electronic
methods in the program is both inevitable and beneficial. At the same
time, we want to make sure that there are good, consistent minimum
standards for the use of this technology, so that the integrity and
confidentiality requirements of the program continue to be met. For
this reason, the Department, in cooperation with HHS and the Office and
Management and Budget (OMB), intend to form an advisory committee under
the Federal Advisory Committee Act. Many of the interested parties
began meeting this past summer to discuss the issues under the auspices
of an OMB information technology initiative.
This committee would be charged with making recommendations to DOT
and HHS concerning changes in our regulations we could make to
accommodate electronic technology. The committee would also make
recommendations about consistent minimum standards for the technology
used in Federal drug and alcohol testing programs. The Department
anticipates that, following the receipt of the committee's
recommendations, DOT and HHS will propose changes to Part 40 and the
HHS Guidelines that will result in authorizing the more widespread use
of electronic technology in the program.
Meanwhile, the Department will make some modest changes to its
requirements. For example, we will permit greater use of faxes and
scanned computer images for reporting test results. Additionally, we
are permitting laboratories to send electronic results reports to the
MROs, provided that the laboratory and the MRO ensure that the
information is accurate and can be transmitted in such a manner as to
prevent unauthorized access or release of this information while it is
transmitted or stored. The Department, at this point, is not requiring
specific transmission or security standards, but as these are developed
in the future, we will provide them as guidance for laboratories and
MROs. Even when the Department has changed its regulations to permit
greater use of electronic methods, we expect to retain the option to
use a paper-based system, however. This is because many of the
participants in our program, such as small transportation employers,
may not be equipped to participate in a fully electronic system.
MRO/Laboratory Conflicts of Interest
The Department has long believed that the MRO has a uniquely
important responsibility for maintaining the integrity of the
Department's drug testing system. For that reason, since the beginning
of the Department's program, we have been concerned about the potential
of conflicts of interest between MROs and other participants in the
system, particularly the laboratory. For example, if an MRO is
reviewing results of a laboratory with which the MRO has a financial
relationship, it could happen, or appear to happen, that the MRO would
be less likely to bring problems in the laboratory's test results to
light. In the NPRM, the Department asked commenters for their thoughts
on conflicts of interest, particularly whether the Department should
state with greater specificity the kinds of relationship that involve
conflicts or the appearance of conflicts.
Comments
Some commenters questioned the NPRM's focus on the MRO-laboratory
relationship, saying there were other relationships among participants
that could be as or more troubling (e.g., laboratory-collection site
relationships). Commenters also differed about what the rule should say
about laboratory-MRO relationships. Some commenters favored a strict
separation of roles, while others said that the program would be more
efficient and less costly if MROs and laboratories could collaborate
more closely. Some commenters, in response to a preamble question,
supported adding more specific guidance to the rule on what sorts of
relationships were considered inappropriate.
A large majority of comments on this issue said it was important
for the rule text to list the kinds of relationships that the
Department regarded as creating conflicts of interest between MROs and
laboratories. The comments acknowledged the significance of maintaining
laboratory/MRO relationships that were free of such conflicts, in order
to maintain the integrity of the program. In the absence of
specificity, however, a general provision prohibiting conflicts or
requiring a certification that there were none would be ineffective,
they said. Commenters generally agreed with the list of conflicts
listed in the NPRM preamble, as a means of ensuring the necessary
separation of functions among participants. Commenters who dissented
from this position usually argued that to prohibit close MRO/laboratory
relationships would interfere with the integrated organizational
arrangements that were most efficient in providing services to
customers economically (e.g., one-stop shopping or ``turnkey''
programs).
DOT Response
We agree that other relationships in the program might create
conflict of interest issues. However, we continue to believe that the
focus on the MRO-laboratory relationship is appropriate. In our view,
the MRO is a key participant in the process, whose role is to be the
most important protector of the accuracy and integrity of the process.
A potential conflict of interest between an MRO and a laboratory, whose
results the MRO must review, oversee, and, if necessary, question, is a
particularly sensitive matter for the integrity of the program. We urge
appropriate caution, use of firewalls, etc. to avoid potential
conflicts of interest among all participants, but we believe that clear
regulatory guidance is important in the MRO/laboratory relationship.
While we recognize that commenters' views differ, we believe the
program is best served by avoiding MRO/laboratory conflicts of interest
or their appearance. We believe that a clear separation of their
respective roles is necessary for this purpose. We have maintained this
separation under the current rule, and we do not have evidence that
this has unduly hampered the efficiency of the program.
In response to comments, we have added list of actions that we view
as creating the reality or appearance of a conflict of interest. These
examples are not new creations: they codify guidance that the
Department has given in several specific situations over the years.
They are essentially the same examples listed in the preamble to the
NPRM, with the clarification that they apply to MROs who actually
review test results produced by the laboratory in question. This list
of examples is not exclusive or exhaustive: other situations may arise
that would constitute conflicts. The list is the following:
(1) The laboratory employs an MRO who reviews test results produced
by the laboratory.
(2) The laboratory has a contract or retainer with the MRO for the
review of test results produced by the laboratory.
(3) The laboratory designates which MRO the employer is to use,
recommends certain MROs, or gives the employer a slate of MROs from
which to choose. We do not interpret this provision to prohibit
laboratories from referring employers to a large, global list of MROs
(e.g., a list of all MROs who have been certified by one of the
[[Page 79478]]
national MRO training organizations), so long as the laboratory does
not edit the list or express a preference or recommendation among the
MROs on the list.
(4) The laboratory gives the employer a discount or other incentive
to use a particular MRO.
(5) The laboratory has its place of business co-located with that
of an MRO or MRO staff who review test results produced by the
laboratory;
(6) The laboratory derives a financial or other benefit from having
an employer use a particular MRO; or
(7) The laboratory permits an MRO, or an MRO's organization, to
have a significant financial interest in the laboratory.
Validity Testing
By validity testing, we mean testing that laboratories conduct to
deter and detect tampering with tests. The two most important
categories of tampering are adulterating a specimen (e.g., putting a
substance into a specimen designed to mask or destroy the drug or drug
metabolite that the specimen may contain) or substituting a specimen
(e.g., supplying water or some other substance in place of urine). The
NPRM proposed to require laboratories to conduct validity testing on
all specimens. It asked for comment on whether MRO review and split
specimen testing should be applied to specimens that laboratories found
to be adulterated or substituted, as they are to specimens that test
positive for drugs. Validity testing is probably the most difficult and
controversial issue in this rulemaking.
Comments
1. Adulteration
A significant majority of commenters on the subject supported the
idea of testing for adulterants. Commenters said that the purpose of
such testing was to counteract tampering, which some said appeared to
be on the rise in their experience. They cited the increased
availability of substances and techniques claiming to protect drug
users from testing positive for drugs, which are quite commonly
advertised in publications and on the internet.
Many commenters cited the volatility of the adulterant market,
noting that the popularity of particular adulterants rise and fall. As
countermeasures to one substance are found, other adulterants come into
prominence, in a continuing ``arms race'' between those who try to
facilitate and those who try to deter and detect ways of ``beating the
test.'' Therefore, commenters said, there needs to be flexibility in
the ``adulteration panels'' that laboratories use, to allow them to
keep up with an ever-changing adulterant market. It is not helpful, in
view of this need for flexibility, to mandate testing for specific
substances such as nitrites, several commenters said.
Two employee groups said that there was no evidence supporting the
need for adulterant testing. They also said that adulterant testing was
too burdensome. One laboratory suggested that adulterant testing should
remain discretionary with laboratories, rather than mandated by the
rule. Another commenter said that there should be standardized DHHS
testing methodologies for adulterants, just as there are for drugs.
Several commenters supported extending the blind testing program to
adulterated and substituted specimens as a further safeguard. A few
commenters addressed the issue of cost, but they did not agree with one
another about whether adulterant testing would add significant costs to
the program. Supporters of alternative testing methods (e.g., saliva,
hair, on-site testing) argued that their methods would be quicker and
more effective at detecting adulterants than the present laboratory-
based urine testing system.
2. Substitution
Generally, commenters who supported testing for adulteration also
supported testing for substitution. However, a number of commenters had
greater concerns about substitution testing. Some comments, including
one extensive comment submitted by a union, contended that the criteria
for substitution developed by HHS, and incorporated in the NPRM, were
faulty and based on inadequate studies. In particular, this comment
criticized the HHS criteria because the literature on which the
specific gravity and creatinine levels had been based included very few
``paired studies'' looking at both criteria at once. Other comments
criticized the studies because they had not specifically covered
certain employee subgroups. A few comments suggested changing the name
of this sort of specimen from ``substituted,'' which they found too
conclusory, to ``hyper-dilute'' or something similar, which they
believed to be more neutral and descriptive.
During the listening sessions and in written comments, a number of
individuals said they, or people they know, had been unfairly
terminated on the basis of substitution. These individuals were not
drug users, they said, but had consumed large quantities of water over
a long work period. In addition, they were often small-framed minority
women, vegetarians in some cases. They suggested that a combination of
these circumstances could have resulted in the natural, innocent
production of urine meeting the substitution criteria. They sought
additional procedural protections and revision of the substitution
criteria to prevent people from being unfairly found to have
substituted a specimen.
3. Split Specimen Testing
The Department presented three basic options for comment concerning
the application of split specimen testing to findings of adulteration
and substitution. The first option would have continued the
Department's current policy of prohibiting split specimen testing in
these cases. The second option would require split specimen testing in
adulteration and substitution cases, on the same model as the current
requirement for drug positives. The third option would add to the
present system a requirement for the laboratory to test an additional
aliquot of the specimen to ensure that the result could be replicated.
All unions who commented favored the second option. They believed
this was necessary if the system was to be fair and provide due process
to employees whose specimens were found to be adulterated or
substituted. They asserted that the scientific basis and technical
standards for adulteration and substitution findings were weaker than
in the case of drug positives, but pointed out that the consequences
were equivalent (or more severe, in some cases). Employees should have
the same chance to double-check the former as the latter. Some
employers and service agents also supported this approach, principally
on fairness grounds.
Supporters of the first and third options, including a number of
employers and service agents, opposed split specimen testing in
adulteration and substitution as providing a second opportunity for an
employee to beat the test. In addition, they said that the properties
of many adulterants were unknown, and an adulterant might degrade in so
short a time so that it would fail to reconfirm on a split specimen
test. Variations in the findings about the urine could result from
something as simple as the freezing and thawing of the split specimen,
one commenter said. Among commenters in this group, a number supported
Option 3 in preference to Option 1 because it would provide some
additional protection for employees without having the disadvantages of
opening the split specimen.
[[Page 79479]]
4. MRO Review
Generally speaking, commenters lined up in the same way concerning
whether MROs should review and verify adulterated and substituted test
results as they did concerning split specimen testing for these
results. Unions and other supporters said that MRO review, parallel to
that for drug positives, should be made available as a matter of
fairness. For example, if a small female flight attendant who has
consumed a lot of water on a long flight gets a substituted test
result, she should have the opportunity to offer an explanation to the
MRO. If she made her case, the MRO should verify the result negative,
just as in the case of a drug positive with a legitimate medical
explanation.
Opponents of MRO review for adulteration and substitution cases
said that it would be cumbersome. Also, there are not established
standards for a ``legitimate medical explanation'' in the adulteration
and substitution area as there are with respect to drugs, meaning that
MROs would be acting in a less well informed way. Some commenters said
that there were no legitimate medical explanations for the presence of
adulterants, so the medical review process would be an empty exercise.
DOT Response
We begin with the premise that tampering with drug tests is a bad
thing and a serious safety concern. When people do so, it is probably
because they want to continue using drugs while also continuing to
perform safety-sensitive duties. Continuing to do both these things is
precisely what the DOT drug testing program, in the interest of safety,
is designed to prevent. To the extent that people believe that they can
successfully beat a test, the deterrent effect of the program is
diminished. One can oppose the concept of testing to catch tampering
only if one believes that it is acceptable for people both to continue
using drugs and to continue performing safety-sensitive duties.
There were no commenters who said that they opposed the concept of
testing to catch tampering with drug tests. Some commenters, however,
said that it was not proven that tampering was so serious a problem as
to warrant validity testing. The majority of commenters disagreed, and
many were parties (laboratories, MROs, C/TPAs) who have significant
experience in reviewing specimens and test results. Our own experience
in working with participants in the program is consistent with that of
commenters who believe that adulteration and substitution are
relatively prevalent, serious issues requiring a regulatory response.
The wide public advertising of substances and techniques to protect
drug users from tests is further suggestive of a thriving cottage
industry designed to help people beat drug tests.
The Department consequently will make validity testing mandatory.
Laboratories will test all incoming primary specimens for dilution,
substitution, and adulteration. We believe that mandating that all
laboratories test all primary specimens will result in greater
uniformity of testing methods. Testing methods must be consistent with
HHS requirements and guidance (HHS Program Documents 35 and 37 at the
present time), upon which DOT will rely for purposes of this rule. As
noted above, we will coordinate the effective date for mandatory
validity testing with the issuance of HHS mandatory requirements on
validity testing. The Department is convinced that testing in
accordance with HHS requirements and guidance results in scientifically
valid tests for pH, creatinine, specific gravity, and various
adulterants.
Consistent with comments that it was not advisable to list specific
adulterants in the rule, since they change rapidly, the Department will
simply rely on HHS rules and guidance, which can change to reflect new
adulterants for laboratories to test. The Department's final rule also
minimizes statements of requirements for laboratory testing
methodology, since that is also an area in which we rely on HHS
requirements and guidance. We do not believe that extensive duplication
is necessary.
The Department has thought a great deal about the HHS substitution
criteria, which were the subject of extensive comment. HHS developed
these criteria based on an extensive review of the literature (``NLCP:
STATE OF THE SCIENCE--UPDATE # 1--Urine Specimen Validity Testing:
Evaluation of the Scientific Data Used to Define a Urine Specimen as
Substituted (February 14, 2000)''). We are aware that this literature
review included only a few ``paired studies'' that simultaneously
looked at both the specific gravity and creatinine criteria.
Nevertheless, there is nothing in the HHS literature review that
suggests any other criteria that would be more appropriate for
determining substitution or that the existing criteria are erroneous.
Notwithstanding the critique in the comment we received, no scientific
paper of which we are aware has suggested criteria that it claimed was
more appropriate. It is very significant that even the most vocal
opponents of the substitution criteria were unable to provide a single
documented instance of an individual meeting both substitution criteria
through natural means in a controlled setting.
We are also aware that most of the studies in the HHS literature
review were studies of the general population that did not focus on
specific subgroups. This is an acceptable practice in medical and
scientific studies. Moreover, the Department does not believe that, to
adopt generally applicable substitution criteria, it must demonstrate
the suitability of the criteria over and over again for every
conceivable subset of the population.
To provide further information about these issues, the Department
conducted its own study. The text of this study is available on the
ODAPC web site (www.dot.gov/ost/dapc). The study was designed
specifically to focus on two issues on which commenters criticized the
HHS literature review, the absence of paired studies and insufficient
study of female subjects. The DOT study made paired measurements of
urine creatinine and specific gravity in a predominately female (40 of
56) group of subjects.
All participants in the study were of reasonable working age (19-
56). All participants volunteered to consume at least 80 ounces of
fluid spread evenly over six consecutive hours. The protocol asked for
40 ounces to be consumed within the first three hours of this six-hour
test period. This would be immediately followed by the consumption of
at least another 40 ounces in the last three hours of the six-hour test
period. Urine specimens were collected prior to the start of the six-
hour period and at the end of each subsequent hour in the test period.
Urine specimens were also collected on awakening the morning of the
test day and on awakening the morning following the test day (this
amounted to a total of nine urine specimens being requested from each
participant).
Each participant was asked to document the amount and type (water,
coffee) of fluid consumed from awakening through completion of the six-
hour period, along with the total amount of urine produced from
awakening through the six-hour period. Height, weight, age, gender,
ethnicity, eating habits, and medications taken regularly and on the
day of the collections were also documented. All urine specimens were
sent to an HHS-certified laboratory where creatinine and specific
gravity were measured using well-established laboratory techniques.
The 56 subjects provided a total of 500 urine specimens. 504
specimens
[[Page 79480]]
were expected; however, three individuals did not collect one of the
specimens on awakening, and one person was unable to complete the
second three hours of drinking per the test protocol. Two participants
were unable to consume the minimum amount of fluid originally intended
(total of 80 ounces, or approximately 2370 mL, spread evenly over the
six hours). The remainder consumed at least the minimum requested.
Twelve participants (five men and seven women) consumed over one gallon
of fluid by the end of their test periods.
Not one of the 500 specimens was identified as ``substituted''
based on the HHS criteria. This point deserves emphasis. The DOT
research involved paired studies of predominately female subjects who
drank copious quantities of water under controlled conditions. This
examination of paired values of creatinine and specific gravity from
500 specimens collected under water loading conditions strongly
supports the criteria developed by HHS. There was no evidence that
individuals, regardless of gender or other factors and despite
consuming unusually large amounts of fluids, are capable of
physiologically producing urine meeting the HHS substitution criteria.
We do note that 113 of the specimens did meet the criteria for
``dilute'' specimens, as defined by HHS. Under Part 40, a dilute
specimen does not constitute a refusal to test.
The propriety of the HHS substitution criteria was not the only
area on which comments were received on validity testing. Several
commenters questioned the tests used to determine validity as not being
equivalent to the tests used in drug testing. Specifically at issue was
whether or not the use of two different technologies is required for
the initial and confirmatory tests.
These comments, and their references to statements by two
professional toxicology organizations--the American Academy of Forensic
Sciences (AAFS) and the Society of Forensic Toxicologists (SOFT)--do
not successfully make a case that the HHS-approved testing methods for
adulteration and substitution are faulty.
Not all types of tests are the same. In testing for the ``HHS
five'' drugs, we are looking for chemically complex substances that we
do not expect to find in most specimens. We use an immunoassay followed
by gas chromatography/mass spectrometry (GC/MS). As applied, for
example, to amphetamines, the immunossay test identifies a broader
category of substances including, but not limited to, amphetamine and
methamphetamine. The GC/MS test is used to increase the specificity of
the testing process and accurately prove the presence of amphetamine or
methamphetamine.
By contrast, creatinine is a very simple substance that we always
expect to find in urine. It is readily identified by colorimetric
techniques, in which a chemical is added to urine to cause a color
change and a special instrument measures light absorbed by the
solution. It is not necessary with creatinine to differentiate specific
complex substances from other substances that may be present in the
specimen. Therefore, a second analytical technique to provide greater
specificity is not needed. A single analytic technique repeated on a
second specimen to ensure that we have a reproducible result is much
more to the point.
In the case of creatinine, the initial validity test result is
analogous to that of a confirmation drug test result. It produces a
quantified result suitable for use in determining whether the specimen
is substituted or diluted. The second validity test performed on the
specimen is sufficient to support fully the first validity test result.
Because of the nature of the creatinine, it is not necessary to use two
different testing technologies to establish a test result with
certainty. (A similar point can be made about alcohol.) The quoted AAFS
and SOFT statements, which apply principally to tests for drugs and
drug metabolites, do not conflict with this analysis.
We also point out that one important purpose of the initial
immunoassay test for drugs is to eliminate negatives in a cost-
effective manner. It would be possible to run two consecutive GC/MS
tests on a specimen and never use the separate immunoassay technique.
Such an approach would lead to results that are completely accurate and
reliable, but the reason we do not require this approach is that it
would be much more expensive.
In the case of substitution, the specific gravity test corroborates
the creatinine result. This provides a level of forensic certainty
equivalent to immunoassay followed by GC/MS in the drug testing case.
Although the specific gravity tests appear to be based on simple
technology, they have been established as reliable through extensive
use over the many years in many clinical settings.
One commenter suggested replacing specific gravity with osmolality,
asserting that measurements of osmotic concentration of urine are
considered more valid than specific gravity measurements. HHS and DOT
believe that there is not a significant difference between osmolality
and specific gravity for validity testing purposes. In fact, specific
gravity is used clinically much more than osmometry. HHS-certified drug
testing laboratories have 12 years of successful experience in testing
for creatinine and specific gravity testing under the HHS guidelines,
and we do not believe that commenters have made a compelling case for
change.
We also note that there are additional testing methods available
for such substances as creatinine, nitrites, glutaraldehyde, chromium,
and various possible adulterants. The fact that other tests exist does
not mean that they must be used to produce an accurate result. The key
point is that the methods we do use must be accurate and above
reproach. DOT and HHS are convinced that the methods we use do produce
the required accuracy for correct results.
Contrary to one commenter's assertion, the Department's approach to
validity testing does not create a ``presumption of guilt.'' A
confirmed laboratory finding, whether for drugs, adulterants, or
substitution, is a matter that calls for explanation. In the absence of
a satisfactory explanation, we are justified in basing regulatory
consequences on the finding.
The Department, in short, has a rational and sound scientific basis
for using the adulteration and substitution criteria we have chosen.
Nonetheless, to ensure fairness and to provide safeguards parallel to
those available in cases of positive drug tests, the Department will
add split specimen testing and MRO review to its procedures in these
cases.
The Department is not legally compelled to include split specimen
testing and MRO review in validity cases. As explained in the preamble
to the NPRM (see 64 FR at 69081-82; December 9, 1999), these additional
safeguards are required neither by the Constitution nor by statute. The
Department's decision is a matter of policy, in the interest of
providing greater fairness to employees in the drug testing program.
The Department notes that situations in which an adulterant is
naturally found or a substitution naturally occurs are likely to be
extremely rare. At the present time, we do not know of any such
situations. However, our policy to allow medical review and use of the
split specimen will provide employees with an additional level of
protection and an added degree of fairness.
With respect to the use of split specimens in validity testing, the
Department's process will parallel the existing split specimen
procedure in the case of drug positives. Within 72 hours
[[Page 79481]]
of being notified by the MRO that his or her test has been verified
adulterated or substituted, the employee may request a test of the
split specimen. A second laboratory will test the split specimen.
Laboratories will use the testing criteria set forth in HHS rules
or guidance. Under current HHS criteria for adulterants, the test of
the split specimen is for the presence of an adulterant, or, in the
case of an adulteration finding based on pH, to ensure that the pH of
the specimen meets the same regulatory criteria as for the primary
specimen. In the case of substitution, the split specimen must meet the
same regulatory criteria as for the primary specimen in order to be
reconfirmed. As with drug positives, the consequence of a failure to
reconfirm is a cancelled test.
With respect to MRO review, the Department's process will also
parallel the existing procedure for drug positives. The employee will
have the opportunity to present a legitimate medical explanation. The
employee, as is the case for all drugs except opiates, has the burden
of proof to demonstrate to the MRO that a legitimate medical
explanation exists. To meet this burden in the case of an adulterated
specimen, the employee will have to demonstrate that the adulterant
entered his or her specimen through physiological means. This will not
be easy to do. Most adulterants are substances that do not naturally
occur in urine. There is no way one can physiologically produce urine
that includes such substances as bleach, glutaraldehyde, or soap, for
example. There cannot be a legitimate medical explanation for the
presence of these substances in urine, any more than there can be a
legitimate medical explanation for the presence of PCP in a specimen.
In cases where there is no reasonable apparent legitimate medical
explanation, the MRO would verify the adulterated result. However, if
an employee presents what the MRO believes could be a legitimate
medical explanation, the MRO will tell the employee he or she may
obtain additional evaluation from another physician, acceptable to the
MRO, who has expertise relevant to the explanation. This would ensure
that the MRO, standing alone, would not be called on to make a decision
for which he or she lacked the needed expertise. The referral physician
would make a recommendation about whether there was a legitimate
medical explanation. The referral physician would evaluate any
information presented by the employee in making his or her
determination. If the referral physician found that there was a
legitimate medical explanation, the MRO would review the referral
physician's recommendation and, if appropriate in the MRO's judgment,
cancel the test.
MROs would follow the same process in the case of a substitution
result. The MRO review provision for substitution emphasizes that it is
not enough for the employee to show that he or she has a medical
condition or has certain personal characteristics. The employee must
establish the link between these facts and the ability to
physiologically produce urine meeting the substitution criteria. For
example, a replication of the employee's original test result, under
carefully controlled conditions (including direct observation) could
establish such a link.
To meet our fairness objectives, we believe it is necessary to
provide MRO review that can result in the cancellation of a test if the
employee provides a legitimate medical explanation. Nevertheless, the
Department emphasizes that it is the employee's burden to prove that
such an explanation exists. The MRO is not responsible for disproving
an employee's assertions.
The Department will retain the word ``substitution,'' rather than
changing to a term like ``hyper-dilute.'' Given the structure of the
final rule, it seems clear that a laboratory ``substituted'' result is
simply a confirmed result that must be verified by an MRO before
becoming final, just like a confirmed drug positive. HHS uses this term
in the Federal employee program, and it is useful to keep terms as
consistent as possible between the two related programs.
The Department works closely with HHS on validity testing issues,
and the Department will use validity testing criteria set forth in HHS
requirements and guidance. Validity testing is a subject that HHS, like
DOT, takes very seriously, and HHS will issue additional guidance, as
needed, to support the DOT validity testing program. We will work with
HHS to ensure that validity testing remains as technically sound as the
rest of the DOT program. The updated and clarified collection
procedures in this final rule will help insure the integrity of the
urine specimen. In addition, each laboratory will conduct validity
testing under specific HHS guidance and quality control review, and the
blind specimen quality control program will include adulterated and
substituted specimens. Validity testing has now become a factor in the
HHS evaluation of laboratories for certification and recertification.
In addition, the application of split specimen testing and MRO review
to validity tests will provide further safeguards for employees,
parallel to the existing drug testing program.
Laboratory Problems
In September 2000, the Department learned of a significant series
of errors by one laboratory involved in validity testing. The first
error that came to our attention involved apparent misconduct by
laboratory personnel. Following a test result that met HHS substitution
criteria, laboratory personnel apparently backdated documents
explaining a minor irregularity in laboratory controls used to check
the accuracy of testing machinery. These documents were then placed in
the ``litigation package'' intended for use in an FAA certification
proceeding involving the employee. To make matters worse, someone
allegedly tore up a purported photocopy of the original of the
backdated documents, and the laboratory official who signed the
litigation package (no longer employed by the laboratory) allegedly had
claimed credentials he did not have. These events undermined the
credibility of the laboratory in this case so much that FAA enforcement
attorneys felt compelled to settle the certification action.
Second, the laboratory made significant errors in reading test
results. One error was the practice of ``truncating'' creatinine
measurements (i.e., expressing results only in whole numbers). This
practice, which was not specifically mentioned in HHS Program Document
35 but was specifically contrary to Program Document 37, causes any
result in the 5 to 5.9 range to be reported as a 5. Since a result of 5
or less is one of the criteria for substitution, this practice could
have the effect of causing a specimen that was outside the creatinine
criterion for substitution to be interpreted as meeting this criterion.
This throws into question substitution results where the creatinine
measurement was a 5. (It does not affect results where the creatinine
result was below 5.) In addition, laboratory personnel apparently
interpreted an error message (``LLL'') from a machine used to measure
specific gravity as a measurement of 1.000. There is not a sound basis
for making this interpretation.
When we learned of these problems, we immediately involved HHS. The
DOT and HHS Inspector Generals reviewed the apparent evidence-
tampering. In addition, this situation led us to add tampering with
documentation by a laboratory as a type of noncompliance that can be
subject to a PIE proceeding (see Sec. 40.365). The
[[Page 79482]]
employer who had used the laboratory in question terminated its
contract with the laboratory and offered to rehire five employees whose
test results had been thrown into question by the laboratory's errors.
The laboratory director subsequently resigned.
HHS promptly conducted a special inspection of the laboratory.
Following the inspection, HHS determined that the laboratory had
corrected the result-reading problems with substitution and had been,
since January 2000, in full compliance with DOT and HHS requirements.
HHS also surveyed all other laboratories to determine if any had made
similar errors in reading results and to determine whether they were in
compliance. No one else had made the error message interpretation
mistake concerning specific gravity. However, HHS determined that, for
varying periods of time (in many cases before the specific guidance on
this point was issued in Program Document 37, but in some cases after),
40 or more laboratories had engaged in ``truncating'' creatinine
results. All the laboratories involved subsequently stopped this
practice, and all are now reading these results properly.
In addition to these problems, HHS also discovered that in some
cases, laboratories had reported tests as substituted that did not meet
both HHS substitution criteria. That is, the laboratories reported
tests as substituted that met the creatinine criterion, even though
they did not also meet the specific gravity criterion.
HHS has examined each individual substitution and adulteration test
result that a laboratory has reported since September 1998, when
Program Document 35 took effect. In any case in which a substitution
result was based on a creatinine reading of 5 at a laboratory that was
truncating results at the time, or in which a substitution result was
reported that did not meet all HHS criteria, HHS and DOT are working to
remedy the problem as it may have affected individual employees. HHS is
in the process of sending a letter to each MRO involved with one of the
approximately 300 specimens involved informing the MRO that the test
must be cancelled. The letter directs the MRO to inform the employer of
the cancellation and to tell the employer to attempt to contact the
employee with this information. The employer is also told to take any
appropriate personnel action in light of the cancellation.
HHS is also conducting special certification inspections of each
laboratory that is performing validity testing to ensure that all its
validity testing procedures are fully consistent with HHS guidance.
These inspections will be completed this month. The laboratories
involved full compliance with HHS validity testing requirements will
now be a condition of maintaining their certification to participate in
the Federal and DOT drug testing programs.
We are deeply concerned about this situation, because laboratory
problems of this kind can result in unfair treatment of employees and
adversely affect the credibility and integrity of our program. We point
out, however, that nothing in this situation suggests that there is
anything wrong with the criteria and methods for validity testing. The
problems in this case were human implementation errors, now corrected,
involving the reading of results and the documentation and reporting of
tests, not in the testing process itself or the scientific basis for
it. The Department believes that it is appropriate to continue to
implement validity testing as called for in this rule.
Section-by-Section Discussion
The following part of the preamble discusses each of the final
rule's sections, including responses to comments on each section.
Subpart A--Administrative Provisions
Section 40.1 Who Does This Regulation Cover?
This section attracted little comment. One commenter expressed
concern about potential coverage of volunteers in one FTA program,
while another wanted to specify that contractors could also be covered.
The final rule specifies that contractors, volunteers, and others would
be covered by Part 40 to the extent that they are subject to other DOT
agency drug and alcohol rules.
The Federal Railroad Administration (FRA) operates a post-accident
drug and alcohol testing program that antedates Part 40 and differs in
a number of ways from the rest of the Department's programs (e.g., with
respect to fluids tested, drugs that are tested for). We do not intend
to interfere with the implementation of this long-standing program, and
we have added a paragraph making this clear.
Section 40.3 What Do the Terms Used in This Regulation Mean?
Commenters expressed interest in several of the definitions of
terms in the NPRM. A commenter made a technical point that some kinds
of evidential breath testing devices (EBTs) do not literally sample the
ambient air, as the definition of ``air blank'' provides. We added a
sentence to the definition noting that for some devices, the ``air
blank'' is a reading of the device's internal standard.
A commenter noted that the definition of ``alcohol use'' talks of
``drinking or swallowing'' rather than ``consumption,'' as in the past.
The reason for this change is to avoid interpretations by enforcement
personnel that such actions as using an inhaler that contain alcohol
are ``alcohol use'' for purposes of this part. For example, the use of
rubbing alcohol, applied topically rather than imbibed, is not intended
to be a violation of this part.
Commenters interested in the role of service agents in the program
asked for definitions of ``consortium'' and ``third party
administrator.'' One commenter provided proposed definitions, which
included a requirement for individuals with certain certifications to
play key roles in the organization. We considered the possibility of
separate definitions for ``consortium'' and ``third-party
administrator,'' but we did not find any basis for defining the terms
separately. There are no meaningful conceptual or operational
distinctions between organizations that call themselves one thing or
the other of which we are aware or which commenters explained. In the
way the terms are used in the regulation, they are for all practical
purposes interchangeable. Consequently, the final rule uses the term
consortium/third party administrator (C/TPA) to refer to any
organization, however structured, that provides or coordinates a
variety of drug and alcohol testing services to employers.
Organizations would not have to change their names to conform to this
definition (i.e., a C/TPA that currently calls itself a ``consortium''
would not have to call itself something else).
Some commenters asked that C/TPAs be regarded as ``employers''
(especially consortia that serve small transportation companies). (This
comment is related to the issue of C/TPAs serving as DERs, discussed
above in the ``Principal Policy Issues'' portion of the preamble.)
While this rule broadens the authorized role of C/TPAs in a number of
respects, we believe that the program works best when C/TPAs and
employers stay within their respective roles. An employer is an
organization like an airline, trucking company, transit authority, etc.
that provides transportation services and employs safety-sensitive
workers. C/TPAs do none of these things. They contract with employers
to provide drug and alcohol testing services. We believe the
distinction between ``employers'' and C/TPAs helps to avoid confusion
and
[[Page 79483]]
counterproductive overlap in roles between the two types of
organizations, and we are retaining the NPRM's statement that C/TPAs
are not employers. Any statements to the contrary in DOT agency rules
would be changed in the agencies' proposed conforming amendments to
this rule.
One commenter expressed concern that it was troublesome to have
service agents contact a DER when there was another company
representative on the scene of a testing event. This comment appeared
to assume that an employer can have only one DER. This is not the case.
An employer can designate as many DERs as it needs to carry out its
program effectively.
Several comments on the definitions of ``medical review officer''
(MRO) and ``substance abuse professional'' (SAP) asked that other
professions or members of professional groups be included within the
definitions. We will discuss these issues in connection with the MRO
and SAP provisions of the rule. Training and qualification matters are
found in substantive sections of the rule (e.g., Sec. 40.121 for MROs),
and it is not necessary to duplicate them here. However, we have added
to this section definitions of terms that are used to label different
types of training for MROs, SAPs, collectors, and BATs/STTs (e.g.,
qualification training, refresher training).
With respect to the term ``chain of custody,'' we note that the
definition of this term is not intended to suggest that the MRO is
responsible, as part of his or her chain of custody review, to examine
the internal laboratory chain of custody. The MRO need only review the
CCF itself.
Commenters questioned the definitions of ``dilute'' and
``substituted'' specimens. One commenter noted that it was unnecessary
to suggest that a ``dilute'' specimen had been watered down by the
improper action of an employee. We agree, and have expressed the
definition, like that of ``substitution,'' in neutral, descriptive
terms. These definitions are augmented later in the rule by
quantitative criteria for dilute and substituted specimens.
One commenter suggested slightly rewording several definitions of
terms for the alcohol testing part of the program. These suggestions
generally did not result in any significant substantive changes in
these definitions, and we have left the definitions as they were in the
NPRM. A few commenters asked for a different term in place of ``service
agent,'' one suggesting ``substance abuse service professional
(SASP).'' The Department believes the ``service agent'' term is short,
easily understood, and inclusive, so we are retaining it. Finally, for
greater clarity, we have added definitions of the ``Office of Drug and
Alcohol Policy and Compliance (ODAPC)'' and ``validity testing'' to
this section.
Section 40.5 Who Issues Authoritative Interpretations of This
Regulation?
Section 40.7 How Can You Get an Exemption From a Requirement in This
Regulation?
There were few comments about these administrative provisions. One
commenter asked how to obtain answers to interpretation questions, and
another asked how one might object to interpretations of Part 40. We
recommend calling or writing ODAPC. A commenter suggested publishing
all interpretations in the Federal Register periodically. We believe
that it is useful to make all interpretations widely available, and we
will post them on the ODAPC web site (www.dot.gov/ost/dapc). We will
also consider whether publication in the Federal Register would be a
useful additional step.
This interpretation authority applies to the application factual
situations of the provisions of this rule. The Department is often
asked whether, for example, the rule requires the cancellation of a
test in a particular circumstance. The answer to this question is, in
effect, an interpretation of the text of the rule as applied to the
facts of the situation. ODAPC and the General Counsel's office work
closely with the operating administrations to ensure consistency of all
such interpretations with both Part 40 and the other DOT agency rules.
We will retain the provision that makes only new guidance, issued
after publication of this rule, valid. We have substantially rewritten
Part 40. Much of the substance of interpretations of the former version
of the rule is found in the text of the new rule. Other guidance
pertains to a version of the rule that will no longer exist. We
anticipate publishing additional guidance pertaining to the new Part 40
(e.g., an MRO manual) before the effective date of the new rule.
We want to emphasize that an exemption is not the same thing as a
waiver. An exemption is, in effect, a rulemaking of particular
applicability that responds to an unusual situation, not contemplated
in the rulemaking and not having general application to a wide variety
of situations. An agency cannot properly make de facto generally
applicable amendments to a rule through exemptions, because this would
circumvent the rulemaking process requirements of the Administrative
Procedure Act. A waiver, on the other hand, is a generally applicable
provision in a rule that permits regulated parties to comply through an
alternative means, if certain conditions are met (e.g., Sec. 40.21).
Part 40 is an Office of the Secretary (OST) rule. Consequently it
is OST, and only OST, that has the authority to grant exemptions from
it. Since Part 40 is applied to regulated employers through the other
DOT agency drug and alcohol testing regulations, exemptions to Part 40
are implemented via the other DOT agency regulations. There may be
situations in which DOT agency regulations impose requirements that go
beyond those of Part 40. In such a case, a regulated party might need
to obtain an exemption from the additional DOT agency provision as well
as from a Part 40 provision.
Subpart B--Employer Responsibilities
Section 40.11 What Are the General Responsibilities of Employers Under
This Regulation?
Most of the comments about this section concerned proposed
paragraphs (d)-(f), which would have required contracts or written
agreements between service agents and employers to include a clause
making compliance with Part 40 a material term of the contract. These
comments and the Department's response are discussed in the ``Principal
Policy Issues'' portion of the preamble.
A few commenters also objected to language in the proposed
paragraph (b) saying that employers must ensure that service agents
comply with their regulatory responsibilities. The thrust of these
comments was that employers do not have the resources or expertise to
monitor the compliance of their sometimes far-flung service agents. In
response, we have merged language of paragraph (b) with Sec. 40.15(c).
It no longer places an active compliance monitoring responsibility on
employers, but simply says that the employer's good faith use of a
service agent is not a defense to a DOT enforcement action. For
example, if an employer's MRO fails to conduct verification interviews,
the employer could be subject to civil penalties from a DOT agency (the
MRO could independently be subject to a PIE proceeding). As an
employer, you can contract out your drug and alcohol testing program
functions, but you cannot contract away your compliance
responsibilities.
[[Page 79484]]
Proposed Sec. 40.13 Nuclear Regulatory Commission (NRC) Program
The NPRM proposed that there be reciprocity between the DOT and NRC
drug and alcohol testing programs. A number of commenters favored this
approach in principle, some asking that the notion of reciprocity be
extended to other Federal testing programs. A few commenters opposed
the proposal, saying that NRC rules did not measure up to DOT rules.
Other commenters pointed to numerous differences between the two
regulatory programs, with respect to program concepts, specific
requirements, forms, and administration. Some suggested that a
reciprocity agreement be created between the two agencies detailing how
these differences would be handled. Others said that the more stringent
of the two rules on each particular point should govern.
The Department has concluded that the wide variety of program
differences between the DOT and NRC regulations make it impractical to
establish reciprocity between the two systems. These differences
involve such matters as testing methods, consequences of some alcohol
test results, alcohol testing forms, reporting and recordkeeping,
inspection and enforcement procedures and responsibilities, and return-
to-duty procedures. We believe it would be very difficult to craft a
provision that did justice to both programs and decreased, rather than
increased, confusion among employers and employees. While we believe
reciprocity and ``one-stop shopping'' are worthwhile objectives, we do
not believe they are practically achievable in this case. In addition,
the numbers of double-covered employees and employers (either with NRC
or other Federal agencies) are quite small in comparison to the total
number of parties covered by the DOT program. For these reasons, we are
not making this proposed section part of the final rule.
Section 40.13 How Do DOT Drug and Alcohol Tests Relate to Non-DOT
Tests?
This section is based on proposed Sec. 40.15 of the NPRM. It
continues to require that DOT and non-DOT tests be kept strictly
separate. Comments were generally supportive of this concept, but some
asked for clarification. Paragraph (b), for example, clearly concerns
collections rather than other parts of the testing process, and the
text has been changed to make this explicit. This provision does not,
as one commenter wondered, mean that laboratories must process DOT and
non-DOT specimens in separate batches. Another commenter suggested that
the ``firewall'' between DOT and non-DOT tests would be stronger if we
required that an employer use separate laboratories for the two types
of tests. We have not become aware of any problems that use of the same
laboratory has created, and we think that this idea would increase
costs and administrative complexity for employers.
A few commenters mentioned a desire to permit tests for other
drugs, beyond the ``HHS five.'' This is a long-standing issue in the
program, and DOT continues to take the position that we ought not go
beyond the testing that HHS has authorized and for which HHS has
certified laboratories. We agree with comments that inadvertent use of
non-Federal forms should be a correctable flaw and that employers may
appropriately use the CCF for Federally-regulated tests (i.e., under
the HHS program for Federal agencies). The final text makes changes to
these effects. The Department does not object to laboratories creating
a standard form for non-DOT tests.
One of the most important provisions of this section prohibits the
use of DOT specimens for tests other than the ones explicitly
authorized by this part. For example, the rule forbids laboratories and
other parties from making a DOT specimen available for DNA testing.
This incorporates in the rule text a long-standing DOT interpretation
of Part 40. We say this for two main reasons. First, under these
regulations, a properly completed chain of custody conclusively
establishes the identity of a specimen. No additional tests are
required for this purpose.
Second, the only thing a DNA test can do is to determine, to a high
level of probability, whether a specimen and a reference specimen were
produced by the same individual. If the DNA test establishes a high
probability that the original specimen tested for drugs and a reference
specimen came from different individuals, this may mean one of four
things. It could mean that there was an error in the collection,
transmission, or handling of the specimen. It could mean that the
employee provided a substituted specimen (e.g., someone else's urine)
at the original collection and provided his or her own urine for the
reference specimen. It could mean that the employee provided his or her
own urine at the original collection and substituted someone else's
urine for the reference specimen. It could mean that the individual
provided substituted specimens from two different sources at the
original collection and for the reference specimen. A DNA test cannot
distinguish among these possibilities. Given a proper chain of custody,
the last three possibilities are significantly more probable in
practice than the first. A DNA finding of difference between the two
specimens is not, then, a valid basis for canceling a test.
Even if a DNA test is performed, contrary to these rules, this
section prohibits employers from changing or disregarding a verified
positive test. In such a case, regardless of the result of the
unauthorized test, the employer cannot return the employee to the
performance of safety-sensitive functions until and unless the employee
successfully completes the return-to-duty process. The same point
applies to other unauthorized tests (e.g., if the employee goes to his
or her own doctor and gets a second urine test or a blood test).
Section 40.15 May an Employer Use a Service Agent to Meet DOT Drug and
Alcohol Testing Requirements?
This provision is based on Sec. 40.17 of the NPRM. It provides that
an employer may use a service agent to carry out drug and alcohol
testing program tasks. There were not many comments on this section,
and they generally supported the provision. Some commenters sought to
limit the responsibility of employers, saying they should not be
accountable if they failed to comply with the rules because a service
agent erred. As noted above, we disagree: employers always remain
accountable for noncompliance, whether they run their own programs or
outsource them. Another comment suggested laboratories should not be
subject to DOT regulations, since they are regulated by HHS. It is
certainly true that DOT relies on HHS for laboratory certification
matters. However, laboratories have responsibilities under Part 40
independent of their HHS responsibilities (e.g., with respect to
relationships with MROs, release of information, and validity testing),
and laboratories must be accountable to DOT in those matters.
We agree, however, that we should not require employers to have
active monitoring responsibilities with respect to service agents,
though employers may choose to monitor their service agents'
performance. Therefore, we have altered paragraph (b) to require
employers simply to make sure that service agents meet regulatory
qualifications. To this end, employers may ask to see documentation
from service agents, who are obligated to provide it.
[[Page 79485]]
Section 40.17 Is an Employer Responsible for Obtaining Information
From its Service Agents?
This is a new section, responding to problems that the Department
has encountered in the enforcement process. It is closely related to
the point, made in previous sections, that an employer is responsible
for its own compliance with DOT rules even in the face of mistakes by
service agents. The section says that an employer has an affirmative
responsibility to get information from service agents that is needed
for compliance purposes. For example, suppose an applicant for a
safety-sensitive job takes a pre-employment drug test, but there is a
significant delay in the receipt of the test result from an MRO or C/
TPA. The employer must not assume that ``no news is good news'' and
permit the applicant to perform safety-sensitive duties before
receiving the result. Rather, the employer would have to seek out the
information about the test result from the service agent before putting
the employee to work.
Section 40.21 May an Employer Stand Down an Employee Before the MRO
Has Completed the Verification Process?
Proposed Secs. 40.19-40.21 have been relocated to Subpart Q, and we
will respond to comments on them in the corresponding part of the
preamble. There is no Sec. 40.19 in the final rule. Section 40.21
concerns the issue of stand-down. This issue was raised by proposed
Sec. 40.159(a) of the NPRM. We have relocated the section here since it
pertains primarily to the responsibilities of the employer. We
discussed the general policy issues surrounding stand-down in the
``Principal Policy Issues'' portion of the preamble.
The comments responding to proposed Sec. 40.159(a) focused almost
exclusively on the pros and cons of stand-down as a policy. They did
not address the details of how a stand-down policy would be
implemented. In formulating Sec. 40. 21 of the final rule, we have
crafted provisions specifically responsive both to the safely and
privacy/employee protections sides of the issue that commenters raised.
Paragraph (a) states the general policy prohibiting stand-down,
except where a DOT agency grants a waiver. We note that this
prohibition, and waivers of it, apply in adulteration and substitution
cases as well as cases in which there is a confirmed test result for
drugs or drug metabolites. Paragraph (b) tells employers to send their
waiver requests to the DOT agency whose rules apply to the majority of
the employer's covered employees. For many employers, whose employees
are covered by only one DOT rule, the decision is obvious. An employer
with covered employees in more than one DOT agency category would count
the employees in each category. For example, an employer with 500
aviation personnel and 1000 truck drivers would send its request to
FMCSA. In such a case, FMCSA would coordinate with FAA before making a
decision on the waiver request.
Paragraph (c) lists the items that an employer must include in a
waiver request. The first set of items are information that DOT
agencies will use in determining whether to grant a waiver. It should
be emphasized that none of the items in paragraphs (d)(1) are intended
to create mandatory prerequisites to receiving a waiver. That is, we do
not require that an organization be a particular size, or have an in-
house MRO, or have had an accident during the period before
verification was completed, in order for its waiver request to be
granted.
Any organization that wants a waiver to do stand-down must have a
written company policy on the subject. An employer must include its
proposed policy with its waiver request, making sure that it covers
seven mandatory elements. The first is distribution of the written
policy to all covered employees. Each employee subject to stand-down
must receive an individual copy of the policy: posting on bulletin
boards or web sites is not sufficient. The second pertains to
confidentiality. There must be an effective means of ensuring that only
those persons with a need to know--the employee, the DER, and the MRO--
are told that the employee is being stood down because of a confirmed
laboratory positive, adulterated, or substituted test result. We
understand, of course, that the employee's supervisor will need to know
that the employee is being removed from performance of safety-sensitive
functions, but the supervisor must not be told the reason for the
action. It is sufficient that the supervisor be given a general
explanation (e.g., medical qualification reasons, personnel evaluation
reasons).
The third item is equality of treatment within a given job
category. An employer cannot pick and choose the employees to whom it
will apply a stand-down policy. That would be unfair. The employer must
choose to stand-down all DOT-regulated employees in each job category
or none. For example, an airline's policy could provide that all pilots
would be subject to stand-down, but mechanics would not. However, the
airline could not choose to stand down some pilots, but not others.
When we use the term ``job categories'' in this paragraph, we mean
broad, inclusive categories of employees, rather than narrower subsets
of employee categories that might be used for pay or personnel
purposes.
The fourth item is a means of ensuring that stand-down is applied
only with respect to the performance of safety-sensitive duties. For
example, suppose a motor carrier's policy calls for stand-down with
respect to drivers. The laboratory reports a confirmed positive drug
test for Driver X. Driver X is scheduled to drive a commercial motor
vehicle over the next few days. The company would stand Driver X down,
so the driver would not be performing a safety-sensitive function
during the verification period. The laboratory also reports a confirmed
positive drug test for Driver Y. However, during the next few days,
Driver Y is scheduled to be in training or to be on personal leave. The
motor carrier would take no action with respect to Driver Y (including
notification of a supervisor), because he or she would not be
performing safety-sensitive duties during the verification period.
The fifth item, concerning pay status of employees, is a very
important matter of policy. As discussed above, employers who stand
employees down must continue to pay them until and unless there is a
verified adulterated, substituted, or positive test result. This
obligation is to pay the employee in exactly the same way he or she
would have been paid but for the stand-down. For example, suppose an
employer stands down an employee from Monday through Thursday. If the
employee would have been paid for 8 hours of work on each of the four
days in the absence of the stand-down, then the employee would be paid
for this amount of work. If the employee would only have worked on, and
been paid for, only Tuesday and Wednesday, then the employer would pay
the employee for these two days' work. We note that this obligation to
pay the employee ends with a verification of a positive, adulterated,
or substituted test, even if the employee subsequently asks for a test
of the split specimen.
For the sake of both employers and employees, it is very important
that verifications proceed quickly when an employee is in a stand-down
status. Therefore, the sixth condition is that the verification process
must start at once and take no more than five days (a time period
consistent with requirements for the verification process elsewhere in
the rule). The process could exceed this five-day limit only for
extenuating circumstances (i.e., the MRO provides a
[[Page 79486]]
written statement to the employer that a longer time is needed to
complete verification).
The seventh mandatory part of the employer policy is that, if an
employee is stood down and the MRO verifies the test negative or
cancels it, the employer must immediately return the employee to
safety-sensitive duties. The employee must not suffer any adverse
personnel or financial consequences. The employer must not maintain any
individually identifiable records of the confirmed positive laboratory
test. That is, the employer would have to expunge any individually
identifiable record of the confirmed positive laboratory test and
maintain only the record of the individual's verified negative or
canceled test. This places both the employer and employee in the same
position they would be in if the employer did not have a stand-down
policy. The MRO will have a record of the laboratory test result that
inspectors can access if necessary.
This provision goes into effect on August 1, 2001. DOT agencies
will not consider petitions for waivers before this effective date. In
considering waivers, each DOT agency will use its own procedures
applicable to waivers from its regulatory requirements. The concerned
DOT agency Administrator, or his or her designee, will make each
decision about whether to grant a waiver considering both the safety
and the employee protection aspects of the matter. Administrators will
informally coordinate proposed responses to waiver requests with ODAPC
and other affected DOT agencies, in order to ensure intermodal
consistency in the Department's responses. DOT agencies will respond to
all waiver requests in writing, stating the reasons for their
decisions.
An Administrator can impose additional conditions on the grant of a
waiver. The Administrator can also revoke a waiver if the employer
fails to implement mandatory provisions of its stand-down policy or
conditions the Administrator has placed on it. Finally, if an employer
implements a stand-down policy without having a waiver, or violates the
terms of the waiver (e.g., tests some employees but not others in a job
category, fails to implement confidentiality safeguards, fails to pay
employees during stand-down periods), the employer will be subject to
DOT agency enforcement action (e.g., civil penalties), just as in any
other case in which an employer violates DOT agency drug and alcohol
regulations.
Section 40.23 What Actions Do Employers Take After Receiving Test
Results?
This section is based, in part, on Sec. 40.159(b)-(g) of the NPRM.
We have added some material to it and placed it in Subpart B in order
to provide employers with a convenient summary of their obligations
when they receive various kinds of drug and alcohol test results. We
believe that the regulatory text is self-explanatory, so we need not
comment on it further here.
There were very few comments on Sec. 40.159(b)-(g). One commenter
said that the company should wait for the signed report from the MRO
before taking action to remove an employee from safety-sensitive
functions after a violation. We understand the usefulness of having
paper in hand, but we believe that speed is more essential for safety
reasons once the MRO or BAT informs the employer of a violation. Of
course, the requirement to immediately remove an employee from the
performance of safety-sensitive duties necessarily implies that
employers may not ``stay'' this action pending any administrative or
legal proceeding (e.g., grievance, arbitration, lawsuit) resulting from
the outcome of the testing process.
Paragraph (i) prohibits employers from changing test results (e.g.,
determining that the laboratory result was incorrect or that the MRO's
judgment on a verification issue should be overturned). Obviously,
there may be some cases in which a court or administrative hearing
officer will require a test result to be expunged from the record, or a
test cancelled, because of a problem in the testing process (e.g., a
previously undiscovered fatal flaw). However, this action does not
involve altering the laboratory finding or MRO determination, as such.
Section 40.25 Must an Employer Check on the Drug and Alcohol Testing
Record of Employees It Is Intending To Use To Perform Safety-Sensitive
Duties?
The NPRM (proposed Sec. 40.329) would have required MROs to
transmit drug test result information to additional employers in
certain circumstances. If an MRO had personal knowledge that an
employee whose test the MRO had verified positive worked in a safety-
sensitive position for another DOT-regulated employer, the MRO would,
under certain conditions, tell the second employer about the positive
test, without the employee's consent. As described in the ``Principal
Policy Issues'' section of the preamble, we are not adopting this
proposal as part of the final rule.
In place of the proposed Sec. 40.329, and in the absence of a
Federal data base, the Department is incorporating in the final rule a
provision based on an existing FMCSA provision. This provision requires
employers to check on the drug and alcohol testing background of new
hires and other employees beginning safety-sensitive work. Employers
would have to get written consent from the applicant (in the absence of
which the employer would not hire the person). The employer sends the
request for information and the employee's consent to all other DOT-
regulated employers for whom the employee had worked within the
previous two years.
The employer cannot let the employee perform safety-sensitive
duties for more than 30 days unless the employer has obtained, or made
and documented a good faith effort to obtain, the required information
from previous employers (as well as from firms to whom the employee
applied for safety-sensitive work, where there was a positive test
result or a refusal). Of course, if the employer finds that the
employee has a violation on his record, and the employee has not
successfully completed the return-to-duty process, the employer must
immediately stop using the employee to perform safety-sensitive
functions.
The Department believes that this section will help to achieve some
of the purposes of the proposal to allow MROs to share test results,
with fewer drawbacks. Admittedly, it affects only new employees rather
than current safety-sensitive employees. However, FMCSA has had success
implementing this provision, and it will help to screen out employees
who are not eligible to perform safety-sensitive functions. It will
also ensure that employees who violate the rules will have to go
through the SAP/return-to-duty process before performing safety-
sensitive duties. It will therefore have safety benefits. Because a
substantial majority of all DOT-regulated employees and employers are
in the motor carrier industry, this provision will result in only a
modest increase in the information collection burden of the DOT
program. The written consent provision of the section avoids some of
the privacy concerns of the MRO information sharing proposal.
In addition to seeking information from previous employers, this
section also requires employers to ask prospective employees if they
have failed or refused a DOT drug or alcohol pre-employment test within
the past two years from an employer who did not hire them. While we
recognize that
[[Page 79487]]
applicants may not always tell the truth about such events, we believe
that it is important to make this inquiry to help ensure that employees
are not put to work in safety-sensitive positions following a pre-
employment test violation without having completed return-to-duty
process requirements.
Section 40.27 Where Is Other Information on Employer Responsibilities
Found in This Regulation?
This is a new section, parallel to several sections (e.g.,
concerning MROs) in the NPRM. It is a list of other sections of the
rule that touch on matters of particular interest to employers. We
believe it will make the rule easier for employers to use if they have
a quick guide to other references in the rule to employer
responsibilities.
Subpart C--Urine Collection Personnel
Section 40.31 Who May Collect Urine Specimens for DOT Drug Testing?
This introductory section to the urine collection personnel subpart
states that only collectors meeting Subpart C requirements can collect
specimens in DOT-regulated tests. They must meet Sec. 40.33 training
requirements. The only subject of significant comment on this section
had to do with the requirement that supervisors could not collect urine
specimens from employees they supervise, unless no other qualified
collector was available and DOT agency drug and alcohol regulations
permitted the supervisor to act in this capacity.
The intent of this provision is to prevent potential conflicts
between supervisors and subordinates, as well as to avoid any claims
that a supervisor was out to get an employee through manipulation of
the testing process. However, commenters asked for clarification of who
we meant to cover when we applied this prohibition to supervisors.
Several suggested we should limit the prohibition to ``immediate
supervisors,'' so that individuals higher in the organizational chain
of command, who did not supervise the employee day-to-day, could act as
collectors. The Department agrees, and we have added this language to
the section.
Section 40.33 What Training Requirements Must a Collector Meet?
There is a strong, though not unanimous, consensus among people
familiar with the DOT drug testing program that collections is the area
of the program where the most errors occur that cause tests to be
cancelled. For this reason, the NPRM proposed several requirements to
strengthen training for collectors, though it did not go so far as to
propose an equivalent of the BAT course used for alcohol testing
personnel. We discussed the key points of this issue in the ``Principal
Policy Issues'' section of the preamble.
We note here two additional changes we made to reduce paperwork
burdens. In response to comments, we dropped the proposed requirement
that called on collectors to ``attest in writing'' that they have read
and understood the rules and DOT guidance. We also eliminated
requirements (from proposed Sec. 40.35) requiring organizations
employing collectors to maintain records of their training. Collectors
will maintain their own training documentation, which they must show on
request to DOT agency representatives as well as employers or C/TPAs
who use their services.
In this section and a number of others, the final rule makes
reference to guidance documents being available on the ODAPC web site.
These will be true statements by the time the rule becomes effective in
August 2001. At the present time, however, these documents are ``under
construction,'' and they have not yet made their debut in cyberspace.
Section 40.35 What Information About the DER Must Employers Provide to
Collectors?
This section is not based on proposed Sec. 40.35 of the NPRM which,
as mentioned above, is not included in the final rule. It is a new
section incorporating a brief statement that employers must make sure
that collectors have the name of and contact information for the
employer's DER, so that the collector can contact the employer
concerning any problems that come up in the collection process (e.g.,
no shows, refusals). We recognize that there may be some situations
(e.g., post-accident tests at locations remote from the employer's
place of business) where this may not be feasible.
Section 40.37 Where Is Other Information on the Role of Collectors
Found in This Regulation?
This is a section listing other sections in the rule that
collectors will find useful in understanding their functions in the
drug testing program.
Subpart D--Collection Sites, Forms, Equipment and Supplies Used in
DOT Urine Collections
Section 40.41 Where Does a Urine Collection for a DOT Drug Test Take
Place?
Most comments on this section focused on two issues. The first was
the conditions on use of a multistall restroom. The NPRM proposed that
a multistall restroom could be used only if a closed room for urination
was not available, and could be used only for monitored collections.
The proposed rule text also said that a multistall restroom must
provide aural privacy to the extent practicable. Several commenters
said these conditions were too restrictive and would effectively
preclude employers from using multistall restrooms for collections.
This was a problem, they said, because in some industries, this was the
most readily available type of urination facility. Some commenters also
noted what they viewed as an inconsistency between the aural privacy
provision of this section and the provision in Sec. 40.69 that called
on monitors to listen for sounds that might indicate tampering.
Some commenters also thought that provisions of the proposal
concerning closed room urination facilities were too restrictive,
particularly the statement that the room should have an external water
source, if practicable. They said that many such facilities (e.g.,
patient rest rooms in doctors' offices) had internal water sources, and
the ``if practicable'' language could lead to legal challenges. They
said it would be better simply to require collection sites to secure
all water sources.
The Department has modified this section in response to these
comments. The final rule provides that either a closed room or
multistall urination facility is acceptable. In the former, while it is
preferable to have an external water source, the rule makes clear that
a facility that has an internal water source is also acceptable, if all
sources of water and potential adulterants are secured and moist
towelettes are provided. This kind of urination facility must have a
full-length privacy door. This means a door that is both opaque and
solid. For example, a glass door, a door with a window or other means
of viewing the interior of the room from outside, or a curtain is not
adequate for this purpose. Nor would it be appropriate to have a video
camera or microphone monitoring the room.
If a multistall restroom is used as the urination facility, the
facility must meet either of two requirements. First, a multistall
restroom may be used without a monitor if all sources of water and
potential adulterants are secured. Second, if these sources are not
secured, the collection must be a monitored collection, meeting the
requirements of Sec. 40.69. The facility must have a partial-length
privacy door (i.e., for the stall in which urination takes place) to
provide as much visual privacy as possible. We
[[Page 79488]]
have deleted the references in this section to aural privacy and in
Sec. 40.69 to ``active listening'' by the monitor.
Regardless of which type of urination facility a collection site
uses, the employee is the only person permitted in the urination
facility during the collection of a specimen. This requirement is
intended to safeguard both the employee's privacy and the integrity of
the process. The only exceptions to this rule are the observer in a
directly observed collection or the monitor in a monitored collection.
Section 40.43 What Steps Must Operators of Collection Sites Take To
Protect the Security and Integrity of Urine Collections?
Commenters made a number of suggestions about this section. One
commenter said that the requirement to ensure that the collection site
is secure before each collection was too much work. We disagree. Making
this check is vital to the integrity of the program. Several commenters
suggested that we clarify the requirement that a collector can have
only one collection going on at a time to allow a collector to continue
other collections while another employee was drinking fluids in a ``shy
bladder'' situation. We think this is a good idea that would avoid
potential delays at collection sites, and we have added language to
this effect.
The NPRM proposed that the collector should keep the collection
container within view ``to the greatest extent [he or she] can.'' A few
commenters thought this requirement should be absolute, with the
consequence being a fatal flaw if the collector let the container out
of his or her sight. We do not believe that the requirement should be
absolute. While it is important for the collector and the employee to
keep the specimen in sight, a brief absence by the collector ought not
be a reason for cancelling a test that otherwise meets Part 40
requirements.
As commenters suggested, we clarified that authorized personnel who
may be present at the collection site may include employer
representatives, that no one but direct observers and monitors could be
in the urination facility with an employee, and that collectors can
remove a disruptive person from the collection site.
Section 40.45 What Form Is Used To Document a DOT Urine Collection?
Earlier this year (June 23, 2000), HHS issued a new CCF for use in
both the Federal employee and DOT drug testing programs. The references
to the CCF in this rule are to the new form. Most provisions of this
rule become effective on August 1, 2001, the same date use of the HHS
form becomes mandatory for use in the Federal employee program. (Before
August 1, 2001, participants in both programs have the option of using
either the old or the new form.) Consequently, there will be no
disconnect between the HHS form requirements and the requirements of
this rule.
A few comments suggested allowing the collector to sign CCFs in
advance, presumably to save time during collections. We think this idea
is fraught with potential for misuse or theft of signed forms, and we
will maintain the prohibition on this short cut. We have added a
specific requirement for the MRO's phone and fax numbers, as a
commenter suggested. A few commenters also suggested allowing the use
of foreign-language versions of the form in the U.S., as well as in
other countries. We have incorporated this suggestion, with the
stipulation that use of a non-English version of the form that ODAPC
has reviewed is allowable in any situation (here or in another country)
only if both the employee and collector understand and can use the form
in that language. For example, a collector who does not read French
could not use a French language form, even for a French-speaking
employee.
Section 40.47 May Employers Use the CCF for Non-DOT Collections or
Non-Federal Forms for DOT Collections?
Some commenters supported permitting the use of the Federal CCF for
non-DOT collections. Some of these comments favored adding boxes to the
form that collectors could check for ``DOT'' or ``non-DOT''
collections. We have believed since the beginnings of the DOT program
that it is very important to maintain ``truth in testing.'' If a form
says ``DOT'' or ``Federal'' on it, despite whatever fine print
qualifications or check boxes might be included, the form may easily
imply to the employee that he or she is being tested under Federal law.
If this is not true, as in the case of a ``company policy'' test, then
we are knowingly misinforming the employee. That is unfair. Moreover,
``company policy'' tests that do not meet DOT requirements, but are
conducted using the CCF, could implicate the DOT program in legal
challenges to the non-DOT tests. We will maintain the existing
prohibition.
Generally, most commenters on the subject agreed with the NPRM's
proposal to make use of a non-Federal form in a DOT test a
``correctable flaw.'' A few comments questioned the need for the
written correction. Correcting the flaw will ensure that there was an
appropriate explanation for use of the non-DOT form (e.g., a post-
accident test where nothing else was available, a simple mistake) and
will help to educate the collector involved about the need to use the
correct form. We will also keep this provision in the final rule.
Section 40.49 What Materials Are Used To Collect Urine Specimens?
There were few comments on this section, which requires the use of
a ``DOT Kit'' (see Appendix A for details). Laboratories and MROs
should treat as a ``red flag'' any situation in which a non-conforming
kit is used. While use of a non-conforming kit is not a fatal or
correctable flaw in the testing process, laboratories and MROs should,
if they discover that a non-conforming kit was used for a collection,
check to make sure that correct collection procedures were used and
that no fatal flaws occurred. Use of a nonconforming kit is a rule
violation that can subject the user to consequences under DOT agency
rules.
Section 40.51 What Materials Are Used To Send Urine Specimens to the
Laboratory?
This provision concerns shipping containers. In response to a
comment, we have omitted a reference to a standard ``box,'' leaving the
provision as a performance standard requiring a container that
adequately protects the specimen from damage during shipping.
Subpart E--Drug Test Collections
Section 40.61 What Are the Preliminary Steps in the Collection
Process?
Commenters responded to a variety of detailed issues in this
section. With respect to employees who showed up late for a test or not
at all, several commenters said it was common for employees not to have
appointments. As a result, employees simply appeared at the collection
site, and collection site people had no notion whether they were on
time or not. Commenters suggested that the proposed ``no show''
provision be limited to situations in which the collection site was at
the employee's worksite or an appointment had been scheduled. We agree,
and have added language to this effect.
Some commenters thought it was unreasonable to ask collection sites
to do their work on a timely basis, and they therefore objected to the
proposed requirement that the collection process begin without delay.
We believe that, for the sake of both employers and employees,
timeliness is essential for decent customer service. However, we
[[Page 79489]]
will respond to concerns about the flexibility of this provision by
adding the modifier ``undue.'' We will also note in Sec. 40.209 that a
collector delay is not a ``fatal flaw.''
The NPRM stated that when alcohol and drug tests were being given
to the same employee at the same site, the alcohol test should be given
first. In response to comments concerned about backups in the testing
process, we have provided additional flexibility and added an example
of a situation in which an employee's urine collection might be
conducted first.
The NPRM would have prohibited the collection of urine from an
unconscious employee by means of catheterization. A few comments asked
for clarification in other situations involving catheters. Some also
suggested testing by alternative means in these cases (e.g., hair,
saliva). The Department is clarifying this section to prohibit
collecting urine by catheterization not only from an unconscious
employee, but also from a conscious employee. The former raises consent
issues, and the latter, even given consent, raises safety issues.
However, in the case of an employee who normally voids through self-
catheterization (e.g., for medical purposes), the collector must
require the employee to provide a specimen in that manner.
With respect to alternative testing technologies such as hair
testing, saliva testing, and on-site testing, which commenters
recommended in context of several sections of the NPRM, the Department
will wait upon the action of HHS before proposing to incorporate
additional methods. Approval of these or other methods, and
establishment of requirements and procedures for them, are matters
primarily within the expertise of HHS, which is currently considering
them with the assistance of the Drug Testing Advisory Board (DTAB).
Concerning identification of employees, commenters suggested that a
driver's license or similar government-issued ID would be acceptable in
lieu of an employer-issued credential. On the other hand, some comments
pointed out that the credibility of employer-issued ID might be
doubtful in the case of a self-employed individual. We have modified
the section on both points. A driver's license or other government-
issued photo ID will be acceptable, and an employer-issued ID from an
owner-operator or other self-employed person will not.
Many of the same commenters who objected to the proposed
requirement to have collectors search boots also objected, for similar
reasons, to the proposed requirement (similar to that of the existing
rule) to have employees empty their pockets. We believe that taking
objects out of one's pockets is a minimal intrusion into the employee's
privacy, which can help deter and detect some attempts to cheat on
tests. In addition, this is a provision that is paralleled in HHS
guidelines. The final rule retains the proposed requirement.
A few commenters objected to the provision that would bar requiring
employees to sign consent forms, waivers, releases, etc. concerning the
collection and testing process. These comments did not explain the
reason why exacting signatures on such documents was necessary for the
DOT testing process, and we do not believe that it is. We have retained
it, but moved it to Subpart Q and made it applicable to all service
agents, not just collection sites. One comment suggested that
collection sites be able to have employees sign consent forms with
respect to non-DOT tests. This rule does not limit employers' or
collection sites' actions concerning non-DOT tests, but the rule does
require strict separation between DOT and non-DOT testing procedures.
This includes separate paperwork for a DOT and non-DOT test conducted
with respect to the same employee during his or her visit to a
collection site. Such a consent form must not be part of the paperwork
for a DOT test, and it could not apply to the DOT test or be filled out
at the same time the employee was filling out the paperwork for the DOT
test.
Section 40.63 What Steps Does the Collector Take in the Collection
Process Before the Employee Provides a Urine Specimen?
Commenters raised few issues concerning this section. A commenter
wanted to eliminate the prohibition on the employee flushing the toilet
after providing the sample, but we will retain this provision because
it limits opportunities to flush away evidence of adulteration.
(However, inadvertantly flushing the toilet does not create a ``fatal
flaw.'') Another commenter suggested training collectors in how to
detect attempts to tamper with specimens. We think this is a good idea,
and our guidance will suggest it. However, we do not think it is
necessary to incorporate it in rule text.
Section 40.65 What Does the Collector Check for When the Employee
Presents a Specimen?
Some commenters noted that the NPRM omitted the existing provision
concerning taking an employee's body temperature when the specimen
temperature was out of range. This was intended. Many collectors are
not medically trained, and the accuracy of some thermometers is not
certain. The provision has not been too useful under the existing rule,
and we will not include it in the final rule. Other comments requested
revision of the temperature range (e.g., to be between 94 and 100
degrees). While this idea has some appeal, we believe we need to keep
Part 40 consistent with HHS provisions on this matter.
Other commenters asked for clarification whether, when one specimen
has not met regulatory requirements (e.g., out of temperature range,
insufficient volume), the specimen should be sent to the laboratory for
testing, as well as any subsequent specimen that is collected. We
agree, and have included specific directions on this point. For
example, when the first specimen is out of temperature range, and a
second specimen is collected under direct observation, both specimens
would be sent to the laboratory and tested. On the other hand, if the
first specimen were out of temperature range, and the employee refused
to provide a second specimen under direct observation, the first
specimen would be discarded and the event simply treated as a refusal.
Section 40.67 When and How Is a Directly Observed Collection
Conducted?
Directly observed specimens are controversial because of their
greater impact on employee privacy. They can be useful because they
reduce the opportunity for tampering. On privacy grounds, some
commenters, including unions and some service agents, would prefer not
to conduct directly observed collections at all. In any case, these
commenters opposed adding any situations in which direct observation
was required or authorized. Other commenters said that the benefit of
greater protection against specimen tampering warranted direct
observation in situations that suggested a heightened risk of
tampering.
The Department agrees with the latter comments. In situations that
may create a higher risk or greater incentive for tampering (e.g., the
previous collection was verified positive, adulterated, or substituted,
but the test had to be cancelled because the split specimen was
unavailable for testing; the previous specimen was invalid and there
was no adequate medical explanation; temperature out of range; apparent
tampering with the specimen at the collection site), the interests of
the integrity of the testing process, with its
[[Page 79490]]
safety implications, outweigh the additional privacy impact of the
direct observation process. On the other hand, dilute specimens may
have a number of innocent causes (e.g., someone likes to drink a lot of
water). A dilute specimen does not necessarily imply the same higher
risk of tampering upon recollection, so the final rule does not
authorize direct observation in this case.
The existing rule and the NPRM both called for use of a same-gender
direct observer. Some comments objected to this requirement, saying it
created practical problems in collection sites that were staffed by
only one collector. Other commenters insisted on retaining this
requirement as a matter of privacy. We believe there is no alternative
to retaining the same-gender observer requirement. Use of opposite
gender observers would not only go counter to deeply held societal
norms of privacy (i.e., the basic reason for separate men's and women's
rest rooms in public places), but might raise genuine safety concerns,
particularly on the part of female participants. We would point out
that the observer need not be a trained collector, so that another
same-gender person could be enlisted for the task.
One commenter recommended we add a provision telling the collector
or employer, as appropriate, to explain to the employee why a directly
observed collection needs to be conducted. We believe that this is a
good idea, and we have included a requirement in the rule to this
effect.
Section 40.69 How Is a Monitored Collection Conducted?
Much of the comment on this section echoed the comments on
Sec. 40.41, supporting the use of multistall restrooms as urination
facilities and urging the Department to permit the use of monitored
collections at the collection sites at the employer's discretion. The
discussion of multistall restrooms and monitored collections in
Sec. 40.41 is the Department's resolution of these issues. This section
sets forth the procedures to be used for monitored collections.
A few commenters focused on the use of toilet bluing agents in
monitored collections. They suggested that bluing not be required
except in the toilet the employee is using while providing the
specimen. We agree with this point with respect to a monitored
collection. In a case in which a collection uses a multistall restroom
as a urination facility but does not conduct monitored collections,
however, all toilets must be secured, including the use of bluing.
A number of commenters again objected to the requirement that the
monitor be of the same gender as the employee, essentially for the same
reasons that commenters objected to the same gender requirement for
direct observers. They added that, in the case of monitors, there is a
less intense privacy concern because the monitors do not actually watch
the employee urinate. We agree that the privacy concern is less intense
in this case, and for that reason we permit the use of opposite-gender
monitors who are medical professionals. Medical professionals are
trained to conduct themselves properly and are less likely than other
persons to raise privacy and safety concerns among employees. But
legitimate privacy and safety concerns still exist to a degree in the
monitored collection situation, and we believe that monitors who are
not medical professionals should continue to be the same gender as the
employee, as under the current rule.
Section 40.71 How Does the Collector Prepare the Specimens?
Proposed Sec. 40.71, concerning single specimen collection
procedures, has been deleted, as all collections will now be split
specimen collections. This section is based on proposed Sec. 40.73.
There were few comments on this section. One suggested that the failure
of the employee to initial the tamper-evident seals be regarded as a
refusal to test. We do not think that that is the best solution to this
problem. The individual has, after all, provided a specimen. By having
the collector note the problem in the remarks line of the form, we
preserve a record that the collection proceeded properly. In this
section, we also clarify at several points that the collector, not the
employee, performs several tasks.
Section 40.73 How Is the Collection Process Completed?
This section is based on Sec. 40.75 of the NPRM. Commenters
addressed a number of technical points. Some commenters wanted to put a
time line in the section to expedite proceedings. We agree, and we have
added a 24-hour/next business day requirement for transmittal of
relevant copies of the CCF and the specimen itself. As another
commenter suggested, we do encourage the immediate faxing of CCF copies
to the MRO and DER.
A commenter asked that we specifically prohibit employees from
providing medical information on the CCF. We agree, and we have spelled
out this point in Sec. 40.61(g). Another commenter suggested deleting
the requirement for a ``box'' as the shipping container. We have
deleted this requirement as a matter of flexibility, both here and in
Appendix A, though we retain mention of a box as an example of
something that can be a shipping container.
A commenter suggested that we eliminate the proposed requirement to
note the entry for a specific courier or shipping service on the CCF.
This requirement is part of the HHS CCF and instructions, so for
consistency's sake we will retain it. However, we also specify in
Sec. 40.209 that omitting this information is not a fatal flaw.
As indicated previously, the shipping container seal was used
primarily to seal the shipping container (box). Laboratories still
tested the specimens when the shipping container seal was broken,
provided the seals on the bottles remained intact. Based on this fact,
we have removed the requirement for a shipping container seal to be
placed on a shipping container. The same rationale applies to placing a
shipping container seal on the plastic bag. The construction of the
plastic bag is such that any tampering will be evident, even without
the seal. Consequently, the final rule does not include any requirement
for placing a shipping container seal across the opening of the plastic
bag or for the collector to sign or initial and date such a seal.
Subpart F--Drug Testing Laboratories
Section 40.81 What Laboratories May Be Used for DOT Drug Testing?
The only comments on this section concerned the application of the
PIE process to laboratories. Some laboratories and other commenters
believed laboratories should not be subject to PIEs, since they are
subject to HHS certification requirements. We believe that laboratories
are service agents providing services to DOT-regulated employers no
less than other parties subject to the PIE provision. Moreover, some
Part 40 requirements affecting laboratories (e.g., information release,
conflicts of interest, validity testing requirement) are not enforced
by HHS through its certification procedures. For these reasons, we
believe laboratories should remain subject to the PIE process. However,
we specify in Sec. 40.365 that the Department does not intend, as a
matter of policy, to initiate a PIE proceeding concerning a laboratory
with respect to matters on which HHS has taken action under its
certification process.
Section 40.83 How Do Laboratories Process Incoming Specimens?
We have added a provision to this section specifically requiring
[[Page 79491]]
laboratories to comply with HHS guidelines concerning accessioning and
processing specimens. We do not believe it is necessary to duplicate
significant portions of the HHS guideline provisions concerning
laboratory processing of specimens, and we have therefore eliminated
some provisions of the proposed Subpart F, such as Sec. 40.87 and
portions of this section and Sec. 40.95.
Some commenters addressed the portion of the NPRM that discussed
situations in which the color of the primary and split specimen differ.
Because we will require a standardized collection kit using a single
collection container, we believe that specimens failing to be color-
coordinated should no longer be a problem, so we have deleted this
provision. This material is covered in the HHS guidelines, so we do not
need to repeat it here. We did incorporate a commenter's suggestion to
direct the laboratory to retain a specimen for five working days while
waiting for the correction of a correctable flaw.
A few commenters recommended that, when a laboratory notes that a
split specimen is unavailable for testing, the laboratory should cancel
the test then and there. We disagree. Most tests turn out to be
negative, and employees do not request a test of the split specimen in
all other cases. Therefore, there is a good probability that the test
of the primary specimen will not turn out to be futile.
Section 40.85 What Drugs Do Laboratories Test for?
Section 40.87 What Are the Cutoff Concentrations for Initial and
Confirmation Tests?
These technical sections have changed very little from the existing
rule. A few commenters supported, and a few others opposed, allowing to
test for other drugs (e.g., barbiturates, benzodiazopenes, ``designer
drugs'') in addition to the ``HHS five.'' This issue has been debated
from the inception of the program. As the Department has said in the
past, we believe the stability and reliability of the program are well
served by limiting testing to the ``HHS five.'' HHS has established
testing protocols and cutoffs for these drugs, and laboratories are
subject to HHS certification for testing of these five drugs. This is
not true for other drugs.
Section 40.89 Are Laboratories Required To Conduct Validity Testing?
Section 40.91 What Validity Tests Must Laboratories Conduct on Primary
Specimens?
Section 40.93 What Criteria Do Laboratories Use To Establish That a
Specimen Is Dilute or Substituted?
Section 40.95 What Criteria Do Laboratories Use To Establish That a
Specimen Is Adulterated?
These sections are the laboratory-related provisions concerning
validity testing. We discussed validity testing extensively in the
``Principal Policy Issues'' portion of the preamble, including issues
pertaining to the scientific validity of adulteration and substitution
criteria.
Section 40.89(b) states that laboratories continue to be authorized
to conduct validity testing. This sentence is included to avoid anyone
mistakenly concluding that, until validity testing becomes mandatory,
there is a question about whether it can remain a voluntary part of the
DOT drug testing program, as it is today. (The parallel section of the
amendments to current Part 40, Sec. 40.205(b), is for the same
purpose.) When HHS issues its mandatory requirements on validity
testing, DOT will amend Sec. 40.89(c) to insert a date on which DOT
will require all DOT specimens to be subject to validity testing. We
would not make this date earlier than August 1, 2001, even if HHS
issues its requirements before that date.
As noted in that discussion, this rule will not specify adulterants
that must be tested, given the changes that can be expected in the
popularity of various substances. However, we expect laboratories to be
able to identify all those listed in up-to-date HHS guidance or rules.
For example, we have not listed nitrites in this rule, but current HHS
guidance calls on laboratories to test for nitrites. If nitrites cease
to be a significant adulterant, and other substances arise to take its
place, HHS guidance or rules will change as well.
One point we believe to be quite important is that laboratories
should remain vigilant for new adulterants. If a laboratory finds a
substance it cannot identify that appears to act as an adulterant or
interfering substance, the rule directs the laboratory, after checking
with another laboratory, to inform ODAPC and HHS about it. Doing so
will enable us to react as quickly as possible to new adulterants being
marketed.
We also note that, while the requirements for split specimen
testing for adulterated and substituted specimens and MRO review will
take effect within 30 days of the publication of this rule, mandatory
validity testing is not required to begin until further notice from
DOT. We will issue this notice in conjunction with the issuance by HHS
of its mandatory requirements for validity testing. We hope that this
will be on or before August 1, 2001. This should give those
laboratories who currently are not conducting validity testing
sufficient time to prepare to implement these requirements fully.
Section 40.97 What Do Laboratories Report and How Do They Report It?
This section is based on parts of proposed Secs. 40.95 and 40.97.
Some portions have been deleted as duplicative of HHS materials. The
topic of greatest interest to commenters was the proposal to continue
the current requirement that laboratories transmit test results
directly to MROs, without using a C/TPA or some other party as an
intermediary. C/TPAs made many of the same arguments on this point as
they did with respect to the transmission of results from the MRO to
the employer.
There is only one party in the DOT drug testing system who is
entitled to see a confirmed laboratory result. That is the MRO. Other
parties, including collectors, employers (except in a limited way if a
stand-down waiver is granted), SAPs, and C/TPAs are not. These other
parties are entitled to learn of a result only after the MRO has
verified it. To permit a C/TPA to receive a confirmed laboratory result
and then transmit it to the MRO would directly violate this key
principle. We do not think that, in the present state of the health
care industry, there should be serious problems with MROs having
appropriate technology to receive results.
As discussed in the ``Primary Policy Issues'' part of the preamble,
the Department has agreed to permit C/TPAs to act as intermediaries in
transmitting results from MROs to employers. However, we believe that
this situation is quite different from allowing C/TPAs to act as an
intermediary in transmitting laboratory results to the MRO.
A number of commenters supported allowing the electronic
transmission of result reports, especially negatives. Paragraph (b) of
this section does permit considerable use of electronic methods. Beyond
that, the Department will consider additional use of electronic methods
through the advisory committee process discussed in the ``Primary
Policy Issues'' portion of the preamble.
[[Page 79492]]
The NPRM mentioned transmitting negative results within 72 hours.
Some commenters thought this period should be shortened to 24 or 48
hours, while one laboratory thought it would be too burdensome to use
couriers on weekends to meet this goal. The final rule says that
results should be transmitted to the MRO on the same day or business
day after review by the certifying scientist is complete. Besides
taking care of any weekend worries, this provision, in tandem with the
use of electronic methods permitted under the rule, should result in
expeditious transmission of results.
Section 40.99 How Long Does the Laboratory Retain Specimens After
Testing?
We have simplified this section. Specimens which were positive,
adulterated, substituted, or invalid must be kept for one year. In
response to requests from commenters, we have provided that the
laboratory must keep the specimens longer only if they receive a
request from an employer, employee, MRO, C/TPA, or DOT agency
representative. Absent such a request, the laboratory may discard the
specimen. This rule applies to primary and split specimens alike. With
respect to negative tests and specimens rejected for testing (e.g.,
because of a fatal or uncorrected flaw), the laboratory should follow
HHS guidance. We do not believe it is necessary to restate the guidance
here.
Section 40.101 What Relationship May a Laboratory Have With an MRO?
This section focuses on potential conflicts of interest between
MROs and laboratories. We discussed comments on this issue and the
Department's responses in the ``Principal Policy Issues'' portion of
the preamble.
Section 40.103 What Are the Requirements for Submitting Blind
Specimens to a Laboratory?
The NPRM proposed to reduce the number of blind specimens employers
and other program participants were required to send to laboratories.
We made this proposal because it would reduce costs and burdens and
because the laboratory testing program appears to be running very
smoothly. Comments were divided on this issue. A majority of
commenters, especially from employers and their groups, supported the
proposal. Some said they had never heard of a laboratory error. Others
said that blind specimen testing had outlived its usefulness and should
be eliminated. On the other hand, a number of commenters said that to
reduce the number of blind specimens would endanger the accuracy and
integrity of the laboratory testing program.
We also received a number of comments saying that if we make
validity testing mandatory, adulterated and substituted samples should
also be included in the blind testing program. Some commenters
expressed concern about being able to find adulterated blind specimens.
A few comments from TPAs suggested that they should not have to send in
blind specimens, even when they submitted more than 2000 specimens in
the aggregate, because doing so should remain the individual employer's
responsibility.
The Department believes the NPRM proposed a good balance between
considerations of reducing burdens and maintaining an effective check
on laboratory performance. We have had few if any laboratory accuracy
problems over the history of the program, and we believe that we can
continue to ensure that this pattern continues while reducing burdens
and costs on participants. We agree that adulterated and substituted
specimens should be made part of the blind specimen testing program,
and we have consequently changed the proportions of specimens in the
program to be 75 percent negative, 15 percent positive, and 10 percent
adulterated or substituted. This is particularly important given the
recent problems at some laboratories concerning validity testing. Given
that this provision will not take effect until next August, we think
that producers will have time to market adulterated and substituted
blind specimens.
We believe that any organization that transmits to laboratories the
requisite number of specimens in the aggregate should be responsible
for participating in the blind testing program. This is true no matter
whether the organization is an employer, a C/TPA, or some other service
agent. The structure of the organization is irrelevant for this
purpose. To decide otherwise would permit large gaps in the blind
testing program. If 100 employers with 20 employees each are served by
a C/TPA, and the C/TPA does not submit blind specimens, then no one
will submit such specimens with respect to these employees, since each
of the employers is too small on its own to be required to participate.
Permitting this gap to exist would be disadvantageous from the program
integrity standpoint.
We would also point out that C/TPAs, in virtually every other area
of program administration, assert that they can perform a multitude of
functions for everyone involved in the program. We do not see any
compelling reason for looking differently at their involvement in blind
specimen testing.
Section 40.105 What Happens if the Laboratory Reports a Result
Different From That Expected for a Blind Specimen?
Some commenters objected to the proposed requirement for
notification of DOT in the event of a laboratory error, or to the idea
that ODAPC could direct laboratories to take corrective action. The
main argument of these comments was that HHS had what they viewed as
exclusive jurisdiction over testing matters, on which DOT should not
infringe. We have refocused the section on unexpected blind specimen
results.
The Department would always coordinate closely with HHS on matters
affecting laboratories, as indeed we have done in drafting this
provision. The fact remains that many MROs and other participants in
the DOT program have their primary Federal agency relationship with DOT
agencies, and it makes sense to have them report problems to DOT. It is
also important to realize that testing laboratories, while certified by
HHS, receive significantly more specimens as a result of the DOT
program than as a result of the Federal employee testing program. Under
these circumstances, a DOT role in noting and helping to correct any
laboratory-related problems affecting the DOT program seems most
appropriate.
Because we are requiring blind specimens in connection with
validity testing, this section necessarily covers errors in validity
testing.
Section 40.107 Who May Inspect Laboratories?
In response to comments, we are clarifying that the employers who
may inspect laboratories are those who use or are negotiating to use
its services for DOT-regulated testing.
Section 40.109 What Documentation Must the Laboratory Keep, and for
How Long?
The Department has simplified this section and acted to reduce
paperwork burdens, as a number of commenters recommended. All records
supporting test results and those cited in Sec. 40.111 must be kept for
two years, unless an MRO, employer, employee, or DOT agency
representatives requests an extension within the two-year period (e.g.,
for litigation purposes). If no such request is received, the
laboratory may discard the records.
[[Page 79493]]
Section 40.111 When and How Must a Laboratory Disclose Statistical
Summaries and Other Information It Maintains?
The NPRM proposed to reduce paperwork burdens by reducing the
reporting frequency for this information from quarterly to semi-
annually. A number of comments supported this reduction. Other
commenters favored eliminating the requirement altogether, or at least
for small employers, on burden and cost reduction grounds. We believe
that cutting the reporting burden in half is a sufficient burden
reduction on this item and that even small employers will find
summarized information on their workforce's participation useful. We
underline the fact that the smallest employers, laboratories and C/TPAs
will not experience the burden of sending ``non-reports,'' since there
is no requirement to send a letter saying there is nothing to report
unless specifically requested as part of a DOT audit. This will further
reduce the paperwork burden of the rule.
Section 40.113 Where Is Other Information Concerning Laboratories
Found in This Regulation?
This is a cross-reference section to inform readers where they may
find other material relevant to laboratories' participation in the
program.
Subpart G--Medical Review Officers and the Verification Process
Section 40.121 Who Is Qualified To Act as an MRO?
The Department believes that MROs play a key role in maintaining a
fair and accurate drug testing program. Ensuring that MROs are in the
best possible position to play this role requires, in our view, that
they be well trained both in the substance of drug testing issues and
the rules they are called on to apply. For these reasons, the NPRM
proposed that MROs participate in a training course every two years or,
in the alternative, self-certify that they have reviewed and understand
these rules.
Commenters raised a number of issues. First, some commenters said
that groups of health professionals other than physicians, like
chiropractors, nurse practitioners, and physicians' assistants, should
be able to be MROs. They perform other functions like physicians (e.g.,
DOT physical examinations for commercial drivers) and are qualified to
perform this one, commenters asserted. The Department does not agree
with this assertion. That other health professionals have some training
similar to that of physicians is undeniable, but the Department
believes that the variety and depth of expertise needed to carry out
MRO responsibilities effectively is unlikely to be found in other
health professionals. There are clearly differences in the level of
training needed to qualify for the various health professions, and we
believe that only those professionals with the highest level of
training should play this key role. Being qualified to perform routine
physical examinations, for example, is not necessarily the same thing
as being able to make capably the difficult judgment calls that MROs
are called upon to make.
Second, many commenters disagreed with the proposal to allow self-
certification of training. More formal training, including a
certification program, was necessary, commenters said. Commenters
pointed to three existing MRO training and certification programs as
models for what the Department should require. These have a five-year
retraining cycle, and a number of commenters thought that five years,
as opposed to two, was sensible. On the other hand, a smaller number of
commenters opposed additional training requirements for MROs, saying it
would drive up the cost and difficulty of being an MRO, and hence
reduce the supply of MROs available to employers.
The Department is modifying this section in response to these
comments. We are persuaded that MROs, given their critical role, should
not only have the highest professional credentials to begin with, but
also receive formal training in the rules and decision process of their
critical role in this program. Therefore, we are dropping the self-
certification proposal of the NPRM. We will require MROs to take a
formal training course, like one of the three national programs
currently being offered. We will also require an examination
administered by a nationally-recognized MRO professional certification
board. We are not requiring ``certification'' of MROs, as such,
however. While people who take the MRO courses typically get a
``certificate'' from the program, DOT is not certifying doctors in a
way analogous to the way that the FAA certificates pilots. We believe
that certification by professional organizations is beneficial, but we
believe that there are sufficient market incentives for certification
that we do not need to require it in this rule. Finally, we are adding
a continuing education requirement to ensure that MROs keep up with
changes and developments in the field and the DOT program.
The final rule establishes a phase-in period for this training
requirement. For example, if a doctor is currently acting as an MRO,
but has not yet had a formal training course, the doctor would have
until January 2003 to meet the requirement. This should prevent any
difficulty caused by lack of training sites or dates convenient for a
particular physician.
Costs for existing MRO training courses tend to average around
$750, including the examination, and the courses take a weekend. This
low cost and time commitment suggest that this training requirement
should not dry up the supply of MROs.
Like other participants, MROs would have to maintain their own
documentation of training and qualification, which they must provide on
request to representatives of the Department and employers and service
agents who are using or negotiating to use their services.
One issue about which the Department inquired in the preamble to
the NPRM concerned issues of MRO work that goes across state lines.
Commenters expressed the concern that some state medical regulatory
organizations may attempt to assert that only doctors licensed in a
particular state could perform MRO services with respect to employees
located in that state. The Department shares these commenters' concern.
This is a national program, and MROs often perform their duties for
employees located in many states. Consequently, this section
specifically provides that a physician licensed to practice in any
jurisdiction (e.g., a state or province of the United States, Canada or
Mexico, consistent with NAFTA requirements) and meeting other MRO
requirements is authorized to act as an MRO with respect to employees
located in any jurisdiction. We would regard any attempt by a state
medical regulatory organization to limit the geographic scope of an
MRO's work as pre-empted under the pre-emption provisions of DOT agency
rules.
Section 40.123 What Are the MRO's Responsibilities in the DOT Drug
Testing Program?
There were a few comments on this section. One commenter liked, and
another disliked, referring to the MRO as a gatekeeper for the accuracy
and integrity of the process. Another suggested that the MRO should be
an advocate for the accuracy and integrity of the process. We have kept
the gatekeeper term and added the idea of being a program advocate. As
other commenters agreed, independence and
[[Page 79494]]
impartiality are essential to the MRO's role.
One commenter thought that the NPRM assumed, incorrectly, that MROs
were solo practitioners. This commenter pointed out that there are MRO
organizations with multiple MROs who perform drug testing program
functions. We are very aware of this phenomenon, which is not
surprising given the emphasis on group practice in today's health care
industry. Nevertheless, each MRO retains individual responsibility for
his or her actions. Groups don't verify test results; individual
doctors do. It is the individual doctor who must make a decision and
sign off on the result.
One employer organization was concerned that the NPRM placed in the
hands of MROs tasks that, in its view, properly belong to the employer,
like providing feedback to collection sites and laboratories on
performance issues. We have added ``employers'' to the list of persons
with whom it is appropriate for MROs to communicate. At the same time,
however, we do not believe that it is consistent with the independence
and impartiality of the MRO for employers to limit the contact of MROs
with other parties.
In particular, we believe that no other party may legitimately
attempt to interfere with the opportunity of an MRO to communicate with
DOT agency representatives about drug testing program matters. For this
reason, we have added language specifically prohibiting anyone from
interfering with an MRO's access to DOT personnel or retaliating
against an MRO for communicating with the Department.
We became convinced of the necessity of this provision, in part,
because of an instance in which an MRO raised an issue about a decision
of a major transportation employer, who had in turn been given
questionable advice by a service agent. The MRO brought the matter to
the Department's attention. The Department wrote a letter to the
employer correcting its understanding of the issue in question. The
employer responded by directing the MRO not to communicate with DOT and
subsequently terminated the MRO's services. The Department wants to put
all parties on notice that conduct of this kind is not permitted by the
new regulation and in future will subject violators to enforcement
action by DOT agencies, in the case of employers, or PIE proceedings,
in the case of service agents.
As a number of commenters noted, since MROs will be involved in
reviewing validity testing results, they will need to be prepared for
the verification process in adulteration and substitution situations.
This section now refers to this facet of the MRO's duties.
In addition, the rule does not deem MROs, in working with employees
under this program, to have established a doctor-patient relationship
with them. Doctors are not diagnosing or treating employees they
encounter in their role as MROs; they are using their medical expertise
to make decisions in the context of a forensic program. In the
Department's view, drug and alcohol tests are not properly viewed as
medical examinations or procedures, notwithstanding the involvement of
medically-trained personnel in their administration.
Section 40.125 What Relationship May an MRO Have With a Laboratory?
This section is the reciprocal of Sec. 40.101, prohibiting improper
MRO-laboratory relationships. It refers to the same improper
relationships listed in Sec. 40.101 and directs MROs to sign a
statement that they have no conflicts of interest or other improper
relationships with laboratories.
Commenters generally concurred with this provision, agreeing with
the need to keep MRO and laboratory functions separate. One commenter
said that MROs should be able to provide a list of laboratories to
customers and laboratories should be able to refer customers to MRO
certifying organizations. We do not endorse this practice, though the
names of HHS-certified laboratories and groups that train MROs are
matters of public record that no one can be forbidden from sharing.
Another commenter asked how the provisions of this section would be
enforced. The answer is through the PIE process. Another commenter
asked that we specifically prohibit having MROs or MRO staff within a
lab facility. The list of prohibited relationships in Sec. 40.101
includes this item.
Section 40.127 What are the MRO's Functions in Reviewing Negative Test
Results?
Commenters raised two main issues concerning this section. While
some commenters, mindful of the necessary role of the MRO in quality
control for the testing process, supported MRO review of negative test
results, most of those commenting said that the review requirements
were too burdensome. It was not necessary for MROs to review 10 percent
of negative results, they said, and this would raise costs that would
be passed on to employers. These commenters appeared to view the
processing of negative results as a simple administrative task that
could safely be delegated to staff. If MROs were to review negative
results at all, these commenters suggested, the amount of review should
be reduced (e.g., to five percent or a numerical maximum).
Reviewing negative test result records is an administrative task,
to be sure, and we anticipate that MRO staffs will do most of the work
involved. But quality control is an important function for which MROs
themselves must remain responsible. In response to comments, we will
reduce the number of reviews by MROs to five percent of results,
including all that have required some corrective action (e.g., to fix a
correctable flaw), to a maximum of 500 results per calendar quarter.
This will reduce the potential burden on MROs, while retaining their
oversight responsibility.
The second major issue was the proposed language that required
review of negative results to be done by staff under the direct
personal supervision of MROs. Some commenters objected to this
language, believing it meant that MROs would have to be co-located with
all staff and provide face-to-face supervision. This would be contrary
to common working arrangements of service agents, they said.
The Department does not intend, through use of this language, to
mandate that MROs must share the same physical space with all their
staff members at all times. As commenters noted, direct personal
supervision need not be physically face-to-face on an all-day, every
day basis. Supervision can also take place through using a variety of
electronic communications. However, the direct personal supervision
must be meaningful. It involves personal oversight of staff members'
work; personal involvement in evaluation, hiring, and firing; line
authority over the staff for decisions, direction and control; and
regular contact and oversight concerning drug testing program matters.
It also means that the MRO's supervision and control of the staff
members cannot be superseded by or delegated to anyone else with
respect to test result review and other functions staff members perform
for the MRO. In addition, CCFs may not contain fictitious addresses for
MROs, and MROs must be personally involved with the review process when
a confirmed positive, adulterated, or substituted result is received.
There were also some comments advocating the use of electronic
means of transmitting negative results from MROs to employers. We
agree, and provide for this in Sec. 40.163. A number
[[Page 79495]]
of comments to this section also touted transmission of negative
results to employers via C/TPAs, which we permit in Sec. 40.165 and
Appendix F. Some commenters also supported eliminating a requirement
that the MRO have any copies of the CCF before verifying a negative
result. We do not believe it is advisable to make this change, because
it is important that the MRO have the MRO copy of the CCF. This allows
the MRO to double-check the accuracy of a result to ensure, for
example, that an employer does not allow someone to begin work in a
safety-sensitive position on the basis of a mistaken or misidentified
negative result on a pre-employment test. Instead, we have tightened
the requirements for appropriate copies of the CCF to reach the MRO in
a more timely fashion.
Section 40.129 What are the MRO's Functions in Reviewing Laboratory
Confirmed Positive, Adulterated, Substituted, or Invalid Drug Test
Results?
Virtually all the comment in this section concerned its references
to the stand-down issue. The comments on this section were essentially
the same with respect to proposed Sec. 40.159, and we discussed this
issue in the ``Principal Policy Issues'' portion of the preamble. Since
we decided to allow employers to ask for a waiver to have a stand-down
policy, this section now tells MROs either to inform the DER that there
is a confirmed laboratory adulterated, substituted, invalid or positive
test result (if the employer has a stand-down waiver in place) or to
avoid telling the employer about such a result, pending verification
(if there is no such waiver in place). Since MRO review will now apply
to adulterated and substituted results as well as invalid and positive
results, this section and all those that follow reference all four
kinds of results.
Section 40.131 How Does the MRO or DER Notify an Employee of the
Verification Process After a Confirmed Positive, Adulterated,
Substituted, or Invalid Test Result?
Most of the discussion of this section concerned the proposed
requirement, based on the Department's current rules and guidance, that
MRO staff may make initial contacts with employees but not gather
medical information or information pertaining to a legitimate medical
explanation. A number of commenters said that staff, especially
medically trained staff like physicians' assistants and nurses, should
be able to perform these functions. This happens in the normal course
of doctors' office and clinic work, they said, and would make the
process less costly and more efficient. Other commenters thought the
proposal was important for protecting employees' rights in the system.
The Department believes that this situation is distinguishable from
the day-to-day operation of a doctor's office. We are talking here
about a key function in protecting the constitutional rights and
livelihoods of employees, a function that has no parallel in daily
clinical work. Our experience is that, if employees talk to staff about
substantive matters, they sometimes think they have talked to the MRO
and need not have further contact with the MRO. They therefore do not
take full advantage of the protections the rule makes available for
them. We also are concerned that clinic staff may not have the
background to talk effectively with employees about legitimate medical
explanations for confirmed positive, adulterated, substituted, or
invalid test results. Staff can still play a useful role by advising
employees to gather all prescriptions and other information together so
as to be prepared to have a productive discussion with the MRO, as well
as by scheduling the discussion with the MRO.
We agree with commenters who pointed out that discussions with the
MRO need not be in person. Most MRO operations use telephone contacts,
and we have no objection to continuing that practice. We also agree
with a commenter that, in instances where the MRO has been unable to
contact the employee, MRO staff can contact the DER to take the next
steps in the process.
The NPRM proposed that the MRO make at least two attempts to
contact the employee over a 24-hour period. There was disagreement
about this point. Some union and other commenters thought the period
was too brief, while some employer and other commenters thought it was
too long. We believe 24 hours is a reasonable middle ground that will
provide a fair chance to contact the employee to exercise an important
right while not allowing a situation to drag on interminably.
However, we have increased the minimum number of attempts to three,
in order to provide a greater chance for attempts to contact the
employee to be successful. These attempts need to be separated in time.
It would be useless to call the employee, get no answer, and call back
five minutes later to get no answer again. The attempts must be spread
reasonably over the 24-hour period involved. There may also be
circumstances in which the employee has provided incorrect phone
numbers. If both phone numbers are ``bad numbers'' (disconnected,
employee not known at that number), the MRO need not wait 24 hours to
take the next actions the rules call for, since it would be futile to
do so.
Section 40.133 Under What Circumstances May the MRO Verify a Test as
Positive, or as a Refusal To Test Because of Adulteration or
Substitution, Without Interviewing the Employee?
Commenters on this section were mainly concerned about time frames.
While there was relatively little disagreement with the idea that the
MRO could verify a test after 72 hours had passed from an MRO or DER
contact with an employee (one commenter suggested 48), many commenters
said that 14 days was too long a time for the MRO to wait before
verifying a test when no one was able to contact the employee. A number
of these comments suggested 5 or 7 days.
The Department will respond to these comments by shortening the
time period to 10 days. We do not believe it is necessary to shorten
the period further. Obviously, if the MRO or DER cannot contact the
employee in that amount of time, either the employee is not performing
safety-sensitive functions (e.g., is away on vacation without a
forwarding phone number) or is as unreachable to be pulled off safety-
sensitive duties as he or she is with respect to talking to the MRO.
There is no additional safety risk in either case.
Section 40.135 What Does the MRO Tell the Employee at the Beginning of
the Verification Interview?
Commenters generally supported this provision, which tells MROs to
inform employees about the verification process, what will be expected
of the employee, and about what information can later be made available
to employers and others. One commenter requested that MROs make
explicit what specific medications might be reported to employers. This
is potentially a very comprehensive list, and we do not believe that
this suggestion is practical.
Section 40.137 On What Basis Does the MRO Verify Test Results
Involving Marijuana, Cocaine, Amphetamines, and PCP?
One of the important provisions of this section, which the final
rule makes explicit, is that employees bear the burden of proof that
there is a legitimate medical explanation for the presence of these
drugs in their specimens. One commenter asked that we not ``shift'' the
burden of proof to the employee. There
[[Page 79496]]
is no ``shift.'' The employee has always had this responsibility.
Consistent with similar provisions in the validity testing context,
we are requiring employees to present their explanation and supporting
evidence at the time of the verification interview. The MRO's staff
will already have told the employee to gather prescription and other
relevant information for this purpose. This should help to expedite the
verification process. However, if the employee persuades the MRO that
there is a reasonable basis to believe that the employee can produce
additional relevant evidence, the MRO can grant up to five additional
days to produce the evidence. This is not mandatory: The MRO should
grant more time only if it appears that there is a good reason to do
so.
We agree with one comment that pointed out that there are no
legitimate medical explanations for the use of PCP. This is also true
of 6AM, a heroin-specific substance found in some opiate specimens.
Section 40.151 now tells MROs not to accept any medical explanations
for these substances.
The NPRM mentioned that an MRO could consider the employee's use of
legally obtained foreign medication. One commenter objected to this
provision. We believe it is appropriate to consider the fact that an
employee obtained medication legally in a foreign country, when
medically appropriate, even if that medication is not legally available
in the U.S. To do otherwise could penalize legal, innocent conduct. We
have adopted, as part of the rule text, the principles underlying the
Department's existing guidance on the foreign medications issue.
We intend that, under this provision, MROs have broad discretion to
determine whether the use of medications legally obtained within a
foreign country should be viewed as a legitimate medical. In doing so,
MROs must exercise their best professional judgment. MROs are neither
required to find a legitimate medical explanation in any particular
case nor prohibited from doing so (except to the extent that one of the
principles set forth in this section requires the MRO to find that
there was not a legitimate medical explanation). One of the reasons for
the prominent position given MROs in the DOT drug testing program is
precisely that we believe trained MROs are the best-equipped persons in
the program to make these difficult medical judgment calls. We are
confident that MROs will be thoughtful in considering the issues.
The rule articulates three principles for MROs use in exercising
their discretion. First, there can be a legitimate medical explanation
only with respect to a medication that is legally obtained in a foreign
country. Second there can be a legitimate medical explanation only with
respect to a substance that has a legitimate medical use. Even if one
obtains a substance abroad legally, it cannot form the basis of a
legitimate medical explanation if it does not have a legitimate medical
use. For example, drugs of abuse like heroin, marijuana, and PCP have
no legitimate medical uses, and they cannot form the basis of a
legitimate medical explanation in any case. Likewise, use of substance
which--if obtained in the United States--would not form the basis of a
legitimate medical explanation (e.g., hemp products, coca leaf teas)
cannot form the basis of a legitimate medical explanation when obtained
abroad.
Third, a foreign medication can form the basis of a legitimate
medical explanation only if it is used consistently with its proper and
intended medical purpose. When someone uses a medication, the person
has an obligation to use the substance for its appropriate purpose and
in keeping with medical instructions for its use. In addressing this
issue, the MRO should look at a number of factors. Did the employee
have a genuine medical need for using the substance (e.g., an acute
condition that arose while the employee was in the foreign country)?
Did the employee use the medication for an appropriate medical purpose
(e.g., as opposed to using a medication intended for one purpose for a
different, and inappropriate, purpose)? Is the quantity of the
substance in the individual's specimen consistent with its proper
medical use?
In applying these principles, it is very important for the employee
to provide the MRO with adequate documentation. Travel documentation
(visa, passport stamps, airline tickets, etc.) can help to check an
employee's assertion that he or she was in the foreign country in
question at the time he or she said the medication was obtained and/or
consumed. Especially where a prescription drug is involved, discussions
with a foreign physician or pharmacist are relevant to confirming the
prescription for the foreign medication and the reason for it. It is
important to note that, in some cases, drugs may be prescribed for
purposes in foreign countries different from the purposes for which the
medications are prescribed in the U.S. In the case of any foreign
medication, the MRO should review documentation of purchase.
Ultimately, it is the employee's burden to produce this information,
though the MRO may need to be involved in some aspects of the effort,
such as discussing medications with a foreign doctor.
In assessing situations in which an employee obtains a medication
abroad and consumes it after returning to the U.S., the MRO should take
special care to ensure that the employee is using the medication for
its intended, appropriate medical purpose. Import and use of some
medications in the U.S. may be inconsistent with U.S. drug laws or
Customs rules. This heightens the concern that an employee who is using
such a medication in the U.S. may not be doing so consistent with its
appropriate, intended medical purpose. In particular, routine or
frequent use of such a medication in the U.S., as distinct from a one-
time or infrequent, inadvertent, or emergency use of the medication,
may support an inference that an individual is not using the medication
for its intended, appropriate medical purpose. If an employee should
have consulted with a U.S. physician before using a foreign medication
in the U.S., it can be relevant for the MRO to ask whether such a
consultation took place. As a general matter, we view the U.S. use of
foreign medication as more problematic than the use of the medication
abroad, and we advise MROs to be more conservative in their
determinations where U.S. use is involved.
As in cases involving drugs obtained domestically, verification of
a test as negative does not end the MRO's job. If use of a substance,
even though not a violation of DOT agency drug and alcohol testing
rules, creates safety or fitness-for-duty problems, MROs have a mandate
to report this information to employers (see Sec. 40.327). An employee
may be medically unfit for safety-sensitive duties because of the use
of a legal medication, foreign or domestic.
Section 40.139 On What Basis Does the MRO Verify Test Results
Involving Opiates?
Most of the discussion on this section concerned the use of the
15,000 ng/mL level of opiates in a specimen for shifting the burden of
proof from the MRO (who in most opiate cases must show clinical
evidence of unauthorized use) to the employee to show a legitimate
medical explanation, as is the case in Sec. 40.137 for other drugs. As
noted in the preamble to the NPRM (see 64 FR 60980; December 9, 1999),
the Department has good reason to believe that this is an appropriate
level (i.e., one high enough to avoid imposing an unfair burden on
people who eat poppy seeds or otherwise engage in legal
[[Page 79497]]
activities for which there are not legitimate medical explanations).
Some commenters appeared confused about the relationship of this
threshold to the 2000 ng/mL cutoff for a confirmed positive test
result. The two are different, and they are used for different
purposes. The latter establishes a confirmed positive test; the former
establishes that the employee, rather than the MRO, has the burden of
proof in the verification process. In one Canadian commenter's example,
codeine medications are legally available in Canada, and might produce
test levels in excess of 15,000 ng/mL. In such a case, the employee
would have the burden of proof with respect to a legitimate medical
explanation, which the employee could meet through showing that he or
she had used a legal over-the-counter medication.
When an employee cannot establish a legitimate medical explanation
for opiate levels (morphine or codeine) above the 15,000 ng/mL, then
the MRO would verify the test positive. There would be no need for the
MRO to find clinical evidence of unauthorized use.
A commenter suggested, and we agree, that the MRO or other
physician's encounter with an employee to determine if there is
clinical evidence of unauthorized opiate use is better styled an
``examination'' than an ``interview,'' and we have changed the language
accordingly.
The Department notes that a situation could arise in which the
primary specimen is positive for opiates and 6-AM. The MRO verifies the
test as positive, without determining whether there is a legitimate
medical explanation or clinical signs of unauthorized use, since these
steps are not necessary when a specimen is positive for 6-AM. The split
specimen reconfirms the presence of opiates but not the presence of 6-
AM.
In this case, the test would not be cancelled. Rather, the MRO
would take additional verification steps. If the amount of morphine or
codeine in the primary specimen were 15,000 ng/mL or more, the MRO
would ask the employee to provide information on any legitimate medical
explanation there might be for the presence of the opiates in the
specimen. If the amount of morphine or coedine were less than 15,000
ng/mL, the MRO would examine the employee for clinical signs of
unauthorized use or refer him or her to another physician for this
purpose. The MRO would then make a decision about whether to verify the
result as positive. The MRO would make this decision without reference
to 6-AM, since the specimen had failed to reconfirm for 6-AM.
Section 40.141 How Does the MRO Obtain Information for the
Verification Decision?
There were few comments to this section. One that we adopted
suggested that in addition to reviewing evidence on its face, the MRO
should take all reasonable and necessary steps to verify the
authenticity of the evidence. We have deleted a provision authorizing
the MRO to tell the laboratory to conduct a reanalysis of the primary
specimen. Because this rule no longer provides for single specimen
collections, we believe that this language is superfluous. Reanalysis
of the primary specimen is no longer authorized.
Section 40.145 On What Basis Does the MRO Verify Test Results
Involving Adulteration or Substitution?
This section adds MRO review provisions concerning the results of
validity tests. The basic policy issue of MRO review for validity
testing was discussed in the ``Principal Policy Issues'' section of the
preamble, which also describes the provisions of these sections. As
noted above, MRO review of validity testing results will begin 30 days
after the publication of this rule.
One point we want to emphasize is that it is not enough for an
employee to come up with a reason that allegedly accounts for the
result (e.g., a medical condition, personal characteristics, proximity
to a chemical). To meet his or her burden of proof, the employee must
demonstrate a link between the alleged reason and the ability to
physiologically produce the laboratory result obtained. For example, if
an employee shows he has medical condition X, then he must also show a
medical/scientific basis for getting from X to a creatinine result
below 5 and a specific gravity below 1.001. If the employee shows he
had topical exposure to chemical Z, he must also demonstrate medical/
scientific evidence that topical exposure to Z in the concentration he
experienced leads to the physiological production of the levels of Z in
his specimen that the laboratory found. Any such evidence must meet
medical/scientific criteria for controls, methodology etc., in order to
have credibility.
In any case in which the MRO cancels an adulterated or substituted
test result because the employee has established a legitimate medical
explanation, the MRO must make a written report to ODAPC. The purpose
of this report is to permit ODAPC and HHS to examine the circumstances.
This examination could lead to additional guidance to MROs or
laboratories concerning the matters that led to the cancellation. ODAPC
would not, in such a case, act as a ``court of appeals'' that would
overturn the results of the MRO review process.
Under the final rule, the MRO reviewing an adulterated or
substituted test result could direct the employee to obtain, within 5
days, a further medical evaluation from someone with expertise in the
medical issues raised by the employee's explanation. This individual
could be a specialist in a particular field of practice, but need not
be. What is important is that the referral physician have enough
expertise to deal effectively with the particular issues in the case.
The Department is aware that, in some cases, it may be difficult
for an employee to secure, on his or her own, an appointment for this
evaluation in a short period of time. Consequently, the Department does
not regard it as a refusal to test if the employee is unable, after
making good faith efforts, to get the appointment within the 5-day
period. However, the MRO and the employer should do everything feasible
to assist the employee in finding and getting an appointment with an
appropriate physician.
Section 40.149 May the MRO Change a Verified Positive Drug Test Result
or Refusal To Test?
This provision is based on proposed Sec. 40.161. There were
relatively few comments. A small number of commenters suggested that
the employer should be able to change an MRO's action the employer
believed to be erroneous, perhaps by referring the matter to another
MRO for a second opinion. We do not believe that it would be advisable
to authorize this sort of forum shopping. Under the new regulation,
MROs will be even better trained in their duties. It would erode the
finality of MRO's decisions and the protections the MRO system affords
to employees to allow employers a second bite at the apple.
Some commenters also believed the 60-day period during which an MRO
could reverse a decision he or she had made was too long. One commenter
thought that 14 days was a more reasonable time period. The point of
this provision is to allow employees to present evidence that was not
originally available. There need be no rush to foreclose this
opportunity, which has no adverse safety implications, since the MRO
will have already communicated the verification decision to the
employer, who will have removed the employee from safety-sensitive
duties. We will leave this provision unchanged, except to add a
reference to adulteration and substitution cases.
[[Page 79498]]
Here is a hypothetical case illustrating how the provision would
work, in concert with the five-day extension provision of the
Secs. 40.137 and 40.145. The MRO interviews the employee, who says she
has a legitimate medical explanation. She asks for, and receives, a 3-
day extension to find evidence of the explanation, but is unable to do
so. The MRO verifies the test as a refusal because of adulteration or
substitution. The MRO reports the verified refusal result to the
employer, who removes the employee from safety-sensitive duties.
Six weeks later, she returns to the MRO with additional data,
including a study performed by the referral physician, acceptable to
the MRO, who she has retained. The study, performed under carefully
controlled conditions, shows that the employee was able to replicate
the laboratory result through physiological means. The MRO determines
that this is a legitimate medical explanation and, after discussing the
matter with ODAPC, reverses the original verification result. At this
point, the employee no longer has an obligation to complete the return-
to-duty process before working again in a safety-sensitive position.
Section 40.151 What Are MROs Prohibited From Doing as Part of the
Verification Process?
This section is based on Sec. 40.143 of the NPRM. There was little
comment. A few comments recommended that MROs should be able to
consider evidence extrinsic to the testing process, such as procedural
errors not reflected on the CCF, tests of additional specimens (e.g., a
hair test), or use of ``medical marijuana'' in a state with a law
authorizing such use. The Department is not adopting these suggestions,
which would authorize collateral attacks on the validity of the testing
process. This regulation prescribes the testing process; if the
procedures in a given test meet this part's requirements, that is
enough to make the test valid. The MRO should not go beyond the rule's
requirements to accept other reasons to cancel a test.
We do not believe it is appropriate to place MROs in the position
of having to decide factual disputes between employees and collectors
about what did or did not occur at the collection site (e.g.,
allegations that the collector left the area or left open urine
containers where other people could access them) or about whether
someone was properly selected for testing. Therefore, this section
directs MROs not to become involved in issues extrinsic to the
documents in reviewing the CCF. We do not intend, through this
provision, to preclude MROs from taking action to cancel a test if the
MRO determines that a fatal flaw has occurred in the testing process.
We have, as some commenters suggested, added provisions related to
validity testing. Certain substances cannot be produced physiologically
in urine, and urine cannot have a zero creatinine content. Likewise,
there is no legitimate medical explanation for PCP or 6-AM. The rule
specifies that MROs cannot find that a legitimate medical explanation
exists in these circumstances. Following a commenter's suggestion, we
have also added coca leaf tea explanations to the same category of
explanations (along with use of hemp products) that MROs may not
accept.
Section 40.153 How Does the MRO Notify Employees of Their Right to a
Test of the Split Specimen?
Commenters said that if, as Sec. 40.145 of the NPRM proposed, MROs
tell employees with verified positive, adulterated, and substituted
tests (1) that they have a right to a test of the split specimen if
they make a timely request, and (2) that they are not required to pay
for the test from their own funds before the test takes place, then
employees will frequently request tests of split specimens. This, in
the view of a significant number of commenters, would be a bad thing:
Few split specimens fail to reconfirm and testing them is an expensive
annoyance that merely serves to delay the inevitable. On the other
hand, as one commenter suggested, requiring advance payment from the
employee's own funds would have the benefit of eliminating most split
specimen tests, since they are most often a ploy used by a guilty
employee in the hopes that the split is unavailable for testing or that
the specimen will not reconfirm.
The problem with these commenters' analysis is that a test of a
split specimen is a right guaranteed to employees by the Omnibus
Transportation Employee Testing Act. We agree with commenters that if
we do not make employees aware of this right and permit employers to
financially deter employees from exercising it, then fewer employees
are likely to request a test of the split specimen. However, we must
disagree with the proposition that reducing the frequency of requests
of a test of the split specimen is an appropriate objective.
When Congress guarantees a right to employees (and we believe we
must treat all DOT-regulated employees in our program alike, even if
they are not covered by the Omnibus Act), our obligation as a Federal
agency is to faithfully execute that legislative decision. The statute
provides a series of other protections to employees as a matter of
right, such as the use of an HHS-certified laboratory and resort to MRO
review for the five HHS drugs. An employer could not say that employees
could have their specimen tested at an HHS laboratory only if they paid
in advance a higher price to have their specimen tested there instead
of a local hospital. Nor could an employer say that it would make MRO
review available only if the employee paid in advance for the MRO's
services. The same rationale applies to a test of the split specimen.
When the statute and rule say that a certain procedure must be made
available to an employee, then the employer is responsible for making
it happen.
Through collective bargaining or subsequent attempts at securing
reimbursement, an employer may seek to have the employee ultimately pay
part or all of the cost of a split specimen. But when the employee with
a verified positive, adulterated, or substituted test result makes a
timely request for a test of the split specimen, it is required that
the test take place, and this requirement cannot be made contingent on
advance payment by the employee. The Department will retain its NPRM
language on this point. (This approach is consistent with the
Department's longstanding interpretation of the current rule.)
Another issue in the comments was how to define ``timely.'' The
NPRM, like the present rule, says the right to a test of the split
specimen is triggered if the employee makes the request within 72 hours
of being notified by the MRO of a verified positive test. On request of
a number of commenters, we are making explicit that it is the
notification of the verified test result that starts this time period
running. Some commenters pointed out that RSPA would have to change its
rule (which currently permits up to 60 days for such a request) to be
consistent with this provision. RSPA will propose such a change as part
of its conforming amendments to this rule.
Employers also asked whether they may take action during this 72-
hour period. In fact, employers must remove employees from safety-
sensitive duties as soon as they are notified of a verified positive,
adulterated, or substituted test result. In addition, employers are
free to take personnel action once they receive the verified result,
although we believe it would be wise to avoid taking final action
(e.g., termination) until the 72 hours are up or, where the employee
requests a test of the split specimen, until the MRO reports the second
[[Page 79499]]
laboratory's split specimen test result to the employer. Nothing
requires the employee to be in paid status during this period, in any
case.
A number of commenters noted that MROs sometimes authorize tests of
the split specimen well after the 72-hour period has elapsed (e.g.,
weeks or months later). Nothing in the rule precludes an MRO from doing
so. However, an employee has a right to a test of the split specimen
only if he or she requests it within 72 hours. The employee cannot
insist on having the split specimen tested after that time, and the
employer is not obligated, financially or otherwise, to make the test
happen.
A few commenters suggested that the request for a test of the split
specimen should be made in writing. It seems to us that a careful
employee would make a written request, in order to have his timely
request on the record. But we do not think it is necessary to require
this action. Another commenter thought that the rule should not direct
the MRO to tell employees that DNA or other tests are not authorized.
The Department believes that this provision is beneficial as a means of
avoiding unnecessary requests for these tests, and we have retained it.
Section 40.155 What Does the MRO Do When a Negative or Positive Test
Result Is Also Dilute?
This section is based on proposed Sec. 40.147 of the NPRM. There
was little comment on this section, most of which concerned the issue
of whether a dilute specimen should be an occasion for a recollection
under direct observation. Such a recollection is not necessary in the
case of a test result that is both positive and dilute. For a test that
is both negative and dilute, we have decided (see Sec. 40.197(b)) to
allow the employer the discretion to conduct an immediate recollection,
but not under direct observation, since there can be many innocent
reasons for a dilute specimen. This is a change from the existing rule,
which permitted tests under direct observation on the next occasion
when the individual would be tested (e.g., in the random program).
Section 40.159 What Does the MRO Do When a Drug Test Result Is
Invalid?
This section is based on Sec. 40.151 of the NPRM. Consistent with
HHS guidelines, we are using the term ``invalid'' rather than
``unsuitable for testing'' to describe such test results. There were a
variety of comments on this section. Some commenters thought we should
treat invalid tests as refusals to test, the same way we treat
adulterated and substituted tests. Another commenter thought it would
save time and effort if we simply cancelled invalid tests, with an
unannounced recollection under direct observation, rather than going
through the MRO inquiry process proposed in the NPRM.
We believe that the Department chose a reasonable middle ground in
the NPRM, and we will use this approach in the final rule. When an
adulterant has not identified, it has not been conclusively shown that
the employee has tampered with the specimen. Recollection under direct
observation is an appropriate response to the suspicion of tampering
that an invalid result raises. On the other hand, there may be medical
reasons for an invalid result. Where these exist, it would be unfair to
impose a directly observed collection on the employee.
A commenter suggested that, when an employee admits to adulterating
or substituting a specimen, the MRO get a written statement from the
employee or make his own contemporaneous written statement of the
employee's admission. We think that having the MRO document such
admissions is a good idea, and we have added it to paragraph (c).
Section 40.161 What Does the MRO Do When a Drug Test Specimen Is
Rejected for Testing?
This section is based on Sec. 40.155 of the NPRM. Most comments
were to the effect that it was unnecessary to have the MRO investigate
the reason for the rejection, which commenters said was usually
obvious. In response, we have removed this requirement and simplified
this section. It now just recites the paperwork steps the MRO follows
when he or she receives a rejected result.
This section no longer calls for a recollection following a
rejected result. There does not seem to be any strong reason for
requiring a recollection because of what, in most cases, is an
administrative error. Of course, in situations (e.g., pre-employment)
where a negative test result is required, there will have to be another
test in order to attempt to obtain the negative result.
Section 40.163 How Does the MRO Report Drug Test Results?
Section 40.165 To Whom Does the MRO Transmit Reports of Drug Test
Results?
Section 40.167 How Are MRO Reports of Drug Results Transmitted to the
Employer?
These sections are all based on proposed Sec. 40.157. We split the
proposed section into three parts to make it easier to understand. The
greatest number of comments on the proposed section concerned the use
of C/TPAs as intermediaries to transmit results from MROs to employers.
We discussed this issue in the ``Principal Policy Issues'' portion of
the preamble and incorporated our decision in Sec. 40.345. Section
40.165 of the new rule references this decision, by saying that the MRO
transmits results either to the DER or to a C/TPA acting as an
intermediary. We emphasize that it is the employer's choice that
determines whether the MRO transmits the information directly or
permits a C/TPA to act as an intermediary.
A number of comments concerned the electronic transmission of
results (e.g., by fax or secure computer link). Electronic signature
issues were also raised in this context. The Department's advisory
committee will take up these issues in greater detail. For now, we will
retain the NPRM language that telephone contact is the preferred means
for transmitting non-negative results. We also note that one commenter
appeared to misunderstand proposed Sec. 40.157(b)(3), which has become
Sec. 40.167(c)(3) in the final rule. We do not require the MRO's verbal
report to include all the points required in the documentation of the
report, which must follow the verbal report. We have also decided to
delete the information item concerning the address of the collection
site, because we do not believe it is necessary for this report.
Some commenters felt that the report format was too complex and
would lead to practical difficulties. In connection with the new CCF,
we have simplified these requirements. All reports can be made on a
stamped (negatives) or signed (all other results) copy of Copy 2 of the
CCF. Otherwise, the MRO must compose a letter with several information
items for each result. We prefer that MROs use copies of Copy 2 of the
CCF for this purpose, which will result in generating much less
paperwork.
[[Page 79500]]
Section 40.169 Where is Other Information Concerning the Role of MROs
Found in This Regulation?
This is another in the series of sections providing, for readers'
convenience, references to other sections of the regulation that
concern, in this case, the role and activities of MROs.
Subpart H--Split Specimen Tests
Section 40.171 How Does an Employee Request a Test of a Split
Specimen?
There were few comments on this section. A number of commenters
wanted to require that requests for tests of split specimens be in
writing. One reason given for this request was that some employees, if
the split specimen test reconfirmed, would deny asking for the test
when the employer asked for reimbursement. We do not think it necessary
to require these requests to be in writing, which in some instances
could delay or burden the employee's right to have the split specimen
retested. However, so that there is a written record of the request,
the NPRM and this final rule direct MROs to document the date and time
of the employee's request.
Section 40.173 Who Is Responsible for Paying for the Test of a Split
Specimen?
This section is related to the provision concerning payment for
split specimen tests in Sec. 40.153, and commenters took very similar
positions on the issues. Not surprisingly, unions and some service
agents liked the proposal better than employers. The Department's
rationale for incorporating this provision in the final rule is
essentially the same as discussed under Sec. 40.153 above. Employers
did want assurance that they could seek reimbursement from employees,
and paragraph (c) of both the NPRM and final rule makes that point
clear. We added an example of how employers could ensure that testing
occurs on time (establishing accounts with laboratories, which they
could do on their own or through a C/TPA).
Section 40.175 What Steps Does the First Laboratory Take With a Split
Specimen?
There were few comments concerning this section. Some commenters
asked that tests be cancelled when a split specimen was unavailable.
For reasons discussed above, the Department believes it is better to
test the primary specimen in such cases. Some commenters addressed
proposed Sec. 40.175(c), which we have deleted because it duplicated
laboratory procedure matters in HHS guidance. Laboratories will follow
this HHS guidance with respect to specimen retention requirements.
Commenters asked for clarification of who gets to choose the laboratory
that tests the split specimen. This is an issue on which the Department
does not have a position. We are satisfied as long as the parties use
an HHS-certified laboratory.
Section 40.177 What Does the Second Laboratory Do With the Split
Specimen When It Is Being Tested To Reconfirm the Presence of a Drug or
Drug Metabolite?
Section 40.179 What Does the Second Laboratory Do With the Split
Specimen When It Is Being Tested To Reconfirm an Adulterated Test
Result?
Section 40.181 What Does the Second Laboratory Do With the Split
Specimen When It Is Being Tested To Reconfirm a Substituted Test
Result?
These sections are all based on proposed Sec. 40.177. Most of the
comments on proposed Sec. 40.177 concerned the addition of validity
testing to the split specimen portion of the program, discussed in
greater detail in the ``Primary Policy Issues'' portion of the
preamble.
Existing HHS guidance (Program Documents 35 and 37) establish
criteria for testing of the primary specimen for adulteration and
substitution. These are the criteria referenced in Secs. 40.93 and
40.95. These Program Documents do not, on their face, apply to testing
of the split specimen. HHS is planning to incorporate split specimen
testing criteria for adulteration in forthcoming mandatory requirements
for validity testing. Pending completion of this formal HHS issuance,
and because we believe it is important to begin split specimen testing
in the validity testing program as soon as possible, the Department in
Secs. 40.179 and 40.181 is requiring that the split specimen meet
exactly the same criteria as the primary specimen in order to be
considered reconfirmed. These criteria already exist in HHS guidance
(Program Documents 35 and 37) and have a sound technical basis. When
HHS issues its final mandatory requirements for split specimen tests in
adulteration and substitution cases, the Department will, if necessary,
amend these provisions to refer to the HHS issuance.
Section 40.183 What Information Do Laboratories Report to MROs
Regarding Split Specimen Results?
This section is based on proposed Sec. 40.181 of the NPRM. There
were no substantive comments. We have adopted the section as proposed,
except that we have added notations applicable to split specimen tests
in adulteration and substitution situations. We also clarified that
laboratories must sign and date the appropriate CCF copy.
Section 40.185 Through What Methods and to Whom Must a Laboratory
Transmit Split Specimen Results?
This section is based on proposed Sec. 40.179 of the NPRM. Comments
focused on two issues: the use of electronic means of transmission and
use of service agents as intermediaries between laboratories and MROs.
In response to comments favoring greater use of electronic means, the
final rule will permit results to be sent by electronic image, as well
as other means. However, for the same reasons applicable to
transmission of primary specimen test results, we will not permit C/
TPAs to receive split specimen results from laboratories.. Laboratories
must promptly send split specimen results directly to MROs.
Section 40.187 What Does the MRO Do With Split Specimen Laboratory
Results?
This section is based on proposed Sec. 40.183 of the NPRM. Some
commenters objected to a retest under direct observation as the
consequence of a failure to reconfirm due to the unavailability of the
split specimen for testing. As noted above, this situation involves
strong evidence of a violation of the rules (e.g., a verified positive
test), with the test being cancelled only because of a process problem
(e.g., the split leaked away). In this situation, there is a stronger
than usual incentive for the employee to attempt to beat the next test,
hence the need for direct observation on the recollection.
The Department deleted proposed Sec. 40.185, concerning retests of
single specimen collections, since all collections under the new rule
will be split specimen collections.
Section 40.189 Where Is Other Information Concerning Split Specimens
Found in This Regulation?
This is another in the series of cross-reference sections designed
to help readers find related material.
Subpart I--Problems in Drug Tests
Section 40.191 What Is a Refusal To Take a DOT Drug Test, and What Are
the Consequences?
If an employee declines to take a drug test or takes a number of
other actions that obstruct the drug testing process, the employee is
deemed to have refused to test. For the most part, the consequences of
a refusal are the same
[[Page 79501]]
or more severe as for any other violation of DOT agency drug and
alcohol regulations.
Commenters generally agreed with the list of actions in this
section that constitute a refusal to test. One commenter wanted
refusals on non-DOT tests to count as refusals under this part. They
cannot, because this part does not require anyone to take a non-DOT
test. A few comments also urged use of alternative testing
technologies, such hair testing and on-site testing, in potential
refusal situations. The Department will defer to HHS on alternative
testing technology issues. HHS has not yet authorized these approaches
to testing. We have added a specific reference to verified adulterated
or substituted test results as a ground for determining that an
employee has refused to test.
Section 40.193 What Happens When an Employee Does Not Provide a
Sufficient Amount of Urine for a Drug Test?
This is the so-called ``shy bladder'' provision of the rule. The
proposed section would keep the core of the Department's current shy
bladder procedures in place, and commenters did not question the
direction of this provision. Commenters did address a number of
specific issues concerning the section. Some commenters wanted to
specify that the physician performing an evaluation of potential
medical reasons for a shy bladder situation be a urologist or other
specialist, on the theory that a non-specialist was not as well
equipped for this function. The Department agrees, and, in parallel
with the language concerning MRO review of adulteration and
substitution provisions, the final rule calls for the use of a licensed
physician with expertise in the medical issues surrounding a failure to
provide a sufficient specimen.
Commenters disagreed about who ought to select the physician for
this evaluation. Some said the referral physician should be acceptable
to the employer. Others said the referral physician should be
acceptable to the employee. We take the view that the rule should not
specify who makes the selection of the referral physician, but we do
think that he or she should be acceptable to the MRO. The MRO is in a
better position than either the employee or the employer to determine
if a particular referral physician is appropriate to this task.
Under the final rule, the an employee in a shy bladder situation
would be directed to obtain within 5 days, a further medical evaluation
from someone with expertise in the medical issues raised by the
employee's situation. This physician could be a specialist (e.g., a
urologist), but need not be. What is important is that the referral
physician have sufficient expertise to deal effectively with the
medical issues in the employee's case.
The Department is aware that, in some cases, it may be difficult
for an employee to secure, on his or her own, an appointment for this
evaluation in a short period of time. Consequently, the Department does
not regard it as a refusal to test if the employee is unable, after
making good faith efforts, to get the appointment within the 5-day
period. However, the MRO and the employer should do everything feasible
to assist the employee in finding and getting an appointment with an
appropriate referral physician.
Commenters raised in this context the issue of whether a refusal to
drink fluids in a shy bladder situation should constitute a refusal to
test. We do not believe that a refusal to drink fluids should be
considered a refusal to test, and we have incorporated this view into
the text of this section.
Some commenters suggested that, during the five days that may
elapse between an employee's provision of an insufficient specimen and
the determination of whether this constitutes a refusal to test, the
employee should be stood down from performing safety-sensitive
functions. We are not adopting this suggestion. Until and unless a
refusal is determined to have occurred, there is no evidence of
violation of the rules on which to base a temporary removal from
performance of safety-sensitive duties (unlike the situation under a
stand-down waiver, where there is the evidence of a confirmed positive
test).
A few comments questioned the three-hour waiting/fluid consumption
period following an employee's provision of an insufficient specimen.
One comment said blood should be drawn after two hours. Other comments
said it made more sense to go immediately to an alternative specimen,
such as saliva or hair. We believe that the three-hour period is by now
well established in the DOT program, and comments did not make a
compelling case for changing it. As noted above, we are waiting for HHS
action before making any further decisions concerning alternative
specimens.
We incorporated in this section an existing DOT interpretation
concerning psychological conditions alleged as reasons for a failure to
provide a sufficient specimen. The meaning of this interpretation (see
paragraph (e)) is that to be regarded as a pre-existing psychological
disorder, it is not necessary that the condition be diagnosed before
the time of the test, but the symptoms have to have been medically
documented before the time of the test. For example, an individual may
have brought urination problems to the attention of his urologist over
a period of time, but the urologist did not enter a specific diagnosis
of a psychological disorder into the medical records. In this
situation, the examining physician has the discretion to determine that
there was a pre-existing psychological condition, if the physician is
convinced that the medically documented symptoms support such a
diagnosis.
Section 40.195 What Happens When an Individual Is Unable To Provide a
Sufficient Amount of Urine for a Pre-Employment or Return-to-Duty Drug
Test Because of a Permanent or Long-Term Medical Condition?
This section is intended to address a rare, but difficult, issue
that may arise in these types of testing. In a pre-employment or
return-to-duty test, an employee who is not now performing safety-
sensitive duties must have a negative test result in order to begin or
resume performing safety-sensitive duties. In a ``shy bladder''
situation, if there is an adequate medical reason for the inability to
provide a sufficient specimen, the test result is cancelled, not
negative. If a permanent or long-term medical condition is the cause of
the inability to provide a sufficient specimen, the employee might
never be physically capable of obtaining a negative result. This could
be very unfair to the employee, and it could raise Americans with
Disabilities Act issues as well.
Some commenters expressed the view that this provision should apply
to other types of testing as well (e.g., random). We do not believe it
is necessary to do so, because employees in these situations do not
need a negative test result to perform safety-sensitive functions. A
cancelled test is not a violation of DOT rules that compels employers
to remove employees from safety-sensitive duties.
In response to a comment, we added language that the MRO can
conduct, or cause to be conducted, the further medical evaluation the
section requires. We have also clarified that, as part of this
evaluation, the physician may use alternative testing methods,
including but not limited to blood testing, to help determine whether
the employee shows clinical evidence of drug abuse. Particularly given
that we do not apply
[[Page 79502]]
this procedure to random testing, we do not agree with a suggestion
that an individual covered by this section should be taken out of the
random testing pool. Doing so would also affect the probability that
other individuals would be selected for testing. As in other situations
calling for medical evaluations, the rule requires that the physician
conducting the evaluation be acceptable to the MRO, rather than to the
employer or employee.
Under this section and Sec. 40.193, the referral physician reports
to the MRO the basis for any conclusion that the individual has a
permanent, long-term disability that prevents providing a sufficient
specimen. However, for privacy reasons, neither the referral physician
or the MRO passes on to the employer any information about the nature
of the disability. The employer is simply told that there is a
permanent, long-term condition.
We have not included similar language in the rule concerning
alcohol testing, because pre-employment alcohol testing is not
mandatory. In the rare situation in which an employee is required to
have a negative alcohol test in a return-to-duty or follow-up test
situation, and could not produce sufficient breath because of a
permanent, long-term disability, we would apply the reasoning of this
section to that situation.
Section 40.197 What Happens When an Employer Receives a Report of a
Dilute Specimen?
This section is based on Secs. 40.147(a) and 40.159(d) of the NPRM.
The NPRM, like the existing rule, would have given employers discretion
to use direct observation the next time the employee was selected for
testing (e.g., in random testing). Comments on this issue and the
Department's responses are discussed under ``Collection Issues'' in the
``Principal Policy Issues'' portion of this preamble. It should be
noted that, unlike the existing rule and the NPRM, this provision
authorizes a new collection immediately following a negative-dilute
result, rather than on the next occasion when an employee is selected
for testing. This recollection is not conducted under direct
observation.
Section 40.199 What Problems Always Cause a Drug Test to be Cancelled?
This section, listing ``fatal flaws'' that invariably result in the
cancellation of a test, is based on Sec. 40.197 of the NPRM. The list
of fatal flaws in the final rule is somewhat different from that in the
proposed rule. Proposed paragraph (b), concerning the lack of a
specimen ID number, is really an instance of the flaw cited in
paragraph (a), a mismatch between the specimen ID numbers on the
specimen bottle and the CCF. The former is included in the latter, so
we have deleted the proposed paragraph (b). Consistent with HHS
guidelines, we have added a new paragraph (b), concerning a situation
in which the printed collector's name and collector's signature are
both missing. This section's list of fatal flaws is now consistent with
the HHS list of fatal flaws.
A few comments suggested either that fatal flaws automatically
cancel a test, without MRO involvement, or that the employer have the
authority to cancel a test when a fatal flaw appears. We believe that,
as the key ``gatekeeper'' and quality control person in the system, the
MRO is the best party to make the actual pronouncement of a
cancellation based on a fatal flaw. Another comment suggested that an
error in the chain of custody documentation should result in the
cancellation of a test. The problem here is that not all errors are
created equal. Depending on the seriousness of an error and our ability
to fix it, an error on the CCF can be a fatal flaw, a correctable flaw,
or a de minimis error that does not result in cancellation.
Finally, a commenter asked whether Bottle B may be redesignated as
Bottle A, as the final paragraph of this section suggests. This has
been an interpretation issue under the existing rule, but we are clear
in this final rule that such redesignations can take place.
Section 40.201 What Problems Always Cause a Drug Test To Be Cancelled
and May Result in a Requirement for Another Collection?
This section is based on Sec. 40.199 of the NRPM. One commenter
suggested treating invalid test results as refusals. As we have
discussed above, the Department did not adopt this suggestion. There
were no other substantive comments on this section, which we have
adopted with some editorial changes and the addition of a paragraph
pertaining to the failure of an adulterated or substituted result to
reconfirm.
Section 40.203 What Problems Cause a Drug Test To Be Cancelled Unless
They are Corrected?
This section is based on Sec. 40.201 of the NPRM and concerns
``correctable flaws.'' Commenters generally approved the proposed
provision, but had varied suggestions. As in the case of fatal flaws,
one suggestion was to allow employers to cancel tests in the case of an
uncorrected flaw. As we said in that case, we believe that MROs are the
best party to take all such actions in the drug testing program. Two
commenters disagreed concerning the situation of a missing employee
signature coupled with a lack of collector notation of the omission:
one said it should be a fatal flaw and the other said it need not be
even a correctable flaw. We believe that the NPRM formulation of making
this situation a correctable flaw makes the most sense, giving due
regard both to the need for completeness of the documentation and the
ability to work around inadvertent administrative mistakes.
A commenter suggested that an incorrect employee social security
number (SSN) or other ID number (e.g., a transposition of numbers)
should not be a fatal or correctable flaw. We agree with this comment.
We also believe that a minor transposition error is the kind of
irregularity that would not cause a test to be cancelled (see
Sec. 40.209). If an ID number is completely wrong (e.g., appears to be
a different number altogether) is too badly garbled to be useful in
establishing the employee's identity, we view the number as having been
omitted, which is a correctable flaw under paragraph (c). Another
commenter suggested that the combination of a wrong ID number and a
missing employee signature should be a fatal flaw. In our view, both of
these items independently are correctable flaws, meaning that if either
is left uncorrected the test is cancelled. This is a sufficient
safeguard, we believe.
Section 40.205 How Are Drug Test Problems Corrected?
This provision is based on proposed Sec. 40.203 and concerns how
correctable flaws and other problems are corrected. There were few
comments on this section. One commenter said there should be a time
limit (e.g., five days) for making corrections, and that errors should
be taken into account during verification. We agree that corrections
should be timely, and while we do not believe that an absolute
``statute of limitations'' is appropriate, we have added language
directing parties to supply this information on the same business day
on which they are notified of the problem, transmitting it by fax or
courier. Aside from fatal or uncorrected flaws that cause a test to be
cancelled, there is no role for consideration of these kinds of
mistakes in the verification process, which focuses on whether there is
a legitimate medical explanation for a test result.
Another comment suggested that the use of a non-DOT form could be
corrected by annotating the remarks
[[Page 79503]]
section of the non-DOT form with the needed information. We do not
object to this form of correction in the situation where the form was
used out of necessity (e.g., only form available for a post-accident
test), though we do not think it is necessary to include this point in
the rule text. It would obviously be contradictory to use this approach
where the non-DOT form was allegedly used ``inadvertently,'' since a
collector who noticed the use of the form sufficiently to make the
annotation would clearly have been aware of what form he or she was
using.
Section 40.207 What Is the Effect of a Cancelled Drug Test?
This section is based on Sec. 40.205 of the NPRM. There was only
one comment, which asked for guidance on what to do if an employee with
a confirmed positive test had his or her test cancelled because of a
fatal or uncorrected flaw. Other provisions of this part determine what
action the employer is authorized or required to take. For example,
following a cancellation of a verified positive test because a split
specimen was unavailable for testing, there must be an immediate
recollection under direct observation.
Section 40.209 What is the Effect of Procedural Problems That Are Not
Sufficient to Cancel a Drug Test?
There were few comments on this section, which is based on
Sec. 40.207 of the NPRM. The NPRM version stated a general principle:
tests cannot be cancelled based on an error that does not have a
significant adverse effect on the right of the employee to have a fair
and accurate test. The point of this proposal was to prevent
administrative or judicial decisions invalidating drug tests that were
fair and correct, but had certain de minimis irregularities. One
commenter objected to this principle, saying that tests should be
cancelled in these situations. Other commenters were supportive.
Because of comments to other sections of the rule asking for
clarification about whether certain mistakes in the process should be
the basis for cancellation, and on the basis of the Department's
experience in dealing with issues in many drug testing cases, we have
decided to add to this section a list of matters that, consistent with
this principle, never result in the cancellation of a test. This is not
an exclusive or exhaustive list. These matters must be documented, and
may result in corrective action for employers or service agents
involved, but the proper remedy is not to cancel the test. This is a
safety rule, and it is not consistent with safety to permit someone
with a positive drug test to continue performing safety-sensitive
functions because a collector made a minor paperwork error that does
not compromise the fairness or accuracy of the test.
One of the points we make in this section is that a urine
collection or an alcohol test must not be cancelled solely because the
collector, BAT, or STT has not met training requirements. Such a test
would be cancelled only if there were a fatal flaw or other
circumstances requiring cancellation. However, an organization that had
a pattern or practice of using untrained collectors, BATs, or STTs
would be subject to DOT enforcement action (in the case of an employer)
or a PIE (in the case of a C/TPA or other service agent).
Subpart J--Alcohol Testing Personnel
Generally speaking, there were far fewer comments on the alcohol
testing portions of the rule than on the drug testing and other
sections. Throughout much of the alcohol testing portion of the rule,
one commenter provided extensive rewrites of the proposed regulatory
text. These comments were clearly the product of substantial and
thoughtful work on the commenter's part. For the most part, however,
the suggested rewrites did not propose significant substantive changes
in the proposed text. We will not discuss these rewrites on a
paragraph-by-paragraph basis, except where they raise a substantive
point that calls for a response.
Section 40.211 Who Conducts DOT Alcohol Tests?
The only comments on this section had to do with the limitation on
supervisors serving as BATs or STTs for their own subordinates. Some
commenters said that this restriction should be modified, since many
supervisors had been trained as BATs and there were some situations,
such as ships at sea, where supervisors might be the only BATs or STTs
available. We note that the proposed regulation already permitted
supervisors to serve as BATs and STTs if no one else were available and
DOT agency alcohol testing regulations allowed this practice. As in the
case of collectors in the drug testing program, we have used the term
``immediate'' supervisors to indicate that someone higher up in the
chain of command was not limited by this restriction.
Section 40.213 What Training Requirements Must STTs and BATs Meet?
The Department has revised this training both in response to
comments and to parallel, as much as feasible, the training
requirements for collectors in the drug testing program. One comment we
adopted in both places was to permit use of a variety of training media
(e.g., classroom instruction, internet, video, CD-ROM) for the academic
portion of the training. For the proficiency demonstration part of the
training, however, absent technological means of real-time monitoring
and evaluation of actual proficiency demonstrations, in-person
monitoring would be necessary. We also replaced the proposed
``sufficiently knowledgeable'' language referring to trainers, which
commenters said was too vague, with a series of criteria relating to
experience or course work in the testing field.
One commenter suggested a list of scenarios that should be randomly
included in the three consecutive error-free collections needed to
demonstrate proficiency for BATs. Without specifically endorsing the
commenter's list, we believe that this is a useful suggestion. The
Department's guidance on training will include a list of this type for
use of persons conducting training.
As in the case of collectors in the drug testing program, BATs and
STTs would have to undergo refresher every five years, and error
correction training when needed. Most commenters on the subject favored
these kinds of training, though some had reservations about what they
viewed as the higher costs of the training. In this matter, we believe
that insistence on high training standards is no vice, and moderation
in the pursuit of a well-trained work force is no virtue. Such a work
force is vital to the integrity of the program.
As in the drug testing collector training, some commenters favored
waiting until more than one error resulting in cancellation of a test
had occurred before requiring error correction training. As in that
case, we believe that any such event creates an important training
opportunity, to make sure that the individual does not make the same
mistake in the future.
Section 40.215 What Information About the DER do Employers Have To
Provide to BATs and STTs?
Proposed Sec. 40.215 proposed various record retention and
information requirements for organizations employing BATs and STTs.
Because we believe it would relieve paperwork
[[Page 79504]]
burdens for employers and C/TPAs to have BATs and STTs maintain
documentation of their training and qualifications (as Sec. 40.213
provides), the only remaining portion of this section is proposed
paragraph (c). This paragraph, on which there were no substantive
comments, tells employers to provide to BATs and STTs the name and
phone number of a DER.
Section 40.217 Where is Other Information on the Role of STTs and BATs
Found in This Regulation?
This is another in the series of cross-reference sections, pointing
readers to other sections of the rule relevant to the functions of BATs
and STTs.
Subpart K--Testing Sites, Forms, Equipment and Supplies Used in
Alcohol Testing
Section 40.221 Where Does an Alcohol Test Take Place?
We adopted this provision without substantive change.
Section 40.223 What Steps Must be Taken To Protect the Security of
Alcohol Testing Sites?
We adopted a comment to include ASDs in the requirement to secure
testing devices when they are not being used. In response to another
comment, we created an exception to the rule that BATs and STTs may not
leave the testing site when a test is in progress. The exception is for
a situation in which the BAT or STT must notify a supervisor or contact
a DER for assistance in the case an employee or other person who
obstructs, interferes with, or unnecessarily delays the testing
process. Otherwise we have adopted the proposed section without
substantive change.
Section 40.225 What Form Is Used for an Alcohol Test?
Most of the comments on this section focused on changes commenters
sought in the ATF. The form has been revised, and we have included it
at Appendix F. Its use will become mandatory on August 1, 2001. We have
also modified the language concerning foreign-language versions of the
form to be consistent with the parallel provision concerning the CCF.
Section 40.227 May Employers Use the ATF for non-DOT Tests, or non-DOT
Forms for DOT Tests?
This section parallels the requirements for use of the CCF in the
drug testing program. The few comments on the section were supportive
of the Department's approach.
Section 40.229 What Devices Are Used To Conduct Alcohol Screening
Tests?
We adopted one comment, including a clarifying note in Sec. 40.231
that only EBTs listed in the NHTSA CPL without an asterisk can be used
in the DOT alcohol testing program.
Section 40.231 What Devices Are Used To Conduct Alcohol Confirmation
Tests?
We adopted one of several editorial comments we received on this
section from a commenter, which is to remove the word ``sequential''
from the requirement that an EBT print a unique number on each copy of
the result. As the commenter noted, the important thing is for the same
unique test number to be displayed before the test and printed out on
the result.
Section 40.233 What Are the Requirements for Proper Use and Care of
EBTs?
A number of commenters said it was unclear in the proposed version
of this section who was responsible for what. To address this problem,
we place responsibility on the user of the EBT, who could be an
employer or a service agent. We asked in the preamble to the NPRM
whether we should retain the requirement for quality assurance plans
(QAPs). Most commenters favored retaining this requirement, and we have
done so. We are not specifying in the rule, however, who is authorized
to perform various maintenance, calibration, etc., functions, as one
commenter suggested. We are not in a good position to determine who can
best perform these functions.
Section 40.235 What Are the Requirements for Proper Use and Care of
ASDs?
Most of the comments on this section were editorial. One commenter
expressed concern that the section appeared to focus on saliva ASDs to
the exclusion of breath ASDs. This is not the case. These sections are
derived from provisions of the existing regulation that apply to breath
devices as well as saliva devices. Because the ``use and care''
requirements for EBTs of Sec. 40.233 also apply to breath ASDs, we have
added a cross reference to Sec. 40.233 for clarity.
Subpart L--Alcohol Screening Tests
Section 40.241 What Are the First Steps in Any Alcohol Screening Test?
Many comments on this section were parallel to the comments on
Sec. 40.61. In response to the concern about tests not being scheduled
in advance, we changed the language to refer to situations in which
tests were scheduled. We also added language telling BATs and STTs to
begin testing without ``undue'' delay. We did not adopt comments
suggesting that it was appropriate for the testing process to wait upon
the arrival of employer or employee representatives.
One commenter noted an inconsistency between the way the NPRM
treated refusals to sign the certification on the drug and alcohol
testing forms, respectively. In the drug testing case, the collector is
directed to note the problem in the remarks section of the form and
continue with the test. In the alcohol testing case, the BAT or STT is
directed to treat the problem as a refusal to test. We agree that these
provisions should be consistent, and we have changed the alcohol
procedure to be like the drug procedure.
Section 40.243 What Is the Procedure for an Alcohol Screening Test
Using an EBT or Non-Evidential Breath ASD?
Commenters had a variety of concerns about this section. One
commenter asked if showing the employee the sequential number displayed
on the device has been omitted from this provision. It has, and the
omission was intended. We do not believe that this action is necessary
to maintain the integrity of the process. In addition, these number
displays are not available on all devices, such as some types of ASDs.
Another commenter had several suggestions for elaborating on
instructions to the BAT or STT as part of the preliminary portion of
the testing process. We will consider including these suggestions in
guidance. Another commenter asked us to specify the number of times an
employee could blow into a breath device. We do not think that this is
necessary. The point is to complete the test successfully. If it
becomes apparent that the employee cannot provide sufficient breath to
activate the device, then we expect the BAT or STT to use good judgment
in determining when to begin the ``shy lung'' procedure.
A commenter suggested allowing the result printout to be attached
either to the front or the back of the ATF. We will adopt this comment
in our pending revision of the ATF. Another suggestion was to use
tamper-evident tapes that do not discolor over time. We think that this
is a good idea, but not one that we need to mandate in rule text. We
have adopted a commenter's suggestion that a self-adhesive label that
is tamper-evident can be used to affix a result printout to the ATF.
[[Page 79505]]
Section 40.245 What Is the Procedure for an Alcohol Screening Test
Using a Saliva ASD?
The Department is adopting the proposed section without substantive
change. One commenter asked to include material pertaining to new
evidentiary saliva devices. At the time of the publication of this
rule, NHTSA is looking at such devices, but NHTSA's review is not
complete. NHTSA is considering modifying its model specifications for
evidential breath testers to accommodate technologies that measure
alcohol in other bodily fluids, such as saliva. If adopted, such
changes would also require technical adjustments to Part 40 so that
both the NHTSA action and Part 40 requirements worked smoothly in
concert. Subsequent to this revision of Part 40, any proposed
modifications to NHTSA model specifications or Part 40 to accommodate
the above advances in technology would be published in the Federal
Register, so that the public may comment on them before any changes are
made final.
Another commenter said that the ATF can get too sloppy when the STT
attempts to use the same form for two separate devices. There is no
mandate to use the same form. If one form is getting too cluttered, the
STT can use a new form for the part of the process involving the second
device. This commenter also said that, in the event the device does not
activate on the first try, the STT should not have to place the device
in the employee's mouth for the second attempt. We believe that
maintaining this requirement is useful to ensure that the second
attempt is more likely to succeed (e.g., in a situation in which the
employee has used the device incorrectly at first). This commenter also
suggested that there may be situations in which it is not possible to
conduct a new test on an EBT, when the STT could not successfully
follow ASD procedures. We agree with the commenter that the regulation
should include language to address this situation, and we have added a
provision to Sec. 40.271(a)(3) for this purpose.
Section 40.247 What Procedures Does the BAT or STT Follow After a
Screening Test Result?
This section is also substantively unchanged from the NPRM. One
commenter preferred splitting the section into several sections,
believing that this would make the requirements more clear. Paragraphs
(a), (b), and (c) each are devoted to a single situation (test result
of less than 0.02, result of 0.02 or greater, invalid result). We
believe this organization is sufficiently clear. This commenter also
suggested that we clarify that the employee must be observed during the
waiting period in all circumstances. We agree, and we have added
language to this effect to Sec. 40.251(a)(1). The purpose of this
observation is to ensure that the employee remains under the control of
responsible personnel during the waiting period and does not take any
actions that could interfere with the successful completion of the
testing process.
Several comments asked that BATs be able to transmit test results
to employers via C/TPAs, acting as intermediaries. Consistent with the
Department's decisions in the drug testing part of the rule, the final
rule will permit transmission of negative results by this means. (We
will not permit positive results to be sent in this way. For safety's
sake it is essential that these results be transmitted immediately and
directly since, unlike drug test results, positive alcohol test results
involve impairment.) Another commenter suggested that the ATF include a
provision for a statement or check box to indicate that the employee
had received instruction about the waiting period between the screening
and confirmation tests. We will consider doing so as part of our
pending revision of the ATF.
Subpart M--Alcohol Confirmation Tests
Section 40.251 What Are the First Steps in Any Alcohol Confirmation
Test?
One commenter suggested editorial changes to clarify the timing of
the waiting period and the confirmation test, in paragraph (a)(1). We
have adopted this language. We have not adopted other editorial
suggestions for this section, because we believe they are not necessary
to clarify the proposed language. We disagree with a comment suggesting
that conducting a confirmation test more than 30 minutes after the
screening test should not be permitted. While, as paragraph (a)(1)
states, it is desirable that the confirmation test begin within 30
minutes, we realize that circumstances (e.g., transportation from the
screening test site to a different confirmation test site) could delay
the test past this point. Better a delayed test than none at all.
Section 40.253 What Are the Procedures for Conducting an Alcohol
Confirmation Test?
At a commenter's suggesting, we added the word ``conducting'' to
the first line of this section. Consistent with Sec. 40.243, we have
added language saying that a self-adhesive label that is tamper-evident
can be used to affix a result printout to the ATF. The section is
otherwise unchanged from the NPRM version. We do not believe extensive
editorial changes are needed. One commenter said that all test results
of 0.02 or greater made on a defective machine before corrective action
is taken must be cancelled. This point is covered by Sec. 40.267(c)(5).
We will leave the word ``sequential'' in paragraph (f). This section
involves the use of EBTs, all of which have sequential test number
displays.
Section 40.255 What Happens Next After the Alcohol Confirmation Test
Result?
Aside from a few editorial changes and additional requests that C/
TPAs be able to act as intermediaries in the transmission of results,
there were no comments on this sections. We have addressed the C/TPA
transmission issue elsewhere. We have adopted the proposed section
without change.
Subpart N--Problems in Alcohol Testing
Section 40.261 What Is a Refusal To Take an Alcohol Test, and What Are
Its Consequences?
In response to a comment, we added language clarifying that the
failure to remain at a testing site until the testing process was
complete constitutes a refusal to test. We have deleted the provision
treating refusal of the employee to sign the ATF certification in Step
4 as a refusal to test. Otherwise, the section is substantively
unchanged from the NPRM. We have not made extensive editorial changes.
Section 40.263 What Happens When an Employee Does Not Provide a
Sufficient Amount of Saliva for an Alcohol Screening Test?
There was no substantive comment on this section, and we have
adopted it unchanged from the NPRM.
Section 40.265 What Happens When an Employee Does Not Provide a
Sufficient Amount of Breath for an Alcohol Test?
We have revised this provision to be parallel, in many respects,
with the ``shy bladder'' procedure in the drug testing portion of the
rule. These changes
[[Page 79506]]
include providing that the evaluating physician must have expertise in
the issues raised by the employee's failure to provide a sufficient
amount of breath and that the employee must obtain the evaluation
within five days. (The physician could be a specialist, but need not
be. What is important is that the physician have sufficient expertise
to deal effectively with the issues presented in the employee's case.)
Three commenters suggested that this time period should be changed to
one, three, or seven days rather than five days. We believe that the
five-day period should be generally sufficient and is consistent with
other medical evaluation provisions of the rule.
However, the Department is aware that, in some cases, it may be
difficult for an employee to secure, on his or her own, an appointment
for this evaluation in a short period of time. Consequently, the
Department does not regard it as a refusal to test if the employee is
unable, after making good faith efforts, to get the appointment within
the 5-day period. However, the employer should do everything feasible
to assist the employee in finding and getting an appointment with an
appropriate physician.
A commenter suggested giving employees additional attempts to
provide a sufficient amount of breath to complete a test. We have
modified this section to permit an additional attempt, if the BAT or
STT believes that it would be useful (e.g., because the employee came
close on the second attempt or made a mistake in using the device that
could be readily corrected). It is not mandatory for the BAT or STT to
provide this third attempt. At this commenter's suggestion, we have
also added language telling the BAT or STT to instruct the employee on
the proper use of the device.
Section 40.267 What Problems Always Cause an Alcohol Test To Be
Cancelled?
One commenter disliked the use of the word ``cancelled,''
preferring ``invalid.'' The term ``invalid'' has a specific meaning in
the drug testing part of the rule, so we think it better to avoid the
word here. ``Cancelled'' has the same meaning here as it does in drug
testing, and should not cause any confusion. A commenter suggested
adding rule text requiring BATs and STTs to notify DERs within 48 hours
of the discovery of a fatal flaw. We agree that prompt notification is
important, and we have added language to Sec. 40.273 to this effect. We
put this provision into Sec. 40.273 so that it applies to all
cancellations.
Section 40.269 What Problems Cause an Alcohol Test To Be Cancelled
Unless They Are Corrected?
There were no substantive comments on this section, which is
unchanged from the NPRM.
Section 40.271 How Are Alcohol Testing Problems Corrected?
As discussed above, we have added a new paragraph (a)(3) to this
section, concerning situations in which a new testing device is not
available at the testing site. We have also added a new paragraph (c),
clarifying that when a correctable flaw cannot be corrected, the test
must be cancelled. We did not receive substantive comments on this
section, which is otherwise unchanged from the NPRM.
Section 40.273 What Is the Effect of a Cancelled Alcohol Test?
There were no substantive comments on this section, the proposed
text of which is unchanged from the NPRM. We have added new paragraphs
( c) and (d), which respectively call for notification of the DER and
state that a cancelled test is not intended to provide a basis for a
subsequent test under company policy,
Section 40.275 What Is the Effect of Procedural Problems That Are Not
Sufficient To Cancel an Alcohol Test?
Section 40.277 Are Alcohol Tests Other Than Saliva or Breath for
Screening and Breath for Confirmation Permitted Under These
Regulations?
There were no substantive comments on these sections, which are
unchanged from the NPRM.
Subpart O--Substance Abuse Professionals and the Return-to-Duty
Process
Section 40.281 Who Is Qualified To Act as a SAP?
Section 40.283 How Does a Certification Organization Obtain
Recognition for Its Members as SAPs?
These sections were both based on proposed Sec. 40.281. We received
extensive comment on the question of who should be viewed as eligible
to perform SAP functions. Many individuals, professional organizations,
and certification organizations (e.g., for drug and alcohol counselors,
marriage and family therapists, licensed professional counselors)
asserted that their qualifications were as appropriate, if not more so,
than groups and professions which the rule views as eligible. Without
denigrating the qualifications of any individuals, professions, and
organizations, the Department believes that the proposed rule continues
to identify those professions and organizations that currently are best
equipped to perform the SAP function in the DOT drug and alcohol
testing program.
This is a program that is national in scope, and we believe that,
for persons who wish to act as SAPs based on membership in a licensed
or certified profession, it is reasonable to require that the licensure
or certification be available in all U.S. states. For persons who wish
to act as SAPs based on an organizational certification, the Department
has set forth criteria in Appendix E for the requirements that must lie
behind such certifications. The Department developed these criteria
under the existing rule as a means of evaluating applications to the
Department for SAP eligibility, and they are consistent with the
requirements of certification organizations that are already part of
the SAP program.
The NPRM proposed to require organizations that certify counselors
to obtain National Commission for Certifying Agencies (NCCA)
accreditation before submitting their requests to have the Department
consider their certified counselors for inclusion in the SAP
definition. The NPRM also proposed that the two certifying
organizations whose counselors are already in the SAP definition (i.e.,
the National Association of Alcoholism and Drug Abuse Counselors
Certification Commission (NAADAC) and the International Certification
Reciprocity Consortium/Alcohol and Other Drug Abuse (ICRC)) would not
be required to have NCCA accreditation because they have already been
through a rigorous Department process prior to their inclusion.
Commenters overwhelmingly supported the concept of having
certification organizations obtain NCCA accreditation prior to
submitting their requests to have their certified counselors considered
for inclusion to the Department. A few organizations opposed any type
of review by any organization, including the Department, prior to
having their certified counselors added to the SAP definition. A few
commenters wanted the Department to maintain total control of the
review process--a process that proved entirely too burdensome and time
consuming for us. Still other commenters wanted us to clarify that the
NCCA accreditation requirement (and Appendix F of Part 40) applied
solely to certifying organizations wishing to have their counselors
included in the SAP definition and not to physicians, social
[[Page 79507]]
workers, psychologists, and employee assistance professionals; and not
to NAADAC and ICRC. Those who commented on NAADAC and ICRC, did not
believe NCCA accreditation was necessary for those two groups.
Part 40 will require certification organizations wishing to have
their certified counselors included in the SAP definition to meet the
requirements (which includes NCCA accreditation) at Appendix F of Part
40 prior to asking the Department to review their inclusion proposals.
The Department will still receive and review all proposals for
inclusion based upon Appendix F standards. It is important to note that
NCCA accreditation is simply one of the prerequisites for inclusion,
but it represents an area of review that the Department found to be the
largest barrier to our streamlining the process for reviewing
certification groups' application materials and for evaluating the
quality of those groups' certification testing processes.
Because NAADAC and ICRC excelled in the Department's previous
review process, they will be compelled neither to have NCCA
accreditation nor to complete the process again. Physicians, social
workers, psychologists, and employee assistance professionals were
never intended to have NCCA accreditation. This requirement is not for
them: it is only for certification organizations wishing to have their
certified counselors added to those of NAADAC and ICRC.
A few commenters suggested that all SAPs be certified by the
Department. One suggested that we support any future proposals by the
Substance Abuse and Mental Health Services Administration to certify
drug and alcohol counselors. While we support efforts to ensure that
SAPs are better trained (and Part 40 has new training requirements for
SAPs), the Department lacks the expertise, personnel, and time needed
to establish and operate a SAP counselor certification effort. Like the
lone commenter mentioned in this paragraph, we would support efforts by
HHS to develop certification standards and subsequently certify all
drug and alcohol counselors.
As was the case with commenters on MRO training, most commenters on
SAP training thought that self-certification was not adequate. Many
comments favored more formal training requirements for SAPs, like those
proposed for MROs. Some of these comments mentioned situations in which
they believed SAPs had made poor decisions based on an incomplete
understanding of their role under the DOT rules.
The Department is persuaded that more formal SAP training is
appropriate. Like MROs, SAPs are highly-qualified professionals. They
play a key role in the return-to-duty process, which has important
safety implications. In addition to their professional qualifications,
they need to be very aware of their role in implementing DOT agency
drug and alcohol testing rules. Consequently, the Department is
revising SAP training requirements to parallel the training
requirements for MROs. The Department is aware that there are not
currently an array of SAP courses analogous to the MRO courses that
medical groups currently present. For this reason, the SAP
qualification training deadline has been extended to December 2003.
However, the Department anticipates that, in the time permitted for new
and current SAPs to meet this requirement (see Sec. 40.281(c)(3)), the
demand for training will lead to a supply becoming available. We
believe that organizations will take the opportunity to create
appropriate training courses and materials.
Like qualification training for MROs, SAP qualification training
includes a requirement for an examination. However, the Department does
not believe that this examination need be a formally designed and
validated examination. SAP functions are narrower in scope and less
complex than MRO functions, and the examination can therefore be
simpler, in our view. The purpose of SAP training and the examination
is not to teach people how to be clinicians, but rather to help SAPs
learn how to operate in their specialized role within the DOT
regulatory framework.
As with MROs, we have added a continuing education requirement to
keep SAPs current on program requirements and issues. This continuing
education must involve a test or other assessment tool to help SAPs
determine whether they have successfully learned the material.
Section 40.285 When Is a SAP Evaluation Required?
This section is based on Sec. 40.283 of the NPRM. Consistent with
other provisions of the rule, we have added adulteration and
substitution results to the situations requiring SAP evaluations. We
disagree with a commenter who said that an alcohol test result of 0.04
or greater was not a violation of DOT agency alcohol regulations. It is
a violation, and a SAP evaluation is a necessary part of the return-to-
duty process following such a violation. Some comments questioned
whether a SAP evaluation was necessary in all cases (e.g., including
pre-employment tests) following a violation. It is, and we have added
some clarifying language to this effect. In the case of a pre-
employment test violation, the employer to whom the individual had
applied would be responsible for providing the individual information
about SAP resources and the return-to-duty process, even if the
employer wanted no further relationship with the individual.
A commenter asked whether a SAP evaluation would be needed for an
employee who had a DUI/DWI charge against him or her in a private
automobile. The answer is no: under Part 40 only a violation of DOT
agency drug and alcohol testing rules triggers the requirement for a
SAP evaluation (though DOT agency rules may impose additional
requirements in some cases). Another commenter recommended that
applicants who test positive on pre-employment tests should be required
to present evidence of having completed the return-to-duty process
before being able to work in a safety-sensitive position for another
employer. We have addressed this issue in Sec. 40.25, concerning
inquiries about previous test results.
Section 40.287 What Information Is an Employer Required To Provide
Concerning SAP Services to an Employee Who Has a DOT Drug and Alcohol
Regulation Violation?
This section is based on proposed Sec. 40.285 of the NPRM. There
were few comments. One asked whether the employer or the employee was
to select the SAP. This section does not address selection of a SAP: it
just says that the employer has to provide the employee a list of SAPs
and how to reach them. The provision does clarify that this requirement
applies to all violation situations, including pre-employment tests. If
an applicant fails a pre-employment test, the employer must provide
this information even if the employer intends not to hire the
applicant.
Section 40.289 Are Employers Required To Provide SAP and Treatment
Services to Employees?
This provision is based on proposed Sec. 40.287 of the NPRM.
Paragraphs (a) and (c) emphasize the employer's provision of SAP
services. An employer may or may not provide SAP-related services to
employees. An employer may or may not pay for such services. These are
matters the Department leaves to employer discretion or labor-
[[Page 79508]]
management negotiations. One commenter suggested that employers be
required to cover these services in their health plans. We believe
that, as the commenter acknowledged, imposing coverage requirements on
health care providers or insurers is outside the Department's
jurisdiction.
The proposed Sec. 40.287 included two paragraphs telling employers
that they must ensure the SAPs used to evaluate employees before they
return to duty meet certain qualifications. In view of the SAP training
and qualification provisions of Sec. 40.281 of the final rule, we
believe these paragraphs are duplicative, and we have deleted them.
This section continues to emphasize that, before an employee who has
violated a DOT agency drug and alcohol testing regulation may return to
safety-sensitive duties, the employee must successfully complete the
SAP evaluation/return-to-duty process.
Section 40.291 What Is the Role of the SAP in the Evaluation,
Referral, and Treatment Process of an Employee Who Has Violated DOT
Agency Drug and Alcohol Testing Regulations?
The content of proposed Sec. 40.291 has been moved to
Sec. 40.355(a). This section now concerns a different subject, stating
the general duties of SAPs.
Section 40.293 What is the SAP's Function in Conducting the Initial
Evaluation of an Employee?
The final rule has no equivalent to proposed Sec. 40.289, the
content of which duplicates other provisions in this subpart. There
were few comments concerning Sec. 40.293, and they were mostly
supportive. Some comments did favor allowing C/TPAs to transmit SAP
reports to employers. As discussed in the ``Principal Policy Issues''
section of the preamble, we have chosen not to permit this, as a means
of preventing anyone from having the opportunity to alter the SAP's
report and recommendations.
We have added three new points to this section. First, as discussed
in the ``Principal Policy Issues'' section of the preamble, we believe
that there are no circumstances in which it is appropriate for a SAP to
find that a violator of our regulations is not in need of education
and/or treatment. Therefore, paragraph (b) requires that SAPs make a
recommendation for education and/or treatment in every case. Second, we
have become concerned that we have not previously given SAPs guidance
with respect to employees' stories that minimize the seriousness of
their violations, analogous to the guidance we give MROs with respect
to legitimate medical explanations. Therefore, paragraph (f)
specifically forbids SAPs from taking certain kinds of factors into
account in making their recommendations.
Third, while we are not making quantitations routinely available to
SAPs in drug testing cases (see discussion in ``Principal Policy
Issues''), we believe it is very important for MROs and SAPs to have
good communications about employees. Paragraph (g) explicitly
authorizes SAPs to consult with MROs, and tells MROs they must
cooperate with SAPs in these consultations.
Section 40.295 Can Employees or Employers Seek a Second SAP Evaluation
if They Disagree With the First SAP's Recommendations?
The purpose of this section is to prevent employers and employees
from forum shopping until they get a SAP evaluation they like. Most
comments supported the proposed prohibition on second opinions, though
one commenter thought this should be permitted if the original SAP does
a bad job. The difficulty with this suggestion is that a party's
perception of the quality of the SAP's work is likely to be influenced
on whether the SAP made a recommendation the party feels is in its
interest. We believe that a prohibition on second opinions is the only
way to prevent forum shopping.
One commenter suggested that we remove the reference to the SAP
being suitable to the employer. We believe the proposed language in
this section is unnecessary, and we have deleted it. Also, to tighten
the provision, we have added a sentence saying that if, notwithstanding
the regulatory prohibition, an employee gets an evaluation from a
second SAP, the employer must not pay any attention to it.
Section 40.297 Does Anyone Have the Authority To Change a SAP's
Initial Evaluation?
Several commenters noted that the language of the proposed section
appeared to prevent even the SAP who originally made the recommendation
from modifying his or her own recommendation. We did not intend to
prevent SAPs from modifying their own recommendations, and we have
added clarifying language that permits SAPs to do so when they receive
new or additional information.
Section 40.299 What Is the SAP's Role and What Are the Limits on a
SAP's Discretion in Referring Employees for Treatment and Education?
A number of commenters appeared to prefer stating one of the
exceptions to the rule against self-referral in terms of SAPs located
in ``rural and remote areas'' rather than the NPRM's ``general
commuting area'' language. The Department does not believe that this
would improve the clarity of the section, since ``rural'' and
``remote'' are rather subjective terms. The exception is intended to
apply, in any case, to a situation in which there is no other source of
services reasonably available in the vicinity. For example, if an
employee had to make an overnight trip to get to another source of
services, we would not consider it reasonably available.
One commenter wanted to consider referrals to spouses as prohibited
by this section. We believe this is covered by the prohibition on
referrals to people with whom the SAP shares a financial interest.
Another commenter wanted to create a fifth exception for in-house
corporate SAPs. We believe that the second and third exceptions are
adequate to cover this situation. We also received a suggestion to
delete the signed statement requirement of proposed paragraph (d).
Given the specificity of the other requirements of the section, we do
not believe that this signed statement adds much of substance, and we
have deleted it in the interest of reducing paperwork.
Section 40.301 What Is the SAP's Function in the Follow-Up Evaluation
of an Employee?
Comments were generally supportive of this section. A few comments
pointed out that some current DOT agency regulations do not make use of
the SAP process. This is true. However, DOT agencies will amend their
regulations to conform to Part 40 before the effective date of this
part. Another commenter asked for clarification of who makes a return-
to-duty determination. SAPs simply determine whether an employee has
successfully demonstrated compliance with the SAP's recommendations. As
this section and Sec. 40.305 make clear, only the employer decides
whether, after all prerequisites have been met, the employee returns to
safety-sensitive duties. In response to comments that employers should
be notified if the SAP process is taking longer than expected (e.g.,
because the employee has not made expected progress in treatment), we
have added a provision requiring the SAP to provide
[[Page 79509]]
written notice to the employer when the employee has not demonstrated
successful compliance on follow-up evaluation.
The Department understands that not every employee will make
strides in dealing with a drug or alcohol problem sufficient to
receiving a SAP follow-up report indicating that he or she has
demonstrated successful compliance with the SAP's recommendation. When
this happens, we believe that it is important that the employer receive
a SAP follow-up report outlining the reason(s) why the employee has not
demonstrated successful compliance. We understand that some employees
may be actively involved in carrying out their education and/or
treatment plan and simply need additional time to complete the work.
Others may have been non-participants in a SAP-recommended program.
Therefore, when the SAP determines that the employee has failed to
demonstrate successful compliance, we have no objection to having the
employer deciding to allow an additional SAP follow-up evaluation to be
made consistent with the employee's progress (or lack of progress) and
with employer policy and/or labor-management agreements. Nor will the
Department object if the employer chooses instead to take other
personnel actions consistent with employer policy and/or labor-
management agreements.
Section 40.303 What Happens if the SAP Believes the Employee Needs
Additional Treatment, Aftercare, or Support Group Services Even After
the Employee Returns to Safety-Sensitive Duties?
As discussed in the ``Principal Policy Issues'' section of the
preamble, we have deleted a proposed requirement that employers
``monitor'' returned employees'' aftercare. This was the subject of the
bulk of the comments on this section. The section now gives discretion
to employers concerning their monitoring and enforcement of SAP
aftercare recommendations. We strongly recommend that employers play an
active role in ensuring that employees who have returned to work
following a violation comply with aftercare recommendations. This is
very important both for safety and the welfare of the employees. The
rule also states that employees are obligated to comply with these SAP
recommendations and are subject to employer discipline if they do not.
Section 40.305 How Does the Return-to-Duty Process Conclude?
This section underlines the point that it is the employer, and the
employer alone, who is responsible for deciding whether an employee who
has violated DOT agency drug and alcohol testing rules will return to
work. A determination by the SAP that the employee has successfully
complied with the SAP's recommendations is a prerequisite to the
employee's return to duty. So is a negative result on a subsequent
return-to-duty test. But only the employer can decide whether or not to
put the person back to work. SAPs do not make ``fitness for duty''
decisions, and employers should not ask them to do so. Commenters asked
that we make these points clear. We think this section is as clear on
this point as we can make it.
Section 40.307 What Is the SAP's Function in Prescribing the
Employee's Follow-up Tests?
Section 40.309 What Are the Employer's Responsibilities With Respect
to the SAP's Directions for Follow-up Tests?
As discussed in the ``Principal Policy Issues'' section of the
preamble, the Department has decided to retain the ``at least six
follow-up tests in the first 12 months'' formulation for follow-up
testing. In response to requests from commenters, we have clarified
that this follow-up testing requirement ``follows the employee''
through job changes and breaks in safety-sensitive service. The six
tests must occur during the first 12 months of safety-sensitive service
after return-to-duty, regardless of for whom or when that service is
performed.
Of course, SAPs have the discretion to require more follow-up tests
than the minimum. One commenter suggested that SAPs negotiate the
number of follow-up tests over the minimum with the employer. We did
not adopt this suggestion, because this is intended to be a clinical
determination, not subject to economic or policy give-and-take.
Employers are obligated to follow the SAP's follow-up testing plan. All
parties involved should be aware that, under this rule, all employees
who return to work after a violation will have a follow-up testing
requirement with which employers and employees must comply.
Section 40.311 What Are Requirements Concerning SAP Reports?
Most of the comment on this section concerned the issue of C/TPAs
acting as intermediaries in the transmission of SAP reports to
employers. As discussed above, the Department is not permitting C/TPAs
to act in this capacity. SAPs must send their reports directly to the
DER. The report must be on the SAP's own letterhead, not that of a C/
TPA or another service agent.
In response to a comment on the content of the SAP report, we have
used the term ``date(s)'' rather than ``date'' to cover the possibility
that assessments will happen over a period of time longer than a single
meeting. We have also clarified that ``reason for the assessment''
refers to the date and nature of the violation of DOT rules, as a
commenter requested, and as DOT's SAP Guidelines outline.
Section 40.313 Where Is Other Information on SAP Functions Found in
This Regulation?
This is the last of the regulation's sections providing
informational cross-references to other provisions concerning, in this
case, SAP functions.
Subpart P--Confidentiality and Release of Information
Section 40.321 What Is the General Confidentiality Rule for Drug and
Alcohol Test Information?
Several commenters disagreed with the proposal to continue the
Department's ban on blanket releases. These commenters believed that
permitting blanket releases would facilitate the flow of information
among parties who needed to know, for example, whether an applicant for
a job had previously violated a DOT regulation. Other commenters
favored retaining this proposal in order to protect employee privacy.
The Department believes that the principle of specific written consent
for any release of test result or medical information to third parties
is critical to protect employees' legitimate expectations of privacy
and confidentiality in the testing program. Permitting blanket releases
is directly contrary to this principle. The Department will include the
proposed provision in the final rule.
Section 40.323 May Program Participants Release Drug or Alcohol Test
Information in Connection With Legal Proceedings?
The existing rule and the NPRM both provide that in a proceeding
brought by, or on behalf of, an employee, resulting from a positive
test (e.g., a lawsuit or grievance), the employer may release employee
test result information without the employee's consent. One commenter
suggested that we add references to substituted and
[[Page 79510]]
adulterated tests and other refusals to test. We have done so.
Another commenter raised the issue of a different kind of legal
proceeding. The commenter asked whether otherwise confidential
information could be released in a personal injury lawsuit where the
employee's conduct was an issue (e.g., a truck or bus driver involved
in a collision). We believe that, if a court orders the production of
such information because it is relevant in such a proceeding, it is
reasonable for the employer to provide it without getting the
employee's consent. In this situation, the requirements of justice in
the litigation outweigh the employee's privacy interest. We have added
a paragraph to this effect. We also added a paragraph telling a service
agent who is holding this information to provide it to the employer
when the employer requests it for use in a legal proceeding covered by
this section.
Section 40.327 When Must the MRO Report Medical Information Gathered
in the Verification Process?
This section provides that, under certain circumstances, MROs must
provide certain otherwise confidential information to employers and
certain other parties. The purpose of providing this information is to
enhance safety. Commenters had a variety of concerns about this
section. One comment suggested that the medical information be provided
in writing in all cases. We think that a prudent MRO may choose to do
so, but we do not believe that a regulatory requirement is needed.
Some commenters objected to the paragraph that allows MROs to
consult with the employee's own physician to see if alternate
medication might be available that would be less likely to adversely
affect safety, saying that MROs should stay out of what looks like a
doctor-patient relationship with employees. A few commenters supported
this proposal. Under the proposal, the MRO would take this step only
with the employee's consent, and for the purpose of helping the
employee find medication that would be compatible with safe job
performance. From both the point of view of employee interests and
safety, we believe that this proposal is sound, and we have retained
it.
One commenter said that Canadian law would preclude a doctor from
releasing this information to an employer. We have added a provision
saying that if the law of a foreign country, such as Canada, prohibits
MROs from providing medical information to the employer, the MROs may
comply with that prohibition.
Another commenter pointed out that not only physicians, but also
other medical professionals, may make determinations about whether an
employee meets physical qualification standards. We have adopted the
commenter's suggestion that the MRO can release information to the
``health care provider'' involved in this activity. Consistent with the
SAP provisions of the rule, we have included SAPs who are evaluating
employees as part of the return-to-duty process as a party to whom the
MRO can provide information under this section.
Finally, as some commenters requested, we have made it mandatory
for MROs to release information under this section if the information
is likely to result in the employee being medically unqualified for
performance of safety-sensitive duties under a DOT regulation or if the
information indicates that continued performance by the employee of his
or her safety-sensitive function is likely to pose a significant safety
risk. In this case, the Department believes that the safety interest
served by the information release outweighs the confidentiality
interest of the employee.
We point out that the medical information described in this section
cannot be transmitted to employers or other parties using a C/TPA or
other service agent as an intermediary. MROs must transmit this
information directly to the employer.
Section 40.329 What Information Must Laboratories and Other Service
Agents Release to Employees?
Proposed Sec. 40.329, concerning release of information by MROs to
third-party employers, has been deleted, for the reasons given in the
``Principal Policy Issues'' section of the preamble. This section is
based on proposed Sec. 40.331 of the NPRM.
One commenter requested that the Department require that
laboratories provide all records requested by an employee, as well as a
laboratory person to testify in a legal proceeding who has firsthand
knowledge of the laboratory, its records, and operating procedures.
This commenter also requested that the rule require the laboratory to
make records available within 10 days, rather than waiting for payment
from the employee. This section does require that laboratories and
other service agents provide a ``data package'' (sometimes referred to
as a ``litigation package'') upon the employee's request. We do require
that they provide it within 10 business days. The rule also limits the
charge the service agent can make for the cost of copying and
preparation. We believe these provisions adequately protect employee
interests. We do not believe it is necessary, as another commenter
suggested, to list the contents of a litigation package, which is quite
standard and well understood among laboratories.
We have not adopted the suggestion that laboratories be required to
produce witnesses for appearances at legal proceedings. Such an open-
ended requirement would impose, in our view, unnecessary costs and
burdens on laboratories and other service agents. There are adequate
means (e.g., documentary evidence) through which employees can raise
issues about the testing process.
The NPRM proposed that laboratories provide to employees, on
written request, information relating to the results of relevant HHS
certification reviews. One comment supported this proposal, which is
consistent with long-standing DOT interpretation of the existing Part
40, while another commenter proposed that the laboratory's obligation
be limited to the latest HHS Federal Register notice listing the
laboratory as certified. Based on conversations with HHS staff, we have
decided to delete this provision. HHS staff believe that providing this
information would unnecessarily intrude on the HHS-laboratory
relationship and could result in the introduction of misleading
information about the laboratory certification process in legal
proceedings involving drug test results.
Section 40.331 To What Additional Parties Must Employers and Service
Agents Release Information?
This section is based on Sec. 40.333 of the NPRM. Some commenters
objected to being required to permit DOT representatives to see a broad
array of drug and alcohol testing information. DOT has significant
safety responsibilities for transportation industries, of which our
drug and alcohol testing rules are an important part. As part of its
safety mandate, DOT must be able to inspect regulated employers and
those who carry out their drug and alcohol testing program
responsibilities. DOT cannot do this job unless we have access to all
relevant information. We believe it is vital to maintain this provision
in the final rule. We would point out, particularly in response to a
comment that Canadian MROs could not legally release certain
information, that this paragraph focuses on the inspection and review
of documents as part of the DOT oversight process, not on release of
information to third parties.
[[Continued on page 79511]]