Rule2024-25403
Procedures for Transportation Workplace Drug and Alcohol Testing Programs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 5, 2024
Effective
December 5, 2024
Issuing agencies
Transportation Department
Abstract
The U.S. Department of Transportation (DOT) revises its drug and alcohol testing procedures, as amended by a final rule published on May 2, 2023, to provide temporary qualification requirements for mock oral fluid monitors, provide for consistent requirements by identifying which individuals may be present during an oral fluid collection, and clarify how collectors are to document that a sufficient volume of oral fluid was collected.
Full Text
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<title>Federal Register, Volume 89 Issue 214 (Tuesday, November 5, 2024)</title>
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[Federal Register Volume 89, Number 214 (Tuesday, November 5, 2024)]
[Rules and Regulations]
[Pages 87792-87798]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-25403]
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DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[Docket DOT-OST-2021-0093]
RIN 2105-AE94
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs
AGENCY: Office of the Secretary, Department of Transportation (DOT).
ACTION: Final rule.
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SUMMARY: The U.S. Department of Transportation (DOT) revises its drug
and alcohol testing procedures, as amended by a final rule published on
May 2, 2023, to provide temporary qualification requirements for mock
oral fluid monitors, provide for consistent requirements by identifying
which individuals may be present during an oral fluid collection, and
clarify how collectors are to document that a sufficient volume of oral
fluid was collected.
DATES: This final rule is effective on December 5, 2024.
FOR FURTHER INFORMATION CONTACT: Bohdan Baczara, Deputy Director,
Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey
Avenue SE, Washington, DC 20590; telephone number 202-366-3784;
<a href="/cdn-cgi/l/email-protection#e5aaa1a4b5a692808788848c89a5818a91cb828a93"><span class="__cf_email__" data-cfemail="c18e85809182b6a4a3aca0a8ad81a5aeb5efa6aeb7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Authority for This Rulemaking
This rulemaking is promulgated under the authority originally
enacted in the Omnibus Transportation Employee Testing Act (OTETA) of
1991, codified at 49 U.S.C. 45102 and 45104 (aviation industry
testing), 49 U.S.C. 20140 (rail), 49 U.S.C. 31306 (motor carrier), and
49 U.S.C. 5331 (transit). OTETA requires that the Department
incorporate the Department of Health and Human Services' (HHS)
Mandatory Guidelines, including amendments, into the Department's
regulations for testing and laboratory requirements for aviation, rail
(except for rail post-accident testing), motor carrier, and transit
testing. Additional authority at 5 U.S.C. 7301 note and Executive Order
12564, specify HHS as the agency that establishes scientific and
technical guidelines for Federal workplace drug testing programs and
standards for certification of laboratories engaged in such drug
testing. While DOT has discretion concerning many aspects of its
regulations governing testing in the transportation industries'
regulated programs, DOT follows the HHS Mandatory Guidelines for the
laboratory and specimen testing procedures.
On October 25, 2019, HHS published a final rule establishing the
Mandatory Guidelines for Federal Workplace Drug Testing Programs using
Oral Fluid (OFMG), which became effective January 1, 2020. (84 FR
57554, Oct. 25, 2019). As of the time of the publication of this final
rule, there have been no laboratories yet certified by HHS for oral
fluid testing.
II. Background
DOT published a final rule amending the procedures for its drug
testing program (49 CFR part 40) on May 2, 2023 (88 FR 27596) (May 2023
final rule). The May 2023 final rule went into effect on June 1, 2023.
The final rule authorized oral fluid drug testing as an additional
methodology for employers to use as a means of achieving the safety
goals of the program.
We have determined instances in which the text of various aspects
of the procedures as amended by the May 2023 final rule need to be
further amended due to unforeseen circumstances that have rendered it
impossible to comply with requirements for mock oral fluid collection
observers, for consistency with regard to privacy during the specimen
collection, and to clarify the means by which collectors document that
a sufficient volume of oral fluid was collected.
To address the issues identified above, DOT published a direct
final rule (DFR) on June 21, 2024. (89 FR 5189) DOT published the DFR
without a prior proposed rule because we viewed the DFR as a
noncontroversial action and anticipated no adverse comments on any of
the provisions of the rule. The DFR was to become effective on August
5, 2024, unless DOT received adverse comments on the provisions of the
DFR. DOT noted that if adverse comments were received, it would publish
a timely withdrawal in the Federal Register informing the public that
the provisions of the rule on which adverse comments were received
would not take effect.
On the same day, DOT published a notice of proposed rulemaking
(NPRM) containing the same amendments in the DFR that served as the
proposed rule to amend Part 40 if adverse comments were received on any
of the provisions in the DFR (89 FR 52002). DOT noted that if adverse
comments were received, DOT would address the public comments received
in a subsequent final rule based on the NPRM. DOT stated that it would
not institute a second comment period on the NPRM.
DOT received adverse comments to each of the provisions in the DFR
and NPRM, and DOT published a notice withdrawing the DFR in the Federal
Register on August 1, 2024 (89 FR 62665).
III. Comments to the DFR and NPRM
DOT received 15 unique comments to the DFR, and 18 unique comments
to the NPRM.\1\ These comments included
[[Page 87793]]
three that expressed concerns about, or opposed the use of, oral fluid
testing generally, and one that was not related to the subject
rulemaking. DOT considered and responded to comments expressing the
same concerns about and opposing oral fluid testing in the May 2023
final rule establishing oral fluid testing as an additional test
methodology for employers. These comments are therefore outside of the
scope of this rulemaking, which makes only technical corrections to the
May 2023 final rule, and are not addressed in this final rule.
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\1\ There were duplicate comments filed for both the DFR and the
NPRM that are included in the docket in <a href="http://www.regulations.gov">www.regulations.gov</a>.
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A. Comments in Support of the Amendments
The Substance Abuse Program Administrators Association (SAPAA), a
nonprofit trade association with a membership encompassing third-party
administrators, in-house program administrators, medical review
officers (MROs), HHS-certified laboratories, substance abuse
professionals (SAP), manufacturers of testing devices, and collection
sites/collectors, supported each of the changes to Part 40 as outlined
in the DFR and NPRM. SAPAA stated that the changes ``emphasize the
necessity of aligning the regulations with practical implementation
realities and reflect the successful introduction of similar guidelines
in the past,'' and that ``nothing in these changes would negatively
impact the ability to train DOT oral fluid collectors once collection
devices are commercially available; and, in fact, would facilitate that
process.''
Airlines for America (A4A) commented, stating that it generally
supports DOT's efforts in the DFR and NPRM to address the issues
identified regarding the May 2023 final rule. A4A suggested that DOT
extend the sunset date for the regulatory relief under Sec.
40.35(c)(3) to 18 months, instead of 12 months as proposed. A4A also
requested that DOT clarify the intent of Sec. 40.35(c)(2)(ii),
specifically with respect to whether the qualified collector under that
section is required to have conducted oral fluid training under Part 40
for a period of at least one year. Finally, A4A suggested that DOT
permit an employee to orally waive the prohibition on others ``actually
witnessing the testing process.''
DOT received one comment supporting the clarifying language to
Sec. 40.73(c)(2) regarding how collectors are to specify that a
sufficient volume of oral fluid was collected. That commenter stated
that the amendment ``brings uniformity to all collectors, maintains
consistent results, and promotes more efficient workflow and data from
collectors.''
B. Comments in Opposition to the Amendments
DOT received comments from two individuals opposing the proposed
amendment to Sec. 40.73(a)(1) regarding who may witness the oral fluid
testing process.
DOT received comments opposing the DFR and the NPRM from the
National Drug and Alcohol Screening Association (NDASA), a nonprofit
association with a membership that includes laboratories, employers'
substance abuse program administrators, compliance auditors, consortia/
third party administrators (C/TPA), specimen collection facilities,
collectors, breath alcohol technicians, screening test technicians,
laboratories, MROs, and SAPs. In addition, several other organizations
and individuals provided comments opposing the DFR and NPRM by either
(1) citing to NDASA's comments as the basis for their opposition, or
(2) attaching a copy of NDASA's comments as their docket submittal.
In discussing comments on this rule and our response to them, we
focus on the substance of positions that commenters expressed, and on
why we did or did not make changes in response. We address each of the
substantive comments provided to the DFR and the NPRM in the discussion
of the amendments to Part 40 in the following section.
IV. Amendments to Part 40
A. Section 40.35 What training requirements must a collector meet for
oral fluid collection?
The May 2023 final rule established requirements for oral fluid
collector qualifications in Sec. 40.35 that mirrored as closely as
possible existing urine collector qualifications in Sec. 40.33. All of
the qualification training requirement categories (i.e., basic
information, qualification training, initial proficiency demonstration,
refresher training, error correction training, and documentation) are
identical. Regarding the mock collections specified in Sec. 40.35(c),
we required oral fluid collectors to demonstrate proficiency in
collections by completing five consecutive error-free mock collections
for each device they will use. These mock collections must be monitored
and evaluated by a ``qualified collector'' who has demonstrated the
necessary knowledge, skills, and abilities by additionally: (i)
regularly conducting DOT drug test collections for a period of at least
one year; (ii) conducting collector training under this part for at
least one year; or (iii) successfully completing a ``train the
trainer'' course.
At this time, however, individuals wanting to be oral fluid
collectors are not able to be qualified because there are no currently
qualified oral fluid collectors per Sec. 40.35(c)(2) with the
additional qualifications at Sec. 40.35(c)(2)(i), (ii), or (iii) to
monitor and evaluate the trainee's mock collections. In the NPRM, we
stated that we did not intend to create a factual impossibility, and
that we meant for the oral fluid monitors for the mock proficiency
demonstrations to be proficient as oral fluid collectors.
To facilitate the training of oral fluid collectors, we proposed to
amend the regulation to authorize individuals to monitor mock oral
fluid collections without meeting the requirement of being a qualified
oral fluid collector specified in Sec. 40.35. To ensure the
proficiency of the collection monitor, we proposed that this regulatory
flexibility would apply only to those individuals meeting the
knowledge, skills, and abilities in Sec. 40.35(c)(2)(ii) or (iii).\2\
With regard to the knowledge, skills, and abilities in Sec.
40.35(c)(2)(ii), we proposed to waive the requirement that individuals
conducting oral fluid collector training have at least one year of
experience conducting collector training, but stated that we expect
those individuals to have a thorough understanding of Part 40 and to be
well versed in the course content they are teaching. The course content
must meet the requirements in Sec. 40.35(b), and individuals
conducting training should maintain good records (for example, the
course content for the instructor and student, the duration of the
training, the dates the course was taught, who attended the course and
any certificate of successful completion provided to students, etc.) to
demonstrate that they conducted the training. We noted that this is no
different than what would be expected of those conducting urine
[[Page 87794]]
collection training today. Individuals conducting this training would
be eligible to observe oral fluid mock collections during the period of
regulatory relief.
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\2\ We noted that the knowledge, skills, and abilities in Sec.
40.35(c)(i) require regularly conducting DOT drug test collections
(in this case, for oral fluids) for at least one year. This is not
possible because until HHS certifies an oral fluid laboratory(ies)
with a device that meets DOT's requirements per appendix B of part
40, oral fluid is not a permissible means of collection. We
determined that, in contrast to paragraphs (c)(ii) and (c)(iii),
there is no way for an individual to otherwise possess the
knowledge, skills, and abilities in paragraph (c)(i) such that the
individual could competently observe mock collections. As a result,
we stated that those who want to act as monitors specified in
subparagraph (c)(2)(i) must still become qualified collectors and
meet the one-year requirement of regularly conducting DOT oral fluid
drug test collections before they can act as monitors.
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We proposed that the regulatory relief would sunset one year after
HHS published a Federal Register notice that it certified the first
oral fluid drug testing laboratory. We stated that we would publish a
Federal Register document specifying the date the first oral fluid
laboratory was certified by HHS and the effective date that individuals
observing mock collections (i.e., monitors) would need to comply with
the qualified collector requirements in Sec. 40.35(c)(2) established
in the May 2023 final rule so that all would be aware of the effective
date of the regulatory flexibility.
Comments
NDASA (and the other commenters that echoed NDASA's comments)
objected to the proposed change to Sec. 40.35(c), expressing concern
that DOT was ``lowering its standards'' by not requiring the monitor of
the mock oral fluid collections to be a qualified oral fluid collector
under the requirements of Sec. 40.35. Instead, NDASA recommended that
DOT retain the language of Sec. 40.35(c)(2) as currently written,
which it contends would permit qualified urine collectors under Sec.
40.33 to serve as monitors for the required mock oral fluid
collections.
Specifically, NDASA recommended leaving Sec. 40.35(c)(2) unchanged
because, as it currently reads, a monitor must be a ``qualified
collector.'' Under the current Part 40, the only qualified collectors
are urine collectors who meet the requirements of Sec. 40.33.
Therefore, if the Direct Final Rule does not become effective, current
qualified urine collectors who have taken a train the trainer class
would be able to be the monitors of the initial proficiency
demonstrations required under Sec. 40.35(c).
NDASA and others also objected to language in the preamble stating
that individuals conducting oral fluid collector training under Sec.
40.35(c)(2)(ii) ``should maintain good records (for example, the course
content for the instructor and student, the duration of the training,
the dates the course was taught, who attended the course and any
certificate of successful completion you may have provided students,
etc.) to demonstrate that they conducted the training.'' NDASA states
that it is the responsibility of those receiving the training, and not
of the trainer, to retain proof of their training and its sufficiency
with Part 40. NDASA believes that the preamble language imposes (1) new
``processes and requirements,'' and (2) an ``additional and arguably
redundant record-keeping requirement for monitors or trainers'' that
were not properly evaluated through regulatory and cost analyses.
As noted above, A4A recommended that DOT extend the sunset date for
the regulatory relief under Sec. 40.35(c)(3) to 18 months, instead of
12 months as proposed.
DOT Response
While the training and qualification requirements for urine
collectors and oral fluid collectors in Part 40 are similar, they are
also unique because of the differences in the collection site,
collection equipment and supplies used, and the collection process for
urine and oral fluid specimens. The intent to have separate training
and qualification requirements for urine collectors and oral fluid
collectors is evident when looking at the manner in which Part 40 was
amended in the May 2023 rule that authorized--for the first time--the
use of a specimen other than urine in the DOT drug testing program. In
the May 2023 final rule, DOT stated that it had ``amended Sec. 40.31
to separately specify the requirements for collectors of urine and oral
fluid specimens, respectively.'' (88 FR at 27600) (emphasis added).
Specifically, Sec. 40.31(b) states that ``A urine collector must meet
training requirements of Sec. 40.33,'' and Sec. 40.31(c) states that
``An oral fluid collector must meet training requirements of Sec.
40.35.''
In the May 2023 final rule, DOT established requirements for oral
fluid collector qualifications in a new Sec. 40.35 that mirrored the
existing urine collector qualifications in Sec. 40.33 as closely as
possible. The qualification training requirements in the new Sec.
40.35 for oral fluid collectors directly parallel those in the
longstanding Sec. 40.33 for urine collectors (i.e., Basic Information,
Qualification Training, Initial Proficiency Demonstration, Refresher
Training, Error Correction Training, and Documentation).
While Sec. Sec. 40.33 and 40.35 mirror each other to the extent
possible, there are provisions in each section that are unique and
tailored specifically to the particular specimen type (urine or oral
fluid), recognizing the distinct differences between a urine collection
and an oral fluid collection (i.e., training on ``shy bladder''
collections for urine in Sec. 40.33(b)(2), and training on ``dry
mouth'' collections for oral fluid in Sec. 40.35(b)(4); completion of
a urine mock collection for a scenario in which the urine temperature
is not within the acceptable range in Sec. 40.33(c)(1), and completion
of an oral fluid mock collection for a scenario in which the employee
has something in the employee's mouth that might interfere with the
collection in Sec. 40.35(c)(1)).
Beyond the training and qualification requirements for collectors
in Sec. Sec. 40.33 and 40.35, DOT established separate requirements
for urine and oral fluid collections in Subpart D of Part 40,
``Collection Sites, Forms, Equipment and Supplies Used in DOT Urine and
Oral Fluid Collections'' (see Sec. Sec. 40.40-40.51), and in Subpart E
of Part 40, ``Specimen Collections'' (see Sec. Sec. 40.61-40.79).
Given the above, DOT clarifies that under the May 2023 final rule,
a qualified urine collector (Sec. 40.33) is not a qualified oral fluid
collector (Sec. 40.35), and vice-versa.
Section 40.35(c)(2) requires that a ``qualified collector'' monitor
and evaluate an individual's performance in a series of mock oral fluid
collections before that individual becomes a qualified oral fluid
collector. And, per Sec. 40.35(c)(2)(i), (ii), and (iii), the
qualified collector that will serve as the monitor for the mock
collections is additionally required to have demonstrated knowledge,
skills, and abilities by (1) ``regularly conducting DOT drug test
collections for a period of at least one year''; or (2) ``conducting
collector training under Part 40 for at least one year''; or (3)
``successfully completing a `train the trainer' course.''
As currently written, Sec. 40.35(c)(2) does not expressly state
that the qualified collector needs to be a qualified oral fluid
collector. Similarly, Sec. Sec. 40.35(c)(2)(i), (ii), and (iii) do not
expressly require the qualified collector that will serve as the
monitor to have: (1) regularly conducted DOT oral fluid drug test
collections for a period of at least one year; (2) conducted oral fluid
collector training under Part 40 for at least one year; or (3)
successfully completed an oral fluid ``train the trainer'' course.
However, and while Sec. 40.35(c)(2) and Sec. 40.35(c)(2)(i),
(ii), and (iii) do not expressly state that the qualified collector for
the oral fluid mock collections must be a qualified oral fluid
collector and have specific experience in oral fluid collections or
training, DOT believes that this is the only reasonable interpretation
of the requirement as written based on (1) the manner in which Sec.
40.35 is drafted and, more importantly, (2) the fact that a qualified
urine collector is not a qualified oral fluid collector and, therefore,
lacks the knowledge needed to monitor and attest in writing that the
mock oral fluid collections are error-free. Qualified
[[Page 87795]]
urine collectors do not have the specific, detailed knowledge, skills,
and abilities directly related to oral fluid devices and collections to
serve as appropriate monitors for mock oral fluid collections. If DOT
had intended to permit qualified urine collectors to serve as monitors
for oral fluid mock collections, it would have affirmatively stated so
in the regulatory text.
DOT acknowledged in its June 2024 DFR that it had inadvertently
created a factual impossibility given the current language of Sec.
40.35. There are no currently qualified oral fluid collectors per Sec.
40.35(c)(2) who meet the additional qualifications at Sec.
40.35(c)(2)(i), (ii) or (iii) to monitor and evaluate the trainee's
mock collections; therefore, no one can be a qualified oral fluid
collector at this time.
To best facilitate the timely training of oral fluid collectors,
DOT continues to believe that it is appropriate to authorize
individuals to monitor mock oral fluid collections without meeting the
requirement of being a qualified oral fluid collector, specified in
Sec. 40.35 as proposed in the NPRM. As discussed above, qualified
urine collectors are not qualified oral fluid collectors, and they are
similarly not qualified to monitor and evaluate a trainee's performance
in oral fluid mock collections merely because they are qualified in
urine collections. As qualified urine collectors are not qualified to
serve in this role, and because there are no qualified oral fluid
collectors to serve in the same role, this rule permits individuals who
are not qualified oral fluid collectors to serve as monitors for oral
fluid mock collections provided that they meet certain requirements.
Specifically, to ensure the proficiency of collection monitors,
this regulatory flexibility--consistent with what we proposed in the
NPRM--will apply only to those individuals meeting the knowledge,
skills, and abilities in Sec. 40.35(c)(2)(ii) or (iii). With regard to
the knowledge, skills, and abilities in Sec. 40.35(c)(2)(ii), we are
waiving the requirement that individuals conducting oral fluid
collector training have at least one year of experience conducting
collector training, but we expect those individuals to have a thorough
understanding of Part 40 and to be well versed in the course content
they are teaching. The course content must meet the requirements in
Sec. 40.35(b), and individuals conducting training should maintain
good records (for example, the course content for the instructor and
student, the duration of the training, the dates the course was taught,
who attended the course, any certificate of successful completion
provided to the students, etc.) to demonstrate that they conducted the
training. This is no different than what would be expected of those
conducting urine collection training today. Individuals conducting Part
40 oral fluid training would be eligible to observe oral fluid mock
collections during the period of regulatory relief.\3\
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\3\ DOT also notes that Sec. 40.209, ``What procedural problems
do not result in the cancellation of a test and do not require
corrective action?,'' provides a list of matters that never result
in the cancellation of a test. Included in that list at Sec.
40.209(b)(3) is ``The collection of a specimen by a collector who is
required to have been trained (see Sec. 40.33 or 40.35), but who
has not met this requirement.'' As noted in the December 19, 2000
final rule (65 CFR 79462), this section is based on a ``general
principle'' that ``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 accurate, but had certain
de minimis irregularities.'' [65 FR 79503] DOT went further, and
specifically with respect to the issue of collector training and
qualifications, stated ``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.'' [Id.]
[Emphasis added]. This means that if a collector properly conducts a
urine test in accordance with the provisions of Part 40 (or an oral
fluid test when laboratories have been approved) without having met
the requirements of Sec. 40.33, the test is not permitted to be
cancelled. Simply stated, if an individual is not a qualified urine
or oral fluid collector and that person collects a specimen by
following Part 40 ``to the letter,'' the collection is a good
collection and is not to be cancelled. In a similar vein, DOT
believes that in these beginning stages of oral fluid testing, it is
appropriate for individuals who are conducting collector training,
and who are well versed in the course content that they are teaching
(i.e., their instruction follows Part 40 procedures), to be
qualified to serve as monitors for mock oral fluid collections.
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As noted above, DOT specified in the preamble to the June 2024 DFR
and NPRM that individuals conducting training should maintain good
records to demonstrate that they conducted the training; however, DOT
did not include regulatory text in the DFR, or propose regulatory text
in the NPRM, regarding record retention requirements or expectations
for oral fluid collector trainers. DOT also does not require in its
Part 40 regulations that such records should or must be maintained--for
trainers of urine collectors, breath alcohol technicians, or oral fluid
collectors. Instead, the preamble language in the June 2024 DFR and
NPRM stating that individuals conducting oral fluid collector training
should keep certain records of these training sessions was based on our
expectation that individuals conducting collector training would
normally be retaining those records as a business best practice. NDASA
and others objected to the same preamble language in the NPRM,
contending that the preamble language imposed new standards and
documentation retention requirements for monitors of mock collections.
The commenters are correct in stating that Part 40 requires urine
and oral fluid collectors and breath alcohol technicians to maintain
documentation showing that they meet all of the requirements to collect
DOT specimens (see Sec. 40.33(g), 40.35(g), and 40.213(g),
respectively). In this final rule, DOT is not establishing any new
regulatory requirement that monitors, trainers, and/or trainees retain
specific records of the training materials used to qualify the
trainees.
A4A recommended extending the sunset provision from 12 months, as
proposed, to 18 months because it believes that 12 months is
insufficient for the industry to establish the necessary number of
qualified collectors to train all other collectors in the oral fluid
collecting process. A4A contends that ``This difficulty is exacerbated
for airlines, which operate globally and in remote locations . . . that
make it unreasonable to expect the establishment of the necessary cadre
of qualified collectors exactly one year after publication that can
train other collectors.''
DOT does not believe that it is necessary to extend the sunset date
beyond 12 months, as proposed. In its comments, NDASA stated that it
alone has trained ``several hundred'' trainers through its train-the-
trainer course since the issuance of DOT's oral fluid rule in May 2023.
This--coupled with the regulatory flexibility established in this
rule--will ensure that there are a sufficient number of qualified oral
fluid collectors within the first year of laboratories being certified
without the need for an extended sunset date.
As noted above, while Sec. Sec. 40.35(c)(2) and 40.35(c)(2)(i),
(ii), and (iii) do not expressly state that the qualified collector for
the oral fluid mock collections must be a qualified oral fluid
collector and have specific experience in oral fluid collections or
training, DOT believes that this is the only reasonable interpretation
of the requirement as written based on: (1) The manner in which Sec.
40.35 is drafted, and more importantly, (2) the fact that a qualified
urine collector is not a qualified oral fluid collector, and therefore,
lacks the knowledge needed to monitor and attest in writing that the
mock oral fluid collections are error-free. To clarify this, and
consistent with our stated intent, we have amended the language in
those
[[Page 87796]]
sections to specifically refer to ``oral fluid'' where necessary. For
the same reasons, we have similarly amended the language in Sec.
40.33(c)(2) and Sec. Sec. 40.33(c)(2)(i), (ii), and (iii) regarding
urine mock collections to refer specifically to ``urine'' where
necessary.
B. Section 40.73 How is an oral fluid specimen collected? (persons
allowed in the testing room)
DOT intended in the May 2023 final rule that the procedures for
oral fluid testing parallel the alcohol testing procedures found in
Sec. 40.223(b), which requires the breath alcohol technician (BAT) or
screening test technician (STT) to prohibit anyone other than the BAT
or STT, the employee, or a DOT representative from witnessing the
testing process. Such a provision also affords privacy to the employee
being tested.
In the NPRM, DOT proposed to correct the inadvertent omission of
this provision from its oral fluid testing requirements. Specifically,
we proposed to add a new paragraph to the regulation instructing the
oral fluid collector not to allow anyone other than the collector, the
employee being tested, or a DOT agency representative to witness the
testing process. This instruction parallels the alcohol testing
procedure found in Sec. 40.223(b) and would afford the employee
privacy during testing.
Comments
Two individuals opposed the proposed amendment, stating that
restricting who may be present during the testing process to the
collector, the employee, or a DOT agency representative is too
restrictive and will hinder the ability of collection sites to train
new staff and monitor for ongoing quality assurance. And, as noted
earlier, A4A recommended that because the oral fluid testing process
does not include immediate testing results or require exposure of
private body parts, DOT ``should empower the employee to orally waive
the prohibition on others `actually witness[ing] the testing process.'
'' A4A believes that doing so may materially improve the efficiency of
the collection process.
DOT Response
Part 40 outlines the steps that must be taken to protect the
security of urine, oral fluid, and alcohol testing sites, including
identifying who is considered to be an ``authorized person'' who is
permitted to enter the testing site (see Sec. 40.43(e)(1), Sec.
40.48(d)(1), and Sec. 40.223(a)(1), respectively). In each case, these
authorized persons are limited to the individual being tested, the
collector/BAT/STT and other collection/testing site workers, DERs,
employee and employer representatives authorized by the employer (e.g.,
representatives authorized pursuant to an employer policy or collective
bargaining agreement), and DOT agency representatives.
However, who may enter the testing site differs from who is
permitted to actually witness the collection/testing process. Beyond
identifying who is an ``authorized person'' that is permitted to enter
a drug or alcohol testing site, Part 40 identifies who may actually
witness the collection/testing process for drug and alcohol tests.
Prior to the approval of oral fluid testing, this was limited to urine
drug testing and alcohol testing. Because of the privacy concerns
associated with urine testing, Sec. 40.43(e)(2) expressly prohibits
the collector from permitting anyone to enter the urination facility in
which employees provide specimens (i.e., actually witness the
collection process) except for the observer in a directly observed
collection or the monitor in a monitored collection. While alcohol
tests are observed tests, Sec. 40.223(b) has long prohibited BATs and
STTs from permitting any person besides the BAT or STT, the employee,
or a DOT agency representative to ``actually witness the testing
process.''
While Part 40 limits who is an ``authorized person'' that may be at
the testing site, those authorized persons include other collection
site workers. DOT understands the concerns articulated by the
commenters, but we believe that limiting who may actually witness the
oral fluid testing process, similar to what has been done for decades
for alcohol testing, will not unduly restrict a collection site from
conducting training or monitoring for ongoing quality assurance given
that other collection site workers (including other collectors) may be
present at the testing site. Oral fluid drug tests, like alcohol tests,
are observed tests. As noted in the NPRM, it was our intention in the
May 2023 final rule that the procedures for oral fluid testing parallel
the alcohol testing procedure found in Sec. 40.223(b), which requires
the BAT or STT to prohibit anyone other than the BAT or STT, the
employee, or a DOT representative to witness the testing process.
We do not believe that there would be any material efficiency gains
to be realized in the oral fluid testing process by permitting
employees to orally waive the prohibition on others actually witnessing
the testing process, as suggested by A4A. We believe that it is
important to maintain consistency in the DOT drug and alcohol testing
program and process and will continue to limit who may witness the oral
fluid testing process to the collector, the employee, and a DOT agency
representative. As noted above and in the NPRM, limiting who may
actually witness the oral fluid testing process also affords privacy to
the employee being tested even though we recognize that the privacy
interest for oral fluid is not as heightened as for urine testing.
Given the above, we have retained the amendment to Sec. 40.73(a)(1) as
proposed in the NPRM.
C. Section 40.73 How is an oral fluid specimen collected?
(specification of the collection of a sufficient amount of oral fluid)
The current Sec. 40.73(c)(2) requires the oral fluid collector to
ensure that a sufficient specimen volume is collected. To be more
specific and provide our interpretation of how collectors ensure that a
sufficient volume is collected, we proposed to require the collector to
also check the ``Volume Indicator(s) Observed'' box in Step 2 of the
CCF. Specifically, we proposed to add language to Sec. 40.73(c)(2) to
instruct the collector to document in Step 2 of the CCF that they
observed the volume indicator(s) during the collection.
Comments
NDASA provided the only comment on this issue and stated that the
collector should not be relying on the volume indicator until after the
specimen is collected. As such, NDASA recommended revising the proposed
language to read as follows: ``After the employee provides a sufficient
specimen, check the ``Volume [I]ndicator(s) Observed'' box in Step 2 of
the Federal CCF to document that you observed the volume
indicator(s).''
DOT Response
DOT agrees with this editorial suggestion, and has incorporated the
revised language as suggested.
D. Other Comments
While acknowledging that the language of the regulatory provisions
of the DFR/NPRM does not prevent qualified trainers from beginning to
train oral fluid collectors before HHS certifies a laboratory to
conduct oral fluid testing, NDASA contends that the preamble to the DFR
sets an ``artificial barrier'' to NDASA members and other qualified
trainers from doing so, thereby ``causing a detrimental financial
burden to small businesses.'' Specifically, NDASA stated ``Delaying
collector training until after laboratories are HHS-
[[Page 87797]]
certified will cause small businesses that have met the train the
trainer requirements to suffer the loss of training revenue.'' In
addition, NDASA anticipates that if the process of training collectors
and conducting those collectors' proficiency demonstrations is delayed
until after HHS certifies laboratories for oral fluid testing, that
there will be a ``rush on the market'' to obtain approved oral fluid
collection devices causing: (1) potential shortages of inventory, and
(2) price increases because demand may exceed supply, and concluded
that ``small businesses will bear the brunt of these problems and
costs.''
NDASA stated that ``There is no need to wait for laboratories to be
certified by the HHS National Laboratory Certification Program (NLCP)
before the training of individuals to collect oral fluid specimens can
begin.'' In addition, NDASA stated that delaying collector training
until after HHS certifies laboratories will ``create a shortage of
properly trained and qualified oral fluid collectors from being able to
collect specimens for possibly months after the first laboratories are
certified.'' Finally, NDASA stated that delaying training and
qualification of oral fluid collectors until after HHS certifies
laboratories will further delay full implementation of the oral fluid
rule provisions, including Sec. 40.67(g)(3), which requires oral fluid
collections to be conducted in specified scenarios.
DOT Response
The purpose of the amendment to Sec. 40.35 is to facilitate the
timely qualification of oral fluid collectors. However, oral fluid
specimens cannot be collected, and DOT oral fluid testing cannot be
implemented, until HHS certifies at least two laboratories, one to
serve as a primary laboratory, and a second to serve as a split
specimen laboratory, and until there is a device that meets DOT
requirements per Appendix B of Part 40. As part of the laboratory
application and certification process, a specific oral fluid collection
device will be identified and approved for use by that laboratory by
HHS and NLCP. To date, HHS has not yet certified any laboratories for
oral fluid drug testing with a device that meets DOT standards. It
follows that no oral fluid collection devices meeting DOT's device
standards have been approved as part of the HHS/NLCP lab certification.
At the same time, DOT acknowledges that oral fluid collection
devices are currently available and are being used for non-DOT oral
fluid drug testing purposes. Further, NDASA states that there is an
oral fluid collection device that has been approved for use by the Food
and Drug Administration (FDA), and that several laboratories expect to
use that same device when submitting applications to HHS/NLCP for
certification at some point in the future.
DOT anticipated that oral fluid trainers and prospective oral fluid
collectors would wait until a specific oral fluid collection device
meeting DOT's standards had been approved by HHS/NLCP as part of the
official laboratory certification process before conducting and
obtaining training on how to use that specific device. Otherwise,
trainers and prospective collectors would be risking the expenditure of
significant time and costs to become trained in the operation of an
oral fluid collection device that may not ultimately be approved as
part of a laboratory's certification by HHS/NLCP.
DOT did not intend to prevent individuals from training on devices
to collect oral fluid specimens before HHS certifies a laboratory and
use of an associated oral fluid collection device. As noted above,
training on an oral fluid collection device that has not been approved
for use as part of an official HHS laboratory certification package
comes with the risk that the device may not be ultimately included and
approved for use by a laboratory by HHS.\4\ This risk is borne entirely
by the trainer and prospective collector, as DOT does not have any role
in determining which particular oral fluid collection device is
submitted by a laboratory to HHS as part of the laboratory's approval/
certification.
---------------------------------------------------------------------------
\4\ Section 40.35(b)(2) requires oral fluid collectors to be
trained to proficiency ``in the operation of the particular oral
fluid collection device(s) you will be using.''
---------------------------------------------------------------------------
Because there is no regulatory requirement to wait until the first
laboratory is certified by HHS before beginning training on the use of
oral fluid collection devices, there is no detrimental financial burden
or loss of training revenue to those small businesses that have taken
train-the-trainer courses. Additionally, while NDASA expressed concern
that: (1) sufficient quantities of approved oral fluid collection
devices may not be available if training is delayed until after
laboratories have been certified, and (2) suppliers of those devices
may increase the price of those devices because demand may exceed
supply, DOT does not believe there will be any issues regarding market
availability or cost of the devices for training purposes.
Importantly, and as discussed above, DOT makes it clear that while
training on the use of an oral fluid collection device can take place
at any time--including prior to the certification by HHS of an oral
fluid drug testing laboratory--mock collections (and therefore,
qualification of oral fluid collectors) cannot take place unless/until
DOT provides regulatory flexibility with respect to the qualifications
of the monitors for the required mock collections, which DOT
accomplishes in this final rule. Therefore, because Sec. 40.35(b)(2)
requires oral fluid collectors to be trained to proficiency in the
operation of the particular oral fluid collection device(s) that the
collector will be using, an individual becoming a qualified oral fluid
collector on a specific oral fluid device before a laboratory is
certified by HHS to use that device risks having to (1) receive
training to proficiency on another device, and (2) complete the mock
collections on that other device if the laboratory is not ultimately
certified by HHS to use the device that the collector was originally
trained on and qualified to use.
IV. Regulatory Notices and Analyses
This rule is a non-significant rule for purposes of Executive Order
(E.O.) 12886, as supplemented by E.O. 13563 and amended by E.O. 14094,
and will not impose any significant costs or have impacts beyond those
analyzed in the May 2, 2023 final rule. DOT has determined that the
regulatory analyses conducted for the May 2, 2023 final rule remain
applicable to this action. DOT makes these statements on the basis
that, as a series of technical amendments that correct or clarify
existing regulatory provisions, specifically to establish temporary
requirements to qualify an initial group of mock oral fluid collection
observers, establish privacy requirements during an oral fluid
collection, and clarify how collectors are to document that a
sufficient volume of oral fluid was collected, this action will not
impose any significant costs or have impacts beyond those analyzed in
the May 2, 2023 final rule.
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. DOT will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United
[[Page 87798]]
States. This rule does not constitute a major rule as defined in 5
U.S.C. 804(2).
In accordance with Compliance with Pay-As-You-Go Act of 2023
(Fiscal Responsibility Act of 2023, Pub. L. 118-5, D. B, Title III) and
OMB Memorandum (M-23-21) dated September 1, 2023, the Department has
determined that this final rule is not subject to the Pay-As-You-Go Act
of 2023 because it will not increase direct spending beyond specified
thresholds.
List of Subjects in 49 CFR Part 40
Administrative practice and procedures, Alcohol abuse, Alcohol
testing, Drug abuse, Drug testing, Laboratories, Reporting and
recordkeeping requirements, Safety, Transportation.
For the reasons stated in the preamble, DOT amends 49 CFR part 40
as follows:
PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL
TESTING PROGRAMS
0
1. The authority citation for Part 40 continues to read as follows:
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and
45101 et seq.
0
2. In Sec. 40.33, revise paragraph (c)(2) to read as follows:
Sec. 40.33 What training requirements must a collector meet for urine
collection?
* * * * *
(c) * * *
(2) Another person must monitor and evaluate your performance, in
person or by a means that provides real-time observation and
interaction between the instructor and trainee, and attest in writing
that the mock collections are ``error-free.'' This person must be a
qualified urine collector who has demonstrated necessary knowledge,
skills, and abilities by--
(i) Regularly conducting DOT urine drug test collections for a
period of at least one year;
(ii) Conducting urine collector training under this part for at
least one year; or
(iii) Successfully completing a urine ``train the trainer'' course.
* * * * *
0
3. In Sec. 40.35, revise paragraph (c)(2) and add paragraph (c)(3) to
read as follows:
Sec. 40.35 What training requirements must a collector meet for oral
fluid collection?
* * * * *
(c) * * *
(2) Another person must monitor and evaluate your performance, in
person or by a means that provides real-time observation and
interaction between you and the qualified collector, who must attest in
writing that the mock collections are ``error-free.'' Except as
provided in paragraph (c)(3) of this section, this person must be a
qualified oral fluid collector who has demonstrated necessary
knowledge, skills, and abilities by--
(i) Regularly conducting DOT oral fluid drug test collections for a
period of at least one year;
(ii) Conducting oral fluid collector training under this part for
at least one year; or
(iii) Successfully completing an oral fluid ``train the trainer''
course.
(3) As the person monitoring and evaluating the collector's five
mock collections pursuant to paragraphs (c)(1) and (2) of this section,
you need not be a qualified oral fluid collector to do so if you meet
the necessary knowledge, skills, and abilities in paragraph (c)(2)(ii)
or (iii) until otherwise specified (one year after HHS publishes a
Federal Register notification of the first certified oral fluid drug
testing laboratory (HHS notification)). Furthermore, the one-year
requirement in paragraph (c)(2)(ii) is not applicable until otherwise
specified (one year after the HHS notification).
* * * * *
0
4. In Sec. 40.73, add paragraph (a)(1) and a reserved paragraph (a)(2)
and revise paragraph (c)(2) to read as follows:
Sec. 40.73 How is an oral fluid specimen collected?
* * * * *
(a) * * *
(1) As the oral fluid collector, you must not allow any person
other than you, the employee, or a DOT agency representative to
actually witness the testing process.
(2) [Reserved]
* * * * *
(c) * * *
(2) The collector must ensure the collection is performed correctly
(i.e., using the oral fluid device in the manner described by its
manufacturer), that the collection device is working properly, and that
a sufficient specimen volume is collected. After the employee provides
a sufficient specimen, check the ``Volume Indicator(s) Observed'' box
in Step 2 of the Federal CCF to document that you observed the volume
indicator(s) during the collection.
* * * * *
Signed pursuant to authority delegated at 49 CFR 1.27(c) in
Washington, DC.
Subash Iyer,
Acting General Counsel.
[FR Doc. 2024-25403 Filed 11-4-24; 8:45 am]
BILLING CODE 4910-9X-P
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