[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 [www.gpo.gov]
[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    This rulemaking is promulgated under the authority originally 
enacted in the Omnibus Transportation Employee Testing Act (OTETA) of 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 www.regulations.gov.
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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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