[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Proposed Rules]
[Pages 52002-52004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12748]


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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: Proposed rule.

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SUMMARY: The U.S. Department of Transportation (DOT) is proposing to 
revise its drug and alcohol testing procedures final rule published on 
May 2, 2023, to provide temporary qualification requirements for mock 
oral fluid monitors, provide for consistent privacy requirements by 
identifying which individuals may be present during an oral fluid 
collection, and clarify how collectors are to specify that a sufficient 
volume of oral fluid was collected. In the ``Rules and Regulations'' 
section of this issue of the Federal Register, DOT is simultaneously 
publishing the revision of DOT's drug testing regulation as a direct 
final rule without a prior proposed rule. If DOT receives no adverse 
comment, it will not take further action on this proposed rule.

DATES: Comments must be received on or before July 22, 2024.

ADDRESSES: Submit your comments, identified by Docket ID No. DOT-OST-
2021-0093, at https://www.regulations.gov/. Follow the online

[[Page 52003]]

instructions for submitting comments. Once submitted, comments cannot 
be edited or removed from Regulations.gov. DOT may publish any comment 
received to its public docket. Do not submit electronically any 
information you consider to be Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. For 
additional submission methods and general guidance on making effective 
comments, please visit https://www.transportation.gov/regulations/rulemaking-process.

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; 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Why is DOT using this proposed rule?

    DOT proposes to revise DOT's drug testing regulation, Procedures 
for Transportation Workplace Drug and Alcohol Testing Programs (49 CFR 
part 40) to amend unforeseen circumstances rendering it impossible to 
comply with requirements in the final rule, address privacy concerns, 
and clarify how collectors are to specify that sufficient volume of 
oral fluid was collected. DOT also published a direct final rule in 
this issue of the Federal Register because it views this revision as a 
noncontroversial action and anticipates no adverse comment. DOT 
explains its reasons for the direct final rule in the preamble to that 
rule. If DOT receives no adverse comment, it will not take further 
action on this proposed rule. If DOT receives adverse comment on any of 
the provisions of the proposed rule, DOT will withdraw those 
provision(s) of the direct final rule and those provision(s) of the 
rule will not take effect. DOT will address public comments in any 
subsequent final rule to finalize those provisions based on this 
proposed rule. DOT does not intend to institute a second comment period 
on this action. Any parties interested in commenting must do so at this 
time. For further information about commenting on this rule, see the 
ADDRESSES section.

II. General Information

    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 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, consistency with regard to privacy during 
testing, and a need to clarify the means by which collectors specify 
that a sufficient volume of oral fluid was collected.

Section 40.35 What training requirements must a collector meet for oral 
fluid collection?

    The May 2023 final rule established qualification 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 the qualification training requirements (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--(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.
    Once the Department of Human and Health Services (HHS) certifies 
its first oral fluid laboratory, oral fluid testing devices will be 
available. 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. We did not intend 
to create a factual impossibility. We meant for the oral fluid monitors 
for the mock proficiency demonstrations to be proficient as oral fluid 
collectors.
    The regulatory flexibility we propose to provide in this action 
will allow individuals sufficiently knowledgeable in part 40's oral 
fluid collection requirements and familiar with an oral fluid testing 
device of their choosing to observe the mock collections and attest in 
writing that the mock collections are `error free'. As a reminder, 
individuals meeting the criteria in Sec.  40.35(c)(2)(ii) or (iii) 
should be prepared to provide any course material and/or certificates 
of successful completion to an employer or DOT representative upon 
request.
    To facilitate the training of oral fluid collectors, we propose 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, however, this regulatory 
flexibility would apply only to those individuals meeting the 
knowledge, skills, and abilities in Sec.  40.35(c)(2)(ii) or (iii).\1\ 
With regard to the knowledge, skills, and abilities in Sec.  
40.35(c)(2)(ii), we propose to waive 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 and any certificate of 
successful completion you may have provided 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 this training would be eligible to 
observe oral fluid mock collections during the period of regulatory 
relief.
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    \1\ We note 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), 
oral fluid is not a permissible means of collection. We have 
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, 
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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    This proposed regulatory flexibility would sunset one year after 
HHS publishes a Federal Register notice that it certified the first 
oral fluid drug testing laboratory. So that all are aware of the 
effective date of the regulatory flexibility, we would publish a 
Federal Register document specifying the date the first oral fluid 
laboratory is certified

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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.
    We want to emphasize that while individuals may become qualified as 
oral fluid collectors after the first laboratory is HHS certified for 
oral fluid drug testing, 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). As of the publication 
of this action, HHS has not yet certified any laboratories for oral 
fluid drug testing. Upon certification, oral fluid laboratories 
currently will be added to the list of HHS-certified laboratories at 
https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list.

Section 40.73 How is an oral fluid specimen collected? (persons allowed 
in testing room)

    DOT intended 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 breath alcohol technician (BAT) or 
screening test technician (STT) to prohibit anyone other than the BAT 
or STT, the employee, or a DOT representative to witness the testing 
process. Such a provision also affords privacy to the employee being 
tested. In this action, DOT is correcting the inadvertent omission of 
this provision from its oral fluid testing requirements.
    Thus, we propose 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 would afford the employee 
privacy during testing and parallels the alcohol testing procedure 
found in Sec.  40.223(b).

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 propose to require the collector to 
also check the `volume indicator(s) observed' box in Step 2 of the CCF. 
To do so, in this action we propose 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.

III. 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 specify 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.
    As required by 5 U.S.C. 553(b)(4), a summary of this rule can be 
found at the entry for RIN 2105-AE94 in the Department's significant 
rulemaking report, available at https://www.transportation.gov/regulations/report-on-significant-rulemakings.

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 
54101 et seq.

0
2. 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 collector who has demonstrated necessary knowledge, skills, 
and abilities by--
    (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.
    (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 (c)(2)(ii) is not applicable until otherwise specified 
(one year after the HHS notification).
* * * * *
0
3. 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. Check the ``Volume 
indictor(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. 2024-12748 Filed 6-20-24; 8:45 am]
BILLING CODE 4910-9X-P