[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Rules and Regulations]
[Pages 51984-51986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12747]



[[Page 51984]]

-----------------------------------------------------------------------

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: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The U.S. Department of Transportation (DOT) is taking direct 
final action to revise DOT's drug testing procedures rule, which became 
effective on June 1, 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.

DATES: This final rule is effective on August 5, 2024, without further 
notice unless DOT receives adverse comment by July 22, 2024. If DOT 
receives adverse comment on any of the provisions in this direct final 
rule, it will publish a timely withdrawal in the Federal Register 
informing the public that the provisions of the rule on which adverse 
comment were received will not take effect.

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

    DOT is publishing this rule without a prior proposed rule because 
we view this as a noncontroversial action and anticipate no adverse 
comment on any of the provisions of the rule. However, in the 
``Proposed Rules'' section of this issue of the Federal Register, we 
are publishing a separate document containing the same amendments that 
serves as the proposed rule to amend the procedures for DOT's drug 
testing program (49 CFR part 40) if adverse comments are received on 
any of the provision in this direct final rule. Any parties interested 
in commenting must do so at this time. We will not institute a second 
comment period on this action. For further information about commenting 
on this rule, see the ADDRESSES section.
    If DOT receives adverse comment on any of the provisions, we will 
publish in the Federal Register a timely withdrawal of the provision or 
provisions that are the subject of the comments, informing the public 
that the provision(s) of the direct final rule on which DOT received 
adverse comment will not take effect unless and until DOT addresses 
public comments in any subsequent final rule.

II. What is DOT including in this direct final rule?

    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 rendering 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 oral fluid 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, but individuals wanting to be oral fluid collectors will not 
be 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 provide in this direct final rule 
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 have 
amended 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 will apply only to those individuals meeting the knowledge, 
skills, and abilities in Sec.  40.35(c)(2)(ii) or (iii).\1\ With regard 
to

[[Page 51985]]

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 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    This regulatory flexibility will 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 will publish a Federal Register 
document specifying the date the first oral fluid laboratory is 
certified by HHS and the effective date that individuals observing mock 
collections (i.e., monitors) will 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 direct final rule, HHS has not yet certified any laboratories 
for oral fluid drug testing. Upon certification, oral fluid 
laboratories 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 direct final rule, DOT is correcting the inadvertent 
omission of this provision from its oral fluid testing requirements.
    Thus, we are adding 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 will 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 are requiring the collector to also 
check the `volume indicator(s) observed' box in Step 2 of the CCF. To 
do so, in this direct final rule we are adding 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 direct final rule. DOT makes these statements on the 
basis that, as 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 direct final rule will not impose any 
significant costs or have impacts beyond those analyzed in the May 2, 
2023, final rule.
    DOT concludes that it has good cause to waive prior opportunity for 
notice and comment to 5 U.S.C. 553(b)(B) as unnecessary unless adverse 
comment is received by July 22, 2024. These amendments correct a 
factual impossibility with regard to mock collection observers, 
incorporate privacy considerations consistent with DOT regulations on 
alcohol testing, and clarify how collectors are to demonstrate 
compliance with the existing regulation that requires collection of a 
sufficient amount of oral fluid. DOT believes these amendments merely 
clarify and operationalize the final rule published on May 2, 2023, and 
are noncontroversial. The amendments do not make significant 
substantive changes to Part 40.
    With regard to the added language in Sec.  40.35 for monitors of 
mock oral fluid collections, DOT explained that the final rule 
published in May 2023 inadvertently created a factual impossibility. 
The temporary allowance in this direct final rule will be in effect 
until one year after HHS certifies an oral fluid laboratory, during 
which time individuals could become qualified oral fluid collectors. 
DOT believes that individuals monitoring collections under this final 
rule will be able to monitor collections with the same level of 
proficiency as qualified collectors meeting the knowledge, skills, and 
abilities set forth in Sec.  40.35.
    With regard to the added instruction in Sec.  40.73 to 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, DOT is correcting the inadvertent omission of this 
provision from its oral fluid testing requirements to afford a 
commensurate level of privacy to all employees subject to testing.
    With regard to the requirement for the collection of a sufficient 
specimen volume, the requirement established in this direct final rule 
to check the `volume indicator(s) observed' box in Step 2 of the 
collection form is intended only to clarify how collectors ensure that 
a sufficient volume is collected as required by the regulation.
    Based on the preceding discussion and the description of the 
measures in this direct final rule, DOT determined that the opportunity 
for prior notice and comment is unnecessary and contrary to the public 
interest, and DOT publishes

[[Page 51986]]

the amendments in this direct final rule. For these same reasons, DOT 
waives the 30-day delay in effective date for this rule pursuant to 5 
U.S.C. 553(d)(3).
    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 States. This 
rule does not constitute a major rule as defined in 5 U.S.C. 804(2).

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 
and the specified DOT agency regulations as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

0
1. The authority 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. 2024-12747 Filed 6-20-24; 8:45 am]
BILLING CODE 4910-9X-P