[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
[[Page 52004]]
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]
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