Rule2024-12747
Procedures for Transportation Workplace Drug and Alcohol Testing Programs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 21, 2024
Effective
August 5, 2024
Issuing agencies
Transportation Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 120 (Friday, June 21, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12747]
[[Page 51984]]
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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: Direct final rule.
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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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from <a href="http://Regulations.gov">Regulations.gov</a>. 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 <a href="https://www.transportation.gov/regulations/rulemaking-process">https://www.transportation.gov/regulations/rulemaking-process</a>.
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#6f202b2e3f2c180a0d020e06032f0b001b41080019"><span class="__cf_email__" data-cfemail="91ded5d0c1d2e6f4f3fcf0f8fdd1f5fee5bff6fee7">[email protected]</span></a>.
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.
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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 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
<a href="https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list">https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list</a>.
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
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