[Federal Register Volume 90, Number 188 (Wednesday, October 1, 2025)]
[Proposed Rules]
[Pages 47286-47290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19119]
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DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[Docket DOT-OST-2021-0093]
RIN 2105-AF28
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs
AGENCY: Office of the Secretary, Department of Transportation
(Department or DOT).
ACTION: Supplemental notice of proposed rulemaking.
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SUMMARY: This action supplements an earlier notice of proposed
rulemaking (NPRM) that DOT published on December 9, 2024. This
supplemental proposal would update terminology in DOT's drug and
alcohol testing regulations consistent with Executive Order 14168 (E.O.
14168), Defending Women from Gender Ideology Extremism and Restoring
Biological Truth to the Federal Government. DOT continues to propose a
provision to require a directly observed urine collection in situations
where oral fluid tests are currently required, but oral fluid testing
is not yet available.
DATES: Comments on this notice of proposed rulemaking should be
submitted by November 15, 2025.
[[Page 47287]]
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. Purpose
DOT is issuing this supplemental notice of proposed rulemaking
(SNPRM) following issuance of a 2024 notice of proposed rulemaking
(NPRM) to amend its drug testing procedures rule. (See 89 FR 97579.)
The NPRM proposed an interim provision to require the conduct of
directly observed urine tests in the limited situations where the rule
requires oral fluid tests, but oral fluid testing is not yet available.
DOT continues to propose a directly observed urine collection in
situations where oral fluid tests are currently required, but oral
fluid testing is not yet available and supplements that proposal by
updating language in its drug and alcohol testing regulations
consistent with E.O. 14168 on Defending Women from Gender Ideology
Extremism and Restoring Biological Truth to the Federal Government.
II. Authority for This Rulemaking
This rulemaking is promulgated pursuant to the Omnibus
Transportation Employee Testing Act of 1991 (OTETA) (Pub. L. 102-143,
Tit. V, 105 Stat. 952). DOT requires urine drug testing and authorizes
oral fluid drug testing as an alternative methodology for the testing
of safety-sensitive transportation industry employees subject to drug
testing under part 40 of Title 49 of the Code of Federal Regulations
(part 40). DOT's part 40 regulations are, in turn, incorporated by
reference in the drug and alcohol testing requirements of each of its
operating administrations.\1\
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\1\ See Sec. 40.3 (defining ``DOT, The Department, DOT Agency''
to include each of the DOT operating administrations).
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III. 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 May 2023 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. Because the Department of Health and Human
Services (HHS) had determined that oral fluid drug testing, like urine
drug testing, is both scientifically accurate and forensically
defensible, DOT saw no reason to eliminate or mandate either
methodology. As such, in the vast majority of collection scenarios,
oral fluid testing is available to employers as an alternate
methodology to choose, and not as a replacement for urine drug testing.
Importantly, for an employer to implement oral fluid testing, there
must be at least two HHS-certified laboratories for oral fluid testing.
There must be one HHS-certified laboratory to conduct the screening and
confirmation drug testing on the primary specimen. There must be a
different HHS-certified laboratory to conduct the split specimen drug
testing on the secondary specimen if the employee requests split
specimen testing for the Medical Review Officer (MRO) verified
positive, adulterated, or substituted result. However, as of the date
of the publication of this rule, there are no HHS-certified
laboratories to conduct oral fluid testing.\2\
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\2\ For a list of HHS-certified laboratories, please see https://www.samhsa.gov/substance-use/drug-free-workplace/drug-testing-resources/lab-list.
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DOT regulations at Sec. 40.67 require that a collection be
directly observed in certain circumstances, e.g., if the original
sample was invalid without an adequate medical explanation or the test
is for a return to duty. In the May 2023 Final Rule, and in response to
comments received on the notice of proposed rulemaking (NPRM) that
preceded that rule, we added a provision at Sec. 40.67(g)(3) to
require a directly observed collection to be an oral fluid test \3\ (as
opposed to a urine test) in situations where an observer as required by
the regulations cannot be easily provided and in certain other
situations. These limited situations are the only ones in which Part 40
expressly requires an oral fluid test to be conducted as opposed to a
urine test; in all other situations, an employer has the choice of
whether a urine test or an oral fluid test will be conducted, including
those conducted as directly observed collections.
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\3\ All oral fluid collections are directly observed because
they are always conducted in front of the collector. See also the
definition of ``oral fluid specimen'' in Sec. 40.3: ``A specimen
that is collected from an employee's oral cavity and is a
combination of physiological fluids produced primarily by the
salivary glands. An oral fluid specimen is considered to be a direct
observation collection for all purposes of this part.'' [Emphasis
added]
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Because there are no HHS-certified oral fluid laboratories, it is
not yet possible to comply with the requirement in Sec. 40.67(g)(3)
that requires the directly observed collection to be an oral fluid test
in the situations specified in that section. In the interim, and to
preserve transportation safety by deterring illicit drug use, it is
necessary to ensure that directly observed collections can still be
conducted when required.
To correct the inadvertent factual impossibility created by the
fact there are no HHS certified oral fluid laboratories, DOT published
an NPRM on December 9, 2024, proposing to amend Part 40, for an interim
period, to require directly observed urine collections in the
situations specified in Sec. 40.67(g)(3) if an oral fluid collection
is not yet available (89 FR 97579). The proposed amendment would simply
maintain the ``status quo'' wherein all directly observed collections
are currently conducted as urine tests, because oral fluid testing is
not yet available.
The Department stated that the amendment to require directly
observed urine tests in situations where an oral fluid collection is
required, but is not yet available, is intended to be a temporary,
short-term solution, as there are currently no certified oral fluid
laboratories. DOT proposed that the provision would sunset one year
after HHS publishes a Federal Register notice that it certified the
second oral fluid drug testing laboratory. To ensure all are aware of
the date when this provision will sunset, DOT stated it will publish a
Federal Register document specifying the date the second oral fluid
laboratory is certified by HHS and the corresponding sunset date.
Importantly, DOT was clear that if, during the interim period, a
collection site is able to conduct an oral fluid collection (HHS has
certified at least two oral fluid drug testing laboratories, and both a
qualified oral fluid collector and a conforming oral fluid collection
device are available at the collection site), an oral fluid collection
would be required to be conducted as specified in Sec. 40.67(g)(3).
III. Comments on the NPRM
DOT received 22 comments on the NPRM. Several commenters expressed
concern and frustration that oral fluid testing is not yet available,
given that the May 2023 Final Rule that authorized the use of oral
fluid testing in the DOT drug testing program became effective on June
1, 2023. DOT made it clear in the May 2023 Final Rule, and we have
again noted above, there must be at least two HHS-certified
laboratories for oral fluid testing for an employer to implement oral
fluid testing under Part 40. HHS is 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
[[Page 47288]]
concerning many aspects of its regulations governing testing in the
transportation industries' regulated programs, DOT is required, by
statute (OTETA of 1991), to follow the HHS Mandatory Guidelines for the
laboratory and specimen testing procedures. While DOT acknowledges the
comments urging DOT to accelerate/expedite the certification of
laboratories to conduct oral fluid testing, DOT has no authority or
jurisdiction to do so because HHS is the agency that certifies
laboratories that can be used in the DOT drug testing program.
Similarly, DOT is not permitted to allow single-laboratory testing on a
temporary basis as recommended by one commenter, as statutory law
(again, OTETA of 1991) gives employees the right to request a test of
the split specimen sample, which must be tested independently at a
second HHS-certified laboratory. Because HHS certifies laboratories,
comments related to laboratory certification are outside of the scope
of this rulemaking.
Several commenters expressed concerns regarding various issues
related to oral fluid testing, including the qualification of oral
fluid collectors, the availability and cost of oral fluid collection
devices, and other associated issues. In addition, some commenters seem
to believe that the NPRM proposed to delay implementation of oral fluid
testing in general, which is not the case. The scope of the NPRM was
very narrow, and proposed to revert to directly observed urine
collections in situations where a required oral fluid collection could
not be done until two laboratories are certified for oral fluid testing
by HHS. As such, these commenters' concerns about oral fluid testing
are similarly outside of the scope of this rulemaking.
Several commenters supported the proposal to conduct directly
observed urine collections in the limited situations where an observer
as required by the regulations cannot be easily provided or in the
circumstances identified in Sec. 40.67(g)(3) but objected to the
manner and timeline in which the provision was proposed to be
implemented. Specifically, a commenter read the NPRM to ``delay and/or
make optional 49 CFR section Sec. 40.67(g)(3) for one year from when
HHS certifies the first two laboratories to conduct Federal testing.''
Other commenters stated similar concerns, citing the comments submitted
by this commenter.
In response, DOT notes that in situations where an observer as
required by the regulations cannot be easily provided or in the
circumstances identified in Sec. 40.67(g)(3), and a directly observed
collection is required, DOT was clear that an oral fluid collection
must be conducted, if possible (i.e., HHS has certified at least two
oral fluid drug testing laboratories, and both a qualified oral fluid
collector and a conforming oral fluid collection device are available
at the collection site) during the period until one year after HHS
publishes a Federal Register notification that a second oral fluid
laboratory has been certified. Otherwise, if oral fluid testing is not
available, a directly observed urine test must be conducted in these
situations during the specified time period. After one year following
the certification of the second oral fluid laboratory, an oral fluid
test must be conducted as required in the May 2023 Final Rule. The
above aligns directly with the commenter's statement that collection
sites with trained personnel prepared to offer oral fluid testing
immediately should be allowed to proceed with oral fluid testing.
Several commenters stated that the proposed changes would have a
significant economic impact on a number of small entities. These
commenters stated that many companies have expended time and costs to
revise their company policies to incorporate changes to facilitate oral
fluid testing in their drug testing programs, and that these policies
will need to be revised again to reflect the changes associated with
the provisions to require the conduct of directly observed urine tests
in the limited situations where the rule requires oral fluid tests, but
oral fluid testing is not yet available. As discussed above, this
regulatory flexibility is very narrow in scope, and affects a very
small percentage of collections (directly observed collections where an
observer as required by the regulations cannot easily be provided or in
the specific circumstances specified in Sec. 40.67(g)(3)). As noted
below, DOT stated in the May 2023 Final Rule that oral fluid testing is
optional except in very rare cases. As such, DOT does not believe that
widespread changes will need to be made to the company policies that
have been developed to facilitate the implementation of oral fluid
testing. Further, employers will not be faced with a ``new choice''
(i.e., whether to conduct an oral fluid test or a urine test) in these
limited scenarios because the rule requires that an oral fluid test be
conducted, if possible, and that a urine test be conducted otherwise.
Finally, in the May 2023 Final Rule in Sec. 40.67(g)(3), DOT
included procedures on what to do when the required ``observer'' cannot
be found but mistakenly used the term ``collector'' instead of
``observer'' in the regulatory text of that section. We proposed to
correct the error in the NPRM and received no comments on this issue.
IV. Proposed Supplement to the NPRM
In Sec. 40.65 there are two scenarios, (b)(5) and (c)(1), that
direct the collector to perform either a directly observed urine
collection or an oral fluid collection. However, nothing in those
sections tells the collector how or who makes that decision. We think
it is important to remind the collector to check if the employer has
standing orders or contact the Designated Employer Representative (DER)
to receive instructions on how to proceed in each of those scenarios.
We would do so in the proposed new paragraph (d).
On January 20, 2025, the President issued E.O. 14168 on Defending
Women from Gender Ideology Extremism and Restoring Biological Truth to
the Federal Government. E.O. 14168 stated, among other things, that it
was the policy of the United States to recognize two sexes, male and
female, that each Federal agency shall use the term ``sex'' and not
``gender'' in its policies and documents, that ``sex'' shall refer to
an individual's immutable biological classification as either male or
female and give meaning to the term ``sex'' as set forth in the E.O.
when applying regulations, statutes or guidance. The Department has
identified several instances in its regulation 49 CFR part 40 (i.e.,
Sec. Sec. 40.67, 40.69, and 40.147) where the word ``gender'' is used.
In these sections, we propose to replace the word ``gender'' with the
word ``sex''. E.O. 14168 also states ``sex'' is not a synonym for and
does not include the concept of ``gender identity''.
The Department is proposing to amend Sec. 40.67(g)(3) by retaining
only the original instructions that require an oral fluid collection
when a same sex observer cannot be found with a slight modification to
the text in (g)(3)(ii) to say that the DER is to instruct the collector
to perform an oral fluid test. The Department is retaining the
originally proposed language that requires a directly observed urine
collection when an oral fluid collection cannot be done for up to one
year after two laboratories are HHS certified for oral fluid testing.
This language was proposed to ensure that a urine collection would be
done in the event the collection site was not ready to conduct oral
fluid collections even after two laboratories were HHS-certified for
oral fluid testing. To summarize the supplemental proposal to (g)(3),
if a directly observed urine collection is required and a same sex
observer cannot
[[Page 47289]]
be provided, then an oral fluid test is to be performed. However,
because oral fluid testing cannot be performed (because there are no
two HHS-certified oral fluid laboratories), we have retained the
originally proposed language that a directly observed urine collection
be performed. This provision applies for one year after HHS certifies
at least two oral fluid laboratories. In the interest of safety, if the
employee initially provided a suspect urine specimen, we would want to
ensure that a second urine collection is performed rather than not
performing a second collection because oral fluid testing is not yet
available.
V. Regulatory Notices and Analyses
Executive Orders 12866, 13563, and 14094
This rule is a non-significant rule for purposes of E.O. 12886, as
supplemented by E.O. 13563 and amended by E.O. 14094 and will not
impose any significant costs or have any significant impacts. Given the
uncertainty of testing costs and lack of data on other aspects of
testing, DOT did not estimate cost savings or other benefits for the
May 2023 Final Rule which permitted oral fluid testing as an
alternative to urine testing in most scenarios. In the regulatory
analyses for the May 2023 Final Rule, DOT stated that oral fluid
testing is optional except in very rare cases. This proposal amends the
transportation industry drug testing program procedures regulation to
comply with E.O. 14168 and proposes to require a directly observed
urine collection be conducted when an oral fluid test is required but
cannot because there are no two HHS-certified oral fluid drug testing
laboratories. This proposal will not impose any significant costs or
have any significant impacts on the DOT testing program, because the
requirement of a directly observed urine collection existed before
issuance of the May 2023 Final Rule, and oral fluid testing has not yet
been able to be conducted since the May 2023 Final Rule in the absence
of at least two HHS-certified oral fluid laboratories.
Regulatory Flexibility Act and Small Business Regulatory Enforcement
Fairness Act (SBREFA)
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.)
requires Federal agencies to consider the effects of their regulatory
actions on small businesses and other small entities and minimize any
significant economic impact. The term ``small entities'' comprises
small businesses and not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with a population of less than 50,000.
For this rulemaking, potentially affected small entities include drug
testing companies (U.S. Small Business Administration (SBA) North
American Industry Classification System (NAICS) Sector 54
(Professional, Scientific and Technical Services), Code 541380 (Testing
Laboratories and Services)) as well as DOT-regulated entities (SBA
NAICS Sectors 48-49 (Transportation and Warehousing)).
The Department does not expect that the rule will have a
significant economic impact on a substantial number of small entities.
This proposal amends the transportation industry drug testing program
procedures regulation to revise language consistent with E.O. 14168 and
proposes a requirement to conduct directly observed urine collections
in situations when an oral fluid collection is required but not yet
available. The requirement for directly observed urine collections was
in existence before issuance of the May 2023 Final Rule, and regulated
entities are therefore familiar with the procedure for directly
observed urine tests. In addition, because oral fluid testing is not
yet available, regulated entities are also likely to still have the
collection devices and personnel to conduct urine testing. As a result,
the proposed amendments will not impose significant costs. For these
reasons, I certify that the rule does not have a significant economic
impact on a substantial number of small entities within the meaning of
the Regulatory Flexibility Act.
Unfunded Mandates
DOT has examined the impact of this rule under the Unfunded
Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This rule does not
trigger the requirement for a written statement under sec. 202(a) of
the UMRA because this rulemaking does not impose a mandate that results
in an expenditure of $206 million or more by either State, local, and
Tribal governments in the aggregate or by the private sector in any one
year.
Environmental Impact
DOT has analyzed the environmental impacts of this action pursuant
to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
et seq.) and has determined that it is categorically excluded pursuant
to DOT Order 5610.1D, ``DOT's Procedures for Considering Environmental
Impacts'' (July 1, 2025) (available at https://www.transportation.gov/mission/dots-procedures-considering-environmental-impacts). Categorical
exclusions are actions identified in an agency's NEPA implementing
procedures that do not normally have a significant impact on the
environment and therefore do not require either an environmental
assessment (EA) or environmental impact statement (EIS). This proposal
amends the transportation industry drug testing program procedures
regulation to comply with E.O. 14168 and requires a directly observed
urine collection when required by part 40 because oral fluid testing is
not yet available. This action is covered by the categorical exclusion
listed at 23 CFR 771.118(c)(4), ``[p]lanning and administrative
activities that do not involve or lead directly to construction, such
as: . . . promulgation of rules, regulations, directives. . .'' The
Department does not anticipate any environmental impacts, and there are
no extraordinary circumstances present in connection with this
rulemaking.
Executive Order 13132: Federalism
DOT has analyzed the rule in accordance with Executive Order 13132:
Federalism. Executive Order 13132 requires Federal agencies carefully
to examine actions to determine if they contain policies that have
federalism implications or that preempt State law. As defined in the
order, ``policies that have federalism implications'' refer to
regulations, legislative comments or proposed legislation, and other
policy statements or actions that have substantial direct effects on
the States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government.
Most of the regulated parties under the Department's drug testing
program are private entities. Some regulated entities are public
entities (e.g., transit authorities and public works departments);
however, DOT has determined that this proposed rule, which would amend
the transportation industry drug testing program procedures regulation
to comply with E.O. 14168 and require the conduct of directly observed
urine testing where employers are required to conduct an oral fluid
test but such testing is not available, does not contain policies that
have federalism implications.
Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments
Executive Order 13175 (65 FR 67249, November 6, 2000) requires
Federal
[[Page 47290]]
agencies to develop an accountable process to ensure ``meaningful and
timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' as defined in the Executive Order, include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.'' This rule does not have Tribal
implications. The proposal does not have substantial direct effects on
Tribal governments, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes, as specified in
Executive Order 13175.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA)
requires that DOT consider the impact of paperwork and other
information collection burdens imposed on the public. The information
collection for DOT's drug and alcohol testing program is approved under
OMB control number 2105-0529. This rule does not require any new
collection of information under the PRA. Notwithstanding any other
provision of law, no person shall be subject to any penalty for failing
to comply with a collection of information subject to the PRA that does
not display a currently valid Office of Management and Budget (OMB)
control number.
Privacy Act
Anyone is able to search the electronic form of all comments
received in any of our dockets by the name of the individual submitting
the comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). For information on DOT's
compliance with the Privacy Act, please visit https://www.transportation.gov/privacy.
Rule Summary
As required by 5 U.S.C. 553(b)(4), a summary of this rule can be
found at regulations.gov, Docket DOT-OST-2021-0093, in the SUMMARY
section of this document.
Pay-As-You-Go Act of 2023
In accordance with Compliance with Pay-As-You-Go Act of 2023
(Fiscal Responsibility Act of 2023, Pub. L. 118-5, div. B, title III)
and OMB Memorandum (M-23-21) dated September 1, 2023, the Department
has determined that this 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 procedure, 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 for 49 CFR part 40 continues to read as follows:
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, 45101
and 60102 et seq.
0
2. In Sec. 40.65, add a new paragraph (d) to read:
Sec. 40.65 What does the collector check for when the employee
presents a urine specimen?
* * * * *
(d) Direct observations. If a new urine collection using direct
observation procedures or an oral fluid collection is required under
Sec. 40.65(b)(5) or (c)(1), you must check if the employer has a
standing order on which specimen collection to perform. If there is no
standing order, you must contact the DER on whether to continue with a
directly observed urine collection or an oral fluid collection.
0
3. In Sec. 40.67 revise paragraph g and in paragraph (h) remove the
word ``gender' and add in its place ``sex'' to read as follows:
Sec. 40.67 When and how is a directly observed urine collection
conducted?
* * * * *
(g) As the collector, you must ensure that the observer is the same
sex (male or female) as the employee.
(1) You must never permit a person of the opposite sex to act as
the observer.
(2) The observer can be a different person from the collector and
need not be a qualified collector.
(3) If a same sex observer cannot be found:
(i) If the employer has a standing order to allow oral fluid
testing in such situations, the collector will follow that order.
(ii) If there is no standing order from the employer, the collector
must contact the DER and the DER will direct the collector to either
conduct an oral fluid test if the collection site is able to do so or
send the employee to a collection site acceptable to the employer for
the oral fluid test.
(4) Notwithstanding paragraphs (g)(3)(i) and (ii) of this section,
until otherwise specified (one year after HHS publishes a Federal
Register notification of the second certified oral fluid drug testing
laboratory), you must conduct an oral fluid collection if possible
(i.e., HHS has certified at least two oral fluid drug testing
laboratories, and both a qualified oral fluid collector and a
conforming oral fluid collection device are available at the collection
site). Otherwise, you must conduct a directly observed urine collection
as required in this section.
* * * * *
0
4. In Sec. 40.69 in paragraph (c), remove the word ``gender'' and add
in its place ``sex (male or female)''; in paragraph (d), remove the
word ``same-gender'' and add in its place ``same-sex''.
0
5. In Sec. 40.145 in paragraph (h)(1)(ii), remove the word ``gender''
and add in its place ``sex (male or female)''.
Issued in Washington, DC.
Sean P. Duffy,
Secretary of Transportation.
[FR Doc. 2025-19119 Filed 9-30-25; 8:45 am]
BILLING CODE 4910-9X-P