[Federal Register Volume 91, Number 90 (Monday, May 11, 2026)]
[Rules and Regulations]
[Pages 25507-25511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-09290]


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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 (DOT).

ACTION: Final rule.

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SUMMARY: The U.S. Department of Transportation revises its drug and 
alcohol testing procedures to require a directly observed urine 
collection in situations where oral fluid tests are currently required 
but cannot be conducted because oral fluid testing is not yet 
available. The rule also updates terminology in these procedures 
consistent with Executive Order (E.O.) 14168, Defending Women from 
Gender Ideology Extremism and Restoring Biological Truth to the Federal 
Government.

DATES: This rule is effective on June 10, 2026.

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. 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 49 CFR part 40. DOT's part 40 regulation is adopted 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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II. 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 either 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, 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 
a 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 49 CFR 40.67 require that a collection be 
observed directly 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 to the notice of proposed rulemaking (NPRM) that 
preceded that rule, the Department added a provision at paragraph 
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 rather than 
a urine test; in all other situations, an employer may choose whether 
to conduct a urine or an oral fluid test, including those

[[Page 25508]]

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 section 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 paragraph 
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, to preserve transportation safety and deter 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 currently 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 paragraph 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.
    DOT 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, 
because there are currently no HHS-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 would 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 paragraph 40.67(g)(3).
    On October 1, 2025, DOT published a supplemental notice of proposed 
rulemaking (SNPRM) (90 FR 47286) proposing to (1) replace the word 
`gender' with the word `sex' in sections 40.67, 40.69, and 40.145 to be 
consistent with E.O. 14168, Defending Women from Gender Ideology 
Extremism and Restoring Biological Truth to the Federal Government; (2) 
add a new paragraph (d) in section 40.65 to remind collectors to check 
if the employer has a standing order or contact the Designated Employer 
Representative (DER) to receive instructions on how to proceed in the 
scenarios in paragraphs 40.65(b)(5) and (c)(1); and (3) amend paragraph 
40.67(g)(3) to require an oral fluid collection when a same sex 
observer cannot be found with a slight modification to paragraph 
(g)(3)(ii) to say that the DER is to direct the collector to perform an 
oral fluid test if they have the capability to do so, or send the 
employee to a collection site acceptable to the employer for the oral 
fluid test.

III. Comments to the SNPRM

    For responses to comments on the December 2024 NPRM, please see 
discussion in the October 2025 SNPRM.
    The majority of the commenters responding to the SNPRM supported 
the proposal to require a directly observed urine collection pursuant 
to paragraph 40.67(g)(3) until oral fluid testing is available. These 
commenters said that this approach keeps safety standards in place, is 
a practical solution that ensures safety and compliance, and does not 
take away from the original rule's purpose of keeping its deterrent 
effect in place. These commenters also stated that it seems reasonable 
and necessary while waiting for oral fluid to become viable and that 
``. . . DOT should continue to rely on urine drug testing, as it has 
been deemed effective and does not require any additional 
certification, until the agency can effectively support oral fluid 
testing.''
    One commentor encouraged DOT to provide guidance on how to 
determine when oral fluid testing is available at a site. In response 
to this comment, DOT notes that when a laboratory is HHS-certified to 
conduct oral fluid drug testing, DOT intends to include that laboratory 
on its web page, https://www.transportation.gov/odapc/HHS_Certified_Oral_Fluid_Laboratories. Similarly, DOT expects that 
certified laboratories will let their customers know when they are 
offering DOT oral fluid drug testing services. Individual collection 
sites will most likely need to make a business decision on whether they 
want to provide oral fluid drug testing specimen collection services to 
DOT-regulated employers. If they choose to provide that service, it 
would make good business sense to let their DOT-regulated clients know 
that they are providing oral fluid drug testing specimen collections.
    Two commenters urged DOT to work with HHS to advance the 
availability of oral fluid testing. DOT and HHS continue to work 
together to support making oral fluid testing available.
    Regarding the proposal to add a new paragraph (d) in section 40.65, 
DOT received general support and no opposition to the proposal. As 
such, the change is adopted as proposed.
    Some commenters expressed concerns related to costs, accuracy of 
the detection of drugs, and the timeline for staffing facilities, while 
another commentor requested guidance on conducting direct observation 
urine collections.
    Specifically, one commentor expressed a concern about the impact on 
small businesses. Given the time and money spent on updating policies, 
it would result in an administrative burden to revise them again in the 
interim. This comment is identical to a comment made to the NPRM. See 
the comment and our response in the SNPRM.
    One commentor had concerns that there were no projected costs for 
the rule and asked about a projected timeline for getting facilities 
staffed to comply with this rule.
    In response to these comments, DOT notes that the requirement of a 
directly observed urine collection existed before issuance of the May 
2023 Final rule. As explained in the SNPRM, this rulemaking would 
require directly observed urine tests be conducted in those very rare 
cases where oral fluid was required by the May 2023 final rule. In 
addition, oral fluid testing has not yet been available as an 
alternative test method for DOT-regulated employers because there are 
not yet two HHS-certified laboratories to conduct oral fluid testing. 
As a result, DOT does not expect an increase in testing costs as a 
result of this rule. And as explained in the SNPRM, DOT does not expect 
widespread changes will be needed for company policies to be developed 
to facilitate the implementation of oral fluid testing. Similarly, 
regarding the concern about getting facilities staffed to comply with 
this rule, DOT reiterates that the requirement of a directly observed 
urine collection existed before the issuance of the May 2023 Final 
rule. In addition, this rulemaking would require directly observed 
urine tests to be conducted only in the small number of cases where 
oral fluid was required by the May 2023 Final Rule, and there is no 
training requirement to be an observer. As a result, the Department 
would expect collection sites to be ready to perform this important 
function without delay.
    Three commenters expressed concern over the accuracy of the 
detection of drugs in oral fluid, given its shorter

[[Page 25509]]

window of detection. This comment is outside the scope of this 
rulemaking to ensure that directly observed testing can be conducted 
when necessary. DOT notes, however, that windows of detection were 
discussed in both the oral fluid NPRM (87 FR 11156, February 28, 2022) 
and final rule (88 FR 27596, May 2, 2023). Given the different windows 
of detection in urine and oral fluid drug testing, DOT left the 
decision to the employer on which type of specimen the employer wants 
to use except in the specific circumstances specified in paragraph 
40.67(g)(3).
    One commentor neither supported nor opposed the proposal to require 
a directly observed urine collection in paragraph 40.67(g)(3) but 
suggested that DOT provide guidance to employers and service agents on 
how to identify the employee's sex for a directly observed urine 
collection. The Office of Drug and Alcohol Policy and Compliance 
(ODAPC) will determine whether guidance is necessary and consider 
developing any guidance separate from this rulemaking.
    One commentor, Airlines for America (A4A), thought DOT proposed to 
delay oral fluid testing for one year until after HHS published in the 
Federal Register a notification of a second HHS-certified oral fluid 
laboratory, after which time oral fluid testing requirements would be 
``reinstated.'' To clarify, DOT did not propose to delay oral fluid 
testing as mentioned by A4A. DOT proposed, in the scenario where a 
directly observed urine collection is required and the same sex 
observer was not available, to provide a grace period of up to one year 
past the HHS Federal Register notice to continue to allow employers to 
conduct directly observed urine collections in the event the employer 
was not set up to conduct oral fluid testing as required in paragraph 
40.67(g). If during the grace period, the employer is set up to conduct 
oral fluid testing, the employer must do so. As a reminder, with 
respect to urine collections that are observed directly, as long as 
there is a same-sex observer, there is no requirement to conduct an 
oral fluid collection.
    A4A, given their understanding of the delayed testing for one year, 
suggested that DOT extend the compliance date to 18 months, six months 
past the `one year delay,' after the HHS Federal Register notification, 
citing the need to understand the testing technology once oral fluid 
testing is available, develop and deploy nationwide training throughout 
the entire air carrier system, and work with suppliers to understand 
the availability of oral fluid collection supplies. After considering 
A4A's comment, DOT agrees with extending the `grace period' following 
the HHS Federal Register notification that there are two HHS-certified 
oral fluid laboratories. To mitigate A4A's concerns over oral fluid 
logistics, the Department will permit an 18-month grace period and 
modify the rule text accordingly.
    A4A's comment raises a question unique to FAA-regulated employers. 
Specifically, FAA's drug and alcohol testing regulation paragraph 
120.123(a) states, ``[e]xcept for those testing processes applicable to 
persons testing pursuant to paragraph 120.1(d), no part of the testing 
process (including specimen collection, laboratory processing, and MRO 
actions) shall be conducted outside the territory of the United 
States.'' As a result, unless an FAA-regulated employer is subject to 
the ``Drug and Alcohol Testing of Certified Repair Stations Employees 
Located Outside the United States,'' effective January 17, 2025 (see 89 
FR 103499), FAA-regulated employers are not permitted, among other 
things, to use a laboratory located outside the United States. ODAPC 
notes that if the first two oral fluid laboratories certified by HHS 
are based in Canada, FAA-regulated employers not subject to the 
aforementioned rule could not use the Canadian-based laboratories. 
ODAPC has determined that in those cases, the 18-month grace period 
should apply, but only when the two laboratories are based in the 
United States.
    Based on the above and in consideration of the comment from A4A, 
the Department has modified the proposed rule text in paragraph 
40.67(g) by re-writing (3) and (4) and adding a new (5) and (6). 
Paragraph (g)(3) now authorizes the conduct of a directly observed 
urine collection when oral fluid is not available, and (g)(4) requires 
an oral fluid collection (once oral fluid testing is available) when a 
same sex observer is not available. Paragraph (g)(5) describes what 
conditions need to be met for an employer to use oral fluid testing, 
including FAA's part 120.123(a) requirement that both laboratories be 
based in the United States. Paragraph (g)(6) authorizes the use of 
directly observed urine collections during an 18-month grace period 
that employers can use to get set up for oral fluid testing. It also 
requires that if during the 18-month grace period the employer is ready 
to conduct oral fluid drug testing, the employer must do so.
    Regarding DOT's proposal to replace the word `gender' with the word 
`sex' in sections 40.67, 40.69, and 40.145 to be consistent with E.O. 
14168, Defending Women from Gender Ideology Extremism and Restoring 
Biological Truth to the Federal Government, several commenters 
supported the proposal and three commenters opposed it. DOT appreciates 
and has considered the comments in developing this final rule. The 
Department is finalizing these changes as proposed in the SNPRM 
pursuant to E.O. 14168.
    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. We have adopted the 
change as proposed.
    One commentor asked DOT and several other Federal departments to 
prioritize investigations and litigation to enforce violations of civil 
rights, among other things. This comment is outside the scope of this 
rulemaking.

V. Regulatory Notices and Analyses

Executive Orders 12866 and 14192

    This rule is a non-significant rule for purposes of E.O. 12886 and 
was not reviewed by the Office of Management and Budget (OMB) pursuant 
to that E.O. The rule 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 that 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 rule amends 
the transportation industry drug testing program procedures regulation 
to comply with E.O. 14168 and requires a directly observed urine 
collection when an oral fluid test is required but cannot be conducted 
because there are not yet two HHS-certified oral fluid drug testing 
laboratories. This rule 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. This rule requires direct 
observation collections only in those very rare cases where oral fluid 
was required but cannot be conducted, 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.
    This rule is not an E.O. 14192 regulatory action because this rule 
is not significant under E.O. 12866.

[[Page 25510]]

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 to 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 has concluded that the rule will not have a 
significant economic impact on a substantial number of small entities. 
This rule amends the transportation industry drug testing program 
procedures regulation to revise language consistent with E.O. 14168 and 
to require the conduct of directly observed urine collection when an 
oral fluid collection is required but not yet available. The 
requirement for directly observed urine collections existed before 
issuance of the May 2023 Final Rule, and regulated entities are 
therefore familiar with the procedure for directly observed urine 
collections. 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. In addition, 
as explained in the SNPRM, this rulemaking would require directly 
observed urine collections to be conducted in those very rare cases 
where oral fluid was required by the May 2023 final rule. As noted 
earlier in this preamble, there is no training requirement to be an 
observer. Therefore, DOT does not expect an increase in testing or 
staff costs as a result of this rule. And as explained in the SNPRM, 
DOT does not expect widespread changes will be needed for company 
policies developed to facilitate the implementation of oral fluid 
testing. As a result, the rule 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 (in $2025) by either State, 
local, and Tribal governments in the aggregate or by the private sector 
in any one year.

Environmental Impact

    The Department has analyzed the environmental impacts of this 
notice of proposed rulemaking pursuant to the National Environmental 
Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.). The Department has 
determined that this rule is categorically excluded pursuant to DOT 
Order 5610.1D, ``DOT's Procedures for Considering Environmental 
Impacts'' (available at https://www.transportation.gov/mission/dots-procedures-considering-environmental-impacts). Categorical exclusions 
are categories of actions that the agency has determined normally do 
not significantly affect the quality of the human environment and 
therefore do not require either an environmental assessment (EA) or 
environmental impact statement (EIS). See DOT Order 5610.1D Sec.  9. In 
analyzing the applicability of a categorical exclusion (CE), the agency 
must also consider whether extraordinary circumstances are present that 
would warrant the preparation of an EA or EIS. Id. Sec.  9(b). This 
rulemaking, which 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, is categorically excluded 
pursuant to 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 E.O. 13132, 
Federalism. E.O. 13132 requires Federal agencies to examine actions 
carefully 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 rule, which amends 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

    E.O. 13175 (65 FR 67249, Nov. 6, 2000) requires Federal 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 E.O. 13175 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 rule 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 E.O. 
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

[[Page 25511]]

subject to any penalty for failing to comply with a collection of 
information subject to the PRA that does not display a currently valid 
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.

Congressional Review Act

    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. NHTSA 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 prior 
to publication of the rule in the Federal Register. This rule does not 
meet the criteria in 5 U.S.C. 804(2) to be considered a major rule.

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 paragraph (d) to read as follows:


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
0
a. Revise paragraph g; and,
0
b. In paragraph (h), remove the word ``gender'' and add in its place 
``sex.''
    The revision reads 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 (i.e., 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 oral fluid testing is not yet available (see paragraph 
(g)(5) of this section) and a same sex observer is not present at the 
collection site, the collector must contact the DER. The DER will 
either arrange for a same sex observer to be present at the time of the 
collection or send the employee to a collection site acceptable to the 
employer for a directly observed urine collection as required in this 
section.
    (4) Once oral fluid testing is available (see paragraph (g)(5) of 
this section), and a same sex observer cannot be found for a directly 
observed urine collection:
    (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.
    (5) For an employer to use oral fluid testing, there must be at 
least two HHS-certified oral fluid drug testing laboratories. For 
employers subject to FAA regulations at 14 CFR 120.123(a), the two 
certified laboratories must be located in the United States. In 
addition, both a qualified oral fluid collector and a conforming oral 
fluid collection device are available at a collection site.
    (6) Once HHS gives notification of a second HHS-certified oral 
fluid drug testing laboratory, there will be an 18-month grace period 
to allow employers to continue to conduct directly observed urine 
collections (see paragraph 3 of this section) until the employer is set 
up to conduct oral fluid testing (see paragraphs 4 and 5). If during 
the 18-month grace period the employer has decided to use oral fluid 
drug testing and the employer is ready to conduct oral fluid drug 
testing, the employer must do so. ODAPC will publish a Federal Register 
notice to let employers and collectors know when the 18-month period 
begins and ends.
* * * * *


Sec.  40.69  [Amended]

0
4. In Sec.  40.69:
0
a. In paragraph (c), remove the word ``gender'' and add in its place 
``sex (i.e., male or female),''; and
0
b. In paragraph (d), remove the term ``same-gender'' and add in its the 
term ``same-sex.''


Sec.  40.145  [Amended]

0
5. In Sec.  40.145 in paragraph (h)(1)(ii), remove the word ``gender'' 
and add in its place ``sex (i.e., male or female).''

    Issued in Washington, DC.
Sean P. Duffy,
Secretary of Transportation.
[FR Doc. 2026-09290 Filed 5-8-26; 8:45 am]
BILLING CODE 4910-9X-P