Petition for Rulemaking; Notification of Petition for Rulemaking; Invalid Specimen Determinations

Issuing agencies

Abstract

This document announces receipt of a petition for rulemaking received by DOT on February 27, 2026, to initiate a rulemaking to amend 49 CFR part 40. The petitioner's proposed amendments seek to incorporate structured medical verification standards when an employee asserts a plausible medical explanation for abnormal specimen validity findings, including abnormal pH values. Specifically, the petitioner proposes: a defined and finite documentation submission window; required written Medical Review Officer determinations addressing submitted documentation; defined evaluation standards for abnormal urinary chemistry findings; consideration of specialist consultation when diagnosed voiding disorders are asserted; and (5) documented review of medically supported functional voiding disorders prior to verifying refusal determinations based on inability to provide a specimen under direct observation. Through this notification, DOT seeks comment on the petition, as well as any information that could be used in DOT's determination whether to grant the petition.

Full Text

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<title>Federal Register, Volume 91 Issue 189 (Thursday, October 1, 2026)</title>
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[Federal Register Volume 91, Number 189 (Thursday, October 1, 2026)]
[Proposed Rules]
[Pages 62409-62411]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20169]


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DEPARTMENT OF TRANSPORTATION

49 CFR Part 40

[DOT-OST-2026-3664]


Petition for Rulemaking; Notification of Petition for Rulemaking; 
Invalid Specimen Determinations

AGENCY: Office of the Secretary, U.S. Department of Transportation 
(Department or DOT).

ACTION: Notification of petition for rulemaking; request for comments.

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SUMMARY: This document announces receipt of a petition for rulemaking 
received by DOT on February 27, 2026, to initiate a rulemaking to amend 
49 CFR part 40. The petitioner's proposed amendments seek to 
incorporate structured medical verification standards when an employee 
asserts a plausible medical explanation for abnormal specimen validity 
findings, including abnormal pH values. Specifically, the petitioner 
proposes: a defined and finite documentation submission window; 
required written Medical Review Officer determinations addressing 
submitted documentation; defined evaluation standards for abnormal 
urinary chemistry findings; consideration of specialist consultation 
when diagnosed voiding disorders are asserted; and (5) documented 
review of medically supported functional voiding disorders prior to 
verifying refusal determinations based on inability to provide a 
specimen under direct observation. Through this notification, DOT seeks 
comment on the petition, as well as any information that could be used 
in DOT's determination whether to grant the petition.

DATES: DOT will accept comments, data, and information with respect to 
the Darcy Kern Petition until November 2, 2026.

ADDRESSES: To ensure that you do not duplicate your docket submissions, 
please submit them by only one of the following means:
    <bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">http://www.regulations.gov</a> and follow the online instructions for submitting 
comments.
    <bullet> Mail: Dockets Operations, U.S. Department of 
Transportation, 1200 New Jersey Ave. SE, West Building, W58-213, 
Washington, DC 20590-0001;
    <bullet> Hand Delivery: West Building, W58-213, 1200 New Jersey 
Ave. SE, between 9 a.m. and 5 p.m., Monday through Friday, except 
Federal holidays. The telephone number is 202-366- 9826;
    <bullet> Instructions: You must include the agency name and docket 
number DOT- OST-2026-3664 at the beginning of your comments. All 
comments received will be posted without change to <a href="http://www.regulations.gov">http://www.regulations.gov</a>, including any personal information provided.

FOR FURTHER INFORMATION CONTACT:  Ms. Alison Stockdale, Office of Drug 
and Alcohol Policy and Compliance, 1200 New Jersey Avenue SE, 
Washington, DC 20590; 202-366-3784, <a href="/cdn-cgi/l/email-protection#f4bbb0b5a4b783919699959d98b4909b80da939b82"><span class="__cf_email__" data-cfemail="4609020716053123242b272f2a0622293268212930">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Submission of Comments

    DOT invites all interested parties to submit, by the date listed 
under the DATES heading, written comments and information regarding 
this petition via <a href="http://www.regulations.gov">www.regulations.gov</a>. All submissions must include the 
agency name, ``Department of Transportation'' and docket number, DOT-
OST-2026-3664, for this rulemaking. All comments received will be 
posted without change to <a href="http://www.regulations.gov">www.regulations.gov</a>, including any personal 
information provided. Do not include personal information you would

[[Page 62410]]

not want publicly shared, including social security information, home 
addresses, or any other personal identifying information not to be 
publicly shared. DOT will not take responsibility for information you 
share. Do not submit to <a href="http://www.regulations.gov">www.regulations.gov</a> information for which 
disclosure is restricted by statute, such as trade secrets and 
commercial or financial information (hereinafter referred to as 
Confidential Business Information (CBI)). Comments submitted through 
<a href="http://www.regulations.gov">www.regulations.gov</a> cannot be claimed as CBI. Comments received through 
the website will waive any CBI claims for the information submitted. 
DOT considers public participation to be a very important part of its 
process for considering rulemaking petitions.
    DOT actively encourages public participation and interaction during 
the comment period. Interactions with and between members of the public 
provide a balanced discussion of the issues and help DOT determine how 
to proceed with a petition.

    Signed in Washington, DC, on September 29, 2026.
Douglas Simon,
Director, Office of Drug & Alcohol Policy & Compliance.

Petition for Rulemaking as Submitted by the Petitioner

Executive Summary

    This petition respectfully requests that the U.S. Department of 
Transportation initiate rulemaking to amend 49 CFR part 40, 
specifically Sec.  40.193 \1\ and related provisions governing invalid 
specimen determinations and directly observed recollection procedures.
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    \1\ Petitioner cites section 40.193 that covers What happens 
when an employee does not provide a sufficient amount of specimen 
for a drug test? Section 40.159, which covers What does the MRO do 
when a drug test result is invalid?, seems to be the appropriate 
provision to be considered for amendment.
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    The proposed amendments seek to incorporate structured medical 
verification standards when an employee asserts a plausible medical 
explanation for abnormal specimen validity findings, including abnormal 
pH values. Specifically, the petition proposes: (1) a defined and 
finite documentation submission window; (2) required written Medical 
Review Officer determinations addressing submitted documentation; (3) 
defined evaluation standards for abnormal urinary chemistry findings; 
(4) consideration of specialist consultation when diagnosed voiding 
disorders are asserted; and (5) documented review of medically 
supported functional voiding disorders prior to verifying refusal 
determinations based on inability to provide a specimen under direct 
observation.
    The requested amendments do not weaken anti-adulteration 
safeguards, eliminate observed testing, or create indefinite delays. 
Instead, they aim to enhance procedural clarity, consistency, and 
transparency while preserving enforcement authority and public safety 
protections.

Statement of the Issue

    49 CFR part 40 requires that certain invalid drug test results, 
including those involving abnormal pH values outside established 
physiological parameters, result in cancellation of the test and 
mandatory directly observed recollection.
    While this framework appropriately prioritizes specimen integrity 
and anti-tampering safeguards, the regulation does not require a 
structured medical verification opportunity when an employee asserts a 
plausible medical explanation for abnormal specimen validity findings.
    Currently, the regulation does not mandate:
    A defined documentation submission window when a medical cause is 
asserted;
    Structured evaluation standards for abnormal urinary chemistry 
potentially associated with diagnosed medical conditions;
    Written determination requirements addressing asserted medical 
explanations prior to escalation;
    Integration of documented functional voiding disorders prior to 
refusal determinations following observed collection.
    The absence of defined medical integration standards may result in 
inconsistent determinations and unnecessary escalation to observed 
testing.

Scope and Impact

    Paruresis (psychogenic urinary retention) and other anxiety-based 
voiding disorders are medically recognized conditions within 
psychiatric and urological literature. Published prevalence estimates 
suggest that a measurable percentage of the general U.S. population 
experiences clinically significant symptoms.
    While only a subset of affected individuals are employed in safety-
sensitive transportation roles subject to Part 40 testing requirements, 
the size of the regulated workforce indicates that even a small 
percentage represents a meaningful number of potentially impacted 
employees.
    Given the significant professional consequences associated with 
refusal determinations--including potential commercial driver's license 
disqualification, Clearinghouse reporting implications, and mandatory 
return-to-duty processes--clear and standardized medical verification 
procedures would enhance consistency and transparency without 
diminishing enforcement safeguards.

Proposed Regulatory Amendments

    The petitioner respectfully proposes the following additions to 
Sec.  40.193:

Proposed Sec.  40.193(f)--Medical Verification Window

    When an employee asserts a plausible medical explanation for 
abnormal specimen validity findings, including abnormal pH values 
outside established physiological parameters, the Medical Review 
Officer (MRO) shall provide the employee a defined period not to exceed 
72 hours to submit documentation from a licensed medical provider 
supporting the asserted condition.
    The MRO shall issue a written determination addressing the 
submitted documentation prior to directing a directly observed 
recollection under Sec.  40.67.
    If documentation is not submitted within the defined period, or is 
determined insufficient to support medical plausibility, observed 
recollection shall proceed in accordance with existing requirements.

Proposed Sec.  40.193(g)--Specialist Consultation Consideration

    When the asserted medical explanation involves a diagnosed 
urological condition or functional voiding disorder, including 
psychogenic urinary retention (paruresis), the MRO shall consider 
consultation with a licensed urologist or licensed mental health 
professional familiar with such conditions prior to issuing a final 
determination.

Pre-Refusal Documentation Review

    Prior to verifying a refusal to test based on failure to provide a 
sufficient specimen under direct observation, the MRO shall document 
consideration of any previously submitted medical documentation 
indicating a functional voiding disorder that may materially impair the 
employee's ability to void under observation.

Safety and Program Integrity Justification

    The proposed amendments do not eliminate or weaken anti-
adulteration safeguards.

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    The documentation window is finite and does not create open-ended 
delay. Observed recollection remains mandatory if documentation is 
insufficient. Refusal determinations remain available when appropriate. 
Laboratory validity thresholds remain unchanged.
    These amendments strengthen procedural clarity, increase 
consistency in medical determinations, and improve confidence in the 
fairness and integrity of the testing framework while preserving 
enforcement authority.

Request for Action

    The petitioner respectfully requests that the Department initiate 
rulemaking proceedings to evaluate and adopt the proposed amendments to 
49 CFR part 40.
    The requested amendments are narrowly tailored to enhance 
procedural clarity and medical integration while preserving the core 
safety objectives of the DOT drug testing program. The requested 
amendments do not weaken anti-adulteration safeguards, eliminate 
observed testing, or create indefinite delays. Instead, they aim to 
exchange procedural clarity, consistency, and transparency while 
preserving enforcement authority and publishing safety protections.
[FR Doc. 2026-20169 Filed 9-30-26; 8:45 am]
BILLING CODE 4910-9X-P


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