PROPOSED Rulemaking: DOT Considering Addition of Fentanyl to Drug-Testing Panel

The U.S. Department of Transportation (DOT) has issued a Notice of Proposed Rulemaking (NPRM) that would align DOT regulations with the Department of Health and Human Services (HHS) drug testing guidelines. Among the proposed updates is the addition of fentanyl (and its metabolite, norfentanyl) to the DOT drug-testing panel.

Other proposed revisions include changes to cutoff levels, technical clarifications, and updated definitions to remain consistent with HHS.

The comment period for the NPRM closes on October 17, 2025. Comments to the docket can be submitted using this link: Comment to NPRM

⚠️PLEASE NOTE: These are proposed changes only. Employers are not currently authorized to test for fentanyl or implement other revisions to Part 40 until a final rule is published.

Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Fentanyl to the Department of Transportation’s Drug-Testing Panel; Harmonization with Certain Items in the HHS Mandatory Guidelines for Urine and Oral Fluid; and Technical Amendments

An NPRM is available for public inspection regarding harmonization with HHS and the addition of Fentanyl to the DOT Drug-Testing Panel. Notice of proposed rulemaking (NPRM).

Summary of Proposed Changes to the DOT Drug-Testing Program Regulation

In keeping with the Department’s statutory obligation under OTETA of 1991 to incorporate the HHS Mandatory Guidelines specifically for the minimum list of drugs for which DOT requires testing, and for the scientific and technical guidelines related to laboratory testing procedures, the Department proposes to amend part 40 to (1) add the drugs fentanyl and norfentanyl and their respective cutoffs for initial and confirmatory testing (as listed in the HHS urine and oral fluid drug testing panels published in the Federal Register on January 16, 2025, (90 FR 4662)) to the DOT drug testing panels (fentanyl would be added to both the urine and oral fluid testing panels, and norfentanyl to the urine testing panel); (2) adjust the laboratory confirmatory test cutoff for morphine in urine drug testing; (3) remove the MRO requirement to determine clinical evidence of illegal opioid use to support a positive codeine or morphine result in urine and oral fluid drug testing; (4) add and define the term “biomarker” and revise the definitions of “adulterated specimen,” “cutoff,” “initial specimen validity test,” “negative result,” “positive result,” and “substituted specimen” for clarity and consistency with HHS; (5) authorize laboratories to conduct biomarker testing once HHS approves laboratory biomarker testing; (6) amend the analyte nomenclature for marijuana in both drug testing panels; and (7) revise the footnotes in both drug testing panels to include more specific and updated criteria for alternate technology initial drug tests. The Department will also provide clarification for certain existing drug testing program provisions and make certain technical amendments

Published in today’s Federal Register (FR) is a Department of Transportation Notice of Proposed Rulemaking (NPRM). The NPRM is available on the FR web page at https://www.govinfo.gov/content/pkg/FR-2025-09-02/pdf/2025-16720.pdf. Today, we will post it on the Office of Drug and Alcohol Policy and Compliance (ODAPC) webpage at https://www.transportation.gov/odapc/frpubs.

The proposals in the NPRM include:

Add Fentanyl and norfentanyl to the testing panels,
Adjust laboratory morphine confirmatory cutoff (urine only),
Remove the additional requirement for MROs to determine clinical evidence of illegal opioid (codeine and morphine use for urine and oral fluid),
Add and modify certain definitions,
Authorize biomarker testing,
Modify analyte nomenclature for marijuana (urine and oral fluid),
Revise footnote #1 to both testing panels to include more specific and updated criteria for alternate technology initial drug tests,
Add a 30-day requirement for drug collectors, STTs, and BATS within which to complete the required training and mock collections,
Adding a new ‘fatal flaw’ related to oral fluid specimens,
Modify several provisions related to oral fluid specimens,
Add clarifying language to other provisions (such as oral fluid collector training, SAP documents, and shy bladder/dry mouth procedures),
Various technical amendments.

DATES:

Comments to this notice of proposed rulemaking should be submitted by October 17, 2025. Late-filed comments will be considered to the extent possible.

Proposal To Add Fentanyl and Norfentanyl to DOT Drug Testing Panels

There are two types of fentanyl: pharmaceutical fentanyl and illicitly manufactured fentanyl. Both are considered synthetic opioids. Pharmaceutical fentanyl is prescribed by doctors to treat severe pain, especially after surgery and for advanced-stage cancer. Most cases of fentanyl-related overdose are linked to illicitly manufactured fentanyl,^[12] which is distributed through illegal drug markets for its heroin-like effect. It is often added to other illicit drugs because of its extreme potency, which makes those drugs cheaper, more powerful, more addictive, and more dangerous. Fentanyl is up to 50 times stronger than heroin and 100 times stronger than morphine. It is a major contributor to fatal and nonfatal overdoses in the U.S.^[13] Even in small doses, it can be deadly. Over 150 people die in the U.S. every day from overdoses related to synthetic opioids, primarily fentanyl.^[14]

The following is a representative sampling of information provided by various organizations that have reported on fentanyl use trends over the past few years:

Drug overdose death rates involving fentanyl increased by 279 percent from 5.7 per 100,000 in 2016 to 21.6 in 2021, according to new data from the CDC’s National Center for Health Statistics (NCHS).^[15]
In 2022, the CDC’s NCHS reported and predicted that the number of drug overdose deaths involving synthetic opioids (including fentanyl but excluding methadone) and psychostimulants with abuse potential (such as methamphetamine) continue to increase compared to the previous year.^[16]
According to the State Health Access Data Assistance Center (SHADAC), “Not only has fentanyl become the dominant substance driving today’s crisis of drug overdose deaths, but it also has become the center of gravity around which other drugs orbit.” ^[17]
According to the DEA, “While recent data shows progress in reducing overdose deaths from record highs, nearly half of teens still don’t know that counterfeit prescription pills often contain lethal amounts of fentanyl. This lack of knowledge is leading to tragic consequences—young people are dying simply because they didn’t know the pill they took was fake. That’s why we need to turn awareness into action.” ^[18]
“While provisional data from the CDC indicates a 25.5% decrease in overdose deaths in the 12 months ending October 2024 compared with the same period in 2023, approximately 150 Americans die every day from overdose involving illegal, synthetic opioids such as illegally made fentanyl. Overdose remains the leading cause of death among Americans aged 18-44. The Administration and HHS remain committed to preventing substance use initiation, reducing the number of lives lost to overdose, and helping Americans to overcome substance use disorders, achieve recovery, and live healthy lives.” ^[19]
“Approximately 70% of U.S. overdose deaths in 2023 were estimated to involve illegally manufactured fentanyls (IMFs). Local reports indicate reemergence of carfentanil, a fentanyl analog.” ^[20]

In light of this compelling information regarding fentanyl use (and the national attention on this issue), and consistent with the action taken by HHS, the Department proposes to amend the DOT drug testing panels to meet our statutory obligation under OTETA of 1991, and to raise the level of safety for the transportation industry and the transported public. Specifically, the Department proposes to amend the drug-testing panels in sections 40.85(a) and 40.91(a) to include fentanyl in the urine and oral fluid testing panel and norfentanyl to the urine testing panel (along with their corresponding test cutoff concentrations), amend the MRO verification process to include these drugs, and amend Appendices D and E of part 40 to add fentanyl and norfentanyl to the drugs listed on the laboratory reports to employers and DOT.

Recognizing that the term “opioid” is used in a broad context to include various natural, synthetic, and semi-synthetic opioids, the Department proposes to modify its definition of “opioid” in section 40.137 to remove the specific semi-synthetic compounds ( i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone) and use the term “opioids” when referring to the opiates, synthetic opioids, and semi-synthetic opioid test results that an MRO may review and verify.

How WorkforceQA Can Help

At WorkforceQA, we are closely tracking this regulation and will keep our clients informed of developments every step of the way.

We provide:

DOT Compliance Expertise – Guidance on Part 40 requirements and how proposed changes could impact your program.
Policy & Program Support – Assistance updating drug and alcohol testing policies when rules are finalized.
Training & Education – Supervisor and DER training tailored to DOT requirements and emerging drug trends.
Drug & Alcohol Testing Services – Nationwide collection sites, laboratory partnerships, and MRO services to ensure compliant testing.
Regulatory Monitoring – Continuous updates on DOT, FMCSA, and HHS rulemakings so you can stay ahead.

If you have any questions about the NPRM or how it may impact your program, please reach out to WorkforceQA — we’re here to support your compliance and employee safety efforts. For more information on WFQA’s DOT-compliant services:

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