DOT Proposes Adding Fentanyl to Drug Testing Panel

In a significant move to address the escalating opioid crisis, the U.S. Department of Transportation (DOT) has issued a Notice of Proposed Rulemaking (NPRM) to amend its drug-testing regulations under 49 CFR Part 40. Published in the Federal Register on September 2, 2025, the proposal aims to add fentanyl—a potent synthetic opioid—and its metabolite norfentanyl to the DOT's drug testing panels for both urine and oral fluid specimens. This change comes amid rising overdose deaths linked to fentanyl, which now claims over 150 American lives daily.

For the trucking industry, where safety-sensitive roles like commercial driving are subject to stringent DOT testing, this proposal could reshape compliance protocols and drug testing policies, and increase operational costs. For their part, CDL drivers will face a new layer of testing that could detect illicit use more effectively but also raise concerns about false positives or unintended consequences from legitimate medications. Comments on this proposal are due October 17, 2025 in docket no. DOT-OST-2025-0049-0001.

Backdrop

Fentanyl has surged as a public health emergency, often laced into counterfeit pills, heroin, or other street drugs due to its extreme potency—up to 50 times stronger than heroin and 100 times stronger than morphine. The Centers for Disease Control and Prevention (CDC) reports that synthetic opioids like fentanyl were involved in 70% of U.S. overdose deaths in 2023, with rates climbing 279% from 2016 to 2021.

In transportation, where fatigue and impairment pose deadly risks, undetected fentanyl use could contribute to accidents on highways carrying millions of tons of freight annually. The Omnibus Transportation Employee Testing Act of 1991 mandates that DOT align its testing with HHS Mandatory Guidelines, which updated their panels on January 16, 2025, to include fentanyl (for urine and oral fluid) and norfentanyl (urine only). DOT's proposal follows suit, citing fentanyl's prevalence in non-regulated workplace testing (0.19% positivity rate) and its role in overdose fatalities.

Key Changes in the Proposal

The NPRM outlines several proposed amendments to Part 40, focusing on drug panels, verification processes, and technical updates. Here are the highlights:

1. Addition of Fentanyl and Norfentanyl to Testing Panels:

   • If DOT moves forward with the proposal, fentanyl will join the existing five-panel test (marijuana, cocaine, opiates, amphetamines, PCP) for both urine (initial/confirmatory cutoffs: 1 ng/mL) and oral fluid (4 ng/mL initial, 1 ng/mL confirmatory).

   • Norfentanyl, a key metabolite indicating fentanyl use, will be added to urine testing (1 ng/mL cutoff).

   • Laboratories must report results using standardized HHS abbreviations, ensuring consistency across DOT agencies like FMCSA.

   
   

   FMCSA-regulated carriers will see this ripple into pre-employment, random, post-accident, reasonable suspicion, return-to-duty, and follow-up tests. With approximately 6.9 million DOT tests annually (many in trucking), adding fentanyl could yield about 13,000 screen positives and 11,000 confirmations yearly, based on HHS data. Companies may face a spike in non-negative results, delaying driver onboarding and increasing SAP referrals. Drivers prescribed pharmaceutical fentanyl for severe pain (e.g., post-surgery) must provide valid prescriptions during MRO verification, but illicit use—common in laced street drugs—will trigger positives without exception.

   
   

2. Adjustments to Opiate Verification and Morphine Cutoffs:

   • The urine confirmatory cutoff for morphine will rise from 2,000 ng/mL to 4,000 ng/mL, reducing false positives stemming from non-ilicit use such as poppy seed consumption.

   • Medical Review Officers (MROs) will no longer need to seek "clinical evidence of illegal opioid use" (e.g., physical exams for needle tracks) for codeine/morphine positives below 15,000 ng/mL in urine or 150 ng/mL in oral fluid. Instead, they'll verify based on legitimate medical explanations.

   • Poppy seed ingestion claims will automatically verify as negative for oral fluid results between 15-150 ng/mL.

     
     

   This change would streamline MRO reviews, potentially saving time and costs for carriers dealing with opiate positives—common in trucking due to pain from long hauls or injuries. In 2023, about 1,782 DOT tests (0.03% of total) fell in the 2,000-15,000 ng/mL morphine range, many requiring costly clinical exams ($200 each). The change could save $356,000 industry-wide annually by eliminating these, per DOT estimates. For drivers, it reduces invasive exams but shifts burden to providing prescription proof, benefiting those with legitimate opioid meds while cracking down on misuse.

   
   

3. Introduction of Biomarker Testing:

   • Laboratories would start testing for "biomarkers"—endogenous substances (e.g., to confirm human origin of urine/oral fluid)—once HHS approves them. This enhances specimen validity testing to detect substitutions or adulteration.

   • Definitions for "substituted specimen" and "biomarker" would be updated, allowing MROs to accept medical evidence for absent/inconsistent biomarkers.

   
   

   Cheating attempts (e.g., synthetic urine) are a persistent issue in trucking, where roadside tests and randoms are routine. Biomarker testing could deter tampering, improving test integrity without immediate mandates—DOT would wait for lab adoption. Carriers would benefit from more reliable results, but drivers with rare medical conditions affecting biomarkers (e.g., kidney issues) may need extra documentation during verification, potentially complicating returns to duty.

   
   

4. Marijuana Nomenclature and Other Technical Tweaks:

   • Regulatory references to marijuana analytes would be updated to Δ9THC (oral fluid) and Δ9THCC (urine metabolite) for scientific accuracy—no cutoff changes.

   • Footnotes clarify alternate technology tests; training timelines for collectors/STTs/BATs tighten to 30 days for proficiency.

   • Minor fixes: Optional fax numbers on forms, clarified refusal reporting, and error correction exemptions for non-collector faults.

Economic and Operational Impacts on Trucking

DOT estimates annual costs at $18.1 million for the industry, primarily from lab screening ($2.61 per test across 6.9 million) and confirmations ($16.50 for ~11,000 positives), plus MRO reviews ($13 each). Trucking, handling ~70% of freight, bears a lion's share—potentially $12-13 million yearly. Savings from morphine cutoff changes (~$356,000) offer minor relief.

In anticipation of the rule change, motor carriers should consider the following:

• Compliance Burden: Carriers will likely need to update their regulated drug/alcohol testing policy, processes, and forms to account for the addition of fentanyl to the list of tested substances.

• Costs: Bundled lab fees may rise 5-10%; C/TPAs must integrate fentanyl into consortia programs.

• Prescriptions: Legitimate fentanyl scripts (rare, for cancer/severe pain) are verifiable, but drivers must disclose during interviews with the MRO.

  
  

Conclusion

In short, this proposal reinforces DOT's commitment to safety in an era of synthetic drugs, but it will create some additional compliance burdens on drivers and carriers. By aligning with HHS, it modernizes testing while addressing fentanyl's lethality. The comment period closes on October 17, 2025 and a final rule could follow (likely sometime in 2026).

About Trucksafe Consulting, LLC: Trucksafe Consulting is a full-service DOT regulatory compliance consulting and training service. We help carriers develop, implement, and improve their safety programs, through personalized services, industry-leading training, and a library of educational content. Trucksafe also hosts a livestream podcast on its various social media channels called Trucksafe LIVE! to discuss hot-button issues impacting highway transportation. Trucksafe is owned and operated by Brandon Wiseman and Jerad Childress, transportation attorneys who've assisted some of the nation’s leading fleets to develop and maintain cutting-edge safety programs. You can learn more about Trucksafe online at www.trucksafe.com and by following Trucksafe on LinkedIn, Facebook, Twitter, and YouTube. Or subscribe to Trucksafe's newsletter for the latest highway transportation news & analysis.