On September 2, 2025, the U.S. Department of Transportation (DOT) issued a Notice of Proposed Rulemaking (NPRM) to amend 49 CFR Part 40, the Procedures for Transportation Workplace Drug and Alcohol Testing Programs. This proposal aims to enhance safety by adding fentanyl, a potent synthetic opioid, to the DOT's drug testing panels for urine and oral fluid. It also includes other harmonizations with the U.S. Department of Health and Human Services (HHS) Mandatory Guidelines. Here's what transportation employers, employees, and compliance professionals need to know.
Background on the Proposal
The DOT's drug testing program, established in 1988 and updated periodically, requires testing for safety-sensitive employees in aviation, trucking, rail, transit, pipelines, and maritime industries. It currently tests for marijuana, cocaine, amphetamines, phencyclidine (PCP), and opioids like codeine, morphine, heroin, hydrocodone, hydromorphone, oxycodone, and oxymorphone.
This NPRM stems from the Omnibus Transportation Employee Testing Act (OTETA) of 1991, which mandates DOT to follow HHS guidelines for drug panels and lab standards. HHS added fentanyl and norfentanyl (its metabolite) to its panels on January 16, 2025, after reviewing overdose data, lab capabilities, and public input. Fentanyl, 50 to 100 times stronger than morphine, drives over 70 percent of U.S. opioid overdoses, with 150 daily deaths reported. Illicit fentanyl is often mixed with other drugs, posing risks to transportation safety.
DOT's proposal aligns with HHS to address this crisis, citing fentanyl's prevalence in overdose deaths (e.g., 279 percent increase from 2016 to 2021) and its detection in non-regulated tests.
Key Proposed Changes
Addition of Fentanyl and Norfentanyl:
- Urine Panel: Add fentanyl (initial cutoff: 1 ng/mL; confirmatory: 0.5 ng/mL) and norfentanyl (initial: 1 ng/mL; confirmatory: 0.5 ng/mL).
- Oral Fluid Panel: Add fentanyl (initial: 1 ng/mL; confirmatory: 0.5 ng/mL).
- Medical Review Officers (MROs) must verify positive results, similar to other opioids. Employers will see fentanyl/norfentanyl on lab reports (Appendices D and E).
Morphine Cutoff Adjustment (Urine Only):
- Raise the confirmatory cutoff from 2,000 ng/mL to 4,000 ng/mL to reduce false positives from poppy seed ingestion.
- Remove the 15,000 ng/mL decision point and MRO requirement to check for clinical evidence of illegal opioid use for codeine/morphine positives below that level.
Biomarker Testing:
- Authorize labs to test for biomarkers (indicators of specimen validity) once HHS approves them. No biomarkers are approved yet, but this allows future detection of substituted or adulterated samples.
Marijuana Analyte Nomenclature:
- Update abbreviations: Urine changes THCA to D9THCC; oral fluid changes THC to D9THC. Footnotes add criteria for alternate initial tests.
Other Harmonizations:
- Revise definitions (e.g., "adulterated specimen," "cutoff," "biomarker") for consistency with HHS.
- No removal of MDMA/MDA, despite low positivity rates. HHS retained them after review.
Important Aspects of DOT Oral Fluid Testing
Oral fluid testing, authorized since May 2023, offers key advantages for DOT programs. It provides direct observation during collection, reducing the risk of cheating, and detects recent drug use more effectively than urine tests. It is also important to be aware that the training requirement is that collectors must complete specialized proficiency training and mock collections before performing oral fluid tests, ensuring accuracy and compliance. This training emphasizes device handling, contamination prevention, and procedural integrity to maintain program reliability.
Implications for Employers and Employees
- Safety Benefits: Adding fentanyl deters use among safety-sensitive workers, reducing impairment risks in high-stakes roles.
- Testing Process: No immediate changes until finalized. Oral fluid testing remains an option for direct observation, helping to combat cheating.
- Compliance Costs: Labs (84 percent already test for fentanyl in non-regulated programs) can handle this with existing tech. DOT estimates minimal added costs per test.
- Employee Impact: Positives trigger removal from safety duties, MRO verification, and Substance Abuse Professional (SAP) evaluation for return-to-duty.
- Public Comments Received by HHS: 118 commenters (e.g., MROs, SAPs, employers) supported adding fentanyl, citing overdose trends.
Timeline and Next Steps
- Comment Period: Submit comments by October 17, 2025, via regulations.gov (Docket DOT-OST-2025-0049), mail, or hand delivery.
- Effective Date: If finalized, changes apply after publication; DOT will issue guidance.
- Preparation Tips: Review policies, train staff on updates, and consult C/TPAs. Monitor DOT's Office of Drug and Alcohol Policy and Compliance (ODAPC) for alerts.
This proposal underscores DOT's commitment to combating the opioid crisis while maintaining reliable testing. For full details, see the Federal Register notice (90 FR 42363). Stay compliant. Safety starts with awareness.
