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DOT Update 2025: Direct Observation Urine Testing Proposed 

The U.S. Department of Transportation (DOT) has released a Supplemental Notice of Proposed Rulemaking (SNPRM) that would require directly observed urine collections in situations where oral fluid testing is mandated under Part 40 but not available.

This proposal, published on October 1, 2025, clarifies procedures as the DOT transitions toward full oral-fluid adoption. It acts as an interim safeguard until HHS-certified oral fluid labs become operational.

Why This Proposal Matters

The DOT’s move builds on its May 2023 Final Rule, which authorized oral-fluid testing under 49 CFR Part 40. (Federal Register, 2023 Final Rule)
However, since no labs have yet been certified by HHS, employers have been unable to implement oral-fluid testing in practice.

The October 2025 proposal closes that compliance gap by mandating directly observed urine testing when oral fluid is required but unavailable, ensuring no lapse in testing integrity.

For employers managing safety-sensitive roles, this update is especially significant. Employees in these positions must remain test-ready under any collection method. Our post on Understanding Safety-Sensitive Positions: A Guide for Employers breaks down who qualifies and why these rules matter.

What the SNPRM Proposes

1. Mandatory Direct Observation in Specific Cases

  • Under § 40.67(g)(3), if oral fluid testing is required but not possible, employers must collect a directly observed urine sample.
  • This rule prevents gaps in enforcement while oral-fluid infrastructure ramps up.

2. Automatic Sunset Clause

  • The temporary provision would expire one year after the second HHS-certified oral fluid lab is approved
  • At that point, oral fluid testing becomes fully operational again.

3. Terminology & Role Clarifications

  • Updated § 40.67(g)(3) language clarifies that the Designated Employer Representative (DER) may instruct the collector to switch from oral to observed urine.
  • Aligns with terminology changes under Executive Order 14168 regarding sex/gender references.

Employers can review and comment on the proposal at Regulations.gov through November 15, 2025.

What Employers Should Do Now

  • Maintain readiness for both test types - Until oral fluid labs are approved, ensure urine testing sites are equipped for direct observation collections.
  • Update policies and DER guidance - Include fallback language specifying when direct-observation urine replaces oral-fluid testing.
  • Re-train collection staff - Collectors should understand § 40.67(g)(3) and the observation process for same-gender observers.
  • Plan for eventual transition - Once HHS certifies two labs, the fallback rule sunsets automatically.

Direct-observation scenarios often overlap with refusal or tampering risks. Employers can revisit What Happens When an Employee Refuses a Drug Test? to ensure they’re following DOT documentation and reporting procedures correctly.

QuickScreen’s Support for Hybrid Testing

Area 

QuickScreen Support 

Policy Updates 

Guidance for drafting fallback language covering both urine and oral-fluid collections 

Collector Training 

Updated modules for § 40.67 direct observation and hybrid protocols 

Testing Operations 

Nationwide clinic network supporting urine + oral-fluid readiness 

Compliance Tracking 

Real-time alerts on HHS lab certifications and DOT rule finalizations 

Next Steps for Employers

This proposal signals DOT’s intent to keep testing programs airtight during the oral-fluid rollout.
QuickScreen helps fleets and safety-sensitive employers stay compliant through every phase, from policy updates to collection logistics.

Need help reviewing your current policy? Contact QuickScreen for compliance support before these rules take effect.