New DOT Rule Effective June 10: What Employers Must Know About Observed Collections and Oral Fluid Testing

The change is practical and overdue, but employers should review their testing procedures and standing orders before the effective date.

Why DOT Issued This Rule

In May 2023, DOT updated 49 CFR Part 40 to authorize oral fluid specimen testing as an alternative to urine collection for most DOT drug tests. The rule also added a specific provision: in certain "directly observed" collection scenarios — such as when a same-sex observer cannot be found at the collection site — the collector would be required to switch to an oral fluid test instead.

On paper, that makes sense. Oral fluid collections are by definition directly observed (the collector watches the employee provide the specimen), which neatly sidesteps the same-sex observer problem.

In practice, it created an impossible situation. As of today, there are no HHS-certified laboratories authorized to process oral fluid specimens for DOT-regulated testing. The 2023 rule required something that couldn't actually happen.

To fix that gap, DOT published a final rule on May 11, 2026 (Document 2026-09290, 91 FR 25507) amending 49 CFR Part 40, effective June 10, 2026.

What the New Rule Actually Changes

The rule amends § 40.67(g), which governs directly observed urine collections. Here's what it does in plain terms:

What "Directly Observed" Means and When It's Required

Most DOT drug tests — pre-employment, random, periodic — are not directly observed. The employee provides a specimen in a private bathroom stall. No one watches.

Directly observed collections are required only in specific circumstances enumerated in 49 CFR § 40.67. The regulation creates two separate tracks: situations where the employer must order an observed collection, and situations where the collector must initiate one on the spot.

The employer must direct an immediate, unannounced observed collection (§ 40.67(a)) when:

1. 1The laboratory reported the specimen as invalid and the MRO found no adequate medical explanation for the result.
2. 2The MRO cancelled an original positive, adulterated, or substituted result because the split specimen could not be tested (i.e., the employee's opportunity to contest the result was lost through no fault of their own, so a fresh observed test is required).
3. 3The laboratory reported the specimen as negative-dilute with a creatinine concentration between 2 and 5 mg/dL, and the MRO directed a second collection under direct observation per § 40.197(b)(1). (Note: not all dilute specimens require observed recollection — only those in this specific creatinine range.)
4. 4A directly observed collection was required but never conducted, or the service agent later identifies that one should have been done.

The employer must also direct an observed collection (§ 40.67(b)) for:

• Every return-to-duty (RTD) test — the first test after a violation is resolved through the DOT Substance Abuse Professional (SAP) process.
• Every follow-up test — the series of unannounced tests that follows a successful RTD test (at least 6 tests in the first 12 months, per § 40.307).

The collector must immediately initiate an observed collection without waiting for employer direction (§ 40.67(c)) when:

1. 1The DER has already directed it (carrying out paragraph (a) above).
2. 2The collector observes materials brought to the site or conduct that clearly indicates an attempt to tamper with the specimen (see §§ 40.61(f)(5)(i) and 40.63(e)).
3. 3The temperature on the original specimen was out of range (§ 40.65(b)(5)) — a temperature below 90°F or above 100°F at the time of collection raises tampering concerns.
4. 4The original specimen appeared to have been tampered with (§ 40.65(c)(1)).
5. 5The test reason is return-to-duty or follow-up (mirroring paragraph (b)).

What Employers Should Do Before June 10

1. 1
   Review your DER standing orders.

   Your Designated Employer Representative may need to issue updated guidance to your collection sites covering what to do when a directly observed collection is required and (a) oral fluid isn't yet available, or (b) once it becomes available. The new rule adds a provision in § 40.65(d) requiring collectors to check for a standing order before contacting the DER in these situations.

2. 2
   Check the DOT oral fluid lab list periodically.

   DOT will maintain a list of HHS-certified oral fluid laboratories at transportation.gov/odapc/HHS_Certified_Oral_Fluid_Laboratories. When two labs appear on that list, the clock starts toward the 18-month transition period.

3. 3
   Watch for the ODAPC Federal Register notice.

   DOT has committed to publishing a notice specifying the date the second oral fluid lab is certified and the corresponding start and end dates of the 18-month grace period. Subscribe to ODAPC updates or check the Federal Register if you want advance notice before the transition kicks in.

4. 4
   Confirm your testing consortium is current.

   Third-party consortium/program administrators (T/CPAs) like APCA track regulatory updates and ensure your program remains compliant as these changes take effect. If you're unsure whether your program reflects the June 10, 2026 changes, contact your administrator.

Bottom Line

The June 10 rule doesn't require any immediate operational changes for most employers — it corrects a regulatory impossibility and maintains the status quo for directly observed collections while the oral fluid testing infrastructure catches up. The bigger transition will come when HHS certifies two oral fluid laboratories. At that point, employers in specific directly observed scenarios will need to be ready to use oral fluid testing (or take advantage of the 18-month grace period). The time to understand the new rule structure is now, before the effective date, so your DER and collection sites aren't caught off guard.

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