On May 11, 2026, the U.S. Department of Transportation published a Final Rule (91 FR 25507) amending the oral fluid testing procedures in 49 CFR Part 40. The rule takes effect June 10, 2026. Most testing won’t change yet, because no second HHS-certified oral fluid laboratory exists, but three things change immediately: a new DER protocol when a same-sex observer isn’t available, a “gender” to “sex” terminology update throughout Part 40, and a defined 18-month grace period that starts once HHS certifies a second oral fluid lab. If you’re a DER, supervisor, or fleet compliance manager, here’s what you need to know and what you need to do this week.

What changed on May 11, 2026

The rule itself is short, but the implications are operational. First, the §40.67(g) directly observed collection procedure was rewritten. Because no HHS-certified oral fluid lab exists yet, the rule maintains the status quo: when a directly observed collection is required under §40.67(b) or (c), the collector must conduct a directly observed urine collection, using the same chain-of-custody steps in §40.67(g)(1) through (g)(4). Nothing operationally changes for the typical return-to-duty or follow-up test on June 10.

Second, the DER gets a new responsibility under §40.65(d). If a directly observed collection is required and a same-sex observer is not present at the collection site, the collector must contact you, the DER. You then have two choices: arrange for a same-sex observer to be present at the time of the collection, or send the employee to a different collection site acceptable to the employer where a same-sex observer is available. Whichever you choose, document the decision and the destination site in your records.

Third, “gender” becomes “sex” throughout §§40.67, 40.69, and 40.145. This is a terminology update under Executive Order 14168. Your training videos, on-screen graphics, supervisor checklists, DER procedures, and any signage at a collection site that references “same-gender observer” need to be updated to read “same-sex observer (male or female).” This applies to documents and audio, not just procedural references. Fourth, the trigger for oral fluid testing is now defined: under §40.67(g)(5), oral fluid testing may begin only when there are at least two HHS-certified oral fluid drug testing laboratories and a qualified oral fluid collector and conforming collection device are available at the collection site (for FAA-regulated employers, both labs must be located in the United States). Fifth, the 18-month grace period is now in the regulation: under §40.67(g)(6), once HHS publishes a Federal Register notice that it has certified a second oral fluid drug testing laboratory, an 18-month grace period begins during which directly observed urine collections continue while employers prepare for oral fluid. As of today, the trigger hasn’t fired; when it does, you’ll have a defined runway.

What carriers need to do before June 10

For DERs: update your written DER procedures to include the §40.65(d) protocol. The new procedure is simple, but it needs to be in writing in your testing program documentation. When a collector calls you saying a same-sex observer isn’t available, you need a documented response — which approved collection site you’d send the employee to (the destination should be pre-vetted), or which observer you’d arrange to be on-site. Don’t wait for the call. For supervisors: if you’ve recently completed §382.603 supervisor training, the language about “same-gender” observers in your training is now outdated; the same procedure applies, but use the current language, “same-sex observer (male or female).” For drivers: the collection process is unchanged — you’ll still provide a urine specimen for directly observed collections, and the physical procedure has not changed, only the terminology in the regulation. For training providers: if your DOT-required training videos, e-learning courses, or LMS modules use the word “gender” in describing directly observed collection, those references should be updated.

What does NOT change

It’s worth being explicit about what June 10 does not change, because there’s noise in the industry about this rule. Alcohol testing is unaffected: it remains breath and saliva via BAT/STT devices under 49 CFR Part 40 Subpart M, and the Oral Fluid Final Rule applies to drug testing only. The five-panel drug test is unchanged: marijuana, cocaine, opiates, amphetamines, and PCP all remain in the testing panel under §40.85. MRO verification standards are unchanged: the MRO process under §§40.121 through 40.171 continues as before, and no new “legitimate medical explanation” categories are created. And random testing rates for 2026 are unchanged: FMCSA’s minimum random rates remain 50% for controlled substances and 10% for alcohol, confirmed in the U.S. DOT 2026 Random Testing Rates announcement on January 8, 2026, and these rates have held for six consecutive years.

The bigger picture

The oral fluid program has been delayed since the 2023 rule that first authorized it (88 FR 27596, May 2, 2023). The bottleneck is HHS lab certification: the National Laboratory Certification Program currently lists no oral fluid drug testing laboratories, so until HHS certifies a second one, oral fluid testing is operationally unavailable nationwide. When that certification happens — and the May 2026 rule signals DOT expects it — the 18-month grace period gives carriers a defined runway to update procedures, retrain collectors, source devices, and update training materials. The DER protocol change in §40.65(d), modest as it sounds, is a meaningful preview of what oral fluid implementation will require: collector-DER decision points at the moment of collection. Building that muscle now, by making sure your DER has the §40.65(d) protocol documented, has pre-vetted backup collection sites, and is available to take a same-sex-observer call, is what carriers should be doing this week.

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