On May 11, 2026, DOT published a final rule amending 49 CFR Part 40, effective June 10, 2026. It is a narrow rule, but it touches some of the most sensitive moments in a collection, so collectors and Designated Employer Representatives (DERs) should understand it well.
The problem it solves
When DOT authorized oral fluid testing in 2023, it added a requirement: if a directly observed urine collection was needed and a same sex observer could not be provided, the collection would switch to oral fluid. Every oral fluid collection is directly observed by definition, so it was a sensible fix. The problem is that oral fluid testing is not yet available, because no laboratory has been HHS certified for it. The 2023 rule required something nobody could do.
What changed
Until oral fluid testing is available: if a same sex observer is not at the collection site, the collector contacts the DER. The DER either arranges for a same sex observer or sends the employee to another collection site acceptable to the employer for a directly observed urine collection.
Once oral fluid testing is available: if a same sex observer cannot be found, the collector follows the employer's standing order. If there is no standing order, the collector contacts the DER, who directs either an oral fluid test at that site or sends the employee to a site that can perform one.
A new standing order check: when a specimen temperature is out of range or a specimen appears to have been tampered with, and a new directly observed urine collection or an oral fluid collection is needed, the collector must first check whether the employer has a standing order on which collection to perform. If there isn't one, the collector calls the DER.
Terminology: the rule replaces "gender" with "sex" in the relevant observation provisions.
A reminder: the observer does not need to be a qualified collector, but must be the same sex as the employee. An opposite sex observer is never permitted.
What to do now
• DERs: put a written standing order in place with your collection sites that covers both scenarios.
• Collectors: update your procedures so you check for a standing order before calling the DER.
• Collection sites: confirm you can reliably provide same sex observers, or know where to send employees when you can't.
How Stratellis Training can help
Our DER Training walks employers through these decisions and responsibilities, and our DOT Urine Specimen Collector Training covers observed collection procedures under Part 40. Contact sales@stratellistraining.com for team pricing.