The Department of Transportation will require “directly observed” urine drug-testing in federal workplace situations where saliva testing has been called for, but is not possible. The clarification to DOT drug and alcohol testing procedures is the latest development in the trucking industry’s years-long push for oral fluid testing as an alternative to urine testing. The new rule was published in the Federal Register on May 11, and will take effect June 10.
Truck drivers, who are subject to an inordinate number of federal regulations, don’t choose their method of drug-testing—their DOT-regulated employers do. The campaign for implementation of oral fluid testing has been led by the American Trucking Association (ATA), which argues that it’s necessary to “keep impaired drivers off the road and uphold the trucking industry’s commitment to safety.”
The Substance Abuse and Mental Health Services Administration approved lab-based oral fluid testing in 2019, and DOT finalized its own regulations authorizing employers to choose this as an alternative to urine testing in 2023. But actual implementation requires at least two laboratories that are Food and Drug Administration-approved to process the tests—one for the initial analysis and another to confirm the results. Currently there are zero.
Oral fluid testing appeals to many employers for a few reasons, one being the efficacy in detecting recent drug use—within the past couple of hours—compared to urine drug testing. Though the trucking industry has become the public face of the campaign, the regulations also affect federal workers in the commercial aviation, rail, public transit and pipeline sectors.
One of the primary concerns expressed by the trucking industry has been that urine drug screens are not witnessed, and therefore easier to circumvent oral fluid testing. Another concern revolves around paruresis, more commonly known as “shy bladder” syndrome—if a driver is unable to produce urine when required to, they’re held for a three-hour waiting period, which obviously impacts their arrival time at their destination. And if they still can’t produce urine during that period, it’s considered a refusal to take the test and they’re removed from their duties. To return, they must “pass” a urine test that is witnessed by a same-gender observer.
The new DOT rule also updates its prevailing terminology by replacing the word “gender” with the word “sex” in accordance with President Donald Trump’s January 2025 executive order, “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.”
However HHS ultimately handles oral fluid testing will set the stage for what happens with hair follicle testing.
“Every month that passes without certified oral fluid testing is another month when federal workers with paruresis face anxiety, discrimination, and career barriers,” Dr. Steven Soifer, co-founder of the International Paruresis Association, stated in March. “We’ve been working on this issue since our founding [30 years ago]. Our members ask the same question every day: When will the federal government complete the work it already approved?”
In April, at the request of the ATA, six members of Congress wrote to Department of Health and Human Services Secretary Robert F. Kennedy Jr. citing FDA regulatory barriers as the reason no United States labs are certified to process oral fluid tests.
They cited an analysis by Quest Diagnostics that showed “substituted” urine specimens increased 370 percent from 2022 to 2023. Quest has a proprietary lab-based oral fluid collection method, Quantisal™, and as such has been an avid supporter of the campaign.
On May 1, the FDA published a notice of its intent to consider revising the requirements that pertain to toxicology testing. That same day SAMHSA published a list of currently certified labs, which presumably will be updated in the future but for the moment simply confirms that there aren’t any.
However HHS ultimately handles oral fluid testing will set the stage for what happens with hair follicle testing. The department was directed to create guidelines for hair testing in 2015, but has not yet done so.
