The Food and Drug Administration (FDA) has proposed a rule that would make it easier for trucking fleets to use advanced drug testing methods, such as oral fluid testing.

The proposed rule would eliminate the 510(k) clearance requirement, which the American Trucking Associations said has been the primary obstacle for labs seeking certification to perform oral fluid testing in safety-sensitive sectors such as trucking.

ATA stated that oral fluid testing was approved for regulated use in 2023, but no U.S. laboratory has obtained 510(k) clearance.  

“ATA is pleased that FDA has finally created a pathway to implement oral fluid testing,” ATA President and CEO Chris Spear said in a statement. “This major development also lays the groundwork for the eventual adoption of hair testing. Empowering employers with these tools will make drug testing more accurate, more cheat-resistant, and less invasive.  The end result will be a stronger trucking workforce and safer roads for everyone.”

Oral fluid and hair testing are considered less susceptible to substitutions or tampering than urine testing. Hair testing also provides a longer detection window.

FDA is accepting public comment on the proposed rule until June 30.