The U.S. Food and Drug Administration on Monday proposed a rule that would remove a regulatory hurdle for advanced drug testing in safety-sensitive industries, potentially ending years of bureaucratic delays.
The agency seeks to eliminate the 510(k) clearance requirement, which has bogged down approved workplace drug testing standards. For example, while oral fluid testing was approved for regulated use three years ago, the American Trucking Associations (ATA) argues the 510(k) process acted as a bottleneck that prevented laboratories from obtaining the necessary certification to perform the tests.
Congress in 2015 first directed HHS to recognize hair testing as a valid alternative to urine testing for commercial motor vehicle drivers, yet HHS has still not issued the necessary guidance despite Congress reaffirming that directive earlier this year.
Beyond oral fluid, the proposal aims to modernize federal drug testing by creating a path for hair testing and increasing the government's ability to respond to emerging threats such as fentanyl and synthetic cannabinoids.
[Related: Feds reclassify marijuana, still banned for truckers]
“Trucking relies on a strong federal drug testing program to protect public safety and ensure that impaired individuals are not operating commercial motor vehicles,” ATA President and CEO Chris Spear said in a statement.
Spear noted that the shift toward oral fluid and hair testing would provide employers with tools that are more accurate and “cheat-resistant” than traditional methods. The ATA has long argued that the industry's reliance on urine testing is flawed. According to the association's analysis of Quest Diagnostics data, the number of substituted urine specimens jumped more than 370% between 2022 and 2023 among federally regulated employees.
Because oral fluid and hair samples are collected under direct observation, they are significantly harder to tamper with or swap. Hair testing also provides a longer window of detection, offering a more comprehensive look at an applicant's substance use history.
The regulatory shift follows a recent push from Capitol Hill. At the ATA’s request, six members of Congress—Reps. Andy Harris, R-Md.; Ben Cline, R-Va.; Pete Sessions, R-Texas; Mike Bost, R-Ill.; Mike Collins, R-Ga.; and Claudia Tenney, R-N.Y.—sent a letter to Health and Human Services Secretary Robert F. Kennedy Jr. urging reform of the nation's drug testing programs.
The FDA’s proposed rule is now entering a 60-day public comment window before it can be finalized.
