DOT Oral Fluid Testing: Regulatory Updates and Next Steps

The U.S. Department of Transportation published a final rule on November 5, 2024, revising several aspects of the recently issued oral fluid testing regulations. These changes may enable sooner implementation of DOT oral fluid drug testing.

What has changed?

Introduction of Temporary Qualification Requirements

Before the final rule, DOT regulations specified that only a “qualified collector” with experience and/or training in oral fluid collection was authorized to oversee mock oral fluid collections. This was an issue, as there were no existing qualified collectors that could qualify other collectors. To amend this, the DOT added two temporary exceptions to the “qualified collector” rule:

• An individual can be considered “qualified” by completing an oral fluid “train the trainer” course.
• An individual can be considered “qualified” if they have a thorough understanding of Part 40, they are well versed in the course content they are teaching, and they maintain records to demonstrate that the training was conducted.

These exceptions will sunset one year after the HHS publishes a Federal Register notice that it has certified a primary laboratory. An up-to-date list of HHS-certified laboratories is available here.

Clarification of Testing Procedures

Additional edits and clarifications in the final rule include:

1. No persons other than the collector, the donor, and any DOT agency representatives may witness the testing process.
2. Collectors must check a box on the Federal CCF to document that the donor provided sufficient oral fluid specimen.

What’s next?

With these new guidelines published, the final requirements for conducting DOT oral fluid testing are an HHS-certified primary laboratory, split-specimen laboratory, and collection device. Until these are available, DOT oral fluid tests cannot be performed; however, in the meantime, individuals can complete oral fluid collection device training and oral fluid mock collections.