DOT Final Rule Ties Up Loose Ends in Saliva Drug Testing

Corrections have been made to address multiple issues with the Department of Transportation's (DOT’s) May 2023 saliva drug testing rule. A final rule published on November 11, 2024, and effective December 5, 2024, corrected deficiencies in the original rulemaking by:

• Providing temporary qualification requirements for mock oral-fluid monitors,
• Identifying which individuals may be present during an oral-fluid collection, and
• Clarifying how collectors should document sufficient volumes of oral fluid.

Earlier this year, DOT published these same changes as a Direct Final Rule, but it was rescinded before its effective date due to adverse comments. As a result, DOT went through the rulemaking process — a published proposal, comment period, and final rule.

A training impossibility corrected

The original saliva drug testing rule attempted to mirror the existing urine collector qualifications. Collectors were subject to basic information, qualification training, initial proficiency demonstration, refresher training, and error correction training.

However, the proficiency demonstration with mock collections was supposed to be monitored by a qualified collector who performed saliva drug test collections for at least a year. This requirement created an impossibility.

Section 40.35 was amended to authorize individuals to monitor mock oral-fluid collections without meeting the requirement of being a qualified oral-fluid collector. To ensure the proficiency of the collection monitor, DOT expects those individuals to have a thorough understanding of Part 40 and to be well versed in the course content they are teaching. This exception remains in place for one year after Health and Human Services (HHS) first certifies a lab, or until otherwise specified.

Collection procedures fine-tuned

Two changes were made to 40.73 collection procedures. Both offered additional clarification to collectors.

One change corrected of an inadvertent omission in the original rulemaking to parallel saliva drug testing with alcohol testing procedures for privacy. The new rule provides explicit instructions to collectors that they must not allow any person other than themselves, the employee, or a DOT agency representative to witness the testing process.

The other revision details instructions to collectors on how to document sufficient specimen volumes. They are told to check the ‘‘Volume Indicator(s) Observed’’ box in Step 2 of the federal chain of custody form after the employee provides a sufficient specimen to indicate that they observed the volume indicator(s) during the collection.

One step closer to implementation

This final rule opens the door to collector training as of December 5, 2024, since the Food and Drug Administration (FDA) has approved one saliva drug testing device.

In addition, labs can begin the HHS certification process to analyze saliva specimens collected using the approved device. The certification process takes several months.

DOT employers who want to use saliva drug testing can use this interim to:

• Confirm that their collection site will offer the testing method and have trained collectors,
• Contract with an HHS certified lab as they become available,
• Update policies, and
• Train employees subject to and those managing DOT testing.