DOT Revises Drug and Alcohol Testing Procedures Regarding Oral Fluid Testing

On Nov. 5, 2024, the U.S. Department of Transportation (DOT) published a final rule revising its drug and alcohol testing procedures to provide temporary qualification requirements for mock oral fluid monitors. The revisions provide consistency in oral fluid testing requirement8/*s by identifying which individuals may be present during an oral fluid collection and clarifying how collectors are to document that sufficient volumes of oral fluid were collected.

These revisions apply to mock oral fluid monitors and collectors and were made in response to the fact that the U.S. Department of Health and Human Services (HHS) has not yet certified any laboratories for oral fluid testing.

This final rule goes into effect on Dec. 5, 2024.

Background on Oral Fluid Drug Testing

In May 2023, the DOT published a final rule authorizing oral fluid drug testing as an additional methodology for employers to use to achieve the safety goals of the drug and alcohol testing program.

All of the qualification training requirement categories (i.e., basic information, qualification training, initial proficiency demonstration, refresher training, error correction training and documentation) in the May 2023 final rule were identical to existing urine collector qualifications. Regarding the mock collections, the DOT required oral fluid collectors to demonstrate proficiency in collections by completing five consecutive error-free mock collections for each device they would use. The mock collections had to be monitored and evaluated by a “qualified collector” who had demonstrated the necessary knowledge, skills and abilities by additionally:

• Conducting DOT drug test collections regularly for a period of at least one year;
• Conducting collector training for at least one year; or
• Completing a “train the trainer” course successfully.

Individuals wanting to be oral fluid collectors are not able to be qualified because there are no currently qualified oral fluid collectors with those additional qualifications to monitor and evaluate the trainee’s mock collections.

However, the DOT identified cases where the May 2023 final rule required further amendments due to unforeseen circumstances that made it impossible to comply with requirements for:

• Mock oral fluid collection observers;
• Privacy consistency during specimen collection; and
• Methods by which collectors document sufficient oral fluid volume.

Oral Fluid Revisions

Due to issues beyond the scope of the DOT, the May 2023 final rule was amended to provide temporary requirements while waiting on the HHS to certify a laboratory for oral drug testing. The November 2024 final rule amends the DOT’s regulated industry drug testing program as it primarily relates to oral fluid testing by:

·         Clarifying that a qualified urine collector is not a qualified oral fluid collector and vice versa;

·         Providing temporary qualification requirements for mock oral fluid monitors;

·         Identifying which individuals may be present during an oral fluid collection; and

·         Clarifying how collectors are to document that a sufficient volume of oral fluid was collected.

Collector Differences

The final rule clarifies that a qualified urine collector under 49 CFR § 40.33 is not a qualified oral fluid collector under 49 CFR § 40.35. Furthermore, a qualified oral fluid collector is not a qualified urine collector. They require separate qualifications.

Temporary Qualification Requirements

The final rule clarifies that generally, a qualified collector for the oral fluid mock collections required under the initial proficiency demonstration section of the specimen collection personnel regulation must be a qualified oral fluid collector and have specific experience in oral fluid collections or training. Prior to this rulemaking, there were no qualified oral fluid collectors to monitor and evaluate a trainee’s mock collections.

To best facilitate the timely training of oral fluid collectors, the final rule now permits an individual who is not a qualified oral fluid collector to serve as the monitor for oral fluid mock collections only if:

·         The individual successfully completes an oral fluid “train the trainer”; or

·         The individual conducts oral fluid collector training.

The final rule waives the requirement that an individual must have at least one year of experience conducting oral fluid collector training. However, the rule states that individuals are expected to:

·         Have a thorough understanding of the DOT’s drug and alcohol testing requirements;

·         Be well-versed in the course content they are teaching; and

·         Maintain records to demonstrate that the training was conducted.

Collectors who teach a collection course must make sure the course meets the requirements under the specimen collection qualification training regulations. Furthermore, as an example of maintaining good records, collectors should record the following information:

·         Course content for the instructor and student; 

·         Duration of the training;

·         Dates the course was taught;

·         Who attended the course; and

·         Any certificate of successful completion provided to students to demonstrate that they conducted the training. 

These requirements are the same as what is expected of those individuals conducting urine collection training. This temporary regulatory relief will sunset one year after the HHS publishes a Federal Register notice that it has certified the first oral fluid drug testing laboratory. The DOT will publish a Federal Register document specifying this date and the effective date that individuals observing mock collections must comply with the qualified collector requirements established in the May 2023 final rule.

Oral Fluid Collector Identification

Under the final rule, an oral fluid collector must not allow any person other than the collector, the employee or a DOT agency representative to actually witness the testing process.

Oral Fluid Collection Documentation

After an employee provides a sufficient oral fluid specimen, the collector must check the “Volume Indicator(s) Observed” box in Step 2 of the federal drug testing custody and control form to document that the collector observed the volume indicator(s). Collectors must provide this documentation on request to DOT agency representatives, employers and consortium/third-party administrators who are using or negotiating to use their services.

Next Steps

Monitors and collectors should review this information, understand the new requirements and start practicing the new procedures by Dec. 5, 2024. In addition, monitors and collectors should continue to check the regulations for any revisions of the DOT drug and alcohol testing procedures once HHS certifies oral fluid drug testing laboratories.

This Legal Update is not intended to be exhaustive nor should any discussion or opinions be construed as legal advice. Readers should contact legal counsel for legal advice. © 2024 Zywave, Inc. All rights reserved.