In early May, 2023, the Department of Transportation (DOT) published a final rule in the Federal Register (88 FR 27596) that amends the U.S. DOT’s drug testing program to include the discretionary use by employers of oral fluid testing. Oral fluid testing is a win for marketers because it offers a cheaper, more immediate, less intrusive, more reliable and quicker method of testing drivers for drug use than urine sample testing. Oral fluid testing also shortens the window of detection for drug use to just 48 hours. The shorter detection window is a more accurate indicator of when a driver is operating under the influence of drugs.

Last year, EMA submitted written comments to the U.S. DOT on the proposed rule supporting the discretionary use by employers of oral fluid testing as an alternative to urine sample testing. Urine Sample testing is less effective than oral fluid testing due to widespread cheating by drivers. According to the U.S. DOT, studies have consistently shown that CDL drivers are increasingly using an array of commercially available products specifically designed to successfully defeat urine specimen drug tests. Cheating on urine testing is difficult to detect since direct observation of specimen collection is prohibited, except under a few narrow exceptions.

Oral fluid testing offers greater convenience for employers over urine specimen testing. Oral fluid tests are inexpensive and provide an immediately available alternative method for testing drivers who are unable to produce a urine sample. Oral specimens can be collected in less than five minutes, anywhere, at any time, including the workplace. A special collection facility or extensive collection site preparation is not required. In addition, with oral fluid testing there is no time lost to rescheduling drivers who attempt to evade drug testing due to shy bladder claims. Finally, oral fluid tests provide a more recent snapshot in time of possible drug use that is important to capture for post-accident and reasonable suspicion testing. All these benefits reduce the amount of time an employee is away from the job for drug testing, which offers significant cost savings for the employer.

Effective Date

The final rule giving employers the choice to use oral fluid testing is effective June 1, 2023. However, oral fluid testing cannot be implemented until the U.S. Department of Health and Human Services (HHS) certifies at least two laboratories (one for primary specimens and the other for split specimens) to conduct oral testing. EMA expects HHS laboratory certification for oral fluid testing to be available within the next 30 days. EMA will notify marketers when certification is complete. In the alternative, marketers can check the U.S. DOT online list of certified laboratories to find oral fluid testing labs once they are approved and listed by the HHS.

What the New Rule Means for Employers

  • The employer, not the employee, chooses the collection methodology for the test reason (e.g., randoms will start with urine; follow-ups will use oral fluid).
  • The employer, not the employee, chooses the collection methodology for the subsequent collection following a shy bladder, dry mouth, or other test that requires a directly observed collection.
  • Employers must establish business relationships with certified oral fluid collectors and labs, whether directly or through company service agents.
  • Employers must have a standing order in place with each collection site indicating the type of collection to be performed (i.e., urine or oral fluid) and when.
  • Employers must have employer representatives available to oral fluid specimen collectors 24-7 just as is currently required for urine testing:
    • Employer representatives must provide collectors with a phone number.
    • Employer representatives must be available to the collector to discuss if there are problem collections.
    • Employer representatives should always be available to discuss standing orders on the type of test employer wants administered if problem collection scenarios arise (e.g., if an employee does not provide a sufficient urine specimen, should an oral fluid collection?).

What the New Rule Means for Employees

  • Employees may be subject to either an oral fluid collection or a urine collection for any DOT-regulated test (i.e., pre-employment, random, reasonable suspicion/ cause, post-accident, return-to-duty, or follow-up).
  • The choice of whether to conduct an oral fluid or a urine test is up to the employer.
  • While the employer may opt for only one methodology, oral fluid testing must be available for directly observed collections for transgender and nonbinary individuals.

The final rule also explains what the rule means for Medical Review Officers (MRO), specimen collectors, laboratories and Substance Abuse Professionals (SAP). More information of the impact on these groups can be found here. Marketers should contact their third-party drug and alcohol testing consortium for specific details on implementation of oral fluid testing.

EMA Contact: Mark S. Morgan, Regulatory Counsel mmorgan@emamerica.org