The Department of Transportation (DOT) issued its Final Rule amending federal drug testing regulations to include oral fluid testing. This addition to regulated drug testing programs will give employers a choice of screening methodologies to help combat employee cheating on urine drug tests and provide a less intrusive means of achieving the safety goals of workplace drug screening programs.

The final rule includes other provisions to update the Department’s regulations and to harmonize, as needed, with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid established by the U.S. Department of Health and Human Services (HHS).

In addition, this rule amends the Federal Aviation Administration (FAA), Federal Motor Carrier Safety Administration (FMCSA), Federal Railroad Administration (FRA), and Federal Transit Administration (FTA) regulations to ensure consistency within the DOT and by removing or adjusting references to the word “urine” and add references to oral fluid, as well as amending some definitions for conformity and other miscellaneous technical changes or corrections.

Pipeline & Hazardous Materials Safety Administration (PHMSA) has determined it doesn’t need to make any changes to its drug testing regulations to permit oral fluid testing; thus, there are no changes to 49 CFR part 199 in this Final Rule.

Oral Fluid Drug Testing

The popularity of oral fluid in non-regulated drug testing programs and the scientific viability of oral fluid testing has dramatically advanced since 2004. In fact, in 2019, the HHS determined that the methodology is accurate and appropriate for Federal employee testing.

In its 2019 final rule, HHS stated that “[t]he scientific basis for the use of oral fluid as an alternative specimen for drug testing has now been broadly established and the advances in the use of oral fluid in detecting drugs have made it possible for this alternative specimen to be used in Federal programs with the same level of confidence that has been applied to the use of urine.” ^[1]  Notably, HHS stated that its “Oral Fluid Mandatory Guidelines (OFMG) provides the same scientific and forensic supportability of drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine….”^[2]

In evaluating the progress of the science of oral fluid testing and its scientific viability, HHS also looked at its forensic defensibility in workplace testing. Specifically, the HHS addressed concerns about passive exposure as the result of someone else’s drug use (e.g., from second-hand smoke) in the context of cutoffs or metabolites used in oral fluid testing, particularly concerning marijuana. HHS concluded that a 4 ng/mL screening test cutoff for Tetrahydrocannabinol (THC) would detect marijuana use while eliminating the possibility of positive tests resulting from passive exposure, as directed by the SUPPORT for Patients and Communities Act. ^[3]

The rulemaking recognized that directly observed urine specimen collections have long been the most effective method for preventing individuals from cheating on their drug tests by substituting or adulterating their specimens. Still, due to employee privacy concerns, directly observed urine collection may only be done in certain circumstances.^[4] All oral fluid collections are directly observed because they are always collected in front of the collector. Unlike a directly observed urine collection, an oral fluid collection is much less intrusive on the tested employee’s privacy. Adding oral fluid testing as an option creates a balance of an individual’s right to privacy, aims to reduce discomfort and potential civil rights issues for transgender or non-binary individuals, and lowers barriers to transportation employment for those deterred by current testing requirements while upholding the DOT’s strong interest in preserving transportation safety by deterring illicit drug use.

This Final Rule includes the option for employers to use either urine or oral fluid testing (except for FRA post-accident drug testing). By allowing an employer to collect an oral fluid or a urine specimen, the DOT is broadening opportunities for testing safety-sensitive employees in the transportation industry.

Not So Fast

The Final Rule was published on May 2, 2023, and is effective ’30 days from publishing,’ which would be June 1, 2023. However, there is more work to be done before employers can use oral fluid testing for regulated testing programs.

Most significantly, as published in the Final Rule, in order for an employer to implement oral fluid testing, there must be at least two HHS-certified laboratories for oral fluid testing. There must be one HHS-certified laboratory to conduct the screening and confirmation drug testing on the primary specimen. There must be a different HHS-certified laboratory to conduct the split specimen drug testing on the secondary specimen if the employee requests split specimen testing for a non-negative result. As of the date of this post, HHS has not yet certified any laboratories to conduct oral fluid testing. This process is expected to take a considerable amount of time and is not likely to be completed before the end of 2023.

In addition to certifying laboratories, as of this post, there is no approved oral fluid collection device(s) that meet these new requirements. Without a doubt, device manufacturers are scrambling to design collection devices now that the rules and requirements have been announced. Still, no regulated oral fluid testing can be conducted until these devices are approved and made available to the screening industry.

Collection sites must then coordinate with providers to stock the necessary supplies to accommodate oral fluid testing. Drug screening collection providers will also be required to train their collectors on the new oral fluid collection guidelines.

The Final Rule brings new requirements for employers and collectors specific to testing procedures, control & custody (COC) form changes, and potential drug screening policy revisions to include oral fluid testing.

Thus, for the reasons above (along with the likelihood of other changes such as new laboratory panel codes, ordering & compliance software updates, etc.), oral fluid testing under DOT Part 40 cannot be fully implemented until these logistical requirements are accomplished. We’re a big step closer, but there’s still work to do.

For those that want to dig into the details, you can view the entire 227-page Final Rule here.

How does this impact background screening in transportation?

This is a new method for trucking companies to use for required DOT drug screening prior to employment. Oral fluid testing will likely be less expensive for carriers, as well as less intrusive for applicants. It will also alleviate some common issues with urine testing, such as “shy bladder.” However, keep in mind that oral fluids detect recent drug use, while urine testing typically offers a longer detection period, which may result in lower detection rates.

While it may take a while to implement oral fluid testing for your federally regulated drug screening program, you can contact Driver iQ + Cisive today to add drug screening to your current onboarding workflow and be prepared when the time comes.

[1] 84 FR 57554; Oct. 25, 2019

[2] 84 FR 57554; Oct. 25, 2019

[3] Public Law 115– 271, § 8107(b). (See 84 FR at 57558; Oct. 25, 2019)

[4] see 49 CFR § 40.67