On May 2nd, 2023, multiple departments under the Department of Transportation (DOT) released a final ruling on procedures for drug and alcohol testing programs in the transportation workplace. This new procedure will include Oral Fluid Specimen Testing for Drugs. (other departments include; Federal Aviation Administration (FAA), Federal Railroad Administration (FRA), Federal Motor Carrier Safety Administration (FMCSA), and Federal Transit Administration (FTA))
By removing references to urine and adding references to oral fluid, this change is expected to provide employers with more options to conduct drug tests, thereby making it easier to achieve workplace safety goals. Despite the change, the use of urine is still acceptable, and employers have the option to choose between the two methods of testing.
The new regulation is set to take effect 30 days from the most recent update which was May 2nd, 2023, and DOT employers and industry professionals are encouraged to read the final ruling in preparation for implementation. The regulation provides detailed responses to comments received in response to the Notice of Proposed Rulemaking (NPRM), which can be valuable for those who have questions about the new regulations. Furthermore, terminology and requirements throughout 49 CFR Part 40 have been updated.
DATIA, an organization that supports the drug and alcohol testing industry, will continue to communicate, educate, and train its members to support compliance with these changes. It is important for employers to stay up-to-date with these changes and remain compliant to ensure the safety of their employees and the public.
Click HERE to view the complete DOT ruling.
What This Means For YOU
Even though there are now mandatory guidelines for drug testing using oral fluid in the transportation workplace, there are currently no laboratories certified by the U.S. Department of Health and Human Services (HHS) to conduct them. At least two laboratories will need to be HHS certified for oral fluid testing.
This requirement is mandated by the Department of Transportation (DOT), which specifies that the drug testing process must involve two separate HHS-certified labs. One lab would conduct screening and confirmation drug testing on the primary specimen, while the other lab would conduct split specimen drug testing on a second specimen.
The goal of this ruling is to prevent urine test “cheating” and offer an option when urine samples are insufficient for testing due to “shy bladder.” Additionally, oral fluid testing is also less intrusive than urine testing and it’s harder to “cheat” because the collection of oral fluid is directly observed.
It’s important to note that the detection window for urine drug testing is potentially longer versus the oral fluid drug testing method. Overall the addition of oral fluid drug testing in the transportation marketplace will mean that it’s harder to “cheat” on a drug test, thus contributing to achieving safety in the respective workplace environments. Additionally, this could also mean an increased demand for oral fluid testing on forensic laboratories.
FAQs: DOT’s Updated Drug Testing Regulations
1. What drug categories does the DOT oral fluid testing panel cover?
The DOT oral fluid testing panel covers the same five drug categories required under the federal workplace drug testing program: marijuana, cocaine, amphetamines (including MDMA), opioids (including semi-synthetic opioids such as oxycodone and hydrocodone), and phencyclidine (PCP). Employers subject to DOT regulations are required to test for all five categories regardless of which specimen type they select. The addition of oral fluid as an authorized specimen type does not alter the scope of analytes employers must address.
2. How does the two-laboratory split specimen process work in practice?
Under the DOT oral fluid rule, a collector obtains two separate oral fluid specimens at the time of collection. The primary specimen is sent to one HHS-certified laboratory for both screening and confirmation testing. If the donor requests a split specimen retest, or if the result is otherwise contested, the second specimen is forwarded to a different HHS-certified laboratory for independent analysis. This dual-laboratory safeguard is designed to protect both the employer and the donor, and it mirrors the chain-of-custody structure already in place for urine-based testing programs.
3. Why do urine and oral fluid testing produce different detection windows, and how should that affect program design?
Detection windows are influenced by how each drug is absorbed, distributed, metabolized, and eliminated by the body. Oral fluid generally reflects more recent drug use, primarily because it captures parent compounds and, in some cases, early-stage metabolites present in saliva shortly after ingestion. Urine, by contrast, reflects a longer window because laboratories detect metabolites that have been processed through hepatic metabolism and concentrated through renal excretion. The length of that window also varies by substance, frequency of use, and individual metabolic factors. Employers and program administrators should evaluate these differences when determining which specimen type, or combination of types, best serves their workplace safety objectives.
4. What does the HHS certification requirement mean for employer and laboratory readiness?
Before oral fluid testing can be operationalized under DOT regulations, the U.S. Department of Health and Human Services must certify laboratories as qualified to perform this testing. The DOT rule specifies that at least two HHS-certified laboratories must be available before covered employers can implement oral fluid testing. Laboratories pursuing certification should review the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs, which define the technical, procedural, and quality system requirements that certified facilities must satisfy. Employers should monitor HHS certification status before making program changes, as implementation is contingent on that milestone being reached.
5. What quality control considerations should laboratories address when adding oral fluid testing capabilities?
Oral fluid presents distinct analytical characteristics compared to urine, including differences in matrix composition, analyte concentration ranges, pH, and viscosity. Laboratories expanding into oral fluid testing should develop and validate QC programs specifically designed for this matrix, rather than directly adapting protocols developed for urine. This includes selecting control materials that reflect the relevant specimen type, establishing method-specific target values and acceptance criteria, and validating extraction efficiency and recovery within the oral fluid matrix. CLSI guidelines and SOFT recommendations provide useful frameworks for structuring these validation activities and building a defensible quality program ahead of implementation.
Do you think your lab will need to make any changes due the new ruling? Let us know your thoughts in the comments below.
